EGTOP/1/2011
Ref. Ares(2013)3235515 - 14/10/2013
Directorate-General for Agriculture
and Rural Development
Expert Group for Technical Advice on Organic Production
EGTOP
Final Report
on
Feed
The EGTOP adopted this technical advice at its 3rd plenary meeting
on 29 and 30 June 2011
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Final Report on feed
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About the setting of an independent expert panel for technical advice
With the Communication from the Commission to the Council and to the European Parliament
on a European action plan for organic food and farming adopted in June 2004, the Commission
intended to assess the situation and to lay down the basis for policy development, thereby
providing an overall strategic vision for the contribution of organic farming to the common
agricultural policy. In particular, the European action plan for organic food and farming
recommends, in action 11, establishing an independent expert panel for technical advice. The
Commission may need technical advice to decide on the authorisation of the use of products,
substances and techniques in organic farming and processing, to develop or improve organic
production rules and, more in general, for any other matter relating to the area of organic
production. These are complex and time consuming exercises, for which a high degree of
specialisation is required. By Commission Decision 2009/427/EC of 3 June 2009, the
Commission set up the Expert Group for Technical Advice on Organic Food.
EGTOP
The Group shall provide technical advice on any matter relating to the area of organic production
and in particular it must assist the Commission in evaluating products, substances and techniques
which can be used in organic production, improving existing rules and developing new
production rules and in bringing about an exchange of experience and good practices in the field
of organic production.
EGTOP Permanent Group
Alexander Beck, Jacques Cabaret, Niels Halberg, Sonya Ivanova-Peneva, Lizzie Melby
Jespersen, Ursula Kretschmar, Nicolas Lampkin, Giuseppe Lembo, Mariane Monod, Robin
Moritz, José Luis de la Plaza Pérez, Bernhard Speiser, Fabio Tittarelli.
Contact
European Commission
Agriculture and Rural Development
Directorate H: Sustainability and Quality of Agriculture and Rural Development
Unit H3 – Organic Farming
Office B232 B-1049 Brussels
Functional mailbox
: xxxxxxxxxxxxxxxxxxx@xx.xxxxxx.xx
The reports of the Expert group present the views of the independent experts who are members
of the Group. They do not necessarily reflect the views of the European Commission. The
reports are published by the European Commission in their original language only, at the
following webpage:
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TABLE OF CONTENTS
ACKNOWLEDGMENTS ............................................................................................................
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TABLE OF CONTENTS ..............................................................................................................
4
EXECUTIVE SUMMARY ...........................................................................................................
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1
BACKGROUND .....................................................................................................................
7
2
TERMS OF REFERENCE ....................................................................................................
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3
CONSIDERATIONS AND CONCLUSIONS ......................................................................
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3.1
E 535 SODIUM FERROCYANIDE ANTI-CAKING MATERIAL ....................................................
8
3.2
E 566 NATROLITE-PHONOLITE ANTI-CAKING MATERIAL ..................................................
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3.3
E 551A SILICIC ACID ANTI-CAKING MATERIAL ..................................................................
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3.4
E 568 CLINOPTILOLITE ANTI-CAKING AGENT ....................................................................
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3.5
E 237 SODIUM FORMATE PRESERVATIVE (FOR SILAGE) .....................................................
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3.6
HUMIC ACID SUBSTANCES - FEED MATERIAL .....................................................................
17
3.7
TEMPLATE FOR DOSSIER IN RELATION TO FEED ADDITIVES, PROCESSING AIDS AND FEED
MATERIALS ................................................................................................................................. 19
3.8
TECHNICAL ASPECTS OF TRANSITION TO 100% ORGANIC FEED FOR NON-RUMINANTS ......
19
4
LIST OF ABREVIATIONS .................................................................................................
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REFERENCES .....................................................................................................................
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GLOSSARY ..........................................................................................................................
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ANNEX 1: OVERVIEW OF COMPLIANCE WITH ORGANIC REGULATIONS ..........
23
ANNEX 2: TEMPLATE FOR DOSSIERS CONCERNING THE REQUEST TO AMEND
ANNEX V AND VI OF COMMISSION REGULATION (EC) NO 889/2008 ......................
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ANNEX 3: EU LEGISLATION GOVERNING FEED MATERIALS, ADDITIVES AND
PROCESSING AIDS ..................................................................................................................
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EXECUTIVE SUMMARY
The expert group for technical advice on organic production (EGTOP; thereafter called ‘the
Group’) in replying to point a) of the mandate concerning substances assessment concludes on
the basis of the knowledge available in the group and information provided with the dossiers and
by the Commission that:
• E 535 Sodium ferrocyanide anti-caking material, should be approved for use as a feed
additive in salt for organic animal feed, subject to:
o a maximum dose rate of 20 mg/kg NaCl (the maximum defined for human food) and
o a limited time period, in order to provide a legal basis for current practice in the short
term and to encourage the adoption of preferred carbonate alternatives longer term.
• E 566 Natrolite-Phonolite anti-caking material should be approved for use as a feed additive
in organic animal feed, subject to the limit of 25,000 mg/kg complete animal feed specified
in EC Reg. 739/2000.
• E 551a Silicic acid by precipitation anti-caking material should not be approved for use as a
feed additive in organic animal feed on the basis of available information about need given
the available, more natural alternatives. Further information on this issue should be provided
to support the application.
• E 568 Clinoptilolite anti-caking material should be approved for use as a feed additive in
organic animal feed, subject to the limit of 20,000 mg/kg complete animal feed and the
livestock classes specified in EC Reg. 1810/2005.
• E 237 Sodium formate preservative should be approved for use as a feed additive in organic
silage, subject to the outcome of the review of the authorisation of this product under Articles
4 and 7 of Regulation 1831/2003 currently in progress.
If approved:
o it should be considered whether formic and propionic acids should be deleted from
Annex VI to Commission Regulation (EC) 889/2008;
o the same restrictions relating to weather conditions and silage quality as currently
apply to formic and propionic acids under the organic regulations should apply;
o the concept of ‘difficult’ silages and/or ‘poor’ weather conditions’ that would
determine eligibility to use the products should be clarified. Initial dry matter content
or sugar content of the forage might be a basis for this.
• Humic acid substances are not currently authorised as a feed additive under EU regulations
so they cannot be considered for use as such in organic farming. Their classification as feed
material was not considered to be appropriate by the Group, which also noted their current
designation as pharmacologically active substances with possible implications for animal
health.
In reaching these conclusions, the Group considered that compliance with the organic regulation
needs to be assessed according to several criteria which are summarised in Annex 1.
The Group in replying to point b) of the mandate concerning the template for the member states
dossier with respect to animal feed materials, feed additives, certain products used in animal
nutrition and processing aids, developed the document presented in Annex 2 to this report. This
includes a section incorporating the criteria for assessment of consistency with the EU organic
regulations. The Group considered that it would be helpful to develop some interpretative
guidelines to support the dossier template.
The Group in replying to point c) of the mandate concerning technical aspects of transition to
100% organic feed requirements for non-ruminants concluded that while there are technical
solutions that can be implemented in the short to medium term, there is a need for further
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research on alternatives and knowledge transfer, a need to reflect on the nature and principles of
organic non-ruminant production (whether semi-industrial or extensive), and a need to consider
continuing with derogations for a short period limited to specific ages and types of non-
ruminants and specific feedstuffs.
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1
BACKGROUND
In recent years, several Member States have submitted dossiers under Article 16(3)(b) of Council
Regulation (EC) No 834/2007 concerning the possible inclusion of a number of substances in
Annex V and VI to Commission Regulation (EC) No 889/2008.
In relation to feed substances, Germany launched a request concerning E 535 Sodium
ferrocyanide, E 566 Natrolite-Phonolite, E 551a Silicic acid in 2007. In the same year, Austria
made a request concerning E 568 Clinoptilolite. In 2009 Sweden submitted a dossier concerning
E 237 Sodium formate and in 2010 Slovak Republic submitted a dossier on Humic acid
substances.
In the light of the changes to organic regulations in recent years, a need has been identified to
provide Member States with an improved template with a view to facilitate the elaboration of
complete technical dossiers.
In addition the issue of the derogation on 100% organic ingredients for monogastric animal feeds
has technical aspects that need to be considered.
The regulatory framework governing animal feed materials and additives is set out in Annex 3 to
this report.
For a definition of key terms used in this report, see GLOSSARY.
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TERMS OF REFERENCE
The EGTOP is asked, in the light of current technical/scientific data and knowledge:
a) to assess if the use of the following substances:
E 535 Sodium ferrocyanide anti-caking material
E 566 Natrolite-Phonolite anti-caking material
E 551a Silicic acid anti-caking material
E 568 Clinoptilolite binder
E 237 Sodium formate preservative
Humic acid substances feed material
is in line with the objectives, criteria and principles as well as the general rules laid down in
Council Regulation (EC) No 834/2007 and therefore if they can be authorised in organic
production under the EU legislation.
In preparing its final report, the Group may also suggest amendments to the current list in
Annex V and VI to Commission Regulation (EC) No 889/2008 as well as take into account
possible alternatives to the substances in question. In such cases, the proposal(s) should be
accompanied by a brief explanation of the reasons.
b) to draft the template of the dossier mentioned in Art. 16(3(b) of Council Regulation (EC) No
834/2007 in relation to feed additives and processing aids and feed materials.
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c) to examine the technical aspects of the transition to 100 % organic feed for non ruminants
with a view to provide technical advice for meeting animal's nutritional requirements as
stipulated in Art. 14(1(d)(ii) of Council Regulation (EC) No 834/2007.
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CONSIDERATIONS AND CONCLUSIONS
3.1 E 535 Sodium ferrocyanide anti-caking material
Identification of substance, terminology, synonyms
E 535 Sodium ferrocyanide is used as an anti-caking (free-flow) agent in salt (sodium chloride)
in animal feed. It is sprayed on the salt in an aqueous solution at a maximum dose of 80 ppm.
Sodium ferrocyanide is also known under the names yellow prussiate of soda or sodium
hexacyanoferrate and is registered as E 535, EINECS No 237-081-9 and CAS No 13601-19-9.
Authorization in general agriculture or feed/food processing
Its use in animal feed as an anti-caking agent to stop the formation of lumps in salt was
authorised by Commission Regulation (EC) No 256/2002 of 12 February 2002 and Commission
Regulation (EC) No 1810/2005 with a maximum limit 80 mg/kg NaCl (calculated as
ferrocyanide anion).
Sodium ferrocyanide (E 535) is also authorised for use throughout the European Union as an
anti-caking agent in salt and salt substitutes for human consumption, pursuant to Directive
95/2/EC with a limit of 20 mg/kg NaCl. In this context it is also allowed for use in salt for human
consumption under EU organic regulations.
Technological or physiological functionality for the intended use
Sodium chloride tends to absorb water at a relative humidity of over 75%, leading to secondary
crystallisation and the formation of clumps and blocks of salt. The addition of a small amount of
E 535 is enough to largely prevent the clumping process. The anti-clumping effect of
ferrocyanides is based on two mechanisms: firstly, the growth of NaCl crystals is altered, and
secondly, the tendency to absorb and release water is affected. A monomolecular ferrocyanide
coating on salt crystals is enough to achieve this effect.
Necessity for intended use, alternatives
The Group recognises that salt is used in livestock feedingstuffs to provide sodium, and that an
anti-caking agent is required to prevent the clumping of salt, which can block and damage
processing equipment and prevent uniform mixing of ingredients. Sodium ferrocyanide has no
direct effect on compound feedingstuffs.
The Group considered whether the positive effect on the flow performance of salt could be
achieved by other means:
• Salt could be left out of compound feeds and fed separately by primary producers. However,
blocks are normally manufactured from salt which has been treated with this or other
additives.
• Other products were identified as having a similar function.
o Sodium bicarbonate, calcium carbonate and magnesium carbonate are already
authorised as feed materials under Annex V to Commission Regulation (EC)
889/2008 and are already used in some countries as a standard alternative in salt for
organic processing. However, these are considered by some industry sources to be
less effective than sodium ferrocyanide at preventing clumping of salt, as anti-caking
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efficacy is influenced by the size of particle of the anti-caking substance (as lower
size has better efficacy). These carbonates are also used as primary feed ingredients at
levels higher than the salt additives.
o While sodium ferrocyanide is the most frequently used anti-caking agent, the
following are also permitted for animal feed, but these are not currently approved in
Annex VI to Commission Regulation (EC) 889/2008 :
E536 potassium ferrocyanide
E538 calcium ferrocyanide
E550 sodium silicate
E 552 calcium silicate
E 554 sodium aluminium silicate
E556 calcium aluminium silicate
Materials of origin, methods of manufacture
Sodium ferrocyanide is synthesised from sodium cyanide and iron (II) chloride. The crystalline
product is obtained by concentrating the solution. The production process takes place in
controlled conditions.
Environmental issues
No environmental risk was identified.
Animal welfare issues
Sodium ferrocyanide is added in trace quantities to salt, not to the compound feeding stuff. The
complex ferrocyanide ion is very stable and consequently possesses very low toxicity.
Human health issues
Human health risk has been assessed as part of the process of approving this substance as a feed
additive in general agriculture and was not separately reviewed by the Group (ADI 0.0-0.025 mg
ferrocyanide per kg body weight).
Food quality and authenticity
Not applicable.
Consistency with objectives and principles of organic production, as well as criteria and general
rules laid down in Council Regulation (EC) 834/2007
See summary table in Annex 1 to this report.
Traditional use and precedents in organic production
Widely used conventionally and is being used inadvertently (i.e. some control bodies and feed
compounders appear unaware that it is not currently permitted) in salt used in organic feedstuffs.
Although allowed for use in salt for human consumption under EU organic regulations, in some
countries (e.g. DE, CH) it is no longer used as carbonates have been the preferred alternatives for
many years.
Aspects of international harmonization of organic farming standards
Not applicable.
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Further considerations
Taking account of all the issues identified, the Group considered that, if the use of sodium
ferrocyanide is to be permitted, the maximum use limit for salt for human consumption of 20
mg/kg NaCl should be applied and the substance should only be permitted for a limited time
period to allow the industry to adapt to the available, preferred carbonate alternatives currently
permitted under organic regulations.
Conclusion
E 535 Sodium ferrocyanide anti-caking material, should be approved for use as a feed additive in
salt for organic animal feed, subject to:
• a maximum dose rate of 20 mg/kg NaCl (the maximum defined for human food) and
• a limited time period, in order to provide a legal basis for current practice in the short term
and to encourage the adoption of the preferred carbonate alternatives longer term.
3.2 E 566 Natrolite-Phonolite anti-caking material
Identification of substance, terminology, synonyms
E 566 Natrolite-phonolite is a finely ground stone meal, the stone being of 100% magmatic
origin.
Authorization in general agriculture or feed/food processing
This substance is permitted for use as an anti-caking feed additive in animal feed for all livestock
categories under Regulation (EC) No 2439/1999 (and as amended by Regulation (EC) No
739/2000) subject to a maximum limit of 25,000 mg/kg of complete feedingstuff.
Technological or physiological functionality for the intended use
The meal is used as a flow modifier in animal feed production. Because it is finely ground, the
meal has a large specific surface and the hollow structure of the natrolite – a hollow-bodied
mineral belonging to the zeolite family of natural ion exchangers - results in high water
adsorption. The addition of 1-2.5% finely ground natrolite-phonolite meal to a compound
mineral feed with added molasses improves the speed of release.
Necessity for intended use, alternatives
Flow modifiers are required in the production of compounded animal feedstuffs. As the use of
compounded feedstuffs as increased in organic farming, so has the need for approved additives.
Various stone meals can be used for this purpose, but each has specific characteristics and may
be preferred for specific purposes. In addition, sources in close geographical proximity may be
preferred for environmental and economic reasons.
Materials of origin, methods of manufacture
The stone is extracted in quarries in certain parts of Europe, finely ground and air sifted. It is a
natural mixture of alkaline and alkaline-earth aluminium silicates and aluminium hydrosilicates,
principally natrolite (43-46.5%) and feldspar.
Environmental issues
The extraction, use and disposal of natrolite-phonolite do not have any adverse effects on the
environment and the substance may be classified as ecologically safe. The reduced transport
requirement for locally sourced materials also confers environmental benefits.
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Animal welfare issues
The animal health impacts were separately assessed as part of authorisation as a feed additive
under Regulation No 2439/1999. This issue was not separately assessed in detail by the Group.
According to the information in the dossier, natrolite-phonolite stone meal does not contain any
quartz and does not have any adverse side-effects if inhaled during feed production or by
animals. It passes through the gastro-intestinal tract of animals. Concerns were raised in
discussion about the potential risk of dioxin and/or heavy metal contamination for some sources
of this product. The Group considered that these concerns are adequately addressed by the
authorisation under the main feed regulations.
Human health issues
Human health risk has been assessed as part of the process of approving this substance as a feed
additive in general agriculture and was not separately reviewed by the Group. The dossier
supporting the proposal stated that the results of studies of pathological irritant effects on human
skin have been negative - the stone meal has been permitted also for use as a medicinal product
applied directly to human skin.
Food quality and authenticity
No specific issues identified
Consistency with objectives and principles of organic production, as well as criteria and general
rules laid down in Council Regulation (EC) 834/2007
See summary table in Annex 1 to this report.
Traditional use and precedents in organic production
In organic farming, it is used as stone meal under Commission Regulation (EC) No 889/2008 as
a soil improver.
Aspects of international harmonization of organic farming standards
No specific issues identified.
Conclusion
E 566 Natrolite-Phonolite anti-caking material should be approved for use as a feed additive in
organic animal feed, subject to the limit of 25,000 mg/kg of complete feedingstuff as specified
in EC Reg. 739/2000.
3.3 E 551a Silicic acid anti-caking material
Identification of substance, terminology, synonyms
E 551a is synthetic, chemically precipitated amorphous silicic acid.
Authorization in general agriculture or feed/food processing
E 551a is permitted for use in animal feed for all livestock categories and all feedingstuffs,
without any restrictions on use, by Commission Regulation (EC) No 2439/1999 (and as
amended by Regulation (EC) No 739/2000) under the ‘binders, anti-caking agents and
coagulants’ group.
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Technological or physiological functionality for the intended use
E 551a Silicic acid, precipitated and dried is used as a carrier of liquid products and as a flow
modifier to improve the flow properties of powdered feed. Silicic acids are capable of binding
many times their own weight in moisture. This property is exploited in the animal feed and food
industries in order to make substances flow freely and maintain them in that condition.
The high absorption and adsorption capacity also makes it possible to transfer oily, semi-solid or
paste-like substances into powdery formulations. E 551a is also used in the conventional sector
as a carrier for vitamins, fatty acids and aromas. However, the application was for use as an anti-
caking material, not as a carrier, and the Group did not consider the merits or otherwise of its use
as a carrier.
Necessity for intended use, alternatives
Unlike the colloidal silicon dioxide (E 551b), E551a Silicic acid is currently not permitted for
use in organic farming. In conventional feed production, however, E551a differs from E551b
mainly in terms of the production process (see below) and the resulting particle size. It is argued
by industry sources that it is not always possible to substitute other (currently permitted) silicic
acids for E 551a, as they have different technological functions owing to their different physical
characteristics (internal surface, absorption capacity and particle size).
Materials of origin, methods of manufacture
E 551a is synthesised by first melting quartz sand, extracted from opencast pits, and sodium
carbonate to produce alkaline silicate, in particular sodium silicate. The molten sand is then
dissolved under pressure in water to produce an alkaline water-glass solution, which is
neutralised with sulphuric acid. The silicic acid is precipitated out as nano-particles during the
neutralisation process and extracted from the aqueous suspension using filter presses. The
particles tend to agglomerate to larger particles subsequently. Drying, and possibly grinding or
granulation, takes place after the filter cake has been washed in water. The final product obtained
from this precipitation process still contains about 0.8% SO3. The final product reaches a purity
of about 94% SiO2 or more.
Environmental issues
According to the information provided in the dossier, the production of synthetically amorphous
silicic acids has no adverse effects on the environment and may be classified as environmentally
safe. The Group did not carry out a separate environmental assessment.
Animal welfare and human health issues
Like E 551b, E 551a contains no crystalline fractions and so does not pose a danger to health in
terms of the occurrence of silicoses. No irritant effect has been noted when silicic acid is applied
to the skin and mucous membranes of rabbits. Low toxicity levels have been measured (LD50
10,000 mg/kg in rats; LC50, 96h in fish above 10,000 mg/l).
Food quality and authenticity
No specific issues identified.
Consistency with objectives and principles of organic production, as well as criteria and general
rules laid down in Council Regulation (EC) 834/2007
See summary table in Annex 1 to this report.
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Traditional use and precedents in organic production
No specific issues identified.
Aspects of international harmonization of organic farming standards
No specific issues identified.
Further issues
The Group was concerned that a synthetic form was being added to already approved, more
natural forms of silicic acid and that the case for this was not sufficiently made.
Conclusion
The Group does not consider that E 551a Silicic acid by precipitation anti-caking material should
be approved for use as a feed additive in organic animal feed on the basis of available
information about need given the available, more natural alternatives. Further information on this
issue should be provided to support the application.
3.4 E 568 Clinoptilolite anti-caking agent
Identification of substance, terminology, synonyms
E568 Clinoptilolite of sedimentary origin is a finely-ground stonemeal of a natural Na-
aluminium silicate. It belongs to the group of zeolites.
Authorization in general agriculture or feed/food processing
Clinoptilolite of sedimentary origin is permitted for pigs, chickens and turkeys for fattening and
for bovines and salmon at max 20,000 mg/kg complete animal feed (all types) as an additive of
the group "Binders, anti-caking agents and coagulants" pursuant to Regulation (EC) No
1810/2005.
Technological or physiological functionality for the intended use
Under normal environmental conditions, Clinoptilolite has a stable crystal structure, with
mineral-specific ion exchange and adsorption properties and reversible hydration capacity. The
addition of 2% to feed compounds improves flow properties. The physiological and chemical
conditions in the digestive system (pH, digestive enzymes, etc.) are not enough to decompose
clinoptilolite. Clinoptilolite is not absorbed and is excreted with the faeces.
Necessity for intended use, alternatives
Flow modifiers are required in the production of compounded animal feedstuffs. As the use of
compounded feedstuffs has increased in organic farming, so has the need for approved additives.
Various stone meals can be used for this purpose, but each has specific characteristics and may
be preferred for specific purposes. In addition, sources in close geographical proximity may be
preferred for environmental and economic reasons.
E567 Clinoptilolite of volcanic origin is also an option, but was not considered specifically and
is not currently approved under organic regulations.
Materials of origin, methods of manufacture
Clinoptilolite of sedimentary origin is a natural Na-aluminosilicate, quarried in Europe. It
belongs to the Zeolite group and is
mineralogically a clinoptilolite. Clinoptilolite of sedimentary
origin can bind water molecules in the zeolite pores. Besides the tightly and loosely bound
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zeolitic water there is also external water, which escapes at as low as 30°C in a vacuum. Through
contact between the zeolite and ions in an aqueous solution the ions can be absorbed. The
specific surface of the zeolite (its size, geometry and energetic characteristics) also influences the
ion adsorption. For clinoptilolite this results in mineral-specific ion-exchange and adsorption
properties and a reversible hydration capacity.
Environmental issues
The reduction, use and disposal of clinoptilolite have no negative effects on the environment.
The mineral rock is very stable and does not decompose in slurries, farmyard manure and litter.
Clinoptilolite of sedimentary origin continues to work in slurry, manure and litter with the ion
exchange and absorption properties peculiar to the mineral as well as a reversible hydration
capacity. Studies have not shown any adverse effects of clinoptilolite of sedimentary origin on
soil fauna and the microbial transformation processes. Clinoptilolite of sedimentary origin also
has no effects on aquatic fauna and flora, plants - or invertebrates.
Animal welfare issues
The animal health impacts were separately assessed as part of authorisation as a feed additive
under Regulation 2439/1999. This issue was not separately assessed in detail by the Group. As
with Natrolite-Phonolite (see above), concerns were raised in discussion about the potential risk
of dioxin and/or heavy metal contamination (including lead and cadmium) for some sources of
this product. The Group considered that these concerns are adequately addressed by the
authorisation under the main feed regulations. The conditions in the digestive system and the
relatively short time spent in the acid medium are not sufficient to change the lattice structure of
clinoptilolite tuff. Clinoptilolite of sedimentary origin is therefore excreted unchanged in the
faeces and does not produce any metabolites in the animal.
Human health issues
No specific issues identified.
Food quality and authenticity
No specific issues identified.
Consistency with objectives and principles of organic production, as well as criteria and general
rules laid down in Council Regulation (EC) 834/2007
See summary table in Annex 1 to this report.
Traditional use and precedents in organic production
No specific issues identified.
Aspects of international harmonization of organic farming standards
No specific issues identified.
Conclusion
E 568 Clinoptilolite anti-caking material should be approved for use as a feed additive in organic
animal feed, subject to the limit of 20,000 mg/kg of complete feedingstuff and the livestock
classes as specified in EC Reg. 1810/2005.
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3.5 E 237 Sodium formate preservative (for silage)
Identification of substance, terminology, synonyms
Chemical name(s): Sodium formate
Other names: Formic acid Sodium salt
Trade name: Not applicable
CAS code: 141-53-7
Other code(s): EINECS-No: 2054880
Composition: Chemical formula CHO2Na
Authorization in general agriculture or feed/food processing
Sodium formate (E237) is approved as a food and feed preservative. Under the provisions of Art.
10 § 2 of Reg. (EC) No 1831/2003, an application, in accordance with Article 7, has been
submitted for Sodium formate (E237) as an approved feed additive for silage (101st edition
(Nov. 2010) European Union Register of Feed Additives), without restrictions on its use. In the
same application, a new authorisation was requested, under Article 4, for a new use as a feed
additive under the functional group of silage additives.
Technological or physiological functionality for the intended use
Sodium formate can be mixed with formic acid and/or propionic acid and used as a liquid
product to produce silage from grass, maize or other crops. However, sodium formate can be
found naturally in silage made with formic acid. At pH 4, 60% of total formic acid is in its salt
form, with the sodium form predominant.
When used, the feed additive is normally added to the crop to be ensiled at the time of harvesting
by suitable application systems and mixed with those feedstuffs. Sodium formate can also be
spread as a solid product on the top of the silage in the silage bunker. Normal inclusion is 4.5
kg/t forage when used alone. The inclusion rate is lower when mixed with formic/propionic acid.
Sodium formate eases the handling of pure acids that are more corrosive. Corrosion tests using
formic / propionic acid with and without sodium formate show that the inclusion of sodium
formate significantly lowers the corrosiveness of the acids.
Necessity for intended use, alternatives
There are different types of silage additives available for organic farmers, including formic and
propionic acids in pure form, as well as other substances for silage production listed in Annex VI
to Commission Regulation (EC) No 889/2008. Acid-based additives can be used for organic
farming only when weather conditions do not allow for adequate fermentation. The most
commonly used acids are formic acid and propionic acid. The disadvantage with both of these
acids is that they corrode. This results in the acids eating into machinery, but most of all they
cause a safety risk for persons handling the products. Sodium formate is not critically necessary
for organic production, but it eases the handling of and can replace pure acids that are more
corrosive and reduces the risk to the operator.
Materials of origin, methods of manufacture
The process for synthesising the main polyol product is based on the reaction, at relatively low
temperature and pressure, between butyraldehyde or acetaldehyde and formaldehyde in alkaline
environment. Sodium formate is a by-product from this production. The reaction is done batch-
by-batch in a rustproof reactor. In the subsequent separation steps the sodium formate is
crystallized, purified and dried.
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Environmental issues
Sodium formate is biodegradable: (BOD28/COD 86% (OECD 306); COD 240 mg/h (O2); Zahn-
Wellen 100%). Sodium formate does not accumulate in organisms. Sodium formate has a low
toxicity for aquatic organisms (EC0 > 1000 mg/l (daphnia); EC10/18 h 10600 mg/l /bacteria);
EC50/48 h 790 mg/l (algae); LC50/96h > 1000 mg/ml (fish)).
Animal welfare issues
No specific issues identified.
Human health issues
Sodium formate is irritating to eyes and might irritate skin. If the product is inhaled it can irritate
respiratory tracts and cause coughing and breathing difficulties. If swallowed irritations of the
mucosae in the mouth, throat, oesophagus and intestinal tract can occur. Usual precautions for
handling chemical products should be followed. Sodium formate makes the acids easier to
handle. Compared to the pure acids already approved for organic silage production, sodium
formate contributes a smaller safety risk.
Food quality and authenticity
No specific issues identified.
Consistency with objectives and principles of organic production, as well as criteria and general
rules laid down in Council Regulation (EC) 834/2007
See summary table in Annex 1 to this report.
Traditional use and precedents in organic production
No specific issues identified.
Aspects of international harmonization of organic farming standards
No specific issues identified.
Further considerations
The review of feed additive regulations currently in progress may restrict use of this additive and
acids to ‘difficult’ silages. There is also a need for a clearer definition of the relevant ‘weather
conditions’ for these additives in the organic regulation, which could be based on dry matter
content or any definition of ‘difficult’ silages that may be adopted. Any use of sodium formate
for silage making should be restricted to the same conditions as currently applied to acids. There
is a case that if permitted, sodium formate should eventually completely replace the use of acids
in organic farming given the operator safety and other risks associated with the acids.
Conclusion
E 237 Sodium formate preservative should be approved for use as a feed additive in organic
silage, subject to the outcome of the review of the authorisation of this product under Articles 4
and 7 of Regulation 1831/2003 currently in progress.
If approved:
• it should be considered whether formic and propionic acids should be deleted from
Annex VI to Commission Regulation (EC) 889/2008;
• the same restrictions relating to weather conditions and silage quality as currently
apply to formic and propionic acids under the organic regulations should apply.
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• the concept of ‘difficult’ silages and/or ‘poor’ weather conditions’ that would
determine eligibility to use the products should be clarified. Initial dry matter content
or sugar content of the forage might be a basis for this.
3.6 Humic acid substances - feed material
The original application received was for the assessment of humic acid substances (HAS) as a
feed
additive. As they are not approved under general feed regulations as a feed additive (see
below), consideration in this context was not possible, and the mandate requested the Group to
consider their use as a feed
material. The Group considered that the information presented was
more consistent with the use of HAS as a feed additive for prophylactic treatment, that the direct
nutritional value was unclear, and therefore that consideration of their use as feed material was
not appropriate. The assessment below reflects this.
Identification of substance, terminology, synonyms
Humic acid substances (HAS) are a group of natural high-molecular-weight macromolecules
composed of aromatic rings forming a very complex structure in the presence of phenolic,
hydroxyl, phenolic hydroxyl, ketonyl, quinone, semiquinone, carboxyl, carbonyl and alkoxyl
groups. The humic acids are often complexed with a mixture of compounds (especially metals).
Functional groups of humic acids are capable of ion exchange reactions. Ability to form chelates
in the presence of carboxylate and phenolate groups is important in regulating bioactivity of
metal ions and pH adjustment.
Authorization in general agriculture or feed/food processing
Humic acids are not currently authorised as a feed additive. This product would need approval
under EC Regulation 1831/2003 before it can be considered for possible inclusion in Annex VI
of Regulation 889/2008. Humic acids and their sodium salts are, however, identified as
pharmacologically active substances with no maximum residue level and no restrictions on use
under Regulation 37/2010 and Annex II of Regulation 2377/90.
Technological or physiological functionality for the intended use
Humic acids are used in horses, ruminants, swine and poultry at oral doses level of 500 to 2000
mg/kg body weight for the treatment of diarrhoea, dyspepsia, and acute intoxications. They exert
a protective action on the mucosa of the intestine and have antiphlogistic, adsorptive, antitoxic
and antimicrobial properties. They are not used in humans (Committee for Veterinary Medicinal
Products). An EFSA scientific assessment of human use of humic acids as a food supplement
(EFSA journal 2009 1147:1-36) concluded that the bioavailability of iron, chromium selenium or
other minerals from their humic acid/fulvic acid chelates might be limited or even absent,
whereas the possibility that the source may reduce the bioavailability of the metals and nutrients
from other sources in the diet cannot be excluded.
Necessity for intended use, alternatives
Although a wide range of advantages have been claimed for humic acids as a feed additive, the
Group found that the evidence provided was insufficient to support these claims. A detailed
evaluation of the claims would need to be carried out as part of the registration process as feed
additive.
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Materials of origin, methods of manufacture
As natural organic compounds, HAS are derived from biological, chemical and microbial
decomposition of organic matter (especially plants). HAS exist from trace quantities in sandy
soils to abundant amounts up to 40 wt.% in peat and brown coal, soil, well water and others.
Where transformed organic matter reaches a point of stability under constant conditions, humus
is formed in considerable extent. The Group did not have sufficient information or technical
expertise to comment on the process of extraction.
Environmental issues
No specific issues identified, but humic acids are widespread in the environment.
Animal welfare issues
As a recognised pharmacologically active substance, there are potential impacts on health and
welfare, which would need further consideration as part of any possible authorisation as a feed
additive.
Human health issues
No specific issues identified (but see above).
Food quality and authenticity
No specific issues identified.
Consistency with objectives and principles of organic production, as well as criteria and general
rules laid down in Council Regulation (EC) 834/2007
See summary table in Annex 1 to this report.
Traditional use and precedents in organic production
No specific issues identified.
Aspects of international harmonization of organic farming standards
No specific issues identified.
Further considerations
Humic acid substances were not considered by the Group to be a feed material and would need
authorisation under EU feed regulations for use as a feed additive. If used as a veterinary
treatment in organic production, their use should be curative, not prophylactic,in accordance with
organic principles. Curative use is also consistent with EMA scientific opinion (EMA, 1999) that
no MRL needed to be defined as humic acids are used only for infrequent and non-regular
treatments.
Conclusion
Humic acid substances are not currently authorised as a feed additive under EU regulations so
they cannot be considered for use as such in organic farming. Their classification as feed
material was not considered to be appropriate by the Group, which also noted their current
designation as pharmacologically active substances with possible implications for animal health.
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3.7 Template for dossier in relation to feed additives, processing aids and feed materials
The Group developed the template presented in Annex 2 to this report. The Group considered
that it would be helpful to develop some interpretative guidelines to support the dossier template.
The template presented in Annex 2 to this report includes in part B a checklist incorporating the
criteria for assessment of consistency with the EU organic regulations.
There was some debate within the Group about whether it was necessary to identify and assess
all the inputs used in the process of manufacturing the feedstuff or feed additive under
consideration, potentially even the chemical reactions involved. While some agreed with this
position, others argued that relevant safety and environmental issues are considered as part of
the additives authorisation process in place under Regulation 1831/2003, and that we are relying,
and should rely, as much as possible on this process as it would not be possible to duplicate this
work within EGTOP.
3.8 Technical aspects of transition to 100% organic feed for non-ruminants
The Group considered various technical aspects of the transition to 100 % organic feed for non
ruminants with a view to provide technical advice for meeting animal's nutritional requirements
as stipulated in Art. 14(1(d)(ii) of Council Regulation (EC) No 834/2007. The following
technical issues were identified:
• A balanced supply of methionine and lysine remains a key problem for monogastrics.
• Attempts to address this at current levels of semi-industrial production intensity can result in
excess of other amino acids leading to potential health and environmental problems,
especially for young animals (piglets, chick broilers, and chick turkeys) and laying hens.
• Failure to provide sufficient amino acids can lead to a severe welfare problem from feather
pecking/cannibalism. This problem is mainly specific to layers and not other monogastrics,
although it can affect other poultry up to 28 days old and pigs up to 3 months old. Other
factors including housing, rearing and breeding can also contribute to the feather-pecking
problem in poultry.
• Other welfare/environmental problems may be caused by the excess levels of other amino
acids present in the diet as a result of trying to achieve minimum levels for the critical amino
acids. This can lead to breathing problems, hock burn and potential pollution risks due to N
surpluses.
• Organic soybean cake is rich in methionine and lysine but there is currently high reliance on
imports. However, there are initiatives to increase European production even in northern
Europe.
• While fishmeal and yeast are permitted options that are used, they are non-agricultural
products and not relevant to the 100% organic feed discussion.
• Conventional potato and maize protein are the main sources currently used to balance rations
but these are not available organically – if organic potatoes or maize were to be processed for
protein, a market would need to be identified for a significantly larger quantity of starch as a
by-product
1
• A number of different potential feed sources, including for example triticale and rapeseed,
have been identified by Nicholas et al. (2007) in a review of the issue. However, these
ingredients are only available in relatively small quantities and in many cases feed
1 E.g. 100 kg of maize produce only 9 kg of gluten and about 90 kg of starch
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manufacturers lack the storage capacity to store these ingredients as well as the main
ingredients such as wheat and therefore prefer not to use them.
• For some ingredients, such as sunflower or rapeseed, the restrictions on processing them as
organic mean the quality of the end product makes them less suitable for use in feed cake.
• Protein extract from alfalfa, might also be a suitable alternative source and legumes are
recommended in crop rotations. Hemp seed is another possibility.
• Proposals for novel feed materials, including (farmed) organic mussel/molluscs meal
2, fly
larvae grown on organic animal manure
3 and micro/macro algae
4 are under development.
Earthworms could also be an option
5. However, despite these advances, there will still be a
time lag before these products are commercially available.
• There is a need to consider whether the same performance standards as for conventional
production should be used as a basis for organic mono-gastric production and ration
formulation. A more extensive approach could reduce required concentrations of methionine
and lysine.
• There is a need to review breeds, or to initiate breeding of genotypes, that would be suited to
a more extensive approach while remaining economically viable and sustainable, but it needs
to be recognised that in many case suitable breeds are not currently available and that there
could be a significant time lag before new, more suitable breeds, can be produced.
• The actual protein requirements of systems and breeds used in organic production should be
reviewed. For example, Spanish research indicates that the nutritional requirements of
Iberico pig are much lower than standard breeds. For French Label Rouge table birds such
information already exists.
• There is a need to consider how more nutritional benefit can be obtained from the rangeland,
including through more diverse management of the land to encourage invertebrates and other
beneficial nutritional components (ORC, 2011). This may require a different model of
production contrasting with the semi-industrial approach of some current organic production
systems.
• Many of the options identified could be implemented now or within a few years with
appropriate knowledge transfer and some additional research, but it may be that a derogation
for very specific classes of mono-gastrics
6 should be retained. However, a new derogation
2 Mussel meal should be regarded as an organic feed ingredient. Under current Danish developments, the mussels
will be produced in the sea, but under controlled conditions, and certified organic. Mussel meal is mechanically
separated from the shell and dried and without chemicals added.
3 The methods of fly larvae production in Denmark have not yet been finalised. The larvae can be produced on
large scale using known methods and the production can be certified organic. The larvae, whether they are used
directly (alive) or processed into meal constitutes a very valuable feedstuff, high in energy, protein, essential
amino-acids and fatty acids. An“on farm” solution would be preferable, feeding the larvae to the animals
(poultry) directly, but this raises questions concerning hygiene that need to be resolved through further research
before the production process can be finalised. The research will be conducted in the next 2-3 years.
4 Dried products of both micro algae (Spirulina) and macro algae are produced under controlled conditions and
can probably be certified organic. There is still a lot of research to be done concerning processing of the algae,
nutritional value and hygienic aspects. Algae do not have as high a nutritional value as mussels and fly larvae.
Macroalgae have a considerable content of carbohydrates that are not very metabolizeable for monogastrics and
may therefore require processing before using as a feed ingredient.
5 It was reported in the discussion that trials with earthworms in France has led to concerns about heavy-metal
concentration, but the substrate (e.g. FYM or household waste compost) needs clarification as a potential
explanation
6 The Group did not have sufficient time to consider the detail of how such derogations might be applieded. One
suggestion was that the derogations should be limited to the following age ranges: chickens 0-4 weeks, turkeys
0-4 weeks, piglets 3-8 weeks, and layers 18-32 weeks, although the case was also made that for piglets the age
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period should be relatively short, e.g. 2-4 years, so as to keep farmers, research institutes and
the industry motivated.
Conclusion
The Group concluded that while there are technical solutions that can be implemented in the
short to medium term, there is a need for further research on alternatives and knowledge transfer,
a need to reflect on the nature and principles of organic non-ruminant production (whether semi-
industrial or extensive), and therefore a need to consider continuing with derogations for a short
period limited to specific ages and types of non-ruminants and specific feedstuffs.
range should be 6-12 weeks. However, concerns were also raised about the practical problems that might arise in
policing this. It was also suggested that the derogation should be limited to specific classes of feed (all fish and
marine animals and their by-products, plant protein extracts, yeasts, molasses, powders and extracts of plants,
spices and herbs, seaweed meal), but this needs to be consistent with organic principles. However, many of these
products are not of agricultural origin and therefore cannot be organic in terms of the regulation and potentially
fall outside the scope of the 100% organic feed requirement in any case.
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4
LIST OF ABREVIATIONS
CAS
Chemical Abstracts Systematic names
EGTOP
Expert Group for Technical Advice on Organic Production
EFSA
European Food Safety Authority
EINECS
European Inventory of Existing Commercial Chemical Substances
EMA
European Medicines Agency
HAS
Humic acid substances
5
REFERENCES
Nicholas, P.; A. Sundrum and S. Padel (2007) Guidance notes to operators including
recommendations in relation to nutrient supply. Deliverable 4.3. EEC 2092/91 (ORGANIC)
Revision - Research to support the revision of the EU Regulation on organic agriculture SSPE-
CT-2004-502397. University of Wales, Aberystwyth
ORC (2011) Position paper on 100% organic feed for monogastrics. Organic Research Centre,
Newbury
EMA (1999) Humic acids and their sodium salts. Summary Report EMEA/MRL/554/99-FINAL.
Committee for Veterinary Medicinal Products.
For list of regulations, see Annex 3.
6
GLOSSARY
Feed (or feedingstuff) means any substance or product,including additives, whether processed,
partially processed or unprocessed, intended to be used for oral feeding to animals (Source: EU
Reg. 178/2002 Art. 3 pt 4).
Feed additives means substances, micro-organisms or preparations, other than feed material and
premixtures, which are intentionally added to feed or water in order to perform, in particular, one
or more of the functions mentioned in Article 5(3) (Source: EU Reg.1831/2003; Art. 2a):
Processing aids means any substance not consumed as a feedingstuff by itself, intentionally used
in the processing of feedingstuffs or feed materials to fulfil a technological purpose during
treatment or processing which may result in the unintentional but technologically unavoidable
presence of residues of the substance or its derivatives in the final product, provided that these
residues do not have an adverse effect on animal health, human health or the environment and do
not have any technological effects on the finished feed (Source: EU Reg.1831/2003; Art. 2h)
Feed materials means products of vegetable or animal origin, whose principal purpose is to meet
animals’ nutritional needs, in their natural state, fresh or preserved, and products derived from
the industrial processing thereof, and organic or inorganic substances, whether or not containing
feed additives, which are intended for use in oral animal-feeding either directly as such, or after
processing, or in the preparation of compound feed, or as carrier of premixtures; (Source: EU
Reg. 767/2009; Art. 2g)
Feed intended for particular nutritional purposes means feed which can satisfy a particular
nutritional purpose by virtue of its particular composition or method of manufacture, which
clearly distinguishes it from ordinary feed. Feed intended for particular nutritional purposes does
not include medicated feedingstuffs within the meaning of Directive 90/167/EEC.
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Annex 1: Overview of compliance with organic regulations
Substance
E535
E566
E551a
E568
E237
Humic
Sodium fer-
Natrolite-
Silicic
Clinop-
Sodium
acids
rocynanide
Phonolite
acid
tilolite
formate
Criterion
Role?
Anti-caking
Anti-caking
Anti-
Anti-caking
Preservati
Feed
agent
agent
caking
agent
ve
material
agent
(additive)
Nutritional
None
None
None
None
None
Not clear
value?
EU-authorised?
Yes
Yes
Yes
Yes
Yes as a
No, but
preservati
listed as a
ve
PAS1
Restrictions (for
Only for salt 25000
None
20000
Under
Not
animal feed)?
max 80
mg/kg for
mg/kg for
review as
authorised
mg/kg NaCl all stock
specific
feed
as an
livestock
additive
additive
Natural (not
No
Yes
No
Yes
No
Yes
chemically
synthesised)?
Traditional
Not
Not
Not
Not
Not
Not
input?
applicable
applicable
applicable applicable
applicable applicable
GMO?
No
No
No
No
No
No
Growth
No
No
No
No
No
No
promoter?
Synthetic amino
No
No
No
No
No
No
acid?
Natural milk
No
No
No
No
No
No
replacer?
Agricultural
No
No
No
No
No
No
origin?
Organic?
Not
Not
Not
Not
Not
Not
(if relevant)
applicable
applicable
applicable applicable
applicable applicable
Land-based?
Not
Not
Not
Not
Not
Not
applicable
applicable
applicable applicable
applicable applicable
Internal?
No
No
No
No
No
No
(on farm)
Pasture access?
Not
Not
Not
Not
Not
Not
applicable
applicable
applicable applicable
applicable applicable
Minimise
No
No
No
No
No
No
additives?
Essential? (need
No, but
No, but
Yes,
No, but
No, but
No
demonstrated)
more
regional
where
regional
safer than
effective
applicability particle
applicability acids for
than
size
difficult
alternatives
critical
silage
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Species
Not
Not
Not
Not
Not
Not
appropriate?
applicable
applicable
applicable applicable
applicable applicable
Environmental
No
No
No
No
No
No
impacts?
Animal health/
No
No
No
No
No
Pharmacol
welfare impact?
ogically
active
Human health
No
No
No
No
Yes, but
Potentiall
impacts?
safer than
y
acids
‘Misleading’
No
No
No
No
No
No
subst./processes?
Careful
Yes
Yes
Yes
Yes
Yes
No
processing?
Solvent
Not
No
No
No
No
No
extracted?
applicable
Food quality/
None
None
None
None
None
None
authenticity?
identified
identified
identified
identified
identified
identified
1 pharmacologically active substance
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Annex 2: Template for dossiers concerning the request to amend Annex V and
VI of Commission Regulation (EC) No 889/2008
Part A
DOSSIER CONCERNING THE REQUEST TO AMEND ANNEXES V and VI concerning feed materials, additives/processing aids and certain substances used in animal
nutrition of Commission Regulation (EC) No 889/2008
Articles 16.3 b and 21 sec. par. of Council Regulation (EC) No 834/2007.
"Where a Member State considers that a product or substance should be added to, or withdrawn
from the list referred to in paragraph 1, or that the specifications of use mentioned in
subparagraph (a) should be amended, the Member State shall ensure that a dossier giving the
reasons for the inclusion, withdrawal or amendments is sent officially to the Commission and to
the Member States."
General information on the request
Nature of the request
Inclusion
Deletion
Change of disposition
Request introduced by
[Member State]
Contact e-mail:
Date
Please indicate if the material provided is confidential
Requested inclusion/deletion/amendment
Name of additive / substance
Primary use/conditions
1. Identification
Common name
Name(s) of active substance
Other names
Trade names
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CAS
7 No. (if appropriate)
IUPAC
82 Name (if appropriate)
E.C Additive Identification No (if appropriate)
Other code(s)
2. Characterisation
Chemical formula/composition of active substance (if appropriate)
Concentration of active substance
If preparation, other components
Physical properties
Origin, inputs and production method of the active substance
Method(s) of analysis
3. Specification of use
Material/additive category
Material/additive functional group
Species groups
7 Chemical Abstracts Systematic Names
8 International Union of Pure & Applied Chemistry
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Minimum or maximum rate according to species group (if appropriate)
Application route
4. Status
Authorization in general agriculture or food processing
Historic use
Regulatory status (EU, national, others) (including expiry dates of authorisation if applicable)
5. Reasons for the inclusion, withdrawal or amendments,
Specifiy in which Annex the inclusion , withdrawal or amendments is requested
V VI
Explain the need for the proposed feed material or additive change
What alternative solutions are currently authorised or possible?
Is there any traditional use or precedents in organic production?
6. Consistency with objectives and principles of organic production
Please use the check list in part B to this Annex to indicate consistency with objectives and
principles of organic production, as well as criteria and general rules, laid down in Council
Regulation (EC) 834/2007 Title II and Title III as applicable.
7. Other aspects
Environment
Animal health and welfare
Human health
Food quality and authenticity
Ethical
Socio-economic
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8. Annexes
9. References
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Part B
CHECKLIST FOR CONSISTENCY
with objectives and principles of organic production with reference to specific articles in
the organic regulations
Criterion
Specific articles
Yes/No/
Brief qualification
in Reg. 834/2007
Not applicable
What is role of material/additive?
Art. § 5 k) &
art.14 § 1. d) iv)
Is it EU-authorised?
Art. 1 § 4.
What restrictions (for animal feed)
General regulation
apply?
& Art. 16 § 2. e)
Does it have nutritional value?
-
Is it natural (not chemically
Art. 4, b) & c).
synthesised)?
Is it a traditional input or does it
-
have organic precedence?
Is it a GMO?
Art. 9
Is it a growth promoter?
Art. 14 § 1. d) v).
Is it a synthetic amino acid or
Art. 14 § 1. d) v).
vitamin?
Is it a natural milk replacer?
Art. 14 § 1. d) vi).
Is it of agricultural origin?
Art. 14 § 1. d) iv).
Is it produced organically?
Art. 14 § 1. d) i) &
iv).
Is it land-based?
Art. 4 - a) & b) &
Art. 5 g).
Is it produced internally (on farm)?
Art. 14 § 1. d) i).
Does it involve pasture access?
Art. 14 § 1. d) iii).
Does it minimise use of additives?
Art. 7 b) & Art. 16
§ 2. a) et e) i).
If an additive, is it essential (need
Art. 7 b) & Art. 16
demonstrated)?
§ 2. a) et e) i).
Is it species appropriate?
General regulation
& art. 16 § 3.
Does it have negative
Art. 3 a) i) & art. 4
environmental impacts?
c) iii).
Does it have negative animal
Art. 5 h) & art. 14
health/welfare impacts?
e) i).
Does it have negative human health Art. 3 b) & c) &
impacts?
Does it involve ‘misleading’
Art. 7 c) & Art. 18
substances/processes?
§ 4.
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Annex 3: EU legislation governing feed materials, additives and processing
aids
Organic regulations
• Council Regulation (EC) No 834/2007 on organic production and labelling of organic
products and repealing Regulation (EEC) No 2092/91
• Commission Regulation (EC) No 889/2008 laying down detailed rules for the
implementation of Council Regulation (EC) No 834/2007 on organic production and
labelling of organic products with regard to organic production, labelling and control
(Annexes V & VI).
Feed additives
• Commission Regulation (EC) No 2439/1999 on the conditions for the authorisation of
additives belonging to the group 'binders, anti-caking agents and coagulants' in feedingstuffs
Repealed by Commission Directive 2003/57/EC.
• Commission Regulation (EC) No 739/2000 amending Regulation (EC) No 2439/1999 on the
conditions for the authorisation of additives belonging to the group 'binders, anti-caking
agents and coagulants' in feedingstuffs. Repealed by Commission Directive 2003/57/EC.
• Commission Regulation (EC) No 256/2002 of 12 February 2002 concerning the provisional
authorisation of new additives, the prolongation of provisional authorisation of an additive
and the permanent authorisation of an additive in feedingstuffs
• Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives
for use in animal nutrition for the new rules on the authorisation, supervision and labelling of
feed additives
• Commission Regulation (EC) No 1810/2005 concerning a new authorisation for 10 years of
an additive in feedingstuffs, the permanent authorisation of certain additives in feedingstuffs
and the provisional authorisation of new uses of certain additives already authorised in
feedingstuffs
• Commission Regulation (EC) No 429/2008 Of 25 April 2008 on detailed rules for the
implementation of Regulation (EC) No 1831/2003 Of The European Parliament And Of The
Council as regards the preparation and the presentation of applications and the assessment
and the authorisation of feed additives
• Commission Regulation (EU) No 892/2010 of 8 October 2010 on the status of certain
products with regard to feed additives within the scope of Regulation (EC) No 1831/2003 of
the European Parliament and of the Council
• European Union Register of Feed Additives pursuant to Regulation (EC) No 1831/2003
Appendixes 3b & 4. Annex : list of additives revision 115 Released 08 April 2011.
Feed materials
• Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing
on the market and use of feed, amending European Parliament And Council Regulation (EC)
No 1831/2003
• Commission Regulation (EU) No 454/2010 on transitional measures under Regulation (EC)
No 767/2009 of the European Parliament and of the Council as regards the labelling
provisions for feed
• Commission Regulation (EU) No 242/2010 creating the catalogue of feed materials.
Repealed by Commission Regulation (EU) No 575/2001.
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Final Report on feed
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Pharmacologically active substances
• Council Regulation (EEC) No 2377/90 laying down a Community procedure for the
establishment of maximum residue limits of veterinary medicinal products in foodstuffs of
animal origin. Repealed by Regulation (EC) No 470/2009 of the European Parliament and of
the Council
• Regulation (EC) No 470/2009 of the European Parliament and of the Council laying down
Community procedures for the establishment of residue limits of pharmacologically active
substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90
and amending Directive 2001/82/EC of the European Parliament and of the Council and
Regulation (EC) No 726/2004 of the European Parliament and of the Council
• Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active
substances and their classification regarding maximum residue limits in foodstuffs of animal
origin.
Food additives
Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food
additives other than colours and sweeteners. Repealed by regulation (EC) No 1333/2008 of the
European Parliament and of the Council.
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Document Outline