Proposal for a Regulation of the European Parliament and of the Council on the placing on the market and use of feed - Approval of the final compromise text with a view to a first reading agreement with the European Parliament

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1. Tekst

The Proposal for a Regulation of the European Parliament and of the Council on the placing

on the market and use of feed was adopted by the Commission on 4 March 2008. The

Commission's proposal aims to simplify the existing procedures for labelling and marketing

animal feed and pet food, while making the overall system more efficient and maintaining the

same high level of protection of animal health, animal welfare and public health.

2.

Intensive work has been pursued at the expert level under the Slovenian and French

Presidencies 1 . After an initial round of examination , the French Presidency prepared a compromise text. Subsequent discussions in the Working Party on Feedingstuffs showed that

some issues still needed to be examined further and clarified, such as the open declaration on

the composition of compound feed, the status of nutritional supplements, the scientific

evaluation of claims and others. In response to these concerns, the French Presidency

identified a number of potential solutions in a second Presidency compromise proposal that

have been further examined by the delegations.

7 Working Parties: 24 April, 9-10 June, 1-2 July, 29-30 July, 4 September, 25-26 September, 20-21 October.

3.

On 5 November 2008, further to the detailed examination of the proposal by the Working Party, the Permanent Representatives Committee (COREPER) agreed that the dossier had

reached a sufficient degree of maturity to start the contacts with the representatives of the

European Parliament, with a view to reaching an agreement at first reading.

1 2

4.

The Working Party gave mandate to the Presidency for the first trilogue . Further to this 3

trilogue, the Working Party further adjusted the Presidency's negotiation mandate, while trying to clarify the Council's position on the notification of new feed materials on the market

and balancing intellectual property with consumer rights.

5.

Following another trilogue on 3 December, the Presidency informed COREPER on the outcome of the discussions with the representatives of the European Parliament on 5

December.

6.

Further to a meeting of the Working Party of the Agricultural Attachés on 9 December, the Presidency, the representatives of the European Parliament and the Commission held a third

trilogue on 10 December. A number of issues, such as balancing intellectual property with

consumer rights, notification of feed materials, modification of the Regulation on additives, as

well as comitology, were solved and a compromise text was elaborated.

7.

The Presidency feels that the revised compromise could now be accepted as a package by 5

COREPER. On this occasion, the Commission and its services will commit to :

revise the Annex III of this Regulation. In this context the Commission will also consider certain feed materials with a moisture content greater than 50%;

11-12 November 2008 2

19 November 2008. 3

25 November 2008. 4

See Annex I, page 4. 5

See Annex II, page 56.

conduct an impact assessment on additives' labelling and introducing codes for additives;

recognise that "any urgency related to human and animal health and the environment" as included in Recital 17 and Articles 5 and 17 may include urgencies generated

amongst others by negligence, international fraud and criminal acts.

8.

According to the standard procedure in first reading agreements with the Parliament, the

Chairman of COREPER confirms the agreement reached between the Institutions in a letter to

the Chair of the relevant Committee in the Parliament with a copy to the Parliament

Rapporteur and the Commission.

9.

The Committee is therefore invited to:

confirm the agreement on the text set out in Annex I to this note;

take note of the Commission's position on the revision of Annex III of this Regulation, labelling of additives and the interpretation of "any urgency related to human and

animal health and the environment" in Recital 17, Articles 5 and 17;

give the Chairman of COREPER a mandate to inform by letter the Chairman of the EP Committee on Agriculture and Rural Development that, should the European Parliament

adopt the amendments to the Commission proposal in the exact form as set out in

Annex I, the Council would adopt the proposal thus amended in order to reach agreement at first reading.

________________

After revision by the legal-linguist experts of both institutions.

ANNEX I

2008/0050 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the placing on the market and use of feed

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 37 and

152(4)(b) thereof,

Having regard to the proposal from the Commission , 2

Having regard to the opinion of the European Economic and Social Committee , 3

Having regard to the opinion of the Committee of the Regions , 4

Acting in accordance with the procedure laid down in Article 251 of the Treaty , Whereas:

(1) The pursuit of a high level of protection of human and animal health is one of the fundamental objectives of food law, as laid down in 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 5

. That Regulation also established the

farm-to-fork approach designating feed as a sensitive stage at the beginning of the food chain. To assure a high level of protection of public health is one of the fundamental objectives of this Regulation.

OJ C [...], [...], p. [...]. 2

OJ C [...], [...], p. [...]. 3

OJ C [...], [...], p. [...]. 4

OJ C [...], [...], p. [...]. 5

OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) o 575/2006 (OJ L 100, 8.4.2006, p. 3).

(1) (a) The production of feed constitutes an important destination for the European agricultural

products, given that the majority of the materials used for the production of feed consists of agricultural products listed in Annex I of the Treaty. Furthermore, feed is of crucial significance for the 5 million livestock farmers in the Community because it is the most important cost factor.

(2) Feed may take the form of feed materials, compound feed, feed additives, premixtures and

medicated feedingstuffs. The rules for the marketing of feed additives are set out in Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition

and for medicated feedingstuffs in

Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community

(3) The existing legislation on the circulation and use of feed materials and compound feed which includes pet food, namely Council Directive 79/373/EEC of 2 April 1979 on the circulation of compound feedingstuffs 3

, Council Directive 93/74/EEC of 13 September 1993

on feedingstuffs intended for particular nutritional purposes ("dietetic feed"), Council 5

Directive 96/25/EC of 29 April 1996 on the circulation and use of feed materials and Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition

("bio-proteins"), needs to be updated. For the sake of clarity, Council Directive

83/228/EEC on the fixing of guidelines for the assessment of certain products used in animal nutrition and Commission Directive 80/511/EEC of 2 May 1980 authorising, in certain cases, the marketing of compound feedingstuffs in unsealed packages or containers should be repealed

(4) As a consequence of the replacement of Directive 79/373/EEC, Council Directive 93/113/EC of 14 December 1993 concerning the use and marketing of enzymes, micro- organisms and their preparations in animal nutrition 8

should also be replaced. Also, in view

of that replacement and given that the present Regulation includes rules concerning the labelling of feedingstuffs incorporating additives, Article 16 of Council Directive 70/524/EEC, which remained in force after the repeal of Directive 70/524/EEC by Regulation (EC) No 1831/2003, should be repealed.

OJ L 268, 18.10.2003, p. 29. Regulation amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).

OJ L 92, 7.4.1990, p. 42. 3

OJ L 86, 6.4.1979, p. 30. Directive as last amended by Regulation (EC) o 807/2003 (OJ L 122, 16.5.2003, p. 36). 4

OJ L 237, 22.9.1993, p. 23. Directive as last amended by Regulation (EC) o 806/2003 (OJ L 122, 16.5.2003, p. 1). 5

OJ L 125, 23.5.1996, p. 35. Directive as last amended by Regulation (EC) o 806/2003. 6

OJ L 213, 21.7.1982, p. 8. Directive as last amended by Commission Directive 2004/116/EC (OJ L 379, 24.12.2004, p. 81). 7

OJ L 126, 21.5.1980, p. 14. Directive as amended by Directive 98/67/EC (OJ L 261, 24.9.1998, p. 10). 8

OJ L 334, 31.12.1993, p. 17. Directive as amended by Directive 97/40/EC (OJ L 180, 9.7.1997, p. 21).

(5) Unlike food as defined in Regulation (EC) No 178/2002, the definition of feed does not include water. Furthermore, given that water is not marketed for animal nutrition purposes, this Regulation should not include conditions for water used in animal nutrition. However, it applies to feed administered in water. On the other hand, the use of water by feed businesses is covered by Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene 1

, which requires

that clean water should be used whenever necessary to prevent hazardous contamination and that water used in feed manufacture should be of suitable quality.

(6) Given the risk of contamination of the feed and food chain, it is appropriate that this Regulation applies to feed for both food and non-food producing animals, including wild animals.

(7) The responsibilities of the feed business operators laid down in Articles 15, 16, 18 and 20 of Regulation (EC) No 178/2002 and Article 4(1) of Regulation 183/2005 should apply, mutatis mutandis, in respect of feed for non-food producing animals.

(8) In order to enforce compliance with this Regulation, Member States should carry out official controls in accordance with Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules 2

. Those controls

should cover not only the mandatory but also the voluntary labelling particulars. In order to allow controls of the compositional data, acceptable tolerances for the labelled values should be determined.

(9) To manage feed safety risks, the list of materials whose placing on the market for animal nutrition purposes is restricted or prohibited, as currently provided for in Commission Decision 2004/217/EC 3

, should be maintained in form of an Annex to this regulation. The

existence of such Annex should, however, not be interpreted so that all products not listed could as such be considered to be safe.

OJ L 35, 8.2.2005, p. 1. 2

OJ L 165, 30.4.2004, p. 1. Regulation as amended by Council Regulation (EC) o 1791/2006 (OJ L 363, 20.12.2006, p. 1). 3

OJ L 67, 5.3.2004, p. 31.

(10) The distinction between feed materials, feed additives, other products such as veterinary drugs has implications for the conditions for placing on the market. Feed materials are in the first place used to meet animals` needs, for example for energy, nutrients, minerals or dietary fibres. They are usually not chemically well defined except for basic nutritional constituents. Effects justifiable by scientific assessment and reserved to feed additives or veterinary drugs should be excluded from the objective uses of feed materials. It is, therefore, appropriate to elaborate non-binding guidelines for the distinction between these kinds of products. In duly justified cases, the Commission should be empowered to clarify whether a product constitutes feed for the purpose of this Regulation. (11) The definition of complementary feedingstuffs in Directive 79/373/EEC gave rise to application problems in various Member States. For the purpose of the correct application of Regulation 183/2005, it is appropriate to clarify the distinction between complementary feedingstuffs and premixtures. 11(a) In order to allow a uniform application of the legislation, feed materials and complementary

feed should not contain additives above a certain level. However, highly concentrated feed, such as licking buckets containing minerals, may be used for direct feeding if the composition meets the particular nutritional purpose in respect of the relevant intended use. The conditions of use of such feed should appear on the labelling in order to ensure that the respective contents of feed additives in the daily ration are complied with.

(12) Directive 82/471/EEC aimed to improve the supply with feed used as direct and indirect protein source in the Community. That Directive requires a pre-market authorisation procedure for all possible bio-proteins. However, only very few new authorisations have been granted in the past and the shortage in protein-rich feed is still evident. Thus, the general pre-market authorisation requirement proved to be prohibitive and safety risks could be tackled instead by means of prohibiting risky products based on market surveillance. In cases where the outcome of the risk assessment of a bio-protein was or is negative, its circulation or use should be prohibited. Hence, the special requirement of a general premarket authorisation procedure for bio-proteins should be abolished with the consequence that the safety system for these products is the same as for all the other feed materials. The existing restrictions or prohibition of certain bio-proteins should not be affected. (13) The provisions of Directive 93/74/EEC implemented by Directive 2008/38/EC establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes 1

have

proved to be working well. The list of intended uses thus established should, therefore, be maintained and provisions should be made in this Regulation for its updating. In particular, the European Food Safety Authority (hereinafter referred to as "the Authority") should be consulted on the efficacy and the safety of such feed when on the basis of available scientific and technical information, there are reasons to believe that the use of the specific feed may not meet the particular intended nutritional purpose or may have adverse effects on animal health, human health, the environment and animal welfare.

OJ L 62, 6.3.2008, p. 9.

(13a) Scientific substantiation should be the main aspect to be taken into account for the use of

claims in respect of feed and the feed business operators using claims should justify them. A claim should be scientifically substantiated by taking into account the totality of the available scientific data, and by weighing the evidence.

(14) Labelling serves enforcement, traceability and control purposes. In addition, labelling should provide the necessary information to the purchasers to enable them to make the optimal choice for their needs and should be consistent, coherent, transparent and understandable. As the purchasers in particular the livestock farmers are making their choice not only at the point of sale where they can inspect the package of the feed the requirements concerning the labelling information must not only be valid for the labels on the product but as well for other kind of communication between vendor and purchaser. Furthermore, those principles should apply also to presentation and advertising of the feed. (15) Labelling provides mandatory and voluntary information. The mandatory information should combine general labelling requirements and specific ones for feed materials or compound feed respectively and additional ones in case of dietetic feed, contaminated material and pet food. (15a) The present situation with respect to chemical impurities resulting from the manufacturing

process of feed materials and from processing aids is not satisfactory. In order to ensure high level of feed safety and thus high level of protection of public health as well as in order to improve the transparency, provisions should be made concerning the tolerable level of such chemical impurities in accordance with good practice as referred to in Regulation No (EC) 183/2005.

(16) The existing principle that only certain feed additives have to be labelled once they are used in feed materials and compound feed proved to work well. However, both the categorisation resulting from Regulation (EC) No 1831/2003 and the fact that particularly pet owners might be confused by some additive labelling requires an updating and modernisation.

(17) As a consequence of the BSE- and dioxin crisis, the obligation to indicate the weight percentage of all feed materials incorporated in compound feed was introduced in 2002 at the initiative of the European Parliament. Nevertheless, the level of food and feed safety has been meanwhile significantly improved as a result of Regulations (EC) No 178/2002 and No 183/2005 as well as their implementing measures, in particular as a result of the focus being put on the responsibility of the feed and food business operators, the improved traceability system, the introduction of the HACCP principle in feed businesses and the creation of guides to good hygiene practice in feed businesses. In the light of these positive achievements, mirrored in the notifications to the Rapid Alert System for Food and Feed, the obligation to indicate the weight percentage of all feed materials incorporated in compound feed on the labelling is no longer necessary for the purpose of ensuring high level of feed safety and thus high level of protection of public health. The exact percentages may, however, be provided for on a voluntary basis for the purpose of providing adequate information to purchasers. Furthermore and given that the competent authorities have access to information on the exact percentages by weight of all feed materials incorporated in compound feed, they may on the grounds of any urgency relating to human and animal health or to the environment and respecting the provisions of Directive 2004/48 on the enforcement of intellectual property rights provide further information to purchasers.

(18) To ensure proper information of the purchaser and to avoid misleading him, the exact weight percentage should, however, be required in those cases where the respective feed material is emphasised on the labelling of a compound feed.

(19) The indication of the feed materials incorporated in compound feed in descending order of weight already provides important information on compositional data. In certain areas where the producer is not obliged to label particulars, the purchaser should be able to request additional information. In this case, a margin of +/- 15% of the declared value should be maintained. (19i) Intellectual property rights of the producers should be protected. For the enforcement of the

intellectual property rights, provisions of Directive 2004/48 should apply. It should also be acknowledged that the quantitative composition of compound feed, in contrast to names of feed materials incorporated, can, under certain conditions, be considered confidential information to be protected.

(20) Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed 1

does not apply to the labelling of feed with excessive

levels of undesirable substances. Therefore, provisions should be laid down in order to ensure adequate labelling and proper implementation of the dilution ban provided by Article 5 of this Directive, until such contaminated materials have been cleaned or detoxified by a detoxification establishment, approved in accordance with Article 10(2) or (3) of Regulation (EC) No 183/2005, or cleaned.

(21) Derogations from the general labelling requirements should be provided for as far as the application of those requirements is not necessary to protect human or animal health or consumer interests and would unduly burden the producer or feed business operators responsible for the labelling particulars. Based on experience such derogations should be provided for, in particular with respect to feed delivered by one farmer to another farmer for use on his farm, for small quantities, for compound feed not constituted of more than three feed materials and for mixes of whole plant grains, seeds and fruits. (22) As a general rule, compound feed should be marketed in sealed containers, but appropriate derogations should be provided as far as the application of that requirement is not necessary to protect human and animal health or consumer interests and would represent an excessive burden for the feed business operators.

(23) Part B of the Annex to Directive 96/25/EC and columns 2-4 of the Annex to Directive 82/471/EEC contain lists with designations, descriptions and labelling provisions for certain feed materials. Those lists facilitate the exchange of information on the product properties between the producer and the purchaser. The experience with engaging stakeholders to set voluntary standards by means of Community guidelines in the field of feed hygiene have been throughout positive. The accomplishment of a more extended listing by the stakeholders could be more flexible and better adapted to the information needs of the user than if undertaken by the legislator. The stakeholders can decide on the efforts they dedicate depending on the value of a feed material list. It seems, therefore, desirable to establish a non-exhaustive Catalogue of feed materials to be used by the feed business operators on a voluntary basis, except as regards the use of the name of the feed material.

OJ L 140, 30.5.2002, p. 10. Directive as last amended by Commission Directive 2006/77/EC (OJ L 271, 30.9.2006, p. 53).

(24) The current lists of feed materials disclosed in Part B of Annex to Directive 96/25/EC and

columns 2-4 of the Annex to Directive 82/471/EEC should constitute the initial version of the Community Catalogue of feed materials. This initial version should subsequently be completed at the initiative of the stakeholders according to their interests, including completion in respect of emerging feed materials.

(24a) In the interest of transparency, it is appropriate that a feed material which is not listed in the

catalogue is notified to the representatives of the stakeholders as soon as such feed material is for the first time placed on the market.

(25) Modern labelling facilitates a competitive market environment in which dynamic, efficient, innovative operators can make full use of labelling to sell their products. Having regard to both the business to business relation in the marketing of livestock feed and the relationship between the producer and purchaser of pet food, Codes of good labelling for these two areas could be useful means of achieving the objectives of modern labelling. The Codes should lay down provisions that would enable the purchaser to make informed choices. They should also give the person responsible for the labelling important guidance on different elements of the labelling. They may interpret the framework given for voluntary labelling or the presentation of mandatory labelling. The Codes should be used on a voluntary basis, except in cases where the use of the Code is indicated on the labelling. (26) Involvement of all parties concerned is the crucial element for the quality and appropriateness of the Catalogue and the Codes for good labelling. In order to improve the users` right to proper information, their interest must be taken into consideration. This can be ensured by the Commission approving the Catalogue and the Codes provided that their content is practicable and that they are suitable to meet the objectives of this Regulation. (26a) The Member States should lay down rules on penalties applicable to infringements of the

provision of this Regulation and should take all measures necessary to ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive.

(26aa) A transitional period is needed to facilitate transition to the application of this Regulation, in

particular in respect of feed meeting a particular nutritional purpose and in respect of level of chemical impurities resulting from the manufacturing process and from processing aids. The marketing of the existing stocks should also be foreseen until their exhaustion, Furthermore, it may be appropriate to specify conditions under which feed may be labelled in accordance with this Regulation prior to the date of its application.

(27) Since the objectives of feed and food safety and a smooth functioning of the internal market

for feed cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(28) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission 1

OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).

(29) Power should be conferred on the Commission in particular to amend the list of materials restricted or prohibited for use as feed, to authorise feed intended for particular nutritional purposes, to establish a list of labelling categories of feed materials for non-food producing animals except fur animals, to adopt amendments to the Catalogue setting maximum content of chemical impurities as referred to in Annex I(1) or levels of botanical purity as referred to in Annex I(2) or particular replacing the compulsory declaration as referred to in Article 16 (1) (b) or the levels of moisture content as referred to in Annex I (6) to adapt the Annexes in the light of scientific and technical development and to adopt transitional measures. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (29a) On grounds of efficiency, the normal time-limits for the regulatory procedure with scrutiny

should be curtailed for adopting updates to the list of intended uses. When, on the imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the amendments to the list of materials whose placing on the market or use for animal nutritional purposes is restricted or prohibited .

(30) Article 16 of Regulation (EC) No 1831/2003 lays down the provisions for labelling and

packaging of feed additives and premixtures. Particularly the rules concerning premixtures have proved to cause practical problems in the implementation for the industry and the competent authorities. In order to allow a more consistent labelling of premixtures, that Article should be amended.

(31) Directives 79/373/EEC, 82/471/EEC, 83/228/EC, 93/74/EEC, 93/113/EC and 96/25/EC, Article 16 of Directive 70/524 ,Commission Directive 80/511/EEC and Commission Decision 2004/217 should therefore be repealed.

HAVE ADOPTED THIS REGULATION:

Chapter 1

Introductory provisions

Article 1

Subject matter

The objective of this Regulation in accordance with the general principles laid down in Regulation (EC) No 178/2002 is to harmonise the conditions for the placing on the market and use of feed, in order to ensure high level of feed safety and thus high level of protection of public health, as well as to provide adequate information of users and consumers and strengthen the effective functioning of the internal market.

Article 2

Scope

1.

This Regulation lays down rules on the placing on the market and use of feed for both food-producing and non-food producing animals within the Community including requirements for labelling, packaging and presentation. 2. The provisions of this Regulation shall apply without prejudice to other Community provisions applicable in the field of animal nutrition, in particular: (a) Directive 90/167/EEC laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community; (b) Directive 2002/32/EC on undesirable substances in animal feed;

(c) Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies 1

;(d) Regulation (EC) No 1774/2002 of

the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption

;

(e) Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed 3

;

(f) Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC 4

;

OJ L 147, 31.5.2001, p. 1 2

OJ L 273, 10.10.2002, p. 1. 3

OJ L 268, 18.10.2003, p. 1. 4

OJ L 268, 18.10.2003, p. 24.

(g) Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition; and (h) Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products.

3.

This Regulation shall not apply to water, either taken in directly by the animals or intentionally incorporated into feed. It shall, however, apply to feed designed to be administered in water.

Article 3

Definitions

1.

For the purposes of this Regulation, the definitions of `feed', `feed business', `placing on the market' and as laid down in Regulation (EC) No 178/2002 and the definitions of "feed additive", "premixture", "processing aids" and "daily ration" as laid down in Regulation (EC) No 1831/2003 shall apply. 2. The following definitions shall also apply.

(aa) "Feed business operator": natural or legal person responsible for ensuring that the requirements of the present Regulation are met within the feed business under their control.

(aaa) "Oral feeding of animals": the introduction of feedingstuffs into an animal' gastrointestinal tract through the mouth with the aim of meeting the animal's nutritional needs and/or maintaining the productivity of normally healthy animals.

(a) `Food producing animal': any animal that is fed, bred or kept for the production of food for human consumption including animals that are not consumed but that belong to species that can be normally consumed in the Community; (b) `Non-food producing animals': any animal that is fed, bred or kept but not used for

human consumption such as fur animals, pets and animals kept in laboratories, zoos or circus;

(c) `Fur animals': non-food producing animal fed, bred or kept for the production of fur and not used for human consumption;

(d) `Pet' or `pet animal': non-food producing animal belonging to species fed, bred or kept, but normally not consumed by humans in the Community;

(e) `Feed materials': products of vegetable or animal origin, whose principal objective 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;

(f) `Compound feed': mixture of at least two feed materials, whether or not containing feed additives, for oral animal feeding in the form of complete or complementary feed; (g) `Complete feed': compound feed which, by reason of its composition, is sufficient for a daily ration;

(h) `Complementary feed': compound feed which has a high content of certain substances but which, by reason of its composition, is sufficient for a daily ration only if used in combination with other feed; (i) `Mineral feed': complementary feed containing at least 40% crude ash;

(j) `Milk replacer": compound feed administered in dry form or after dilution in a given quantity of liquid for feeding young animals as a complement to, or substitute for, post-colostral milk or for feeding young animals such as calves, lambs or kids intended for slaughter; (k) `Carrier': substance used to dissolve, dilute, disperse or otherwise physically modify a feed additive in order to facilitate its handling, application or use without altering its technological function and without exerting any technological effect themselves;

(l) `Particular nutritional purpose': the purpose of satisfying the specific nutritional needs of animals whose process of assimilation, absorption or metabolism is or could be temporarily or irreversibly impaired and can therefore benefit from the ingestion of feed appropriate to their condition; (m) `Feed intended for particular nutritional purposes': feed which can satisfy a particular

nutritional purpose by virtue of its particular composition or method of manufacture, which clearly distinguish it from ordinary feed. Feed intended for particular nutritional purposes does not include medicated feedingstuffs in the meaning of Directive 90/167/EEC;

(ha) "Contaminated materials": feed containing a level of undesirable substances in

excess of that tolerated under Directive 2002/32/EC;

(n) `Minimum storage life': period during which, under proper storage conditions, the person responsible for the labelling guarantees that the feed retains its declared properties ; only one minimum storage life may be indicated in respect of the feed as a whole and is determined on the basis of the minimum storage life of each of its components

(o) `Batch' or `lot': Identifiable quantity of feed determined to have common characteristics, such as origin, variety, type of packing, packer, consignor or labelling; and in case of a production process a unit of production from a single plant using uniform production parameters or a number of such units, when produced in continuous order and stored together; (p) `Labelling': attribution of any words, particulars, trade marks, brand name, pictorial matter or symbol to a feed by placing this information on any medium like

packaging, container, notice, label, document, ring, collar or the internet referring to or accompanying such feed, including for advertising purposes;

(q) `Label': any tag, brand, mark, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed, impressed on, or attached to a package or container of feed;

(r) `Presentation': the shape, appearance or packaging and the packaging materials used for the feed, further to the way in which it is arranged and the setting in which it is displayed. Chapter 2

General requirements

Article 4

Safety and marketing requirements

1.

Feed may only be placed on the market and used if : a) it is safe; for the purpose of this Regulation, the requirements set forth in Article

15 of Regulation (EC) No. 178/2002 shall apply, mutatis mutandis, to feed for non-food producing animals;

b)

it does not have a direct adverse effect on the environment or animal welfare.
2.

In addition to the requirements set forth in paragraph 1, feed business operators placing feed on the market shall ensure that the feed: a) is sound, genuine, unadulterated, fit for purpose and of merchantable quality;
b)

is labelled, packaged and presented in accordance with the provisions laid down in this Regulation and other applicable Community legislation; for the purpose of this Regulation, the requirements set forth in Article 16 of Regulation 178/2002 shall apply, mutatis mutandis, to feed for non-food producing animals.
3.

Feed shall comply with the technical provisions on impurities and other chemical determinants set out in Annex I. Article 5

Responsibilities and obligations of the feed businesses

1.

Feed business operators shall, for the purposes of this Regulation, comply, mutatis mutandis, with obligations set forth in Articles 18 and 20 of Regulation (EC) No 178/2002 and Article 4(1) of Regulations (EC) No 183/2005 in respect of feed for non-food producing animals.
2.

The person responsible for the labelling of feed shall make available to the authorities responsible for carrying out official controls any information concerning the composition or claimed properties of the feed such person places on the market which enables the accuracy of the information given by the labelling to be verified, including the exact percentages of weight of feed materials used in compound feed.
3.

On the grounds of any urgency relating to human and animal health or to the environment and without prejudice to the provisions of Directive 2004/48 the competent authority may provide the purchaser with information that is available to it under paragraph 2 provided that, after having weighted the respective legitimate interests of the manufacturers and the purchasers, it concludes that such provision of information is justified. If appropriate, the competent authority shall provide such information subject to signing of a confidentiality clause by the purchaser.

Article 6

Restriction and prohibition

1.

Feed shall not contain or consist of materials whose placing on the market or use for animal nutritional purposes is restricted or prohibited. The list of such materials is set out in Annex IIa.
2.

The Commission shall amend the list of materials whose placing on the market or use for animal nutritional purposes is restricted or prohibited taking into account in particular scientific evidence, technological progress, notifications under the Rapid Alert System for Food and Feed or results from official controls according to Regulation (EC) No 882/2004. Those measures which are designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 29(4). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 29(5) with a view to adopting those measures.

Chapter 3

Placing on the market of specific types of feed

Article 7

Characteristics of types of feed

1.

In accordance with the procedure referred to in Article 29(3), the Commission may adopt guidelines clarifying the distinction between feed materials, feed additives and other products such as veterinary drugs.
2.

Where necessary, the Commission may, in accordance with the regulatory procedure with scrutiny referred to in Article 29(4), adopt measures in order to clarify whether a certain product constitutes feed for the purposes of this Regulation.

Article 8

Content of feed additives

1.

Without prejudice to the conditions of use provided for in the relevant legal act authorising the respective feed additive, feed materials and complementary feed shall not contain feed additives incorporated at levels more than 100 times the relevant fixed maximum content in complete feed or five times in case of coccidiostats and histomonostats.
2.

The factor of 100 referred to in paragraph 1 may only be exceeded if the composition of such products meets the particular nutritional purpose in respect of the relevant intended use according to Article 10. The conditions of use for such feed shall be further specified in the list of intended uses. If the producer of such feed uses feed additives referred to in Chapter 2 of Annex IV to Regulation (EC) 183/2005, he has to be approved according to Article 10 of that Regulation.

Article 9

Marketing of feed intended for particular nutritional purposes

Feed intended for particular nutritional purposes may only be marketed as such if its intended use is included in the list of intended uses established in accordance with Article 10 and if it meets the essential nutritional characteristics for the respective particular nutritional purpose set forth in that list.

Article 10

List of intended uses of feed intended for particular nutritional purposes

1.

The Commission may update the list of intended uses as currently set out in Directive 2008/38 by adding an intended use, withdrawing an intended use or by adding, removing or changing the conditions associated with such intended use.
2.

The procedure for updating the list of intended uses may be started on application made by a physical or legal person established in the Community or by a Member State. Such an application shall be submitted to the Commission. A valid application shall include a dossier demonstrating that the specific composition of the feed meets the particular intended nutritional purpose and that it has no adverse effects on animal health, human health, the environment and animal welfare. 3. The Commission shall forthwith make the application including the dossier available to the Member States.
4.

If, on the basis of available scientific and technical information, the Commission, has reasons to believe that the use of the specific feed may not meet the particular intended nutritional purpose or may have adverse effects on animal health, human health, the environment or animal welfare, the Commission shall, within three months after receiving a valid application, seek an opinion from the European Food Safety Authority (`the Authority'). The Authority shall give an opinion within six months of receipt of the request. This time limit shall be extended whenever the Authority seeks supplementary information from the applicant .
5.

Within six months after receiving a valid application or, where appropriate, after receiving the opinion of the Authority, the Commission shall adopt a Regulation updating the list of intended uses if the conditions as laid down in paragraph (2) are met. .

Those measures which are designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 29(6).

6.

By way of derogation from paragraph 5 and in accordance with the procedure referred to in Article 29(3), the Commission shall, within six months after receiving a valid application, or, where appropriate after receiving the opinion of the Authority, end the procedure and decide not to proceed with the update, at any stage of the procedure, if it judges that such an update is not justified. In such cases, where applicable, the Commission shall inform the applicant and the Member States directly, indicating in its letter the reasons for not considering the update justified. 7. The Commission may adopt , in accordance with the regulatory procedure referred to in Article 29(3) implementing measures concerning the preparation and presentation of the application.

Chapter 4

Labelling, presentation and packaging

Article 11

General principles

1.

The labelling and the presentation of feed shall not mislead the user, in particular:

(a) as to the intended use or characteristics of the feed, in particular, the nature, method of manufacture or production, properties, composition, quantity, durability, species or categories of animals for which it is intended; (b) by attributing to the feed effects or characteristics that it does not possess or by suggesting that it possesses special characteristics when in fact all similar feeds possess such characteristics, or (c) as to the compliance of the labelling with the Community Catalogue and the Community Codes referred to in Articles 25 and 26.

2.

Feed materials or compound feed marketed in bulk or in unsealed packages or containers in accordance with Article 23(2) shall be accompanied by a document containing all mandatory labelling particulars in accordance with this Regulation 3. Where feed is offered for sale by means of distance communication as defined in Article 2 of Directive 97/7/EC of the European Parliament and of the Council 1

the mandatory

labelling particulars required by this Regulation, except for the particulars provided in Articles 15 (b), (d), (e), and 16 (2) (c) or 17(1)(d), shall appear on the material supporting the distance selling or be provided through other appropriate means prior to the conclusion of a distance contract. The particulars provided in Articles 15 (b), (d), (e), and 16 (2) (c) or 17(1) (d) shall be provided at the latest at the time of delivery of the feed.

4.

Labelling provisions additional to those set forth in this Chapter are laid down in Annex II.
5.

Permitted tolerances for discrepancies between the labelled compositional values of a feed material or compound feed and the values analysed in official controls in compliance with Regulation (EC) No 882/2004 are listed in Annex III to this Regulation.

OJ L 144, 4.6.1997, p. 19.

Article 12

Responsibility

1.

The feed business operator first placing feed on the market shall be the person responsible for the labelling and shall ensure the presence and substantive accuracy of the labelling particulars. 2. By derogation from the first paragraph, the person responsible for the labelling shall be the feed business operator with whose name or business name the feed is marketed.
3.

To the extent their activities affect labelling within the business under their control, feed business operators shall ensure that the information provided through whatever medium satisfies the requirements of this Regulation.
4.

Feed business operators responsible for retail or distribution activities which do not affect labelling shall act with due care to help to ensure compliance with the labelling requirements, in particular by not supplying feed which they know or should have presumed, on the basis of the information in their possession and as professionals, do not comply with those requirements. 5. Within the business under their control feed business operators shall ensure that mandatory labelling particulars are transmitted throughout the food chain in order to enable the provision of the information to the final feed user in accordance with this Regulation. Article 13

Claims

1.

The labelling and the presentation of feed materials and compound feed may draw particular attention to the presence or the absence of a substance in the feed, to a specific nutritional characteristic or process or to a specific function related to any of these, provided that the following conditions are met: (a) the claim is objective, verifiable by the competent authorities and understandable by the user of the feed, and

(b) the person responsible for the labelling provides on request of the authority responsible for carrying out official controls a scientific substantiation of the truthfulness of the claim, either via publicly available scientific evidence or through documented company research. The scientific substantiation shall be available at the time the feed is placed on the market. Purchasers shall have the right to bring to the attention of the competent authority their doubts in respect of the truthfulness of the claim. Should it be concluded that the claim is not sufficiently substantiated, the labelling in respect of such claim shall be considered misleading for the purpose of Article 11. In the case where the authority responsible for carrying out official controls has doubts regarding the scientific substantiation of the claim concerned, it may submit the issue to the Commission. The Commission may adopt a decision, where appropriate after obtaining an opinion from the Authority, according to the procedure laid down in Article 29(2).

2.

Without prejudice to paragraph 1, claims concerning optimisation of the nutrition and support or protection of the physiological conditions are permitted, unless they contain a claim mentioned in paragraph (3)(a). 3. The labelling or the presentation of feed materials and compound feed shall not claim that

(a) it will prevent, treat or cure a disease, except for coccidiostats and histomonostats as authorised under Regulation 1831/2003, this subparagraph, however shall not apply to claims concerning nutritional imbalances provided that there is no pathological sign associated ; (b) it has a particular nutritional purpose as provided for in the list of intended uses as referred to in Article 9, unless it satisfies the requirements laid down therein. 4. Specifications referred to in the requirements laid down in paragraphs 1 and 2 may be included in the Community Codes referred to in Article 26. Article 14

Presentation of labelling particulars

1.

The mandatory labelling particulars shall be given in their entirety in a prominent place on the packaging, the container, the accompanying document as foreseen in Article 11 (2) or on a label attached thereto, in a conspicuous, clearly legible and indelible manner, in at least the language or one of the official languages of the Member State or Region in which it is placed on the market. 2. The mandatory labelling particulars shall be easily identifiable and not be obscured by any other information. They shall be displayed in a colour, font and size that does not obscure or emphasize any part of the information, unless such variation is to draw attention to precautionary statements. 3. Specifications to the requirements laid down in paragraphs 1 and 2 and to the presentation of the voluntary labelling referred to in Article 22 may be included in the Community Codes referred to in Article 26.

Article 15

General mandatory labelling requirements

A feed material or compound feed shall not be placed on the market unless the following particulars

are indicated by labelling:

(a) the type of feed: 'feed material', `complete feed' or `complementary feed', as appropriate; for `complete feed' the designation "complete milk replacer feed' may be used, if appropriate;

for `complementary feed' the following designations may be used if appropriate: `mineral feed', `or `complementary milk replacer feed';

for pets other than cats and dogs `complete feed' or `complementary feed' may be replaced by `compound feed';

(b) the name or business name and the address of the feed business operator responsible for the labelling;

(c) if available, the establishment approval number of the person responsible for the labelling granted in accordance with Article 13 of Regulation (EC) No 1774/2002 for establishments authorised according to Article 23, paragraph 2 (a)-(c) of Regulation (EC) No 1774/2002 or Article 17 of Regulation (EC) No 1774/2002 or with Article 10 of Regulation (EC) No 183/2005. If a person responsible for the labelling has several approval numbers he shall use the one obtained under Regulation 183/2005; (d) the batch or lot reference number;

(e) the net quantity expressed in units of mass in the case of solid products, and in units of mass or volume in the case of liquid products;

(f) the list of feed additives preceded by the heading "additives" in accordance with Chapter I of Annex V or VI, as applicable, and without prejudice to labelling provisions laid down in the legal act authorising the respective feed additive. (g) the moisture content in accordance with point 6 of Annex I.

Article 16

Specific mandatory labelling requirements for feed materials

1.

In addition to the requirements provided for in Article 15, the labelling of feed materials shall also include: (a) the name of the feed material; the name shall be used in compliance with Article 25(5);

(b) compulsory declaration corresponding to the respective category as set out in the list in Annex IV; the compulsory declaration may be replaced by the particulars laid down in the Community Catalogue referred to in Article 25 for each feed material of the respective category.

2.

In addition to the requirements provided for in paragraphs 1, the labelling of feed materials shall include the following when additives are incorporated:
a)

the species or categories of animals for which the feed material is intended where the respective additives have not been authorised for all animal species or have been authorised with maximum limits for some species; b) instructions for proper use in accordance with Annex II (5), where a maximum content of the respective additives is set c) minimum storage life for additives other than technological ones. Article 17

Specific mandatory labelling requirements for compound feed

1.

In addition to the requirements provided for in Article 15, the labelling of compound feed shall also include the following: (a) the species or categories of animals for which the compound feed is intended;

(b) the instructions for proper use indicating the purpose for which the feed is intended; such instructions shall, where applicable, be in accordance with Annex II (5);

(c) in cases where the producer is not the person responsible for labelling particulars, the following shall be provided: the name or business name and address of the producer, or

the approval number of the producer as referred to in Article 15 (c) or an identifying number according to Articles 9, 23 or 24 of Regulation (EC) No 183/2005; if such number is not available, an identifying number attributed on the producers' or on the importing feed business operators' request in accordance with the format laid down in Chapter II of Annex V to Regulation (EC) No 183/2005; (d) the indication of the minimum storage life in accordance with the following requirements:

`use before...' followed by the date indicating a certain day in the case of feed highly perishable due to degradation processes; `best before...' followed by the date indicating a certain month in the case of other feed.

If the date of manufacture is labelled, the date indicating minimum storage life may be provided as well as `... (time period in days or months) after the date of manufacture';

(e) the list of the feed materials of which the feed is composed, bearing the heading "composition" and indicating the name of each feed material in accordance with Article 16(1)(a) and listing those feed materials in descending order by weight calculated on the moisture content in the compound feed; that list may include the percentage of weight. (f) the compulsory declarations provided for in Chapter II of Annex V or VI, as applicable. 2. As regards the list provided for in paragraph 1(e), the following requirements shall apply:

(a) the name and percentage of weight of a feed material shall be indicated if its presence is emphasised on the labelling in words, pictures or graphics;

(b) if the percentages of weight for the feed materials incorporated in compound feed for food producing animals are not indicated in the labelling, the person responsible for the labelling shall, without prejudice to the provisions of Directive 2004/48/EC, make available to the purchaser on request information on the quantitative composition data in a range of +/- 15% of the value according to the feed formulation; (c) in the case of compound feed intended for non-food producing animals except for fur animals , the indication of the specific name of the feed material may be replaced by the name of the category to which the feed materials belong .

2a. On the grounds of any urgency relating to human and animal health or to the environment

and without prejudice to the provisions of Directive 2004/48 the competent authority may provide the purchaser with information that is available to it under article 5(2) , provided that, after having weighted the respective legitimate interests of the manufacturers and the purchasers, it concludes that such provision of information is justified. If appropriate, the competent authority shall provide such information subject to signing of a confidentiality clause by the purchaser.

3.

For the purposes of paragraph 2(c), the Commission shall establish a list of categories of feed materials which may be indicated instead of individual feed materials in the labelling of feed for non-food producing animals except for fur animals . Those measures which are designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 29(4).

Article 18

Additional mandatory labelling requirements for feed intended for particular nutritional purposes

In addition to the general mandatory requirements laid down in Articles 15 and 16 or in Article 17,

as applicable, labelling of feed intended for particular nutritional purposes shall also include:

(a) the qualifying expression `dietetic', reserved solely for feed intended for particular nutritional purposes, next to the designation of the feed as laid down in Article 15(a); (b) the particulars prescribed for the respective intended use in columns 1, 2, 3, 4, 5 and 6 of the list of intended uses referred to in Article 9;

(c) the indication that the opinion of a nutrition expert or veterinarian should be sought before using the feed or before extending the period of use. Article 19

Additional mandatory labelling requirements for pet food

On the label of pet food a free telephone number or other appropriate means of communication shall

be indicated in order to allow the purchaser to obtain information in addition to the mandatory

particulars on:

(a) the feed additives incorporated into the pet food,

(b) the feed materials incorporated that are designated by category as referred to in Article 17(2)(c).

Article 20

Additional mandatory labelling requirements for non-compliant feed

1.

In addition to the requirements laid down in Articles 15, 16, 17 and 18, feed which does not comply with the EU legal requirements set out in Annex VII, such as contaminated materials, shall bear the labelling particulars laid down in that Annex. 2 The Commission may amend Annex VII in order to bring it into line with legislative progress towards the development of standards. Article 21

Derogations

1.

The particulars referred to in Article 15(c), (d) (e), (g) and Article 16(1 ) (b) shall not be required where before each transaction the purchaser has stated in writing that he does not require this information. A transaction may consist of several consignments.
2.

On packaged feed the particulars referred to in Article 15(c), (d), (e) and Article 16 (2) (c) or17(1)(c), (d),(e) may be given on the package outside the place of the label as referred to in Article 14(1). In such cases it shall be pointed out where these particulars appear.
3.

Without prejudice to Annex I to Regulation (EC) No 183/2005, the particulars referred to in Article 15(c), (d), (e), (g) and Article 16(1 ) (b) of this Regulation shall not be mandatory for feed materials that do not contain feed additives, with the exception of preservatives or silage additives, and which are produced and delivered by a feed business operator according to Article 5(1) of Regulation (EC) No 183/2005 to a feed user in primary production for use within its own holding. 4. The compulsory declarations referred to in Article 17(1)(f) shall not be required for mixes of whole plant grains, seeds and fruits.
5.

In the case of compound feed constituted from no more than three feed materials the particulars referred to in Article 17(1)(a) and (b) shall not be required where the feed materials used appear clearly in the description.
6.

For quantities not exceeding 20 kg of feed materials or compound feed intended for the final user and sold in bulk, the particulars referred to in Articles 15, 16 and 17 may be brought to the purchaser's attention by means of an appropriate notice at the point of sale. In this case, the particulars referred to in Article 15(a) and Article 16(1) or Article 17(1)(a)

and (b), as appropriate, shall be provided for the purchaser at the latest on or with the invoice.

7.

For quantities of pet food sold in packages with several containers, the particulars referred to in article 15(b), (c), (f) (g) and article 17(1)(b), (c), (e) and (f) may be given only on the outer package instead of each container, provided that the combined total quantity of the package does not exceed 10 kg.
8.

By way of derogation from the provisions of this Regulation, Member States may apply national provisions for feed intended for animals kept for scientific or experimental purposes on condition that its label clearly indicates such purpose. The Member States shall notify those provisions to the Commission without delay.

Article 22

Voluntary labelling

1.

In addition to the mandatory labelling requirements, the labelling of feed materials and compound feed may also include voluntary labelling particulars, provided that the general principles laid down in this Regulation are respected. 2. Further conditions for the voluntary labelling may be provided in the Community Codes referred to in Article 26.

Article 23

Packaging

1.

Feed materials and compound feed may be placed on the market only in sealed packages or containers. Packages or containers shall be sealed in such a way that, when the package or container is opened, the seal is damaged and cannot be reused. 2. By way of derogation from paragraph 1, the following feed may be placed on the market in bulk or in unsealed packages or containers: (a) feed materials;

(b) compound feed exclusively obtained by mixing grain or whole fruit; (c) deliveries between producers of compound feed;

(d) deliveries of compound feed directly from the producer to the feed user; (e) deliveries from producers of compound feed to packaging firms;

(f) quantities of compound feed not exceeding 50 kilograms in weight which are intended for the final user and are taken directly from a sealed package or container; (g) blocks or licks.

Chapter 5

Community catalogue on feed materials and Community Codes of

good labelling practice

Article 25

Community Catalogue of feed materials

1.

The Community Catalogue of feed materials (hereinafter `the Catalogue') shall be created as a tool to improve the labelling of feed materials and compound feed. The Catalogue shall facilitate the exchange of information on the product properties and list the feed materials in a non-exhaustive manner. It shall include for each feed material listed at least the following particulars: (a) the name;

(b) the identification number;

(c) a description of the feed material including information on the manufacturing process, if appropriate; (d) particulars replacing the compulsory declaration for the purpose of Article 16(1)(b)

(e) a glossary with the definition of the different processes and technical expressions mentioned.

2.

The first version of the Community Catalogue shall be adopted in accordance with the advisory procedure referred to in Article 29(2) no later than six months after the entry into force of this Regulation and its entries shall consist of those listed in Part B of the Annex to Directive 96/25/EC and columns 2-4 of the Annex to Directive 82/471/EEC. The glossary shall be constituted by point IV of Part A of the Annex to Directive 96/25/EC. 3. The procedure laid down in Article 27 shall apply to amendments to the Catalogue.
4.

The provisions of this Article apply without prejudice to the safety requirements as laid down in Article 4 of this Regulation.
5.

The use of the Catalogue by the feed business operators shall be voluntary. However, a name of a feed material listed in the Catalogue may be used only provided that all relevant provisions of the Catalogue are complied with.
6.

The person for the first time placing on the market a feed material that is not listed in the Catalogue shall immediately notify its use to the representatives of the European feed business sectors referred to in Article 27(1). The representatives of the European feed business sectors shall publish a register of these notifications on the Internet and update the register on a regular basis.

Article 26

Community Codes of good labelling practice

1.

The Commission shall encourage the development of two Community Codes of good labelling practice (hereinafter `Codes'), one for pet food and one for compound feed for food producing animals, which may include a section concerning compound feed for fur animals.
2.

The Codes shall aim at improving the appropriateness of the labelling. They shall, in particular, include provisions on the presentation of labelling particulars provided for in Article 14, on the voluntary labelling provided for in Article 22 and on the use of claims provided for in Article 13. 3. The procedure laid down in Article 27 shall apply for the establishment and for any amendment to be made to the Codes.
4.

The use of the Codes by the feed business operators shall be voluntary. However, the person responsible for labelling may indicate the use of any of the Codes on the labelling only provided that all relevant provisions of such Code are complied with.

Article 27

Establishment of the Codes and amendments to the Community Catalogue and the Community

Codes

1.

The draft amendments to the Community Catalogue and drafts of the Codes as well as any draft amendments thereof shall be developed and amended by all appropriate representatives of European feed business sectors: (a) in consultation with other concerned parties, such as feed users;

(b) in collaboration with the competent authorities of the Member States and, where appropriate, the Authority;

(c) taking into account relevant experiences from opinions issued by the Authority and developments in scientific or technical knowledge.

2.

Without prejudice to the third paragraph, the Commission shall approve measures for the purpose of this Article in accordance with the advisory procedure referred to in Article 29(2).
3.

Amendments to the Community Catalogue setting maximum content of chemical impurities as referred to in Annex I(1) or levels of botanical purity as referred to in Annex I(2) or particulars replacing the compulsory declaration as referred to in Article 16(1)(b) or the levels of moisture content as referred to in Annex I(6) shall be adopted. Such measures of general scope designed to amend non essential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 29(4). 4. Any measures under this Article shall be adopted provided that the following conditions are met: (a) they have been developed in accordance with paragraph 1;

(b) their contents are practicable throughout the Community for the sectors to which they refer; and (c) they are suitable to meet the objectives of this Regulation.

5.

The Catalogue shall be published in the L Series of the Official Journal of the European Union. The title and the references of the Codes shall be published in the C Series the Official Journal of the European Union.

Chapter 6

General and final provisions

Article 28

Amendments to Annexes and implementing measures

1.

The Commission may amend the Annexes in order to adapt them in the light scientific and technical development.

Those measures designed to amend non-essential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 29(4).

2.

Implementing measures necessary for the application of this Regulation may be adopted in accordance with the procedure referred to in Article 29(3), unless specifically provided otherwise. Article 29

Committee procedure

1.

The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, set up by Article 58 of Regulation (EC) No 178/2002, hereinafter referred to as the `Committee'. 2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
4.

Where reference is made to this paragraph, Article 5a (1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
5.

Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 6. Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The time-limits laid down in Article 5a(3)(c), (4)(b) and (4(e) of Decision 1999/468/EC shall be set at two months, one month and two months respectively.

Article 30

Amendment to Regulation (EC) No 1831/2003

Article 16 of Regulation (EC) No 1831/2003 is amended as follows:

(1) Paragraph 1 is amended as follows:

(a) Subparagraph (d) is replaced by the following: `(d) where appropriate, the approval number of the establishment manufacturing or

placing on the market the feed additive or the premixture pursuant to Article 10 of Regulation (EC) No 183/2005 of the European Parliament and of the Council [or, as applicable, to Article 5 of Directive 1995/69/EC*;]

----------------------------------------

*

OJ L 35, 8.2.2005, p. 1.';

(b) The following subparagraph is added at the end of paragraph 1:

`In the case of premixtures, points (b), (d), (e) and (g) shall not apply to the incorporated feed additives.' (2) Paragraph 3 is replaced by the following:

`3. In addition to the information specified in paragraph 1, the packaging or container of a feed additive belonging to a functional group specified in Annex III or of a premixture containing an additive belonging to a functional group specified in Annex III shall bear the information, presented in a conspicuous, clearly legible and indelible manner, indicated in that Annex.' (3) Paragraph 4 is replaced by the following:

`4. In the case of premixtures, the word `Premixture' shall appear on the label. Carriers shall be declared, in the case of feed materials, in compliance with Article 17(1)(e) of Regulation (EC) No .../... of the European Parliament and of the Council [on the placing on the market and use of feed]*, and, where water is used as a carrier, the moisture content of the premixture shall be declared. Only one minimum storage life may be indicated in respect of each premixture as a whole; such minimum storage life shall be determined on the basis of the minimum storage life of each of its components.

----------------------------------------

*

OJ L ... .'. Article 31

Repeal

Directives 79/373/EEC, 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC, Article 16 of Directive 70/524/EEC and Commission Directive 80/511/EEC and Commission Decision 2004/217, are repealed as from the date of application of this Regulation. References to the repealed Directives shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VII.

Article 32

Penalties

Member States shall lay down the rules on penalties applicable to infringements of the provision of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by [date of application] at the latest and shall notify it without delay of any subsequent amendment affecting them.

Article 33

Transitional measures

1.

By derogation from Article 34 (2), feed placed on the market or labelled in accordance with the provisions of Directives 79/373/EEC, 82/471/EEC, 93/74/EEC and 96/25/EC prior to the date of application of this Regulation may be placed on the market until stocks are exhausted. 2.

By derogation from Article 8(2), types of feed referred to in that Article that have already been legally placed on the market prior to the date of application of this Regulation may be placed on the market until a decision on the application for updating the list of intended uses as referred to in Article 10 has been taken, provided that such application has been submitted prior to the date of application of this Regulation.

By derogation from Annex I(1), feed materials may be placed on the market and used until the specific maximum content of chemical impurities resulting from their manufacturing process and from processing aids is fixed, provided that they comply at least with the conditions set forth in Annex, Part A(II)(1) to Directive 96/25/EC. This derogation, however, may apply no later than two years after the date of application of this Regulation.

measures may be adopted in order to facilitate transition to the application of this Regulation. In particular, conditions may be specified under which feed may be labelled in accordance with this Regulation prior to the date of its application. These measures designed to amend the non-essential elements of this Regulation by amending or supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 29(4).

Article 34

Entry into force

1.

This Regulation shall enter into force on the twentieth day following that of its publication in the

Official Journal of the European Union.

2.

It shall apply from [date = twelve months after the date of its publication].
3.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament For the Council The President The President

ANNEX I

TECHNICAL PROVISIONS ON

IMPURITIES, MILK REPLACER, FEED MATERIALS FOR BINDING OR

DENATURISING, THE ASH LEVEL AND MOISTURE CONTENT REFERRED TO IN

ARTICLES 4

1.

In accordance with good practice as referred to in Article 4 of Regulation (EC) No 183/2005, feed materials shall be free from chemical impurities resulting from their manufacturing process and from processing aids, unless a specific maximum content is fixed in the Catalogue referred to in Article 25.
2.

The botanical purity of feed materials shall not be less than 95 %, unless a different level has been laid down in the Catalogue as referred to in Article 25. Botanical impurities comprise impurities of plant materials without adverse effects on the animals e.g. straw and seeds of other cultivated species or weeds. Botanical impurities such as residues of other oil seeds or oil fruits derived from a previous manufacturing process, shall not exceed 0,5 % for each type of oil seed or fruit. 3. The iron level in milk replacer feed for calves of a live weight less than or equal to 70 kilograms shall be at least 30 milligrams per kilogram of the complete feed at a moisture content of 12 %.
4.

Where feed materials are used to denature or bind other feed materials, the product may still be considered to be a feed material. Name, nature and quantity of the feed material used to bind or denature shall be labelled. If a feed material is bound by another feed material the percentage of the latter shall not exceed 3 % of the total weight. 5. The level of ash insoluble in hydrochloric acid shall not exceed 2,2 % of the dry matter. However, the 2,2 % level may be exceeded, for feed materials;

compound feed containing authorized mineral binding agents; mineral feed;

compound feed containing more than 50 % of rice or sugar beet by-products;

compound feed intended for farmed fish with a fish meal content of over 15 %, provided that the level is declared on the label.

6.

Provided that no other level is laid down in Annex IV or the Catalogue referred in Article 25 the moisture content of the feed must be stated if it exceeds: 5 % in the case of mineral feed containing no organic substances;

7 % in the case of milk replacer feeds and other compound feed with a milk-product content exceeding 40 %; 10 % in the case of mineral feed containing organic substances; 14 % in the case of other feed.

ANNEX II

GENERAL PROVISIONS ON LABELLING REFERRED TO IN ARTICLE 11(4)

1.

Contents or levels indicated or to be declared relate to the weight of the feed, unless otherwise stated. .
3.

The numeric indication of dates shall follow the order of day, month and year and the format shall be indicated on the label by means of the following abbreviation: "DD/MM/YY". 4. Synonymic expressions in certain languages;

(a) In German the designation "Einzelfuttermittel" may be replaced by "FuttermittelAusgangserzeugnis", in Greek " " may be replaced by " " ,in Italian "materie prime per mangimi " may be replaced by "mangime semplice"; and in Czech the designation "produkty ke krmení" may be replaced by "krmiva" as applicable

(b) In the designation of feed for pets the following expressions shall be allowed: in Dutch "samengesteld voeder"; in English `pet food'; in Hungarian "állateledel"; in Italian "alimento"; in Polish "karma"; in Slovenian " hrane za hisne zivali; in Spanish "alimento", in Finnish "lemmikkieläinten ruoka". in Czech the designation "kompletní krmná sms" may be replaced by "kompletní krmivo" and "doplková krmná sms" may be replaced by "doplkové krmivo"; in Bulgarian " ".

5.

The instructions for proper use of complementary feed and feed materials containing additives in excess of the maximum levels fixed for complete feed shall state the maximum quantity
-

in grams or kilograms or units of volume of complementary feed and feed materials per

animal per day or

-

percentage of the daily ration or - per kilo of complete feed or percentage in complete feed

in order to ensure that respective maximum contents of feed additives in the daily ration are complied with.

6.

Without affecting the analytical methods, for pet food the expression "crude protein" may be replaced by "protein", "crude oils and fats" may be replaced by "fat content" and "crude ash" may be replaced by "incinerated residue" or "inorganic matter".

Annex IIa

List of materials whose placing on the market or use for animal nutritional purposes is

restricted or prohibited as referred to in Article 6

Chapter 1: Prohibited materials

1)

Faeces, urine as well as separated digestive tract content resulting from emptying or removal of digestive tract, irrespective of any form of treatment or admixture
2)

Hide treated with tanning substances, including its waste.
3)

Seeds and other plant propagating materials which, after harvest, have undergone specific treatment with plant protection products for their intended use (propagation), and any derived by-products.
4)

Wood, including sawdust or other materials derived from wood, which has been treated with wood preservatives as defined in Annex V of Directive 98/8/EC of the European Parliament and of the Council (1).
5)

All wastes obtained from the various phases of the urban, domestic and industrial waste water as defined in Article 2 of Council Directive 91/271/EEC (2) treatment process, irrespective of any further processing of these wastes and irrespective also of the origin of the waters (3).
6)

Solid urban waste, such as household waste.
7)

The packaging and parts of packaging from the use of products from the agri-food industry.

Chapter 2: Restricted materials

ANNEX III

PERMITTED TOLERANCES FOR THE COMPOSITIONAL LABELLING OF FEED

MATERIALS OR COMPOUND FEED FOR THE PURPOSE OF ART 11(5)

1.

The tolerances laid down in this Annex include technical and analytical deviations. Once analytical tolerances covering measurement uncertainties and procedural variations are fixed at Community level, the values set in paragraph 2 should be adapted accordingly in order to cover only the technical tolerances. 2. Where the composition of a feed material or compound feed is found to depart from the labelled composition in a manner such as to reduce its value, the following tolerances are permitted: (a) for crude protein, sugars, starch and inulin; 3 units for declared contents of 30 % or more,

10 % of the declared content for declared contents of less than 30 % but not less than 10 %, 1 unit for declared contents of less than 10 %; (b) for crude fibre, crude oil and fats;

2,2 units for declared contents of 15 % or more,

15 % of the declared content for declared contents of less than 15 % but not less than 5 %, 0,8 units for declared contents of less than 5 %;

(c) for moisture, crude ash, ash insoluble in hydrochloric acid and chlorides expressed as NaCl, total phosphorus, sodium, calcium carbonate, calcium, magnesium, acid index and matter insoluble in light petroleum: 1,5 units for declared contents (values) of 15 % (15) or more, as appropriate,

10 % of the declared content (value) for declared contents (values) of less than 15 % (15), but not less than 2 % (2), as appropriate, 0,2 units for declared contents (values) of less than 2 % (2), as appropriate. (d) For the energy value 5% and for the protein value 10 %;

(e) for feed additives ; 10 % if the declared content is 1000 units and more;

100 units for declared contents of less than 1000 units but not less than 500 units; 20 % of the declared content of less than 500 units but not less than 1 unit;

0,2 units for declared contents of less than 1 unit but not less than 0,5 units; 40 % of the declared content of less than 0,5 units.

These tolerances shall apply also to the maximum levels of feed additives in compound feed.

3.

As long as the fixed maximum level for each feed additive is not exceeded, the variation from the declared content may be up to three times the relevant tolerance laid down in paragraph 2. 4. For feed additives belonging to the group of micro-organisms the acceptable upper limit shall correspond to the fixed maximum level.

1 9

1 unit in this paragraph means 1 mg, 1.000 IU, 1x10 CFU or 100 enzyme activity units of the respective feed additive.

ANNEX IV

COMPULSORY DECLARATION FOR FEED MATERIALS FOR THE PURPOSE OF

ARTICLE 16(1)

Feed material consisting of Compulsory declaration of 1. Forages and roughage Crude protein, if > 10 % Crude fibre

2.

Cereal grains
3.

Products and by-products of cereal grains Starch, if > 20 % Crude protein, if > 10 %

Crude oils and fats, if > 5 %

Crude fibre

4.

Oil seeds, oil fruits
5.

Products and by-products of oil seeds, oil fruits Crude protein, if > 10 % Crude oils and fats, if > 5 %

Crude fibre

6.

Legume seeds
7.

Products and by-products of legume seeds Crude protein, if > 10 % Crude fibre
8.

Tubers, roots
9.

Products and by-products of tubers and roots Starch Crude fibre

Ash insoluble in HCl, if > 3,5 % of

dry matter

10.

Products and by-products of the sugar beet processing industry Crude fibre, if > 15 % Total sugar, calculated as sucrose

Ash insoluble in HCl, if > 3,5 % of

dry matter

11.

Products and by-products of the sugar cane processing industry Crude fibre, if > 15 % Total sugar calculated as sucrose
12.

Other seeds and fruits, their products and by-products, except those Crude protein mentioned in 2-7 Crude fibre

Crude oils and fats, if > 10 %

13.

Other plants, their products and by-products, except those mentioned Crude protein, if > 10 % in 8-11 Crude fibre
14.

Milk products and by-products Crude protein Moisture, if > 5 %

Lactose, if > 10 %

15.

Land animal products and by-products Crude protein, if > 10 % Crude oils and fats, if > 5 %

Moisture, if > 8 %

16.

Fish, other marine animals, their products and by-products Crude protein, if > 10 % Crude fat, if > 5 %

Moisture, if > 8 %

17.

Minerals Calcium Sodium

Phosphorus

Other relevant minerals

18.

Miscellaneous Crude protein, if > 10 % Crude fibre

Crude oils and fats, if > 10 %

Starch, if > 30 %

Total sugar, as sucrose, if > 10 %

Ash insoluble in HCl, if > 3,5 % of

dry matter

ANNEX V

LABELLING PARTICULARS FOR FEED MATERIALS AND COMPOUND FEED FOR

FOOD PRODUCING ANIMALS

Chapter I: : Labelling of feed additives for the purpose of Article 15(f) and 22(1)

1.

The following additives shall be listed with their specific name as defined in the relevant legal act authorising the respective feed additive, added amount, identification number and respective name of the functional group as laid down in Annex I of Regulation (EC) No 1831/2003 or the category referred to in article 6(1) of that Regulation (a) additives where a maximum content is set for any kind of target species,

(b) additives belonging to the categories `zootechnical additives' and `coccidiostats and histomonostats',

(c) additives belonging to the functional group of `urea and its derivatives' of the category `nutritional additives' as laid down in Annex I of Regulation (EC) No 1831/2003.

2.

The name as laid down in the relevant legal act authorising the respective feed additive and the added amount of the feed additive shall be indicated if its presence is emphasised on the labelling in words, pictures or graphics. 3. The person responsible for the labelling shall disclose the names, the identification number and the functional group of the feed additives not mentioned in paragraph 1 to the purchaser on his request. 4. Feed additives not mentioned in paragraph 1 may be voluntarily indicated in the form as laid down in paragraph 1 or partially.
5.

If a sensory or nutritional feed additive as referred to in Annex I of Regulation (EC) No 1831/2003 is labelled on a voluntary basis its added amount shall be indicated.
6.

If an additive belongs to more than one of the functional groups, the functional group or category appropriate to its principal function in the case of the feed in question shall be indicated.

Chapter II: Labelling of analytical constituents as referred to in Articles 17(1)(f) and 22(1)

1.

The composition of compound feed for food producing animals shall be labelled as follows: Feed Analytical constituents and levels Target species Complete feed - Crude protein All species - Crude fibre All species
-

Crude oils and fats All species - Crude ash All species
-

Lysine Pigs and poultry
-

Methionine Pigs and poultry - Calcium All species - Sodium All species
-

Phosphorus All species

Complementary feed - Lysine Pigs and poultry Mineral - Methionine Pigs and poultry - Calcium All species - Sodium All species

-

Phosphorus All species - Magnesium Ruminants

Complementary feed - Crude protein All species Other - Crude fibre All species - Crude oils and fats All species - Crude ash All species

-

Lysine Pigs and poultry
-

Methionine Pigs and poultry
-

Calcium 5 % All species - Sodium All species
-

Phosphorus 2 % All species - Magnesium 0.5% Ruminants
2.

If amino acids,vitaminsand/or trace elements are indicated under the heading of analytical constituents, they shall be declared with their total amount.
3.

If the energy value and protein value are indicated, this indication shall be done according to the EC-method, if available or to the respective official national method in the Member State where the feed is placed on the market, if available.

ANNEX VI

LABELLING PARTICULARS FOR FEED MATERIALS AND COMPOUND FEED FOR

NON FOOD PRODUCING ANIMALS

Chapter I: Labelling of Feed additives for the purpose of Article 15(f) and 22(1)

1.

The following additives shall be listed with their specific name as defined in the relevant legal act authorising the respective feed additive and/or their identification number, added amount and the respective name of the functional group as laid down in Annex I of Regulation (EC) No 1831/2003 or the category referred to in article 6(1) of that Regulation.

(a) additives where a maximum content is set for any kind of target species ,

(b) additives belonging to the categories `zootechnical additives' and `coccidiostats and histomonostats',

(c) additives belonging to the functional group of `urea and its derivatives' of the category `nutritional additives' as laid down in Annex I of Regulation (EC) No 1831/2003. By way of derogation from paragraph 1, for additives of the functional groups

`preservatives', antioxidants' and `colorants' as laid down in annex I to regulation (EC)

1831/2003 only the respective functional group may be the indicated.

In this case the information pursuant to paragraph 1 shall be disclosed by the person

responsible for the labelling to the purchaser on his request.

2.

The name as laid down in the relevant legal act authorising the respective feed additive and the added amount of the feed additive shall be indicated if its presence is emphasised on the labelling in words, pictures or graphics. 3. The person responsible for the labelling shall disclose the names, the identification number and the functional group of the feed additives not mentioned in paragraph 1 to the purchaser on his request. 4. Feed additives not mentioned in paragraph 1 may be voluntarily indicated in the form as laid down in paragraph 1 or partially.
5.

If a sensory or nutritional feed additive as referred to in Annex I of Regulation (EC) No 1831/2003 is labelled on a voluntary basis, its added amount shall be indicated.
6.

If an additive belongs to more than one of the functional groups, the functional group or category appropriate to its principal function in the case of the feed in question shall be indicated.
7.

The person responsible for the labelling shall make available to the authorities responsible for carrying out official controls any information concerning the composition or claimed properties of the feed such person places on the market which enables the accuracy of the information given by the labelling to be verified, including the complete information on all additives used.

Chapter II: Labelling of analytical constituents as referred to in Articles 17(1)(f) and Article 22(1)

1.

The composition of compound feed for non food producing animals shall be labelled as follows: Feed Analytical constituents and levels Target species

Complete feed - Crude Protein Cats, dogs and fur animals - Crude fibres Cats, dogs and fur animals

-

Crude oils and fats Cats, dogs and fur animals - Crude ash Cats, dogs and fur animals

Complementary feed - - Calcium All species Mineral - Sodium All species - Phosphorus All species

Complementary feed - - Crude Protein Cats and dogs and fur animals Other - Crude fibres Cats and dogs and fur animals - Crude oils and fats Cats and dogs and fur animals - Crude ash Cats and dogs and fur animals

2.

If Amino acids, vitaminsand/or trace elements are indicated under the heading of analytical constituents, they shall be declared with their total amount.
3.

If the energy value and protein value are indicated, this indication shall be done according to the EC-method, if available or to the respective official national method in the Member

State where the feed is placed on the market, if available.

Annex VII

Specific provisions for the labelling of feed that does not meet

safety and marketing compliance with EU legal requirements as

referred to in Article 20 (1)

1.

Contaminated materials shall be labelled as `feed with excessive level(s) of ... (designation of the undesirable substance(s) in accordance with Annex I to Directive 2002/32/EC), only to be used as feed after detoxification in authorised establishments'. The authorisation of those establishments shall be based on Article 10(2) or (3) of Regulation (EC) No 183/2005. 2. In case the contamination is intended to be reduced or eliminated by cleaning, the additional labelling of contaminated materials shall be `feed with excessive level(s) of ...

(designation of the undesirable substance(s) in accordance with Annex I to Directive

2002/32/EC), only to be used as feed after adequate cleaning'.

ANNEX VIII

CORRELATION TABLE

Directive 79/373/EEC Directive 96/25/EC Other acts: Directives This Regulation 80/511/EEC (1), 82/471/EEC (2),

93/74/EEC (3) or

93/113 EC (4)

-

- - Article 1

Article 1 Article 1 (2), (4): Article 1 (3): Article 4 Article 2 Article 2 Article 2 (2), (3): Article 2 Article 3

-

- - Article 4(1)

Article 3 Article 3 (3): Article 1(2) Article 4(2)

Article 4 Article 4(3)

-

- - Article 5(1)

Article 12 (3): Article 10(2) Article 5(2)

Article 10a(3) Article 11(b) (2): Article 8 Article 6 - - - Article 7 - - - Article 8

(3): Article 3 Article 9

(3): Article 6 Article 10 Article 5e Article 11(1)

Article 5(2) Article 5(1) (2): Article 5(2) Article 11(2) Article 11(3)

-

- - Article 11(4)

Article 5(6) Articles 4 and 6(4)

Article 6 Article 4 Article 11(5) Article 5(1) Article 5(1) Article 12

Article 5e Article 5(2) (3): Article 5(6) Article 13 Article 5(1), Article 11 Article 5(1), Article 9 Article 14

Articles 5(1) and 5(5)(c) Article 5(1) (4): Article 7(1)E and Article 15

Directive 70/524/EEC:

Article 16

Article 5(1)(c), (d) and 7 Article 16

Articles 5(1), 5c and 5d Article 17(1) - - - Article 17(2)

Article 5c(3) Article 17(3)

(3): Articles 5(1), (4), (7) and 6(a) Article 18 - - - Article 19

Article 8 Article 20

Article 6(1)(a) Article 21(1) Article 21(2)

Article 5(5)(d) Article 21(3)

Article 6(3)(a) Article 21(4)

Article 5(5)(b) Article 21(5)

Article 5(5)(a) Article 21(6)

Article 5(2) Article 5(3), 6(1)(b) Article 21(7)

- - -

Article 14(c) Article 21(8)

Article 5(3), 5c(4) and 5e Article 5(2) Article 22 Article 4(1) (1): Article 1 Article 23 Article 5(4) Article 24 Article 25

-

- - Article 26
-

- - Article 27
-

- - Article 28

Article 10 Article 11 Article 29

Article 13 Article 13 (2): Article 13 and 14 (3): Article 9 - - - Article 30 - - - Article 31 - - - Article 32 - - - Article 33 - - - Article 34

Annex Part A(2), (3), (4) Annex Part A(II), (VI), Annex I Annex Part A(1) and Article 5(6), Article 6(4) Annex II Annex Part A(5), (6) Annex Part A(VII) Annex III Annex Part C Annex IV Annex Part B Annex V

Annex Part B Annex VI

____________________

ANNEX II

Commission's Declarations

on the subject of:

1.

Revision of Annex III: "In order to adapt Annex III (on the tolerances for the compositional labelling of feed materials and compound feed) as provided for in Article 11 of the Regulation to scientific and technical development, the Commission and its services envisage to take up the examination of the above mentioned Annex III. In this context the Commission will also consider certain feed materials with moister content greater than 50%." 2. Labelling of additives:

"The Commission will study whether the principles of information through labelling of feed could also apply to the additives and premixtures authorised under Regulation 1831/2003 on additives for use in animal nutrition." 3. Interpretation of "any urgencies related to human and animal health and the environment

as addressed by Recital 17, Article 5 and Article 17

"The Commission understands that "any urgencies related to human and animal health and the environment" may include urgencies generated amongst others by negligence, intentional fraud and criminal acts."

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Proposal for a Regulation of the European Parliament and of the Council on the placing on the market and use of feed - Approval of the final compromise text with a view to a first reading agreement with the European Parliament - Hoofdinhoud

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publicatiedatum	16-12-2008
kenmerk	17194/1/08 REV 1