Ref. Ares(2015)2430276 - 10/06/2015
Cloning is generating a growing interest in the medical and pharmaceutical areas,
where the technique could potentially be used to produce donor organs and
medicines. Such kinds of applications are reasonably well accepted by EU
consumers, who can see a benefit for human health.
In contrast, for a variety of reasons ranging from ethical and animal welfare
concerns to the wish to support a less intensive and industrialised farming system,
the vast majority of Europeans have little appetite for cloning to produce food.
Cloning is indeed used in several third countries to replicate elite farm animals (e.g.
high-yielding dairy cows). It is a relatively new technique, for which success rates
are still very low, and it has been associated with frequent miscarriage and
pregnancy problems for the surrogate mothers (who carry the clones).
As for the clones, most of them simply do not survive birth or die shortly after. The
cost of producing a clone remains fairly high; therefore cloned animals are not
meant for food supply, but instead for breeding purposes. Food from their offspring
and descendants, on the other hand, is meant to end up on supermarket shelves
and might find its way onto Europeans’ plates.
In December 2013, the European Commission published a package of two
legislative proposals on the use of the cloning technique and the sale of food from
cloned animals respectively.
These proposals fall short of EU consumers’ expectations. Whereas the vast
majority of Europeans have little appetite for food produced with the use of cloning
and would overwhelmingly want food from the offspring of clones to be labelled
(83%), the Commission proposals merely suggest a (temporary) ban on the cloning
of animals for food supply and on the sale of food from clones in the EU. They do
not say a word about food from cloned animals’ offspring and descendants.
In view of the upcoming discussions in the Council and European Parliament, The
European Consumer Organisation (BEUC), wishes to stress the following:
Many EU consumers strongly disapprove of the use of cloning for food
. This should be recognised and respected
EU consumers should be able to make an informed choice
when it comes to
purchasing and consuming food from cloned animals’ offspring and
As the minimum, we wish to see the reintroduction of the package of
on which the Council and European Parliament could have agreed
back in 2011.
As the EU negotiates free trade agreements with countries using cloning e.g.
Canada and the US, we look to the Council and European Parliament to stand
by EU consumers and put their interests before trade
Cloning is a relatively new technology
which allows for the production of almost
exact replications of an animal. The method commonly adopted for mammals is
known as “somatic cell nuclear transfer” (SCNT), whereby a genetic copy of an
animal is produced by replacing the nucleus of an unfertilised egg cell (from another
animal) with the nucleus of a body cell from the animal to be cloned to form an
embryo. The embryo is then transferred to a surrogate dam (mother), where it
develops until birth.
Cloning technology has been applied to animals since the early 1980s but the major
breakthrough came with the birth of Dolly the sheep in 1996. Cloning has a range of
applications including research, production of pharmaceuticals or the conservation
of endangered species and breeds. However, this position paper focuses on
application to the agri-food sector where it has been used for several farm animal
species, notably cattle and pigs. The use of the cloning technique in the agricultural
sector aims to replicate “elite” breeding animals
, e.g. highest yielding dairy
cows or fastest growing pigs.
Given the cost of producing a clone (approximately €15,000)1, cloned animals are
normally not meant to end up as a steak on consumers’ plates, but for
(semen, ova and embryo). This reproductive material
produces, via traditional2 breeding techniques, progeny (i.e. offspring – also known
as “first generation” – and descendants) mostly destined for direct use in the food
Although clones are not produced to obtain meat or milk
for the food chain, this may happen for meat at the end
are not meant to
of the clone’s breeding life after being sent to the
produce meat or
milk, they can end
up in the food
While the limited data available seems not to indicate
chain when too old
any food safety risk stemming from the consumption of
meat and milk from cloned animals and their offspring3,
the animal welfare issues associated with cloning
both for the clone itself and its surrogate mother.
Moreover, ethical considerations are also at stake. In the EU, an overwhelming
majority4 of consumers do not want cloning to be used for food production
Under current EU rules, food from clones is considered a “novel food” and so is
subject to pre-market approval
. Regulation (EC) No 258/97 on novel foods
1 European Commission Staff Working Document (2013) 519 final. Impact Assessment accompanying
the cloning legislative proposals from December 2013.
2 Artificial insemination in most cases.
3 EFSA Scientific Opinion on Food Safety, Animal Health and Welfare and Environmental Impact of
Animals derived from Cloning by Somatic Cell Nucleus Transfer (SCNT) and their Offspring and
Products Obtained from those Animals
, 15 July 2008.
4 84% of respondents. ‘Europeans’ attitudes towards animal cloning
’, Flash Barometer 238, Oct. 2008.
makes authorisation compulsory in order to sell e.g. meat and milk from clones.
Food from the progeny
of clones, on the other hand, is not subject to any particular
regulation. While commercial cloning
for food supply currently takes place in
(e.g. US, Canada, Argentina, Brazil), to date cloning is not used
in the EU and no company has ever applied to sell food from cloned animals on the
However, clones’ reproductive material, the live
offspring from clones, their semen and embryos as
Selling food from
well as food from clones’ offspring can be imported
to the EU from such countries as the US, Brazil
approval in the EU. To
and Argentina without consumers having the
date, no authorisation
has ever been sought.
But food from clones’
When the Novel Foods Regulation was reviewed in
offspring can freely
2011, the cloning issue was such a stumbling block
reach EU supermarket
it made negotiations between the EU institutions
collapse. The question of the clone offspring and
food thereof and whether these deserved specific
measures particularly divided the Council and
European Parliament5. As a result, the European Commission committed itself to
presenting a standalone proposal on animal cloning for food.
In December 2013, following an extensive consultation process, the European
Commission finally published a package of two proposals
with the use of cloning technology and the placing of food from cloned animals on
the EU market6. It suggests temporarily prohibiting both the use of cloning for food
production and the sale of food from clones in the EU. By way of contrast and most
disappointingly, the crucial issue of cloned animal’s offspring remains
As the cloning proposals are being debated in the Council and European Parliament,
this paper aims to present the consumer perspective on
animal cloning for food.
to make informed
food choices is
We believe that not only should food derived from
denied by the lack
cloning be unequivocally proven safe, but it is also
of EU rules on
important to hear consumer concerns over a technique
labelling food from
which causes unnecessary animal suffering.
The European Consumer Organisation (BEUC) calls on
EU legislators to adopt cloning regulations which
respect European consumers’ lack of appetite for food derived from cloning
and recognise their right to decide themselves
on the food they put on their
5 European Parliament press release on the novel food talks failure.
6 Proposals for a Council Directive on the placing on the market of food from clones and 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. 18 December 2013.
Food derived from animal cloning: safe to eat?
The European Food Safety Authority (EFSA) was tasked with evaluating the safety
of food derived from cloned animals3. Due to the limited data available on other
species, EFSA’s assessment was limited to meat and milk from cloned cattle and
meat from cloned pig.
In a 2008 Opinion, looking at the composition, nutritional value, microbiological
quality and potential allergenicity of food from clones, EFSA found no indication
that differences may exist in terms of food safety
between food products from
healthy cattle and pig clones and their progeny, compared with those from healthy
conventionally-bred animals. It must be noted, however, that cloning being a
relatively new technique, the extent of the current knowledge on this
technology and whether it may affect food safety and quality is still limited
EFSA itself recommended that the “database on compositional and nutritional
characteristics of edible animal products derived from clones and their progeny
should be extended
Moreover, research tends to suggest that clones’ immune system may be
than that of their conventionally-produced counterparts7.
Due to the scarcity of information with regard to clones’ immune functions, EFSA
recognised it is unclear whether or not cloned animals might be more susceptible to
animals. This might mean an increase in risk of
Clones may be more
infections, which in turn could present risks to
prone to infections due
human health if clones are more prone to carry
to a weaker immune
bacteria, some of which may be of concern to
system. The potential
human health are yet
As pointed out by EFSA, should clones’ reduced
to be fully studied.
immune functions be confirmed, “it should be
investigated whether, and if so, to what extent,
consumption of meat and milk derived from clones or their offspring may lead to an
increased human exposure to transmissible agents
Another potential consequence of clones’ weaker immune systems and increased
susceptibility to infections might be a more frequent need to recourse to and
administer veterinary medicines, including antibiotics. This in turn might impact on
the global, life-endangering problem of antibiotic resistance.
EFSA statements published subsequently in 20098, 20109 and 201210 have
7 Vajta G, Gjerris M. Science and technology of farm animal cloning: state of the art. In Anim Reprod
2006 May; 92(3-4):211-30.
8 EFSA Statement (2009). Further Advice on the Implications of Animal Cloning (SCNT).
9 EFSA Statement (2010). Update on the state of play of animal cloning.
10 EFSA Statement (2012). Update on the state of play of Animal Health and Welfare and Environmental
Impact of Animals derived from SCNT Cloning and their Offspring, and Food Safety of Products
Obtained from those Animals.
consistently confirmed the 2008 Opinion, concluding on the “still limited information
available on species other than cattle and pigs
” to conduct a risk assessment and
underscoring animal welfare issues.
III. Animal health and welfare concerns linked to cloning
It is widely recognised that cloning is associated with animal health and welfare
issues for both the surrogate mother (who carries the clone) and the cloned animal
With regard to the surrogate mother
, high rates of
as well as problems during pregnancy
miscarriage and C-
(e.g. placental abnormalities and enlarged umbilical
section rates. Most
cords with dilated vessels) have been observed
clones do not
(particularly in cattle). As the risk of abnormally large
survive birth or die
offspring is also higher than for “conventional”
pregnancies, Caesarean sections tend to be more
frequent in cattle carrying a clone3.
As far as the clones
are concerned, most of them simply do not survive birth
or die shortly thereafter
. The “efficiency” of the technique is very low (6-15% for
cattle and about 6% for pigs1) and increased mortality rates have been reported in
the perinatal period for pigs and bovine clones as well as during the juvenile period
(before weaning) for bovine clones. For those few animals who do survive, they
appear to be normal and healthy although uncertainties remain as to the possible
effects of cloning on their longevity3.
The aforementioned adverse health outcomes mean reduced welfare for both
animal clones and the surrogate mothers
. An indirect side-effect of cloning – as
with similarly selective breeding techniques – may also be the loss of genetic
diversity within livestock populations if only a limited number of animals are
multiplied in breeding programmes3. This may in turn increase susceptibility to
infections and diseases, threatening animal health and welfare, which are
interconnected. All the more so as “elite” farm animals are often those with the
highest welfare problems, e.g. incidences of
mastitis and lameness in dairy cows has been
linked to their milking performance11.
Data pertaining to the health and welfare of the
progeny of clones
(i.e. their offspring and
descendants) is very scarce. From the limited
evidence available, there seems no indication
that these animals’ health might be affected3.
No specific studies on the welfare of clones’
progeny have been reported in livestock species.
Nevertheless, previous considerations related to the loss in genetic diversity and the
selective reproduction of highly productive animals and their effect on animal
welfare are equally relevant for clones’ progeny
11 EFSA (2009). Scientific opinion on welfare of dairy cows in relation to udder problems based on a risk
assessment with special reference to the impact of housing, feeding, management and genetic
EU consumers’ attitudes towards cloning
EU consumers overwhelmingly disapprove of the use of cloning for food
, as reflected by two Eurobarometer surveys which investigated
Europeans’ perceptions of animal cloning for food supply.
According to the 2008 Eurobarometer report12, 84%
of EU citizens had concerns
over the long-term effects of animal cloning on nature
. While the use of the
cloning technique for certain purposes such as preserving endangered species was
acceptable to some extent among EU citizens
(approximately two-thirds), they were significantly less
While 2/3 of EU
willing to accept cloning for food production. 58%
citizens may accept
considered it totally unjustifiable
cloning as a means
A majority of EU citizens said it was unlikely that they
would buy meat or milk from cloned animals
they see its use for
(regardless of whether or not it is safe to eat) and
83% said that they would want food from the
offspring of cloned animals to be labelled
were to become available in EU supermarkets.
The ethical dimension
of consumers’ lack of appetite for food from clones and
their progeny must be stressed with three-quarters
of Europeans agreeing there
could be ethical grounds for rejecting animal cloning
animal cloning would risk treating animals as commodities
rather than creatures
This echoes the European Group on Ethics (EGE)’s stance on
83% of EU
animal cloning for food supply: in a 2008 report13, the EGE
stated that "considering the current level of suffering and
health problems of surrogate dams and animal clones, [it
had] doubts as to whether cloning animals for food supply
[was] ethically justified
”, while recognising that further
research was needed before any such conclusion could be
drawn in relation to clones’ progeny.
The EGE made it equally clear it “[did not see] convincing arguments to justify the
production of food from clones and their offspring
”. The Treaty on the Functioning
of the European Union itself acknowledges that animals are “sentient beings
states “full regard [shall be paid] to the welfare requirements of animals
The 2010 Eurobarometer15 findings confirmed that EU consumers “have strong
reservations about animal cloning in food production (67%), do not see the benefits
(57%), and feel that it should not be encouraged (70%)
12 Flash Eurobarometer 238 published in October 2008. Europeans’ attitudes towards animal cloning.
13 The European Group on Ethics in Science and New Technologies to the European Commission. Ethical
aspects of animal cloning for food supply. Opinion N°23 published in January 2008.
14 TFEU. Title II, Article 13.
15 Special Eurobarometer 341 published in October 2010. Biotechnology.
Traceability of clones, their offspring and descendants
Commercial cloning of farm animals is not taking place in the EU for now. However,
this technique is developing (especially for cattle) in a number of countries from
which the EU imports reproductive material (essentially bovine material from the US
and Canada), beef, sheep meat and dairy (notably from Argentina, Brazil and the
US) as well as a small number of live animals (mostly pigs and, to a lesser extent,
cattle, sheep and goats)16.
In terms of numbers, imports of live animals represent less than 0.01%
EU’s livestock. Imports of (mostly bovine) reproductive material account for 2.5% on average
of the EU’s use of reproductive material, but may represent up to 20%
in some Member States. The share of EU imports of meat and dairy products is also
low (<5%), except for sheep and goat meat (20%, essentially from New Zealand)1. Individual animal traceability is already in place
in the EU for bovine animals
While the EU has
imported into the EU). For pigs, sheep and goats,
traceability is generally in place on a batch basis, while
systems in place
individual systems are limited to high-value animals.
animals and their
Pedigree information is generally recorded in
databases managed by the national herd books for
material, this is not
bovine breeding animals16. Private initiatives are also
the case for all of
developing in some countries (e.g. The Netherlands,
France) to collect parentage information for elite
breeding pigs. As far as reproductive materials
concerned (including imported to the EU), EU law
requires individual identification and traceability
i.e. the donor and parents
must be known for semen and embryo respectively16. Germany is an exception
, as it exports clone semen to third countries and has set up a registration
system for clones and their reproductive material. There is currently no EU
requirement to specifically register clones
in herd books. There are however a few
voluntary initiatives, such as that registering clones from the dairy cattle breed
Looking now to the EU’s trading partners, most of them – except for the US –
do have individual beef traceability systems in place
. However this is not the
case for other species16. New Zealand
is the only country requiring
identification of cloned animals and registration
in an official database (with
the declared purpose of facilitating access to foreign markets, should an importing
country introduce restrictions on food derived from clones)1.
In Canada, food from clones and their progeny is considered novel
requires pre-market safety assessment (although the system rests on notification
by industry)1. In all other countries, clones, their progeny and reproductive
materials are subject to the exact same regulations as conventional animals1.
16 ICF/GHK study (Dec. 2012). Impact in the EU and third countries of EU measures on animal Cloning
for food production.
17 World Holstein Friesian Federation. Guidelines for registering clones. October 2006.
Clones are registered by private companies in the US, Canada and Brazil. There are
some private systems in place in the US and Canada that can help exclude
reproductive materials from clones from EU imports16. In contrast, Argentina and
Australia reported to the European Commission that clones are not registered. VI.
As of today, although no official figures are available given the absence of clone
traceability, considering the novelty of the cloning technique and its low “success
rate” it can be reasonably assumed that third countries’ livestock populations
include very few clones. This is therefore the right moment for the EU to set its
conditions towards potential exporters and urgently adopt a robust regulatory
framework on cloning for food production
that fully recognises the right of EU
consumers to decide whether or not to eat food produced with the use of the
As the European Commission’s two legislative proposals on cloning are in the
Council and European Parliament for debate, BEUC wishes to stress the following
The view of the overwhelming majority of EU
consumers who disapprove of the use of cloning
of appetite for
production must be heard and respected
cloning must be
As they stand, the cloning proposals largely fail to
address Europeans’ concerns. Indeed although they
reflected in the
do (on a temporary basis) ban cloning in the EU as
well as the sale of food from cloned animals, they do
not touch upon the crucial issue of the progeny of
. However, it is widely admitted that clones, unlike their progeny, are not
meant to produce meat or milk, but rather to be used as elite breeding animals.
The assumption that “the cloning technique itself may improve over time and
thus become more acceptable to consumers
”18 disregards the fundamental
many consumers have with the cloning technique, regardless
of its technical “efficiency” (see section IV. above).
EU consumers should be able to make informed choices
when it comes to
purchasing and consuming food derived from cloned animals’ offspring
(for as many generations as is scientifically feasible).
In March 2011, just before the Novel Foods conciliation failed, the Council had
proposed the following package of measures19 including:
1. a temporary ban on animal cloning in the EU for food production;
2. a temporary ban on food from cloned animals, whatever their origin;
3. a temporary ban on any supply of clones in the EU for food production;
18 EC Proposal for a Council Directive on the placing on the market of food from animal clones.
as well as
4. a traceability system for semen and embryos from cloned
5. a traceability system for the live offspring
of cloned animals
6. introducing labelling requirements for
Traceability is a
fresh meat of cloned cattle offspring
must, be it for
within six months of the new regulation’s
entry into force;
7. labelling requirements would have been
extended to all other foods from the offspring
of cloned animals, subject to a Commission
As a minimum
, we seek the reintroduction of these measures deemed
feasible back in 2011 to
the cloning proposals on the table.
As the EU already has a strong traceability system in place for beef, new EU
requirements for the traceability of cloned cattle and its progeny and for the
labelling of meat from cloned cattle offspring should be adopted as a matter of
urgency. In parallel, a feasibility study20 should look at other food products (e.g.
milk), more extensive labelling requirements (on several generations as far as is
scientifically feasible), and other species (pig, sheep, goat and horse).
The remarkable developments since 2011 are
the free trade agreement negotiations the EU
Pressure from its
has meanwhile engaged into (with Canada
and the US notably). It is hard not to believe
should not prevent
this new situation might have influenced the
the EU from adopting
European Commission’s decision to not even
rules on cloning in
propose the “lowest common denominator” on
line with its citizens’
which the Council and Parliament could have
agreed three years ago. As a leaked legal
opinion21 from the Council legal Services
revealed, requiring food from cloned animals’ offspring to be labelled
would not put the EU in breach of international trade rules
. Therefore, we
look to the Council and European Parliament to stand by EU consumers and
put their interests before trade
- END -
20 Whereas the terms of reference of the study commissioned by the EC on the labelling of products
from cloned animals and their offspring also cover meat from cloned cattle’s offspring.
21 Full opinion available on the website of Food & Water Watch:
See also joint BEUC/Eurogroup for Animals press release of 11 May 2011.