Ceci est une version HTML d'une pièce jointe de la demande d'accès à l'information 'Contact European Commission and US interest groups on cloning'.



















 
Ref. Ares(2016)1627298 - 06/04/2016
 
EUROPEAN 
  COMMISSION 
Brussels, 18.12.2013  
SWD(2013) 519 final 
  
COMMISSION STAFF WORKING DOCUMENT 
 
IMPACT ASSESSMENT 
 
Accompanying the document 
Proposal for a  
 
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on the cloning of animals of the bovine, porcine, ovine, caprine and equine species kept 
and reproduced for farming purposes, and 
 
 

Proposal for a  
 
COUNCIL DIRECTIVE 
 
on the placing on the market of food from animal clones 
{COM(2013) 892 final} 
{COM(2013) 893 final} 
{SWD(2013) 520 final} 
 
EN    EN 

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Table of Contents 
1.  PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED 
PARTIES..................................................................................................................... 7 
1.1.  Introduction ....................................................................................................... 7 
1.2.  Organisation and timing.................................................................................... 8 
1.2.1. Member States ......................................................................................... 8 
1.2.2. Stakeholders and third countries............................................................. 9 
1.2.3. Responses to the public consultation “IPM consultation” & 
position papers .................................................................................... 9 
1.2.4. Results of Eurobarometer of 2008 and 2010......................................... 10 
1.2.5. Impact Assessment Steering Group (IASG)........................................... 10 
1.2.6. External expertise.................................................................................. 10 
1.3.  Opinion of the IAB........................................................................................... 11 
2.  PROBLEM DEFINITION ........................................................................................ 12 
2.1.  Animal welfare concerns linked to the use of the cloning technique .............. 12 
2.2.  Concerns of EU citizens .................................................................................. 13 
2.3.  Risk of diverging national laws on cloning ..................................................... 13 
2.4.  The underlying drivers .................................................................................... 14 
2.5.  Who is affected, in what ways, and to what extent? ........................................ 15 
2.6.  Baseline scenario............................................................................................. 16 
2.6.1. EU legal framework .............................................................................. 16 
2.6.2. Baseline scenario regarding the farming, breeding and food 
sectors................................................................................................ 19 
2.6.3. International dimension......................................................................... 20 
2.7.  Does the EU have the right to act (subsidiarity)? ........................................... 23 
3.  OBJECTIVES ........................................................................................................... 24 
3.1.  General objective............................................................................................. 24 
3.2.  Specific objectives ........................................................................................... 24 
3.3.  Consistency with other EU policies and horizontal objectives ....................... 25 
4.  POLICY OPTIONS................................................................................................... 25 
4.1.  Policy options included in the analysis ........................................................... 25 
4.2.  Options discarded at an early stage................................................................ 27 
5.  ANALYSIS OF IMPACTS....................................................................................... 28 
5.1. Option 1: No policy change................................................................................ 28 
5.1.1. Description of the option ....................................................................... 28 
5.1.2. Economic Impacts ................................................................................. 29 
5.1.3. Impacts on consumer protection ........................................................... 31 
5.1.4. Impacts on food prices and employment ............................................... 31 
5.1.5. Impact on Animal Welfare..................................................................... 32 
5.2. Option 2: Pre-market approval for food from clones, offspring and 
descendants...................................................................................................... 32 

 

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5.2.1. Description of the option ....................................................................... 32 
5.2.2. Economic Impacts ................................................................................. 33 
5.2.3. Impacts on consumer protection ........................................................... 34 
5.2.4. Impact on prices and employment......................................................... 34 
5.2.5. Impact on Animal Welfare..................................................................... 34 
5.3. Option 3: labelling of food from clones, offspring and descendants ................. 34 
5.3.1. Description of the option ....................................................................... 34 
5.3.2. Economic impacts in EU - costs ............................................................ 35 
5.3.3. Economic impacts on trade with third countries................................... 40 
5.3.4. Impacts on consumer protection ........................................................... 42 
5.3.5. Impacts on food prices and employment ............................................... 43 
5.3.6.. Impact on Animal Welfare.................................................................... 43 
5.4. Option 4: temporary suspension of the technique and of imports of live 
clones, their reproductive material and their food........................................... 43 
5.4.1. Description of the option ....................................................................... 43 
5.4.2. Economic Impacts ................................................................................. 44 
5.4.3. Impacts on consumer protection ........................................................... 46 
5.4.4. Impacts on prices and employment ....................................................... 46 
5.4.5. Impact on Animal welfare ..................................................................... 46 
5.5. Impacts on control (applicable to all options including non-policy 
change) ............................................................................................................ 47 
6.  COMPARING THE OPTIONS ................................................................................ 47 
6.1.  Comparing the options in terms of impacts..................................................... 48 
6.1.1. Option 1 (no policy change) .................................................................. 48 
6.1.2. Option 2: Pre-market approval of food from clones to food from 
offspring and descendants ................................................................. 48 
6.1.3. Option 3: labelling of food (from clones, offspring and 
descendants) ...................................................................................... 48 
6.1.4. Option 4: temporary suspension of the technique and the use of 
clones (food and reproductive material) ........................................... 49 
6.2.  Comparing the options in terms of objectives for coherence and 
efficiency.......................................................................................................... 49 
6.2.1. Option 1 (no policy change) .................................................................. 49 
6.2.2. Option 2: Pre-market approval of food from clones to food from 
offspring and descendants. ................................................................ 49 
6.2.3 Option 3: labelling of food (from clones, offspring and 
descendants) ...................................................................................... 50 
6.2.4. Option 4: temporary suspension of the technique and the use of 
clones (food and reproductive material) ........................................... 50 
6.3.  Table summarising the impacts ....................................................................... 51 
7.  MONITORING AND EVALUATION..................................................................... 52 
ANNEXES ........................................................................................................................ 53 
 

 

 
Executive Summary Sheet 
Proposals for Directives of the European Parliament and of the Council on cloning of food 
producing animals   
A. Need for action 
Why? What is the problem being addressed?  
a) Welfare and health of animals linked to the use of the cloning technique 
EFSA1 highlighted that surrogate dams (carrying the clones) and the clones themselves suffer in 
the application of the technique. 
b)  The negative perception that EU citizens have cloning technique if used for food 
production
 
In surveys the vast majority (above 80 %) of EU citizens expressed broadly negative perception of 
the use of cloning technique for food production. This perception appears to be at least partly the 
result of: 
-  the unfounded assumption that cloning of food producing animals poses a risk to food 
safety and human health;  

the false idea that this cloning involves genetic modification; 

general scepticism towards new technologies in biosciences; 

fear that negative effects of cloning manifest themselves only later. 
c) The request of the co-legislator to address the issue  
Inter-institutional discussions on cloning started in 2009 in the context of the negotiations on a 
proposal streamlining the approval process of the 1997 Novel Food Regulation. No agreement 
could be reached between Member States and the European Parliament on any of the issues 
linked to cloning. The conciliation failed and the Commission was requested to present a proposal 
on cloning based on an impact assessment. 
What is this initiative expected to achieve? 
General objectives  
To address concerns on cloning for farming purposes, to ensure uniform conditions for farmers in 
the EU and to protect consumer interests as regard food from cloned animals. 
Specific objectives  
- Objective 1:   To ensure uniform conditions of production of farmers in the EU while protecting 
health and welfare of farmed animals; 
- Objective 2:   To protect consumer interests as regards food from cloned animals; 
- Objective 3:   To safeguard the competitiveness of farmers, breeders and food businesses in the 
EU 
What is the value added of action at the EU level?   
Council Directive 98/58/EC lays down general minimum welfare standards for animals bred or kept 
for farming purposes. It calls on Member States to avoid unnecessary pain, suffering or injury of 
farm animals. If cloning causes unnecessary pain, suffering or injury, Member States have to act at 
national level to avoid it.  
Yet different national approaches to animal cloning could lead to market distortion. Measures 
regulating the use of the cloning technique would address the associated animal health and 
welfare concerns. They would prevent the development of diverging national legislation and the 
consequent disruptions of the concerned agricultural markets. They would thus also ensure level 
playing field for breeders and farmers and uniform conditions of production for farmers.  
                                                 
1 opinion of 2008 up-dated in 2009, 2010 and 2012 

 

 
As breeding/cloning companies and food operators in third countries are also concerned it is 
necessary to ensure that the same conditions apply to them. The matter should thus be addressed 
at Union level. 
B. Solutions 
What legislative and non-legislative policy options have been considered?  Is there a 
preferred choice or not? Why?  
Four legislative policy options have been assessed: (1) the status quo; (2) premarket-approval of 
food from clones, offspring and descendants; (3) labelling of food from clones, offspring and 
descendants; and (4) suspension of the cloning technique in the EU (with the suspension of use of 
clones, their reproductive material and their food).  
None of the options would on their own enable to attain the objectives. Therefore to define the 
most appropriate policy approach, elements of options may need to be put together. No preferred 
option is thus proposed at this stage.  
Who supports which option?  
All professional organisations representing the various farming, breeding and food industry sectors 
are in favour of the status quo and resist new measures on cloning as they may trigger additional 
costs and administrative burden. Conversely, the European consumer organisations and other 
NGOs are in favour of a mandatory labelling of food products derived from the progeny (offspring 
and descendants) of clones and the suspension of the cloning technique in the EU. 
C. Impacts of the preferred option 
What are the benefits of the preferred option (if any, otherwise main ones)? 
This option has a positive impact on animal welfare and creates a level playing field for all farmers 
and breeders in the Union. It is restricted to the technique, to clones and food obtained thereof. Its 
impact on Union FBOs and trade is limited because trade, if any, is likely to be insignificant as 
FBOs have no interest to market food from clones. The suspension of the technique would not 
stifle innovation and research as it would be temporary and limited in scope. It thus signals that 
research outside this policy can be pursued. 
Traditional breeding techniques use clones to produce offspring. Hence the suspension of the use 
of reproductive material of clones could jeopardize the competitiveness of the Union's farming 
sector as it would deprive it of competitive genetic material. 
This option has a positive impact on consumers: their concerns about animal welfare will be 
addressed as no cloning would take place in the Union and no food from clones marketed in the 
Union. 
What are the costs of the preferred option (if any, otherwise main ones)? 
The impact of the preferred option on business is negligible as trade in animal clones and food 
derived thereof is quasi non-existent and food business operators have no commercial interest in 
marketing clones or food from clones. 
How will businesses, SMEs and micro-enterprises be affected? 
The freedom to conduct business might be restricted but this would be justified for the purpose of 
protecting animal health and welfare and the suspension would be stopped as soon as the 
technology has evolved.  The Directives will not have an impact on SMEs and micro-enterprises 
Will there be significant impacts on national budgets and administrations?  
There would be no additional costs for Member States' control authorities as official controls are 
already in place on animals and their reproductive material, as well as on food labelling in general. 

 

 
Will there be other significant impacts?  
The preferred option could have indirect long term effects on the allocation of innovation 
investments. Organisations looking to invest in the development of cloning in general may be more 
inclined to place their investments elsewhere. Therefore we need to continue to encourage cloning 
for research. 
D. Follow up 
When will the policy be reviewed?   
Both proposals trigger a review process By 5 years after the date of transposition of this Directive 
when  
Member States will have to report to the Commission on the experience gained by them on the 
application of the Directives. 
 
 

 

 
1. 
PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES 
1.1. 
Introduction 
Cloning is a relatively new reproduction technique which allows the asexual 
reproduction of an individual farm animal that has shown good productivity. Cloning 
does not involve any genetic modification. In fact, the clone is a near exact genetic copy 
of the original animal (the donor) and should have the same high quality reproductive 
material (semen, ova or embryos) as that of the donor. Although cloning does not 
improve the animal's performance, breeders may consider cloning beneficial in order to 
increase the output of reproductive material of a particularly valuable animal.  
Clones for food production are used to produce reproductive material. As shown in the 
schema below, the reproductive material of the clone enables the production of progeny 
(composed of offspring and then of descendants). This progeny is produced via 
traditional breeding techniques (not involving cloning). It is mostly destined for direct 
use in the food chain although elite animals may be retained for breeding purposes.  
Clones are not produced to obtain meat or milk for the food chain. This may however 
happen for meat, at the end of the breeding life of the clone or when the clone obtained is 
less efficient than originally foreseen and therefore no longer kept for breeding purposes. 
The process of cloning is further detailed in Annex XIII (Paragraph 1). 
        
BREEDING  
 
Cell/DNA of donor  
MAIN 
FOOD 
Cloning technique   
OCCASIONAL  
 
PURPOSE 
 
 
 
 
CLONE 
 
Reproductive materials of clones  
 
with traditional breeding technique  
G
 
IN
R

 OFFSPRING (1st generation)  
 
OFFSP
 
Reproductive materials of 
offspring  
with traditional breeding technique  
FOOD 
 
BREEDING  
PRODUCTION  
OCCASIONAL  
 
 
(elite animals only) 
MAIN 
DESCENDANTS (2nd generation)  
 
PURPOSE  
NTS
 
Reproductive materials of descendants   
DA
with traditional breeding technique  
 
N
 
DESCE
 
DESCENDANTS (3rd generation)  
etc. 
 

 

 
As cloning is a novel reproduction technique and as food from clones is susceptible to 
enter the food chain, food from clones is presently subject to a pre-market approval under 
the existing Novel Food Regulation2. The inter-institutional discussions on a proposal 
streamlining this approval process reached a stalemate on issues related to cloning (such 
as the use of the technique in the EU, the use of reproductive material of clones, of their 
food, the traceability of progeny of clones and of their food). In spite of the 
Commission’s report of October 2010, which suggested adopting specific measures on 
cloning3, no agreement could be reached and the Conciliation ended in March 2011. This 
led to the request to the Commission4 to prepare a separate legislative proposal on all 
aspects of cloning for food production based on a detailed impact assessment. 
This impact assessment therefore covers the five species susceptible to be cloned (i.e. 
bovine, porcine, caprine, ovine and equine) and used for food production. Cloning of 
animals for research purposes, for producing medicinal products or medicinal devices, 
for preserving rare breeds or endangered species or for sport purposes is excluded from 
this policy initiative. A Glossary of technical terms is to be found in Annex I.  
 
1.2.  Organisation and timing 
The public consultation and collection of expertise took place between end 2011 and end 
2012.  
 
1.2.1. Member States 
Member States were consulted in the meetings of Standing Committee for the Food 
Chain and Animal Health between February and July 2012 to clarify whether cloning 
takes place and if so to what extent, and were subsequently invited to respond to a 
specific questionnaire on these issues in March 2012. All 27 Member States responded 
with Germany authorities clarifying their final position in May 2013.  
In response to the questionnaire on the use of cloning on their territory, to know whether 
clones are produced for food production or imported and if so to what extent, all Member 
States confirmed that cloning for food production does not take place on their territory. 
Most of them specified that Directive 98/58/EC5 (see section 2.6.1) is transposed into 
national animal welfare law. Only Denmark refers explicitly to cloning which is banned 
on their territory. Germany who reported in the past the existence of cloned bulls for 
selling their reproductive material outside the EU confirmed in writing in May 2013 the 
absence of any such clones on their territory. France reported cloning of horses but only 
for sport purposes. The positions of Member States are summarised in Annex III 
(paragraph 1).  
 
                                                 
2 Regulation (EC) N° 258/97 of the European Parliament and the Council of 27 January 1997 concerning 
novel foods and novel food ingredients.   
3 Report from the Commission to the European Parliament and the Council on animal cloning for food 
production COM (2010) 585 of 19.10.2010 suggested to (i) to suspend temporarily the use of the cloning 
technique, clones and of food from clones for five years; (ii) to trace imported reproductive materials of 
clones. http://ec.europa.eu/dgs/health_consumer/docs/20101019_report_ec_cloning_en.pdf 
4 For example, the European Parliament resolution of 6 July 2011 on the Commission Work Programme 
2012 requested a legislative proposal to prohibit food from clones, offspring and descendants: 
http://www.europarl.europa.eu/sides/get  
5 Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes; see 
in particular Article 3 and 4 and Point 20 of its Annex. 

 

 
1.2.2. Stakeholders and third countries6 
Multi stakeholders meetings took place via the Advisory Group of the Food Chain 
(Annex II) with 22 organisations representing all concerned stakeholders (farmers and 
breeders, meat and milk industry, food industry, retail industry, consumers and animal 
welfare) on their position on possible action regarding the use of the cloning technique in 
the EU and the appropriateness to label food from clones and of their progeny so as to 
offer consumer choice. 
Five technical bilateral meetings were held with specific industry organisations on 
technical issues linked to breeding for food production to understand the baseline 
scenario regarding traceability of animals and of meat and milk. The minutes of the 
meetings are to be found in (Annex II).  
15 third countries with major trade (in meat, milk products and reproductive materials) 
with the EU were also consulted via a specific questionnaire sent in March 2012.  13 
countries responded to the questionnaire and one (New Zealand) sent instead a letter 
expressing their position. China and Chile did not reply to the questionnaire.  
Based on the responses received to the questionnaire on cloning activities to understand 
whether traceability systems are in place for clones, their progeny and food, the 
responses received can be summarised as follows: cloning for food production takes 
place in USA, Canada, Argentina, Brazil and Australia.  In Canada the situation on 
cloning is similar to that in the Union, i.e. food produced from food is considered novel 
and requires pre-market approval. In the other countries, clones, their progeny and 
reproductive material are subject to the same regulation as conventional animals 
regarding the food safety, animal health and welfare. Clones are registered by private 
companies (USA, Canada and Brazil)7 but Argentina and Australia report that clones are 
not registered. The number and activities of cloning companies on their territory are not 
known by any of the authorities. The positions of third countries are summarised in 
Annex III (Paragraph 2).  
1.2.3. Responses to the public consultation “IPM consultation” & position papers 
The public consultation was launched in March 2012 via the Interactive Policy Making 
(the so called "IPM consultation") for 16 weeks with reminders sent during this period 
via the Enterprise Europe Network, on DG Health and Consumers website and via the e-
news network reaching approximately 6000 subscribers: 360 replies were received 
among which 34 from professional organisations, 34 from non-governmental 
organisations, 10 from Member States, one third country and 230 from individuals.   
Almost all8 professional organisations representing farmers, breeders, food industry and 
retail, when asked about policy change on any of the issues of cloning indicated their 
favourable position towards the status quo (no legislation on cloning, maintaining food 
from clones under the Novel Food Regulation, no measures on food from progeny of 
clones, no labelling). The additional position papers received from industry (farmers, 
                                                 
6 For the selection of these third countries see Annex III (Paragraph 2). 
7 Breeding companies in third countries and as, in the USA, organisation and data base sponsored by 
industry of a "supply chain management system" to track clones and exclude them from the food supply 
chain the data bases in the USA and Canada contain the DNA profile of the clones. See Annex XIII 
Paragraph 4). 
8 EuroCommence considers that “should food methods from clones and offspring be authorised for the EU 
market, a practical solution needs to be found to enable traceability of these products along the whole food 
supply chain”. 

 

 
breeding sector and food industry) confirmed that the current situation represents for 
them the best scenario.  
Conversely consumer organizations, animal welfare associations and individuals, 
expressed themselves against the use of cloning technique and the placing of the food 
from clones and their progeny on the EU market. Finally, EU citizens participating in the 
"IPM consultation"  emphasised that if food products originating from clones and their 
progeny would be available on the EU market, they would want to be able to make 
informed choices. 
The responses to the IPM consultations are summarised in Annex IV. The position 
papers of specific stakeholders are summarised in Annex III (Paragraph 3).  
1.2.4. Results of Eurobarometer of 2008 and 2010 
 
To understand the consumers’ position, a specific Eurobarometer of 2008 on cloning9, 
which surveyed 25000 randomly selected citizens in EU 27 and the 2010 Eurobarometer 
on biotechnology of were used. 
The Eurobarometer of 2008 on cloning  showed that around 80% of the interviewees 
agreed that there could be ethical grounds for rejecting animal cloning and around 70% 
that animal cloning would risk treating animals as commodities rather than creatures with 
feelings. Concerning animal welfare issues linked to the use of cloning technique, 41% 
agreed that it would cause animal unnecessary pain, suffering and distress and 42% 
disagreed. In the Eurobarometer on biotechnology of 2010 EU citizens expressed strong 
reservations about the use of animal cloning in food production. More information on the 
responses is available in Section 2.2. (concerns of EU citizens). 
1.2.5. Impact Assessment Steering Group (IASG) 
The Impact Assessment Steering Group (IASG) was set up in November 2011 with 11 
Directorate-Generals as well as EFSA: DG AGRI, ENV, TRADE, MARKT, RTD, 
JUST, ENTR, TAXUD, JRC, SG and LS. The Group was consulted frequently. It agreed 
on the Roadmap in February 201210 and dealt with the work carried out by the contractor, 
the  IPM public consultation, the consultation process with Member States and third 
countries as well as the elaboration of this impact assessment report.  
1.2.6. External expertise 
The European Food Safety Authority (EFSA) delivered an opinion in 2008 on the food 
safety, animal health, animal welfare and environmental implications of clones, of their 
progeny and of the products obtained from those animals followed by three statements in 
2009, 2010 and 201211. Based on the available data EFSA confirmed the welfare 
problems related to the health of surrogate mothers (carrying the clones) and clones 
themselves. Regarding food safety, EFSA concluded that there is no indication of any 
difference for food safety for meat and milk of clones and their progeny compared with 
those of conventionally bred animals.  
                                                 
9 Europeans’ attitudes towards animal cloning http://ec.europa.eu/public_opinion/flash/fl_238_en.pdf 
10http://ec.europa.eu/governance/impact/planned_ia/docs/2013_sanco_007_use_of_cloning_technique_for_
food_production_en.pdf 

11 Food safety, animal health and welfare and environmental impact of animals derived from cloning by 
SCNT and their offspring and products obtained from those animals (opinion and statements):  
http://www.efsa.europa.eu/en/efsajournal/doc/767.pdf  
http://www.efsa.europa.eu/en/efsajournal/doc/319r.pdf; 
http://www.efsa.europa.eu/en/efsajournal/doc/1784.pdf ; 
http://www.efsa.europa.eu/en/efsajournal/doc/2794.pdf 
10 
 

 
The specific report on cloning by the European Group on Ethics in Science and New 
Technologies (EGE) of 200812 was also used as source of expertise. The EGE expressed 
doubts on the ethical justification on animal cloning for food production purposes, 
"considering the current level of suffering and health problems of surrogate dams and 
animal clones". EGE also concluded that it did "not see convincing arguments to justify 
the production of food from clones and their offspring".  
In December 2012 
13
a study  by ICF-GHK was finalised concerning mainly the feasibility 
and costs of the possible measures on animal cloning (summary in Annex V).  
 
1.3. 
Opinion of the IAB 
 
The IA report was submitted to the IA board on 19. June 2013 and was formally 
presented on 17 July 2013. Following this meeting the board issued a positive opinion on 
19 July 2013. The opinion suggested clarifying a number of points, which have been 
addressed in the following manner: 
1) Explain better the uncertainty in interpreting Directive 98/58/EC as regards the 
use of the cloning technique, its potential circumvention and the likelihood of 
unilateral national measures and explain better why the existing pre-market approval 
would still be considered fit for purpose for food from bovine and porcine clones.  
These issues have all been addressed in section 2.3. "risk of diverging national laws 
on cloning" and section 2.6.1. (b) "Novel Food Regulation".  
2) Explain why measures to improve consumer awareness or upgrade/revise existing 
voluntary (organic) label schemes have not been considered, give further insights 
into consumers views clarify whether there is any evidence of undermined 
consumer confidence because of absence of information on cloning, and to what 
extent consumers are ready to pay higher prices, and why food business operators 
have not developed voluntary labelling schemes.  
This explanation has been added in section 2.2. on "concerns of EU citizens" and in  
section 2.4 "the underlying drivers". 
3) Present and asses the  provisions on "mandatory" and "voluntary" labelling versus 
"offspring" and "descendants" separately and clarify the proportionality of option 2 
and explain difference between status quo and labelling food from 
clones/suspension of the cloning technique.  
This has been done in section 5.2.1. "description of option 2" and in section 4.1. 
"Policy options". In addition, sections 5.3. , 6.1., 6.2. and 6.3. present and assess the 
options distinguishing between "offspring", "descendants", "voluntary", 
"mandatory". 
 4)Provide (as appropriate) a more conclusive assessment of competitiveness 
impacts, clearly differentiating between the impact on EU farmers, importers of 
food and the food chain industry operators, clarify readiness of third countries to put 
in place the traceability systems. These requests have been dealt with in section 
5.3.3.(b) and (c) and  overview tables (numbers 4 and 5) has been inserted in Annex 
IX.  
                                                 
12 Ethical aspects of animal cloning for food supply 16 January 2008: 
http://ec.europa.eu/bepa/european-group-ethics/docs/publications/opinion23_en.pdf 
13   Source ICF-GHK study on animal cloning December 2012.   
11 
 

 
5) Section 5.1 on the pre-market approval of food from clones and section 5.3.2. (a) 
on the labelling of food from clones explain why the related costs would be 
marginal. Regarding food from offspring and descendants, section 5.3.2. (b) 
explains the costs of traceability and labelling. 
6) Identify which Member States will be impacted most and explain how the 2 % 
increase in the beef sector has been calculated. This has been integrated in Annex 
IX.  
7) Clarify why national authorities / EU budged are not expected to bear additional 
costs: The clarification has been added to section 5.5. "Impacts on control".   
8) Give the key results in a comprehensive overview table:  Table 9 has been added 
in Section 6. In view of the many possible options, in particular on labelling, this 
table 9 is a summary of the more elaborate overview which is to be found in Annex 
XII.  
9) Mention monitoring indicators corresponding to the data collection and respective 
objectives: this data has been added in section 7. 
10) Complete Summary and Executive Summary sheet with most relevant 
information: this   has been done.  
 
2. 
PROBLEM DEFINITION 
As indicated under 1.2.6. above EFSA concluded that there is no indication of any 
difference for food safety for meat and milk of clones and their progeny compared with 
those of conventionally bred animals. 
2.1. 
Animal welfare concerns linked to the use of the cloning technique 
In the EFSA's opinion on animal cloning of 2008 and subsequent statements until 2012 it 
is highlighted that issues of welfare and health of animals for the surrogate dams 
(carrying the clones) and the clones themselves are arising. This evaluation is however 
based on limited data and related primarily to bovine and porcine species. In particular:  
a) For bovine and porcine species EFSA noted that surrogate dams suffer in particular 
from placenta dysfunctions contributing to increased levels of miscarriages. This 
contributes, amongst others, to the low efficiency of the technique (6-15 % for bovine 
and about 6 % for porcine species) and the need implant embryo clones14 into several 
dams to obtain but one clone. In addition, clone abnormalities and unusually large 
offspring result in difficult births and neonatal death. After weaning no significant 
differences from conventional animals are noted. 
b) for other species (ovine, caprine and equine), EFSA stated that there was not enough 
data available to complete its assessment on animal welfare aspects. 
c) As regards offspring and descendants of clones, EFSA concluded that no animal health 
or welfare problems affect offspring and descendants of clones, as compared to 
conventionally bred animals, for all species as they are produced, via traditional 
reproduction techniques. 
                                                 
14  Embryo clones need to be distinguished for the “embryo” classified under reproductive material. The 
first is a clone, the second not. 
12 
 

 
2.2. 
Concerns of EU citizens 
The vast majority (above 80 %) of EU citizens interviewed in the Eurobarometer survey 
had a broadly negative perception of the use of cloning technique for food production15. 
This was primarily due to welfare and ethical concerns. EU citizens also indicated that if 
food products originating from clones and their progeny would be available on the EU 
market, they would want to be able to make informed choices. Half of the interviewees 
also considered – incorrectly- that animal cloning involves genetic modification.  
This is highlighted by both the 2008 and 2010 Eurobarometer and the IPM consultation 
launched for this impact assessment (see chapter 1.2.4. above).  
This strong negative perception of cloning appears to be at least partly the result of: 
-  the unfounded assumption that cloning of food producing animals poses a risk to 
food safety and human health;  
-  the false idea that this cloning involves genetic modification; 
-  general scepticism towards new technologies in biosciences; 
-  fear that negative effects of cloning manifest themselves only later. 
2.3. 
Risk of diverging national laws on cloning 
The growing concern of public opinion in particular about the animal health and welfare 
issues associated with the use of cloning for food production could push Member States 
to take measures unilaterally on issues linked to the use of the cloning technique, the use 
of clones (reproductive material and/or food) and to the labelling of food to inform 
consumers.  
Member States may ban explicitly the use of cloning technique on their territory in 
accordance with provisions of Directive 98/58/EC on animal welfare on all species or 
only on some of them. Directive 98/58/EC forbids the use of "breeding procedures which 
cause unnecessary pain" but does not explicitly forbid the cloning technique. Denmark 
adopted in 200516 a national legislation which forbids the use of the technique on the 
national territory but does not regulate the intra-Union trade and the imports of animals, 
their reproductive material or food. It therefore has no impact on the functioning of the 
internal market. However, it is not certain that other Member States, when taking 
national measures, in the absence of EU initiatives would take a similar line as Denmark. 
They may interpret the provision of the Directive in a way that the use of clones, whether 
produced nationally or imported, and their products (reproductive material and food) are 
also forbidden on their territory. 
There is no information about the circumventing of the de-facto ban on the use of cloning 
technique as there is no legal requirement for EU operators to register any information 
related to the cloning status of their animals or informing the competent authorities when 
                                                 
15 EU citizen concerns were threefold (in descending order % of replies, see page 11 of the summary 
http://ec.europa.eu/food/food/resources/docs/eurobarometer_cloning_sum_en.pdf) 
1. (84%): the EU do not know enough about the long term health and safety effects of using cloned 
animals for food. 
2. (75%): Cloning for human consumption could not be seen just as a technical issue, since there could 
be ethical grounds for rejecting such cloning. 
3. (69%): using cloning for food production purposes would be unacceptable because it would mean 
that animals are treated as commodities rather than creatures with feelings. 
16 LOV nr 550 af 24/06/2005 - Lov om kloning og genmodificering af dyr m.v 
https://www.retsinformation.dk/Forms/R0710.aspx?id=2116 
13 
 


 
buying a clone or its reproductive material (same requirements as for conventionally bred 
animals).    
During the Conciliation referred to in paragraph 1.1.above, Member States expressed 
their willingness to see measures on cloning at EU level but did not specify which type of 
national measures they would adopt in the absence of EU initiative. Taking into 
consideration the outcome of the inter institutional debate on food from clones, it appears 
that the absence of comprehensive EU measures on cloning could present some 
challenges to the good functioning of the concerned markets as divergent national 
legislations could be adopted by Member States. However, since the end of the 
conciliation (as referred to in paragraph 1.1. above), only Austria highlighted in writing 
the need to address cloning at EU level to avoid adoption of diverging national laws 
without specifying to which aspects such laws would refer to.  
 
2.4. 
The underlying drivers 
They are three-fold and can be summarised as follows:  
- The animal health and welfare problems identified by EFSA are due to the use of the 
cloning technique and its current level of development. EFSA clearly indicates that the 
negative effects have been observed in other assisted reproductive techniques (not 
involving cloning) but at much lower frequencies17. In the latest update of 2012, EFSA 
concludes18 that the scientific knowledge available has increased but that only limited 
progress has been achieved to diminish or solve of the problems identified as the 
efficiency of cloning is still low compared to other techniques; in particular, EFSA 
mentions that to overcome the relative low cloning efficiency, researchers continue to 
amend cloning procedures, with however limited improvements shown by some 
researchers.  
- The consumer's attitude towards the cloning has been summarised as follows in the 
2008 Eurobarometer study (page 11 of the summary):   
 
 
                                                 
17 EFSA opinion of 2008 and Statement of 2012  
18 EFSA Statement of 2012 overall conclusion p.18. 
14 
 

 
 
 
It is thus a general negative perception of this reproduction technique generated by 
different motives. 
This general negative perception give rise to a desire to recognize the food derived from 
clones and their progeny as clearly shown by the survey's results. 
The results show that consumers are reluctant to buy products of cloning origin. There is, 
however, no evidence that buying behaviour for food of animal origin would in practice 
be influenced by the knowledge on the reproduction technique used. 
It is not clear to what extent consumers are ready to pay a premium for information on 
the food from clones and their progeny. Respective questions were not asked in the 
context of the various consultations held19 due to the known discrepancy between the 
consumers' replies to such questions and their actual purchasing behaviour. The situation 
is thus not comparable to that of the BSE crisis20. 
- The request to produce a dedicated policy on cloning is due to the outcome of the 
discussions on the Novel Food legislative proposal (see Section 1.1.), where it appeared 
necessary to clarify and address all different aspects related to cloning going beyond the 
food aspects. In this context, the Member States already requested the Commission to 
prepare a proposal on all aspects of cloning, based on an impact assessment. As the 
conciliation did not conclude, the final positions of Member States and Parliament 
remain unclear.  More specifically Member States requested by unanimity a pre-market 
approval for food from offspring in first reading but in the subsequent discussions it 
appeared that some Member States were in favour of labelling and others were totally 
opposed. The European Parliament21 requested a ban of the technique, of meat and dairy 
products of clones and of their offspring as well as of their reproductive material, and 
then, in second reading, a total ban of any food from clones and descendants22. More 
recently in the context of the discussions of electronic identification of bovine23, the 
European Parliament requested mandatory labelling of fresh meat of offspring of clones 
pending the presentation by the Commission of the specific proposal on cloning.  
 
2.5. 
Who is affected, in what ways, and to what extent? 
The range of actors that could be potentially affected by any measure taken covering the 
three aspects of cloning (technique of cloning, live animals, their reproductive material 
and their food) is very wide and include the following :  
                                                 
19 i.e. the 2008 and 2010 Eurobarometer and the IPM consultation for the cloning study 
20 The lack of consumer confidence in beef following the crisis in 2000 resulted in a severe drop of beef 
consumption which was solved through a set of EU measures, including the mandatory labelling of the 
national origin21 European Parliament Resolution of 3 September 2008 on the cloning of animals for 
food supply. 
http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P6-TA-2008-
0400&format=XML&language=EN  
22 European Parliament Resolution of 7 July 2010 on Novel Food. 
http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P7-TA-2010-
0266&format=XML&language=EN 
23 The Conciliation on this proposal failed in May 2013. 
http://ec.europa.eu/food/animal/identification/bovine/elec_id_bovine_en.htm 
15 
 

 
- The breeders,  which produce and market the reproductive materials (semen, embryo 
and ova) to improve the genetic performances of farm animals for the meat and milk 
production or other relevant traits. The sector is composed of cooperative of farmers or 
specific companies specialised in livestock genetics. They may be affected in so far as 
they presently import reproductive material from third countries some of which could 
derive from clones. They import limited numbers of live animals but these could also be 
clones or offspring or descendants of clones, in which case they would also be impacted.  
 -  The  farmers (or livestock sector), which  raise animals for food production, which 
accounts for a large part of the EU agricultural output (41% of in value terms, 
representing 1.2% of the European Union’s GDP); they may be impacted when they buy 
reproductive material of clones to raise offspring and subsequently descendants on the 
EU territory of food production.  
 -The EU food industry at the different stages of the food chain (from slaughterhouses to 
distribution and retail) when using food from clones, offspring or descendants of clones 
raised in the EU or importing such food from third countries. SME's play a key role in 
the EU food sector on every stage of the supply chain, representing nearly 452 billion € 
of turnover (Annex X). 
-Third country operators who trade live animals, reproductive material, or food with the 
EU would also be affected. This would be in particular the case of cloning companies 
and breeders who may produce reproductive materials from clones (or from offspring or 
descendants of clones) and export it to the EU; it may also affect food operators in third 
countries who export meat, milk or the derived products to the EU and which could 
derive from clones or progeny of clones 
EU consumers as purchasers of the food products available on EU the market. 
2.6. 
Baseline scenario 
2.6.1. EU legal framework 
a) Legislation on animal welfare 
The EU Directive 98/58/EC on the protection of animals kept for farming purposes24 
does not refer explicitly to cloning but requires Member States to act at national level to 
avoid unnecessary pain, suffering or injury in the context of raising farm animals and 
mentions that such obligation also applies in the use of reproduction techniques. In so far 
as cloning causes unnecessary pain, suffering or injury, as highlighted by EFSA it cannot 
be used for food production on the EU territory pursuant to this Directive. The feasibility 
and the appropriateness of introducing specific welfare indicators to ensure uniform 
application of EU legislation is being studied under the Welfare Strategy25. 
b)  Novel Food Regulation 
The Novel Food Regulation26 covers, to date, the food derived from cloned animals, 
which are subject to a pre-market approval and a risk assessment by a national competent 
authority. If an authorisation would be granted mandatory labelling could be requested 
on a case by case basis. The cloned animals and their food would need to be identified as 
                                                 
24 OJ L 221, 8.8.1998, p. 23 
25  Communication from the Commission to the European Parliament and the Council on the European 
Union Strategy for the Protection and Welfare of Animals 2012-2015, COM(2012) 6 final/2 15.2.2012 
http://ec.europa.eu/food/animal/welfare/actionplan/docs/aw_strategy_19012012_en.pdf  
26 Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 
concerning novel foods and novel food ingredients OJ L 43, 14.2.1997, p. 1 
16 
 

 
"clones" or "derived from clones". To date this identification system dedicated to cloned 
animals is not in place. Moreover no request for authorisation has ever been made up to 
now (see further details in Annex V).  
 
c)  Legislation on identification of animals  
The EU legislation on identification of animals is a prerequisite for the traceability of 
animals in case of disease outbreaks. 
Animal identification systems are established with Regulation (EC) 1760/200027, Council 
Directive 2008/71/EC28, Council Regulation (EC) 21/200429 and Commission Regulation 
(EC) No 504/2008. These measures provide for mandatory identification devices or 
marks, passports and registers. All equine animals are identified individually30 for their 
life time and registered in databases. Bovine, caprine, and ovine species31 are in principle 
identified individually but are subject to some exceptions granted to Member States. 
Porcine animals are not identified individually; they are identified in "batches" (i.e. same 
registration number for each pig belonging to the batch).  
In addition, all holdings have to record the individual animals (or the batches, in the case 
of pigs) as well as their movements in their own registers.  
No system requires information on the reproduction methods the animals were produced 
with. It is thus nowhere specified whether the animal is or not a clone or a progeny of 
clone.   
All five species can only be moved between Member States or imported into the EU 
when accompanied by a "health certificate" delivered by an official veterinarian of the 
Member State or the third country of dispatch. 
Further details are given in Annex VI. 
 
d)  Legislation on identification of reproductive material and 
traceability of the reproductive material to an individual animal 

The EU legislation requires - for both imported and EU produced reproductive material- 
the individual identification of the donor animal. The precise identification of the animal 
needs to be indicated on the straws, or ampoules, or packaging, or  the accompanying 
"health certificate".   
There is no requirement to specify that the donor is or not a clone or a progeny of clone.  
Further details are given in Annex VI. 
                                                 
27 Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 
establishing a system for the identification and registration of bovine animals and regarding the 
labelling of beef and beef products and repealing Council Regulation (EC) No 820/97, OJ L 204, 
11.8.2000, p. 1 
28 Council Directive 2008/71/EC of 15 July 2008 on the identification and registration of pigs, OJ L 213, 
8.8.2008, p. 31 
29 Council Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the identification 
and registration of ovine and caprine animals and amending Regulation (EC) No 1782/2003 and 
Directives 92/102/EEC and 64/432/EEC, OJ L 5, 9.1.2004, p. 8– 
30 Universal Equine Life Number (UELN). 
31 Where derogations are applied in specific Member States for certain or all stock of the ovine and caprine 
species, the animals have to be registered by batches in the national data bases. 
17 
 

 
 
e) Legislation on traceability of animals 
Traceability of animals is the ability to track an animal or a group of animals from one 
point in the supply chain to another, either backwards or forwards.EU legislation imposes 
traceability systems for the purposes of animal health to provide the information required 
to implement control measures against disease. They allow that animals can be traced 
from holding of birth to death/slaughter.  
Further details are given in Annex VI.  
 
f) Legislation on traceability of food from animals 
Traceability of food is imposed on all food business operators (FBOs) established in the 
EU by the General
32
 Food law . FBOs must be able for any food and through all stages of 
production, processing, and distribution, to identify the immediate supplier of the product 
in question as well as the subsequent recipient. FBOs organise their production by 
batches (groups of products with homogeneous characteristics) so as to be able to 
identify the batches which contain the food to be withdrawn in case of fraud or food 
safety issue.  
This system does not ensure that food (such as a piece of meat) can be traced to an 
individual animal. 
The compulsory labelling system established with Regulation 1760/2000 obliges food 
business operators to label the beef at all stages of the marketing process and thus to 
establish the underlying identification and traceability system to allow them to provide 
the information required, i.e. country where the animal was slaughtered, the license 
number of the slaughterhouse, the country where cutting was performed, the license 
number of the cutting plant, the country where the animals were born, the country where 
the animals were fattened/bred. Imported meat for which not all compulsory information 
is available is labelled "Origin: non-EC", followed by the name of the third country in 
which it was slaughtered. 
Further details are given in Annex VI.  
 
  g) Legislation on zootechnics and voluntary guidelines 
To be entered in a herd-book of the same breed, purebred animals of all five species and 
their genetic material must comply with EU requirements (e.g. parents and grant parents 
of that breed must be registered in the same herd book and mentioned on the 
certificate)33. Compliance is attested in specific "zootechnical certificates".  
There is no EU requirement to register clones specifically in herd books. However, for a 
particular dairy cattle breed, guidelines have been established on a voluntary basis by the 
World Holstein Friesian Federation (WHFF)34 on how to register clones, the donor 
animal and the required ancestors. It is not known how far this is implemented by 
                                                 
32 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety 
33 http://ec.europa.eu/food/animal/zootechnics/legislation_en.htm 
34 http://www.whff.info/search/index.php. 
18 
 

 
breeders, whether it exists for other breeds and how much attention EU breeders and 
farmers give to this information.  
Further details are given in Annex XIII (Paragraph 5). 
 
2.6.2. Baseline scenario regarding the farming, breeding and food sectors 
The EU livestock production accounts for 41% of agricultural output in value terms, 
representing 1.2% of the European Union’s GDP. In value terms, beef and milk represent 
over 50% of total output, with sheep meat representing over 20%35.  
Regarding number of actors across the meat and dairy supply chain, there are almost 8 
million farmers/producers, around 80.000 processors and the same amount of 
wholesalers and close to 700.000 food and specialist meat and dairy retailers across 
Europe36. 
The EU food sector represents37 a total turn-over of 1,017 Billion € and approximately 
287,000 companies employing 4.25 million people in the EU. Around 98 % companies 
are SMEs which represent around 49 % of total turn-over and 63% of employment in the 
sector. It is the largest manufacturing sector in terms of turnover, value added and 
employment. It contributes for around 15 % of EU gross value added of manufacturing 
sector.  
SMEs play a key role in the EU food sector, at every stage of the supply chain. They 
represent nearly EUR 452 billion of turn-over, with EUR 93 billion of value added and 
employ about 2.7 million people in 271,000 enterprises which are 99.1% of total Food & 
Drink companies, and 48.7% of total turnover38. 
The meat consumption is expected to remain high.  On a per capita basis, EU meat 
consumption in 2022, at 82.6 kg, would be at approximately the same level as it was in 
2009. Pork is expected to remain the preferred meat in the EU with 40.8 kg/capita 
consumption in 2022, compared to 24.1 kg for poultry, 15.7 kg for beef/veal and less 
than 2.0 kg for sheep and goat meat. Meat demand in Northern America and Europe 
would remain globally stable by 205039  but still remain highest in the world by 2050 at 
around 89 kg per inhabitant (against an estimated 83 kg in 2010). 
Regarding the economic performance, gross profit margins are generally not high in the 
livestock sector but they are positive. However, measured by economic profit and thus 
also taking into account estimates of the unpaid family factors is negative in most cases, 
which suggests that resources are not being optimally allocated40. Thus, across the food 
chain, efficiency gains through technological or process innovation are being pursued, 
which is also a factor leading to concentration in the sector.  
The structure of livestock breeding in Europe is primarily composed of elite breeders at 
the top (mostly organised in cooperatives owned by farmers, which are often SMEs) who 
supply commercial herds in charge of meat and milk production.    
                                                 
35 Eurostat data 2011. 
36 Eurostat Structural Business Statistics (2009). 
37 Source  Food Drink Europe – data & trends of European Food and Drink Industry 2012.  
38 Food Drink Europe: Data trends 2012. 
39 Food and Agriculture organisation – livestock’s long shadow – environmental issues and options (2006).    
40 European Commission 2011: 'EU Beef farms report 2010', DG AGRI 2011. 
19 
 

 
Cloning for food production is not taking place in the EU as reported by Member States 
(see Section 1.2.1. above) and there is little prospect of commercial cloning activity in 
the period to 2020, or at least to any significant scale..  
The actual impact of cloning on farm-level economics can be estimated as providing an 
annual increase in milk yields of 300kg (estimate for a period of ten years)41. For 
comparison, it is necessary to know that current high end producers are at an EU average 
of 7000 kg per annum which would mean cloning could provide for an additional 
increase of 4%. This has to be put into comparison to the current EU dairy market: over 
the last 3 years, milk deliveries remained relatively stable, with only small variations 
while forecast for 2020 predict EU-27 total milk production to exceed the 2009 level by 
about 3%42. 
Further details are given in Annexes VII and VIII.  
 
2.6.3. International dimension 
a) Legal framework 
For live animals, animal products (including reproductive materials and food), the 
following multilateral agreements of the World Trade Organization (WTO) are relevant: 
the General Agreement on Tariffs and Trade (GATT), the Agreement on the Application 
of Sanitary and Phytosanitary Measures (SPS) and the Agreement on Technical Barriers 
to Trade (TBT). The precise determination which of the WTO provisions are relevant 
would depend on the objective and the drafting of the envisaged legislation. 
Any measure adopted would have to honour the principle of "National Treatment", which 
prohibits less favourable treatment of like products imported (Article III: 4 GATT). 
Departures from this general rule could be justified under Article XX of GATT (General 
Exceptions) which allows for measures taken on grounds of "public morals", which could 
be interpreted as including animal welfare or for measures taken on grounds of the 
protection of life and health of human or animal health. The WTO exemptions are 
subject to strict requirements, amongst others, proof of the necessity of the measure to 
obtain the objective in question, which implies that it has to be investigated whether there 
is not a less trade restrictive way to obtain the same objective, as well as proof of 
application in a non-discriminatory, non-arbitrary manner. In addition to the GATT, the 
envisaged legislation would be subject to either the SPS Agreement or the TBT 
Agreement, depending on its objective and design. 
The SPS Agreement applies to measures taken with the objective to protect human, 
animal or plant health from diseases carried through food, feed, animals, plants or pests. 
A measure that conforms to international standards is presumed to be in compliance of 
the SPS Agreement, but there are no international standards on cloning. The SPS 
Agreement requires measures within its scope to be based on science, proportionate and 
non-discriminatory. 
To the extent the legislation lays down product characteristics or related processing 
methods, labelling, packaging or other requirements
, and these requirements do not 
relate to SPS objectives, the TBT Agreement would apply. The TBT Agreement requires 
                                                 
41 Dematawewa, C.M.B., & Berger, P.J. 1998: "Break-even cost of cloning in genetic improvement of 
dairy cattle". Journal of Dairy Science 81(4): 1136-1147. 
42 European Commission 2010: "Evolution of the market situation and the consequent conditions for 
smoothly phasing out the milk quota system" 8.12.2010 COM(2010) 727 final. 
20 
 

 
measures to be non-discriminatory and not more trade-restrictive than required to achieve 
a legitimate objective. Measures should not create unnecessary obstacles to international 
trade. 
b) Cloning activity in third countries 
As commercial cloning for food production is presently taking place in third countries 
and as the EU imports animals, reproductive material and food, which could potentially 
be clones or derive from clones, the third country trade aspect of this policy must be 
taken into account. Based on the replies to the questionnaire (see Section 1.2. above), 
third countries' authorities do not have any information about the number of clones and 
the specific activities carried out by cloning companies on their territory, or about the 
amount of food products of clones or progeny of clones. Based on the consultant's study 
and information received from US companies and stakeholders (Annex II), cloning takes 
place primarily for bovine (for food production) and equine (for elite sports horses). It is 
also carried out for porcine (for food production) but to a much lesser extent. It is 
presently not known whether it is used commercially for ovine species and should have 
just started for caprine in the US. The possible reasons for this relatively limited 
development could be due to the low efficiency of the technique as highlighted by EFSA 
and the related high costs, placing prices of clones above the prices of high quality 
animals. This could also explain why cloning could represent  a higher commercial 
interest in the case of more expensive animals such as bovine for breeding purposes or 
horses for sport purposes.  
The overview of commercial cloning is summarised below:  
Overview of commercial cloning in third countries  
Bovine animals:  the most developed. Applied to cattle in the US, Canada, Argentina and 
Australia43 It may also be undertaken in Brazil, New Zealand, Chile, China and Uruguay based on 
the presence of cattle cloning companies in these countries.  
Milk and meat
 from the offspring or descendants of cloned bovine animals have entered the 
food chain in the US and may have done so in Argentina; these are the products most likely to 
continue to enter human food chains in the near future. The Swiss government says that 
‘several hundred’ second or third generation descendants of clones are in Switzerland (of a total 
1.5 million head of cattle);44  
Porcine animals
: consultations with the US cloning industry suggests that there is some 
commercial cloning for pigs in that country and that it is becoming more common. It may also 
be undertaken in New Zealand and China based on the presence of pig cloning companies in 
these countries. 
Ovine and caprine animals: consultations with industry stakeholders in the EU of third country 
Competent Authorities indicate that commercial cloning of ovine or caprine animals outside the 
EU is uncommon.  Some commercial cloning of these animals has started in the US, but at very 
small scale. Equine animals: consultations of third country Competent Authorities indicate that 
there is no livestock cloning activity currently being conducted for equine animals. Sport cloning 
is undertaken in North and South America and Brazil and South Korea..45 
Source GHK study page 26  
                                                 
43 DG SANCO survey to Member States and third countries regarding cloning activity, 2012.   
44 Kanter, J. (2010) ‘Cloned Livestock Gain a Foothold in Europe’, New York Times, July 29, 2010, 
available from: http://www.nytimes.com/2010/07/30/business/global/30cloning.html?pagewanted=all. 
45 Carroll, R. (2011) ‘Argentinian polo readies itself for attack of the clones: Player forms alliance with 
genetics laboratory to clone equine champions in hope of replicating performance’, The Guardian, 
http://www.guardian.co.uk/world/2011/jun/05/argentinian-polo-clones-player, 2011  
21 
 

 
 
c) EU imports of live animals, reproductive material and food of 
animal origin  

The EU imports live animals (LA), reproductive material (RM) and animal products, in 
many cases from one or more of the five countries (USA, Canada, Argentina, Brazil, 
Australia) where commercial cloning is taking place. The extent to which these imports 
are related to clones, to the reproductive material of clones or their progeny is presently 
unknown as there is no requirement (neither under EU law; nor in third countries) to 
identify them as such.  
As shown in the table 1 below, the share of imports of live animals and of reproductive 
material compared to EU production or livestock is very low (respectively <0.01% of EU 
livestock and 2.5 % of EU use of reproductive material). The share of EU imports of 
meat and milk products is also low except for ovine /caprine and equine meat, where it 
ranges between 20 % and 50 % of EU production respectively.  
For these species, however cloning is not taking place for food production or may have 
started to a very limited extent.     
Table 1 Summary of EU imports from main exporting countries  
 
 
Species 
Main exporting country 
Amount 
% of EU imports of 
livestock, use or 
production 

Live 
Bovine  
Canada and New Zealand  
Very low 
<0,01 % of livestock 
animals  
Pigs  
Russian federation, Canada and 
Very low 
<0,01 % of livestock 
USA  
Others  
USA, Argentina, New Zealand 
Very low  
<0,1 % of livestock  
and Chile  
Reproducti
Bovine  
USA, Canada, New Zealand and 
Low at EU level  
2.5 % of use of semen in 
ve 
Australia  
but 
EU in average   and up to 
material   
medium to high in  20 % or more in certain 
(semen) 
some MS  
MS * 
Others  
Canada, USA, Australia and New 
Not available 
Not available 
Zealand   
Reproducti
Bovine 
Canada and USA 
Not available 
Not available 
ve 
material    
(embryo) 
Meat  

Bovine  
Argentina, Brazil and Uruguay 
Low  
EU net importer (5 % of EU 
(70 % of all imports), Australia, 
production)  
USA, New Zealand  
Ovine  
New Zealand (80 % of all 
EU net importer (23 % of 
High 
Caprine 
imports)  
EU production)  
Porcine  
Chile, USA and Australia  
Very low 
EU self-sufficient (<0.1% of 
EU production)  
Equine  
Canada, Argentina, Mexico, 
High 
EU net importer (50 % of 
Uruguay 
EU production)  
Fresh milk   Bovine 
Croatia, Switzerland and Norway 
Very low   
 0.01% of EU production  
Caprine 
(99 % of all imports) 
Ovine  
Cheese & 
Bovine 
Switzerland, New Zealand, USA, 
Low   
 2 % of EU production 
butter  
Caprine 
Australia and Norway 
Ovine 
Very low: <1%; low: 1% - 5%; medium: 6% -20% high: 21% -50%; 
22 
 

 
Sources: Eurostat External Trade Statistics (COMEXT), Traces; * Source: Commission report on animal 
cloning for food production–COM (2010) 585 and stakeholders in Advisory group meetings (minutes in 
Annex II). 
 
However, in terms of value, as shown in table 2 below, out of a total value of 3.6 billion 
€ of imports of food per year, imports of meat accounts for 80 %, of which the highest 
share is composed of bovine meat (60 %) imported from countries where cloning takes 
(notably USA, Argentina, Brazil). The share of ovine and caprine meat in value of all 
meat imports is also relatively high (35 %) but as stated above, cloning for these species 
is not developed for the time being.  
EU trade on reproductive material takes primarily place with the USA and Canada.  
Imports of reproductive material account for a small percentage of total use in the EU 
(2.5% on average46) but the breeding sector considers access to this genetic material as 
essential to the continued viability of the industry47. The majority of imported 
reproductive material is from bovine (in value): for example in 2011, the value of all 
imported reproductive material (all species) was of €48 million in 2011, originating at 
93% from bovine.  The US and Canada are very dominant in EU supply of reproductive 
material for all species (bovine at 98%, porcine at 100%, ovine and caprine at 80 %, 
equine at 98%). 
-The EU exports bovine semen worth €25 million each year48 of which almost half to the 
US, Canada and Latin America. 
 
Table 2 Import value in million € from 2010 to 2012 
 Species 
2010 
2011 
2012 
 
 
 
TOTAL Live animals 
193 
120 
185 
Bovine 0.91 

0.62 
Live animals 
Swine  

0.53 
0.77 
Sheep and goats   
0.28 
0.85 
0.12 
Equidae 191 
118 
184 
Meat 
TOTAL Meat  
2731 
3046 
2847 
Bovine 1576 
1702 
1693 
Porcine 58 
55 
52 
Ovine/caprine 999 
1195 
1003 
Equine 98 
94 
99 
RM*  
TOTAL  
45 
48 
49 
Milk &Milk products**   TOTAL  
644 
688 
722 
TOTAL 
3612 
3901 
3802 
* Reproductive Material from bovine         ** from bovine, caprine, ovine  
Source: Eurostat. Comext -Extracted 7/06/2013 

 
2.7. 

Does the EU have the right to act (subsidiarity)? 
Right to act (EU competence) 
Article 13 TFEU specifies that welfare requirements of animals shall be taken into 
account by the Union and the Member States when formulating and implementing Union 
                                                 
46 There are no statistics on EU use of reproductive material; the share of imports is therefore based on 
estimates – source : Commission report of 2010   
47 ICF GHK report 2012 
48 Figures based on 2006-2011 COMEXT data 
23 
 

 
policies. However, this Article in itself does not grant the EU a competence to legislate 
on animal welfare. 
Existing Union legislation on both animal welfare and identification of farm animals and 
their reproductive materials is based on Article 43 TFEU (Agriculture). Measures 
regulating the use of the cloning technique would address the associated animal health 
and welfare concerns, and would prevent the development of diverging national 
legislation on this technique adopted to implement the general principles laid down in 
Directive 98/58/EC on the protection of animals kept for farming purposes and the 
consequent disruptions of the concerned agricultural markets. They would therefore 
ensure legal certainty and a level playing field for breeders and farmers and to ensure 
uniform conditions of production for farmers.  Therefore, it may be possible to base 
certain measures on Article 43 TFEU.  
As regards the EU competence under Article 114 TFEU (Internal Market), this requires a 
risk of divergence between national legislations as explained in paragraph 2.3 above. 
Finally, EU competence for certain measures could be drawn from Article 352 TFEU 
(Flexibility Clause) under the conditions set out therein. 
Necessity of the EU to act (Subsidiarity) 
Issues linked to animal cloning relate to the identification and traceability of life animals 
and of their reproductive material. As live animals, their reproductive materials and 
derived food can be freely traded in the Internal Market the issue needs to be addressed at 
Union level. Isolated national approaches could lead to market distortion.  
Proportionality 
The options identified as feasible as a result of this impact assessment should be suitable 
and necessary to achieve the objectives set out below and they should present the best 
cost benefit ratio to resolve the issues at stake, as explained in the comparison of options 
in chapter 6.2. 
 
3. 
OBJECTIVES  
3.1. 
General objective 
To address concerns raised as regards cloning for farm purposes and ensure uniform 
conditions for farmers in the EU and to protect consumer interests as regard food from 
cloned animals. 
 
3.2. 
Specific objectives  
Objective 1:  
To ensure uniform conditions of production of farmers in the EU while protecting health 
and welfare of farmed animals; 
Objective 2: 
To protect consumer interests as regards food from cloned animals  
Objective 3: 
To safeguard the competitiveness of farmers, breeders and food businesses in the EU. 
 
24 
 

 
3.3. 
Consistency with other EU policies and horizontal objectives 
The objectives identified are in particular in line with:  
- the Europe 2020 Strategy in favour of a sustainable development based on innovation 
and competitiveness of EU economy and agriculture;  
- the Common Agricultural Policy objectives including in relation to the rearing of 
animals for food production; 
- the EU Food Law defines the requirements applicable to all foods as regards food 
safety and consumer information. 
It also improves coherence with other EU policies notably on: 
- the Novel Food Regulation, which as mentioned in 2.6.1.a. above, addresses only food 
from clones;  
- the Animal welfare strategy for the protection and welfare of animals for 2012-201549
which  in addition to the Directive 98/58/EC (see 2.6.1 above), aims to further improve 
the welfare of animals in the European Union; 
- the
50
 EU legislation on Food Information to Consumers  which lays down labelling 
requirements applicable to all foods.  
 
Finally, it takes into consideration the impacts of this initiative on the Charter of 
Fundamental Rights of the European Union 
especially as regards the freedom to conduct 
a business (Article 16) and consumer protection (Article 38) as further analysed in 
section 6.2. 
4. 
POLICY OPTIONS 
4.1. 
Policy options included in the analysis 
In light of the problems and objectives outlined above, 4 options were retained. They are 
described below and are also summarised in Table 3 (below). 
Option 1: no policy change. The pre-market approval for food from clones under the 
current Novel Food Regulation would be maintained. Regarding cloning, Member States 
would continue to be entitled to act at national level, in line with Directive 98/58/EC on 
animal welfare.  
Option 2: Pre-market approval of food from clones, from offspring and descendants. 
As regards food from clones, this option differs from the status quo from a procedural 
point of view only51.   
The main difference to option 1 is that it would enlarge the scope of the pre-market 
approval from food of clones to food of offspring and descendants of clones.  
                                                 
49 Communication on the European Union Strategy for the Protection and Welfare of Animals 2012-2015 
COM(2012) 6 final/2. 
http://ec.europa.eu/food/animal/welfare/actionplan/docs/aw_strategy_19012012_en.pdf 
50 Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on 
the provision of food information to consumers.  
51 Under this option, a streamlined and centralised approval process would be introduced which would 
involve the Commission and EFSA  
25 
 

 
Accordingly this food would become subject to a scientific risk assessment by EFSA 
followed by a decision of the Commission to authorise or not the food52.  
It has to be stressed that EFSA has already confirmed the absence of a risk to food safety.   
However, it is important to assess this policy option since this option had been put 
forward by the co-legislators during the discussions between 2008 and 2011 on a reform 
of the Novel Food Regulation. Moreover, EFSA could not establish the absence of food 
safety concerns for the other species than porcine and bovine (ovine, caprine, equine) in 
the absence of specific data. Therefore the pre-market approval would be useful (i) to 
confirm the safety for the bovine and porcine species; and (ii) to encourage the 
establishment of data for the other species so as to be able confirm in a second stage their 
safety. 
 
Option 3: labelling of food from clones, offspring and descendants  
Sub-option 1:  labelling of food from clones 
Sub-option 2:  labelling of food from offspring  
Sub-option 3: labelling of food from descendants 
Under this option food from clones, offspring and descendants would be labelled. The 
labelling would apply incrementally to the various generations analysed in the two sub-
options or only to one of them according to the results of the analysis. 
In order to be able to label this food, traceability systems would need to be in place for 
the live animals (as regards previous generations of animals), reproductive material and 
the food from the animal (as regards the individual animal which was the source of the 
food). 
Sub-option 4: voluntary labelling 
Sub-option 5: mandatory labelling 
Under this option the possibility to introduce voluntary labelling (sub-option 4) or 
mandatory labelling (sub-option 5) will be investigated as well as the different type of 
food covered:  direct fresh food (fresh meat or fresh milk or both) or  all types of food 
(fresh food and processed food such as sausages, cheese, etc.). 
Overall, this option differs from the status quo as it does not require a pre-market 
approval and extends the labelling to food from offspring and descendants.   
 
Option 4: temporary suspension of the technique and of imports of live clones, their 
reproductive material and their food.   

Under this option the use of the cloning technique would be suspended in the EU until 
this reproduction technique has been developed further so that the welfare issues are 
alleviated. As a consequence, no clones, reproductive material and food from clones 
would be produced on the EU territory.  
To avoid circumvention of the suspension of the technique in the EU and create uniform 
conditions of production for breeders and farmers, imports of the "results" of the use of 
                                                 
52 Streamlined procedure was already foreseen in the original Commission proposal of 2008 (referred to in 
Section 1.1 above) 
26 
 

 
the technique in third countries (live clones, their reproductive material and their food) 
would be suspended as long as the technique is suspended in the EU. As a result, no 
offspring of clones would be produced in the EU.  
This option differs from the status quo as it forbids explicitly cloning on a temporary 
basis throughout the EU whereas the rules in place (i.e. Directive 98/58/EC)  require 
Member States to act at national level in a more general manner (i.e. "to avoid 
unnecessary pain, suffering or injury
" (…) including in the "context of the breeding 
technique
").  
In addition this option includes explicitly the suspension of the use of the clones (i.e. 
suspension of the import of reproductive material and food of clones).  
 
Table 3. Summary of the description of options: 
Option Description 
Generation 
Traceability to implement the 
covered 
option 
No Policy change 
- PMA (+ labelling of the food 
Clones 
- For PMA live clones + their food 
on a case by case basis) 
(in EU and third countries 
- Directive 98/58/EC (animal 
exporting to EU) ;  
welfare) 
- For animal welfare, none  
Pre-market 
PMA  
Clones, Offspring  Traceability of live clones, 
approval 
and Descendants 
offspring and descendants,  
Labelling of food 
Labelling of food – voluntary or 
Clones, 
+ reproductive material & food of 
mandatory (fresh meat or fresh 
Offspring, 
clones  (in EU and third countries 
milk or all type of food) 
Descendants 
exporting to EU) 
 
 
Suspension  
Suspension of : cloning 
Clones 
Traceability of clones + their food 
technique in EU + imports of 
 
+ their reproductive material  
clones + reproductive material & 
(in third countries)  
food of clones 
 
  
4.2. 
Options discarded at an early stage 
The preliminary options below have been discarded after discussion in the IASG based 
on the following criteria: i) the legal feasibility of the proposed options (in light of 
TFEU, EU secondary legislation and WTO); ii) the technical limitations.  
(i) A permanent ban of the cloning technique, clones and their use (reproductive 
material and food) 
was discarded as the underlying animal health and welfare concerns 
identified by EFSA are linked to the present scientific and technological development of 
the cloning technique. The latter may, however, mature and thereby alleviate partially or 
fully the concerns: the prohibition linked to the use of the technique and of the clones 
needs therefore to be temporary with a review clause.  A permanent ban would be 
unjustified and disproportionate. 
(ii) A permanent ban or temporary suspension of food from offspring and 
descendants
 was discarded as in the light of the EFSA opinion there is no scientific 
concern or food safety reason to forbid - whether temporarily or permanently - market 
access for such food. There is therefore no legal basis to act for this option.  
(iii) The option of setting up harmonised conditions of use of the cloning technique 
for food production was discarded based on the EFSA opinion: under current scientific 
knowledge, it is not possible to define any conditions of use of the technique which 
would alleviate animal health and welfare concerns identified by EFSA. It is therefore 
not possible to define technical parameters to this end. 
27 
 

 
(iv) Measures to improve consumer awareness that would potentially alleviate the 
consumer concerns or to upgrade voluntary labelling schemes have also been discarded 
for the following reasons:  
a)  consumers who reject the technique for ethical reasons, would not accept it more 
if the technique is explained better and in further detail; 
b)  as long as the technique, even explained better, implies the suffering of clones 
and surrogate mothers, the reticence of consumers would remain unchanged;   
c)  informing consumers that offspring and descendants are produced with traditional 
breeding techniques and that no particular welfare concerns can be associated 
with this, could clarify the difference between clones and offspring. It would 
however not alleviate the reticence of consumers towards cloning in the absence 
of measures on clones and the cloning technique;   
d)  it is difficult to establish a link between cloning and benefits to consumers. 
Clones are of interest in high productivity farms where "elite" animals are already 
used. Links between cloning and positive effects on consumers (such as lower 
prices or contribution to agricultural landscape) may therefore be difficult to 
establish;  
e)  information campaigns on such issues could be carried out by the food sector  and 
not necessarily by public authorities whether at national or EU level; 
(v) Upgrade of labelling schemes: existing specific labelling schemes (whether organic 
or other similar quality labelling schemes) do not exclude the production of food from 
offspring of animal clones. This is because offspring is produced with traditional 
breeding techniques and does not therefore deserve or require special treatment. Based on 
the information available, no FBO has so far set up any voluntary labelling scheme on 
the non-cloning origin of animals. In cases where FBO could guarantee non-cloning 
origin of animals the food is obtained from specific breeds produced exclusively locally 
(not cloned or obtained from reproductive material of clones).  This is presumably 
because the other positive messages have a better impact on consumer behaviour. If there 
would be an interest to bring out products of non-cloning origin, it would have to be in 
combination with other positive messages - such as organic, GM free, special 
consideration of welfare of animals concerns etc.  
 
5. 
ANALYSIS OF IMPACTS  
The analysis has been performed using data provided by the external contractor ICF-
GHK and gathered through other data sources available53. However, limited quantitative 
data have not allowed for a detailed quantitative analysis. 
 
 
5.1. Option 1: No policy change 
 
5.1.1. Description of the option  
 
Food from clones would remain within the scope of the Novel Food Regulation and 
subject to a pre-market approval (PMA) based on a food safety assessment. As described 
                                                 
53 Stakeholder consultations in meetings of Advisory Group on the Food Chain and bilateral meetings.  
28 
 

 
in section 2.6.1. paragraph b), the FBO's need to submit an authorisation application to 
the Member State's authority to perform a scientific risk assessment and pay fees for this. 
In case of objections by other Member States to the risk assessment, the file is sent to the 
Commission who consults EFSA who performs a new risk assessment on the basis of 
which the Commission adopts a Decision for authorisation or not. If an authorisation 
were requested and then granted, clones would need to be traced.  At present this 
traceability system does not exist. In addition, labelling (as “derived from clones”) could 
be requested on a case by case basis. 
Food from offspring and from descendants would continue to be marketed without any 
distinction as to the animals it is obtained from. This food is not covered by this option, 
consumers would not be able to know if the product they are purchasing is deriving from 
offspring and/or descendants 
The use of the cloning technique would continue to be regulated by Directive 98/58/EC.  
Where Member States fail to implement the Directive in relation to cloning, the 
Commission could start infringement procedures. If Member States would take measures 
specific to cloning to comply with the relevant requirements of that Directive, such 
measures would not necessarily be uniform and could apply, for example, to different 
species or types of breeds, to the technique as such or also to the imports of lives clones 
and their products. Different national approaches might disturb the functioning of the 
concerned agricultural markets.  
As EFSA has already identified animal health and welfare issues linked to the use of the 
cloning technique, the future use of welfare indicators, which could be developed in the 
context of the Animal Welfare Strategy (see section 2.6.1., paragraph a) above) would 
not affect the status of this issue.  
5.1.2. Economic Impacts 
Regarding the pre-market of food from clones,  the potential economic impact relates to 
food business operators (FBOs) which would like to market food from clones in the EU. 
The FBO will have to file an authorisation application to be submitted to the national 
competent authority who would charge fees to FBOs54. Where a fee is in place, it ranges 
from EUR 830 to EUR 25 000 and from EUR 900 to EUR 2 000 for a simplified 
procedure. 
FBOs bear a series of additional costs related to the preparation of the file and the 
application procedure. In detail, the cost of filing an application under the Novel Food 
Regulation has been estimated to be up to 400.000 €55 when toxicological tests are 
required (see details in table 4 below). Where the file is referred to EFSA for an opinion, 
there is additional EU budget needed to finance the costs borne by EFSA in processing 
applications, evaluated around 83 000 € per application for Novel Food56. Under the 
current Novel Food Regulation, authorisations are individual: each FBO who intends to 
put food from clones on the EU market would require a pre-market approval for the 
products; subsequent operators who wish to put similar products to those already 
authorised on the market would need to get approval from their national authorities for 
                                                 
54 Fees perceived by Member State agencies to make the scientific risk assessment under Novel Food 
Regulation. 
55 Estimation done by assuming the equivalence with the costs of filing an application under Novel food 
Regulation. Source: Impact assessment on Revision of Regulation 178/2002 laying down the general 
principles and requirements of food law, establishing the European Food Safety Authority (EFSA) and 
laying down procedures in matters of food safety on the establishment of fees for EFSA. 

56 Source : EFSA impact assessment, Annexes page 56   
29 
 

 
"substantial equivalence", which, if granted, would not imply a new application dossier 
and risk assessment. 
Table 4:  Costs linked to applications dossiers for pre-market approval 
Cost Action 
from 20.000 € to 45.000 € 
to set up an application file for risk assessment 
around 300 000 €  
only if toxicological tests are required 
administrative fees from 800 to 25 000 €  
for the risk assessment by Member State 
 
In addition to above application costs, FBOs would be obliged to adapt their traceability 
system to trace food from clones and could also be requested to label their food. Farmers 
and breeders would need to trace the clones. The additional costs are not significant:    
•  in view of the rather limited number of animals concerned and the likelihood that 
they would be processed apart and labelled through a segregated food supply 
chain
* (see Section 5.3.2. paragraph b) below), the traceability cost of food from 
clones for all EU operators along the food chain would be negligible57 and the 
amount of food produced in this way limited;  
•  costs for tracing clones by farmers and breeders are also considered marginal (see 
Section 5.3.2.b paragraph b) below);  
•  the average cost at company level for a small label change has been estimated at 
€2,000-4,000; a full label redesign has been estimated at €7,000-9,000 (or €9,000-
13,000 in total). It should be noted that most companies (~80%) redesign their 
label every three years as a normal part of their business operation58 (see section 
5.3.2 paragraph c).  
 
European associations59 representing the food industry, the milk and meat sectors are in 
favour of this option, i.e. maintain the principle of a pre-market approval for food of 
clones only (see Annex III.3). 
As regards the "no policy change" on cloning  and taking into consideration the very 
limited cloning activity in the EU, the economic impact on production costs for EU 
breeders, farmers and on third country trade is considered non-significant. This is mainly 
linked to the low economic profitability of the cloning technique which has an efficiency 
rate60 according to EFSA (calculated as the number of live offspring as a proportion of 
the number of transferred embryos) still in the range of 6-15% for cattle and of 6% for 
pigs, albeit occasionally higher success rates were reported. Farmers and breeders would 
be able to continue to import live clones or their reproductive material from third 
countries where commercial cloning takes place.  
Regarding SMEs, the specific impact mainly arises from the costs for having to recruit 
specialists not permanently available in FBOs themselves to prepare the applications. 
Another issue, which could present particular challenges for micro and small enterprises 
-including direct on-farm sales of food of animal origin to the final consumer- stems 
                                                 
57 Source ICF-GHK study on animal cloning December 2012. 
46 Source Impact Assessment Report on general food labelling issues 30/01/2008, SEC (2008) 92 
59 EDA (European Dairy Association); Eucolait (European Association of Dairy Trade); UECBV 
(European Livestock and Meat Trade Union); CLITRAVI (liaison Centre for the Meat processing industry 
in the EU); Food and Drink Europe.  
60  According to EFSA, if the comparator for cattle cloning is in vitro fertilisation (IVF), the background 
(i.e. the percentage of live offspring per transferred embryo from IVF) is 45-60%. Compared to this 
efficiency of IVF, the efficiency of cloning can be estimated at 13-25%. 
30 
 

 
from the rules on traceability and labelling, where the lack of economies of scale 
(lowering the cost per unit) may lead to higher relative costs for SMEs.  
As far as third countries are concerned, in case their food industry would intend to put 
food from clones on the EU market, exporters would need to file an application for 
authorisation to EFSA. They would have to incur the same application costs of the EU 
business operator as well as additional labelling and traceability costs. If no authorisation 
is granted61, food industry in third countries where cloning technique is used, would have 
to either remove food of clones from their food chain or remove it from the food 
exported to the EU. The clones would need to be identified and registered as such if their 
food is to be authorised by the EU before being exported.  
Apart from food from clones which needs to be identified, no other impact under this 
option is expected on third countries: they would continue to be able to export live 
animals (clones and progeny), their reproductive material and their food.   
5.1.3. Impacts on consumer protection 
The impact of the pre-market approval  of food from clones on  consumer protection  is 
considered positive: in case labelling is requested upon authorisation, consumers would 
be able to identify the food derived from clones and to make informed choices as to 
whether a food product contains or not products derived from clones. More than 70% of 
the total respondents to the IPM public consultations are in favour of a mandatory 
labelling of food not only from clones, but also from offspring and descendants of clones.  
This approach is also supported by the European consumer association (BEUC)62. In its 
comments BEUC urges the Commission to set up: “a full compulsory traceability system 
(which includes clones and their offspring)
”.  
The retail sector (Euro Commerce) confirms that they would sell the products according 
to acceptance by consumers but "practical solutions" would need to be found to ensure 
traceability (Annex III paragraph 3).    
However, this option does not entirely respond to consumer expectations as information 
of food from offspring and descendants would not be provided. 
5.1.4. Impacts on food prices and employment 
In case the authorisation of food from clones would impose labelling, some price-effects 
could be expected due to the additional costs for ensuring traceability of clones and food 
obtained thereof. However, as explained in Section 5.3.2. paragraph c) below, the impact 
is expected to be low although it is not possible to quantify it.. Moreover it is not possible 
to quantify the effect on employment for lack of data.   
Regarding the prices for food from offspring and descendants, they would remain 
unchanged, as no system is set up to ensure the expected information is available to 
consumers and therefore no impact on employment resulting from labelling and 
traceability requirements is expected. 
 
                                                 
61 Which is the case at present. 
62   Cloning for food production - BEUC comments on the European Commission report at 
http://www.beuc.org/Content/Default.asp?PageID=2139 
31 
 

 
5.1.5. Impact on Animal Welfare 
Under this option animal welfare problems are addressed by the Member States under the 
Directive 98/58/EC.   
 
  5.2. Option 2: Pre-market approval for food from clones, offspring and descendants 
 
5.2.1. Description of the option  
Under this option FBOs would have to file an application for authorisation to market 
food derived from clones, offspring and descendants. Contrary to option 1, the 
authorisation would be submitted directly to the Commission who consults EFSA for an 
opinion, avoiding thereby that FBOs have first to go to Member States' authorities for a 
first assessment. This streamlined centralised procedure was already foreseen in the 2008 
Novel Food proposal as described in Annex VI paragraph 5.   In addition, under this 
option, the scientific assessment would cover food from offspring and descendants, 
although not considered as being "novel" (as derived from conventionally bred animals) 
and presenting no safety issue as indicated by EFSA.  
This option would be more efficient than option 1, by imposing a centralised 
authorisation system based on a risk assessment.. Yet this option does not address 
directly the specific objectives set out in Section 3.2. However, it has been considered 
worthwhile analysing it as it was supported - for food from clones and offspring(1st 
generation) - by unanimity by the Council in first reading during the inter-institutional 
discussions on the Novel Food proposal (referred to in paragraph 1.1. above). As the 
offspring and the following generations present exactly the same characteristics63, it is 
appropriate for sake of coherence and completeness that this option also includes food 
from descendants of clones. This option could be considered appropriate for food from 
clones because of their novelty aspect and because this option provides a more efficient 
approval system than under option 1.  However, as regards food from offspring and 
descendants this option is inappropriate in the absence of any specific food safety issue 
as highlighted by EFSA. 
Under this option, an application for authorisation would need to be submitted by EU or 
third country FBOs, and authorisations would be granted based on a risk assessment. In 
order to do so an underlying traceability system would need to  be  in  place.  At  present 
this traceability system does not exist. The implementation of this option implies that in 
the absence of authorisation, the food could no longer be put on the EU market.  
This approach is also supported by the European consumer association (BEUC)64. In its 
comments BEUC urges the Commission to set up: “a suitable risk assessment and 
authorisation procedure complemented by a compulsory labelling system for food 
derived from clones and their offspring, should the temporary suspension be lifted in the 
future
”. 
                                                 
63 In terms of (i) not presenting any novelty aspect justifying their inclusion in a Novel Food Regulation 
and of (ii) not raising food safety concerns as indicated by EFSA. 
64   Cloning for food production - BEUC comments on the European Commission report at 
http://www.beuc.org/Content/Default.asp?PageID=2139 
32 
 

 
Conversely, industry representatives65 are against taking measures beyond food of 
clones, as there is no food safety concern with food from offspring and descendants. 
They base themselves mostly on the EFSA opinion of 2008 and subsequent statements.   
   
5.2.2. Economic Impacts  
As regards the EU, the expected economic impact of this option touches overall the same 
aspects of the assessment performed for food from clones under option 1. However the 
magnitude of the impact is considered more important as this option covers a longer 
chain and entails additional impacts: the offspring and descendants of one single animal 
increases exponentially by thousands of animals per generation (see Annex XIII 
paragraph 2).  
The costs for filing an application for pre-market authorisation are the same than those 
detailed in section 5.1.2 except for the fees paid at national level which will no longer 
exist. In the case of an individual authorisation as under current Novel Food Regulation 
(option 1), agreement on substantial equivalence for each FBO is required. In the case of 
a generic authorisation, a single FBO would bear the costs of application for a given food 
while all other operators would benefit from this authorisation. 
All FBOs –whatever the type of authorisation foreseen- would have to be able to identify 
this food as stemming from offspring or descendants of clones to be able to prove that it 
has been approved beforehand. The impact for traceability would be high for the EU food 
industry as the number of animals concerned (offspring and descendants) would be much 
extended (as compared to clones).  
FBOs would need to adapt their traceability system to trace food from the respective 
animals.  There would therefore be costs for (i) the traceability of food for all EU 
operators along the food chain, which would be important in view of the very high 
number of animals concerned; and for (ii) the identification and registration of clones, of 
offspring and descendants (and of their reproductive material). The cost of traceability of 
animals and of food are described in further detail in Section 5.3.2. below.   
Under this option, EFSA would have to perform a risk assessment on food from 
offspring and descendants of clones not considered at risk for public health. There would 
in addition be cost to be borne by the EU budget to cover the costs involved in 
processing applications (estimated at 83000 € per application) for Novel Food66.  
Such assessment is only appropriate when possible risks are identified. In the case of 
food from clones, offspring and descendants of clones, EFSA did not consider them 
different from other food. The only justification for an authorisation could be applied to 
food from clones, as here the animal is produced with a "novel" reproduction technique; 
for other food such pre-market approval would be even less justified from a scientific 
point of view.  
SME's cannot be excluded from any of the PMA mentioned above. This option has 
therefore potential to impact SME profit margins and thus growth in particular as they do 
not benefit from efficient production systems and/or economies of scale enjoyed by 
                                                 
65 Food Drink Europe; British Agricultural Bureau, the European Forum of Farm Animal Breeders 
(EFFAB); the European Dairy Association (EDA); and European Association of Dairy Trade (Eucolait); 
European farmers /cooperatives (Copa Cogeca). 
66 Source : EFSA IA annexes page 56  
33 
 

 
larger firms. Traceability of food could present particular challenges for micro and small 
enterprises but there may be some differences among Member States (see Annex X)  
As regards third countries, the PMA requirement for food from offspring or descendants 
would create major difficulties for EU importers and their third country suppliers. EU 
importers need to have the guarantee that either (i) imported food does not derive from 
offspring or descendants, or (ii) imported food has been approved. Otherwise, they would 
no longer be able to maintain these imports. As explained in Section 5.3.3. below, third 
country operators would need to identify the food and therefore the animals concerned 
(clones, offspring and descendants of clones) which is not the case at present. Imports 
could be reduced or halted because third countries would be unwilling or unable to meet 
the requirements of the EU legislation. This would have an impact on EU imports of 
meat, milk and other food products accounting67 today for around 1.7 billion € for beef, 1 
billion € for sheep and goat meat and 722  million € for milk products68 and could lead to 
major trade disruptions. 
 
5.2.3. Impacts on consumer protection  
Under this option, consumers would be reassured that the food is safe but still, it would 
not allow consumers to identify food from clones, offspring or descendants and make 
informed choices. For this to happen, mandatory labelling, as described in Option 3 
below, would need to be provided for.   
 
5.2.4. Impact on prices and employment 
There would be a negative impact on food prices  as the price of meat and milk and 
derived products could increase to compensate for additional compliance costs due to 
extended requirements. The negative impact on consumer markets (prices and choice) 
would be even higher if the major import, such in beef, would cease. It is however not 
possible to quantify the envisaged impact as no data is available, nor is it possible to 
quantify the effect on employment. 
 
5.2.5. Impact on Animal Welfare  
Under this option animal welfare problems are not addressed.   
  5.3. Option 3: labelling of food from clones, offspring and descendants  
 
5.3.1. Description of the option  
 
As set out above (section 4.1), this option has two elements: the scope of the labelling, 
and its modalities (obligatory or voluntary) 
(i)  In terms of scope, this option covers the labelling of food of clones, offspring and 
descendants. The following two sub-options have been identified:  
- Sub-option 1: labelling of food from clones  
- Sub-option 2: labelling of food from offspring  
                                                 
67 Sources Eurostat 2012 
68 Source ICF-GHK study on animal cloning December 2012, page 18   
34 
 

 
- Sub-option 3: labelling of food from descendants  
Labelling of food as stemming from these animals is not a self-standing option. Whether 
such labelling is voluntary or compulsory, it is subject to two main conditions: (i) the 
identification and traceability of animals and their reproductive material (RM), and (ii) 
the traceability of the food.  These two requirements imply costs in addition to the cost of 
labelling as such as described in paragraphs 5.3.2. to 5.3.3. below.  
(ii) In terms of modality of labelling, the following two options have been identified:  
- sub-option 4: voluntary labelling  
- sub-option 5: compulsory labelling.  
The modality of labelling is particularly relevant for consumer protection and is assessed 
in further detail under paragraph 5.3.4. The voluntary labelling could be of interest to 
FBOs when it represents an added value for selling their products, which would enable 
them to cover extra costs. It would be put in place by some FBOs depending on market 
demand. The mandatory labelling implies that costs are borne by all FBOs, who have to 
check whether the food derives from clones, offspring and/or descendants.  
The requirements increase exponentially with the generations as shown in table 5 below:  
 
Table 5 Conditions of identification/ traceability  to be fulfilled  
to label food from clones, offspring and descendants of clones  
CONDITIONS OF IDENTIFICATION/TRACEABILITY  
CLONES  
OFFSPRING  
DESCENDANTS  
1st generation  
2nd generation  
3rd generation  
etc. 
Food from :  
Fo
LA   RM   Food 
LA 
RM 
Food 
LA 
RM 
Food   LA   RM  
 
od 
Clones 


           
Offspring  
 X X  X  X                 
2nd 
 X X    X X  X  X           
generati
on  
3rd 

 X X    X X    X X  X  X     
generati
Descendants  
on  
4th  etc.  

 
 
 
 
 
 
 
 
 
 
 
 
 
LA : live animals ; RM reproductive material  
 
5.3.2. Economic impacts in EU - costs 
 
Labelling requires confidence that its content is correct. To provide the information as to 
whether food was obtained from clones, their offspring or their descendants on the label, 
it is necessary to create a documented link between a food and the animal/animal clone.  
This requires that parentage information for every food producing animal is conveyed 
through the food production chain. This becomes more costly with every generation 
between the clone and the animal, reproductive material and the food.  
As explained above (section 2.6.1.) current legislation on traceability does not conserve 
the require link between an individual animal and the food obtain thereof throughout the 
food production chain. It does not ensure the link between the animal and its parents 
throughout all stages of livestock production. As a result to label food derived from 
35 
 

 
clones, their offspring or their descendants, production processes would have to be 
profoundly amended to ensure such link. 
It is obvious that, depending on the sub-option chosen, costs can vary substantially. This 
was also highlighted in the consultations, where industry representatives expressed 
themselves against labelling of food from offspring and descendants (as highlighted in 
Annex II and Annex III paragraph 3) and underlined the risk of trade disruption.  
Representatives of European farmers/cooperative associations69 consider that traceability 
extended to offspring puts an administrative burden on operators at all levels of the 
supply chain. 
 
a) Sub-option 1: food from clones  
While no precise numbers exist, it can be presumed that few animals will be cloned as 
the conventional breeding techniques will remain mainstream and the cloning one 
ancillary. Evidence indicates that productivity increases resulting from use of cloning 
technique as currently performed are marginal.  
There is thus little economic incentive to use it. As a result the technique would not be 
used for food production in the EU up to 2020. Moreover, as set out above, the clone 
itself does usually not serve as source for food.  
The consultant70 thus presumed that if these assumptions are correct the clones in 
circulation would be so few and that they could be closely traced with limited efforts. 
The consultant could, however, not demonstrate that this is really the case. 
 
b) Sub-options 2 and 3 - Cost of traceability of food  of offspring and 
descendants   

To the contrary of clones, the traceability of food from offspring and descendants implies 
a higher number of conditions (see Table 5), which increase exponentially per generation 
and which need to be fulfilled.  
In particular, both farmers and breeding companies have to adapt their registration and 
traceability systems and to introduce the information related to the status of their 
offspring or descendants and their reproductive material (see (i) below). 
Moreover, a traceability system would have to be set up which links every piece of meat, 
and every litre of milk to a specific animal. Due to the complexity of such system, the 
multitude of actors involved and the uncertainties surrounding the functioning of existing 
systems costs could not be calculated. However, surely, they come at a cost (see ii 
below).  
(i)  Traceability at the level of farmers and breeders 
The costs for adapting traceability systems of animals and their reproductive material 
have been calculated by the consultant71 on the basis of costs per operator (working 
time72 and investments).  
                                                 
69  European association of farmers /cooperatives (Copa Cogeca). 
70 IFC GHK 2012 
71 IFC GHK 2012 
72 The working time necessary as a minimum to learn the new legal requirements and define what is 
necessary to record the new information has been estimated at one hour per farm. For breeding companies 
 
36 
 

 
They were divided into: i) one-off learning costs to familiarise with new requirements;  
ii) one-off  investments in equipment; iii) annual operating costs for recording 
information on  status and parentage ; and  iv) annual  reporting and inspection costs to 
respond to information requests from customers and control authorities.  
As shown in Table 6 below, the costs for farmers have been qualitatively assessed and 
considered marginal. The costs for breeding companies (importers and established in the 
EU) as well as importers of live animals would be low: the one off costs per operator 
range between 3 000 € and 3 600 € and the annual costs per operator around 100 €.   
These costs should be, in principle, relatively limited as EU operators have already the 
obligation to introduce information on all animals in systems in place in the EU (see 
Section 2.6.1. above). In practice, the cost is most likely to be higher because of the 
number of animals concerned.   
 
Table 6: Cost of traceability for offspring and descendants and their reproductive material (RM) 
 
in € 
EU farmers  
Live animals  
Breeding companies  
EU Importers    EU Importers  
EU Producers   
Number of operators 
Over 7 million 
22 
69 
215 
Learning  
Learning all operators     Marginal 
71 000 
251 000 
783 000 
Per operator 
Marginal  
3 227  
3 637  
3 641 
Complianc
Investments in 
Minor modifications 
Not available 

equipment  
to existing systems 
Operating costs  
Marginal  
Marginal  
Reporting 
all operators  
Marginal  
2000 
8 000 
22 000 

per operator  
Marginal  
90 
116 
102 
inspection  
* Source ICF GHK study tables 8.6, 8.7 and 8.8. 
 
   
ii) traceability of food and link with the individual animal  
 
Operators would need - throughout their operations - to be able to recognise whether 
every food is derived or not from progeny of clones. This would require a detailed and 
sophisticated (probably electronic) traceability system.  Without such a system, linking 
the food of progeny (over generations) to the animal clone is unworkable73. The setting 
up and implementation of such a system would produce require major investments and 
maintenance costs that the consultant was unable to estimate as shown in Table 7 below.  
 
                                                                                                                                                 
this time has been estimated at 70 hours per company. The minimum time necessary on a yearly basis to 
record the data and report it has been estimated at 2 hours per operator. Source : ICF-GHK Study   
73  As explained in Section 5.5. there is no physical difference between food from clones, food from their 
progeny and food from other animals.  
37 
 

 
 
Table 7: cost of traceability of food of offspring and descendants in non-segregated food supply chains 
 
In €  
Slaughterhouse 
Importers 
Food processors/ 
Wholesalers Retailers 
/ markets/ 
food  
manufacturers   
assembly 
 
centres  
Number of operators  
15 491 (bovine 
715  
81 993 (all species) 
82 801 (all 
623 812 
only) 
species) 
(all 
species) 
Learning  
All 
713 000 
30 000 
3 772 000 
No data 
No data 
operators  
Per operator  
46 
43 
46 
No data 
No data 
Compliance 
Unfeasible – no quantitative data   
(invest-
ments and 
operating 
costs) 
Reporting 
All 
1 426 000 
6 000 
7 544 000 
Marginal 
Marginal 
and 
operators  
inspection  
Per operator  
92  
8  
92  
Marginal 
Marginal 
Source ICF GHK study tables 8.6, 8.7 and 8.8. 
 

The consultant argued that these costs would be avoided in food supply chains if all 
actors involved (farmers, slaughterhouses, cutting plants, traders, etc.) “segregate” 
between  “clone/progeny” or “non-clone/progeny” .   
While this may limit implementation costs in terms of traceability, segregation would 
still bring about considerable market disruption, since a large part of the market of food 
would be not accessible for certain FBOs. It is not possible to quantify these impacts.  
However, considering that the number of animals concerned increases exponentially per 
generation (for example, for one single bull the number of offspring can be as high as 
5,000 to 10,000; for the 2nd generation up to 140,500 descendants and up 662,000 of the 
following 3rd generation, etc. (see details in Annex XIII paragraph 2). The repercussions 
on the market place for food could be very substantial74. 
While quantitative figures are not available, any additional costs are particularly relevant 
for meat, which is already very price-sensitive and where margins are generally low.  
The traceability of milk is even more difficult and costly than meat as it is systematically 
mixed from different animals at farm level and would need, separate collecting tanks75 at 
farm level and all following stages of the supply chain (transport, dairy, retail, etc.). The 
dairy industry76 explained that separate milk collection is strictly speaking feasible as it 
happens already for animals under medical treatment77 but the likely consequence of 
                                                 
74Although it is unlikely that all reproductive material of a single cloned will be used in one country. 
75 Milk from the animals is mixed in one tank at farm level and dairy plant level ; separate systems  already 
exist in some Member States for the collection of milk produced with specific requirements (related to 
animal feed, animal welfare etc.) but for larger production and with added value which compensate extra 
costs.  
76 The European Dairy Association (EDA).  
77 However, in this case, the traceability of the milk is no longer needed as it is destroyed and does 
therefore not enter the food chain.  
38 
 

 
having to label milk from progeny of clones is that farmers would avoid having those 
animals on their farms (see Annex III paragraph 3).  
At the following stages of food processing (such as meat products, dairy products and 
milk ingredients such as casein, etc.) the link with the animals concerned becomes more 
difficult and costly to establish as it imposes detailed segmentation of the different food 
products (or raw materials) before the processing can take place78.   
As regards SME's, they cannot be excluded from any of the traceability requirements 
mentioned above. This option has therefore a potential to impact SME profit margins and 
growth in particular as they do not benefit from efficient production systems and/or 
economies of scale enjoyed by larger firms. Labelling could present particular challenges 
for micro and small enterprises but there may be some differences among Member States 
(see Annex X).  
Thus, the traceability requirements for food poses risks of triggering significant impacts 
on the EU supply chain due to changes in third country trade patterns, mainly in meat 
(see Section  5.3.3. below). In case third countries' operators would be unable to label the 
food from offspring or from descendants, EU buyers would seek alternative supplies, 
which would result in changes in the distribution of demand across the supply chain.  
The impacts on the different Member States would depend on several factors, in 
particular the importance of animal production and their dependence on imports. As 60 
% of EU total production of dairy and beef originate in four Member States (France, 
Germany, Italy and United Kingdom), it could be assumed that in principle the farmers, 
breeders and FBOs in those Member States would be relatively more affected than those 
in the other Member States.  
During the consultations, industry representatives expressed themselves against labelling 
of food from offspring and descendants (as highlighted in Annex II and Annex III 
paragraph 3). They also underlined the risk of trade disruption.  In particular, 
representatives of European farmers /cooperative associations79  consider that traceability 
extended to offspring represent a real administrative burden for the whole supply chain 
without benefit to consumers and would be faced with legal uncertainty as they would 
depend entirely on accuracy of information provided by third countries. They would 
rather be in favour of using voluntary information schemes.  Professional organisations 
who responded to the "IPM consultation" also expressed themselves against (around 
65%) labelling of food from offspring and descendants of clones (including the 
association representing the European food industry80).   
Conversely consumer organisations, animal welfare associations and individuals, 
expressed themselves by a very high majority (between 75% and 90%) in favour of 
traceability system of reproductive material from clones and of labelling of food from 
offspring and descendants; results also showed that the absence of information was - 
wrongly81- perceived by consumers as an issue of food safety. Some industry 
                                                 
78 This is confirmed by evidence from an on-going study 2013: 'Study on the application of rules on 
voluntary origin labelling of foods (VCOOL)' FCEC (forthcoming) commissioned by the Commission that 
shows that segregation of supply chains can have significant impacts, depending on the sector, company 
and production method. For the last factor, in the case of continuing production process, the change to 
batch production in order to ensure segregation of different supplies can imply significant investments and 
adaptations of production processes. This is particularly the case for processed products.  
79  European association of farmers /cooperatives (Copa Cogeca). 
80 Food Drink Europe.  
81 EFSA concluded there is no safety issue -see paragraph 2.1. 
39 
 

 
representatives82 suggested during the consultations (Annex II) to inform generally 
consumers about the benefits and risks of cloning so that they would be well informed 
and would no longer have unfounded concerns.  
 
c) Cost for changing the label of the food   
Compared to the costs for ensuring traceability the costs for re-designing and re-printing 
labels are negligible. Estimates provided by the Commission impact report on food 
labelling range between 2000-4000 € for a small label change and between 7000-9000 € 
for full label redesign and per operator.  Results of other studies also show limited costs 
(see Table 8 below). 
 
Table 8 cost of labelling of food products 
European Commission (2008)  
Average cost at company level for a small label change: €2,000-4,000 per 
Impact Assessment Report on 
stock keeping unit (SKU); Additional cost for full label redesign: €7000-
General Food Labelling Issues 
9000.  
Private Label Buyer  (2011) 
Cost of redesigning a small private label line of approximately 100 SKUs: 
Special Report — Labelling 
$100-$3000 (€77 to €2320) in design fees ; Photography and illustration 
costs could more than double total cost 
Defra (2010) 
Average costs of changing a label for a food manufacturer: Voluntary 
Developing a Framework for 
redesign 4857 £/SKU (€6050) 
Assessing the Costs of Labelling 
Implementing of new legislation 2945 £/SKU (€3670) ; Average costs for 
Changes in the UK 
country of origin labelling for meat – large company: £600 - £1,150 (€748 
 
to €1433). 
Source: Defra (2010) Private Label Buyer (2011) European Commission (2008)  
The economic impacts of labelling depend also on whether it is voluntary (sub-option4) 
or mandatory (sub-option5):  
Sub-option 4 (voluntary labelling): operators interested in differentiating their products 
would label food as not stemming from clones, offspring or descendants on a voluntary 
basis. They could in these cases offset the additional costs (linked for example to private 
control schemes) by a higher selling price in so far as  there is market demand for such 
(more expensive) products and they can trace the food as described in section 5.3.2. (b) 
above. 
Sub-option 5 (mandatory labelling): unlike in the case of voluntary labelling, the costs 
set out above for sub-options 2 and 3, would fully incur if the labelling was mandatory. 
So if extended to offspring and descendants the additional cost would have to be borne 
by all (as explained in second indent of Section 5.3.5. below). 
    
5.3.3. Economic impacts on trade with third countries  

a) sub-option 1: food from clones  
The cloning companies and breeders in some third countries already register their 
animals as clones on a voluntary basis as reported in the consultations (see section 
1.2.2.). The cost for third country breeders has not been estimated but the cost for 
                                                 
82 In particular European association of retailers (Eurocommerce) and European Livestock and Meat Trade Union 
(UEBCV). 
40 
 

 
identifying clones and their reproductive material can be reasonably the same83as 
estimated for the EU and therefore relatively low (e.g. around 20,000 € if companies 
decided to set up a database of clones and around 4,000 € per company to upgrade their 
registration and traceability system of reproductive material84).   
 
b) sub-option 2: food from offspring   
If food from offspring of clones would need to be traced and labelled to be exported to 
the EU, the adaptation costs would be much higher in third countries85 than in the EU for 
food from offspring and descendants. Third countries generally86 do not dispose of 
individual animal identification and of national databases as the EU does. It is very 
unlikely that third country operators would afford such costs for the EU market only. No 
third country has expressed any readiness to put in place the identification and 
traceability system. 
  
In fact, EU's trading partners have repeatedly stated87 that no measures should be 
imposed on the reproductive material and on offspring of clones by the EU; they 
underlined in particular that “there is no scientifically justifiable basis for imposing a 
regulatory differentiation between the progeny of clones and other animals of the same 
species” and “that restrictions specifically aimed at food from progeny of clones – such 
bans or labelling requirements – could have negative impacts on international trade
”. 
They also pointed out that “science-based verification of audit and enforcement 
measures on progeny would be impossible
” and “that systems put in place would be 
potentially subject to fraud
” (see Section 5.5. below on control).   
This option may therefore create major trade disruptions with the EU88.  Exports of live 
animals and their reproductive material to the EU would also need to specify whether 
they originate from offspring or descendants so that EU FBOs could label their future 
food accordingly.  
The trade at risk for food could be substantial. Food imports of meat, milk and milk 
products are worth approximately € 3.6 billion each year89.  
c) sub-option 3: food from descendants 
If food from descendants of clones would need to be traced and labelled to be exported to 
the EU, third countries would first need to put in place a system to trace the offspring and 
their reproductive material (as described in sub-option 2 above) which is unlikely. In 
addition, as for offspring adaptation costs would be much higher in third countries90 than 
                                                 
83 No ICF-GHK figure on cost calculation for third country companies. 
84 Result of ICF-GHK interview of private breeding companies.  
85 It has to apply both in the third country which export to the EU and also the other third countries from 
which either live animals or reproductive materials are supplied. 
86  The EU requirements for individual identification apply (as described in section 2.6.1.) only if these 
animals are exported live or their reproductive material is exported to the EU.  
87 Joint statement on animal cloning for livestock production of 16 March 2011 by Argentina, Brazil, New 
Zealand, Paraguay, United States at www.ustr.gov. Correspondence to Commission of 26. October 
2012 signed by missions or embassies of Argentina, Brazil, New Zealand and United States in 
Brussels  
88 Meat and milk from our main trading partners may be exported to other international markets where 
consumption and financial resources are significantly increasing. 
89 Sources Eurostat 2012 – see table 2 in Section 2.6.3., paragraph c). 
90 It has to apply both in the third country which export to the EU and also the other third countries from 
which either live animals or reproductive materials are supplied. 
41 
 

 
in the EU. In view of the reluctance of third country operators to afford costs for tracing 
offspring and their reproductive material91 this option would be clearly rejected by third 
countries. This sub-option may therefore create even more trade disruptions with the 
EU92 in food and in live animals and their reproductive material.   
 
5.3.4. Impacts on consumer protection  
a) sub-option 1:  food from clones 
This option has a positive impact on consumers but as limited to food from clones, may 
not satisfy totally their request.  In view of the consumers' negative perception towards 
cloning, it is likely that FBOs would not market this food if "mandatory labelling" is 
requested and would not label it either on a "voluntary" basis.   
 
b) sub-option 2: food from offspring  
This sub-option brings in principle an added value in terms of protection of consumer 
interests as it is to offer consumer choice but does not cover food from clones.  There is 
also a considerable difference between voluntary and mandatory labelling for this type of 
food.  
 
c) sub-option 3: food from descendants 
This sub-option should offer an even higher benefit for consumers but would not make 
much sense if food from clones and from offspring would not be labelled. In effect, as 
shown in the consultations held, consumers have an interest for consumer choice linked 
to cloning and a partial one limited to descendants would not satisfy their expectations.   
  
d) sub-option 4: voluntary labelling  
In the case of voluntary labelling and if there is a market demand, the FBO could see an 
interest in differentiating their products. In this case, the voluntary labelling, would 
probably be "negative", i.e. specify that the food does not derive from cloning. FBOs 
have no interest in advertising food from clones, food from progeny of clones 
considering the strong negative attitude of consumers. It is therefore reasonable to 
assume that, based on consumer preferences, the market would decide for a "negative" 
labelling. This approach would however only offer a fragmented picture to consumers: 
not all FBOs would indicate the non-cloning origin of their food.  As a result, consumers 
would not know whether unlabelled food is in effect derived or not from clones/progeny 
of clones. In addition, it is also possible that no FBO would decide to label, in which case 
consumers would not be informed.  
                                                 
91 As it is a prerequisite to label food from descendants. 
92 Meat and milk from our main trading partners may be exported to other international markets where 
consumption and financial resources are significantly increasing. 
42 
 

 
 
e) sub-option 5: mandatory labelling  
Conversely, mandatory labelling would create a clear picture for consumers and a level 
playing field for all operators. It should be "positive" (i.e. specify that the food derives 
from cloning) in order not to impose a burden on farmers, breeders and FBOs not 
involved in cloning. Mandatory labelling provides for a clear and uniform consumer 
information and thus put consumers in the position to choose but, as explained above, it 
is very costly to implement.   
 
5.3.5. Impacts on food prices and employment   
The extra cost of positive voluntary labelling (as described in Section 5.3.4. (d) above) 
would be borne by consumers and would probably relate to local food production (e.g. 
cheese produced exclusively from local bovine breeds) which uses exclusively traditional 
breeding techniques, therefore limiting the cost of voluntary labelling and giving to the 
food an added value.  
In the case mandatory labelling (as described in 5.3.4. (e) above)  there would be an 
impact on production costs due to the cost of the obligatory traceability system and the 
pressure on suppliers to be able to prove whether their products derive or not from 
offspring or descendants. There could be a price increase for food which could be 
transferred to consumers, if elasticity of demand is low. If not, this would have 
consequences on breeders, farmers and importers who would need to bear additional 
costs and even suffer a reduction in activity and employment, in particular for SME's. 
 
5.3.6.. Impact on Animal Welfare 
Under this option animal welfare problems are not addressed.  
 
5.4. Option 4: temporary suspension of the technique and of imports of live clones, their 
 
reproductive material and their food.
5.4.1. Description of the option 
The temporary suspension of the cloning technique in the EU would ensure that Member 
States do not adopt national measures for welfare reasons, offering thereby legal certainty 
and clarity. Live clones, their food and their reproductive material would therefore not be 
produced on the EU territory.  
Imports of live clones93, of their reproductive material would need to be suspended to 
ensure a level playing field between all breeders and farmers in the EU and ensure full 
consistency with the suspension of the technique in the EU. 
As the technique may evolve over time and alleviate the welfare concerns, the suspension 
would need to be linked to a scientific review to assess whether it should be maintained 
or stopped, based on the possible technological evolution of the technique.   
The suspension of food of clones would address consumer perceptions on the use of food 
from animal clones; it would complement the suspension of the technique and of 
marketing live clones.  
                                                 
93 Including embryos, which are part of the cloning process as defined in Annex XIII paragraph 1,  and 
which if the cloning process is successful, will become life clones.   
43 
 

 
 
5.4.2. Economic Impacts  
As far as the EU is concerned, Member states have confirmed that cloning is not used for 
food production and therefore, no food from clones and no reproductive material from 
clones is produced on the EU territory. No food from clones has been imported so far in 
the EU and imports of live animals are in any case very limited. Therefore the expected 
economic impact of the temporary suspension of the cloning technique, of the clones and 
of their food is not expected to be significant to the contrary of reproductive material as 
explained below (Annex XI).  
 
- Suspension of the technique  
The suspension would have limited effect as no cloning is taking place in the EU. In the 
hypothesis that cloning for food production were more used in the EU, an increase in 
farming sector productivity could in principle be expected as the technique aims at 
reproducing elite animals94. However a recent economic study95 estimated that the 
increase of productivity in the milk sector would be limited to 0.35%, which is minimal 
compared to the annual productivity increase of 1.5% observed in Europe between 2006 
and 2009 without cloning activity.  
Representatives of European farmers and agri-cooperatives96 confirm that there is limited 
interest of European livestock keepers in cloning in view of the high cost of the 
technology but still consider that cloning could represent an interest in specific cases 
such as the preservation of valuable genetics (see summary of positions in Annex III 
paragraph 3 and Annex XIII paragraph 2 for the cost of cloned animals). This is also 
confirmed by the meat association97 as other breeding methods work better and faster for 
the purpose of animal selection; nonetheless cloning might in their view become more 
relevant in the future (minutes of meeting in Annex II). 
 
 
- Suspension of reproductive material of clones  
The actual impacts on Member States of suspending the reproductive material of clones 
may differ according to the importance of their livestock. As shown in Table 1 (see 
Section 2.6.3. above), imports of reproductive material from third countries are on 
average low (2.5 %) but represent in certain Member States more than 20 %. It is not 
known how much of this imported reproductive material is obtained from clones or from 
conventional animals. It is difficult to assess whether there are major differences 
regarding the impact of this suspension according to Member States, particularly as the 
breeding sector requires continuous exchange of high quality reproductive material 
especially for high output species.  
During the consultations and interviews with the consultants, EU breeders and farmers 
underlined that it is important to continue to have access to this genetic material to be 
                                                 
94 In fact according to a relatively recent study, there should be an increase in the milk production if 
cloning were more used in Europe: Butler, L.J., McGarry Wolf, M. (2010) 'Economic Analysis of the 
Impact of Cloning on improving Dairy Herd Composition', AgBioForum, 13(2): pp. 194-207. 
95 Buttler study 2010 Economic analysis of the impact on improving dairy herd composition. AS bioforum 
13(2):194-207. 
96 European association of farmers /agri cooperatives (Copa Cogeca). 
97 European Livestock and Meat Trade Union (UEBCV) 
44 
 

 
able to decide on their strategies to improve the productivity on a large base of genetics 
and improve or maintain their competitiveness (Annex XIII paragraph 4).  
 
 
 
- Suspension of food from clones  
As clones are not reared for food, it is unlikely that third country trading partners would 
from now on export food from clones to the EU in the future. This has not happened so 
far also because of the obligation to submit such food to a pre-market approval under the 
current Novel Food Regulation. Food industry in third countries where cloning technique 
is used would either remove food of clones from their food chain or remove it from the 
food exported to the EU. Taking into account the low number of clones and the fact that 
already today food cannot be imported as long as there is no PMA, this option has a very 
limited impact. 
 Regarding impact on competitiveness (Annex IX), the suspension of cloning technique 
in the EU is not expected to have direct effects on EU breeding companies, as there is no 
commercial cloning activity98 expected for food production until 2020. Possible impacts 
on cost competitiveness are expected to arise through the additional costs incurred in 
assuring that inputs meet the terms of the suspension in the EU and the contingent risk of 
loss of access to imports of live animals, their food and reproductive material. EU 
farmers (especially in the bovine meat/dairy and ovine sectors) would benefit from loss 
of competition from imports of food (meat and milk production) in scenarios where 
exports from third countries to the EU are disrupted or lost.  
Although research is not covered by this policy initiative, the potential for research may 
be affected if the commercial exploitation on the market is restricted. For example, 
cloning is used as a means to research in genome editing (which enables to identify at an 
early stage the productivity potential or other qualities of the adult conventional animals). 
Innovation in the breeding and farming sector could be more difficult to achieve in the 
EU and have serious long-term consequences on the ability of European farmers to 
access improved genetics, if European breeding organisations, which are global leaders, 
would relocate their activities outside the EU. It is therefore essential under this option, 
to consider the suspension as only a temporary measure so as not to discourage research 
and innovation in Europe and adapt the suspension to the evolution of the technique 
regarding its impacts on animal welfare.  
As reported in Annex III paragraph 3, the organisations representing farmers, breeding 
sector, food industry as well as research institutes99 expressed support for continuing and 
encouraging research in animal cloning. One organisation in particular100 acknowledged 
the concerns of health and welfare linked to cloning, considered that they should be 
further addressed through research and that a broader analysis would be needed in the 
longer term to assess the benefits of cloning.   
Regarding SME's, it is not possible to exclude them from the temporary suspension as 
this would undermine the objectives of providing for uniform conditions of production 
for the whole farming sector while ensure adequate protection of the welfare and health 
                                                 
98 Source ICF-GHK study. 
99 European farmers/agri cooperatives (Copa Cogeca); European association of retailers (Eurocommerce);  
the European Association for Animal Production (EAAP); the International Committee for Animal 
recording (ICAR); the International Embryo Transfer Society (IETS); the French institute for agronomic 
research (INRA)  
100 European farmers/agri cooperatives (Copa Cogeca) 
45 
 

 
of animals.  The impact on SME's mirror those expected on businesses as a whole (see 
Annex X). 
Third countries would, under this option, not be allowed to export live clones, their food 
and their reproductive material to the EU. The impact for live animals would be limited 
as trade of live animals is generally very low (in total only around 40 bovines and around 
800 porcine imported in the EU in 2011) the cost of identification and traceability of 
clones in third countries is relatively low (see paragraph a) Section 5.3.3 above).  The 
impact on food would be insignificant in third countries as of today food from clones can 
only enter the EU market subject a pre-market authorisation, which has never been 
requested and as clones are not produced to this end it is unlikely the situation will 
evolve. The pragmatic approach already adopted by some third countries (see footnote 6 
in Section 1.2. above) is to exclude the clones from the food chain on their territory. The 
suspension of exports of reproductive material of clones could have an impact but it is 
difficult to specify in the absence of any quantification of this material.  
 
5.4.3. Impacts on consumer protection  
This option has a positive impact on consumers: their concerns about animal welfare will 
be addressed as no cloning would take place in the EU. Consumers will have more 
confidence on the origin of products they are purchasing as food from clones would be 
forbidden and no food from offspring produced in the EU. However, they would not be 
able to make informed choices on food from descendants and imported food from 
offspring.   
 
5.4.4. Impacts on prices and employment  
The expected ‘direct’ employment impacts of the option of suspending the cloning 
technique and the use of clones is considered not significant because few EU jobs are 
sustained by commercial cloning for the farming sector. The potential employment 
impacts could arise through the induced and indirect effects of the legislation. Efforts to 
confirm compliance with the suspension legislation in particular for the reproductive 
material would create employment in the supply of verification services but this growth 
would come at the expense of employment elsewhere (more supply chain resources 
would be channelled into compliance activities at the expense of core business). It is 
however not possible to quantify such impact due to the lack of data available. 
As regards food prices, no impact is expected as the technique is not currently used in the 
EU (see Annex IX). 
 
5.4.5. Impact on Animal welfare  
This option has a positive impact on animal welfare, as it creates a level playing field for 
all farmers and breeders in the EU who no longer be able to make recourse to it. The 
suspension would be maintained a long as the concerns on animal welfare and health are 
not alleviated and be subject to scientific review so as to assess whether it should be 
maintained or stopped.  
46 
 

 
 
  5.5. Impacts on control (applicable to all options including non-policy change) 
 
Control on the implementation of any measure on cloning by control authorities can only 
be based on documentary and traceability systems, set up and managed by the successive 
operators along the food chain including in third countries where the cloning activity 
takes place.  
Physical controls based on analytical methods are not possible as the DNA of the clone is 
identical to the DNA of the donor and therefore the derived products (reproductive 
material and food) of clones and of progeny cannot be distinguished via laboratory 
testing. This could create potential legal uncertainty for operators, who would not be in a 
position to attest by analytical methods that the animals, reproductive material or food 
they have procured is derived or not from cloning.  
There would be no additional costs for Member States' control authorities as regards  the 
controls of intra-Union trade and imports of live animals,  their reproductive material and 
their food. The absence of additional costs is due to the fact that live animals, their 
reproductive and food are already submitted to specific official controls both as regards 
those produced in the EU and those imported101. Therefore, the additional information 
required as a result of this policy initiative would not trigger new activities by Member 
States. Conversely, additional resources would be required from FBOs (as described in 
Section 5.3.2) to check the reliability of the traceability systems, which support the 
labelling of food of clones and their progeny. 
 
The effectiveness of control relies primarily on third countries' readiness to put in place 
the identification and traceability systems of the clones as any of the policy options are 
dependent on this prerequisite. Controls in third countries can be ensured by the Food 
and Veterinary Office (FVO) which would verify that breeding companies and food 
operators exporting to the EU have put in place the necessary identification and 
traceability systems of the animals, reproductive material and food to ensure proper and 
reliable information. There would be no impact on the EU budget as the FVO already 
carries out inspections in the fields covered by this policy initiative.  
 
6. 
COMPARING THE OPTIONS 
The ranking of the impacts and objectives per option is given in detail in Annex XII.  
A summary of the ranking is given at the end of this Chapter. The impacts in terms of 
economic (costs), consumers (freedom of choice) and social (prices of food & 
employment) are compared for the various options.  As the options have no or very 
limited impact on environment (biodiversity), this criterion does not appear relevant to 
rank the options. All measures on cloning would produce costs for operators for part or 
                                                 
101 Intra-Union trade and imports of live animals and reproductive material must be accompanied by 
"health certificate" delivered by official authorities in Member States and Third Countries as described in 
Annex III.  
47 
 

 
for the food chain. These costs need to be justified balanced by added value in terms of 
animal welfare and consumer protection.   
 
6.1. 
Comparing the options in terms of impacts 
6.1.1. Option 1 (no policy change)  
This option has the lowest economic impact but only partially addresses consumer 
protection and welfare. It implies costs on FBOs interested to market food from clones as 
this requires pre-market approval of food. It allows labelling of approved products. Yet 
as there is no commercial interest in the marketing of food from clones, the actual 
implementation of PMA is unlikely.    
As to welfare, in light of the EFSA opinion, full implementation by Member States of the 
Directive 98/58/EC on animal welfare implies in principle that the cloning technique is 
not used for food production in the EU. This option has thus a positive impact on 
welfare. It has no impact on FBOs in general as they can under this option continue to 
import animals and food.  
 
6.1.2. Option 2: Pre-market approval of food from clones to food from offspring 
and descendants 

This option triggers impacts due to the multiplication of application dossiers for the 
required market authorisations for both EU and third country operators, to unavoidable 
additional burden on EFSA, to the necessity to trace the animals and their reproductive 
material in addition to the food. In the absence of food safety issues, the measures under 
this option are not proportionate in particular as regards food from offspring and 
descendants.  
    
6.1.3. Option 3: labelling of food (from clones, offspring and descendants) 
This option requires the traceability of animals, of their reproductive material and of the 
food to enable FBOs to label the food.  
 
a) For sub-option 1 (labelling food from clones), the impact on both FBOs and third 
countries is limited. 
b) For sub-options 2 and 3 (labelling of food from offspring and descendants) the costs 
for traceability would be substantial. The costs increase even further with the inclusion of 
each generation and with non-segregated food supply chains because of the underlying 
need for more sophisticated traceability systems. This is particularly the case when the 
labelling is compulsory (sub-option 2 and 3 combined with sub-option 4).  
 c) in the case of voluntary labelling of food from offspring or from descendants (sub-
options 2 and 3 combined with sub-option 4): FBOs would be able decide to label the 
“non-cloning origin” of their food if they dispose of the necessary information upstream. 
If this information is limited to the traceability of clones and their reproductive material 
and offspring, as foreseen in the Commission report, the impact is limited. However as 
labelling would be decided by FBOs,   consumers would only be informed scarcely.  
 
48 
 

 
6.1.4. Option 4: temporary suspension of the technique and the use of clones (food 
and reproductive material) 

This option ranks higher than option 1 as it creates legal certainty for all EU operators 
and applies in a coherent manner to the use of the technique as wells as to the use of 
clones. Its efficiency depends on its scope:  
(i) if limited to the technique, to clones and their food, the impact on EU FBOs and trade 
is limited as trade, if any, is likely to be extremely low and FBOs overall have no interest 
to market food from clones. The suspension of the technique would not impact 
negatively on innovation and research as it would be temporary and signal that research, 
(not touched upon by this policy) needs to be pursued. The possible use of imported 
reproductive material of clones (as mentioned in section 5.4.2. second indent above), 
justified for economic reasons, would not diminish the effects of this measure as the 
welfare of animals reared in the EU would be secured by the suspension of the technique 
in the EU and the suspension of live clones.  
 (ii) if the suspension would also include that of reproductive material of clones, it offers 
the highest coherence with the objective of animal welfare but may prevent EU breeders 
and farmers to have access to this genetic material, which they may have had so far, and 
thereby undermine their competitiveness.  
Therefore the elements of this option, which rank highest in terms of animal welfare, are 
the suspension of all elements except the reproductive material from clones. Otherwise, it 
ranks lower than option 1.   
 
 
6.2. 
Comparing the options in terms of objectives for coherence and efficiency  
6.2.1. Option 1 (no policy change)  
This option is coherent with the objective of consumer protection but only as regards 
food from clones. For food from offspring and descendants, this objective would not be 
fulfilled. In addition, this option adds costs linked to pre-market authorisation and risk 
assessment.  
The implementation of Directive 98/58/EC is coherent with the objective on welfare. It is 
not efficient as it applies only to the cloning technique and not to the use of clones, which 
means that farmers and breeders can still import them and use them.   
  
6.2.2. Option 2: Pre-market approval of food from clones to food from offspring 
and descendants.  

This option provides for consumer protection102 as it reassures consumers on safety as it 
applies to all food of the animals concerned. In the absence of "novelty" for food from 
offspring and descendants and in the absence of food safety issues, it is unjustified and 
incoherent to impose any PMA for this type of food, particularly as the food in question 
must in any case comply with the legislation on food safety (hygiene, control, additives, 
etc.). The PMA for offspring and descendants is also disproportionate; as described in 
section 5.2.2 above, unjustified costs would need to be borne for FBOs (linked to risks 
                                                 
102 Charter of Fundamental Rights of the European Union (2000/C 364/1) Article 38 on Consumer 
protection. 
49 
 

 
assessments and application dossiers, to the required traceability requirements of the 
animals concerned and of their food) and trade disruptions most likely.   
Therefore, the element of this option, which ranks highest, is the pre-market approval of 
food from clones.  
6.2.3 Option 3: labelling of food (from clones, offspring and descendants) 
 
Sub-option 1 (labelling of food from clones) would rank highest as not having any 
impact on trade but this type of food is unlikely to be marketed.  
 
Sub-option 2 (labelling of food from offspring) combined with sub-option 5 (mandatory 
labelling) for all food, would not be efficient as very difficult to put in place. In addition, 
it would considerably disturb trade with third countries and not attain the general 
objective (as described in  section 3.1).  
If sub option 2 is combined with option 4 (voluntary labelling) it would rank lower than 
mandatory labelling and option 1.   
Sub-option 3 (food from descendants) would be totally inefficient if mandatory 
(combined with sub-option 5) as unfeasible to put in place. If voluntary (combined with 
sub-option 4) it would not meet consumer expectations. Sub–option 3 ranks therefore 
lowest.  
Therefore, the elements of this option, which would rank highest in relative terms are the 
mandatory labelling of food from clones (sub-option 1 combined with sub-option 5) and 
of fresh meat of offspring (elements of sub-option 2 combined with sub-option 5).   
 
6.2.4. Option 4: temporary suspension of the technique and the use of clones (food 
and reproductive material)  

This is the only option (together with option 1) which addresses animal welfare. In terms 
of achieving the objective of creating uniform conditions for farmers while resolving the 
welfare issue, this option ranks higher than option 1. The freedom to conduct business 
might be restricted but this would be justified for the purpose of protecting animal health 
and welfare103. The objective of animal welfare can therefore be best achieved at Union 
level with this option. The suspension of the use of reproductive material of clones would 
not be coherent with the objective of safeguarding the competitiveness of the EU farming 
sector. Therefore, the elements of this option, which rank highest, are the suspension of 
the technique, of imports of clones and of food.  
 
 
                                                 
103 Charter of Fundamental Rights of the European Union (2000/C 364/1): Article 16 on freedom to 
conduct a business. 
50 
 

 
6.3. 
Table summarising the impacts 
 
 
Table 9  Summary of comparison of options of Section 6
OPTIONS 
Economic impact/ 
Effectiveness in reaching the objectives  
 
costs 
 
Animal welfare  
Consumer  protection 
Option 1     No Policy Change: Pre-market approval + labelling of food from clones on case by 
0 + 

case + Directive 98/58/EC on animal welfare. 
Option 2     Pre-market approval : Food from clones 


0/+ 
                     Food from offspring and descendants  
- - - 

0/+ 
Food from Mandatory labelling of food from clones (sub-option 1 + sub-option 5) 
0 0 
++ 
clones  
 
 
104  d
Food fr
Voluntary labelling of food fr
om 
om offspring (sub-option 2 + sub-option 
0 0  0/+ 
o
offspring 
4)  
f fo
o

 
 
 
Mandatory labelling of food from offspring (sub-option 2 + sub-option 
- - - 

+++ 
ling 
5) 
Food fr
 
om 
0 0  0/+ 
descendants  Voluntary labelling of food from descendants (sub-option 3+sub-
on 3 Label
option 4) 
Opti
- - - 

+++ 
Mandatory labelling of food from descendants (sub-option 3+sub-
option 5) 
Cloning technique 0 
+++ 
++ 
 
Clones 0 
+++ 
++ 
on in
nsi

Reproductive materials of clones - 



on 4 
pe

Food from clones 0 

++ 
Opti
(Sus
EU
                                                 
104 Option 3 is divided in five sub-options: sub-option 1 (food from clones), sub-option 2 (food from offspring), sub-option 3 (food from descendants), sub-option 4 (voluntary 
labelling), sub-option 5 (mandatory labelling). 
 +++ strongly positive; ++average positive +limited positive, - - -strongly negative, - - average negative; - limited negative; 0 no effect. 
51 
 

 
7. 
MONITORING AND EVALUATION 
In order to monitor and evaluate how the two specific objectives are implemented and 
performed in the various options, the following monitoring indicators could be used:  
Objective 1:  To ensure uniform conditions of production of farmers in the EU while 
protecting health and welfare of farmed animals
:  Scientific progress could be monitored 
by EFSA for both option 1 (to assess whether cloning is still a breeding that causes 
unnecessary pain) and  option 4 (to  measure  whether the suspension should be stopped, 
amended, for example in terms of coverage or be maintained);  
Objective 2: To protect consumer interests as regards food from cloned animals :  
- for both options 1 and 2, the number of applications made (and approvals given with 
labelling requirement) for food subject to a pre-market authorisation enables to assess 
which food has been authorised and which  food (if any) could not be authorised and for 
which reasons; 
- regarding option 3, specific surveys at national or EU level could assess which food is 
labelled on the EU market, if consumers' attitude has changed towards cloning, the 
effects of the measures on FBOs; statistics105 on the number of 
clones/offspring/descendants raised in the EU or imported would also give a picture of 
their share in the EU livestock.   
 
 
 
 
------------------- 
 
                                                 
105 Eurostat, TRACES (Commission management tool for tracking the movement of animals and of 
products of animal origin from both outside of the EU and within EU territory).  
52 
 

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ANNEXES 
ANNEX I: GLOSSARY ................................................................................................... 54 
ANNEX II: MINUTES OF THE ADVISORY GROUP AND BILATERAL 
MEETINGS WITH STAKEHOLDERS................................................................... 56 
ANNEX III: CONSULTATION STAKEHOLDERS....................................................... 77 
1. State of Cloning in Member States – Summary.................................................... 77 
2. State of Cloning in Third Countries – Summary .................................................. 82 
3. Stakeholders position ............................................................................................ 90 
4. Third country competent Authorities .................................................................... 92 
ANNEX IV: IPM SUMMARY REPORT AND ORIGINAL QUESTIONNAIRE ......... 94 
ANNEX V: EXECUTIVE SUMMARY OF THE ICF-GHK STUDY ON THE 
IMPACT IN THE EU AND THIRD COUNTRIES OF EU MEASURES ON 
ANIMAL CLONING FOR FOOD PRODUCTION .............................................. 109 

ANNEX VI: SUMMARY OF EU REQUIREMENTS ON THE IDENTIFICATION 
AND TRACEABILITY OF LIFE ANIMALS AND REPRODUCTIVE 
MATERIAL AND NOVEL FOOD ........................................................................ 127 

ANNEX VII: BASELINE SCENARIO (ECONOMIC)................................................. 136 
ANNEX VIII: EU STATISTICS ON IMPORTS OF LIVE ANIMALS, 
REPRODUCTIVE MATERIALS, MEAT, MEAT PRODUCTS, MILK AND 
MILK PRODUCTS (SOURCES COMEXT AND TRACES) ............................... 149 

ANNEX IX: IMPACT IN THE EU AND THIRD COUNTRIES OF THE EU 
MEASURES ON ANIMAL CLONING FOR FOOD PRODUCTION – 
EFFECTS ON SECTOR COMPETITIVENESS.................................................... 166 

ANNEX X: SME TEST .................................................................................................. 180 
ANNEX XI: ANALYSIS OF IMPACT ON TRADE IN CASE OF SUSPENSION OF 
CLONING TECHNIQUE....................................................................................... 188 
ANNEX XII: COMPARISON OF OPTIONS ON IMPACTS AND OF OPTIONS 
ACCORDING TO OBJECTIVES .......................................................................... 189 
1: COMPARISON OF OPTIONS ON IMPACTS................................................................. 189 
2: COMPARISON OF OPTIONS ACCORDING TO OBJECTIVES ........................................ 190 
ANNEX XIII: BASELINE SCENARIO (BACKGROUND INFORMATION)............ 191 
1. Technical Description of the Cloning Process .................................................... 191 
2. Price of Cloning, Cloning Activity Projected to 2020 and simulation of the 
number of offspring and descendants............................................................ 192 
3. Background Information on Cloning-Companies, Number of Clones in third 
countries and Supply Chain Management for clones in the US.................... 194 
4. Genetic Diversity....................................................................................... 196 
5. World Holstein Friesian Federation Guidelines for Registered Clones.... 197 
53 
 

 
ANNEX I: GLOSSARY 
"Artificial Insemination": Can be described as the injection of semen from a superior-
quality male in the reproductive tract of a female to make her pregnant. 
"Breeding": Consists in selecting the most suitable animals as parents of the next generation 
so as to improve1 on a regular basis the performance (in milk production, amount of muscles, 
resistance, longevity etc.) of the following generation(s). The improvements can bring high 
economic returns at breeding and farm level and be disseminated widely especially thanks to 
the high reproductive rates of the animals, the use of artificial insemination, embryo transfer, 
in-vitro fertilisation and more recently the use of genomic selection.  
"Breeding animals": Pure breed animals companies with high genetic value which produce 
reproductive materials (semen, embryos and ova) to perform artificial insemination or embryo 
transfer (males and females detained by farmers which are used for natural mating or calf 
production are excluded).  
"Cloning": Means a technique of asexual, artificial reproduction with the aim of producing 
an identical or nearly identical copy of the original animal by transferring the nucleus of a cell 
from the donor animal into an enucleated oocyte which is subsequently implanted into a 
surrogate mother (cloning does not involve any genetic modification). 
"Conventional animals": For the purpose of this report, conventional animals means all 
animals other than those having a cloning background (clones, offspring and their 
descendants). 
"Descendants (second and further generations)": Means an animal produced by a 
traditional breeding technique, where none of its parents is a clone but at least one of its 
ancestors was a clone. 
"Embryo Transfer": It consists in using a very good female to produce embryos (with the 
genetic material of both the female and the male). Each embryo from this female is 
transferred to surrogate mothers to give birth to the actual animals. 
"EU Food Law": (Regulation (EC) 178/2002): establishes the common basis for food law in 
Member States and includes common definitions, general provisions and specific 
requirements such as food traceability. 
"Generic authorisation": The pre-market authorisation is granted to all operators who can 
put the authorized product on the EU market provided they respect all the specifications and 
conditions of use. 
"Genome editing": Small changes or moving polymorphisms within a breed. 
"Genomic Selection": Is a technology that incorporates information from tens of thousands 
ADN positions to determine directly from the genome of an animal its genetic merit and 
future production and performances. 
                                                 
1 This is done by using the naturally occurring genetic variations that exists always between individual animals. 
54 

 
"Gross profit margin": describes the difference between revenue (price of a product) and 
cost (total costs incurred in production). 
"Herd book":  A book containing the list and pedigrees of one or more herds of choice 
breeds of cattle, pigs etc.; - also called herd record, or herd register.  
"Individual authorisation": The pre-market authorisation is only granted to the operator 
who filed the application. 
"In-vitro fertilisation": Is a process by which an oocyte is fertilised by semen outside the 
body of the animal to be then transferred into a surrogate female. 
"Offspring (first generation)": Means an animal produced by a traditional breeding 
technique, where at least one of its parents is a clone.  
"Pre-market approval": Is a regulatory measure according to which, new food products 
have to be authorized by the competent Authorities before being placed on the EU market. 
"Reproductive material": Means the semen, ova and embryos of animals to be used for 
traditional breeding techniques. These materials are produced by the breeding companies and 
used by farmers to obtain animals intended for meat and milk production.  
"Segregated food supply chain": Means that food operators would treat separately (on a 
separate processing chain or at a different period) the carcasses, the meat or the milk of clones 
and their progeny in order not to mix it with meat or milk from conventional animals. Basic 
identification and traceability (e.g. colour code) is sufficient not to mix the two types of food 
products. 
"Selection farms": Farms of animals with high genetic values used for the genetic 
improvement of specific breeds. In order to estimate the genetic value of these animals it is 
necessary to have an individual identification of them and at least to know the father and the 
mother of the animal. 
"Whole food supply chain": Means that food operators would treat simultaneously and on 
the same processing chain the carcasses and meat from i) clones and their progeny and ii) 
from conventional animals. This would require the setting up of new traceability systems or 
the upgrading of existing ones (such as those used for beef labelling of the origin). N.B. not 
possible for milk when mixed in the same tank. 
"Surrogate mothers": A surrogate mother is a female animal who bears a cloned embryo. 
She carries and gives birth to an animal that she is not the biological mother. 
"Traditional reproduction techniques": Are artificial insemination (AI), embryo transfer 
(ET) and natural mating (NM) used in the sexual reproduction of farm animals. 
"Veterinary Health Certificate": Is an official document signed by the official veterinarian 
certifying in accordance to general provisions laid down in Directive 96/93/EEC that the 
animals or products thereof meet certain generic (e.g. no clinical sign of disease) and specific 
(e.g. being tested with negative results) health requirements. 
 
 
55 

 
 
ANNEX II: MINUTES OF THE ADVISORY GROUP AND BILATERAL MEETINGS WITH 
STAKEHOLDERS 
1.  Plenary meeting of the Advisory Group on the Food Chain and Animal and Plant Health 
16 March 2012 (Point 5 of the agenda). 
2.  Working Group of 14 May 2012 on the Impact Assessment of measures on animal cloning 
for food production in the EU (Agenda and Summary).  
3.  Plenary meeting of the Advisory Group on the Food Chain and Animal and Plant Health 
26 November 2012 (Point 8 of the agenda). 
4. Report on the meeting of 20 September 2012 with EFFAB (European Forum of farm 
Animal Breeders). 
5.  Report on the meeting of 25 October 2012 with EDA (European Dairy Association). 
6. Report on the meetings of 5 September and 10 October 2012 with UECBV (European 
Livestock and Meat Trading Union). 
7. Report on the meetings of 12 September and 8 November 2012 with COPA-COGECA 
(European Farmers and European Agri-cooperatives). 
8. Report on the meeting of 18 December with UECBV (European Livestock and Meat 
Trading Union). 
56 

 
1. Plenary meeting of the Advisory Group on the Food Chain and Animal and Plant 
Health 16 March 2012 (Point 5 of the agenda). 

Impact assessment in the EU and third countries of measures on animal cloning for 
food production in the EU. 
 
COM presented the state of play of the Commission impact assessment on animal cloning for 
Food production; briefly clarified the terminology used and explained individual roadmap 
policy options. COM offered links to all available relevant information and informed 
participating organisations of the various general, as well as targeted consultations which are 
scheduled in the near future. COM also mentioned its request to EFSA to update its opinion 
on cloning by June 2012. 
 
COM presented the external study for the collection and analysis of data, the main objectives 
of which are to analyse the feasibility of options and to assess socio-economic and 
environmental impacts. COM asked participating organisations to provide written positions 
by 30 April 2012 and that public consultation using the Interactive Policy Making tool (IPM) 
will be available on its website by April. The impact assessment will be finalized by the end 
of 2012. COM's proposal on animal cloning for food production is planned for 2013, as 
indicated in the road map which has been recently published. 
 
COM's contractor, GHK Consulting, presented the main goals of its study, which are to 
examine the feasibility and the impacts of various policy measures that would govern animal 
cloning and the marketing of derived products in the EU, ranking from suspension of the 
cloning technique in the EU, the setting up of traceability systems for reproductive materials 
from clones and live clones and offspring, to pre-market approval, traceability and mandatory 
labelling for derived foodstuffs. 
 
GHK explained that the analysis will apply to several species (cattle, pigs, sheep, goats and 
horses) and be built around a model of the market that captures the EU production, imports 
and exports and a simplified schematic representation of the full supply chain. The external 
study will be finalized in the summer of 2012. 
 
Comments and questions raised: 
FESASS commented on the differences in legislation in the EU and 3rd countries and asked 
how the different implementations of legislation would be treated in the study. 
 
GHK confirmed that these would be considered in the study. 
 
FOODDRINKEUROPE asked what types of questions are in a questionnaire sent to the 
Member States and whether they are related to traceability. It also raised the question of novel 
food and asked when it is foreseen to come forward with the legislation on cloning and novel 
food, whether they would be separated and what the time line is. 
 
COM clarified that at the moment it has only been decided to present a proposal on animal 
cloning, which is scheduled for 2013. Regarding the novel food legislation, there is no 
decision yet on when it might be presented. With regard to the questionnaire sent to the 
Member States, COM pointed out that the questions are related to traceability and possible 
labelling and recording in the Member States. 
 
57 

 
EDA expressed concern about the feasibility of tackling such a broad issue within the given 
timeline. If stakeholders are to be asked to provide relevant data, sufficient time is needed. 
 
In reply to a request from EUROGROUP FOR ANIMALS on public consultations, COM 
gave further details, in particular that the questionnaire for the general public will be available 
on the Your Voice in Europe website in April for a twelve-week period. 
 
COM/GHK clarified to FESASS that there is indeed the intention to categorise different costs 
in the study so that it shows clearly which costs are related to the setting up of the traceability 
and labelling system. 
58 

 
2. Working Group on the Impact Assessment of measures on animal cloning for food 
production in the EU (Agenda and Summary).  

 
EUROPEAN COMMISSION 
HEALTH AND CONSUMERS DIRECTORATE-GENERAL 
Safety of the Food Chain 
Innovation and Sustainability 
   
Brussels, 14 May 2012 
D(2012)  
Working Group of the Advisory Group of the Food Chain, Animal Health and Plant 
Health on the impact assessment of measures on animal cloning for food production in 
the EU 
Summary report 
14 MAY 2012 
Participants: 
Commission - DG Health and Consumer: 
Chantal Bruetschy (Head of Unit E6) 
José Luis de Felipe Gardón (Deputy Head of Unit E6) 
Stakeholders: please see list attached 
1. Introduction 
Ms Bruetschy, Head of Unit E6, chaired the meeting. She explained that the purpose of the 
meeting, in the framework of the impact assessment procedure, was to collect the 
stakeholders' views on the possible measures to regulate the use of cloning for food 
production in Europe, as set out in the published roadmap. The aim of the impact assessment 
is to define the most appropriate policy while ensuring the functioning of the internal market, 
respecting the WTO agreements and guaranteeing consumer information.  
2. General positions on cloning 
CIWF stated its position against cloning, based on two general problems: the welfare issues 
for clones and the surrogate mothers and the fact that the technique will be used to produce 
copies of animals genetically selected for high yields despite the EFSA reports showing that 
high yielding animals often suffer from serious health and welfare problems. In this regard, 
the representative felt that current animal welfare legislation is not up to date on problems of 
high yield animals. He emphasized the need for ethic consistency and thus that any measure 
on offspring should take into account that such animals are the result of the use of the cloning 
technique at some stage. He also worried that feasibility hurdles would serve as an excuse for 
inaction. Finally, he stressed that the absence of safety issues does not make the problem of 
cloning less relevant to consumers. 
59 

 
UECBV is of the view that cloning is not of great interest for the meat industry in Europe 
today, as other breeding methods work better and faster for the purpose of animal selection, 
but that cloning might become relevant in the future. However, cloning is currently used in 
third countries that have trade relations with the EU. The uncertainty regarding the usage of 
the technique in the world would make identification and labelling requirements difficult to 
implement. The representative also felt that the tracing systems in place for cattle should not 
lead to an excessive and unfair burden on the beef industry. 
CLITRAVI said that WTO obligations must be respected, as import restrictions for products 
related to cloning (reproductive material, live animals and food) could be negatively 
perceived as technical barrier to trade.  
COPA-COGECA stressed the importance of SME's in Europe and that the majority of 
farmers are against cloning for food production purposes, since consumers are against it. 
However, Europe cannot isolate itself from the rest of the world, and the use of the cloning 
technique outside the EU has to be carefully assessed. The fact that food from clones and 
offspring is not distinguishable from other food raises feasibility issues for traceability and 
labelling. 
EFFAB mentioned that measures must be enforceable and that animal cloning is a 
reproduction technique, not a breeding technique. 
HOLSTEIN UK felt that progeny from clones and food from clones and offspring would be 
hard to trace and, therefore, expressed concern about the effectiveness of possible legislation. 
EUROGROUP for ANIMALS is not in favour of cloning for the same reasons exposed by 
CIWF. They believed that farmers that buy breeding material to improve the yield of animals 
should have information on where the reproductive material comes from.  
BEUC stated its position against the use of cloning for food production, given the great 
dissent of consumers. The representative stressed that consumers should have the right to 
choose and that, if marketed, food from clones and offspring should be labelled. 
FOODDRINK EUROPE has yet no official position on cloning; however it felt that, given 
there is no food safety but only an animal welfare issue, the topic relates more to actors 
upstream in the agricultural industry than to consumers. Possible measures should avoid trade 
disruptions, be proportionate and enforceable, and preserve the trust of consumers in the food 
industry.  
3. Detailed discussion 
To help the discussion, it was suggested to divide the theme into four main streams:  
a) current traceability of reproductive material/live offspring, b) possible tracing of 
reproductive material from clones/live offspring from clones, c) labelling and d) pre-market 
approval 
a) Current traceability of reproductive material/offspring 
Cattle: HOLSTEIN UK said that for pedigree animals, it is possible to know the ancestry of 
animals and reproductive material.  
60 

 
COPA-COGECA and UECBV observed that not all animals are purebred and registered in 
herd books, as it is not mandatory. Moreover, COPA-COGECA and HOLSTEIN UK pointed 
to the cross-bred animals, which are also not in the herdbooks. The percentage of cross breeds 
varies between 25% and 50 %, depending on the breed. 
FVE held that farmers sometimes trust an expert breeder and choose the semen based on 
production expectations rather than based on its ancestors. In relation to this, COPA-
COGECA mentioned that farmers may follow breeding programs to select the reproductive 
material they buy. In both cases, farmers may not be interested in the identity of the sire. 
Pigs: In most cases, breeding takes place with artificial insemination (AI) and no longer with 
natural mating (in some countries AI is reaching 80-90 %). COPA-COGECA said that, when 
AI is used, it is done with fresh and not frozen semen. Semen is traded in limited amounts. 
Goats:  Farms are usually small and not attached to breeding organizations. The percentage of 
AI is very low (it dropped considerably compared to 20 years ago, maybe between 5 % and 
10 %, exact figures are not available),UECBV observed that in the Netherlands production of 
breeding material for goats was stopped because it was not profitable. 
b) Possible tracing of reproductive material from clones/live offspring from clones 
HOLSTEIN UK said information on whether an animal is a clone can be included in the 
supporting documentation of pedigree animals, but that it would be difficult to verify the 
reliability of this information. However, not all Holsteins have a pedigree. The representative 
stressed that individual identification of animals does not exist in many countries, making a 
global certification system an unlikely possibility. 
UECBV said that, in order to be credible, a declaration on import certificates should not be 
based on the information on herd books only. It should instead be supported by official 
certification from public authorities. However, the representative considered that this measure 
could put the EU at risk of retaliation.  
A database with information on individual animals, similar to the one in place for European 
cattle, would only be useful if the major trade partners had one. This is not seen as a realistic 
possibility. Finally, a system restricted to European production would represent an unfair 
burden on European farmers, decreasing their competitiveness. 
CLITRAVI stated that a traceability system based on unreliable information would open the 
possibility for food scares. The representative doubted that third countries, such as the USA, 
would accept a measure requiring official certification of imports. 
EDA noted that, today, imports are allowed on the basis of the information provided by 
official certificates. They thus considered that inspections on procedures and official 
certificates would be sufficient to guarantee that foreign producers provide reliable 
information on reproductive material from clones and live offspring. Although less preferred, 
a system of "own check" procedures could work as well. This would force foreign producers, 
who wish to export into the EU, to have a procedure in place to guarantee reliable 
information. 
EFFAB reiterated the statement of COPA-COGECA on the impossibility of checking if a 
product involved cloning at some stage. FVE mentioned that a clone can be recognized by 
testing DNA.  
61 

 
Reacting to CLITRAVI’s statement on unreliable traceability system and food scares, BEUC 
stressed that information is key to building consumer confidence in the food system. Rather 
than waiting for news stories on “cloned” food to appear in the media – which will also result 
in costly food scares -, BEUC emphasized the importance to have, as soon as possible, a 
reliable system in place to inform consumers. UECVB thought that giving reliable 
information to consumers is important in this respect and mentioned the hormone free beef 
scheme as an example. 
Horses are usually not bred for food production purposes, but EDA said imported sports 
horses can be slaughtered and enter the food chain. COPA-COGECA said AI is not allowed 
in several major breeding organizations. Only geldings could need to be cloned, as they 
cannot reproduce naturally. 
c) Labelling 
CIBC noted that mandatory labelling would have the consequence that food from clones and 
offspring from clones would not be marketed and that no label would then exist in Europe. 
UECVB are not in favour of labelling. They stressed that labelling must be based on a good 
traceability system with strong guarantees on the reliability of the initial information. This is 
particularly important because the technique is perceived negatively by consumers. FVE 
suggested cloning could become a positive attribute in the future and that labels would be 
perceived as a value added to products. UECVB responded that, currently, this is not the case. 
They felt that the likely consequence of labelling would be the interruption of imports of 
reproductive material from clones.  
EUCOLAIT noted that any measure relating to food from offspring and descendants of clones 
(suspension, pre-market approval or mandatory labelling system) would effectively block 
imports of dairy products and likely be challenged at the WTO. As regards labelling of 
products from offspring and descendants born in the EU, EUCOLAIT considered that it 
would be difficult to label processed milk products because the milk comes from many 
animals. EDA responded that, in the production process, separating the milk of specific cows 
is feasible and is done regularly in the case of animals under medical treatment. This could be 
done also for cows that are clones or offspring from clones. However, it is likely that as a 
consequence farmers will avoid having clones and offspring from clones in their herd. 
Finally, EDA stressed that a labelling system should not be retroactive and should include a 
transition period. 
CLITRAVI expressed the view that labelling of food from clones could create trade 
disruptions. 
CIWF noted that retailers and consumers in Europe do not want cloning and that justifying 
measures with the WTO would not be impossible. The argument would need to be 
constructed properly, based on consumer perceptions and behaviour, the clause on public 
morals and case law. 
FOODDRINK EUROPE does not have an official position on labelling yet. It noted that in 
Europe, so far, labelling has killed technology and that it would be difficult to guarantee 
reliable information at all. It believed that labelling of food from clones could create trade 
disruptions. 
62 

 
BEUC stressed the importance of informing consumers and that trust is always involved in 
the business to business relation between producers and their suppliers. Consumers have not 
supported products deriving from new technologies when they do not see the benefits for 
them of using such technologies. Also in the US, consumers have strong concerns over the 
use of animal cloning for food production and consumer organizations in the EU and US, 
through the Transatlantic Consumer Dialogue (TACD), issued a joint resolution in 2008 for 
the suspension of food from clones. Reacting to a comment that it would be very difficult to 
impose labelling on imported food of animal origin, the representative said that, even though 
direct labels would be the preferred option also for third country products, country of origin 
information could be used by consumers as an indication of the possibility that cloning took 
place at some level of the production chain. 
EUROCOMMERCE has no position on labels yet. In general, retailers aim at offering 
consumers what they expect. 
COPA-COGECA expressed a preliminary position against labelling of food from offspring of 
clones because it does not see traceability as a feasible possibility. Farmers are not likely to 
take the risk of having clones and offspring form clones in their herds. The result of labelling 
would be to segregate the production flows of food from clones and their offspring and food 
from conventional animals. In the medium term, restricting the commercial use of the cloning 
technique could have a negative impact on the competitiveness of European farmers. They 
considered that if a certification system would be required only at European level, an unfair 
burden would be put on European producers with respect to producers outside Europe. 
Finally, COPA-COGECA underlined that research would only be pursued if it has prospects 
of commercial application. 
EFFAB worried that labelling and traceability measures would hinder research on cloning in 
Europe, which would risk decreasing the competitiveness in the future.  
There were no particular comments on descendants of offspring of clones or on the pre-
market approval measure. 
AVEC, ECSLA, FESASS, INFOAM EU, UEAPME and OIE did not express an opinion on 
the questions raised. 
4. Conclusions 
COM thanked the stakeholders for their contribution and asked them to complete the public 
consultation questionnaire with all the necessary technical explanation and data where 
possible.  
63 

 
Participation list 
Table 1: ADVISORY GROUP MEMBERS 
 

Association of Poultry Processors and Poultry Import and Export Trade 

AVEC 
in the European Countries 

BEUC 
Bureau Europeen des Unions de Consommateurs 
Centre de liaison des Industries Transformatrices de viandes de l'Union 

CLITRAVI 
Europeenne 
Comité des organisations professionnelles agricoles de l’Union 

COPA-COGECA 
européenne – Confédération générale des coopératives agricoles de 
l’Union européenne 

ECSLA 
European Cold Storage and Logistics Association 

EDA 
European Dairy Association 

EUROCOMMERCE 
European Representation of Retail, Wholesale and International Trade 

EUROCOOP 
European Community of Consumer Cooperatives 
EUROGROUP FOR 

Eurogroup for Animal Welfare 
ANIMALS 
10 
FESASS 
Fédération européenne pour la santé animale et la sécurité sanitaire 
11 
FoEE 
Friends of the Earth Europe 
FOODDRINK 
12 
EUROPE  (former Confederation des Industries Agroalimentaires 
CIAA) 
13 
FVE 
Federation of Veterinarians of Europe 
International Federation of Organic Agriculture Movements — 
14 
IFOAM-EU GROUP 
European Union Regional Group 
15 
UEAPME 
Union européenne de l’artisanat et des petites et moyennes entreprises 
16 
UECBV 
Union européenne du commerce du bétail et de la viande 
 
64 

 
Table 2: NON MEMBERS 
 

CIBC 
Confederation International de la Boucherie et de la Charcuterie 

CIWF 
Compassion in World Farming 

EUCOLAIT 
European Association of Diary Trade 

EFFAB 
European Forum of Animal Breeders 

HOLSTEIN UK 
Breed Society 

OIE 
Office International des Epizooties 
 
65 

 
3. Plenary meeting of the Advisory Group on the Food Chain and Animal and Plant 
Health 26 November 2012 (Point 8 of the agenda). 

Impact assessment for possible measures on animal cloning for food production – state 
of play on information received from stakeholders 
 
The Commission thanked the members for the various position papers received on cloning 
issue and the responses to the IPM consultation which are being examined. Commission also 
thanked for the technical explanation (breeding issues, herdbooks, genomics, etc.) given in 
bilateral meetings with COPA-COGECA, EFFAB, EDA and UECBV. 
The Commission acknowledged the difficulty for the members to obtain data related to the 
use and imports of reproductive materials in the EU and invited them to share information on 
this for all relevant species (bovine, but also porcine, caprine and ovine) in so far it is not 
commercially sensitive. Several members agreed to do their best and mentioned the fruitful 
cooperation with the Commission services on the technical understanding of the all related 
aspects.  
The Commission indicated that the work on the impact assessment report was on going and 
the legislative proposal on animal cloning for food production is planned for adoption by mid-
2013. 
66 

 
4. Report on the meeting of 20 September 2012 with EFFAB (European Forum of farm 
Animal Breeders) 

BTO report of E6 meeting with EFFAB on cloning issue (20/09/2012) 
Present: 
EFFAB, Topigs, UNCEIA representatives. 
SANCO: C. Bruetschy, J.L. De Felipe, J.F. Roche 
EFFAB is the European organisation representing the breeding sector for farm 
animals. 
1. Use of A.I. and embryo transfer 
•  Bovines 
- EU average of 75% of A.I. for milk production and < 10% for meat 
production (except for BE breed "blanc bleu belge" with very high %). 
- EU imports of reproductive materials mainly for milk production. Around 10 
% of semen is imported (milk) mainly to UK, Irl, NL, Italy and to lesser extent 
DE, BE, FR etc. 
- Costs for semen doses: 10-20 € for standard bull, 2-300 € for top bulls. 
•  Porcines 
- Use of locally produced fresh semen for production farms 
- Use of frozen semen (both from EU and third countries) limited to nucleus 
herds (selection: multiplication farms). Only 300 bores (males) at world level 
are used for A.I. with frozen semen. 
- Huge development of A.I. for meat production (95%). 
- Mixing of semen to increase fertility. 
- Cloning not interesting due to short intervals between the generations and 
quick genetic improvements; 
•  Ovines 
- Very limited use of A.I. for ovines because not economically worthwhile (for 
Lacaune breed for Roquefort production and only for selection farms for meat 
production). 
- Use of fresh semen only: No imports of semen. 
- Mixing of semen to increase fertility. 
•  Caprines 
- Use of A.I. for selection/ multiplication farms only. 
- No imports of semen. 
- Mixing of semen to increase fertility. 
 
2. Traceability for reproductive materials 
- Imports of semen only for pure breeds with full identification of the donor (EU health 
certificates). 
- No mixing of semen collected by semen centres (except for porcine and ovine); 
- Straws: identification of collect centre, animal individual identification, and date of 
collection. 
- DNA profiles to check the identity of the donor and its parentage but not applicable to make 
distinction between the original bull and its clones. 
67 

 
- Use of cloned bovine for reproductive materials to continue the semen production of top 
bulls when the original animals are no longer in use but overlap cannot be excluded as frozen 
semen may be stored up to 50 years. 
 
- No problem to trace in the EU imported semen from clones once it has been declared as 
such (no obligation under EU legislation to do so), but no idea about feasibility of such 
traceability in US / Canada. 
 
- EFFAB has set up a code of Good Breeding practices for bovines, porcine and poultry 
which is applied by breeding companies which are members of EFFAB but not by individual 
farmers which can directly import reproductive materials: to impose transit through EU 
agreed semen centres for registration and control. 
 
- Difficulty to control possible EU measures requesting third country exporters to identify and 
trace semen from clones: it cannot be based on DNA testing but on traceability systems based 
on documents. To set mutual agreements based on ISO certification and to involve the 
Authorities at some stage (e.g. validation of certification schemes). 
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5. Report on the meeting of 25 October 2012 with EDA (European Dairy Association) 
BTO report of E6 meeting with EDA (25/10/2012) 
Present: EDA, EUCOLAIT and Danish Agriculture and Food Council representatives. 
SANCO: C. Bruetschy, J.F. Roche 
EDA represents the EU milk industry. The EU milk sector is shared between 
cooperatives (60%) owned by farmers and private companies (40%). It is the milk 
industry which defines the standards and criteria applicable to milk quality (direct link 
to milk price paid to farmers). 
1. Trade of milk and milk products 
The EU does import very few milk, cream, butter or cheese (less than 1 % of EU production) 
while EU exports mainly cheese, milk powder and butter. However, the EU imports some 
high value milk ingredients amongst others from the US: MPC (milk proteins concentrates) 
and WPC (whey protein concentrates) and lactose. They are intended for incorporation in a 
large variety of EU milk products or foods (meat products, sport drinks, baby foods) to 
strengthen the protein content. 
2. Milk production 
- Reproductive materials 
Technical aspects to be discussed with COPA-COGECA. 
- Traceability for milk and milk products 
At farm level; all the milk is collected in the same tank (no separate collection on a regular 
basis would be feasible for milk from one or two cows in a herd). 
A 30 ton tanker is collecting milk each 1 to 3 days from a series of farmers. 
At dairy plant level, usually one storage facility where all the milk collected in a single day is 
mixed in the same tank(s). New marketing trend for bio milk or grazing cows' milk lead to the 
splitting of milk storage and processing at the dairy plant level where it is feasible but not at 
the farm level (specialised in that specific production). This segmentation is possible because 
of the economic interest (higher milk price) which would not be the case with milk labelled as 
originating from offspring/descendants of clones. 
Therefore, EDA is of the opinion that if EU traceability measures with a separate milk 
collection at farm and dairy plant would be imposed to the milk obtained from 
offspring/descendants of clones, then EU dairy farmers would exclude the use of reproductive 
materials from clones. This would be a fortiori the case if a labelling requirement is also 
imposed (no market for milk or milk products earmarked as from clones or offspring from 
clones). 
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6. Report on the meeting of 5 September and 10 October 2012 with UECBV (European 
Livestock and Meat Trading Union). 

BTO report of E6 meeting with UECBV on cloning issue (5/09/2012 and 
10/09/2012) 
Present: 
UECBV, Dutch and French Federation representatives. 
SANCO: C. Bruetschy, J.L. De Felipe, J.F. Roche 
UECBV is composed of 56 national federations of meat industry including EEA 
countries, Croatia, Turquia and Russia. They are competent for meat production (EU 
slaughterhouses and cutting plants) and imports and exports of meat. 
1. Bovines 
•  Background: EU production and trade 
The EU is the 2nd world producer for pork meat (after China) and for bovine 
meat
 (after USA). EU is self-sufficient for porcine and poultry and in deficit 
for bovine (3-4%), ovine (20-22%) and horses (80%) meat
EU beef production originates 2/3 from milk breeds (by product of milk 
production) and 1/3 beef breeds.  
EU bovine and ovine meat production decreasing on a regular trend and 
EU  consumption  as well. Porcine production is stable but rentability is 
negative for most farmers. 
EU imports bovine meat from: 
i) 
South America (mainly Argentine, Brazil, Uruguay) but in significant 
decrease (local and emerging countries demand is increasing and other 
competing productions (bio-fuel, feed) severe decrease of cattle 
production in Argentina partly compensated by Brazil). 
ii) 
USA mainly with major increase of EU imports (extension of UE 
import quota in context of new EU-US agreement on hormone free 
beef production for EU).  
EU exports bovine and pork meat in Russia mainly but also in China, Japan, 
South Korea and Turkey. 
•  Individual identification 
EU system: Based on double ear tags (electronic identification proposed in 
Commission legislative proposal which revises Regulation 1760/2000). 
Third countries: no individual identification except for Australia, New-
Zealand (whole production) and Argentina 
(for farms which export to the 
EU). 
For US and Canada feed lots (identification by batch, certification on methods 
of production (hormone free etc.) before slaughtering. No information on the 
background and parentage of individual animals before age of 3 to 4 months 
where they enter into feed lots (A.I. and cloning would also be used for meat 
breeds such as Hereford and Angus). 
70 

 
•  Reproductive materials 
-  Imports of reproductive materials
 quasi exclusively for milk breeds 
(Holstein mainly), very limited imports for beef breeds (Angus and Hereford in 
UK / IRL). 90-95% of I.A. for milk production among which around 20% 
imported from 3rd countries. 
-  30% of EU Holstein cattle would have common genetic with US Holstein 
cattle (due to imports of reproductive materials from US). The cloning issue 
(reproductive materials aspects) is in the hands of the EU milk sector (both 
farmers and milk industry). 
-  Top list of 50 to 100 US / Canada Holstein bulls with ranking system (on milk 
quantity, proteins, conformation of animals) with possibility for EU farmers to 
order directly semen from these bulls.  
•  Food products 
-  
There would be no market for beef identified and labelled as derived from 
clones, offspring and descendants. If EU cloning legislation would set up 
traceability and labelling measures for those food products, no products will 
be labelled in practice as meat from clones/ offsprings/descendants would 
be excluded from EU production: 
It would therefore potentially apply only 
to beef imports. 
-  According to NL federation representative, the same objective (EU clone free 
beef and milk production) could be met through a commitment of all EU 
operators (farmers and industry) to put in place commercial agreements on a 
contractual basis with third countries exporters to ensure the importation of 
"clone free" reproductive materials (and of live animals). This could be done 
through a formal commitment of EU farmers and EU meat and milk 
industry, 
as already done in the "Bruxelles declaration" against pig castration 
practices in the EU (supported by both Council and EP). 
-  Each food operator has its mandatory traceability system for the labelling of 
beef origin which is chosen and adapted by each operator depending its needs 
(slaughterhouse/ cutting plant / retailers). 
-  Those traceability systems enable to trace back from a steak to a batch of 
around 20 adult bovines or 100 calves originating from various farms. 
 
2. Ovines and caprines 
•  Individual identification 
- On paper similar individual identification than for bovines (except electronic 
identification instead of ear tag). In practice, individual identification for ovine 
and caprine would not work properly: i) complexity and high costs for 
electronic identification and ii) many derogations which are foreseen by either 
EU Regulation (ex < 650.000 ovine for a M.S. such as in Hungary) or decided 
at national level (derogation for ovine which are directly intended for 
slaughtering and remain on national territory). 
•  Reproductive materials 
- No more use of A.I. for ovine and caprine in the EU and therefore no 
imports of reproductive materials from third countries. 
•  Food products 
Imports of ovine meat mainly from N-Z and Australia. 
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7. Report on the meetings of 12 September and 8 November 2012 with COPA-COGECA 
(European Farmers and European Agri-cooperatives). 

BTO report of E6 meeting with COPA-COGECA on cloning issue 
(12/09/2012 and 8/11/2012) 
Present: 
COPA-COGECA representatives. 
SANCO: C. Bruetschy, J.L. De Felipe, J.F. Roche 
1. Bovine 
The general problem is that there is no harmonized EU statistics, but rather 
information from single countries, which is not collected in the same way. In addition, 
it shows a large variation with respect to the requested figures or indicators. 
Use of A.I. and embryo transfer 
- High level of A.I. (around 90%) in main producing countries for bovine milk 
production while only 20 % for bovine meat production (in NL it is 40 %). 
- For beef production, use of A.I. is limited to multiplication farms (breeding 
programs) and not use by meat production farms. The reason for that is that AI 
is rarely used for beef cows is that they are outside for most of the year and 
thus not accessible for the farmer or the AI technician. 
- EU average of 10-15% of imported bovine semen (would be up to 40 % in 
U.K. / NL for Holstein breed) mostly managed by European subsidiaries of US 
/ Canada breeding companies.  
Overall imports of the EU-27 have been about 9.7 millions doses in 2011 
(Eurostat). A large share is traded between Member States, showing the 
increasing collaboration between breeding organisations in different Member 
States, e. g. Germany and Austria, the Netherlands and Belgium or Denmark, 
Sweden and Finland.) 
Semen marketed in the EU by US breeding companies would not be from 
clones (commercial agreement) but  this commercial agreement has not been 
confirmed by competent professional organisations.  
- No statistics on national production nor on intra-CE trade of semen: data are 
kept by the semen centres; however, data on the use of semen at national level 
are collected by national professional organisations but only for some Member 
States and not in a harmonised way. 
- There is no EU statistics, Eurostat also provides figures for intra-Union trade; 
however these do not always look reliable as you can find big discrepancies 
between the imports of country A from country B compared to the exports of 
country B to country A although the figures should be roughly the same.  
- Data on Traces are different and lower than those from Eurostat (1.8 Million 
doses of imported bovine semen compared to around 10 Million doses for 
Eurostat). This results mainly from the lack of harmonisation of the 
72 

 
registration of semen doses (by kg, by volume, by number of doses etc.) by the 
competent Authorities at EU Border Inspection Posts where the primary 
objective is to control the compliance with EU animal health and zootechnical 
legislation. 
WHFF guidelines (Holstein breed) on cloning (2006) requires that: 
- name of cloned calf = name of original animal followed by number 2 
(2.1; 2.2 etc.). 
- semen from clones and embryo obtained by cloning technique should 
bear a suffix ETA /ETN for their identification and registration. 
- it is important to note that the identification of the source animal 
should be recorded, too, and that each breed association should 
establish its own procedure relating to the registration of progeny of 
clones. 
 
•  EU Breeding organisations 
- Semen centers and breeding organisations are either cooperatives or private 
companies: relative importance between the 2 types of actors varies depending 
Member States. 
- Use of embryo transfer in breeding programs only: to obtain mothers which 
will produce reproductive bulls (100% genetic under control with embryo 
transfer while only 50 % with semen). 
- Management by milk/meat performance organisations with computing 
centres. Assessment of breeding value based on several criteria (health, milk, 
meat, fertility, longevity, functional traits etc.) 
- All breeding bovines in semen centres are registered in herd books as well as 
pure bred bovines from production farmers (to be supplied only with approved 
semen). 
- Milk farmers produce and sell calves to meat producers of calf meat and JBB 
for feedlots (JBB jeunes bovins de boucherie). Milk farmers do not register the 
pedigree of the calves intended for meat production. 
2. Porcine 
- A.I. is the rule (100%) for selection / multiplication schemes but also in rapid 
increase for meat production. 
- Very limited imports of semen (frozen semen) and only for 
selection/multiplication schemes: Use of fresh semen locally produced except 
for imports. 
- Common practice to mix the semen of different reproductors to produce 
semen doses in order to boost fertility (no parentage traceability). This practice 
is not done for selection purposes. 
- Pork meat production is very competitive and prices are relatively high for 
the moment, however, feed prices as well, hence margins remain low: no 
market for "clone free" pork meat.  
73 

 
 
 
3. Ovine and caprine 
- A.I. is the rule for selection / multiplication schemes. 
- Common practice to mix the semen of different reproducers to produce 
semen doses in order to boost fertility (no parentage traceability).  
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8. Report on the meeting of 18 December with UECBV (European Livestock and Meat 
Trading Union). 

BTO report of E6 meeting with UECBV on cloning issue – porcine sector 
(18/12/2012) 
Present: 
UECBV, Dutch Federation and Pig Research Centre in Denmark representatives.  
SANCO : J.F. Roche, J.L. De Felipe 
Porcine sector: 
Cloning in the porcine sector is not in use in Europe for production purposes. This 
technique is not needed for reproduction of pigs as there are large litters and a short 
time interval from one generation of pigs to the next, and the costs of cloning is not 
justified, either in the nucleus herds or at the production level. This report is therefore 
more a description on the structure of the pig production, the breeding and 
reproduction techniques used, like AI, and the trading of pigs in the porcine sector.   
The structure of the porcine sector is divided mainly in three levels. The nucleus farms 
in which the boars and sows are present for genetic distribution, the multiplying farms 
with sows producing crossbred gilts and finally the production farms for for crossbred 
production and fattening of the piglets for slaughter. 
AI for pigs started in the 70' and since then is done mainly by the farmers using fresh 
semen. The preservation system of fresh semen has been improved enlarging the life 
time of semen from 3 to 5 days.  Frozen semen is reducing the quality of semen and 
consequently the litters are small. 
The use of AI is generalized and in average the use is >90% in countries like DK and 
NL. For the selection in the top of the pyramid the percentage even could reach 95%. 
It is difficult to give a figure for others EU Member States. Embryo transfer technique 
is not used in the porcine sector. Inseminated sows have 2.3-2.4 litter per year. Mixed 
semen from 5 different boars is a common practice in the production level in several 
Member States. This technique has proven to increase the litter size with one-two 
more piglets per litter. Germany is not using the mixing of semen. Nevertheless, the 
mixing is never done between boars of different AI centres for sanitary reasons. In 
case of an animal health problem the blockage of the AI centre has more serious 
implications than the blockage of the animals at farm or slaughter level. Porcine 
semen is managed via AI centres, EU approved or not, for international trade or local 
trade. Boars from the top of the pyramid (breeding herds) are used in average 6-8 
months and for boars used at the production level the boars are used during 1 year to 
1.5 years (differs from country to country). Breeding values are calculated for all 
breeding pigs and these values are used for selection of the new generation of breeding 
pigs.   
As regards trade of semen, the practice is not to import or export frozen semen but 
fresh semen or live boars. A certificate of pedigree (several known generations) and a 
health certificate usually will accompany this type of trade.  
75 

 
Import of live animals is very limited (Denmark and Netherlands). On the other hand a 
lot of live females, semen and some boars are exported from these countries all over 
the world. 
At the production level Denmark and the Netherlands are exporting 9.3 (DK, 2012) 
and 3,8 million (NL, 2012) piglets for fattening per year and Germany is one of the 
biggest recipients. These piglets are not individually marked and cannot be traced by 
pedigree, but identified by batch when they leave the farm or the country. Production 
sows, mainly crossbreds, could be identified at the farm but they don´t have a known 
pedigree.  
Cloning activities in pigs is not taking place in Europe. In Canada, in a research 
project, a type of transgenic pig has been cloned some years ago to produce a pig with 
the capability to excrete less phosphorus than ordinary pigs. There is no known 
activity on cloning for farming purposes in the EU.  There is only cloning activities 
and research going on in the medical humane sector. However, possibilities to 
evaluate and develop the cloning technique for research could be important for the 
sector in the future. 
The lack of cloning activities in pigs is justified by the short production period for a 
boar (generation interval could be 400 days for a boar) and the large litters of pigs 
produced. There is no economic interest to clone specific boars as their production life 
is so short and the cost of cloning is high. Farmers buy a genetic line more than a 
specific boar. The genetic lines are adapted to the different type of production and the 
preferences of the consumers in the different Member States (e.g. more or less fat in 
the meat).    
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ANNEX III: CONSULTATION STAKEHOLDERS 
1. State of Cloning in Member States – Summary 
The following summary contains the information given by Member States that replied to the 
consultation questionnaire. All 27 Member States have answered.  
National Legislation  
The Member States do not have special legislation regarding the cloning technique and its use 
for food production purposes, with the exception of Denmark. In Denmark cloning and 
genetic modification of animals, including import and breeding, is regulated by law nr. 550 of 
June 24th 2005. Essentially, the use of cloning is subject to an authorisation and it is allowed 
only when it is of substantial benefit for health and environmental purposes. In addition in the 
United Kingdom, cloning for research purposes is covered by the Animals (Scientific 
Procedures) Act 1986, but its use for commercial purposes is not regulated.  In the 
Netherlands, the Dutch Animal Health and Welfare Law forbids the use of biotechnical 
techniques on animals, unless the minister decides to grant permission, based on ethical 
motivations on the purpose of research. In Finland cloning is indirectly covered by general 
law on vivisection and animal welfare and in Portugal by law on the protection of animals 
kept for farming purposes. Finally in Germany commercial cloning is indirectly covered by 
animal welfare and in case of experimental trials permission is required.  
 
Use of cloning for breeding purposes 
None of the surveyed authorities reports the use of the cloning technique in breeding of 
species used for food production purposes, and therefore no country has identification 
requirements for clones or reproductive material from clones, except in Germany where 
clones are registered as such in herd books and detained in semen centres and whose semen is 
exported to third countries outside the EU. This semen is neither distributed nor used inside 
the EU. The products of these cloned animals cannot enter in the food chain. 
 
Information from Germany, received after this consultation, confirms that there are 
currently no live cloned bulls anymore in Germany
. In France the technique has been 
used for the breeding of race horses; a registration system for the identification of horses' birth 
origin is in place. This system can provide information on the reproduction technique, 
including cloning. In Spain the technique has been used successfully on bovine only once. 
 
Identification or registration 
Member States authorities do not monitor if imported animals or reproductive material 
originates from cloned animals; in most cases it is thus not possible to know whether there 
have been any imports of cloned animals or reproductive material from clones. The exception, 
again are  the cases of Germany of clones of elite bulls who are registered in herd books and 
their semen is marketed in third countries and the race horses in France, which have a 
specific registration system (SIRE/Haras nationaux). 
 
Animal health and welfare  
No information about improvements in the health and welfare conditions of animals used in 
cloning is known to any Member State competent authority. An "Opinion on the Welfare 
implications of Breeding and Breeding Technologies in Commercial Livestock Agriculture" 
77 

 
has been published in November 2012 by the United Kingdom Farm Animal Welfare 
Committee. No improvements in the health and welfare of animals are mentioned. 
 
Scientific risk assessments  
The French national agency for the safety of food, environment and work (ANSES) has 
published a report in September 2005 on the risks and benefits related to cloning. This 
assessment is mainly focus on Bovines, descendants of clones are considered as similar as the 
animals obtained by traditional reproduction techniques and due to the reduced data it 
suggested to perform more analysis and collection of data during several generations.  
The Board of the Food Standard Agency in the United Kingdom asked the Advisory 
Committee on Novel Foods and Processes to conduct a hypothetical assessment of an 
application of food from cloned animals (cattle and pigs) under the EU Novel Food 
Regulation 258/97/EC. The main conclusions were that: no differences in composition 
between meat and milk of conventional animals and clones and their progeny, which is 
therefore unlikely to present any food risk; the data on composition are limited and more 
evidence is required on how different environments may affect the meat and milk; any 
potential differences between conventional cattle and the progeny of a clone were unlikely to 
exist from the second generation onwards and finally consumers may want to see effective 
labelling of products from clones and their offspring.   
Other Member State authorities base their opinion on the EFSA scientific documents. 
 
Research 
Cloning is used for research purposes in the Czech RepublicDenmarkEstoniaFrance
Germany,  Italy, Spain and the United Kingdom. In the Czech Republic studies focus on 
processes of reprogramming of transferred nuclei – epigenetic modifications. In France
research focused on the technique itself, on the development of cloned animals and to study 
the contribution of epigenetic to the variability of phenotypes in cloned animals. In Italy one 
company is working on cloning with pigs for humane health purposes. In Spain research is 
pursued with the purpose of improving the SCNT technique itself, of using pigs for human 
disease research and for animal species preservation. 
 
See summary table below. 
 
78 

  
Country 
National 
Use of cloning 
Identification of clones 
Identification of  Imports of clones or 
Identification of Improvements 
Risks assessment 
Cloning for research 
legislation 
Rep. Materials 
Rep.Materials 
imported clones or 
on animal 
Rep. Materials 
health 
Austria 
No 
No 
No 
No 
No 
No 
No 
No 
No 
Belgium 
No 
Yes for horses. 
No official registration. 
No 
Yes for horses Yes for live horses. 
No 
No 
No 
Unknown for 
AWE foresees a code at 
Unknown for other  Imported horses 
Unknown for 
other species 
the end of the name. 
species 
have specific 
horses 
None have been 
identification with a 
registered. 
Greek letter in their 
name registered in 
the Studbook. 
Bulgaria 
No 
No 
No 
No 
No 
No 
No 
No  
No 
Cyprus 
No 
No 
No 
No 
No 
No 
No 
No  
No 
The Czech 
No 
No 
No 
No 
No 
No 
No 
No 
Yes, at the Institute 
Republic 
Animal Science  
and the Institute 
Animal Physiology 
and Genetics 
Denmark 
Yes, Law on  No 
All cloned animals 
No 
Unknown 
No 
No 
No 
Yes, at the University of 
cloning and A permission is  produced following the 
Aarhus 
genetically 
needed for 
research permission are 
modification 
research purposes 
identifiable by 
of animals, 
registration of the 
law nr. 550 of 
animal. Imported cloned 
June 24th 
animals, who are 
2005.    
regarded to be few, are 
not registered. 
Estonia 
No 
No 
No 
No 
Unknown 
No 
No 
No 
Yes 
Finland 
Indirectly 
Unknown 
No 
No 
Unknown 
No 
No 
No 
No 
 
through 
 
legislation on 
 
animal 
 
welfare and 
 
animal 
 
testing. 
 
Cloning not 
 
specifically 
 
mentioned. 
 
 
 
 
 
 
 
 
79 

  
Country 
National 
Use of cloning 
Identification of 
Identification of Imports of clones or 
Identification of Improvements 
Risks assessment 
Cloning for research 
legislation 
clones 
Rep. Materials 
Rep.Materials 
imported clones or 
on animal 
Rep. Materials 
health 
France 
No 
Yes. Only one 
Yes. Only for horses  No 
Unknown 
No,  
No 
ANSES report on 
Yes, at the National 
company  that 
bred for use in sports 
except  
the risks and 
Research Institute for 
breeds horses for 
(SIRE/Haras 
for  
benefits related to 
Agriculture (INRA) 
sport purposes is 
nationaux). 
horses 
cloning by (2005) 
known to the 
authorities 
Germany* 
No 
There are 
No, but they are 
No 
Unknown 
Unknown 
No 
No 
Yes, at the Friedrich-
Legislation on  currently no live 
registered in herd 
Loeffler-Institut (FLI) 
animal 
cloned bulls in 
books. It is not 
welfare. 
Germany 
possible to give exact 
Permission 
figures on the number 
for 
of clones. 
experimental 
trials. 
Greece 
No 
No 
No 
No 
Unknown 
No 
No 
No 
No 
Hungary 
No 
No 
No 
No 
No 
No 
No 
No 
No 
Ireland 
No 
No 
No 
No 
No 
No 
No 
No 
No 
Italy 
No 
No 
No 
No 
No 
No 
No 
No 
Yes, the genetic center 
AVANTEA on pigs for 
humane health purposes  
Republic of 
No 
No 
No 
No 
No 
No 
No 
No 
No 
Latvia 
Lithuania 
No 
No 
No 
No 
No 
No 
No 
Yes (EFSA 
No 
assessments) 
Luxembourg 
No 
No 
No 
No 
Unknown 
Unknown 
No 
No 
No 
Malta 
No 
No 
No 
No 
Unknown 
Unknown 
No 
No 
No 
*Information received from Germany after this consultation confirms that there are currently no live cloned bulls in Germany
80 

 
 
Country 
National legislation 
Use of 
Identification 
Identification of Imports of clones 
Identification of imported  Improvement
Risks assessment 
Cloning for research 
cloning 
of clones 
Rep. Materials 
or Rep.Materials 
clones or Rep. Materials 
s on animal 
health 

The 
Indirectly through 
No 
No 
No 
Unknown 
No 
No 
No 
No 
Netherlands 
the Dutch Animal 
Health and Welfare 
Law. Special 
permission for 
research purposes 
Poland 
No 
No 
No 
No 
No 
No 
No 
No 
No 
Portugal 
Indirectly through  
No 
No 
No 
No 
No 
No 
No 
No 
protection of animals 
kept for farming 
purposes (Dir 98/58) 
Romania 
No 
No 
No 
No 
Unknown 
Unknown 
No 
No 
No 
Slovak 
No 
No 
No 
No 
Unknown 
Unknown 
No 
No 
Yes (In cooperation 
Republic 
with INRA) 
Republic of No 
No 
No 
No 
No 
No 
No 
No 
No 
Slovenia 
Spain 
No 
Not 
No 
No 
Unknown 
No 
Yes (Article No 
Yes, Universidad 
currently 
from 2008) 
Autónoma de 
Barcelona,  University 
of Murcia,  Research 
and Agroalimentary 
Technology Center of 
Aragón (C.I.T.A.)  
Sweden 
No 
No 
No 
No 
Unknown 
No 
No 
No 
No 
United 
Only for research 
Unknown 
No 
No 
Unknown 
No 
No. 
Yes. 
Yes.  
Kingdom 
purposes through the 
Report by the   
Not possible to 
Animals Act 
Farm Animal 
disclose this 
(Scientific 
Welfare 
information obtained 
Procedures) 1986. 
Committee. 
in the course of 
Commercial SCNT 
No 
functions under the 
is not covered by the 
improvements 
Animal Act of 1986.  
Act. 
are mentioned 
81 

 
 
2. State of Cloning in Third Countries – Summary 
The European Union trades with partner countries in sectors that are relevant to the cloning 
technique. Fifteen countries were consulted, based on two main criteria: the countries which 
carry out cloning activity and, in addition, the main exporters of meat and reproductive 
materials to the EU Third Countries (Argentina, Australia, Botswana, Brazil, Canada, Chile, 
China, Japan, Namibia, New Zealand, Norway, Paraguay, Uruguay, United States and 
Switzerland). The following summary contains the information given by the government 
authorities of Third Countries that replied to the consultation questionnaire. 13 third countries 
have answered. China and Chile did not reply to the questionnaire. For the USA, information 
provided from the public authority was complemented with information given from private 
companies to the Commission. 
Some third countries which together supply the majority of livestock-product imports of the 
European Union made a Joint Statement on animal cloning for livestock production signed by 
Argentina, Brazil, New Zealand, Paraguay and the United States of America on 16 March 
2011 a second one on 26 October 2012 signed by the same countries except Paraguay.  
The main points identified in this statement are the following: 
-Regulatory approaches should be science based and no more trade-restrictive than necessary 
to fulfil legitimate objectives,  
-No evidence indicating that food from clones or the progeny of clones is any less safe than 
food from conventionally bred livestock, 
-Progeny of clones are the same as any other sexually-reproduced animal of their own 
species,  
-Restrictions on food from progeny of clones could have negative impacts on international 
trade and  
-Any audit or enforcement measure on progeny of clones would be impossible to apply 
legitimately and would results in onerous, disproportionate and unwarranted burdens on 
livestock producers. 
 
National Legislation  
Most authorities have stated that they do not have specific legislation governing the use of 
animal clones, with the exception of Norway in which the animal cloning is forbidden by law. 
Animal clones, their progeny and products deriving from animal clones are subject to the 
same regulations as conventional animals regarding food safety, animal health and animal 
welfare. Regulations on the use of animals for research purposes also apply. 
In most third countries, food from clones is not considered to be different from food derived 
from conventional animals, based on the assessment of the risks of consumption of food 
derived from clones (see below). 
An exceptional case is Canada, where food from clones and their progeny falls under the 
novel food definition and, as such, it requires a pre-market safety assessment. Animal feed 
that derives from clones and their progeny is also considered novel feed, which has to be 
notified for assessment to the Canadian Food Inspection Agency prior to introduction to the 
feed chain. Finally, SCNT animal clones, their progeny and their products and by-products 
are considered new substances under the Canadian Environmental Protection Act and 
82 

 
manufacturers or importers of such substances must notify it to the Minister of the 
Environment. 
In Japan, the Ministry of Agriculture, Forestry and Fisheries has imposed a voluntary ban on 
the use of cloning for livestock animals except for research purposes.  
In Australia there is an explicit industry moratorium on products of cloning entering the food 
supply. 
Brazil is in the process to set up legislation on cloning. The Brazilian Senate draft proposal is 
regulating the activities of research, production, import and sale of cloned animals. This 
project will go to the House of Commons to be analysed. The main purpose of the project is 
to provide a legal framework of the animal cloning activity already in place in Brazil, 
including research, and strengthen the official control.  
Use of cloning for breeding purposes 
Cloning is used for breeding purposes in Australia, Argentina, Brazil and the USA. However, 
since cloning is not regulated in any of these countries, authorities do not have specific 
information about these activities.  
In Canada, no companies of which the government is aware are currently using cloning with 
the purpose of breeding animals for the commercial livestock sector. One company operates a 
laboratory for the purpose of harvesting elite performance horse embryos for use in cloning 
but the embryos are exported and not brought to term in Canada. 
In December 2011, US private companies that engage in cloning have provided the 
Commission with the following data for the number of clones of different species: 1100 
bovines, 190 pigs, more than 100 horses. Cloning of goats was just starting, while no sheep 
had been cloned so far. 
Identification or registration 
In most of the countries examined clones are not distinguished and registered separately from 
conventional animals. 
In Canada registration of cloned animals is voluntary. Some livestock breed registries have 
provisions to identify animal clones through a supplemental designation on the registration 
documents. Semen and embryos are collected, identified and transferred in accordance with 
protocols established by the Canadian Embryo Transfer Association. The documentation for 
semen and embryos must identify animal clones through a supplemental designation on the 
registration documents.  
In the USA, public authorities do not require clones to be distinguished from conventional 
animals. However, private companies have set up a supply chain management system for 
livestock, whereby animals are registered. Cloned animals are individually identified and 
registered by private companies. For reproductive materials (semen and embryo), it is up to 
each breeding centre to decide whether to identify, or not, material from cloned animals.  
In New Zealand, the New Zealand Food Safety authority adopted a regulated control scheme, 
which applies to all ungulate animals. Under this scheme, owners of cloned animals must 
provide the Ministry of Agriculture and Forestry with a statement that provides information 
83 

 
that allows identification of the cloned animal and registration in an official database. This 
measure is intended to facilitate access to foreign markets should an importing country 
introduce restrictions relating to products derived from clones. There are currently 13 cloned 
animals in New Zealand, most of which are owned by the Crown Research Institute. 
In Brazil, cloned animals are registered via the breeding organisations, but the public 
authority does not keep this information. 
The Japanese Ministry of Agriculture, Forestry and Fisheries keeps records of the number of 
cloned livestock. The cumulative number of cloned cattle produced in Japan until 2011 is 591 
cattle, 609 pigs and 9 goats. 
Imports 
Most government authorities said they do not have information on the nature of live animals 
or reproductive materials that are imported in their countries. Whether such imports are live 
clones or reproductive material from clones is thus unknown. 
In Canada a pre-import notification is required to import clones and their reproductive 
material, but at this time no notification was submitted to government authorities. No country 
has a system of identification and registration in place for such imports. 
Animal welfare 
Argentina cited several papers as evidence of improvements of the animal welfare 
implications of cloning. In their experience of Argentine cloning techniques are not different 
from other assisted reproduction techniques in use worldwide. So, in no case animal welfare 
can justify any trade restrictive requirement. 
 FDA recently submitted to EFSA its most recent bibliography on scientific papers addressing 
this issue. The newer data all support that the risks of health and welfare appear to be quite 
low. 
Scientific risk assessments 
Studies on the risk of consuming food derived from clones and offspring has been carried out 
by scientists in several countries and are often the basis on which third country authorities 
form their opinions.  
USA, Canada, Switzerland and Japan have carried out their own risk assessments. All these 
risks assessments, except the one from Japan, include also considerations on risks posed on 
animal health. 
Traceability and labelling 
No country has traceability and labelling systems for food derived from cloned animals and/or 
their offspring in place. Switzerland, however, considers that this could be an option for 
future action. 
84 

 
Research 
Research on cloning is pursued in all countries except Paraguay, Namibia and Botswana, but 
authorities do not have detailed information on it. In Canada, animals used for research 
purposes are explicitly prohibited to enter the food chain or be released into the environment. 
In New Zealand, research is pursued by AgResearch Limited (a Crown Research Institute), 
which has an explicit voluntary moratorium preventing products derived from cloned animals 
they own entering the food chain. In Japan, research on the SCNT is promoted by the 
authorities competent for the improvement and increased production of livestock. 
See summary table below. 
 
85 

 
Country 
National 
Use of cloning 
Identification of  Identification 
Imports of Identification of  Improvements 
Risks assessment 
Traceability and Cloning for research 
legislation 
clones 
of Reprod. 
clones or 
imported clones  on animal 
labelling of clones 
Materials 
rep.mat. 
or rep.mat. 
health and 
and offspring 
welfare 
Argentina 
No. Indirectly 
Yes 
No 
No 
Unknown 
No 
Yes   
Yes 
No 
Yes, but detailed 
through animal 
information is not 
welfare legislation 
Papers cited 
Papers cited 
available 
applicable to 
animals used for 
scientific 
purposes.       
Australia 
No 
Yes + voluntary 
No 
No 
Yes. But no 
No 
No 
No 
No 
Yes but detailed 
moratorium on 
Government 
information is not 
products of 
register. 
available. Cloning is 
cloning entering 
covered by national 
the food supply. 
animal research 
guidelines. 
Botswana 
No    
No 
No 
No 
No 
No 
No 
No 
Yes 
No 
 
Brazil 
No. A draft 
Yes 
Yes, the cloned 
No 
Unknown 
No 
Unknown 
No 
No 
Yes but detailed 
 
proposal initiated 
animals are 
information is not 
 
by the Senate 
registered via 
available 
 
regulating the 
breeding 
 
activities of 
organisations 
 
research, 
 
production, import 
 
and sale of cloned 
 
animals in under 
 
discussion. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
86 

 
Country 
National 
Use of cloning 
Identification of  Identification 
Imports of Identification of  Improvements 
Risks assessment 
Traceability and Cloning for research 
legislation 
clones 
of Reprod. 
clones or 
imported clones  on animal 
labelling of clones 
Materials 
rep.mat. 
or rep.mat. 
health and 
and offspring 
welfare 
Canada 
No. Cloning falls 
Yes. A few 
Yes. Some 
Yes.  
Unknown. 
No 
No 
Yes, draft 
No 
Yes, but such 
under Novel food 
bovine artificial 
Canadian 
Documentation 
Pre-import 
scientific opinion 
animals do not enter 
legislation. 
insemination 
livestock breed 
for semen and 
notification 
for internal 
the food chain 
Products or by-
centres in the 
registries have 
embryos must 
requirement. 
reference only. 
products of any 
past but 
voluntary 
identify animal 
At this time, 
animal clones or 
euthanized 
provisions to 
clones through a 
no pre-import 
their progeny to 
since then. No 
identify animal 
supplemental 
notification 
the human food 
entry into the 
clones through a 
designation on 
submitted to 
supply are subject 
food chain. One 
supplemental 
the registration 
government 
to a pre-market 
company 
designation on 
documents. 
authorities. 
safety assessment. 
haversting elite 
the registration 
performance 
documents. 
horse embryos 
Holstein Canada 
for use in 
has special 
cloning and 
protocols for 
exported before 
recording clones. 
the end of the 
process.  
Japan 
No. The Ministry 
No 
Yes. All cloned 
Yes. Research 
Unknown 
No 
Unknown 
Yes, only on the 
Yes, for animals 
Yes 
 
of Agriculture had 
animals in the 
Institutes 
risks of 
used in Research 
 
imposed a 
research Institutes   control 
consuming food 
Institutes. Products 
 
voluntary ban to 
are notified to the 
reproductive 
derived from 
from clones have to 
 
research institutes  
public authority 
materials and 
clones (June 
be disposed after use 
 
on the use of 
and registered. 
after use for 
2009). 
for research by 
 
cloning except for 
Carcasses of 
research they 
incineration or 
 
the purpose of 
cloned animals 
shall be 
No assessment has 
burial. 
 
research. 
after research are 
disposed 
been conducted 
 
incinerated or 
properly by 
from the point of 
No for offspring of 
 
buried properly. 
incineration or 
view of animal 
clones 
 
burial. 
health and 
 
welfare. 
 
 
 
 
 
 
 
 
87 

 
Country 
National 
Use of cloning 
Identification of  Identification 
Imports of Identification of  Improvements 
Risks assessment 
Traceability and Cloning for research 
legislation 
clones 
of Reprod. 
clones or 
imported clones  on animal 
labelling of clones 
Materials 
rep.mat. 
or rep.mat. 
health and 
and offspring 
welfare 
Namibia 
No 
No 
No 
No 
No 
No 
No 
No 
No 
No 
New Zealand 
No. Indirectly, 
No 
Yes. Regulated 
No 
Unknown 
No 
No 
Yes,A  based on 
No 
Yes, it is pursued by 
market access of 
control scheme 
relevant scientific 
AgResearch Limited 
food derived from 
requiring cloned 
external evidence 
(a Crown Research 
clones and their 
livestock to be 
Institute), which has 
progeny and 
identified with an 
a voluntary 
welfare 
ear tag unique to 
moratorium 
implications for 
each animal and 
preventing products 
cloned animals are 
listed in an 
derived from cloned 
covered by 
official database. 
animals they own 
general 
entering the food 
legislation. 
chain. 
Norway 
Yes. Cloning is 
No 
No 
No 
No 
No 
No  
No 
No 
No 
forbidden by law. 
Exception for 
research. 
Paraguay 
No 
No 
No 
No 
No record. 
No record 
No 
No 
No 
No 
Switzerland 
Yes, Legislation 
No 
No 
No 
Only once in 
No 
No 
Yes, studies relate 
No, but setting up a 
Not for farm 
on animal 
2005 of 
to animal health 
traceability and 
animals. More 
experiments 
semen from a 
and welfare, food 
labelling  system for 
information in life 
applies needing a 
bull whose 
safety and ethical 
cloned animals and 
sciences (animal 
licence from the 
mother was 
considerations. 
their direct offspring 
experimentation) is 
cantonal 
cloned, none 
is one option 
not available. 
authorities. 
since. 200 live 
discussed for future 
cattle with a 
action. 
cloned cattle 
in the 
pedigree. 
 
88 

 
Country 
National 
Use of 
Identification 
Identification 
Imports of  Identification 
Improvement
Risks 
Traceability and  Cloning for researc
legislation 
cloning 
of clones 
of Reprod. clones or of imported 
s on animal  assessment 
labelling of clones 
Materials 
rep.mat. 
clones or 
health and 
and offspring 
rep.mat. 
welfare 
Uruguay 
No 
No 
No 
No 
Yes 
No 
No 
No 
No 
Yes in vitro 
fertilisation. No 
results on live 
clones yet 
USA 
No. Same 
Yes 
No. 
No 
Unknown 
No 
Yes, FDA 
Yes, FDA 
No 
Yes, but detailed 
regulations apply 
recently 
scientific opinion. 
information is not 
as to 
However, there is 
submitted to 
available 
conventionally-
an industry-
EFSA its most 
bred animals with 
sponsored supply 
recent 
respect to animal 
chain 
bibliography on 
care and welfare, 
management 
scientific papers 
treatment with 
system for 
addressing this 
animal drugs, and 
livestock, to track 
issue. The 
introduction into 
clones. 
newer data all 
the food/feed 
support that the 
supply. 
risks of health 
and welfare 
 
appear to be 
quite low. 
89 

 
3. Stakeholders position 
In addition to the participation in the IPM public consultation, the main sectors concerned by 
the animal cloning have also provided their position paper on this issue. The different position 
papers from European farmers to the European consumer association are summarized below.  
a. Farmers and breeding sector 
COPA-COGECA as EU representatives of farmers and agri-cooperatives consider that any 
measure on animal cloning should be Science-based, cost-effective and workable in practice. 
They are also concerned about the possible indirect impact on European farmers of a ban of 
food from cloned animals since several third countries do not have traceability systems in 
place. Copa-Cogeca considered that traceability of clones may not be problematic but 
imposing a traceability scheme to offspring represents a real administrative burden for all the 
supply chain without benefits for the consumers. They would rather favour voluntary 
information schemes.  
BAB (British Agriculture Bureau) feels that is inappropriate to ban a technology in food 
production when there is no scientific basis for a food safety risk, as confirmed by the 
European Food Safety Authority (EFSA). The UK farming unions believe option 1 is the 
preferred option and importantly the most scientifically sound option in light of the EFSA 
opinion that there are no food safety issues with the offspring from cloned animals. 
EFFAB (European Forum of Farm Animal Breeders) strongly supports maintaining the status 
quo. EFFAB believes that any measures must be based on sound scientific evidence and 
enforceable not only by EU member States but also by third countries. They also considered 
that the adverse effects of cloning technology are limited at present and will reduce with 
further developments. They also share the view of EFSA and the USA Food and Drug 
Administration (FDA) where current evidences suggests that meat and milk for healthy clones 
or healthy offspring of clones is as safe as that from conventional healthy animals. 
EAAP (European Association for Animal Production) and ICAR (International Committee 
for Animal Recording) expressed the interest of both organisations in supporting the research 
in animal cloning, independently from the concerns that the European consumers may express 
in other forums. Even if the use of cloning in animal production is limited certainly their 
medical applications appear to be promising. Both organisations support clone research, to 
allow the European scientists may retain the necessary tools and knowledge to achieve 
beneficial goals. 
The  IETS (International Embryo Transfer Society) and the INRA (Institut National de la 
Recherche Agronomique), both from scientific area, considered that more research in the 
cloning process and in the animal health issues needs to be encouraged. The IETS has issued 
a set of guidelines based on scientific knowledge of research teams to lower the incidence of 
neo-natal concerns. Concerning food safety and labelling aspects, the IETS considered that 
based on EFSA and U.S. FDA scientific opinions concluding on the lack of evidence of food 
safety concerns for food derived from clones or offspring, there is no necessity to label such 
food.  
The FVE (Federation of Veterinarians of Europe) stated that there is no evidence that food 
safety is adversely affected, but the public are concerned for ethical and other reasons such as 
poor welfare due to a focus on agricultural productivity, a reduction in genetic diversity and 
environmental impact. 
90 

 
b. Food industry 
The dairy association EDA (European Dairy Association) and EUCOLAIT  (European 
Association of Dairy Trade) both supported the status quo for which a pre-market approval 
for food from clones is necessary. Offspring first generation and descendants are considered 
as conventional bred and not distinguishable from any other animal of the same species and 
therefore cannot be considered clones. They also based their position in the EFSA conclusions 
and recommendations of 2008 followed by their statements of 2009, 2010 and 2012 in which 
the safety of food from clones and progeny are not different to those from conventionally bred 
animals. 
The European meat sector via UECBV (European Livestock and Meat Trades Union) and 
CLITRAVI (Liaison Centre for the Meat Processing Industry in the EU) provided also their 
positions. In both cases the support the status quo. In their view the EU policy on cloning 
should be based in sound science, practicality to implement identification traceability and 
labelling of animals and food and public concerns should be taken into account in a balanced 
and proportionate manner. They also suggested in order to prevent misinformation and 
unfounded public concerns the implementation of appropriate information campaigns to 
explain the issues to the public. Another key point of concern for the meat industry is the 
potential trade disruption with important trade partners like USA, China, Canada, Brazil and 
Japan. 
Food Drink Europe organisation (EU food industry) is in favour to take measures 
(identification, traceability and labelling) only on clones which are already included in the 
current Novel Food regulation via the pre-market authorisation of food from clones. They are 
against to take measures on offspring and descendants of clones based on that there are no 
food safety concerns. In the other hand FoodDrink Europa is in favour of the traceability of 
reproductive materials from clones to be able to monitor the animal health and welfare of the 
offspring of clones. 
CELCAA (Agricultural trade) considered that a complete ban or a mandatory labelling 
system of food both from clones and their offspring based solely on ethical considerations 
would be completely disproportionate in light of its uncontrollable economic impact and 
therefore very difficult to justify. Furthermore, traders question the feasibility of an effective 
enforcement of potential bans (as requested in the past by the European Parliament), be it to 
prohibit imports completely. In addition, the measures would be very difficult to defend 
within the WTO.  
 
Euro Commerce (Commerce/retail/wholesale sector)  
Considered it is necessary to keep up with the continued research progress on animal cloning 
techniques. Besides scientific data, other legitimate factors, such as ethical considerations 
need to be taken into account in the decision process. Nevertheless, Euro Commerce has no 
intention to participate in the ethical debate. They also consider essential to take into 
consideration the consumer acceptance on this issue in addition to inform the citizens about 
animal cloning versus genetically modified animals, the benefits, risks and impacts, so that 
consumers are well informed. If products from clones and offspring of clones are authorised 
find a practical solution to trace these products along the whole food supply chain. 
c. Consumer organisations 
BEUC, the European Consumers Organisation, (based on IPM consultation) considered that 
the current situation does not guarantee a sufficient level of consumer protection as food 
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derived from offspring or descendants of clones is not subjected to any pre-market 
authorisation. They state that consumers should have the right to make an informed choice 
and in this case, that is to decide whether or not they wish to eat food from clones, their 
offspring or descendants. The Flash Eurobarometer on Europeans' Attitude towards animal 
cloning (October 2008) found that a majority of EU citizens do not want food derived from 
cloned animals to enter the food chain. A more recent Special Eurobarometer Survey on 
Food-related Risks (November 2010) also showed that cloning animals for food production is 
one of the most widespread food safety-related concerns of Europeans consumers. Finally 
another recently Special Eurobarometer Survey on Biotechnology (October 2010) showed 
that Europeans have strong reservations and concerns about the safety of animal cloning for 
food production.   
d. Animal welfare associations 
Eurogroup for Animals and Compassion in World Farming are the two NGOs who have 
provided a position paper on this matter. Both consider that cloning technique is inefficient 
and involves severe animal suffering linked to health and welfare problems for cloned 
animals and their surrogate dams. In addition, the routine use of cloning would reduce genetic 
diversity and increase productivity with insufficient attention to the animal welfare. Finally 
they also underline the well-documented public concerns related to the use of cloning for food 
production purposes.    
In summary, both professional organisations of the farming, breeding and the food sectors are 
in favour of the status quo. They do not support the ban of cloning technique as they consider 
that this technique may improve and could be important in the future for the competitiveness 
of the EU farming and breeding sectors. They are also against any labelling measures 
concerning food from offspring or descendants as there are no food safety concerns and such 
measures would entail additional administrative burden and costs for operators along the food 
chain. On the other hand, consumer and animal welfare organisations are in favour of a ban of 
the cloning technique in the EU and of mandatory labelling for food from offspring and 
descendants to provide consumer choice. 
4. Third country competent Authorities 
Consultations with main trade partner third countries competent authorities (Argentina, 
Australia, Botswana, Brazil, Canada, Chile, China, Japan, Namibia, New Zealand, Paraguay, 
Switzerland, Norway, Uruguay and United States of America) have taken place using a 
special questionnaire to assess the situation on animal cloning for food production, via 
bilateral meetings or in some cases using the IPM public consultation. Most of the authorities 
do not have specific legislation governing the use of animal cloning for food production. 
Animal clones, their progeny and products derived are subject to the same regulations as 
conventional animals regarding the food safety, animal health and welfare.  
Japan has imposed a ban on the use of cloning for livestock animals and Australia and New 
Zealand have an explicit industry moratorium on products on cloning entering in the food 
chain. 
Some third countries which together supply the majority of livestock-products which are 
imported in the European Union made a Joint Statement addressed to the Commission on 
animal cloning for livestock production signed by Argentina, Brazil, New Zealand, Paraguay 
and the United States of America on 16 March 2011 a second one on 26 October 2012 signed 
by the same countries except Paraguay.  
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The main points identified in this statement are the following: 
•  Regulatory approaches should be science based and no more trade-restrictive 
than necessary to fulfil legitimate objectives,  
•  No evidence indicating that food from clones or the progeny of clones is any 
less safe than food from conventionally bred livestock, 
•  Progeny of clones are the same as any other sexually-reproduced animal of 
their own species,  
•  Restrictions on food from progeny of clones could have negative impacts on 
international trade and  
•  Any audit or enforcement measure on progeny of clones would be impossible 
to apply legitimately and would results in onerous, disproportionate and 
unwarranted burdens on livestock producers. 
 
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ANNEX IV: IPM SUMMARY REPORT AND ORIGINAL QUESTIONNAIRE 
 
 
EUROPEAN COMMISSION 
HEALTH AND CONSUMERS DIRECTORATE-GENERAL 
 
CONSULTATION ON ANIMAL CLONING FOR FOOD PRODUCTION 
SUMMARY OF THE REPLIES TO THE IPM CONSULTATION 
This document does not represent an official position of the European Commission. The 
suggestions contained in this document do not prejudge the form and content of any future 
proposal by the European Commission.
 
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INTRODUCTION 
On 3 May 2012 the European Commission launched an IPM public consultation on animal 
cloning for food production. This consultation sought to gather the views and opinions of all 
interested parties on various aspects surrounding the issue of cloning for food production, 
such as the use of the cloning technique, the use of clones and their reproductive materials 
(semen and embryo) for breeding purposes and the use of live clones, their offspring and 
descendants for food purposes.  
It targeted companies, organizations with an interest in the matter, experts in the field as well 
as ordinary citizens. The consultation was open online for 16 weeks (from 03.05.2012 until 
03.09.2012). Reminders were done by the DG Health and Consumers using its website (Flash 
news) and via the e-news network on 4 July 2012 reaching approximately 6000 subscribers. 
Another reminder was also launched on 21 June 2012 using the Enterprise Europe Network 
(EEN). The consultation period ended on 3 September 2012. 
The Commission received 360 replies (56 requesting confidentiality, 150 anonymously and 
154 under the name indicated): 
- 99 Stakeholders (Professional Organisations, NGOs, International organisations and 
Academic). 
- 16 from National Competent Authorities (NCA), IRL(2), UK, AT, FIN, DE, CZ, PT(2), FR, 
LX, IT and ARG (4).  
- 9 from enterprises, including  7 from SMEs (including 2 micro enterprises) and 2 large 
enterprises. 
- 236 from individual persons (209), self-employed (17) and others (10). 
28%
Stakeholders
N.C.A.
Entreprises
4%
65%
Individuals
3%
 
This document summarises the responses to the public consultation on the possible measures 
on animal cloning for food production. It is in no way to be understood as an endorsement of 
any comment. For the sake of brevity, consultation items are not reproduced. Therefore, this 
summary should be read in conjunction with the original questionnaire and the roadmap on 
animal cloning for food producing published in February 20121
                                                 
1http://ec.europa.eu/governance/impact/planned_ia/docs/2013_sanco_007_use_of_cloning_technique_for_food_
production_en.pdf 
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In addition, main comments of position papers received from stakeholders organisations are 
also mentioned in chapter 3.   
The public consultation is part of the on-going impact assessment exercise. The information 
and views gathered in this public consultation will be taken into consideration in the impact 
assessment process. 
GENERAL REMARKS 
The public consultation was appreciated by the stakeholders with an acceptable participation. 
The vast majority of respondents 72.5% were well informed on the subject animal cloning for 
food production and also a large majority 68.6% considered that the current situation is 
inappropriate and need to be changed.  Based on the participation distribution mentioned 
above, some cautions needs to be exercised when drawing conclusions from these figures as 
all the different categories from individual to professional organisations or international 
organisation have the same value as a single record even if the stakeholder organisations are 
representing a group of persons. 
The majority of the respondents were in favour of a ban of the animal cloning covering all the 
different areas such as the cloning technique, the use of live cloned animals, clone 
reproductive materials, live offspring and descendants of clones and the food derived. The 
most important reason was the animal health and welfare. 
Concerning the pre-market approval of food from clones, offspring and descendants of clones 
the majority of the respondents were in favour of such pre-market approval given the food 
safety concerns as the most important reason to put in place this measure. In the other hand 
the most important reason against a pre-market approval was also the no food safety concerns. 
It is important to underline that for some areas such as placing food from clone origin on the 
market and pre-market approval there was a slight decrease in the percentage for the 
descendants of clones in relation to the clones. 
The majority of the respondents were in favour of the identification and registration of clones, 
reproductive materials of clones and offspring and descendants of clones. In this case also 
there was a slight decrease in the percentage from the clones (86.91%) to the descendants 
(71.9%). The most important reason in favour to set up this identification and registration 
system was the possibility to monitor the animal health and welfare. In the other hand the 
most important reason against to set up this system was that this measure is not based on 
science. 
Similarly to the previous areas the majority of the respondents were in favour of a traceability 
system for food from clones and offspring and descendants of clones. Again the percentages 
in favour are decreasing from 88.6% for clones to 71.9% for descendants of clones. The 
majority of the respondents (79.2%) considered that the traceability system can be established 
and the cost should be bear by the food industry (60.3%) covering all the species (cattle, pigs, 
horses, goats and sheep). 
The consumers' information based on labelling schemas was supported by a majority of the 
respondents using a mandatory approach. Again there was a decrease in the percentages for 
the clones (82.2%) to the descendants of clones (71.1%). The majority of the respondents 
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considered that all the products proposed need to be labelled and the cost will be mainly bear 
by the food industry (42.8%). 
Finally, concerning the proposed 5 options nearly half of the respondents (49.2%) were in 
favour of option 5 on a suspension of the use of the cloning technique in the EU, the use of 
clones and live offspring of clones, the reproductive material from clones and the placing on 
the market of food from clones and their offspring and descendants. The options 1, 2 and 4 
got approximately 10% and option 3 got 5%. The remaining 15% did not select any of the 
options proposed. 
SUMMARY OF RESPONSES (ALL RESPONDENTS) 
Awareness about the developments on animal cloning for food production 
A large majority of respondents were very well (22.2%) or fairly well (50.3%) informed. Only 
19.4% and 8.1% were not respectively very well or not at all informed on animal cloning. 
1. Use of cloning technique, clones and food from clones 
Nowadays the animal cloning technique is allowed and a pre-market approval for food from 
clones is required in the EU. So far no such authorisation has yet granted or even requested. 
A large majority of respondents 68.6% considered that the current situation is inappropriate, 
29.7% were in favour to keep the current situation as it is and 1.7% had no opinion. 
Ban and pre-market approval of food on the EU market  
The ban on animal cloning is covering the cloning technique, live cloned animals for breeding 
purposes, clone reproductive materials, live offspring and descendants of clones and the food 
derived. 
Concerning the ban the respondents replied the following:  
Ban 
In favour % 
Against % 
No opinion % 
Cloning 
technique 
65.5 26.9 7.5 
Live 
cloned 
animals 
71.9 21.1 6.9 
Clone reproductive 
67.2 26.4 6.4 
materials 
Offspring of clones 
69.2 
25.8 

Descendants of clones 
68.9 
26.4 
4.7 
 
For all areas concerning the ban, there were a majority of respondents from 65.5 to 71.9 % in 
favour of the ban on animal cloning. 
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The most important reason in favour of the ban was animal health and welfare (25.6%) 
followed by ethical reasons (23.3%), reduction of diversity and genetic variety (17.2%), food 
safety concerns (15.8%) and the least important reason was the restriction of access to genetic 
heritage for example via patents (25.3%). 
The most important reason against the ban was the no food safety concerns (13.1%) followed 
by loss of innovation (8.9%), increase of administrative burden and international trade barrier 
(5.3% both) and higher costs of production and reduction of food supply (4.2% both). 
Concerning the placing of food from clones, offspring of clones and descendants of clones the 
respondents replied the following: 
Food  
In favour/% 
Against/% 
No opinion/% 
Clones 15.3  77.5 7.2 
Offspring 24.4 
72.5 
3.1 
Descendants 25 
71.4 
3.6 
 
The majority of the respondents were against to put on the EU market food from clones, 
offspring of clones and descendants of clones (77.5%, 72.5% and 71.4% respectively). It 
should be noticed that the percentage against the food is slightly decreasing from 77.5% for 
clones to 71.4% for the descendants. 
Regarding the necessity of a pre-market approval for food from clones, offspring of clones 
and descendants the opinion of the respondents were the following: 
Pre-market approval of  Necessary 
Not necessary 
No opinion 
food 
Clones 78.1  13.1 8.9 
Offspring 68.3 
23.3 
8.3 
Descendants 66.1 
24.2 
9.7 
 
The majority of the respondents were in favour of a pre-market approval for all food from 
clones, offspring and descendants of clones. It should be noticed that the percentage for the 
pre-market approval is slightly decreasing from 78.1% for clones to 66.1% for descendants. 
The most important reason in favour of a pre-market approval was food safety concerns 
(26.9%) followed by animal health and welfare (24.7%), ethical reasons (22.2%) and 
biodiversity and genetic variety (20.3%). 
The most important reason against a pre-market approval was the no safety concerns (11.1%) 
followed by the use of cloning technique should be banned (7.5%), increased administrative 
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burden (6.4%), loss of innovation (5.3%), higher cost of production (4.2%) and delay in the 
marketing of the food product (3.3%). 
The identification and registration of live clones, of reproductive materials (semen, embryos 
and ova) and of live offspring would be a prerequisite for the monitoring of animal health and 
welfare aspects and for the setting up of traceability and labelling systems for food products 
which are derived. 
Concerning the identification and registration the respondents replied the following:  
 
In favour of 
Not in favour of 
No opinion 
identification and 
identification and 
registration of 
registration of 
Clones 87.5 
6.4 
6.1 
Offspring of clones 
76.9 
17.2 
5.8 
Descendants of 
73.9 19.4 6.7 
clones 
Clone reproductive 81.4 11.1 7.5 
materials 
 
For all areas concerning the identification and registration the majority of the respondents 
were in favour to set up a specific identification and registration system for clones, offspring, 
descendants and reproductive materials of clones produced or imported into the EU.   
The majority of respondents considered that the way to put in place the identification and 
registration system for all the areas concerned need to be via a compulsory system. It should 
be noticed that the percentage for the identification and registration is slightly decreasing from 
86.91% for clones to 71.9% for descendants. 
The most important reason in favour to set up an identification and registration system was 
the possibility to monitor the animal health and welfare (from 50% to 61.4%) followed by to 
allow food labelling (from 46.9% to 52.8%), the farmer knowledge that the animals are 
cloned (from 43.9% to 50.8%), and to allow targeted recalls of food from the above categories 
(from 35.8% to 39.7%).  
The most important reason against to set up an identification and registration system was that 
this measure is not based on science. This reason got the higher percentage in all categories. 
Regarding the species to be cover by the identification and registration the majority of the 
respondents considered that all species need to be covered (Cattle 83.9%, Pigs 81.9%, Horses 
77.5%, Goats 77.8 and Sheep 80.3%). 
 
 
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2. Traceability  
The setting up of EU identification and registration systems for clones, clone reproductive 
materials, offspring and their descendants would allow the setting up of traceability systems. 
Concerning the traceability system the respondents replied the following:  
Traceability system 
In favour 
Against 
No opinion 
Food from clones 
88.6 
7.2 
4.2 
Food from offspring 
77.2 
16.9 
5.8 
Food from descendants 
76.4 
17.5 
6.1 
 
The majority of the respondents were in favour of a traceability system for all the categories 
mentioned. It should be noticed that the percentage for the traceability system is decreasing 
from 88.6% for clones to 71.9% for descendants. 
Concerning the feasibility of this traceability system 79.2% of the respondents considered that 
can be established, 15.6% not and 5.3% had no opinion. In addition, 29.7% of the respondents 
considered that this traceability system may lead to unacceptable cost, 54.4% not and 15.8 had 
no opinion.    
Regarding who should bear the traceability additional costs the respondents considered the 
food industry in 60.3% followed by the farmers 38.6%, tax payers 38.1 ad consumers 28.1%. 
Regarding the species to be cover by the traceability the majority of the respondents 
considered that all species need to be covered (Cattle 94.7%, Pigs 91.4%, Horses 85.3%, 
Goats 84.2 and Sheep 87.5%). 
3. Consumers' information 
Traceability systems for food from clones, offspring and their descendants would allow food 
producers and retailers to inform consumers via labelling. The possible labelling schemas 
proposed were none, mandatory, voluntary and others. 
Concerning labelling the respondents replied the following:  
 No 
labelling 
Mandatory 
Voluntary labelling of  Others 
labelling 
"clone free food" 
Clones 6.7  82.2  5.8 
5.3 
Offspring of 
16.1 74.7  6.1 
3.1 
clones 
Descendants of 16.9 71.1  8.6 
3.3 
clones 
 
 
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The majority of the respondents were in favour of a mandatory labelling for clones, offspring 
and descendants of clones. It should be noticed that the percentage for the mandatory labelling 
is decreasing from 82.2% for clones to 71.1% for descendants of clones.  
Concerning the products to be covered by the labelling systems the majority of the 
respondents, more than 80%, considered that all the products proposed need to be labelled. 
They also considered in 81.1% that such labelling can be established and that these labelling 
may no cause unacceptable costs in 59.7%. 
Concerning the group of stakeholders would likely more affected for possible additional costs 
the respondents considered that will be the food industry 42.8%, followed by tax payers 
35.6%, farmers 35% and consumers 33.1%. 
4. Policy options 
The Commission in its roadmap on animal cloning for food production identified in summary 
the following 5 policy options:  
Option 1. Retain the current legal framework 
Option 2. Allow the use of the cloning technique in the EU for food production 
Option 3. Temporary ban of food from clones in the EU and tracing of imports of clone 
reproductive materials 
Option 4. Temporary ban of food from clones in the EU and imposition of mandatory 
labelling of food from offspring and descendants 
Option 5. Temporary ban of food from clones, offspring and their descendants 
The nearly half of the respondents 49.2% were in favour of option 5 followed by none 15% 
[to be explain looking in detail the replies], option 1 10.6%, option 2 10.3%, option 4 10% 
and option 3 5%. 
SUMMARY OF THE RESPONSES BY CATEGORIES OF RESPONDENTS 
- Individual and self-employment 
There were 226 responses from individual (209) and self-employed (17). The majority of the 
respondents were from Finland (36), United Kingdom (32), France (29), Estonia (25), 
Germany (18), Italy (15), Portugal (13) and Spain (10). 
The respondents in this category were very well informed 13.2% and fairly well informed 
52.2% and 34.5% were not very well or not at all informed. In addition 73.9% considered that 
the current situation is not appropriate. 
Concerning the ban of the cloning technique, live cloned animals, reproductive materials of 
clones, offspring of clones and descendants of clones the respondents were in favour of a ban 
for all areas: cloning technique 73% live cloned 81.4%,reproductive materials of clones 
76.1% and offspring and descendants of clones 79.6% in both cases. The main reason 
expressed by the respondents to be in favour of a ban was the animal health and welfare with 
a 27.4% and against the ban the main reason was the loss of innovation with 8.8%. 
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In relation to the placing of food from clones, offspring of clones and descendants of clones in 
the EU market the respondents were against to allow the placing of food from clones (86.3%) 
offspring (84.1%) and descendants (83.2%) of clones. 
The pre-market approval was considered by the respondents necessary for food from clones in 
a 88.9%, 76% for offspring of clones and 75% for descendants of clones. The main reason for 
the pre-market approval was the food safety concern. 
The respondents were in favour of the identification and registration of clones with a 87.2%, 
84.5% for offspring of clones, 81.9% for descendants of clones and 85.4% for reproductive 
materials of clones. In case of the setting up of an identification and registration the majority 
of the respondents were in favour of a compulsory system for clones 87.2%, offspring of 
clones 83.2%, descendants of clones 80.1% and 82.3% for the reproductive materials of 
clones. The main reason to put in place this system was to monitor the health and welfare of 
the animals. In case of identification and registration the respondents considered that all 
species proposed should be covered. 
In respect to the traceability systems for food the majority of respondents were in favour with 
a 91% for food of clones, 87% for offspring of clones and 86.3% for the descendants of 
clones. 
Concerning labelling the majority of respondents were in favour of a mandatory labelling for 
food from clones 89% and offspring and descendants of clones 84% and 82.3% respectively. 
Finally concerning the choice within the 5 policy options proposed 58% considered that 
option 5 was the most appropriate. 
- Stakeholders organisations (Professional Organisations, International organisations, 
Academic and NGOs) 

There were 99 responses from stakeholder's organisations, 34 Professional Organisations, 34 
NGOs, 26 Academic and 5 International organisations. 
The respondents in this category were very or fairly well informed 83.9% and considered that 
the current situation is not appropriate in a 52.5%. 
Concerning the ban of the cloning technique, live cloned animals, reproductive materials of 
clones, offspring and descendants of clones the stakeholders' respondents were in favour of a 
ban for all areas, 54.5% for the cloning technique, 57.6% for lived cloned animals 55.6% for 
reproductive materials of clones 53.5% for offspring of clones and 52.5% of descendants of 
clones. The main reason expressed by the respondents to be in favour of a ban was the 
problem of animal health and welfare and against the ban the main reason was the no food 
safety concern. 
In relation to the placing of food from clones, offspring of clones and descendants of clones in 
the EU market the stakeholders respondents were against to allow the placing of food from 
clones 64.6%, offspring 55.6% and descendants 53.5% of clones. 
The pre-market approval was considered by the stakeholders' respondents necessary for food 
from clones in a 81.8%, for food from offspring of clones 59.6% and descendants of clones 
with a 56.6%. The main reason for having necessary the pre-market approval was the food 
safety concern. 
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The Stakeholders' respondents were in favour of the identification and registration of clones 
with 89.9%, for offspring of clones 64.6%, descendants of clones 62.6% and for reproductive 
materials 75.8%. In case of the setting up of an identification and registration the majority of 
the respondents were in favour of a compulsory system for clones 88.9%, offspring of clones 
64.6%, descendants of clones 60.6% and the reproductive materials of clones 71.7%. There 
was not a clear majority for the reasons in favour or against to put this system in place. The 
main reason to put in place this system was to monitor of the animal health and welfare. In 
case of identification and registration the respondents considered that all species proposed 
should be covered.   
In respect to the traceability systems for food the majority of stakeholders' respondents were 
in favour for food of clones in a 85.9% and food from offspring and descendants of clones in 
61.6% for both. In case of identification and registration the respondents considered that all 
species proposed should be covered. 
Concerning labelling the majority of stakeholders' respondents were in favour of a mandatory 
labelling for food from clones 70.7% and offspring 57.6% and descendants 51.5% of clones. 
Finally concerning the choice within the 5 policy options proposed 32.3% considered that 
option 5 was the most appropriate, followed by option 1 with a 20.2%. 
- Entreprises  
There were 9 responses under the category of enterprise, 2 of them were large, 5 SME (2 
small and 3 medium) and 2 micro enterprises. 
The respondents in this category were very or fairly well informed 88.9% and considered that 
the current situation is not appropriate in a 66.7%. 
Concerning the ban of the cloning technique, live cloned animals, reproductive materials of 
clones, offspring of clones and descendants of clones the enterprise respondents were in 
favour of a ban for all areas 55.6% except for offspring of clones and descendants of clones 
with the same percentage 55.6%. The main reason expressed by the respondents to be in 
favour of a ban was the possible reduction of biodiversity and genetic variety and be against 
the ban the main reason was the no food safety concern. 
In relation to the placing of food from clones, offspring of clones and descendants of clones in 
the EU market the enterprise respondents were in favour to allow the placing of food from 
offspring and descendants of clones with a 55.6% but for food from clones the respondent 
were against with a 66.7%. 
The pre-market approval was considered by the enterprises respondents necessary for food 
from clones in a 88.9%, but the pre-market approval was not considered necessary for food 
from offspring of clones and descendants of clones in both cases with a 55.6%. The main 
reason for not having necessary the pre-market approval was the no food safety concern. 
The enterprise respondents were in favour of the identification and registration of clones with 
100%, for offspring of clones and descendants of clones also in favour with a 55.6% in both 
cases and for reproductive materials 77.8% were also in favour. In case of the setting up of an 
identification and registration the majority of the respondents were in favour of a compulsory 
system for clones 100%, offspring of clones 55.6%, descendants of clones 55.6% and the 
reproductive materials of clones 77.8%. There was not a clear majority for the reasons in 
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favour or against to put this system in place. In case of identification and registration the 
respondents considered that all species proposed should be covered.   
In respect to the traceability systems for food the majority of enterprise respondents were in 
favour for food of clones in a 100% and food from offspring and descendants of clones in 
55.6% for both. 
Concerning labelling the majority of enterprise respondents were in favour of a mandatory 
labelling for food from clones 77.8% and offspring and descendants of clones 55.6% in both 
cases. 
Finally concerning the choice within the 5 policy options proposed 55.6% considered that 
option 5 was the most appropriate, followed by option 1 with a 22.2%. 
- National Competent Authorities  
16 replies were received under the NCA category. 12 were coming from EU Member States 
and 4 from third countries. It should be noted that 8 out of 16 did not mention the name of 
their organisations at all or were regional authorities. The 10 Member States were Ireland(2), 
United Kingdom, Austria, Finland, Germany, Portugal(2), Czech Republic, France, 
Luxembourg and Italy. Argentina was the only third country participating four times, one of 
them without mentioning the name of the organisation and the other three from the same 
organisation. 
The respondents from the Member States National competent authorities were very or fairly 
well informed 83.3% and considered that the current situation is not appropriate in a 58.3%. 
Concerning the ban of the cloning technique, live cloned animals, reproductive materials of 
clones, offspring of clones and descendants of clones the Member States respondents were 
41.7% in favour and 41.7% against. 
In relation to the placing of food from clones, offspring of clones and descendants of clones in 
the EU market the Member States respondents were against to allow the placing of food from 
clones but for food from offspring and descendants it was equal percentage in favour and 
against (41.7%). 
The pre-market approval was considered by the Member States respondents necessary for 
food from clones in a 66.7% and for offspring of clones in a 58.3%, but the pre-market 
approval was for descendants of clones there was an equal percentage in favour 41.7% and 
against 41.7%.  
The Member States respondents were in favour of the identification and registration of clones 
91.7%, offspring of clones 75%, descendants of clones 58.3% and reproductive materials of 
clones 83.3%.  
In respect to the traceability systems for food the majority of the Member States respondents 
were in favour for food of clones 91.7%, 66.7% were in favour for the food from offspring 
and 58.3% were against the system for the descendants of clones. 
Concerning labelling the majority of the Member States respondents were in favour of a 
mandatory labelling for food from clones and offspring of clones 75% in both cases, in the 
104 

 
other hand 58.3% of the Member States respondents were in favour of no labelling for the 
descendants of clones. 
Finally concerning the choice within the 5 policy options proposed, options 1 and option 5 
were considered the most appropriate both with a 25% each. 
DETAILS OF RESPONSES BY CATEGORIES OF RESPONDENTS.  
The comparative tables below are presented the detailed positions expressed by the different 
categories than cannot be observed within the above global assessment. For instance contrary 
to the position of NGOs and individuals in favour of a general ban of the technique and 
animals derived from clones, the Professional Organisations are in favour of the ban of the 
cloning technique, live clones and the traceability of reproductive materials of clones but 
against any measures on the progeny of clones.  
Concerning Competent Authorities of Member States it should be noticed that 5 out of 12 
replies do not provide the name of the organisation they are representing and Ireland and 
Portugal replied twice. For all these reasons some cautions need to be exercised when drawing 
conclusions from these figures. 6 out of 10 are in favour of the status quo. Concerning the 
general ban there are the same number of Member States in favour than against. The majority 
are also in favour of the pre-market approval of food from clones (7 out of 10) and offspring 
of clones (6 out of 10). Competent Authorities of Member States are in favour of the animal 
identification and registration and the traceability and labelling of clones and their progeny. 
Questions NGOs PROFESSIONAL 
Individuals 
Member 
ORGANISATIONS 
and self-
States* 
employed 
Level of 
94.1% 79.4% 
65.5% 
83.3% 
information – 
Well informed 
Current situation 
88.2% not 
55.9% agree with the 
73.9% not 
58.3% agree 
appropriate 
current situation 
appropriate 
with the 
current 
situation 
 
* The National competent authorities of EU Member States participating in this public consultation were Ireland (2); United Kingdom; 
Austria; Finland; Germany; Portugal (2); Czech Republic; France; Luxembourg and Italy. 
 
105 

 
Cloning Technique 
Questions NGOs  PROFESSIONAL Individuals and 
Member 
ORGANISATIONS 
self-employed 
States 
Ban of Cloning 
85.3% in  38.2% in favour 
73% in favour 
41.7% against 
technique 
favour 
and 41.7% in 
favour 
Ban of Live 
91.2% in  38.2% in favour 
81.4% in favour 
41.7% against 
cloned animals 
favour 
and 41.7% in 
favour 
Ban of clone 
94.1% in  52.9% against 
76.1% in favour 
41.7% against 
reproductive 
favour 
and 41.7% in 
materials 
favour 
Ban offspring of 
91.2% in  61.8% against 
79.6% in favour 
41.7% against 
clones 
favour 
and 41.7% in 
favour 
Ban of 
88.2% in  61.8% against 
79.6% in favour 
41.7% against 
descendants of 
favour 
and 41.7% in 
clones 
favour 
 
 
 
Foodstuff 
Questions NGOs 

PROFESSIONAL 
Individuals and 
Member 
ORGANISATIONS 
self-employed 
States 
Placing food 
91.2% against  
52.9% against 
86.3%  against 
50% against 
from clones 
Placing food 
94.1% against 
64.7% in favour 
84.1% against 
41.7% against 
from offspring 
and 41.7% in 
favour 
Placing food 
91.2% against 
67.6% in favour 
83.2% against 
41.7% against 
from descendants 
and 41.7% in 
favour 
Pre-market 
79.4% in favour 
79.4% in favour 
79.2% in favour 
66.7% in 
approval for food 
favour 
from clones 
106 

 
Pre-market 
79.4% in favour 
64.7% against 
75.7% in favour 
58.3% in 
approval for food 
favour 
from offspring of 
clones 
Pre-market 
79.4% in favour 
64.7% against 
74.8% in favour 
41.7% against 
approval for food 
and 41.7% in 
from descendants 
favour 
of clones 
 
Animal identification and registration 
Questions NGOs 
PROFESSIONAL 
Individuals 
Member States 
ORGANISATIONS 
and self-
employed 
Identification and 
97.1% in 
79.4% in favour 
87.2% in favour 
91.7% in favour 
registration of clones 
favour 
Identification and 
91.2% in 
58.8% against 
84.5% in favour 
75% in favour 
registration of offspring of 
favour 
clones 
Identification and 
88.2% in 
58.8% against 
81.9% in favour 
58.3% in favour 
registration of descendants 
favour 
of clones 
Identification and 
97.1% in 
47.1% in favour 
85.4% in favour 
83.3% in favour 
registration of reproductive 
favour 
materials of clones 
 
Traceability and labelling 
Questions NGOs 
PROFESSIONAL 
Individuals 
Member 
ORGANISATIONS 
and self-
States 
employed 
Traceability of 
94.4% in favour 
73.5% in favour 
90.7% in favour  91.7% in 
food from clones 
favour 
Traceability of 
88.2% in favour 
58.8% against 
86.7% in favour  66.7% in 
food from 
favour 
offspring of 
clones 
Traceability of 
91.2% in favour 
58.8% against 
83.6% in favour  58.3% in 
food from 
favour 
descendants of 
clones 
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Labelling of food  88.2% in favour 
50% in favour mandatory  88.9% in favour  75% in favour 
from clones 
mandatory 
mandatory 
mandatory 
Labelling of food  85.3% in favour 
64.7% against 
84.1% in favour  75% in favour 
from offspring of  mandatory 
mandatory 
mandatory 
clones 
Labelling of food  82.4% in favour 
64.7% against 
82.3% in favour  58.3% in 
from descendants  mandatory 
mandatory 
favour 
of clones 
mandatory 
 
Options 
Questions NGOs 
PROFESSIONAL 
Individuals 
Member 
ORGANISATIONS 
and self-
States 
employed 
Options 
41.2% Option 5  
29.4% Option 1 
58% Option 5 
25% Option 1 
and 25% 
option 5 
 
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ANNEX V: EXECUTIVE SUMMARY OF THE ICF-GHK STUDY ON THE IMPACT IN THE EU AND 
THIRD COUNTRIES OF EU MEASURES ON ANIMAL CLONING FOR FOOD PRODUCTION 
Executive Summary  
Introduction  
This is a summary of a study commissioned by DG SANCO of the European Commission 
from ICF GHK to inform and support development and appraisal of proposals to regulate 
animal cloning in the EU. It provides a feasibility and impact assessment of four possible 
approaches to regulation of animal cloning for livestock in the EU. It includes a description of 
the use of and concerns about the technique and the outlook for livestock cloning to 2020. It 
then compares the expected impacts of various measures, specified by the European 
Commission, through which the four approaches would be implemented. The appraisal covers 
feasibility, administrative burdens, induced costs, trade-mediated impacts, employment 
effects, and then impacts on consumers, SMEs and the environment.  
There is currently a lack of inter-institutional agreement between the Commission and the 
Parliament regarding the regulation of animal cloning in the EU. A Roadmap was developed 
in February 2012 to address this issue. This study will assist the Commission as it prepares an 
impact assessment of the five options set out in the Roadmap. The four approaches assessed 
here are:  
■ A suspension or ban on animal cloning in the EU, including use of the cloning technique, 
marketing of reproductive materials from clones, marketing of live clones, and marketing of 
clone offspring, descendants, and the reproductive materials of offspring and descendants.  
■ Traceability for clone reproductive materials, live clones, their offspring and descendants, 
their reproductive materials and derived food products.  
■  Labelling requirements for food products derived from clones, their offspring and 
descendants, in addition to the traceability requirements.  
■ Premarket approval requirements for food products derived from clones, their offspring and 
descendants, in addition to the traceability requirements.  
The scope of work includes bovine, porcine, ovine, caprine and equine animals and spans the 
full breadth of the food supply chain from production to consumption. The study considers the 
impacts of the four approaches on both the EU and third countries. It does not consider 
cloning for research purposes, pharmaceutical production or other commercial uses, including 
sport and leisure or conservation of endangered species or breeds.  
ICF GHK acknowledges with thanks the support given to the study by many stakeholders 
who participated in the consultation and research process.  
 
Context to the study - livestock cloning in the EU and third countries 
 
 
Scientific and social context of livestock cloning  
Commercial cloning is a form of assisted reproductive technology and may be used to 
replicate ‘high quality’, high value breeding animals. It can increase the number and therefore 
the availability of animals with superior genetics. Cloning can multiply the number of such 
animals, but it is not a breeding technique — an animal with desirable attributes can be 
replicated, but the technique cannot be used to acquire or refine desirable traits.  
Commercial cloning is most common in sectors where assisted reproductive technologies are 
already widely used and where breeding animals carry a particularly high value. Cloning is 
currently considered to be of greatest benefit in the dairy industry, where larger numbers of 
high quality animals could increase overall herd milk yield, the availability of stock with 
disease resistance and other desirable traits associated with milk quality.  
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Cloning has been used for bovine, porcine, ovine, caprine and equine animals. Its use has 
been mostly limited to dairy cattle and horses, however, largely due to their high value as 
breeding animals. Cloning is relatively expensive and has a high failure rate, making it viable 
only where the prospective returns are worth the investment. The overall success rate of the 
cloning procedure is less than 10 per cent in bovine animals and between 5 and 17 per cent in 
pigs. Its use in equine animals is limited to sport horses. Little use of the technique is made 
for ovine, caprine and porcine animals. 
There are animal health and welfare concerns associated with cloning, particularly the higher 
mortality rate of clones compared with sexually produced animals. A majority of cloned 
embryos do not develop to term and of those that do, another proportion die during or shortly 
after birth from a variety of causes. Surrogate cattle dams also have problems including late 
gestational loss and more difficult delivery. Studies have shown that survival of offspring and 
descendants of clones is similar to the survival of conventionally bred animals. 
Studies carried out on in the EU and third countries on the safety of food products derived 
from clones, their offspring and descendants conclude that there are no additional risks 
associated with consuming these products and that there is no increased risk compared to food 
products derived from conventionally-bred animals. 
Nonetheless, research suggests that EU citizens and consumers are concerned about animal 
cloning, and oppose its use for livestock. The supply chain does not generally perceive 
investment in cloning to be worthwhile at this time due to consumer concerns, coupled with 
high costs to use the technique and availability of other assisted reproduction techniques.  
A joint statement on animal cloning issued in 2010 by the governments of Argentina, Brazil, 
New Zealand, Paraguay and the United States observes that regulatory approaches to 
agricultural technologies should be ‘science based’ and should not restrict trade more than 
necessary to fulfil ‘legitimate objectives’. It states that there is no basis to differentiate 
offspring or descendants of clones from other sexually reproduced animals. New Zealand is 
the only country that currently regulates cloning activity. No third country identifies or tracks 
the offspring or descendants of clones. 
 
Current use of animal cloning and the outlook to 2020  
The research suggests that there is currently no commercial cloning of livestock animals in 
the EU and none is expected before 2020. Commercial cloning of bovine animals is 
happening in a small number of third countries, particularly in North America and Argentina. 
Cloning is also being applied to porcine, ovine and caprine animals in third countries, but to a 
much lesser extent. Commercial cloning is concentrated in the US, Canada and Argentina, 
although there is some activity in New Zealand, Australia, Chile, China and South Korea.  
Commercial cloning of beef and dairy cattle is likely to continue in third countries. It is 
expected to become more efficient and less expensive, but remain limited to high value 
breeding animals. Commercial pig cloning may also become more widespread by 2020. Its 
application to ovine and caprine animals is expected to remain limited.  
The most likely route for clones, clone offspring and descendants or their reproductive 
materials to come into the EU is as reproductive materials from bovine animals, and possibly 
porcine animals from North America, and beef products from Argentina. Offspring of bovine 
dairy clones have been produced in the EU from imported reproductive materials from North 
America (two such animals entered the UK food chain in 2010). It is possible, if unlikely, that 
equine clones produced for sport could enter the EU food chain when the animals reach the 
end of their working life or through equine meat imports from third countries. 
 
 
 
110 

 
Supply chain and trade profile  
The supply chains that may be affected by the proposed approaches to regulation of animal 
cloning reach from ‘farm to fork’, including the breeding sector, producers, markets, 
slaughterhouses, cutting plants, meat and dairy processors, wholesalers, retailers, as well as 
importers of live animals, reproductive materials and food products. Species-specific 
information is available on the number of enterprises involved in animal breeding and 
production, as well as for imports of live animals and their reproductive materials. Beyond 
these points in the supply chain the available data only provide aggregate numbers of 
enterprises across the different sectors.  
The policies potentially affected a very large number of businesses – relatively few firms in 
the breeding sector but very many producers, processors and retailers. There are fewer than 10 
companies operating in the EU that could conduct cloning activities (none are known to be 
doing so). Approximately 300 AI companies operate in the EU livestock breeding sector. 
There are an estimated 120 importers of reproductive materials. Almost all the importers of 
live animals deal in equine animals, though there are a few importers of bovine, porcine, 
ovine and caprine animals.  
The EU has nearly 8 million producers of bovine (3.3 mil), porcine (2.7 mil), ovine (1.2 mil) 
and caprine (0.7 mil) animals. The total number of markets, slaughterhouse and cutting plants 
is unknown, though there are an estimated 15,000 of these operations for bovine animals. 
Further down the supply chain there are around 82,000 processors / manufacturers, 83,000 
wholesalers, and 624,000 retailers of meat and dairy products. There are around 715 importers 
of meat and dairy products.  
The measures assessed could affect trade, particularly imports into the EU. At present:  
 
■ Parts of the EU livestock sector are heavily reliant on imported reproductive materials, 
particularly from US and Canada. Commercial cloning activities occur in both countries, but 
the proportion of materials sourced from clones, their offspring and descendants is unknown. 
  
■ A small number of live bovine, ovine and caprine animals and a larger, but still relatively 
small number of porcine animals are imported to the EU each year. Due to the high 
transportation costs, these are all expected to be high value breeding animals, which the EU 
livestock sector also considers to be important to the breeding industry. A relatively large 
number of equine animals imported into the EU each year (11,000 in 2011), but these are all 
expected to be for sport and leisure purposes rather than food production. 
  
■ The EU is a net importer of beef and veal worth around €1.7 billion per year. Sheep meat 
imports are valued at approximately €1 billion. Cheese and butter are worth more than half a 
billion euro, despite the EU being a net exporter of these products. 95 per cent of beef imports 
are sourced from eight countries, with 70 per cent coming from Argentina, Brazil and 
Uruguay. Milk and dairy products are sourced primarily from Switzerland, New Zealand, and 
Ukraine and Belarus. The EU is self-sufficient in pig meat though there is small volume of pig 
offal imports from Switzerland and of pig meat, mainly from US and Chile. Sheep and goat 
meat is primarily sourced from New Zealand and Australia. Around 70% of equine meat is 
sourced from Argentina, Brazil, Uruguay and Mexico, most of the remainder is sourced from 
Canada and the US. 
 
 
111 

 
Feasibility and impacts of the four approaches108  
The individual measures provided are not, with a few exceptions, viable in isolation so for the 
purposes of analysis were combined into coherent ‘packages’ of measures. In some cases, 
different strategies have also been modelled to explore the implications of alternative possible 
interpretations of the stated policy objectives. For example, for traceability, one strategy looks 
at the impacts assuming that best use is made of existing traceability systems, another looks at 
the impacts of implemented full traceability of every individual animal, and another looks at 
whether the objectives could be achieved via voluntary approaches.  
 
The feasibility and impact assessment process therefore involved, for each approach: 
specifying the packages of measures; mapping these packages onto the supply chain; defining 
the obligations that the packages place on different sectors and the systems required to 
achieve the objectives of the different approaches; assessing the feasibility of each package; 
analysing the impacts on operators and competent authorities arising from the packages, 
including impacts on SMEs, EU competitiveness, consumers and the environment. The 
feasibility and impacts of the four approaches have been considered comparatively and 
progressively through the supply chain, from packages that focus on live animals and their 
reproductive materials through to food products.  
 
Feasibility  
The feasibility assessment considered the issues involved in the construction and operation of 
systems that could be developed to deliver on each of the four approaches. It focused on 
technical feasibility, that is, whether a compliant system could be constructed, as well as the 
strengths and weaknesses of each package of measures.  
 
Feasibility of packages focused on live animals – clones  
The suspension of the cloning technique in the EU and marketing of clones and traceability of 
live clones by adapting existing traceability systems are both feasible (measure S1 / package 
S-A, measureT1 / package T-A). Use of the cloning technique requires specialist expertise 
and technology not widely available. Clones are high-cost animals that would be used for 
breeding purposes. As such, they are highly identifiable since operators involved in breeding 
such high-value animals tend to keep detailed records of the animals. With few firms to 
regulate, domestic cloning would be relatively easy for competent authorities to control. 
Imports are more problematic, but there are only a small number of animals to control. 
Imported live animals can be controlled relatively easily through risk-based surveillance of 
trade focusing on the main sources of food production animals with the highest levels of 
cloning activity. 
 
Feasibility of packages focused on reproductive materials from clones 
 
Suspension of the marketing of reproductive materials from clones (package S-B) and 
traceability of reproductive materials from clones (package T-B) under all traceability 
strategies are feasible without significant adjustment to existing EU (or third country) 
systems. The production of reproductive materials is already a highly regulated industry in the 
EU and in the third countries from which the EU sources imported materials. Individual 
                                                 
108 As defined in Commission Roadmap on measures on animal cloning for food production in the EU 
http://ec.europa.eu/governance/impact/planned_ia/docs/2013_sanco_007_use_of_cloning_technique_for_food_p
roduction_en.pdf 
 
112 

 
identification and traceability is already enabled in the EU for all semen and embryos. There 
is no known domestic production of clone reproductive materials for bovine, porcine, ovine or 
caprine animals. Private sector agreements also already identify cloned reproductive materials 
from bovine and equine animals originating in the US and Canada. There is no known trade in 
reproductive materials from clones of the other species.  
Feasibility of packages focused on live animals – offspring and descendants  
Suspension of the marketing of clone offspring and descendants (packages S-C, S-D), and the 
traceability of clone offspring and descendants (packages T-C, T-D) using existing 
infrastructure are both feasible, but would require considerably more adjustment to existing 
systems than controls that applied only to clones. These packages are more vulnerable to 
fraud than those covering only clones and clone reproductive materials; third countries are 
unlikely to change their traceability systems to ensure that imports of live animals into the EU 
conform to EU requirements. Together, these issues put packages related to clone offspring 
and descendants at risk of not meeting their objectives.  
Domestically produced offspring of clones are identifiable due to agreements with North 
American operators to identify reproductive materials from clones. The offspring produced 
from these reproductive materials are most likely to be high-value breeding animals and 
therefore, records will be kept of these animals’ parentage. Identifying domestically produced 
descendants will be complicated by the record keeping required. As descendants become part 
of multiplication herds, parentage information may not be fully reliable due to mixing of 
animals on farm. Incentives may not encourage compliance, especially if operating the system 
entails additional cost and identification of animals as clone descendants has an impact on 
their market value.  
 
Few live animals of the species covered here are imported into the EU and those that are 
imported are ‘high value’ animals whose heritage would normally be documented. Offspring 
of clones will be relatively easy to identify since parentage records are kept for these high-
value animals for at least the previous generation. Identifying clone descendants is much more 
complicated than for clone offspring because current systems in third countries do not require 
traceability of clone offspring or descendants. Assuming that the EU requires documentary 
evidence at the point of import, this package would therefore require countries exporting to 
the EU to establish new systems that identify each clone offspring and descendant. These 
systems would need to incorporate trade in animals and reproductive materials amongst third 
countries to be comprehensive. It seems unlikely adequate systems would be built.  
 
Information on the pedigree status of reproductive materials would be needed to implement 
these packages; such documentation is not currently required. Systems in place in North 
America to identify clone reproductive materials do not extend to reproductive materials from 
clone offspring or descendants. Additional steps would need to be taken by operators to 
identify these reproductive materials as derived from clone offspring or descendants.  
 
‘Legacy’ presence of clone offspring and descendants in the EU is a potential problem and a 
source of additional regulatory costs for suspension and traceability packages covering 
descendants because identifying all such animals could be difficult and expensive. A decision 
would be needed on how to treat these animals. One option would be to accept a low level 
legacy presence of clone offspring and descendants in the food chain and focus efforts on 
excluding new sources.  
 
 
113 

 
Feasibility of packages that require identification of the status of all animals or batches 
of animals/reproductive materials  
 
Packages covering traceability of clone offspring (T-C, Strategy 1 – ID all animals or batches 
and Strategy 2) and descendants (T-D, Strategy 1 - ID all animals or batches and Strategy 2) 
are technically feasible, but would require major changes to the systems for some species, 
even where there is likely to be little, if any, cloning activity.  
 
A traceability strategy that requires identification of the ‘clone status’ of all animals or 
batches of animals will require adjustment to all existing traceability systems to enable an 
indication to be provided as to whether or not the animal is a clone, clone offspring or 
descendant, or batch of animals contains animals that are clones, clone offspring or 
descendants. At present, this should be straightforward for porcine, ovine and caprine 
animals, since cloning activity for these species is very limited. Bovine animals are more 
complicated because offspring and descendants may be produced in the EU. There is also an 
issue of ‘legacy’ bovine offspring and descendants in the EU.  
 
Traceability approaches that require individual animal identification and traceability will 
require significant adjustments to existing traceability systems and may require new systems 
where existing systems cannot cope with identifying the number of new animals that require 
traceability. Third countries are unlikely to implement new traceability systems in the absence 
of evidence on human health or safety risks.  
 
Feasibility of packages focused on food products  
The greatest challenge to feasibility of packages covering food products arises from imports. 
Confirmation of the status of these food products as being derived from clones, clone 
offspring or clone descendants would need to rely on traditional documentary methods used in 
supply chain traceability systems. This kind of documentation is not currently required for 
imported food products. International trade in reproductive materials will make it difficult to 
be certain that the animals, and thus food products, from a country that does not use the 
cloning technique were not actually derived from reproductive materials from clones, their 
offspring or descendants obtained in another country. Extension of traceability requirements 
into processed food products would not be feasible in most instances.  
 
Suspending the marketing of food products derived from clones (S-E) is the most feasible of 
the packages covering food. The number of potential EU suppliers is small. Proportionate 
systems for suspension of clone imports are also technically feasible through working with 
trading partners. The risk of clones being used systematically for food in the next few years is 
low as clones are uncommon and very valuable, though there is a theoretical risk of such 
animals entering the food chain at the end of their working lives as breeding animals. 
Nonetheless, demonstrating and documenting that foods are free of clones would require 
systems that do not currently exist. Third countries that export to the EU would require 
appropriate traceability systems or segregated supply chains, unless a pragmatic agreement 
was reached with third countries to exclude clones from exports to the EU. Verification of 
claims would not be possible. Moreover enforcing the suspension of use of clones in imported 
food products would be a significant challenge due to the high volume of EU meat product 
imports, especially bovine products.  
 
Constructing a system that can exclude clone offspring (S-F) and descendants (S-G) is less 
feasible than one covering clones alone. Trading partners would need to either identify and 
114 

 
trace all clone offspring as live animals and then trace them through the food chain to 
demonstrate that exports to the EU did not contain products derived from clone offspring, or 
to establish fully segregated ‘clone-free’ supply chains. The feasibility of the system for all 
animals would depend on the specification of the evidential requirements applied by the EU 
to imports under the new EU ‘cloning’ legislation.  
 
Traceability packages for clone offspring and clones descendants (T-F, T-G) face the same 
challenges as suspension packages for food products derived from clone offspring and clone 
descendants – identification and traceability beyond clones themselves is difficult, if not 
impossible, without completely segregated supply chains. The EU’s trading partners (and 
those countries’ other trading partners) will need to adapt their traceability systems. It seems 
unlikely they will do so.  
 
 
Feasibility of labelling and premarket approvals for food products derived from clones, 
their offspring and descendants 

Labelling and premarket approval approaches for food products derived from clones (package 
L-A, P-A), their offspring (package L-B, P-B) and descendants (package L-C, P-C) are 
feasible only to the extent to which the underlying traceability systems are feasible. The 
limitations of traceability described above are thus also present for labelling and premarket 
approvals. Where it is difficult or impossible to confirm that a food product contains clones, 
their offspring or descendants (e.g. mixed meat products), then it will be difficult to label 
these products, for example, and there are likely to be more errors in identification. 
A labelling approach that requires ‘positive’ labelling (e.g. “contains products derived from 
descendants of clones”) is likely to prompt the industry to exclude products from the supply 
chain that would be required to carry the positive label. This is due to the negative perception 
of the cloning technique by consumers and supply chain operators’ concern about negative 
responses of consumers to any label referring to cloning. A labelling approach that required 
food products to be labelled with information telling the consumer that they may be derived 
from clone offspring or descendants could be used in a context where food exports to the EU 
were unable to provide full traceability. This would enable imports to continue in a way that 
would not be possible if declaration of clone status was a formal requirement for import into 
the EU.  
A labelling approach that is voluntary and ‘negative’ (e.g. “produced without cloning 
technology”) is likely to be appealing to some operators. A certification approach could be 
used in which sufficient documentary evidence would confirm that the process used involved 
sufficient effort by the supply chain to exclude these animals, even if the product is not 
verifiable. Even so, there is a risk that the two labelling packages covering food products from 
clone offspring (L-B) and descendants (L-C) would not achieve their objectives because of 
difficulties in confirming the claims made for imported food products derived from offspring 
and descendants. 
Impacts  
Given that little or no commercial cloning is expected in the EU in the period to 2020, 
virtually all of the impacts arising from the proposed approaches assessed in this study arise 
from the development of systems to control activities and products that are not present in the 
supply chain or, in the case of bovine animals, present only at very low levels. Direct and 
indirect effects are expected on the EU supply chain. The imposition of new requirements that 
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exporters in third countries may be unwilling or unable to satisfy poses a risk of causing 
interruption to trade, especially for packages that cover clone offspring and descendants, and 
food products. These trade-mediated effects could negatively impact the EU’s animal 
breeding at one end of the supply chain, and affect choice and price of food for consumers at 
the other. Some packages are also expected to cause a large number of businesses to spend 
time (and thus incur cost) understanding the implications of the new legislation for their 
operations, even in circumstances where they would not be expected to encounter any animals 
or products regulated (under that legislation). This is a form of additional deadweight cost. 
  
By making products derived from clones, clone offspring and clone descendants more 
‘visible’, the interventions are likely to reinforce a drive towards exclusions of such animals 
and products from the supply chain. Labelling requirements, which makes clone status visible 
to consumers, are likely to further reduce demand for livestock animals produced from the use 
of cloning technology and their introduction into the EU supply chain. Mandatory ‘positive’ 
labelling is likely to result in downward pressure on upstream operators by retailers and 
manufacturers to exclude clones, their offspring and descendants from the supply chain. 
Operators will face additional costs to take measure to exclude these animals.  
 
Fully segregated supply chains are feasible in some cases, such as for milk, but due to the lack 
of market demand for products formally recognised as being derived from clones (or clone 
offspring / descendants), operators are unlikely to invest in those operations. 
 
Direct burdens  
The direct burdens on EU operators will vary significantly depending on the approach taken, 
the information requirements of the approach and the compliance, reporting and enforcement 
strategy of competent authorities (sections 7.4 and 8.4).  
 
‘Learning costs’  
‘Learning costs’ are the staff time and advisory costs incurred by directly affected operators 
as they familiarise themselves with the new legal requirements (sections 7.4.2 and 8.4.2). 
Under the suspension and traceability (Strategy 1) approaches such costs are likely to be 
modest where packages focus on breeders and the ‘upstream’ parts of the supply chain 
operators (estimated at less than a €100,000 for packages S-A and T-A due to the small 
number of directly affected operators, and approximately €1 million for packages S-B to S-D 
and T-B to T-D). Most of the costs under these packages are borne by the AI industry.  
 
Learning costs increase significantly where packages include regulation of food products. 
Under the suspension packages (S-F to S-G) meat food importers will also be directly 
affected, increasing costs by more than €5 million. Under traceability packages (T-E to T-G) 
costs could increase by approximately €200 million under each package as other 
‘downstream’ operators in the EU supply chain (slaughterhouses, markets, food importers, 
processors, manufacturers, wholesalers, and retailers) are required to learn about the new 
requirements (Table 7.5 and Table 8.9).  
 
Learning costs for breeders / holdings can vary from relatively modest (a couple of million 
euro) where packages focus only on identification and traceability of clones themselves to 
hundreds of millions of euro where all holdings must learn about new requirements related to 
traceability under Strategy 1 if all animals/batches of animals must be identified as a clone (or 
not) and under Strategy 2 if all individual animals must be identified and traced. This is 
because the scope of the regulation changes from focusing only on those operators handling 
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animals that may be clones, offspring or descendants to all operators raising livestock animals 
in the EU. Even if each of these operators only needs a minimal amount of time to learn about 
the new requirements, there are nearly eight million operators that may be directly affected 
under these scenarios. 
 
Reporting and inspection costs  
Reporting and inspection costs are incurred as breeders, livestock producers and food business 
operators responses to requests for information (i.e. reporting) and/or inspections from 
competent authorities (CAs) (sections 7.4.2 and 8.4.3).  
 
CAs’ approach to regulation will determine the precise burdens on operators. If CAs take a 
risk-based approach that focuses on EU organisations capable of conducting cloning and 
targeted checks on imports, then regulatory costs can be reduced. If CAs implement a 
comprehensive monitoring and reporting framework then the costs will be far higher. In all 
cases, the costs increase as the packages involve more of the supply chain, and particularly for 
those that cover food products.  
Annual reporting burdens under the suspension approach and (the less ambitious, Strategy 1) 
traceability approach will be modest where packages focus on clones. For example, 
traceability costs are estimated at approximately €2,000 per year for packages focusing on 
clones (T-A and T-E). Estimated annual reporting burdens grow to approximately €32,000 
under traceability packages that cover clone offspring and clone descendants (packages T-B, 
T-C, T-D, T-F, T-G) (Table 7.7 and Table 8.13). Additional annual reporting burdens could 
be zero to negligible for breeders/holdings under traceability Strategy 1 where positive ID is 
required only for clones, their offspring and descendants (sub-strategy (a)) but more than 
€100 million per year if all animals require individual identification where this is not already a 
requirement under EU legislation (Strategy 2) (Table 8.15).  
 
Compliance costs  
The traceability approach will impose additional costs on competent authorities and 
businesses, including livestock producers. The costs to CAs include one-off costs for 
changing paper-based documentary and IT based traceability systems to achieve compliance 
with the new rules and on-going costs for operation of the expanded system (section 8.4.4).  
 
If the traceability approach focused on making best use of existing traceability infrastructure 
(Strategy 1) consultations with selected MS representatives suggest that these changes could 
be made through minor adjustments to existing systems. Sub-strategy (a) requires 
identification only of clones, their offspring, descendants, reproductive materials and derived 
food products, which would also keep costs low given the small number of animals in the 
system. Sub-strategy (b) would impose much higher costs since it would require an indication 
of the status of all animals or batches of animals, and derived products (i.e. clone, offspring, 
descendant ‘yes’ or ‘no’).  
 
If each animal had to be individually identified for all species without derogations (Strategy 
2) much larger investments in databases and associated systems would be required. Countries 
with large populations of porcine, ovine and caprine animals would need to have systems that 
could accommodate individual ID of all of these animals (potentially millions of additional 
animals and many millions of animal movements). New systems are likely to be needed to 
record this information. The costs of adjusting or creating new systems under Strategy 2 
would likely run into millions of euros in total across the EU.  
 
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There would also be large additional capital and operating expenses for the livestock sector to 
work to the new system in which individual animal ID and traceability is required. That 
change would involve removing the derogations put in place under current traceability 
legislation. There would be additional costs in acquiring and maintaining equipment (such as 
ear tags, and modifying readers). The requirement to identify the clone status of each small 
ruminant would require more than 50 million animals to be tagged each year at a cost to 
breeders and producers in tags and other equipment estimated at €37million to €98 
million/year. The cost for porcine animals would be higher because many more porcine 
animals are produced each year (approximately 260 million) than ovine/caprine animals 
(approximately 89 million), and most are currently batch-identified. The cost is estimated at 
between €193 and €510 million each year (section 8.4.4.3). Added to this would be the cost of 
time taken by operators to administer the system. The inputs required for an accurate 
estimation of additional costs are not all available but the incremental cost of recording clone 
status on an individual animal basis is estimated at €24 million for ovine and caprine animals 
and €71m/year for porcine animals (Table 8.20).  
 
The suspension approach would not impose additional compliance costs on the EU. But it 
would require compliance expenditure by third countries that would be required to develop 
segregated supply chains or traceability systems sufficient to demonstrate that their exports to 
the EU of animals were not clones, their offspring or descendants, and exports of reproductive 
materials and food products were not derived from such animals, much as would be needed 
under the traceability approach (section 7.4.1). These systems do not exist at present.  
The labelling and premarket approval approaches would impose further compliance costs on 
operators and competent authorities. These include:  
 
■ Costs for labelling changes: operators that need to adapt or redesign product labels in order 
to accommodate new labelling requirements will incur additional costs that are expected to 
range from as little as €100 to as much as €13,000 per stock keeping unit depending on the 
requirements (Table 9.3). The incremental costs will be lower where changes can be 
integrated into the labelling ‘lifecycle’ and included during the regular ‘refresh’ of a product 
label.  
 
■ Costs for premarket approval: the expected costs to industry of approvals are less than 
€30,000 per product for a purely administrative approval mechanism. Toxicological tests are 
unlikely to be required, but if they were, the costs could be more than €300,000 for testing 
and detailed risk assessment (section 10.4.2). The designated authority will also incur costs to 
establish the approval system. The assumptions made about evidence required are illustrative 
for this appraisal only.  
 
The total expected costs on the supply chain are small because it is expected that relatively 
few products would be labelled or brought to the market. The detail of the labelling 
requirements (e.g. whether they specify a note in the list of ingredients or a prominent front of 
pack label) would influence impacts.  
 
In a scenario where imported foods were required to be labelled as potentially derived from 
clones, clone offspring or clone descendants (i.e. “may contain”), there would be impacts on 
exporters in third countries. This route would however enable food imports to continue in 
circumstances where third countries are unable (or unwilling) to establish robust traceability 
systems for such animals and derived products. 
 
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Trade-mediated effects  
Many of the measures assessed risk disrupting EU import trades, with the potential for 
impacts across the supply chain, from the artificial insemination and elite breeding sectors all 
the way through to consumers. Imports of reproductive materials are of direct importance to 
the EU breeding and livestock production sector and benefit the rest of the supply chain 
indirectly. If the EU imposes conditions relating to clone status that exporters are unable or 
unwilling to satisfy, €3.67 billion worth of annual imports of meat and other animal-derived 
food products are at risk of interruption (sections 7.5.3 and 8.5.2). Given the international 
trade in reproductive materials, animals and food, to achieve traceability or exclusion of 
products of clone offspring and descendants from the EU supply chain would demand that the 
other trading partners of the EU’s direct trading partners have adequate traceability systems 
for clone status – in effect a global traceability system. The feasibility and reliability of such a 
system is in doubt.  
 
The size of such trade-mediated contingent risks varies depending on the scope of the 
legislation. The precise impacts will also depend on the behavioural responses by the EU 
supply chain and by actors in third countries. The analysis has therefore estimated trade and 
jobs ‘at risk’ rather than specifying definitive losses. The value of trades and the number of 
businesses at risk are set out in Table E.1. Both short-run effects (e.g. loss of access to South 
American beef) and long-run effects (e.g. impacts on EU dairy breeding strategies and 
productivity if EU breeders are denied access to elite genetic materials from North America) 
are anticipated.  
EU requirements to trace or excludes products based on a clone status add cost and 
complexity for operators exporting to the EU and for EU importers. Evidential requirements 
under all scenarios are expected to be harder to meet, and therefore entail additional costs.  
 
Premarket approvals (PMAs) could also create issues for importers of meat and other products 
into the EU if importers cannot be sure that imported products are free of animal clones, 
offspring and descendants because they will not be able to place them on the EU market. 
PMA requirements risk triggering trade disruptions to meat and other animal product imports. 
Generic authorisations could reduce the problem. Even under a generic system, issue remains 
until the first authorisation is granted Authorities could provide for a transitional period for 
PMA to allow food products that may be derived from clone offspring and descendants to 
continue to enter the market without approval until end of the transition period. A PMA 
requirement would create an additional barrier for exporters to the EU over and above that 
posed by traceability requirements. 
 
Impacts on competitiveness  
 
In addition to direct economic impacts and indirect trade-related effects on EU and third 
country operators and competent authorities, there may be impacts arising from the proposed 
approaches related to competitiveness, including cost competitiveness, capacity to innovate 
and international competitiveness. These are each considered in turn below.  
 
 
 
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Table 1: Summary of potential trade-mediated impacts arising from suspension and traceability 
approaches 
 
Issue  
Package  
Number of businesses  Value of 
Significance of impacts 
at risk  
trade at risk  if full cessation of trade  
(€m/yr)  
Cloning 
All suspension 
LOW  – no known N/A  
LOW  – potential limited 
technique 
packages (S-A to 
food-related 
impact to 2020 in the 
is 
S-G)  
companies conducting 
dairy sector  
unavailabl
cloning in the EU  
e in EU  
Imports of  All suspension and  LOW - small numbers  LOW - 2.3  
MEDIUM 
– small 
live 
traceability 
of live animals 
numbers of animals, but 
animals 
packages (S-A to  imported  
important to EU breeding 
cease  
S-G and T-A to T-
sector  
G)  
Imports of  S-B to S-G and T- MEDIUM 
– 120 MEDIUM -  MEDIUM  -  HIGH  The 
reproducti
B to T-G  
companies may go out  14  
EU breeding industry is 
ve 
of business; 294 AI 
heavily reliant on 
materials 
companies may be 
imported reproductive 
cease  
affected  
materials, especially for 
bovine animals  
Imports of  S-F, S-G and T-F,  MEDIUM – 715  HIGH - 
LOW – caprine food 
food 
T-G109  
companies may go out  3,667  
imports  
products 
of business; effects 
MEDIUM – porcine, 
cease  
greatest for bovine, 
ovine and equine food 
ovine and equine meat 
imports  
importers  
HIGH – bovine food 
imports  
 
Cost competitiveness 
Packages that extend beyond control of cloning are expected to have negative impacts on the 
cost competitiveness of EU businesses. It is not clear that EU controls on use of cloning 
would confer an advantage in export markets that would help to offset the additional costs. In 
the EU domestic market the negative impacts of the additional administrative burdens would 
be mitigated by an increase in demand for domestically production if access to imports was 
reduced.   
The largest direct cost impact domestic producers is triggered by a requirement for individual 
animal traceability in the porcine and ovine/caprine sectors; many producers in those sectors 
already exist on low margins and it is unlikely that the incremental costs could be passed in 
full down the supply chain.  The packages that impose additional traceability and reporting 
burdens would make these sectors less competitive. Indirect effects may be greater than the 
direct effects, particularly where trade losses occur due to third countries not being able or 
willing to meet traceability requirements. If trades are halted, input costs could rise in the EU, 
for example, in the breeding sector. 
                                                 
109 Food products derived from clones are highly unlikely since clones are scarce and expensive and, it is 
assumed, could be excluded through pragmatic measures without putting EU trade as a whole at risk.   
120 

 
Packages 
Direct effects 
Indirect effects 
Control of 
None as no commercial cloning 
Some additional administrative costs to 
cloning and 
expected in the EU in the baseline 
meet requirements 
use of clone 
(business as usual) scenario 
Risk of loss of access to imports of live 
reproductive 
animals and RM which could raise input 
materials  
costs, if existing private schemes are not 
S-A, S-B & 
recognised and extended 
T-A, T-B 
Controls on 
Negative impacts on farmers and 
Potential trade losses where third 
clone 
importers of animal genetics for bovine  countries do not meet traceability 
offspring and  species 
requirements to allow importers to meet 
descendants 
Where all animals require ID, 
requirements of suspension or 
S-C, S-D & 
significant additional administration 
traceability approach in the EU –could 
T-C, T-D 
and equipment costs in porcine and 
raise input costs in the EU 
ovine/caprine sector would negatively 
impact cost competitiveness of these 
sectors 
Controls on 
Increased compliance and reporting 
Risk of widely distributed negative 
food  
costs 
impacts due to loss of imports 
S-F, S-G & 
Some negative impacts may be offset if 
T-F, T-G 
imports are restricted from third 
countries due to lack of compliance with 
traceability requirements and EU 
producers benefit from loss of 
competition 
 
Impacts on EU’s capacity to innovate 
The indirect (and uncertain) trade-mediated effects have the potential to immediately impact 
on innovation and thus productivity growth in the livestock sector in the EU, particularly for 
bovines. If trading partners cut off trade with the EU in live animals and reproductive 
materials, it would also affect Europe’s access to high quality genetics in key breeds and thus 
the sector’s ability to improve the quality of the EU breeding stock. Suspension measures 
which prohibit use of cloning technologies risk inhibiting the EU’s capacity to innovate in this 
area, though the short-term impacts of the approach on cloning research and innovation are 
expected to be small.   
International competitiveness 
Traceability and suspension packages that reach beyond regulation of clones and clone 
reproductive materials risk having a negative impact on the EU’s international 
competitiveness. Packages that result in lack of access to high quality genetic materials from 
third countries could, especially over the longer term, negatively impact on competitiveness in 
price-sensitive export markets. The additional administrative burden imposed on the food 
chain would be expected to reduce the competitiveness of the affected sectors.  This is 
particularly true of the more ambitious traceability strategy which could have negative 
impacts for porcine, ovine, caprine and equine animal industries due to significantly higher 
costs imposed on operators. 
There would potentially be some benefits for EU domestic producers in-so-far as: 
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■  Packages that interrupt imports could reduce domestic producers’ exposure to competition 
in the EU market, which could improve their competiveness in the domestic EU market;  
■  Suspension, traceability, and labelling approaches that enable ‘clone free’ status for EU 
products, could have a positive impact on demand for those products in third countries if 
this is seen as a premium attribute by consumers; and 
■  Competitiveness impacts arising from the labelling and premarket approval approaches are 
expected to flow predominantly from the traceability systems underlying them.  
Impacts on SMEs 
The four approaches as specified do not provide an exclusion from the requirements for SME 
businesses. The food chain contains large numbers of SMEs, from the farming sector through 
to manufacturing and retail. All four approaches therefore have the potential to impact on 
SME growth. The impacts on SMEs are likely to vary depending on the approach and strategy 
chosen, as well as information requirements. Indicative likely impacts are described in Table 
E.3. 
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Package Sectors 
Principal 
impacts 
Comments Significance 
expected 
Control of 
Live 
Risk of loss of market in 
Aggregate value of trade is 
High for 
cloning 
animal 
live animal imports 
small 
affected 
S-A & T-A 
importers 
Few businesses rely on trade in  businesses 
live animals to the EU, but 
Low overall 
important to those few 
businesses 
Animals are high-value and 
therefore likely to be traceable 
with modest effort 
Clones plus 
Importers  Materials will need to be 
Existing system can and does 
Low 
clone 
of RM 
identified as derived from 
already screen out clone RM 
reproductive 
clones and excluded (S-B) 
where required 
materials 
from EU market 
S-B  
Clones plus 
Importers  Materials will need to be 
Materials are already traceable  Low 
clone 
of RM 
identified as derived from 
and identifiable in major 
reproductive 
clones and traced in EU 
exporting countries as derived 
materials 
market 
from a clone 
T-B 
As above 
Importers  Risk of loss of access to 
Existing ‘screening’ system 
High 
plus 
of RM 
imported RM leads to loss 
does not extend to offspring 
offspring and 
of business for importers 
and descendants of clones 
descendants 
where exporters cannot or 
S-C, S-D & 
will not identify RM from 
T-C, T-D 
clone offspring/ 
descendants 
 
Breeders 
Loss of access to high 
Some Member States are 
High in select 
quality Holstein/other 
heavily dependent on AI and 
MS 
genetics would negatively 
imported RM for breeding 
Low in other 
affect breeding 
programmes 
MS 
programmes 
As above, 
Food 
Risk of loss of access to 
Higher input prices likely 
High/critical 
plus food  
importers,  imported meat and dairy 
Some businesses rely entirely 
for businesses 
S-E, S-F, S-
processors suppliers 
on imports 
dependent on 
G & T-E, T-
,  
Import substitution from 
imports 
F, T-G 
manufactu
Food products derived from 
domestic supply should 
General 
rers, 
clones (T-E) are highly unlikely 
raise prices/profitability for 
negative 
retailers 
and could be excluded through 
EU suppliers 
impact from 
etc. 
pragmatic measures without the 
negative impacts expected from  higher input 
T-F and T-G. 
prices 
 
Social (employment) impacts 
Few EU jobs are currently sustained by commercial livestock cloning so suspension will have 
little direct impact on employment in the breeding sector. The more substantial employment 
impacts expected are: 
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■  Employment losses prompted by the additional administrative burdens place on livestock 
producers and other food business operators (FBOs); and 
■  The risk to jobs in EU livestock sector and supply chains created by requiring third 
countries to comply with traceability conditions that they may be unable or unwilling to 
meet.  
Direct and indirect (trade-mediated) employment impacts of the suspension and traceability 
approaches, as well as labelling and premarket approvals are summarised in Table E.4. 
Impacts on consumers 
The suspension and traceability approaches that reach beyond control of cloning and clone 
reproductive materials could result in negative impacts on EU consumers. These may include 
both price effects (i.e. price changes in consumer markets) and choice effects (i.e. changes in 
the availability of goods and services available to consumers). Short run impacts are likely to 
be highest for packages that include food products, mainly because of the potential trade-
related impacts on food imports. These could limit the availability of certain products and 
increase prices where alternatives must be sourced from other trading partners or 
supplemented by domestic production. Traceability Strategy 2 may also increase the 
production costs for operators, and these costs may be passed to consumers, increasing costs 
to purchase these products. 
 
Direct impacts 
Indirect (trade-mediated impacts) 
Suspension  Negligible for all packages – few if any EU 
Potential high negative impacts; 
jobs sustained by commercial cloning in the 
suspension puts jobs at risk in businesses 
food chain 
importing products and in downstream 
supply chains – impacts expected in the 
EU and third countries, especially for 
packages related to food products (S-E, 
S-F, S-G) 
Traceability  Negligible for live clones (T-A) and their 
May have negative impacts for domestic 
– Strategy 1  reproductive materials (T-B) – few EU jobs 
and third country operators for 
sustained by commercial cloning; 
reproductive materials from clone 
reproductive materials are already traceable 
offspring (T-C) and descendants (T-D) – 
and the status of the RM is easy to determine  third countries unlikely to implement 
required systems to enable traceability. 
Packages related to food products (T-E to 
T-G) could produce significant 
employment impacts in sectors currently 
sustaining thousands of jobs in the EU 
and third countries if traceability 
requirements results in a cut-off in trade 
of these products 
Traceability  Direct impacts for live bovine animals, and 
Impacts for food products of all species 
– Strategy 2  RM of all species (T-A, T-B) expected to be  (T-E to T-G) expected to be the same as 
the same as under Strategy 1 
under Strategy 1. 
EU jobs would be created for live porcine, 
Employment gains through expanded 
ovine, caprine and equine animals to produce  traceability for porcine, ovine, caprine 
tags, equipment, computer systems for 
and equine animals likely to be offset by 
individual ID and to implement the systems 
employment losses caused by additional 
(T-A, T-C, T-D) 
administrative burdens place on livestock 
124 

 
sectors and supply chain.  
Labelling 
Few products likely to be brought to market 
Impacts are expected to be related to the 
under ‘positive’ labelling 
underlying traceability systems, rather 
Voluntary labelling may result in creation of  than labelling itself 
a small number of jobs in administration of 
requirements, inspections, etc. 
Premarket 
No measurable employment impacts 
Primary impacts are expected to be 
approval 
expected – demand for approvals likely to be  related to traceability rather than the 
zero 
PMA itself; though PMA would present 
an additional barrier to trade if / once the 
traceability issues had been overcome. 
 
Package 
Price effects 
Choice effects 
S-A, S-B & T-A, T-
None expected 
None expected 
B (Strategy 1, 
positive ID only) 
S-C, S-D & T-C, T-
Price effects in dairy markets if 
Limited, except as a consequence of product 
D (Strategy 1, 
dairy sector loses access to 
scarcity 
positive ID only) 
imported reproductive materials 
Marked short run effects may 
occur in MS with high 
dependence on imported RM and 
heavy use of AI 
Price effects in meat and meat 
products sector if meat 
production sector loses access to 
imported RM 
T-A, T-C, T-D 
Negative price effects if all 
None expected 
(Strategy 1 and 2, ID  animals must be identified 
all animals/batches) 
S-F, S-G and T-F, T- Price effects in dairy markets if 
Product-specific and seasonal due to loss of 
G (Strategy 1 and 2)  imports of dairy products cease 
access to specific brands/types of dairy 
Potentially significant price 
product.  
effects in meat and meat 
Significant for bovine meat and meat 
products sector if imported meat  products 
products cease (primarily bovine,  Significant for ovine and caprine meat 
as well as ovine meats) 
products 
Limited for porcine and equine meat 
products 
 
Environmental impacts 
The evidence suggests that the negative welfare impacts are concentrated in the cloning 
process itself. The incremental animal welfare benefits are thus highest for the measures and 
packages that focus only on cloning (measure S1, package S-A; measure T1, package T-A).   
As the scope of the packages increases to cover offspring, descendants and food, the 
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additional animal welfare benefits decline while the additional economic impacts, and risks, 
increase. 
There is uncertainty about the impacts of use of cloning on genetic diversity in domesticated 
species, but the most likely outcome is a reduction in the genetic diversity of the gene pool, 
and potentially further concentration in the use of a small number of breeds. The EU’s 
exposure to these impacts is likely to be indirect, mediated through the use of genetic 
materials imported from North America. Regulating the use of cloning could reduce the risk 
of this loss of diversity, though it could also deny EU breeders access to high quality genetics 
from North America that are used to supplement ‘domestic’ genetics. If, in extremis, imports 
of reproductive materials ceased then EU breeders in the dairy sector and elsewhere would be 
denied access to the global ‘pool’ of genetic resources used in animal breeding and would 
need to develop alternative strategies for the same breeds or turn to other domestic EU breeds.  
Conclusion 
The analysis suggests that controls that were limited to the use of cloning in the EU in the 
period to 2020 would not have a significant economic impact, partly because little or no 
commercial cloning is expected even without regulation.  Suspension of, or requiring 
traceability for, clone reproductive materials is feasible and would not have a large economic 
impact if existing supply chain arrangements can be recognised, formalised and extended. 
However, as the scope of the packages increases beyond cloning to cover offspring, 
descendants and food, the incremental animal welfare benefits decline while the additional 
economic impacts, and risks, increase. Packages also become progressively less feasible. The 
key issues are: 
■  The costs associated with traceability requirements imposed on the EU supply chain under 
the traceability approach, and the exact specification of those traceability requirements; 
■  The systems or documentary evidence that entities exporting animals, reproductive 
materials and to the EU will be required to have to support declarations on whether those 
goods are clones, clone offspring and clone descendants, or derived from such animals; 
and 
■  How to foster a system that is robust and reliable in a context where claims of the clone 
status of animals and products will not (with few exceptions) be verifiable except by 
documentary evidence, where mistakes as to parentage are easily made (e.g. through 
mixing of young animals and parents in extensive systems), and where incentives in the 
supply chain may not encourage compliance (e.g. higher costs, lower market value). 
The proportionality of the actions represented by many of the packages evaluated is doubtful 
given the absence of commercial cloning in the EU and that commercial cloning for food 
production in third countries is largely confined to bovine animals. 
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ANNEX VI: SUMMARY OF EU REQUIREMENTS ON THE IDENTIFICATION AND TRACEABILITY OF 
LIFE ANIMALS AND REPRODUCTIVE MATERIAL AND NOVEL FOOD 
1. Live animals 
a) For Bovine animals, the main objectives of the current system of identification, 
registration and traceability are to identify individually and to trace animals for the control of 
infectious diseases and  to re-establish consumer confidence in beef and beef products through 
transparency and traceability of bovine animals and the meat derived. 
The system is based on 4 elements: “double ear tag”, “holding register”, “cattle passport” and 
“national computerised database”. The identification is individual and the registration of 
individual movements is compulsory by keepers in the holding register and in the database. 
The holding register and the database contain among others information on the date of birth 
and the mother of each bovine animal. 
In the case of imported live bovines, EU legislation ensures identification on the animal in 
question upon arrival and subsequent tracing once the bovine enters the EU. Information 
about parentage and date of birth is not requested in the import health certificate. However 
the whole pedigree (parents and grand parents) is provided in the zootechnical certificate for 
pure bred animals which are  intered to be registered in herd books. The total number of live 
bovine imported into the EU is limited but these are mainly pure bred animals with 
zootechnical certificates. 
b) For sheep and goats, the objective is mainly animal health. Sheep and goats born after 1 
January 2010 must either be i) individually identified with an electronic identifier and an 
eartag or ii) by two conventional eartags. National computerized databases have been set up 
also for ovine and caprine but only holdings have to be registered. The registration of 
individual animals and their movements has only to be done in the holding registers and not in 
the database. The holding register and the database do not contain information on the 
parentage  
It has to be noted that the current legislation on small ruminant identification provides for a 
derogation to individual identification for slaughter animals under 12 months old under 
certain conditions.  
In relation to imports of sheep and goats from third countries, the current import health 
certificate does not impose to record information on the parentage, but the whole pedigree 
(parents and grand parents) is provided in the zootechnical certificate for pure bred animals. 
The number of live sheep imported into the EU is limited.  
c) For Pigs, the objective is mainly animal health. The current system for identification in the 
EU is less sophisticated than the system set up for bovine, ovine, caprine and equine since it is 
not based on individual identification but on "batch/holding" identification which enables to 
determine the last holding from which they come from and the holding on which they were 
born. Each animal is identified at birth with the identification number which is attributed to 
the farm of birth and keeps it up to slaughtering. The same animals receive a second eartag 
from the farm of fattening (same number attributed to the whole batch of production). All 
farms are registered in the national database of porcine holdings.  
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The database does not contain records of animal movements but all holdings have to register 
in their holding registers the information related to animal movements between holdings 
(including slaughterhouses) based on batches of animals. The traceability of batches of 
animals is therefore paper based (holdings registers and possible documents accompanying 
the movements of animals).  
In relation to imports of pigs from third countries, the current import health certificate does 
not impose information on the parentage but the whole pedigree (parents and grand parents) is 
provided in the zootechnical certificate for pure bred animals. The number of live pigs 
imported into the EU is limited (around 800 per year). 
d) For Equine animals, the objective is mainly animal health. Horses born after 1 January 
2009 must be individually identified (electronically) but the registration of individual 
movements is not done in the database. The current system for identification is based on a 
single lifetime identification document (individual passport) and the registration of individual 
animals in a database. The database is updated only following to a change in the ownership of 
the animal. The microchip contains the Unique Equine Life Number (UELN), and the 
microchip number can be linked to a central database and/or to the passport. 
In relation to imports of horses from third countries, the current import health certificate does 
not impose information on the parentage but the whole pedigree (parents and grand parents) is 
provided in the zootechnical certificate for pure bred animals. The number of horses imported 
is around 10000 horses per year, but most of them are not intended for the food chain. 
For all species, the responsibility to register and to feed the system with information related to 
animal movements, births, deaths, etc. falls on the keeper of the animal. EU legislation 
describes clearly the information to be recorded per every animal, which varies depending on 
the animal species. This includes information on the mother but only for bovines. Information 
on the father is not requested for any of the farm animal species. 
Table 1: Main EU legislation and type of identification and traceability by species 
Species 

Identification 
Traceability (Registration of 
EU Legislation 
animals) 
Bovine 
Individual (Ear tag) 
Individual + passport 
Regulation 1760/2000 
National Database 
Ovine/caprine 
Individual (EID or ear tag) 
Individual / holding register 
Regulation 21/2004 
Batch (Lambs) (Holding 
register) 

Porcine 
Batch (Ear tag) 
Batch  
Directive 2008/71 
holding register 
Equine 
Individual (EID) 
Individual + passport 
Regulation 504/2008 
National Database or passport 
 
2. Reproductive material  
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Health certificates are required for intra-community trade and imports of reproductive 
material. Current rules on trade of either EU produced or imported semen and embryo 
establish a registration system which is based on the individual identification of the donor 
(semen) or both donors (for embryo). That system ensures that these reproductive materials 
can only be marketed if the individual identification of the donor animal(s) is indicated on the 
straws, ampoules or other packaging, containing the individual dose of semen or embryos 
and on the veterinary import certificate accompanying these products. This information then 
allows the traceability of these reproductive materials from the breeding centre of production 
up to the farm of destination. 
a) Intra-community trade 
•  Information in the health certificate contains provisions related to identification 
and registration of the donor animal(s). For each consignment of semen: 
approval number(s) of semen centre(s), identity of the donor animal(s), 
identification mark(s) of doses and the consignee(s). Similar rules for embryo. 
•  This information is transferred electronically via TRACES. 
•  Traceability requirements provides for an unique identification number of 
donor animal(s) which is labelled (bar code) for each semen straw / embryo 
ensuring full traceability from the donor animal to the farm(s) of destination. 
b) Imports from third countries 
•  Equivalent requirements on identification and registration apply for imports of 
reproductive material from third countries than to those for intra-EU trade 
•  Only EU agreed collect and storage semen centres can provide semen to the 
EU market. 
c) National trade 
 
•  No health certificate and therefore no registration are needed for national trade 
of reproductive materials.  
•  However EU Law foresees that semen centres have the obligation to register 
the consignee (approved entities of destination) for each semen consignment 
they put on the market. 
 
3. Registration of zootechnical certificates for trade of live animals and reproductive 
material (pure bred only). 

As regards farmers willing to register their pure bred animals in herd books: on top of the 
above-mentioned requirements on identification and registration, pure bred animals must 
comply with additional requirements resulting of the provisions contained in the EU 
zootechnical legislation. This includes the possibility to have additional information on the 
parentage of these animals via the herd-books, like registration of both parents and the 4 
grand-parents. This information is managed by private organisations and on a voluntary basis. 
The number of farm animals for which this additional information on identification and 
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registration could be available represents a small percentage of the total animal farm 
population in the EU.  
a) Imports from third countries 
Imports of reproductive material and pure breed animals from third country may on the top of 
the identification and registration requirements referred in points 1 and 2, comply with 
additional requirements resulting of the provisions contained in the zootechnical legislation. 
EU zootechnical certificates110 are not systematic for the imports of pure bred live animals 
and their reproductive material as it depends if the farmer of destination intends to register the 
animal(s) imported or obtained in the national herd-book of the breed. 
b) Intra-community trade 
•  Member States may also impose EU genealogic/zootechnical certificates111 (delivered 
by herd-books) for pure breed animals and pure breed reproductive material intended 
for intra-community trade. 
•  These certificates provide information on the pedigree (see paragraph 1 b) for 
registration in the national herd-book of the breed of i) pure bred live animals and ii) 
the offspring obtained from their reproductive materials. 
4. Traceability of food 
Food traceability is the ability to track any food, food producing animal or substance that may 
be destined for human consumption through all stages of production, processing and 
distribution of foods. For the proper application and enforcement of origin labelling, an 
effective traceability system is required to ensure the passing of the origin information along 
the food chain.  
a) General EU traceability requirements. 
The EU traceability legislation aims at ensuring food safety. Accordingly, Regulation (EC) 
No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down 
the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety112 sets out a comprehensive 
system of traceability within food and feed businesses to meet this objective.  The traceability 
requirements can be summarised as follows:113 
  The traceability of food, feed, food-producing animals, and any other substance intended 
to be, or expected to be, incorporated into a food or feed should be established at all stages 
of production, processing and distribution. 
  FBOs must be able to identify any person from whom they have been supplied with a 
food, a feed, a food-producing animal, or any substance intended to be, or expected to be, 
                                                 
110 Council Directive 94/28/EC laying down zootechnical and genealogic conditions applicable to imports from 
third countries of semen, ova and embryo. 
111 Could be replaced by genealogic documents issues by semen centres. 
112 OJ L 31, 1.2.2002, p. 1. 
113 Article 18 of Regulation (EC) No 178/2002; Guidance on the implementation of Articles 11, 12, 14, 17, 18, 
19 and 20 of Regulation (EC) No 178/2002 on General Food Law - Conclusions of the Standing Committee on 
the Food Chain and Animal Health, January 2010, to be found at: 
http://ec.europa.eu/food/food/foodlaw/guidance/docs/guidance_rev_8_en.pdf.   
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incorporated into a food or feed. To this end, FBOs must have in place systems and 
procedures that allow for this information to be made available to the competent 
authorities on demand. 
  FBOs must have in place systems and procedures to identify the other businesses to which 
their products have been supplied. This information must be made available to the 
competent authorities on demand. 
  Food or feed which is placed on the market or is likely to be placed on the market in the 
Union must be adequately labelled or identified to facilitate its traceability, through 
relevant documentation or information in accordance with the relevant requirements of 
more specific provisions. 
The requirement to identify suppliers and other businesses to which products are supplied is 
known as the ‘one step back - one step forward’ approach. The ‘one step back - one step 
forward’
 approach implies for food business operators that:  
-  They must have in place a system enabling them to identify the immediate supplier(s) 
and immediate customer(s) of their products; 
-  a link ‘supplier-product’ must be established (which products supplied from which 
suppliers);  
-  a link ‘customer-product’ must be established (which products supplied to which 
customers). Nevertheless, food business operators do not have to identify the 
immediate customers when they are final consumers.  
As such, the existing traceability requirements do not foresee a cumulative traceability 
system. 
The traceability requirements set out in Regulation (EC) No 178/2002 are worded in terms of 
their goal and intended result, rather than in terms of prescribing how that result is to be 
achieved. This allows certain flexibility to the FBOs in the implementation of these 
requirements.  
b) Traceability of food of animal origin. 
As far as foods of animal origin are concerned, Commission Implementing Regulation (EU) 
No 931/2011 of 19 September 2011 on the traceability requirements set by Regulation (EC) 
No 178/2002 of the European Parliament and of the Council for food of animal origin114 sets 
out additional traceability requirements. In particular, it applies to unprocessed and processed 
foods of animal origin.115 It requires FBOs to ensure that the following information 
concerning consignments of food of animal origin is made available to the FBO to whom the 
food is supplied and, upon request, to the competent authority:  
-   an accurate description of the food;  
-  the volume or quantity of the food;  
-  the name and address of the food business operator from which the food has been 
dispatched;  
                                                 
114 OJ L 242, 20.9.2011, p. 2. 
115 However, it does not apply to foods containing both products of plant origin and processed products of animal 
origin. 
131 

 
-  the name and address of the consignor (owner) if different from the food business 
operator from which the food has been dispatched; 
-  the name and address of the food business operator to whom the food is dispatched;  
-  the name and address of the consignee (owner), if different from the food business 
operator to whom the food is dispatched;  
-  a reference identifying the lot, batch or consignment, as appropriate; and  
-  the date of dispatch. 
These information requirements must be updated on a daily basis and kept at least available 
until it can be reasonably assumed that the food concerned has been consumed. 
In addition, Regulation (EC) No 853/2004 of the European Parliament and of the Council of 
29 April 2004 laying down specific hygiene rules for food of animal origin116 requires that 
products of animal origin should have an identification mark indicating the last approved 
establishment in which the product was handled. The identification mark must indicate the 
country where the establishment is located and its approval number. Establishments located 
within the Union must be indicated as EC (or equivalent abbreviation in other languages).  
Imports of live animals and animal products from third countries into the EU are governed by 
detailed legislation in the veterinary field. Third countries exporting to the EU must have 
traceability systems in place for exports, which are able to provide equivalent standards to 
those in the EU. In that respect, Regulation (EC) No 853/2004 sets out general obligations for 
the importation of products of animal origin from third countries, including the fact that foods 
of animal origin can only be imported from countries and establishments laid down in EU 
lists.  
c) Specific requirements for fresh beef 
With regard to bovine animals and fresh beef, Regulation (EC) No 1760/2000117 and 
Commission Regulation (EC) No 1825/2000118 lay down mandatory origin labelling as well 
as detailed traceability requirements for bovine animals and fresh, chilled or frozen beef 
products for the purposes of food safety, origin labelling and animal health including disease 
control. Operators at all stages of production up to the point of sale must have systems in 
place to ensure the link between bovine animals, carcasses and/or cuts of fresh, chilled or 
frozen beef including minced beef. In that respect, the following indications must be included 
on the label of such food products: 
-  a reference number or code linking the meat to an animal or group of animals; 
-  the approval numbers of the slaughterhouse and cutting plant; 
-  the Member State or third country of birth; 
-  the Member State or third country of rearing; 
                                                 
116 OJ L 139, 30.4.2004, p. 55. 
 
117 Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a 
system for the identification and registration of bovine animals and regarding the labelling of beef and beef 
products and repealing Council Regulation (EC) No 820/97 (OJ L 204, 11.8.2000, p. 1). 
118 Commission Regulation (EC) No 1825/2000 of 25 August 2000 laying down detailed rules for the application 
of Regulation (EC) No 1760/2000 of the European Parliament and of the Council as regards the labelling of 
beef and beef products (OJ L 216, 26.8.2000, p. 8). 
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-  the Member State or third country of slaughter; 
-  the Member State or third country of cutting. 
Where meat is derived from animals born, reared and slaughtered in the same Member State 
or third country, the indication may be given as ‘Origin: [name of Member State/third 
country]’.Where beef is derived from animals that have been reared for 30 days or less, the 
indication of origin should provide: 
-  the Member State or third country of birth, or; 
-  the Member State or third country where slaughter took place; 
Where full information is not available for beef imported from third countries, it may be 
permitted to state the country of origin as ‘non-EU’, provided that the name of the third 
country of slaughter is indicated. In this case, live animals must generally have been kept for a 
minimum of six months in the designated country before slaughter and export of the beef into 
the EU.  
A derogation is allowed for minced meat where the label must indicate as a minimum 
‘Prepared: [name of Member State/third country]’ to show where the minced meat was 
prepared; and ‘Origin: [name of Member State/third country]’ if the meat originated from a 
country or countries other than the country of preparation. 
Traceability of processed beef meat is subject to the general requirements of Regulations (EC) 
No 178/2002 and 931/2011, which do not address the passing of origin information along the 
food chain.  
d) Specific traceability requirements for sheep and goat meat 
Council Regulation (EC) No 21/2004119 concerns the identification and registration of live 
sheep and goats to permit individual traceability throughout their lifetime via electronic 
identification for animals born after 1 January 2010, subject to certain derogations.  
The sheep and goat traceability system enables the complete traceability within the EU of live 
sheep and goats through individual electronic identification. Traceability, however, of 
unprocessed and processed sheep and goat meat is subject to the general requirements of 
Regulations (EC) No 178/2002 and 931/2011, which do not address the passing of origin 
information along the food chain.  
In addition, national databases containing information on individual sheep and goat 
movements are not compulsory but may be implemented voluntarily in Member States. The 
lack of national databases makes full information on the origin of sheep and goat meat more 
difficult to access than in other systems, particularly traceability of unprocessed beef. 
e) Specific traceability requirements for pig meat 
Council Directive 2008/71/EC120  concerns the identification and registration of live pigs. Pigs 
must be identified and registered in such a way that movements of animals and the farm of 
                                                 
119 Council Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the identification and 
registration of ovine and caprine animals and amending Regulation (EC) No 1782/2003 and Directives 
92/102/EEC and 64/432/EEC (OJ L 5, 9.1.2004, p. 8). 
 
120 Council Directive 2008/71/EC of 15 July 2008 on the identification and registration of pigs (OJ L 213, 
8.8.2008, p. 31). 
 
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origin can be traced rapidly and accurately. The pig identification system is based on batch 
identification and not individual identification. In particular, Directive 2008/71/EC requires:  
-  identification marks to be applied before pigs leave the holding of birth, making it 
possible to determine the holding of origin; 
-  animal keepers must keep records of movements of animals entering and leaving a 
holding, at least on a batch basis and including the origin or destination, as applicable; 
-  keepers must supply the competent authority on request with all information 
concerning the origin, identification and where appropriate the destination of animals 
that they have owned, kept, transported, marketed or slaughtered; 
-  these procedures apply to intra-Union movements; and, 
-  pigs imported from third countries must be similarly identified and a link established 
and recorded to identify the third country. Imported animals going direct to a 
slaughterhouse need not be re-identified. 
The pig identification and recording system enables identification of the holding and country 
of birth, and identification of the last holding from which an animal has come. Intermediate 
holdings may be traced through records of movements, although the system does not 
guarantee the traceability of all intermediate holdings prior to the last holding for individual 
animals. This system of traceability does not allow the passing of information on origin along 
the full chain. 
Traceability, however, of unprocessed and processed pig meat is subject to the general 
requirements of Regulations (EC) No 178/2002 and 931/2011, which do not address the 
passing of origin information along the food chain. In addition, the national databases for pigs 
do not contain information on individual movements, making it more difficult to ensure the 
full origin information as regards pig meat, compared to the traceability of unprocessed beef. 
 
5. Novel Food Regulation 
The Novel Food Regulation (EC) n° 258/97 covers the food derived from animals which are 
obtained by non-traditional breeding techniques and therefore the food from cloned animals. 
As offspring and descendants are conventionally bred, their food is not covered by this 
Regulation. 
Food from clones could only be placed on the EU market after the submission of an 
application -by an applicant to the competent Authorities of a Member State- has gone 
through a scientific risk assessment performed at national level and, if objections from 
member State(s), at EU level by the EFSA and finally obtained an individual authorisation by 
the European Commission. When a Novel Food authorisation is granted, mandatory labelling 
can be requested. Once an individual authorisation has been given to a prior applicant, other 
applicants can submit an authorisation request for the same product through a simplified 
procedure called "notification" based on the opinion of a national food assessment body that 
has established "substantial equivalence" with the novel food already authorised. 
                                                                                                                                                         
 
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Based on an impact assessment report made in view of the revision of Novel Food 
Regulation, the 2008 Novel Food proposal provided for the simplification of legislation and 
of the administrative procedures for public Authorities and food business operators: 
- The procedure for the assessment and authorisation of novel foods is fully centralised at EU 
level. National administrative procedures and double risk assessment -at national and most 
often at EU level (EFSA)-are repealed. 
- The authorisation procedure is streamlined, increasing its efficiency and reducing the 
administrative burden and the length of the authorisation procedure. 
- Individual authorisation currently granted only to the applicant are replaced by generic 
authorisations available to all food business operators which comply with the specifications of 
the authorisation. 
- A simplified procedure for the placing on the market of the traditional foods from third 
countries is introduced to alleviate the administrative burden for their placing on the EU 
market. 
However, the 2008 legislative proposal was not adopted in Conciliation in March 2011: a 
separate legislative proposal on Novel Food is planned to be adopted at the same time than the 
legislative proposal on cloning. 
To date no application for authorisation of food from clones has ever been made. If an 
authorisation would be requested, it is likely that the authorisation would include a mandatory 
labelling of food from clones to ensure consumer information which implies that the cloned 
animals and their food will have to be traced. To date, the identification as such and the 
traceability of cloned animals is not in place. 
 
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ANNEX VII: BASELINE SCENARIO (ECONOMIC) 
The scope of activities and sectors which may be impacted by measures on cloning covers the 
breeding sector, the farming sector (meat and milk production) and the food sector, covering 
five species (bovine, porcine, ovine/caprine and equine). The baseline is structured as follows: 
A.  EU livestock sector  
B.  The breeding sector  
C.  Food sector (including market outlook)  
A. Livestock sector 
1. EU livestock 
 
Figures on the EU livestock for bovine, ovine, caprine are provided in table 1: 
Table 1: EU livestock population – annual data – millions of animals)  
ANIMALS 2010 
2011  2012 
Live bovine animals 
87,3 
86,2 
85,9 
Live goats 
13,3 
12,4 
8,1 
Live sheep 
85,9 
85,6 
75,8 
Live swine,  
151,1 
148,5 
144,7 
 
 
Source: Eurostat 2008 
 
In 2007, EU livestock production accounted for 41% of agricultural output in value terms, 
representing 1.2% of the European Union’s GDP. Highest GDP shares are found in Bulgaria, 
4.4%, and Romania, 3.8%, while lowest shares are found in Luxemburg (0.5%), UK (0.6%) 
and Sweden (0.7%). In value terms, beef and milk represent over 50% of total output, with sheep 
meat representing over 20%121.  However, the relative importance of livestock production per 
member states as expressed in the share of the agricultural output ranges from 28% in the case 
of Greece to 69% in Ireland, which is obviously at least partly the result of specific 
conditions. 
Regarding number of actors across the meat and dairy supply chain, there are almost 8 
Million farmers/producers and around 80.000 processors and the same amount of wholesalers 
and close to 700.000 food and specialist meat and dairy retailers across Europe.122 
Dairy farming sector 
                                                 
121 Eurostat data 2011 
122 Eurostat Structural Business Statistics (2009) 
136 

 
It remains characterized by an important diversity and heterogeneity in the EU27, despite 
strong restructuring, which expresses itself through labour input, the (feed) resource base and 
the intensification and specialization levels including a trend towards landless livestock 
production.  
Meat farming sector 
The EU produced 7,900 thousand tonnes of bovine meat for the purpose of food production in 
2010 among which 2/3 originate from dairy herds and 1/3 from beef production. Almost 
60% came from four countries (France, Germany, Italy and the UK). The structure of EU 
production has changed little over time: the same four countries accounting for 57% of bovine 
meat production in 2004.  
Pig production is generally an intensive, indoor, large scale business which combined with the 
much weaker dependence on the local resource base and bio-physical conditions leads to a 
relatively low level of variability in production systems.   
Across the sector, the general trend in production continues to concentrate on fewer, larger 
farms. For example, in dairy production where about 50% of dairy cows are in herds of at 
least 50 heads and 85% of EU milk production is derived from high input/output production 
units.  
 
Table 2: EU livestock sector’s 2007 – economic output 
 
Member 
Livestock Production 
Share (%) of livestock production(value terms) 
state 
)
Million 
Agricultural 
GDP
Milk
Beef
Pig 
Sheep
euro 
output share 
share
meat 
and goats
fr 
23542 
36.4% 
1.2% 
 
31
34 
12 
3   
de 
20400 
45.1% 
0.8% 
 
47
15 
25 
0   
it 
14441 
33.5% 
0.9% 
 
30
23 
16 
2   
es 
14296 
36.6% 
1.4% 
 
19
15 
33 
11   
uk 
12301 
56.8% 
0.6% 
 
33
26 

9   
nl 
9140 
39.9% 
1.6% 
 
43
18 
22 
1   
pl 
8994 
45.5% 
2.9% 
 
35
10 
28 
0   
dk 
5449 
60.2% 
2.4% 
 
27

44 
0   
ro 
4584 
34.7% 
3.8% 
 
30
11 
21 
4   
Ie 
4092 
68.5% 
2.1% 
 
40
37 

4   
Be 
3799 
52.0% 
1.1% 
 
25
27 
34 
0   
At 
2883 
48.0% 
1.1% 
 
33
29 
23 
1   
Gr 
2881 
27.9% 
1.3% 
 
37


27   
Pt 
2499 
37.9% 
1.5% 
 
30
20 
19 
5   
Hu 
2296 
35.4% 
2.3% 
 
22

28 
2   
Fi 
2259 
55.2% 
1.3% 
 
46
15 
15 
0   
Se 
2225 
47.7% 
0.7% 
 
44
18 
16 
1   
Cz 
1763 
41.6% 
1.4% 
 
43
16 
23 
0   
Bg 
1259 
41.4% 
4.4% 
 
39

13 
13   
Sk 
941 
48.9% 
1.7% 
 
31
13 
21 
1   
Lt 
892 
45.7% 
3.1% 
 
51
16 
16 
0   
Si 
572 
50.6% 
1.7% 
 
32
29 
18 
2   
Lv 
411 
43.4% 
2.1% 
 
49
11 
15 
1   
cy 
305 
50.9% 
2.0% 
 
28

28 
11   
Ee 
303 
48.2% 
2.0% 
 
55

22 
1   
Lu 
165 
60.7% 
0.5% 
 
57
30 
10 
0   
Mt 
71 
59.5% 
1.3% 
 
24

22 
1   
EU-27 
142190 
41.4% 
1.2% 
 
34
20 
21 
4   
 
137 

 
Source: Eurostat 2008 
 
Meat consumption 
Forecasts are mainly driven by increasing poultry and pork meat consumption, as well as by a 
firm external demand and higher prices. On a per capita basis, EU meat consumption123 in 
2022, at 82.6 kg, would be at approximately the same level as it was in 2009 and 1% lower 
than in 2011, despite the improved macroeconomic prospects. Pig meat is expected to remain 
the preferred meat in the EU with 40.8 kg/capita consumption in 2022, compared to 24.1 kg 
for poultry, 15.7 kg for beef/veal and less than 2.0 kg for sheep and goat meat. 
2. International trade 
 
The EU import trade in live animals for food production is fairly small except for horses. In 
2011, 98% of the €120m value of live animal imports for the species of interest here related 
to horses (generally originating in the US). Most, if not all, of these animals were destined for 
sport and leisure uses rather than food production. 
3. Economics 
 
Gross margins in the livestock sector are generally not high but they are positive. In the EU15 
in 2007 farmers respectively i) breeders or ii) breeder and fatteners obtained on average 
comparable Gross Margin -including with EU and national coupled payments- of €310/cow 
and €297/cow respectively and an average of €135/male for fatteners (not directly 
comparable). The EU-10 margins were lower than the EU-15 for all three groups, which can 
be explained in part by the smaller number of cows/cattle per farm and lower prices for beef.  
However, when looking at economic performance measured by Economic Profit (also taking 
into account estimates of the unpaid family labour) it is negative in most cases. Given the 
constraints and incentives, beef producers can be expected to adopt strategies of minimising 
production costs, underpaying family factors and subsidising farm production from decoupled 
payments and other sources of income124. 
In the meat processing sector, the concentration process due to very low margins is 
continuing. For example, in Germany three slaughterhouses process more than 50% of all 
pigs. Similarly, in the retail sector, for the very same reason of decreasing profit margins, the 
concentration process is equally increasing with the top four retailers in Germany providing 
65% of the total turnover of the sector.125  
B. Breeding sector  
1. Description 
                                                 
123 Meat demand in Northern America and Europe would remain globally stable by 2050 but still remain highest 
in the world by 2050 at around 89 kg per inhabitant (against an estimated 83 kg in 2010); Source : Food and 
Agriculture organisation – livestock’s long shadow – environmental issues and options (2006).    
124 European Commission 2011: EU beef farms report 2010', DG AGRI 2011 
125 DBV 2012: Situationsbericht 201/13 – Trends und Fakten zur Landwirtschaft', 2012 
138 

 
The structure of livestock breeding in Europe can be described as a pyramid with the elite or 
nucleus breeders at the top, one or more middle tiers of purebred or crossbred multipliers in 
the middle, and a final tier of commercial herds below. Most nucleus breeders and multiplier 
organisations are cooperatively owned by farmers, and are often SMEs organised in national 
umbrella organisations. For disseminating desired genotypes, these national or local 
organisations of farm owners are internationally co-ordinated by a small number of private, 
elite breeding companies and cooperatives.  
Important terms are: 
•  Nucleus herds: elite breeders producing breeding stock, particularly males.  
•  Multiplier herds: take improved stock from nucleus herds to create larger number of 
animals for sale to tier below. 
- Purebred multipliers produce greater numbers of purebred animals, particularly 
males, for sale to the tiers below. 
- Crossbred multipliers producing crossbred animals, particularly females, for use in 
the commercial tier. 
•  Commercial herds: animals primarily involved in the production of milk and meat.  
Have little or no involvement in selling stock for further breeding. 
Table 1: Beef and dairy breeding structure 
 
 
Tier 1
Dairy herds 
AI
Bulls Heifers
Nucleus herds
AI
AI
Tier 2
Purebred multiplier herds
Tier 3
Crossbred multiplier herds
Tier 4
Commercial herds
Dairy cattle for milk production
 
Most nucleus breeders and multiplier organisations are cooperatively owned by farmers, and 
are often SMEs, operating in their native language, organised in national umbrella 
organisations. For disseminating desired genotypes, these national or local organisations of 
farm owners are internationally co-ordinated by a small number of private, elite breeding 
companies and cooperatives.  
139 

 
The  European Forum of Farm Animal Breeders (EFFAB) reports that the livestock 
genetics industry mainly consists of ‘(small or) medium enterprises or small units in larger 
organisations.’ According to one source, the size of livestock breeding companies tends to be 
medium scale, with at most 2000 employees, and annual turnovers not exceeding €0.5 
billion126. 
Table 3: Economic operators in the EU by sector and species (indicative): General 
overview 

Sector 
All species  
Bovine   Porcine 
Ovine 
Caprine  
Equine  
Companies that could  
7 4 


0 2 
conduct cloning activities 
294 
150 50 10  5 [79 studs] 
All companies 
Source: Eurostat 2008 
AI companies, breeders and producers are often involved directly in the import of 
reproductive materials and live animals
. Alongside those making direct use of the imported 
reproductive materials, live animals and products, there also exists a number of specialist 
import/export trading companies;  
Globally, the main markets for trade in bovine semen are the EU, the US, Canada and Latin 
America. The market value of international trade in livestock genetics as a whole is 
relatively small: US and Canadian exports of bovine semen to the EU from 2006-11 were 
worth an annual average of €21 million and €17 million respectively.  
Approximately 99% of bovine semen which is imported into the EU (around 1.9 million 
doses in 2011) are sourced from either the US or Canada. The US and Canada are also 
dominant in the markets for genetic materials of porcine, ovine, caprine and equine. A 2008 
USDA report indicates that ‘the largest U.S. export in livestock genetics is bovine semen’127. 
Parts of the EU livestock sector are now heavily reliant on reproductive materials imported 
from outside the EU. For example, while imported bovine semen represents on average 2.5% 
of the semen used in artificial insemination in the EU (considered much higher128 in some 
Member States), the breeding sector considers access to this genetic material as essential to 
the continued viability of the industry129. 
On average, the EU exports of bovine are semen worth €25 million each year130. EU exports 
of bovine semen to the US, Canada and Latin America represent less than half of this total 
export value from 2006-2011. A further quarter of this trade is to neighbouring countries, 
particularly Turkey and Switzerland, while more modest amounts are exported to Australia, 
China and Japan.  
                                                 
126 Gura, 2007 
127 USDA, 2008 
128 No data on national imports of reproductive material from third countries are available.  
129 ICF GHK report 2012 
130 Figures based on 2006-2011 COMEXT data 
140 

 
2. State of play on cloning activity 
Taking into account that no cloning activity is taking place in the EU (see Annex III.1), it can 
be estimated that the economic viability of cloning depends mainly on the cost of a clone and 
the pregnancy rate: The higher the costs, the more likely the use of cloning remains restricted 
to long-use high output animals (dairy cows, race horses), the lower the costs, the more likely 
the use of offspring for short term use (e.g. beef production). 
Commercial cloning activity in third countries is concentrated in a small number of 
countries. The countries with the most well-developed commercial cloning sectors are the US, 
Canada, and Argentina.  New Zealand, Australia, Chile, China and Korea are also undertaking 
commercial cloning for livestock species.  
•  Bovine animals: commercial cloning activity for livestock is best developed in bovine 
animals. Cloning technology is being applied to cattle in the US, Canada, Argentina 
and Australia131 It may also be undertaken in Brazil, New Zealand, Chile, China and 
Uruguay based on the presence of cattle cloning companies in these countries.  
•  Milk and meat from the offspring or descendants of cloned bovine animals have 
entered the food chain in the US and may have done so in Argentina; these are the 
products most likely to continue to enter human food chains in the near future. The 
Swiss government says that ‘several hundred’ second or third generation descendants 
of clones are in Switzerland (of a total 1.5 million head of cattle);132  
•  Porcine animals: consultations with the US cloning industry suggests that there is 
some commercial cloning for pigs in that country and that it is becoming more 
common. It may also be undertaken in New Zealand and China based on the presence 
of pig cloning companies in these countries. 
•  Ovine and caprine animals: consultations133 with industry stakeholders in the EU of 
third country Competent Authorities indicate that commercial cloning of ovine or 
caprine animals outside the EU is uncommon.  Some commercial cloning of these 
animals is on-going in the US, but at very small scale.  
•  Equine animals: consultations134 of third country Competent Authorities indicate that 
there is no livestock cloning activity currently being conducted outside the EU for 
equine animals. Sport cloning is being undertaken in North and South America and 
Brazil and South Korea.135 
Examples of on-going cloning activities: 
•  TransOva, a US cloning company estimates that it costs between USD 18,000-20,000 
(approximately €15,000-16,000) to produce a clone. This range is likely to be 
competitive elsewhere in the world. Typically, clones are used as breeding animals 
due to their high cost. A clone can generate on average USD 60,000 in semen/embryo 
sales in the first year of production. 
                                                 
131 DG SANCO survey to Member States and third countries regarding cloning activity, 2012   
132 Kanter, 2010 
133 See 5 
134 See 13 
135 Carroll, 2011 
141 

 
•  Consultation with EU industry association COPA-COGEGA indicates that the cost of 
producing a clone for research purposes in the EU is approximately €12,000-15,000 
(i.e. similar to the TransOva estimate).  Embryos of cloned bulls sold at auction in the 
US have fetched USD 10,000-20,000 (€8,000-16,000), which is the same price as 
embryos from an animal from a ‘non-cloned’ high-value embryo line.  
•  A cloned sport horse can fetch USD 800,000 on the market, based on auction prices 
in Buenos Aires in 2010 for a cloned polo horse136. Cryozootech, a French horse 
cloning company sells a dose of semen from a cloned horse for between €450 and 
€700 depending on the clone.  
•  To produce the first cloned fighting bull, the Spanish breeders group May spent 
around €30,000. The family which owns the bull could expect to make around €1.5 
million from selling the bulls that the clone fathers naturally during his lifetime.137 
 
C. Food sector 
1. General description 
The EU food sector represents138 a total turn-over of 1,017 Billion € and approximately 
287,000 companies employing 4.25 million people in the EU. Around 98 % companies are 
SMEs which represent around 49 % of total turn-over and 63% of employment in the sector.  
It is the largest manufacturing sector in terms of turnover, value added and employment. It 
contributes for around 15 % of EU gross value added of manufacturing sector. The net trade 
balance was of 13.2 billion € in 2011 (see table 4 below). 
Table 4: EU 27 data on Food and drink industry (Turnover, Number of employees, 
Trade)   

 
2010
2011 2011/2010(%) 
Turnover (Euro billion) 
953
1.017 + 
6,8
Number of employees (million) 
4,25
4,25 0
Exports (Euro billion) 
65,2
76,2 + 
16,6
Imports (Euro billion) 
55,5
63 + 
13,5
 
The EU food sector for meat, milk and derived products is present at three stages of the food 
supply chain: 
The first stage is composed: 
                                                 
136 Carroll, 2011 
137 Kanter, 2010 
138Sources "Data and Trends of the European Food and Drink Industry 2012" of FoodDrink Europe. 
142 

 
•  for meat: slaughterhouses, cutting plants (primary and secondary cutting) and minced 
meat plants 
•  for milk: dairy farms, dairy plants (collect, storage, processing and packaging of milk 
and production of cheese and butter and milk industrial ingredients such as caseins). 
 
The second stage is composed: 
•  for meat: meat processing (meat products), meat industrial ingredients (gelatine etc.) 
and all derived food products where meat is an ingredient 
•  for milk: processed milk products (yogurts, milk based specialities) and all food 
products which contain milk ingredients. 
 
The third stage is composed: 
•  wholesalers, distributors and food retailers including food markets and direct sale at 
farms. 
•  caterers (canteens, restaurants etc). 
 
2. Meat and milk sectors 
- EU dairy sector 
Dairy farming systems remain characterized by an important diversity, despite strong 
restructuring (the number of dairy holdings in the EU15 is now well below the one observed 
in France in the beginning of the 1970s), technical modernization and the wide adoption of 
the high yield races (Holstein).  
The most striking aspect of the sectors heterogeneity is the substantial variation in size 
(surface, herd and quota), from small units (southern EU but also Austria) to large units 
(dominant in the UK, Denmark and the Netherlands). The heterogeneity also expresses itself 
through the natural production conditions, labour input, the (feed) resource base and the 
intensification and specialization levels and the trend towards landless livestock production. 
The  average milk quota per farm also varies strongly between dairy regions: Less than 
160,000 kg in Austria, Spain, Italy, Finland, Portugal and south Germany (Bayern), milk 
quotas exceed 400,000 kg in the UK, Denmark, the Netherlands and Eastern Germany. A 
majority of total dairy holdings are relatively small in terms of cow numbers and contribution 
to total EU production. These farms are probably less specialised than those accounting for 
the majority of production with dairying being one of a number of enterprises (mainly other 
livestock enterprises) undertaken. However, to these farms dairying as an activity remains an 
important part of total economic activity. 
EU dairy production is very stable, largely as an effect of the milk quota system, but this 
hides important trends. Due to the milk quota system, productivity gains in milk yields lead to 
a continuing reduction in the total number of dairy cows in the EU. In general, dairying in the 
EU continues to intensify and specialize, with herd sizes of individual farms increasing in all 
MS. 
 
143 

 
Together this means that production continues to concentrate on fewer, larger farms (e.g. 
about 50% of EU dairy cows are in herds of at least 50 heads) resulting in a corresponding 
decrease of dairy farming on many holdings and in some cases abandonment of holdings. This 
is true for virtually all dairy farms irrespective of system or bio-geographical region; noting 
that  85% of EU milk production is derived from high input/output economic/technical 
class of dairy farming.  
 
- EU meat sector 
The EU produced: 
 
- 7.844 million tons of bovine meat in 2011 (almost 60% came from France, Germany, Italy 
and the UK). It originates 2/3 from milk breeds and 1/3 beef breeds. 
- 22.011 million tons of porcine meat in 2011 (almost 75 % came from Germany, Spain, 
France, Poland, Denmark and Italy). 
- 0.732 million tons of sheep meat in 2011 (almost 75% from U.K., Spain, France and 
Greece) 
- 0.059 million tons of goat meat in 2011 (almost 60% from Greece). 
- 0.053 million tons of horse meat in 2008 (almost 75% from Italy and Poland). 
 
3. International trade 
- Meat sector 
 
The EU exports bovine and pork meat mainly to Russia but also China, Japan, South Korea 
and Turkey. The EU is the 2nd biggest producer of pork meat (after China) and bovine meat 
(after USA) in the world. EU is self-sufficient for pork and poultry and has a deficit for 
bovine (3-4%), ovine (20-22%) and horse (80%) meat. 
 
- Beef and veal 
The EU is a net importer of beef which is mainly imported from: 
- South America (mainly Argentine, Brazil, Uruguay) with a significant decrease trend. 
- USA with significant increase trend following extension of EU import quota in context of 
new EU-US agreement on hormone free beef production for EU (20.000 tonnes).  
Beef imports are forecast to increase. The trade in beef products could reach half a million 
tonnes by 2020. Market effects (e.g. price changes) are more likely to be observed where 
measures have an impact on these trade flows. In 2011, approximately 300,000 tonnes of 
bovine meat products worth over €1.7 billion were imported into the EU. More than 95% of 
these imports came from eight countries. Argentina, Brazil and Uruguay accounted for 
approx.70% of total trade volume 
In recent years, Australia, New Zealand, Paraguay, Namibia and the US all increased their 
bovine product exports to the EU. By 2011 these five countries together accounted for 27% of 
total trade (5% in 2006).  
EU beef and veal imports are forecast to increase by 10% from 2011 to 2020 according to the 
latest projections (OECD-FAO, 2012). Globally, the EU is the third largest importer of beef 
and veal behind Russia and Japan. 
144 

 
In total, EU imports of beef, veal, dairy products and sheep meat are worth € 3.3 billion per 
year. 
 
Table 6: Overview annual value of EU imports 
Species Product 
Approximate 
Summary 
Total Annual 
Value  

Bovine   Beef and 
€ 1.7 billion 
The EU is a net importer of bovine meat products and the third 
veal 
largest importer in the world; the net trade imbalance is expected 
products139 
to grow to 2020 
 Cheese 
and 
€ 610 million 
The EU imports considerable quantities of cheese and butter 
butter 
despite being a net exporter of these products 
Ovine 
Sheep meat 
€1 billion 
The volume of imported sheep meat is equivalent to over a 
quarter of domestic EU production; 85 per cent was supplied by 
New Zealand; the EU is a net importer of sheep meat 
Source based on COMEXT data 
Table 7: Import sector overview: Number of importers 
Sector 
All 
Bovine
Porcine
Ovine Caprine 
Equine
species 
1667 3 12 

2 1645 
Importers: live 
animals 

715 
280 
40 
374 (sheep and 
 
Importers: meat 
goat) 
21 
Source: Eurostat 2008 
- Porcine meat 
The  EU is self-sufficient in pig meat and EU porcine production is stable. The EU 
consequently imports relatively little (approximately 15,000 tonnes per year). It accounts for 
less than 0.1% of global imports. In 2011, the EU imported just 14,000 tonnes of pig meat, 
and a further 18,000 tonnes of offal at a total value of €61 million. 99.9% of pig offal was 
imported from Switzerland; over 80% of imported pig meat came from the US and Chile. The 
EU also imports relatively high quantities of low value prepared pig meat such as ham and 
sausages and offal products; On average the EU imported 126.000 tonnes of such products at 
an approximate value of € 18 million per year from 2006-2011. 
In addition, the EU also imports gelatine for EU food, cosmetics and pharmaceutical 
industries. Total annual EU imports of gelatine are relatively stable, with 20,000 tonnes 
imported annually over the period 2006-11, valuing at approximately €76 million per year.  
- Ovine and caprine meat 
The EU is a net importer of ovine and caprine meat (23% of EU production). Imports from 
New Zealand and Australia are the most important trades for ovine and caprine products. 
From 2006-2011, EU imports of sheep meat were valued at just over €1 billion per year 
                                                 
139 Value includes all fresh, frozen, chilled, prepared and preserved bovine meat, offal and derived products 
including gelatine 
145 

 
(averaging 210,000 tonnes per year). Of the total volume imported into the EU over this 
period, 85% of total sheep meat imported was supplied by New Zealand at an average of 
178,000 tonnes each year. A further 8% of EU sheep meat imports were sourced from 
Australia. Though these figures are relatively low, it is notable that the volume of imported 
sheep meat is equivalent to over 25% of domestic EU production. 
Table 8: Overview annual value of EU imports 
Species Product  Approximate 
Summary 
Total Annual 
Value 
Caprine  
 
 
 
Ovine Sheep €1 billion 
The volume of imported sheep meat is 
meat 
equivalent to over a quarter of domestic EU 
production; 85 per cent was supplied by New 
Zealand; the EU is a net importer of sheep 
meat 
Source based on COMEXT data 
- Horse meat 
The EU is a net importer of horse meat (50% of EU production). In 2011, the EU imported 
28,000 tonnes of horse meat, valued at €94 million. The volume of imported horse meat is 
equivalent to over 50% of domestic EU production. From 2006-2011, the EU imported a total 
of €592 million worth of horse meat, 60% of which was sourced from Latin America 
(Argentina, Brazil, Uruguay and Mexico) and a further 38% from Canada and the US. 
Dairy sector 
The EU is largely self-sufficient in dairy products. It is a net exporter but still imports 
considerable quantities of cheese from third countries and, to a lesser extent, butter. These two 
product groups accounted for almost 90% of the €610 million average annual value of EU 
dairy imports from 2006-2011.  
The EU is a major player in international dairy markets. It accounted for 24-30% of world 
dairy exports from 2005-2010. The big four dairy producers in order of their market share are 
New Zealand, the EU, Australia and the US. Over half of all EU imports of cheese in 2006-11 
were purchased from Switzerland, representing 70% per cent of the total value of EU cheese 
imports (€1.79 billion).  In this period, a further 150,000 tonnes of cheese worth €348 million 
were shipped to the EU from New Zealand. In the same period, New Zealand was also the 
source of 88% of all EU butter imports, at the average annual value of €110 million from 
2006-2011. 
Imports of milk proteins and caseinates were also significant over this period, with the EU on 
average importing €178 million each year from 2006-11. Of this total amount, 80% was 
sourced from just three countries: New Zealand, Ukraine and Belarus. 
146 

 
4. Outlook all markets 
The  EU meat market is likely to be affected by the on-going economic downturn and 
historically high levels of unemployment, which tend to push EU demand towards cheaper 
meat options. The new animal welfare requirements in the pig sector are also expected to play 
an important role in the near future. As a consequence, total EU meat production, after having 
increased during both 2010 and 2011, will contract by 2% over the next two years. 
The OECD-FAO Agricultural Outlook (2011) forecasts that EU exports in beef and veal will 
fall steadily year-on-year from 2010 to 2020, dropping by an estimated total of 41% over the 
period.  EU beef accounts for only 3% of global beef and veal exports. The marginal role of 
the EU in these markets is expected to continue to 2020. Major third country beef exporters 
include Australia, Canada, India, the US, and the South American countries of Brazil, 
Argentina and Uruguay.  Brazil, Uruguay and Australia are also major global suppliers of live 
bovine animals, exporting to the EU’s main markets in North Africa and the Middle East. 
The net trade position of the EU is projected to deteriorate over the outlook period, driven by 
an increase in meat imports (of beef/veal, sheep and goat and poultry meats) and a parallel 
decline in exports of poultry. Aggregate meat imports would grow by 5.2% (2022 vs. 2011) 
and exports would decline by 6.8%, leaving the EU, nevertheless, a net exporter of pig and 
poultry meats in 2022. 
 
The  EU milk production is projected to continue increasing from 2012 onwards, at a 
moderate growth rate. Aggregate EU production would remain below the potential growth 
rate provided by the gradual elimination of the quota regime. EU milk production is projected 
to reach 159.3 million tonnes in 2022, accounting for a cumulative increase of 5% since 2011.   
 
Medium term prospects for milk and dairy products appear favourable due to the continuing 
expansion of world demand. Global population and economic growth, and increasing 
preference for dairy products are expected to be the main drivers, fuelling EU exports and 
sustaining commodity prices. The best export performance is shown by cheese and SMP, 
whose exports over the outlook period would expand by two thirds and triple respectively. 
 
While the global market situation has recently been favourable, DG AGRI (2011) reports that 
expectations for the next two years depend on the extent of increased milk production both in 
the EU and in the main supplying countries (e.g. New Zealand, Australia, and the US) and the 
sustainability of strong demand on the world market led by China and other countries of 
South-East Asia as well as by the Near and Middle East.  
The OECD-FAO Agricultural Outlook (2011) projects that global imports of dairy produce 
will rise by a million tonnes from 2010 to 2020. Despite this growth in the market the EU’s 
share of global dairy products is forecast to fall below 20% in this period. This is largely as a 
result of competitive pressure from New Zealand. 
From 2009 to 2010, EU bovine exports increased in volume by 125%. Particularly marked 
increases occurred in the trade of fresh, chilled and frozen bovine meats as well as in the trade 
of live bovines.  From 2004-2011, the relatively stable EU exports in bovine offal represented 
25% of total bovine meat and meat product exports. As a result of such rapid growth, the total 
value of EU exports of live bovines and bovine meat in 2011 was worth of €1.7 billion. 
Exports doubled in size in a single calendar year from 2009 to 2010. 
147 

 
EU porcine export market outlook: pig meat accounted for roughly a quarter of total world 
pig meat exports from 2005 to 2010.  Pork exports from the US and Canada accounted for a 
further quarter each in this period; Brazil is the fourth largest pork exporter.  
EU pig meat exports are forecast to decline year on year to 2020, with the EU seeing its share 
of the market fall to 20% (OECD-FAO 2011). This decline is likely to occur in the context of 
global growth in the volume of pig meat exports (likely to be sustained by demand in Japan, 
Russia, Ukraine and other East Asian markets), which is forecast to be mostly captured by US 
pig exporters. There is also growing import demand for pig meat in markets where EU 
exports currently have less market presence such as Mexico, the US and Australia. 
Looking ahead for the EU ovine and caprine export market to 2020, the forecast to increase 
but still account for just 2% cent of global sheep meat exports (OECD-FAO 2011).  Australia 
and New Zealand together account for over 75% of this trade. The EU is the world’s biggest 
importer of sheep meat, taking 25% of global sheep imports in 2010. Saudi Arabia, the US 
and China are the next biggest markets for sheep imports. The volume of EU imports of sheep 
meat is forecast to decline by 22% from estimated 2010 levels.140 
References 
Butler, L.J., and Marianne McGarry Wolf (2010). Economic Analysis of the Impact of Cloning on Improving 
Dairy Herd Composition. AgBioForum 13 (2): 194-207. 
Carroll, R. (2011) ‘Argentinian polo readies itself for attack of the clones: Player forms alliance with genetics 
laboratory to clone equine champions in hope of replicating performance’, The Guardian, 
http://www.guardian.co.uk/world/2011/jun/05/argentinian-polo-clones-player. 
Dematawewa, C.M.B., & Berger, P.J. (1998). Break-even cost of cloning in genetic improvement of dairy cattle. 
Journal of Dairy Science 81(4): 1136-1147. 
Eurostat External Trade Statistics (COMEXT), http://epp.eurostat.ec.europa.eu/newxtweb/ 
European Commission 2012: "Prospects for Agricultural Markets and Income in the EU 2012-2020", DG AGRI 
12/2012 
European Commission 2012: "Report from the European Commission to the European parliament and the 
Council "Evolution of the market situation and the consequent conditions for smoothly phasing-out the milk 
quota system - second "soft landing" report COM(2012) 741 final, Brussels, 10.12.2012 
Gura (2007) ‘Livestock genetics companies: Concentration and proprietary strategies of an emerging power in 
the global food economy’, League for Pastoral Peoples and Endogenous Livestock Development. 
IFC GHK 2012: Impact in the EU and third countries of EU measures on animal cloning for food production, 
2012 
JRC 2010: Evaluation of the livestock sector's contribution to the EU greenhouse gas emissions (GGELS), Final 
report 2010 
JRC 2013: Contribution to the economic impact assessment of policy options to regulate animal cloning for food 
production with an economic simulation model. JRC Scientific and Policy Report, EUR XXXXX (forthcoming) 
Kanter, J. (2010) ‘Cloned Livestock Gain a Foothold in Europe’, New York Times, July 29, 2010, available 
from: http://www.nytimes.com/2010/07/30/business/global/30cloning.html?pagewanted=all. 
United States Department of Agriculture (USDA) (2008), ‘EU-27 Livestock and Products Animal Genetic 
Markets in EU Member States 2008’, Foreign Agricultural Service Global Action Information Network Report. 
 
                                                 
140 ICF GHK 2012 page 34 
148 

 
 
ANNEX VIII: EU STATISTICS ON IMPORTS OF LIVE ANIMALS, REPRODUCTIVE MATERIALS, 
MEAT, MEAT PRODUCTS, MILK AND MILK PRODUCTS (SOURCES COMEXT141 AND TRACES142) 
Statistics on imports below provide from 2 EU sources (Comext and TRACES) and may 
differ between the 2 sources. Data of reference are those from Comext. TRACES data are 
provided as a complement and should be considered mainly for the imports of live animals 
and reproductive materials. 
The discrepancy in the trade volumes between Eurostat and TRACES data for the products of 
animal origin is due to the different methodology applied for the definition of the products 
group (meat, milk etc.). The custom code applied for the custom tariff purposes do not take 
account the veterinary description of the goods. For example, in case of the custom code 
applied for the meat products allows the use of the added salt, whereas such products under 
veterinary legislation is categorised as meat preparations. 
In case of  data differences for the reproductive material, there is no conventional rate of duty 
applied for the import and  reproductive material is not presented as unit volume as straw, but 
converted as a weight calculated number of straws.  The TRACES data are recorded by 
Member State border veterinarian and in such cases as well different volume measurements 
have been applied: number of straws,  amount presented in kilograms, amount presented in ml 
etc. 
I. Live animals 
Importations of live bovine in the EU are very low apart from Turkey in 2011. The EU also 
imports few bovines in a sporadic way from various third countries including Canada and 
USA.  
The same situation occurs for imports of live ovine and caprine. Imports of live porcine 
though limited are more significant and originate mostly from Canada and Russian 
Federation. 
Imports of live horses are more developed and originate from a large set of countries. On the 
contrary to other above species where imported animals are intended for reproduction, live 
horses are mainly imported for horse races and leisure activities. 
                                                 
141 Comext: is a statistical database on trade of goods managed by Eurostat, the Statistical Office of the European 
Commission. 
142 TRACES: is a management tool for tracking the movement of animals and products of animal origin from 
both outside of the European Union and within its territory. 
149 

 
- EU live bovine imports compared to EU livestock (Source Comext) 
Origin/Year/Nbr. Anim. 
2007 
2008 
2009 
2010 
2011 
Turkey 0 



18.548 
Albania 0 

67 


FYROM 0 
62 



Canada 1 


10 
42 
Croatia 0 

14 
10 

United States 

15 



Ukraine 3 




Argentina 2 




United Arab Emirates 





New Zealand 





TOTAL 6 
78 
81 
26 
18.590 
EU live bovines 
89.037.000 88.867.000 
88.300.000 87.391.200 
86.250.200 
% of imports/EU 
0.000006 0.00008 0.00009 0.00003  0.021 
production 
 
- EU live bovine imports (Source TRACES) 

Origin/Year 
2006 2007 2008 2009 2010 2011 
Nbr. Anim. 
Canada  0 0 0 0 10 42 
New 
Zealand 
0 0 0 0 0 3 
TOTAL 
0 0 0 0 10 
45 
EU live 
N/A143  89.037.000 88.867.000 88.300.000 87.391.200 86.250.200 
bovines 
% of 
-- 0 0 0 
0.00001 
0.00005 
imports/EU 
production 

 
                                                 
143 N/A: not available 
150 

 
- EU live ovine imports (Source Comext) 
Origin/Year 
2007 2008 2009  2010  2011 
Nbr. Anim. 
Turkey 
0 0 0  0 25.690 
Bosnia and Herzegovina 

631 



Croatia 20 


510 

New 
Zealand 
2 5 0 10  29 
Canada 0 

11 
21 

Russian 
Federation 
0 0 0  0  7 
Iceland 
5 0 0  0  0 
TOTAL 27 
636 
11 
541 
25.726 
EU live ovines (source 95.803.000 90.907.000 88.757.000  85.945.500  85.648.000 
Eurostat) 
% of imports/EU production 
0.00002 0.0006 0.00001  0.0006 
0.03 
 
- EU live ovine imports (Source TRACES) 

Origin/Year 
2006 2007 2008 2009 2010  2011 
Nbr. Anim. 
New 
Zealand 0 2 21 0 22 29 
Croatia 
0 0 0 0 510 0 
Canada 0 


11 


TOTAL 0 

21 
11 
541 
29 
EU live ovines 
N/A  95.803.000 90.907.000 88.757.000 85.945.500  85.648.000 
(source Eurostat) 
% of imports/EU 
-- 0.000002 
0.00002 
0.00001 0.0006 0.00003 
production 
 
- EU live caprine imports (source Comext) 
Origin/Year 
2007 2008 2009 2010 2011 
Nbr. Anim. 
Bosnia 
and 
Herzegovina 0 55 
0 0 0 
Chile 
0  0 0 44 0 
Canada 
16 0 0 0 0 
Russian 
Federation 
0 1 3 0 0 
United 
States 
0 0 0 0 1 
TOTAL 
16 56 3 44 1 
EU live caprine 
13.212.000 11.430.000 12.920.000 13.364.800 12.480.700 
(source Eurostat) 
% of imports/EU 
0.0001 0.0004 
0.00002 0.0003 0.000008 
production 
 
151 

 
- EU live caprine imports (source TRACES) 
Origin/Year 
2006 
2007 2008 2009 2010 2011 
Nbr. Anim. 
New 
Zealand 0 
0 0 0 0 6 
Croatia 

0 0 4 0 5 
Chile 

0 0 3 0 0 
Canada 
23 
16 0 1 0 0 
TOTAL 
23 
16 0 8 0 11 
EU live caprine 
N/A  13.212.000 11.430.000 12.920.000 13.364.800 12.480.700 
(source Eurostat) 
% of imports/EU 
-- 0.0001  0  0.00006  0  0.00008 
production 
 
- EU live swine imports (Source Comext) 
Origin/Year 

2007 2008 2009 2010 2011 
Nbr. Anim. 
Russian Federation 
135 
792 
1.639 
1.382 
170 
Canada 623 
517 
449 
346 
88 
United States 
87 
126 
106 
88 

Albania 
42 0 0 0 0 
Belarus 
20 0 0 0 0 
TOTAL 907 
1.435 
2.194 
1.816 
265 
EU live porcine (source 
159.965.000 152.988.000 151.911.000 151.130.100 148.556.500 
Eurostat) 
% of imports/EU 

0.0005 0.0009  0.001  0.001  0.0002 
production 
 
- EU live porcine imports (Source TRACES) 
Origin/Year 

2006 2007 2008 2009 2010 2011 
Nbr. Anim. 
Canada 
254 324 611 727 551 845 
TOTAL 
254 324 611 727 551 845 
EU live porcine 
N/A 
159.965.000 152.988.000 151.911.000 151.130.100 148.556.500 
(source Eurostat) 
% of imports/EU 
--  0.0002 0.0003 0.0004 0.0003 0.0005 
production 
 
152 

 
 
- EU live equine imports (source Comext) 
Origin/Year 
2007 2008  2009 2010  2011 
Nbr. Anim. 
United 
States 
3.679 3.551  3.090 2.359  2.256 
Argentina 
3.036 2.561  1.589 1.308  789 
Belarus 2.637 
1.910 
1.154 
518 
16 
Iceland 1.135 
1.399 
1.445 
961 
915 
Croatia 
627 397  275 656  898 
Uruguay 
790 449  421 248  26 
United Arab Emirates 
363 
249 
230 
290 
184 
Canada 
311 279  169 122  116 
Ukraine 546 
24 
27 
19 
11 
Morocco 322 
46 
36 
59 
92 
Russian Federation 
105 
139 
86 
126 
83 
Montenegro 
0 0  0 0  500 
Australia 130 
104 
92 
71 
65 
Brazil 112 
139 
38 
62 
27 
New Zealand 
127 
81 
34 
42 
58 
TOTAL 26.327 
10.606 
7.403 
6.081 
9.287 
EU live equine (DG Sanco  6.000.000 6.000.000  6.000.000 6.000.000  6.000.000 
website) 
% of imports/EU production 
0.4 0.1  0.1 0.1  0.1 
 
153 

 
- EU live equine imports (source TRACES) 
Origin/Year 
2006 2007 2008 2009 2010  2011 
Nbr. Anim. 
United 
States 
2407 3094 2896 2364 1986  6530 
Argentina 
2472 2615 2594 1604 1409  904 
Iceland 
1163 1237 1452 1230  970  561 
United Arab 
533 375 385 380 407  473 
Emirates 
Qatar 
31 84 95 70 127 156 
Russian 
Federation 
122 156 192 112 229  141 
Belarus 
4255 2493 1913 1193  475 
31 
New 
Zealand  142 154 110  41  66  95 
Australia 
187 168 198 165 106  47 
Uruguay 
320 425 482 421 301  69 
Brazil 
125 85 188 59 139  74 
Morocco 
313 344 76 97 90  110 
TOTAL 12070 
11230 
10581 
7736 
6305 
9191 
EU live equine 
6.000.000 6.000.000 6.000.000 6.000.000 6.000.000  6.000.000 
(DG Sanco 
website)
 
% of imports/EU 
0.2 0.18 0.17 0.1  0.1  0.15 
production 
 
II. Semen and embryo 
The EU imports significant amounts of bovine semen doses mainly from USA, Canada and to 
a lesser extent from New Zealand, Australia, Switzerland and Norway. Imports from these 
countries are well established for many years and are growing regularly (with high growth 
trend for imports from New Zealand and Norway). 
Imports of bovine semen do represent on average 2.5 % of the total amount of semen doses 
used in the EU. However, this low percentage does not reflect their importance in EU 
breeding schemes as imported semen is of high genetic value for the dairy production. 
Imports of porcine semen are more limited than for bovine: the use of frozen porcine semen is 
very limited as the number of piglets obtained with frozen semen is far lower than with fresh 
semen. However some trade of frozen porcine semen of high genetic value takes place and 
originates mostly from Canada and USA. 
Imports of ovine and caprine semen are very limited and originate mostly form USA, Canada, 
Australia and New Zealand. Though import figures are low, they may be significant both in 
terms of percentage and genetic value as the use of artificial insemination for ovine and 
caprine in the EU is very limited compared to its use for bovine specie. 
 
154 

 
- EU bovine semen imports in doses (Source Comext) 
 
Origin country /  Year / 

2007 
2008 2009 2010 2011 
Dosis 
United 
States 
3.418.197 
3.553.153 3.678.915 4.283.701 4.241.689 
Canada 
2.453.611 
2.670.217 2.613.608 3.380.888 3.610.052 
New Zealand 
39.840 
1.800 
66.294 
413.371 
574.755 
Australia 
41.933 
78.283 39.142 44.446 28.778 
Croatia 0 

5.010 
21.000 
103.011 
China 0 

60.000 
7.701 

Serbia 
0  9.000 
0 0 0 
Philippines 
4.829  0 0 0 0 
Costa 
Rica 

0 3.000 0  0 
Venezuela 
0  1.800 
0 0 0 
Malaysia 
500  0 0 0 0 
Argentina 

0 0 0 36 
TOTAL 
5.958.910 
6.314.253 6.465.969 8.151.107 8.558.321 
 
- EU bovine semen imports in doses (Source Traces) 
Origin 
2006 2007 2008 2009 2010 2011 
country / 
 
Year / 
Dosis 

United 
115537 171256 724156 716299 817718 977402 
States 
Canada  81963  172686 478279 557304 661156 898107 
Australia 7384  5832 11897 7395 11311 2225 
New 
18549 297  14 1418 664 803 
Zealand 
Croatia  



13 
1000 
84 
Chile 
20692 
0 0 2 0 0 
Argentina 4896 

780 



China  0  0 14036 0  0  0 
India 0 
36410 
46669 
0 0 0 
TOTAL  248.967  386.505  1.275.083 1.281.962 1.492.000 1.878.600 
 
155 

 
 
- EU porcine semen imports in doses (Source Traces) 
Origin 
2006 2007 2008 2009 2010 2011 
country / 
 
Year / 
Dosis 

Canada 9  210 373 200 782 176 
United 
280 517  5  75 173 59 
States 
Australia 
127 
126 0 16 0  0 
New 
10414 
0 0 0 0 0 
Zealand 
South 
0 0 73 0 0 0 
Africa 
TOTAL 
10830 
853 451 291 955 235 
 
- EU equine semen imports in doses (Source Traces) 
Origin 
2006 2007 2008 2009 2010 2011 
country / 
 
Year / Dosis 
United States 
725 
174479 5898 3119 7427 260772 
Canada 
523 1442  2895  99 
42  286 
Brazil 
0 0 0 0 0 80 
Australia 
0 27 0 67 11 3 
New Zealand 
0 0 0 0 2 2 
Morocco 
0 0  0 30 0  1 
United Arab 
0 0  0 19 1  0 
Emirates 
Mexico 
15 0  0 13 0  0 
Argentina 
0 30  18  0  0  0 
Tanzania 
0 0 1 0 0 0 
TOTAL  1263 
175978 
8812 3347 7483 
261144 
 
156 

 
 
- EU semen imports (ovine and caprine) in doses (Source Traces) 
 
Origin 
2006 2007 2008 2009 2010 2011 
country / 
 
Year / Dosis 
United 
States 
469 
1685 535 385 572 912 
Canada 79 7 82 128 
317 
267 
Australia 312 586 265  63  177 242 
New 
Zealand 
83  18  23 1763 14  14 
Japan 1 


22 
210 

South 
Africa 
0  0  29 51 28  0 
Brazil  0 1 0 0 0 0 
TOTAL  944 2297 936 2412 1318 1435 
 
Imports of bovine embryo take place on a regular basis and are reducing since 2009. They originate mostly from 
Canada and USA. No figures are available for other species. 
- EU bovine embryo imports (Source TRACES) 
 
Origin 

2006 2007 2008 2009 2010 2011 
country / 
 
Year / 
Quantity 
(number of 
embryos) 

Argentina 
0 0 0 2 0 1 
Australia 81  6  106 37 104 64 
Canada  2008 3008 2165 3934 3762 2955 
New 
Zealand 
0 16 0  0  0  1 
Philippines 
0 0 1 0 0 0 
Turkey  0 0 0 0 1 0 
United 
States 
2670 2924 3402 2959 2613 2494 
TOTAL  4759 5954 5674 6932 6480 5515 
 
III. Meat, meat products, milk and milk products 
1 Meat and meat products 
Imports of bovine meat originate from a wide range of countries. More than 95 % of these 
imports come from 9 countries (Brazil, Argentina, Uruguay, Botswana, New Zealand, 
Namibia, United States, Australia, Paraguay) and imports from Brazil, Argentina, and 
Uruguay represented around 80 % of the total trade volume in 2010. These imports are on a 
slow growing trend, except for USA where there are in major increase since 2010. 
157 

 
Imports of swine meat originate mainly from Chile, United States, Brazil, Australia and 
Canada. There is no general trend as they have increased from Brazil, Australia and decreased 
from Chile, USA, Argentina, New Zealand. 
Imports of ovine and caprine originate mostly from New Zealand (around 80 %), Australia 
(around 10 %) and Chile, Argentina, Uruguay and Macedonia (around 10 %). Figures are 
common for ovine and caprine imports but caprine imports are very limited. There is no 
significant trend as the EU is importing the vast majority of its ovine consumption since the 
last decade. 
- EU bovine meat imports in tons (source Comext) 
 
Origin country /  Year / 

2007 2008 
2009 
2010 
2011 
Quantity 
Brazil 181.594 
41.951 
40.449 
43.578 
45.390 
Argentina 57.595 
56.168 
73.578 
50.168 
44.780 
Uruguay 25.252 
46.441 
58.289 
47.537 
39.001 
Australia 6.310 
8.952 
10.770 
9.556 
12.480 
Namibia 8.051 
7.960 
9.674 
10.440 
6.904 
United States 
2.061 
4.943 
7.394 
11.753 
16.171 
New Zealand 
2.592 
7.870 
10.465 
9.607 
11.169 
Botswana 10.452 
7.855 
8.669 
12.090 
736 
Chile 2.099 
1.832 
2.343 
1.861 
1.663 
Paraguay 0 
168 
1.823 
3.671 
3.184 
Serbia 2.322 
1.777 
984 
1.122 
784 
Croatia 1.067 
1.287 
1.185 
1.152 
1.505 
Canada 883 
679 
572 
551 
707 
TOTAL 
 
 
 
 
 
Beef 
297.582 
188.569 
226.504 
203.429 
184.694 
Total bovine meat 
N/A 
391.800 
425.600 
369.900 
N/A 
EU production 
 
 
 
 
 
 
6.113.00 
6.050.000 
5.612.000 
5.716.000 
N/A 
Beef 
8.204.000 
8.072.000 
7.717.000 
7.918.000 
7.844.000 
Total bovine meat 
(source Eurostat) 
% imports/EU production 
 
 
 
 
 
 
4,86 % 
3,11 
4,03 
3,56 
-- 
Beef 
-- 
4,85 
5,51 
4,67 
-- 
Total bovine meat 
 
158 

 
- EU bovine meat imports in tons (sources TRACES) 
Origin country 
2006 2007 2008 2009 2010 2011 
/  Year / 
Quantity  

Brazil 
173974 
200977 61276 40560 56668 88765 
Argentina  7995 24159 34354 39357 49180 48007 
Uruguay 
11644 16361 46823 41357 39119 43046 
New Zealand 
2315 
4592 
9971 
10770 
10457 
28857 
Australia  9109 7331 9700 8189 7826 27114 
United 
States 
242 1639 4555 3109 9292 15694 
Namibia  4030 5409 7728 9295 9044 10344 
Paraguay 0 0 144 
1069 
5324 
3173 
Canada 
526 759 673 555 528 2452 
Chile 1062560 
1187896 
671837 
1206082 
1597986 
1763572 
Croatia 
 
644854 1065554 1303234 1232284 1179209 1555919 
Serbia 
0  1991161 1778254 978283 1126053 796406 
Botswana 
4253350 7212455 6517167 10529026 11037246 689238 
Swaziland 0 
74982 
268720 
190695 
328487 
38869 
Serbia and 
1893666 
349895 
0 0 0 0 
Montenegro  
South Africa 
1962395 
1000 
3034 



Syrian Arab 

21951 
0 0 0 0 
Republic 
Thailand 0 
12518 
25641 
0 0 0 
Uganda 0 
11041 
50459 



Viet Nam 
23130 
12013 
35343 



TOTAL 
10049790 12201693 10828913 14290631 15456419  5111456 
159 

 
 
- EU porcine meat imports in tons (source Comext) 
 
Origin country /  Year / 

2007 2008 2009 2010 2011 
Quantity 
Chile 
12.323 17.142 16.554 8.875  7.105 
United States 
9.979 
22.951 
7.147 
6.222 
2.598 
Australia 1.923 
1.557 
879 
1.234 
1.736 
Japan 110 
94 
1.693 
48 
53 
Russian Federation 
98 
141 
946 
58 
109 
South Korea 
160 

158 
66 
327 
Canada 
0  0 295 
350 5 
Belarus 148 

60 
190 
97 
Croatia 
22 50 70 22 61 
China 0 
17 
146 

24 
Hong Kong 


158 
28 

Brazil 130 
23 



Ukraine 0 

39 
47 
20 
TOTAL 
24.893 41.978 28.145 15.140 12.135 
EU porcine meat production 
N/A 22.574.000 
21.279.000 
22.011.000 
22.388.000 
(source Eurostat) 
% imports / EU porcine 

-- 0.19% 
0.13% 
0.07% 
0.06% 
meat production 
 

160 

 
- EU swine meat imports (source TRACES) 
Origin 
2006 2007 2008 2009 2010 2011 
country / 
 
Year / 
Quantity 
(kg) 

Brazil 
28757737 27461301 19959328 22456542 40669925 34722611 
Chile 
1808137  9181850 10335403 10454470 12321828 6589425 
Australia 299575 737652 649168 326483 1306825 3371357 
United 
6709709 27363029 21490418 6710900  4416382  2486045 
States 
Argentina 
5655380 4626748 1220232 2991189 2033793 1624437 
Croatia 
691875  794008 1030038 645050 1212180 1278558 
(Local 
Name: 
Hrvatska) 
New 
45602  187024 615579 245574 159525 109116 
Zealand 
Uruguay  42779  94266  222218  631154 2073887 106583 
Canada 50955 37067 41310 142883 315379 61318 
Thailand 
156804 84934 23301 67186 149424 39748 
Serbia 0  0  0 13152 
23337 
20000 
Botswana 
0 0 0 0 
18701 
18268 
South 
0 43191 
109168 
4155 567  0 
Africa 
TOTAL  44218553 70611070 55696163 44688739 64701753 50427466 
 
161 

 
 
- EU ovine and caprine meat imports in tons (source Comext) 
Origin country /  Year / 
2007 
2008  2009 2010 2011 
Quantity 
New Zealand 
191.693 
189.432 
185.174 
164.348 
149.224 
217.921 
432.800 
229.746 
197.043 
Australia 
16.920 
18.057  17.645 14.585 16.639 
Argentina 
4.646 
4.548  5.912 4.796 3.605 
Chile 
4.072 
3.376  5.104 5.278 4.749 
Uruguay 
3.627 
3.557  3.426 2.709 2.994 
FYROM 
2.605 
2.346  2.598 2.173 2.574 
Iceland 
517 
829  1.404 1.872 1.210 
Falkland 
Islands 
321 
298  322 327 396 
TOTAL 
442322 
655243  451331 393131 181391 
EU ovine / caprine meat 
N/A 1.022.000 
808.000 
786.000 
791.000 
production 
(945+77) 
(748+60) 
(725+61) 
(732+59) 
% imports / EU ovine and 
-- 64.1% 
55.8% 
50% 
22.9% 
caprine production 
 
-  EU ovine and caprine meat imports (source TRACES) 
 
Origin country / Year / 

2006 2007 2008 2009 2010 2011 
Quantity (kg) 
New Zealand 
169241349 207819306 421658085 218614718 186705599 237765575 
Australia 
15753193 15940698 38283820 19722278 15058534 19939478 
Chile 
1016565 1456320 1979460 2300314 3500822 4863268 
Argentina 
2025915 2204192 2798619 3913173 3784742 3373474 
Uruguay 
2215407 2328314 3629467 2788308 2545345 2803375 
FYROM 
2299000 2164609 2274887 2630773 2365727 2529928 
Iceland 
475934 400907 905287 941638 1519615 1199528 
Falkland Islands 
235899 249602 300086 293021 284397 411320 
(Malvinas) 
Greenland 
591 793 10302 867 770 1343 
United States 
33476 64362 28903 22376  0 
807 
162 

 
Brazil 
56447 187702  0 
11829 127113  0 
TOTAL 
193353776 232816805 471868916 251239295 215892664 272888096 
 
- EU horse meat imports in tons (source Comext) 
Origin country / Year / 
2007 2008  2009 2010  2011 
Quantity (Tons) 
Argentina 16.414 
13.277 
11.921 
8.767 
7.300 
Canada 7.442 
13.727 
10.114 
9.126 
8.874 
Brazil 11.636 
8.449 
8.464 
2.774 
1.602 
Mexico 4.327 
6.758 
7.037 
7.404 
5.430 
Uruguay 2.785 
2.957 
3.034 
2.422 
2.884 
United States 
3.983 


211 
2.038 
Australia 542 
407 
1.305 
324 
120 
New Zealand 
142 
135 
116 
150 
64 
Iceland 13 
36 
46 
26 

TOTAL 
47.284 46.000  42050  31204  28312 
EU horse meat production 
56.000 53.000  N/A  N/A 
N/A 
(Source Eurostat) 
% imports / EU horse meat 
84.4% 87 

-- 
-- 
-- 
 
IV. Milk and milk products 
The EU does import very limited quantities of fresh milk (for dairy plants at EU borders). 
Therefore data on imports can be assumed as referring to milk products (including milk 
powder for further processing). 
Milk products imports originate mostly from Switzerland, New Zealand, USA and Australia. 
- EU milk imports in tons (source Comext) 
 
Origin country / Year / 
2007 2008 
2009 
2010 2011 
Quantity (Tons) 
Croatia 8.623 
4.613 
13.430 
2.697 
2.944 
FYROM 1.302 
659 
384 


Lebanon 0 



773 
Australia 546 
48 
50 
55 

Japan 0 

191 


United States 

86 



163 

 
Russian Federation 



20 
20 
United Arab Emirates 




43 
TOTAL 
10474 5408 
14069 
2774 3782 
EU milk production* 
N/A 
46.351.000 
46.056.000 
46.592.000 
46.918.000 
(source Eurostat) 
N/A 
47.994.000 
47.749.000 
48.253.000 
48.657.000 
% imports / EU milk 
-- 0.011% 
0.03% 
0,005 

0.008% 
production 
* liquid milk and cream 
- EU milk products* imports in tons (source Comext) 
 
Origin country / Year / 
2007 2008 
2009 
2010 2011 
Quantity (Tons) 
New Zealand 
111.406 
73.860 
84.799 
63.723 
50.479 
United States 
16.832 
18.972 
1.491 
7.570 
10.693 
Australia 14.008 
9.817 
6.828 
4.210 
2.773 
Canada 6.609 
6.832 
3.487 
2.082 
40 
Croatia 4.562 
3.248 
2.405 
2.621 
2.764 
Israel 918 
818 
3.254 
948 
1.003 
Belarus 2.233 
229 
1.140 
79 

Iceland 288 
782 
477 
545 
740 
Algeria 221 
236 
32 
164 
276 
China 41 
247 
152 
80 
172 
Malaysia 26 
645 



Russian Federation 
29 
85 
60 
330 
51 
Morocco 41 
21 
246 
200 

TOTAL 
157.214 115.792 
104.372 82552  68.992 
EU milk products* 
N/A 12.775.000 
12.766.000 
12.686.000 
12.878.000 
production (source 
Eurostat) 
% imports / EU milk 

-- 1.96% 
1.84% 
0,97 

1.5% 
products production 
* milk powder, butter and cheese 
164 

 
- EU milk and milk products imports (source TRACES) 
 
Origin 

2006 2007 2008 
2009 
2010  2011 
country / 
Year / 
Quantity 
(kg) 
New Zealand 

95108490 80129396 75292875 
61587614 
50565513  50893373 
United 
3434991 33926500 19124228 
3047930 
9002031  45916436 
States 
Croatia  
6863128 30169565 12702743 
19507523 
7146446  9488242 
Australia 
6875292 11623617 8885125 3742873 
5616374  5304817 
Israel 
620006 1068296 1328196 
2112820 
717722  1077929 
Iceland 
20057 302149 869784 
425009 
192319 712893 
Canada 
4652339 5784890 6751666 
3183618 
1044195  72218 
Argentina 
31745 15588 15657 
46744 
21202  40138 
FYROM 
1129424 748770 2679875 
365504 3234 
8104 
TOTAL 118735472 
163768771 
127650149 
94019635 
74309036 
113514150 
 
165 

 
 
ANNEX IX: IMPACT IN THE EU AND THIRD COUNTRIES OF THE EU MEASURES ON ANIMAL 
CLONING FOR FOOD PRODUCTION – EFFECTS ON SECTOR COMPETITIVENESS 
I. Introduction 
1 Context  
In the context of the identification of economic impacts of this initiative144, particular 
attention has been paid to factors determining productivity and subsequently to the 
competitiveness of EU economic sectors involved. In this respect, competitiveness is defined 
as a measure of an economy’s ability to provide its population with high and rising standards 
of living and high rates of employment on a sustainable basis. To deliver on these objectives, 
competition in a supportive business environment is a key to promote growth and 
competitiveness of sectors. 
The EU sectors which would be potentially affected by measures on cloning are the animal 
farming sector (meat and milk production), the animal breeding sector (production of high 
genetic value reproductive material) and the food and retail industry (meat and milk 
production, processed foods, food imports, distribution and retail). 
This analysis of impacts on competitiveness ('competitiveness proofing')145 is performed 
through an assessment of the impacts on (i) costs and prices, (ii) innovation implications and 
(iii) the international competitiveness of the sectors involved. It is mainly qualitative, working 
with assumptions and draws mainly on studies prepared by an external consultant (GHK IFC 
2012)146 and the Commission's own Joint Research Centre (JRC Seville 2013).147 However, 
the JRC study assumes that a "mandatory traceability and labelling system for food coming 
from offspring of cloned animals can be established in third countries" and that "the existing 
traceability system in third countries can be applied for the cloning technique without extra 
costs148".  It will centre on the two main regulatory approaches (a) the suspension approach 
and (b) the traceability and labelling approach. 
                                                 
144 This annex has been elaborated based on available data and information (see list of references). It reflects the 
policy options as identified in the IA report, except where otherwise stated.  
145 European Commission 2012: 'A "Competitiveness Proofing" Toolkit for use in Impact 
Assessments', Commission Staff Working document SEC(2012) 91 final 
146 IFC GHK 2012: "Impact in the EU and third countries of EU measures on animal cloning for food 
production", Final report to DG SANCO, 6 December 2012. 
147 JRC 2013: "Contribution to the economic impact assessment of policy options to regulate animal cloning for 
food production with an economic simulation model", JRC Scientific and Policy Report, EUR 25856 JRC 
79995 
148 This assumption is however in contradiction with the third countries joint statement and no data on costs for 
third countries are available. 
166 

 
Taking into account that productivity increases resulting from use of cloning technique are 
marginal, it is assumed that cloning technique and cloned animals will not be used in the EU 
for food production up to 2020. Until then exposure of affected sectors in the EU is likely to 
be indirect, i.e. via the imports of reproductive material from clones, of live offspring and the 
food derived. 
2 Background 
The animal breeding sector aims at improving of genetic characteristics to increase production 
(e.g. of meat or milk). Breeding may indirectly affect production costs, notably feeding costs. 
Improvements resulting in better feed conversion rates (unit of feed/ unit of weight gained) 
are thus considered a major breeding progress as they have direct effect on the economic 
performance of the livestock farming sector. 
The price of breeding stock (i.e. animals used for the purpose of planned breeding) or for 
animals used for production has a rather low impact on total production costs. For instance, 
considering the costs of pig meat production in EU countries in 2007149, it emerges that 
breeding, veterinary medicine and energy costs are only about 6% of the total production 
costs. Production costs are mainly due to feed costs (about 50%). The situation is similar in 
the EU27 beef sector where breeding costs are about 6% of the total cost of beef production. 
On the demand side, farmers' share of the end consumer meat price is about 25%150.  
Evidence indicates151 that productivity increases resulting from use of cloning technique as 
currently performed are marginal. There is thus little economic incentive to use it. As a result 
it is presumed that the technique would not be used for food production in the EU up to 2020.  
II. Competitiveness analysis 
1. Cost competitiveness 
Production costs are only one of the many factors determining the competitive strength of a 
sector. They are influenced by the price, quality and dependability of purchased inputs and 
determined by the costs of land, labour, capital, machinery and stock as well as fertiliser, seed 
and fodder prices in e.g. animal production chains. Also in international trade transportation 
and import levies may also be significant. These additional costs counterweigh the usually 
higher in production costs between EU MS and between EU MS and third counties. 
a) Suspension of cloning technique in the EU, imports of live clones, their reproductive 
material and their food (suspension approach). 

As explained above it is presumed that the technique would not be used for food production in 
the EU up to 2020. As a result the suspension of cloning technique in the EU is not expected 
to have direct effects on costs for farmers and breeders in the EU.  
There is a contingent risk of cost created by the loss of access to imports of live animals, 
reproductive materials and food derived could increase input costs for EU food business 
                                                 
149 DG SANCO 2009: 'Draft background paper – the EUs role in the Global Food Supply Chain', based on Dutch 
Agricultural Economics Research Institute (Hoste R. (2009): Environment and welfare melt Dutch cost 
advantage. Pig Progress Volume 25 nr 3) and CRPA (De Roest, K. Jongeneel, J. Dillen, K. Winsten, J. (2008): 
Cross compliance and competitiveness of the European Beef and Pig Sector. Research Center on Animal 
Production (CRPA)) 
150 Von Thunen-Institut 2013. 
151 IFC GHK 2012 
167 

 
operators. This risk would, however, only materialise if third country trading partners would 
not segregate clones and their products from other animals. In return EU farmers (especially 
in the meat/dairy bovine and ovine sectors) could benefit from loss of competition from 
imports if exports from third countries to the EU are disrupted or lost. 
EU breeders currently import significant amounts of reproductive material from third counties 
(US and Canada) which is worth 50 millions €. Thus suspension import of reproductive 
material from clones may have a significant impact on both the EU breeding and farming 
sectors if third countries are unwilling or unable to identify reproductive material from clones. 
In consequence imports of reproductive material would become difficult. This could affect 
EU farmers if they would lose access to imported high performance genetic resources on 
certain farmer largely depend (e.g. dairy farmer using the Holstein breed). 
b) Traceability and labelling of food from clones, offspring and descendants (traceability 
and labelling approach)  
The cost of labelling can be split into the cost for underlying traceability and the cost of 
marking the food for retail.  
The compliance cost of marking is negligible. Cost for adaptation or redesign of product 
labels are modest: the average cost at company level for a small label change has been 
estimated at €2,000-4,000. A full label redesign has been estimated at €7,000-9,000 (or 
€9,000-13,000 in total). Most companies (~80 per cent) redesign their label every three years 
as a normal part of their business operation (EC 2008).  
The compliance costs for the underlying traceability, i.e. identification of animals, of 
reproductive material and of derived food becomes more costly with every generation 
between the clone and the animal, reproductive material or food traded and the degree of 
integration of supply chains. Increase in cost depend also on the degree that animals are 
already individually identified. Bovine and equine animals are already individually identified. 
For caprine and ovine species this is, with some exceptions, the case. Porcine animals are 
raised and moved in distinct groups. Thus traceability requirements related only to animal 
cloning in the EU are expected to have in principle minimal direct effects on companies’ cost 
competitiveness for bovine animals if number of concerned animals152 remains small and no 
direct effects for the other species in food production in the business (as usual baseline to 
2020). 
Impacts on cost competitiveness may arise through trade losses where third countries cannot 
or will not meet import traceability requirements for food. This could raise input costs in the 
EU market. If all live animals or batches of live animals require identification as a clone, 
offspring or descendant, the effects on cost competitiveness could be more significant, 
particularly for operators working with animal species for which profit margins are 
particularly low (e.g. ovine and caprine animals). 
Some of the negative impacts may be offset if imports are restricted from third countries due 
to lack of compliance with traceability requirements and thus, EU producers would benefit 
from the subsequent loss of competition. 
                                                 
152 The assumption is that only animals which are derived from cloning (clones or offspring) and reproductive 
material from clones would be subject to additional traceability requirements and that no additional 
traceability requirement would apply to other animals and reproductive material. 
168 

 
2. Capacity to innovate 
The options assessed have the potential to change genetic diversity in the EU through 
changing the EU breeding sector’s access to genetics from elsewhere in the world. If, in 
extremis, trade in reproductive materials ceased then EU breeders in the dairy sector and 
elsewhere would need to develop alternative strategies for the same breeds or turn to other 
breeds. The EU would, in functional terms, be cut off from access to the global ‘pool’ of 
genetic resources. 
a) Suspension approach  
As explained above it is presumed that the technique would not be used for food production in 
the EU up to 2020. Elsewhere the use of the technique is restricted to a very small number of 
animals and is concentrated in a single species (bovine animals).  
The EU’s ‘exposure to the impacts of cloning over that period are likely to be indirect, 
mediated though use by operators in the EU of genetic materials brought in from North 
America. The net innovation impacts of the approach on cloning research and innovation are 
expected to be small in the short term. Stakeholder input suggests that EU industry would not 
invest in cloning for food production if unrestricted. 
Suspension could have longer and indirect effects on the allocation of innovation investments 
in industry and upstream research funding by signalling explicitly that market prospects for 
the technology are not positive in the EU. Organisations looking to invest in the development 
of such technologies may be more inclined to place their investments elsewhere. 
This may give rise to a competitive disadvantage for EU breeding companies on the long 
term. However, alternative approaches to cloning, in particular genomic selection153 have 
been developed in the EU and their potential appears higher than that of cloning for livestock 
genetic improvement. 
b) Traceability and labelling approach 
Commercial cloning is unlikely to occur in the EU to 2020, the introduction of traceability 
requirements for reproductive material from clones is not expected to alter this.  
There is no direct link between this approach and the capacity to innovate in the breeding 
sector but an indirect link as the additional costs for ensuring traceability and labelling of 
concerned animals and the lack of market in the EU for their food could decrease the interest 
for the technique. 
3. International competitiveness 
a) Suspension approach  
The potential impacts of the suspension approach on international competitiveness are mixed 
and complex. The EU is not only the biggest importer but also a major exporter of 
reproductive material (semen, embryos). European breeding organisations are competitive on 
the global market for high value genetics that depends on continuous exchanges. Measures 
that hamper import or export of genetic material would weaken the position of the EU 
breeding sector in this global business. 
                                                 
153  Genomic selection is based on detection at embryo level of the genetic potential of animals. This technology 
saves much time and resources compared to classical selection based on testing of adult animal 
performances for meat or milk production. 
169 

 
Table 1 summarizes the impacts of suspension approach on both import and export 
sides. 

Suspension approach: effects on the import side 
Suspension approach: effects on the export 
side 

•  An interruption of imports would reduce the  •  Possible positive impacts on demand for 
exposure of domestic producers to competition in 
EU products in third countries if the 
the EU market and would be expected to increase 
‘clone free’ status was perceived as a 
their relative competitiveness / market share. This 
premium attribute by consumers.   
could result in EU market share in third countries  •
declining as a larger part of domestic output is    The acceptability of meat from clones, 
absorbed by domestic demand. For example, bovine 
clone offspring and clone descendants 
semen that the EU currently exports might be used 
for different religious faiths could also 
for domestic production and North America would 
be relevant to the market prospects for 
be likely to replace the EU in its current markets 
EU products in such circumstances 
(typically South America) 
 
•  A loss of access to high quality genetic materials 
could have long term impacts on output and on 
productivity, both of which could negatively impact 
on competitiveness in price-sensitive export markets 
 
There is thus some uncertainty about the scale and direction of the net effect on the EU’s 
international competitiveness. However, it must be noted that the potential reduction of 
international competitiveness through loss of market access due to retaliatory trade measures 
introduced by third countries is out of the scope of this analysis. 
A quantification of the likely effects of the suspension approach on international trade and EU 
domestic production has been attempted in a recent study by Commission Joint Research 
Center (JRC).154 Among the various scenarios which have been used as a model for analysis 
by JRC, a scenario155 considers that the cloning technique is suspended in the EU but remains 
available in third country main trading partners156 which signed the joint statement on animal 
cloning for livestock production (Argentina, Brazil, New Zealand and the USA). 
Under these assumptions no trade restrictions exist and the only difference between EU and 
Third countries lies in the productivity increase associated with cloning. The results show that 
imports would increase slightly in the case of a suspension of cloning in the EU but at the 
same time allowing the imports of food stemming from cloning. The EU would import 
marginally more cattle, beef and dairy, but the effects on prices and domestic production are 
negligible as imports represent only a small part of domestic use. This indicates that the 
productivity increase from cloning is not significant enough to change trade patterns. 
Trade-mediated effects resulting from third country unwillingness or inability to comply with 
the requirements may negatively impact innovation, particularly for the bovine breeding 
                                                 
154 JRC 2013: In the study the choice was made to perform the analysis through the use of a computable general 
equilibrium model called GLOBE. The different model scenarios are constructed based on combinations of 
the identified policy options such as suspension; traceability and labelling requirements with the 
productivity increase associated with cloning. 
155 Scenario 3 of 2013 JRC study. 
156 Most of them signed the joint statement on animal cloning for livestock production (Argentina, Brazil, New 
Zealand and the USA). 
170 

 
industry which relies on imported reproductive material to improve the quality of the breeding 
stock. 
b) Traceability and labelling approach  
The potential impacts of the traceability and labelling approach on international 
competitiveness have been assessed in the 2013 JRC study mentioned above. Some of the 
relevant impacts are reported in Table 2 below.  
Table 2: Traceability approach - impacts on international competitiveness 
negative impacts  
positive impacts  
Negative impacts in the case of fully  Traceability could have positive impacts on demand for 
comprehensive traceability for porcine, EU products where it allowed operators to identify their 
ovine, caprine and equine animal industries,  products as ‘clone free’ and where this is perceived as a 
due to significantly higher costs to operators  premium attribute by consumers. The extent to which 
(particularly breeders/farmers) in industries  this characteristic may be desired by consumers in third 
that already have low profit margins. This is  country markets is unknown.  
particularly likely for pork products (batch   
traceability), for which the EU is a net 
exporter.  
No third country has such traceability 
requirements in place resulting in an 
advantage over EU operators in trade with 
other third countries. For domestic 
consumption, if the requirement is put in 
place for all third countries as well, then the 
overall competitiveness effect will be 
determined by the ease with which EU 
operators can comply with the requirements 
versus their competitors in third countries. 
The traceability and labelling approach poses the risk of triggering significant impacts on 
importers of food products and on the EU food supply chain due to changes in trade patterns.  
When food business operators from third countries cannot identify food products as derived 
from the offspring or descendants of clones and cannot satisfy the EU’s import conditions for 
traceability, a compulsory product labelling scheme might drive EU buyers to seek alternative 
supplies. This would result in changes in the distribution of demand across the supply chain 
with EU buyers sourcing rather from EU producers/farmers. 
The significance of major impacts for the three affected sectors in the context of the scenario 
'suspension of imports of clones and meat from clones' and the scenario 'traceability and 
labelling of meat from clones and offspring' is summarised in table 3 below: 
 
171 

 
Table 3: Significance of the impacts of the two scenarios on the four main actors in the 
food chain 
 
Actors 
Suspension of imports of clones and meat 
Traceability and Labeling of meat from 
 
from clones 
clones and offspring 
Farmers  
No impact on direct cost competitiveness; in  Only minimal direct cost impacts for 
the long term, there might be a potential  bovines; 
contingent risk of loss of access to imports of  EU domestic farmers/producers will 
live animals and especially reproductive  increase their market shares on the EU 
material. Due to the fact that it is not  Single market due to slightly increased 
conceivable how large the share of cloned  production which substitutes for decreased 
animal will be, and which species will be  imports (notably from US beef and New 
covered, this risk to innovation and Zealand sheep meat) 
competiveness is hard to estimate but likely   
to remain limited.  
Benefits (limited) due to import substitution 
(price increases for producers) 
 
Traders  
No imports of all meat types from clones,  For live animal imports, no significant 
 
which are expected to be very limited in the  additional costs (except USA*) due to 
first place  
requirements for individual animal 
 
identification  
Similarly, decreasing exports as meat demand  For meat importers, significant additional 
on EU domestic market increase  
traceability/labeling costs due to segregation 
of supply chains  
For EU exporters, potential comparative 
advantage on specific export markets of 
'clone free' meat  
FBO  
No impact on direct cost competitiveness but  Significance of the impact on costs 
in the long term potentially increased cost for  depending on (1) existing traceability 
private compliance mechanisms to ensure  system according to species; (2) 
clone-free status  
establishment of segregated supply chains  
Higher meat prices due to lack of imports and  and (3) details of labeling rules including the 
only partly substitution by domestic FBOs possibility for integration into 
production (depending on species) notably for  Business-as-usual costs 
the meat processing industry 
 
* Individual animal identification system exists in most of the major exporting countries with 
the exception of the USA. 
In the absence of data on the shares that Member States have on EU imports, the significance 
of impacts by Member State, in order to determine which would be most affected, cannot be 
made. However, in order to provide best possible estimates, four factors can be considered: 
1) The importance of animal production: For example, 60% of EU total production of dairy 
and beef originate from four countries (France, German, Italy and UK) while in sheep and 
goats, biggest producers in numbers are Greece, Bulgaria, Spain and Cyprus, with UK and 
Ireland also significant producers. It can be assumed, that the potential impacts of lack of 
access to genetic resources from third countries is more significant in these Member States. 
2) The importance of the use of reproductive materials potentially from clones: This remains 
highly hypothetical for the time being. It is obvious that global breeding efforts will require 
continuous exchange of high-quality reproductive materials, especially for high-output 
species. At the same time, as the example of the World Holstein-Friesian Association (see 
172 

 
annex XIII) demonstrates, these sectors are already putting appropriate traceability systems 
in place on a voluntary basis. 
3) On-going cloning activities in the EU: Of the 35 companies undertaking cloning activity 
worldwide, only four are active in the EU, and their commercial activities in Europe may 
not include the cloning technique.157  Only France reported currently on-going cloning 
activities, but limited to sport horses. In Germany, in the past, clones were kept in semen 
centres but only for exports to third countries, not for distribution or use in the EU. 
Therefore, this factor currently has no impact on Member States at all.  
4) Imports of meat and dairy into the EU: For the main imports (beef meat from South 
America, sheep meat from Australia and New-Zealand), specific impacts on Member 
States- are difficult to assess once products have been introduced into the internal market. 
For detailed trade numbers see annex VIII. However, imports decrease should be limited to 
a few products and remain rather insignificant as it would be at least partly substituted.    
A summary of the impacts on competitiveness of the suspension approach and the traceability 
and labelling approach on the various affected EU sectors in presented in tables 4 and 5 
below. 
 
                                                 
157 Suk et al. (2007). Dolly for dinner? Assessing commercial and regulatory trends in cloned livestock. Nature 
Biotechnology, 25(1):47-53. 
173 

 
Table 4 Suspension approach (cloning technique, live clones, reproductive material from clones, food from clones) 
Assumptions:  1) Suspension approach would reduce or cut access to genetic resources from third countries  
2) Cloning technique would remain considered an efficient technique for improving livestock production. 
 
Competitiveness / Sectors 
Breeders / importers of RM  Farmers 
Food industry and distribution/retail 
 
cost and price 

No impact 
Negative impact 
short term: No impact as technique is not used in 
competitiveness 
Cloning technique unlikely to   
EU and not widely spread in third countries 
 
be used in the EU for food  Short term: insignificant as  long term: increased costs through non availability 
production up to 2020. 
technique is not widely spread  of imports of cheaper  conventional global market 
yet and imports represent only  in food of animal origin yet effects on prices are 
a small part of domestic use 
negligible as imports represent only a 
long term: significant if 
performance cannot be 
increased though other 
techniques 
 
capacity to innovate 
Negative impact 
Negative impact 
No impact 
 
Direct: 
If access to high performance  Not the way food industry innovates 
EU breeders cut off global  reproductive material is 
 
gene pool 
disrupted or stoppedd 
Indirect: 
allocation investments in 
breeding industry  and 
upstream research => 
investments elsewhere 
international 
Negative impact 
- No access to high quality  short term: No impact 
competitiveness 
 
reproductive materials => long term: increased costs through non availability 
 
Loss of market share in the  long term impacts on of imports of cheaper  conventional food of animal 
global market in reproductive  output/productivity  
origin from global market. 
material  
- May be outbalanced by gain 
 
in special/niche market  
 
174 

 
Table 5 Labelling and traceability approach (traceability of live clones, reproductive material from clones, live offspring; food from 
clones and offspring). 

Assumptions: 
 1) Labelling of food from clones and offspring can be put in place on the EU based on existing identification and traceability systems for live 
animals and reproductive material and possible adaption of food industry for traceability and labelling of fresh meat / food from offspring. 
2) Most third countries would be unable or unwilling to put in place similar identification and traceability systems. 
 
Competitiveness  Breeders / importers of RM 
Farmers 
Food industry and distribution/retail 
/ Sectors 
 
cost 
No 
impact 
increase in compliance increase in compliance costs 
competitiveness 
costs 
1.  marking of food: negligible if incorporated 
  
due to more detailed  into ‘label lifecycle’ 
identification of animals 
2.  traceability (identification of food through the 
increase depends on  
food chain): potentially significant and 
•  degree of 
increasing with: 
identification 
•  length of food chain 
already established 
•  complexity of food chain number of 
for species) 
generations of animals to be identified 
number of generations to be 
•  raise input costs as of cheaper  
identified 
conventional global market in food of 
animal origin not available 
capacity to 
No impact 
May trigger development of  May trigger development of new more efficient 
innovate 
 
new more efficient ways to  ways to ensure traceability 
 
identify animals 
175 

 
 
Competitiveness  Breeders / importers of RM 
Farmers 
Food industry and distribution/retail 
/ Sectors 
 
international 
Loss of share of global market in Loss of share of 
short term: no impact 
competitiveness 
reproductive material  
conventional global market  long term: 
 
+ An interruption of imports would reduce  in food of animal origin 
- increased cost through non availability of 
the exposure of domestic producers to  May be outbalance by gain  imports of cheaper  conventional global market in 
competition in the EU market and would be  in special market and loss  food of animal origin 
expected to increase their relative of competition in Internal  - positive impact  if EU clone free’ products are 
competitiveness / market share. This could  Market 
premium attribute in TCs 
result in EU market share in third countries   
 
declining as a larger part of domestic output 
is absorbed by domestic demand. For 
example, bovine semen that the EU currently 
exports might be used for domestic 
production and North America would be 
likely to replace the EU in its current 
markets (typically South America) 
 
 
176 

 
III Combined scenario from JRC study. 
Another scenario158 analysed by JRC study is to combine the suspension approach and the 
traceability and labelling approach (suspension of cloning technique in the EU + mandatory 
traceability and labelling of food from clones and offspring). In particular, this scenario 
implies that the cloning technique is forbidden in the EU and remains available and used in 
third countries which signed the joint statement on animal cloning for livestock production 
(Argentina, Brazil, New Zealand and the USA). In addition, a mandatory traceability and 
labelling system for food coming from clones and offspring is established. 
The following matrix (Table 6) aims to present the results of the qualitative screening for the 
JRC combined scenario. 
Competitive 
Affected sectors 
Sizing 
of  Duration 
Risks and 
losses 
impacts 
uncertainty 
of impact 
(significance) 
Directly Indirectly  
 
 
Cost and price  Domestic EU  EU exporters, Indirect effects  Short/long  Risk of loss of 
competitiveness 
market: Live consumer price  may be greater  term 
access to imports 
animal 
increase 
than the direct 
of live animals 
importers, 
effects, 
and RM 
Importers of 
particularly 
RM, Breeders, 
where trade 
Food 
losses occur 
Potential trade 
importers, 
due to third 
losses where 
processors, 
countries not 
third countries 
manufacturers, 
being able or 
do not meet 
retailers 
willing to meet 
traceability 
traceability 
requirements to 
allow importers 
 
requirements 
to meet 
requirements of 
suspension or 
traceability 
approach in the 
EU  
Risk of widely 
distributed 
negative impacts 
due to loss of 
imports 
Capacity to 
Breeding 
EU exporters, Insignificant 
Long term  Risk 
of 
innovate 
industry, 
research linked  and small short 
inhibition of  the 
particularly 
to reproduction  term impact. 
EU’s capacity to 
bovines 
and cell biology  Significant 
innovate in 
impact in the 
cloning  
long horizon 
                                                 
158 Scenario 4 of 2013 JRC study. 
177 

 
International 
Domestic EU   Employment 
Negative 
Short/long  The additional 
competitiveness 
market: Live impacts for 
impact on 
term 
administrative 
animal 
FBO, consumer  competitiveness 
burden imposed 
importers, 
price increase 
in price-
on the food chain 
Importers of 
sensitive export 
would be 
RM, Breeders, 
markets 
expected to 
Food 
especially over 
reduce the 
importers, 
the longer term 
competitiveness 
processors,  
of the affected 
manufacturers, 
sectors  
retailers . In 
particular 
some benefits 
for  EU 
domestic 
producers 
Note: RM stands for reproductive materials, FBO stands for Food Business Operators 
 
Under this scenario, imports increase slightly when the EU decides not to use cloning but to 
allow the imports stemming from cloning. At the same time, the additional costs of setting up 
traceability systems in third countries would reduce the imports compared to the baseline for 
imports of primary products.  
Concerning changes in the EU’s domestic production, no significant differences to the 
baseline scenario are observed. This is expected as the changes in imports were marginal 
under this scenario and the competitive position of different sectors in the EU remains stable 
as the cloning technique cannot be used by EU farmers. Similarly, changes in import flows 
from main trading partners remain insignificant. 
178 

 
References   
De Roest, K. Jongeneel, J. Dillen, K. Winsten, J. (2008): "Cross compliance and competitiveness of the 
European Beef and Pig Sector". Research Center on Animal Production (CRPA). 
Defra 2010: "Developing a Framework for Assessing the Costs of Labelling Changes in the UK", UK 2010 
DBV 2012: "Situationsbericht Landwirtschaft 2012",  
European Commission 2012: " Comparisons of production cost structure for animal products: EU and non-EU 
countries", DG SANCO 03/2010. 
European Commission 2012: 'A "Competitiveness Proofing" Toolkit for use in Impact Assessments', 
Commission Staff Working document SEC(2012) 91 final  
Hoste R. (2009): "Environment and welfare melt Dutch cost advantage", Pig Progress Volume 25 nr 3". 
IFC GHK 2012: "Impact in the EU and third countries of EU measures on animal cloning for food production", 
2012.  
JRC Sevilla 2013: "Contribution to the economic impact assessment of policy options to regulate animal cloning 
for food production with an economic simulation model". 2013 
Suk et al. 2007: "Dolly for dinner? Assessing commercial and regulatory trends in cloned livestock", Nature 
Biotechnology, 25(1):47-53. 
179 

 
ANNEX X: SME TEST 
I. SME in the Food chain  
SMEs play a key role in the EU food sector, at every stage of the supply chain. They represent 
nearly EUR 452 billion of turn-over, with EUR 93 billion of value added and employ about 
2.7 million people in 271,000 enterprises which are 99.1% of total Food & Drink companies, 
and 48.7% of total turnover. 1 
The EU definition of small and medium-sized and micro enterprises2: 
Enterprise 
Headcount 
Turnover                    or                     Balance sheet total 
Category 
Medium 
< 250 
≤ € 50 million 
≤ € 43 million 
sized 
Small < 
50 
≤ € 10 million 
≤ € 10 million 
Micro < 
10 
≤ €   2 million 
≤ €   2 million 
With a view to the main drivers in producing and marketing clones for food, 3 types of actors 
mainly composed of SMEs can be identified: 
•  Breeding companies (private and public), including multiplier organisations (breeding 
companies and farmers); 
•  Farmers/producers for meat and dairy; 
•  Food industry (processing). 
1. Breeding sector  
The breeding industry it is driven principally by SMEs. According to the European Forum of 
Farm Animal Breeders (EFFAB)3, the livestock genetics industry mainly consists of SME and 
small units in larger organisations. The size of livestock breeding companies tends to be 
medium scale, with at most 2000 employees, and annual turnovers not exceeding €0.5 
billion.4  
The small number of players in the livestock breeding industry is the reflection of the 
specificities of the industry whereby genetic improvements brought about by breeding are 
cumulative (build on experience), permanent (no further breeding input is required once a 
superior animal has been bred), and can be rapidly disseminated to livestock farmers.5 
Cloning and the advancements in cloning techniques is expected to accelerate and intensify 
the activities of the livestock genetics industry, especially with regards to delivering semen of 
top bulls and boars. In cattle, where artificial insemination (AI) can enable up to a million 
offspring, the economic prospects are seen as particularly promising, especially in comparison 
to pigs, where AI can produce around only 2000 offspring. 6 
                                                 
Food Drink Europe: Data trends 2012 
2 It is worth noting that this classification does not apply to the agriculture sector 
3 http://www.effab.org/  
4 Gura, 2007 
5 Simm et al. 1997 
6 Merks, 2006 
180 







 
Most multiplier organisations are SMEs cooperatively owned by farmers, operating in their 
native language, organised in national umbrella organisations. These national or local 
organisations of farm owners are internationally co-ordinated by a small number of private, 
elite breeding companies and cooperatives. 
2. Farmers/producers 
  Holdings structure  
In the EU Member States with the largest cattle and dairy cow populations, the majority of 
animals are kept on holdings with over 100 heads in size.  In contrast, in the EU12 the 
majority of cattle and dairy cows are kept on small holdings of 9 animals or less.   
The proportion of animals held on small holdings decreased while the number of animals held 
on large holdings increased. This trend occurred across the EU27 but was more pronounced in 
the new EU12.1 
The production tends to be dominated by larger holdings in Northern Europe while the 
majority of cattle farms in Southern and Eastern Member States are smaller holdings of less 
than 50 heads. 
Structure of the producers across the main EU countries 
100%
90%
07
80%
ze, 20
 si

70%
 herd
60%
 by
e

50%
 cattl
40%
 of
on

30%
ti
u
b

20%
istri
D

10%
0%
Belgium
France
Germany
Ireland
Italy
Netherlands
Poland
Romania
Spain
United
EU27
Kingdom
<10 heads
10-50 heads
50 - 99 heads
100 heads or more
 
The distribution of cattle holdings follows a different pattern to the distribution of the cattle 
population.  Over 50 per cent of European cattle holdings are located in Romania and Poland 
and only 34 per cent are located in the EU15.  The majority of holdings (79%) in Poland 
(98%) and Romania are of between 1 – 9 heads. 
By comparison, a large proportion of the holdings in Germany and France are of 50 heads or 
more (45 per cent and 60 per cent respectively). There are a larger number of dairy cow 
holdings in the new EU12, the majority of which are small holdings. 2 
3. Food sector 
The Food sector is dominated by a large number of SMEs and micro-enterprises, which can 
be as high especially in the dairy products industry where 72% of all operators are micro-
enterprises.  
                                                 
1 GHK, 2012 
2 GHK, 2012 
3 IA OCR, 2012 
181 

 
For instance in Slovakia, only 13% of relevant enterprises are micro-enterprises and potential 
impact might be expected to be smaller, whereas in Sweden, the figure rises to 80% and 
potential impact would be expected to be much larger3. 
Micro Enterprises in meat sector 
 
Processing and 
Manufacture of 
Total 
preserving of meat 
dairy products 
and production of 
meat products 
 
Total Micro Share
Total Micro
Share
Total Micro 
Share 
AT 1,092 
763 
70% 
158 
117 
74% 
1,312 907 
69% 
BE 823 
571 
69% 
442 
373 
84% 
1,470 1,020 
69% 
BG 475 
201 
42% 
273 
125 
46% 
885 381 
43% 
CY 71 
46 
65% 
147 
127 
86% 
256 201 
79% 
CZ 
1,467* :  : 146 :  : 1,613 : 

DK 147 
89 
61% 
75 
49 
65% 
408 232 
57% 
EE 53 
20 
38% 
31 
11 
35% 
156 63 
40% 
FI 204 
142 
70% 
52 
29 
56% 
480 355 
74% 
FR 10,410
: : 
1,457 
: : 
12,363 : 


DE 
11,044 6,558 59% 401  207 52% 
12,098 7,028 
58% 
HU 592 
334 
56% 
100 
53 
53% 
901 517 
57% 
IE 133 
26 
20% 
59 
20 
34% 
318 83 
26% 
IT 
3,559  2,495  70% 3,295 2,469 75% 7,875 5,606 
71% 
LV 128 
62 
48% 
42 
15 
36% 
294 121 
41% 
LT 176 
69 
39% 
69 
46 
67% 
336 162 
48% 
LU 27 
14 
52% 


20% 
32 15 
47% 
NL 491 
325 
66% 
258 
206 
80% 
1,046 691 
66% 
PL 
3,283 2,134 65% 718  467 65% 4,872 3,224 
66% 
PT 633 
382 
60% 
439 
345 
79% 
1,411 891 
63% 
RO 909 
532 
59% 
633 
413 
65% 
1,711 1,058 
62% 
SK 72 
17 
24% 
38 

8% 
178 23 
13% 
SI 163 
110 
67% 
87 
77 
89% 
271 198 
73% 
ES 
4,153  2,771  67% 1,462 1,168 80% 7,141 4,295 
60% 
SE 494 
367 
74% 
127 
108 
85% 
935 746 
80% 
UK 1,035 
545 
53% 
543 
357 
66% 
2,347 1,354 
58% 
Total 29,757
18,573 62% 9,454*
6,786 72% 60,709 29.171 
48% 
** 

 
Source: Eurostat.   
The impact on the food sector and notably the many SME will mainly draw from any new 
rules on labelling. However, in considering the economic impacts that might occur due to 
changes to labelling rules it is important to understand that even in the absence of labelling 
legislation, pre-packed food (such as dairy products) would still be labelled. Therefore, whilst 
changes in food labelling legislation may mean some additional costs associated with 
including the information required, companies producing pre-packed foods will always have 
costs of labelling that are not due to legislative requirements.1 
                                                 
1 IA FIC 2008 
182 

 
Food retailers are composed of large companies (distribution chains) and of SMES (butchers, 
independent food retailers, local markets). 
Food retail markets in the EU are increasingly concentrated with the market share of the top 3 
retailers ranging from 30% to 50% in most MS, sometimes reaching between 70-90% 
(Ireland, Sweden, Finland and Denmark). In addition, this market concentration drives private 
label penetration, which has reached almost 35% in Germany and almost 40% in the UK 
(2010).1 
The impact of new traceability and labelling rules for food would be very limited for these 
distribution chains: they have already put in place traceability systems for meat products for 
their own processing activities and would require their food suppliers to put in place all 
relevant traceability and labelling measures.  
The impact would be considerably higher for independent retailers, butchers, local markets in 
terms of additional costs and administrative burden which could have significant impact on 
their business operations. 
II. Impacts on SMEs  
1 Suspension approach 
The suspension approach2 cannot provide an exclusion from the suspension requirements for 
SME businesses, from the farming sector through to manufacturing and retail. The approach 
therefore has the potential to impact on SME growth. 
The expected impacts on SMEs mirror the expected impacts on EU businesses as a whole, but 
would be limited to impacts of live clones and their food which will be suspended. Trade-
mediated impacts therefore dominate. Expected impacts on the farming sector (which has a 
high concentration of SMEs) are mixed: the number of imported live animals as low but with 
the potential for higher prices as the market seeks to compensate for the loss of high yielding 
animals. This in turn might have short run impacts on breeding plans for some businesses and 
the potential for longer run impacts on productivity growth for the sector as a whole. 
Expected scale, distribution and type of impact on SMEs- suspension approach  
Sectors where impacts will be 
Principal impact expected 
Significance  
concentrated  
 
 
 
Live animal imports 
Risk  of  loss  of  market  in  live  High for affected 
animal imports (clones) 
businesses but 
aggregate value of the 
trade is small 
Importers of reproductive materials (RMs)  
No impact 
 
 
 
Breeders 
No impact 
 
 
 
Dairy/beef farmers 
Farmers need to find alternative  High in Member 
 
RM suppliers to maintain output  
States with high 
dependency on AI & 
imported RM 
 
Food processing and retail 
No access to food from clones 
Low 
                                                 
Food Drink Europe 2012: Data and trends 2011 
2 No use of cloning technique in the EU 
183 

 
2 Traceability and labelling approach 
The traceability and labelling approach1 does not foresee exclusion for SME businesses, from 
the farming sector through to manufacturing and retail, and the approach therefore has the 
potential to impact on SME profit margins and growth. 
The impacts on SMEs will vary depending on the chosen path. If all operators are subject to 
the traceability requirements such that they must identify the clone status of all animals, 
reproductive materials and food products then SMEs will be affected similarly to all other EU 
operators.  
The requirements are more likely to affect the profits of small producers because they do not 
benefit from efficient production systems and/or economies of scale enjoyed by larger firms.  
There is also likely to be variance in these impacts among Member States. Some MS have a 
large number of small producers. For example, in Poland (one of the EU countries with the 
largest pig populations) more than 60 per cent of the pigs are kept on farms with fewer than 
50 animals. In Germany, higher production costs are already expected to cause the exclusion 
from the market of a large proportion of farms with fewer than 200 sows in 2013.2 Additional 
costs for traceability could aggravate this impact. 
Expected scale, distribution and type of impact on SMEs – traceability approach for clones, food derived from 
clones and reproductive materials 

Sectors where impacts  Principal impact expected 
Significance  
will be concentrated  
 
Aggregate value of the trade is small  
Low   
Live animal importers 
Few businesses likely to rely on trade in live  High in Member States with 
animals to the EU 
high dependency on AI & 
Animals are high-value and therefore likely to be  imported RM 
traceable with modest effort 
 
 
 
Importers of reproductive  Materials are already traceable and identifiable  Low  
materials (RMs) 
in the major exporting countries as derived from  High  
 
a clone  
 
Risk of loss of access to imported reproductive 
materials leads to loss of business for importers 
where exporters cannot or will not identify 
reproductive materials from offspring of clones 
 
 
 
 
Breeders 
Loss of access to high quality Holstein/other  High in Member States with 
genetics would negatively affects breeding  high dependency on AI & 
programmes if RM importers halted 
imported RM 
 
 
 
 
Dairy/beef farmers 
Farmers need to find alternative RM suppliers to  High in Member States with 
maintain output 
high dependency on AI & 
imported RM 
 
 
 
Food importers, 
Risk that import trades would be affected  Low  
processors, food 
because exporters are unwilling or unable to 
manufacturers, retailers 
 
meet the requirements on food products, but a 
and food service 
supply chain solution to exclude clones from 
companies 
food suppliers seems more likely than a solution 
for clone offspring and descendants, which are 
more numerous and not traced 
                                                 
1 Imports of clone from TC allowed only if full traceability is provided  
2 http://www.thepigsite.com/reports/?category=903&id=903 
184 


 
Labelling mainly affects the food business operators (EU food industry, food importers, food 
distributors and retailers) which will have to comply with new labelling requirements. 
The first impact of labelling results primarily from the setting up of new traceability systems 
or the upgrading of existing ones in order to ensure that labelling requirements are properly 
implemented. This has been assessed in the previous chapter. 
The second impact of new labelling requirements result from the adaptation of the labels and 
labelling equipment and the need to replace the existing stocks of labels by new ones (see 
scheme below)1.  
Labelling process: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The evidence suggests that a move towards a mandatory labelling approach could present 
particular challenges for micro and small enterprises. This is because larger firms enjoy 
economies of scale, which lowers the cost per-unit of complying with regulations. 
The changes in food labelling legislation may mean some additional costs associated with 
including the information required, companies producing pre-packed foods will always have 
costs of labelling that are not due to legislative requirements (for example printing and 
packaging costs). 
 
A label change can be triggered by various reasons; the most common ones are: changes in 
regulations, marketing reasons and the producers usually change them at regular intervals. 
This label's life cycles may range from a few months for highly marketed, or it might take a 
few years for niche products. Before designing/redesigning a label the company needs to be 
familiar with the legislation to identify the legal requirements for the new label. 
                                                 
1 Defra May 2010, "Developing a Framework for Assessing the Costs of Labelling Changes in the UK", Report 
185 

 
For instance, in the light of an administrative burden exercise UK estimated the costs 
attributed to familiarisation and understanding the General Food Labelling regulations as 13% 
of all administrative costs across all the food regulations.  
An administrative measurement exercise conducted in Denmark estimates the costs associated 
with familiarisation with food labelling legislation to account for 5% of the total 
administrative burden associated with the food regulations.1 
However, the recent public consultation-based Communication on the ten most burdensome 
regulations for SME revealed that only 23 organisations mentioned the Food Information for 
Consumers (Regulation (EC) No 1169/2011).  
In this context, it is relevant to point to the on-going exercise on a possible country of origin 
labelling (COOL) for meat and meat products as well as the revision of the Hygiene package, 
both of which are taking SME impacts specifically into account.2 
 
III. Conclusions 
A high level of protection of human life and health, as well as consumer protection, is the 
overarching objective of all DG SANCO policies and legislation (Art 169 TFEU).  
The cross-cutting principles of promoting health, safety and the interests of European 
consumers are directly embedded in the Treaty. Therefore, as a matter of principle, all EU 
legislation regarding food safety and public health should apply to all business operators as 
their impact on the health and safety of citizens is highly significant.  
The Commission is therefore cautious when considering any exemptions or lighter regimes 
for SMEs and micro-enterprises for these policy areas, since such exemptions should not 
undermine the high level of protection which has already been achieved.   
Furthermore, the food safety requirements often bring positive, direct benefits to businesses - 
for example, a safe supply of raw materials for production, clear guidance to staff handling 
the production process, a high degree of consumer confidence and of our global partners and 
export markets. 
In conclusion, it can be stated that the difference between SME and other FBO is not 
significant with reference to the factors subject to the preferred option. 
This means, that although impacts can be identified, their impact is similar on all FBO 
regardless of size or turnover, while the overarching objective of the preferred option as 
outlined in the specific objectives of the IA can only be achieved if no exception is granted to 
SME.  
                                                 
1 FSA (2006), “Food Standards Agency: Administrative Burdens Measurement Exercise: FinalReport”, June 2006. 
2 http://ec.europa.eu/governance/impact/planned_ia/roadmaps_2012_en.htm#SANCO  
186 

 
References 
Merks, J. (2006) The European Perspective for Livestock Cloning, Institute for Pig Genetics, 
presented at BIO2006, Chicago, 11 April 2006 
Simm, G. (1998) Genetic Improvement of Cattle and Sheep. 
Gura (2007) Livestock genetics companies: Concentration and proprietary strategies of an 
emerging power in the global food economy, League for Pastoral Peoples and Endogenous 
Livestock Development 
IFC GHK 2012: Impact in the EU and third countries of EU measures on animal cloning for 
food production, 2012 
JRC 2010: Evaluation of the livestock sector's contribution to the EU greenhouse gas 
emissions (GGELS), Final report 2010 
JRC 2013: Contribution to the economic impact assessment of policy options to regulate 
animal cloning for food production with an economic simulation model. JRC Scientific and 
Policy Report, EUR XXXXX (forthcoming) 
Food and Drink Europe Data Trends 2012 
FSA 2006: “Food Standards Agency: Administrative Burdens Measurement Exercise: Final 
Report”, June 2006 
 
187 

 
 
ANNEX XI: ANALYSIS OF IMPACT ON TRADE IN CASE OF SUSPENSION OF CLONING 
TECHNIQUE 
-  imports of (i) reproductive materials of clones, of (ii) life offspring & (iii) descendants 
would continue to take place without restriction (eg subject to the relevant animal health and 
zoo-technical legislation applicable to all food and animals – see Summary of legislation on 
animal health and import certificates. 
-  imports of food from these animals (offspring and descendants of clones) would not be 
recognised as such and continue to be subject to all the relevant food legislation without any 
change ;  
The suspension of cloning in the EU together with the suspension of imports of clones and the 
food from clones has very limited impact on trade but the clones need to identified as such in 
those third countries where cloning takes place and their food from clones not be put on the 
food export market.  
In addition the possible number of  imported  of  live clones - although there are no official 
figures - should be extremely low if non-existent: imports of live animals overall is extremely 
low; and the purpose of using clones is to trade their reproductive material (which is not 
affected by this option) and not to trade the clones themselves; imported live animals require 
documentation of the pedigree information of the animal, to confirm it is a clone or not. This 
information should be relatively easy to confirm given the small number of operators 
producing clones in third countries and EU operators' awareness of the status of the imported 
animal1. Based on the information received from breeding association they would be imported 
as pure bred or breeding animals for which the parentage is obligatory2.   
-  imports of food from clones produced in third countries   The cost to exclude food from 
clones from EU imports should be minimal and be put against the very small number of 
clones, compared to the livestock in third countries, and the fact that clones are not produced 
for food production. The voluntary system in the USA for example enables the food producer 
to decide whether or not to put it in the food chain.  
 
                                                 
1 GHK study table 7.2. page 52  
2 See Annex XI.  
188 

 
ANNEX XII: COMPARISON OF OPTIONS ON IMPACTS AND OF OPTIONS ACCORDING TO OBJECTIVES 
1: COMPARISON OF OPTIONS ON IMPACTS 
Economic Social  Consumers 
OPTIONS 
EU Third  EU 
 Protection 
Food prices 
country 
Employment 
Option 1 (No Policy Change): Pre-market approval + labelling of food from clones on case by case + Directive 98/58/EC 
on animal welfare. 
0 0  0 
+  0 
Option 2 (Pre-market approval): food from offspring and descendants  
- - - 
- - - 
- - 

- - 
Sub-option 1
Mandatory 
Segregated 
All food 
Clones  
Food from clones 

0/- 

+ + 

Offspring 
 - - 
- - - 

+ + + 
0/- 
Meat 
Descendants 
- - - 
- - - 

+ + + 

Segregated 
Offspring 
- - 
- - 
- - 
+ + + 
- - 
Other food 
Sub-option 4: 
Descendants 
- - 
- - 
- - 
+ + + 
- - 
Mandatory 
Sub-option 2 
Offspring 
- - - 
- - - 
0/- 
+ + + 

Option 3 (Labelling of food) 
Meat 
and 3: Food 
Descendants 
- - - 
- - - 
0/- 
+ + + 

from offspring 
Non Segregated 
Offspring 
- - - 
- - - 
- - 
+ + + 

and descendants 
Other food  Descendants 
- - - 
- - - 
- - 
+ +  + 

Segregated or 
Sub-option 5: non 
All food  
All 
Voluntary 
0/+ 0  + 


segregated** 
Cloning technique 
0 0  0  ++  0 
Clones 
0 0  0  ++  0 
Option 4 (Suspension in EU) 
Reproductive materials of clones 
- - 




Food from clones 
0 0/-  0 
++  0 
++ strongly positive; + positive; - negative; - - strongly negative; 0 no impact. 
* meat process product; milk and  milk processed products, meat ingredients; milk ingredients.  
** Not to be set up by regulatory measure but by the FBOs depending on their activity, facilities and traceability equipment. 
 
 
189 

 
 
2: COMPARISON OF OPTIONS ACCORDING TO OBJECTIVES 
OPTIONS 
Specific Objectives 
Animal welfare 
Consumer 
Competitiveness 
farmers / breeders / 

 
Protection 
FBO 
Option 1 (No Policy Change): PMA + labelling of food from clones on case by case + Directive 98/58/EC on animal 
welfare. 
           + 


Option 2 (Pre-market approval):  Food from offspring and descendants 
0 0/+ 

Sub-option 1: 
Mandatory Segregated  All 
food 
Clones 
Food from clones
0 ++ 

 
Offspring 
0 +++ 

Meat 
Descendants 
0 +++ 


Segregated** 
Other 
Offspring 

+++ 
- - - 
food** 
Descendants 

+++ 
- - - 
Option  3  (Labelling of  Sub-option 2 and 
Sub-option 4: 
food) 
3: Food from 
Mandatory 
Offspring 

+++  
- - - 
Meat 
offspring and 
Non 
Descendants 

+++ 
- - -  
descendants 
Segregated** 
Other 
Offspring 

+++ 
- - - 
food** 
Descendants 

+++ 
- - -  
Sub-option 5 
Segregated** or  All food  All food 
Voluntary 
non segregated 
0 + 

Cloning technique  
+++ ++ 

Clones 
+++ ++ 

Option  4  (Suspension in 
EU)
 
Reproductive materials of clones 


- -  
Food from clones 
0 ++ 

Magnitude of impact of the option to attain the objective: ++ strongly positive; + positive; - negative; - - strongly negative; 0 no impact. 
* Milk, meat and milk processed products, meat and milk ingredients.  
** Not to be set up by regulatory measure but by the FBOs depending on their activity, facilities and traceability equipment. 
 
190 



















 
ANNEX XIII: BASELINE SCENARIO (BACKGROUND INFORMATION) 
1. Technical Description of the Cloning Process 
The animal cloning means an asexual reproduction technique of animals that involves the 
genetic material of one animal only (either a male or a female). This animal is called the 
donor and the technique aims at producing an almost exact genetic copy of the donor by using 
a surrogate mother. The technique does not involve any genetic modification.  
More specifically, the technique consists (Figure 1) in taking the nucleus (which contains the 
genetic material DNA) of a cell of the donor and transferring this nucleus into an oocyte of a 
female. The original nucleus of the oocyte has been excluded. This implies that the genetic 
material of the oocyte has disappeared. The oocyte containing the transferred nucleus 
therefore bears only the genetic material of the donor. This new cell if successful develops 
into an embryo, which is then implanted into a surrogate mother. The surrogate mother - if the 
embryo develops properly - gives birth to the clone.  
Figure 1 Process on animal cloning SNCT technique (Somatic Nuclear Cell Transfer-EFSA 2008 Scientific 
opinion) 

Cloning 
process 
Traditional 
reproduction 
techniques 
 

 
This technique is rather complicated having for the moment a high rate of failures and it is 
therefore very expensive. At this moment the main species which are cloned for food 
production are bovine and pigs.  
2. Price of Cloning, Cloning Activity Projected to 2020 and simulation of the number of 
offspring and descendants 

a. Costs of cloned animals  
Taking into account that no cloning activity is taking place in the EU (See 1.2.1 above) it can 
be estimated that the economic viability of cloning depends mainly on the cost of a clone and 
the pregnancy rate: The higher the costs, the more likely the use of cloning remains restricted 
to long-use high output animals (dairy cows, race horses), the lower the costs, the more likely 
the use of offspring for short term use (e.g. beef production). 
 
Currently, the cost to produce a clone in third countries is thought to be €12,000-15,000 
(COPA-COGECA interview). These animals can sell for more than €50,000. Breeding 
auctions in the EU sell good quality heifers for between €1,500-1,800 and bulls for €8,000-
12,000, placing clones well above the top end of the range. Auctions in the United States have 
reported sale prices for the embryos of cloned bovine animals at a competitive price (USD 
10,000-20,000), similar to the price of a ‘conventionally bred’ high-value line. 
 
Due to the high cost of cloning and low success rates from SCNT techniques, cloning is 
currently seen as potentially useful as ‘insurance’ whereby breeders may seek to protect 
themselves from the premature injury or death of highly valuable animals by creating and 
storing somatic cell lines of those animals. Clones of elite animals could thus be used as sires 
for multiplication of beef cattle and dairy cattle with desirable characteristics.  
 
b. Projection of the use of cloning in the EU 
Suk et al 2007 estimated that the offspring of cloned cattle would likely enter the food chain 
somewhere in the world before 2010. The industry's view at that time suggested that the 
estimated timeline for commercialisation of cloned animal food products was:  
■  2005 – 2010: semen and offspring from cloned cattle and milk, meat and derivatives from 
offspring of cloned cattle. 
■  2010 - 2015: cloned cattle and milk, beef and derivatives from cloned cattle would enter 
the food chain. 
 
Offspring from cloned cattle did enter the food chain in the UK in 2010 through the slaughter 
of two sires for dairy cattle. No other such activity has been reported in the EU, although the 
EU does not currently regulate the import of reproductive material from clones. It is possible 
that additional offspring of clones have been produced elsewhere in the EU. No clones are 
known to have entered the food chain in Europe to date as no pre-market approval requests 
have been submitted under the Novel Foods Regulation.  
192 

 
c. Simulation of the potential number of offspring and descendants from a cloned bull 
The exponential increase of the number of offspring and descendants happens for semen, ova 
and embryos. It is particularly important when semen is used in artificial insemination. The 
number of offspring from one single bull is in order of thousands in his entire lifetime. In the 
case of elite bull the number of offspring (male and female) can be as high as 5000 to 10000. 
In case of elite cows and after superovulation treatment for embryo transfer, the number of 
transferable embryos can be 50 embryos in her entire lifetime. Like the artificial insemination 
has done for the bull, embryo transfer can greatly increase the number of offspring that an 
elite important cow can produce. Without this embryo transfer technology a cow will produce 
an average of 8 calves in her entire lifetime under normal management programs (See table 1 
on the simulation of number of offspring and descendants). 
 Table 1 Simulation of number of offspring and descendants 
 
Offspring first 
Descendants Second Descendants Third generation  
generation (usually  generation (only 
(only female offspring*** used-
half female and half  female offspring*** and males sent to slaughtering) 
male)  
used- and males sent 
to slaughtering) 
Elite Bull * 
5000- 10 000 
20 000  - 40 000 
80 000 - 160 000 
10 elite bulls from 
50000 -100 000 
200 000 – 500 000 
the 2500-5000 males 
10 elite cows from 
the 2500-5000 
500 2000 
females 
TOTAL 
5000 – 10 000 
70 500 -140 500 
282 000 – 662 000 
Elite cow** (after 
superovulation treatment 
50 200 
800 
for embryo transfer) 
5 elite cows from the 
25 females 
250 1000 
1 elite bull from the 
25 males 
5000 – 10 000 
20 000 – 40 000 
TOTAL 
50 
5450 -10 450 
21 800 – 41 800 
Source Information provided by UNCEIA (French National Association of livestock & Artificial Insemination 
Cooperatives). 
*An elite bull can produce in average between 5000 and 10000 offspring first generation (half male and half female). 
**An elite cow can produce in average 50 offspring first generation (half male and half female).  
***A cow will produce an average of 8 calves in her entire lifetime under normal management programs 
193 

 
3. Background Information on Cloning-Companies, Number of Clones in third countries 
and Supply Chain Management for clones in the US 

a. Cloning companies 
Based on the information gathered by the consultant GHK on companies' websites few 
companies carry out cloning only – most of them are also producers of other livestock 
reproductive material. The consultant did not succeed in getting any information directly from 
the cloning companies. The GHK study also reports that JRC study (2007)177 found that of the 
35 companies undertaking cloning activity worldwide, nine of these applied cloning 
technology to cattle.  Four of these companies are represented in the EU, although their 
commercial activities in Europe are not thought to include use of the cloning technique. 
Company Name 
Head 

Employees 
Revenue 
Europe 
Offices Presence in key 
Office 
third countries 
AltaGenetics Canada 
Canada: 
5-10 Canada: $500,000 
NL Uruguay, 
Argentina, 
US: 50-100 
US: $10-$25m 
Chile, US 
Celentis NZ 
Celentis: 
50-100 
Celentis: $10-$25m 
 
 
AgResearch: 780 
AgResearch: 157.7m 
Cyagara/ Goyaike* 
US 
1001-5000 
 
 
Brazil, Argentina 
Genus/ Bovec/ ABS  UK 
1000-5000 
309.9m  (Euro) 
IT, DE, FR, IE 
US,  Canada,  Brazil, 
Argentina, Australia, 
Chile 
Minitube (Intl Centre  US 
400+ 
US: $10-$25m 
 
Asia, Australia, North 
for Biotechnology) 
American, South 
America 
TransOva  
US 
50-100 
$10-$25m 
 
 
Viagen US 
50-100  $1-$15m 
 
 
Yangling Keyuan 
China 50+ 
2-3m 
(RMB) 
 
 
cloning co. 
 
Source: Cloning company websites 
 
                                                 
177 Suk et al. (2007). Dolly for dinner? Assessing commercial and regulatory trends in cloned livestock. Nature 
Biotechnology, 25(1):47-53. 
194 


 
b. Number of clones in USA 
Information provided by USA cloning companies (TransOva and ViaGen) to DG SANCO on 
9 December 2012 by teleconference. 
Species 
Number of clones in the USA  
Success rate of cloning technique 
Cost of a clone 
Bovine 
1100 (50% male and 50% female) 
10 to 20% depending of races 
18000$ 
Pigs 
190 
>50% 
1500$ for each piglet (6 on average) 
Horses >100 
15% 
165000$ 
Sheep 0 
-- 
-- 
Goats 
At start 
No information provided 
No information provided 
 
c. Supply Chain Management for Clones in the US 

A paper-based supply chain management programme for verification of clones was set up in 
the US but has since been discontinued. It was implemented voluntarily in the US for clones 
(but not their offspring or descendants) and reached to the point of slaughter. The system was 
developed by the largest US livestock cloning companies, ViaGen and Trans Ova Genetics.  
The Supply Chain Management Program (SCMP) involved a registry system that followed 
livestock clones from birth to death and carcass disposal. The key components of the program 
were education, a national clone registry, affidavits, and incentives (Figure 2).  
 
Figure 2 US Livestock Cloning Supply Chain Management Program Overview  
Source: http://www.clonesafety.com/documents/SCM_How.pdf 
195 

 
The Colorado based company, AgInfoLink, managed the database of animals identified with 
an Animal Identification Number. The system was designed to manage only cloned animals, 
not their offspring. Consultation with the cloning industry in the US indicates that the SCMP 
system was operational for five years but that it was discontinued because there was no 
demand for it, neither from consumers nor from companies. No claims for labelling of cloned 
pedigrees were submitted. 
 
 The program functioned as follows:  
■ Cloning company contracts to produce animal following owner education.  
■ Owner signs an affidavit committing to proper marketing or disposal of animal or milk 
products.  
■ Owners get refunded an incentive deposit they had previously paid to the cloning company 
when they notify the company of animal death (verified by a veterinarian), consumption by 
owner (verified by the meat locker) or sale to a packer/processor who accepts livestock 
produced through cloning (verified by a signed statement from the packer/processor).  
■ The incentive deposit was based on a value higher than market value for a similar animal.  
 
4. Genetic Diversity 
Regarding genetic diversity, the suspension of the cloning technique should have no major 
impact as the breeding sector has to pay much attention to avoid consanguinity and avoid 
having too many animals with the same genetics 
Traditional breeding of farm animals already concentrate on the genetic improvement of 
specific traits (such as milk yield or meat production), which results in a reduction of animal 
species and a low range of breeds in particular in industrialised countries178. 
  
Cloning can be used commercially to duplicate elite breeding animals and therefore reduce 
the number of animals used in breeding programmes. This could contribute to the further loss 
of genetic diversity (EFSA, 2008). Breeding programmes utilising only a few bloodlines also 
may increase the susceptibility of an animal population to risk factors such as infection by 
disease and climate change (EFSA, 2008). 
EFSA (2008) reports that, where used appropriately and with suitable management measures, 
these adverse effects can be avoided. While EFSA foresees no ‘new or additional’ 
environmental risks from cloning, the data are limited (2008). This was confirmed in the 
updated EFSA 2012 statement (EFSA, 2012). 
In the dairy sector consanguinity could in the future become a serious problem179 as a high 
output dairy cattle breeds like the Holstein account already for 75 per cent of the world's milk 
supply (FAO 2007)180. This situation is not necessarily linked to cloning but could be
                                                 
178 The impact of genetic selection for increased milk yield on the welfare of dairy cows. PA Oltenacu and DM 
Broom.  
179 The impact of genetic selection for increased milk yield on the welfare of dairy cows. PA Oltenacu and DM 
Broom 
180 FAO, 2007. 'The state of the World's Animal Genetic Resources for Food and Agriculture'  
196 

 
exacerbated if cloning is used widely in third countries and their reproductive material 
imported in the EU.  
 
5. World Holstein Friesian Federation Guidelines for Registered Clones 
1.  International Embryo Transfer Society (IETS) forms (or forms with similar format and 
information) should be completed and submitted to appropriate breed association prior 
to, or with application for registration of a clone. The type of cloning technology 
should be provided by the company producing clones -- cells from an adult animal, a 
foetus; or an embryo.  
2.  A code or suffix should be used in the name or as a part of the record of identification. 
This code or suffix should show on certificates of registration, pedigrees, and all other 
official Association documents. NOTE: (Holstein Canada records the code “ETA” on 
the second line, under the name of an animal, on a certificate of registration if cells are 
from an adult animal or foetus, and uses ETN if cells are from an embryo. Holstein 
USA uses the suffix “ETN” in naming all clones.)  
3.  When a cloned calf is registered, the breeder of the entity from which the nuclear 
material originates should be recorded as the breeder and the breeder’s prefix should 
be used in the name.  
4.  The name of each clone should be distinguished by an Arabic number starting with the 
digit 2 either preceding the suffix or at the end of the name. Cloned calves can be 
registered with the same name as the source animal followed by the appropriate 
Arabic number. The sire and dam of a clone should be the same as the sire and dam of 
the source animal, foetus or embryo.  
5.  The identification of the source animal should be recorded on the registering 
Association’s records and associated with the registration record for the resulting 
clones. This information should be made available, if requested. 
6.  Each breed association should establish its own policy on the amount of parentage 
testing to be conducted, using either DNA genotyping or blood typing, but it is 
recommended that all clones be DNA genotyped or blood typed. The testing results 
must show that the source animal and clones have identical genotypes/blood types.  
7.  Each breed association should establish its own policy and procedure relating to the 
registration of progeny of a clone.  
8.  If cloned animals or embryos resulting from cloning are exported, the accompanying 
documents should provide all information required by the Association in the importing 
country.  
WHFF-Council Recommendation (October 2006, Killarney, Ireland). 
197 

Document Outline