Proposal for a Regulation of the European Parliament and of the Council on the placing on the market and use of feed

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1. Tekst

At its meetings on 4, 25 and 26 September, the Working Party examined Articles 1-34 and Annex I

of the Presidency compromise text. Delegations will find in the Annex the results of the Working

Party proceedings.

____________________

ANNEX

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 , b

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

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

Acting in accordance with the procedure laid down in Article 251 of the Treaty d , 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 e

. 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.

(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 is the most important cost factor.

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

b OJ C [...], [...], p. [...]. c

OJ C [...], [...], p. [...]. d

OJ C [...], [...], p. [...]. e

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).

(2) Feed can be categorised in feed materials, compound feed, feed additives and medicated feed. 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 f

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

g 1 .

(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 h

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

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

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 m

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, is repealed.

(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.

OJ L 268, 18.10.2003, p. 29. Regulation amended by Commission Regulation (EC) o 378/2005 (OJ L 59, 5.3.2005, p. 8).

OJ L 92, 7.4.1990, p. 42. 1

Some delegations (DELETED) indicated that this recital might need to be revised. One delegation (DELETED) made a reservation on this recital. h

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). i

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). j

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

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). l

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

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

Instead, 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

, which requires that clean water is used whenever necessary to prevent

hazardous contamination and that water used in feed manufacture is of suitable quality.

It is not appropriate to apply the provisions of this Regulation to feed which are intended exclusively for export to third countries because in general these countries have their own regulations. Such feed must, however, comply with the requirements laid down in Article12 of regulation (EC) No 178/2002. The scope of Regulation (EC) No 1831/2003 should also be explicitly clarified in this regard.

(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. Given that regional and/or country- specific practices and traditions exist which might influence the classification of an animal as food-producing or non-food producing, it is appropriate to provide for specific labelling obligations.

(7) The responsibilities of the feed business operators laid down in Articles18 and 20 of Regulation (EC) No 178/2002 and Article 4 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 o

. 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 prohibited, as currently provided for in Commission Decision 2004/217/EC p

, should be maintained. The existence of such a list should, however, not be

interpreted so that all products not listed could as such be considered to be safe.

(10) The distinction between feed materials, feed additives and veterinary drugs has implications on 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 adopt rules for such distinction.

OJ L 35, 8.2.2005, p. 1. o

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). p

OJ L 67, 5.3.2004, p. 31.

(11) The definition of complementary feedingstuffs in Directive 79/373/EEC gave rise to application problems in various Member States. For the purpose of correct application of Regulation 183/2005, it is appropriate to clarify the distinction between complementary feedingstuffs and premixtures. In order to allow a uniform application of the legislation, complementary feed should not contain additives above a certain level.

(12) Directive 82/471/EEC aimed to improve the supply with protein-rich feed 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 case 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 pre-market authorisation procedure for bioproteins should be abolished with the consequence that the safety system for these products is the same as for all the other feed materials. (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 r

proved to

be working well. It should, therefore, be maintained and provisions should be made 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.

(14) Labelling serves enforcement, traceability and control purposes. In addition, labelling should provide the necessary information to the customers to enable them to make the optimal choice for their needs and should be consistent, coherent, transparent and understandable. As the customers in particular the livestock farmers are making their choice not only at the point of sale where they can peer 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 customer. 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.

(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.

OJ L 62, 6.3.2008, p. 9.

(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. In parallel, the level of food and feed safety has been meanwhile significantly improved due to Regulations (EC) No 178/2002 and No 183/2005 and their implementing measures, explicitly the focus 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 guides to good hygiene practice in feed businesses. These positive achievements, mirrored in the notifications to the Rapid Alert System for Food and Feed, justify that the obligation to indicate the weight percentage of all feed materials incorporated in compound feed should be abandoned. The exact percentages could be provided for on a voluntary basis. (18) To ensure proper information of the customer and to avoid misleading him, the exact weight percentage should be required in case the respective feed material is emphasised on the labelling of a compound feed.

(19) In certain areas where the producer is not obliged to label particulars, the customer should have the possibility to request additional information. Nonetheless, the indication of the feed materials incorporated in compound feed in descending order of weight, already provides important information on compositional data. Taking into account the recent developments in Community legislation which give higher guarantees as regards in particular HACCP, traceability, strict hygiene rules and the development of Community guides to good practice for hygiene, the manufacturer should be allowed to reject the request if he considers the requested disclosure to infringe his intellectual property rights or to divulge commercially sensitive information. This would not affect the food and feed safety, since the competent authorities always have the right to get the exact percentages of all feed materials. (20) Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed s

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 until such contaminated feed has been detoxified by a detoxification establishment, approved in accordance with Article 10(2) and

(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 manufacturer 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. (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.

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). 2

One delegation (DELETED) suggested replacing "and" with "or" for consistency reasons.

(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 manufacturer 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. (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 become the initial version of the Community Catalogue of feed materials. This initial version should subsequently be completed by the stakeholders according to their interests, including completion in respect of emerging feed materials.

(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 manufacturer and purchaser of pet food, Codes of good labelling for these two areas could be useful means of achieving the objectives of modern labelling. These Codes may interpret the framework given for voluntary 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 considered particularly. This can be ensured by the Commission by approving the Catalogue and the Codes. (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.

(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 t

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 decide on products 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, to amend the list of voluntary labelling particulars and to adapt the Annexes in the light of scientific and technical development. 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 the adoption of [measures.....]. On the grounds of urgency, it is necessary to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of [measures....].

(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, 80/511/EEC, 82/471/EEC, 83/228/EC , 93/74/EEC, 93/113/EC and 96/25/EC, and Article 16 of Directive 70/524should 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.

It has been requested to clarify the status of nutritional supplements, with one delegation

2.

The provisions of this Regulation shall apply without prejudice to other Community provisions applicable in the field of animal nutrition, in particular: 4

[(a) Directive 90/167/EEC;] (b) Directive 2002/32/EC;

(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 v

;(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 ab

; and

(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 ac .

(g) Regulation (EC) No 1831/2003.

3.

This Regulation shall not apply to: 5

(a) water, either taken in directly by the animals or intentionally incorporated into feed. (b) feed which are shown, a least by an appropriate indication, to be for export to third countries.

(DELETED) requesting to add "and other types of supplements" to this paragraph.

Two delegations (DELETED) expressed the view that no reference to medicated feedingstuffs should be included in this proposal, while a great number of delegations (DELETED) and the Commission were of the view that Article 2 (a) should be maintained as proposed by the Commission. One delegation (DELETED) entered a scrutiny a reservation on this issue. v

OJ L 147, 31.5.2001, p. 1 aa

OJ L 273, 10.10.2002, p. 1. ab

OJ L 268, 18.10.2003, p. 1 ac

OJ L 268, 18.10.2003, p. 24. 5

Some delegations (DELETED) expressed concerns about excluding water from the scope of this proposal, especially when incorporated in feed, while some other delegations supported the current Presidency proposal (DELETED). One delegation (DELETED) requested the deletion of the words "or intentionally incorporated in feed".

Article 3

Definitions

1.

For the purposes of this Regulation, the definitions of `feed', `feed business', `feed business operator' 6

, `placing on the market' and `traceability' 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.

(a) `Food producing animal': any animal that is fed 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; 7

(b) `Non-food producing animals': animals kept or bred 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 animals kept or reared 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, in the preparation of compound feed or as carrier of premixtures; (f) `Compound feed': mixture of feed materials, whether or not containing feed additives, for oral animal feeding in the form of complete or complementary feed; 8

(g) `Complete feed': compound feed which, by reason of its composition, is sufficient for a daily ration; 9

(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;

One delegation (DELETED) requested removing "feed business operator", as it is now defined in Article 3(2). 7

Two delegation (DELETED) suggested replacing the words " animals kept or bred" with "any animal that is fed or reared" for consistency reasons. 8

One delegation (DELETED) requested considering the status of dietary feeds in relation to compound feed. 9

One delegation (DELETED) suggested inserting a special definition for ruminants.

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

that tolerated under Directive 2002/32/EC;

(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 11

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;

(n) `Minimum storage life': date until which, under proper storage conditions, the person responsible for the labelling guarantees that the feed retains its declared properties; 12

(o) `Batch' or `lot' : It consists of an identifiable quantity of feed and is determined to

have common characteristics, such as origin, variety, type of packing, packer, consignor or labelling; and in case of a production process 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, 14

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;

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

One delegation (DELETED) suggested removing the words "which has a high content of certain substances but which...". 11

One delegation (DELETED) suggested including "or nutritional". 12

One delegation (DELETED) requested clarification on why the definition includes the production process in addition to the first part. Two delegations (DELETED) queried if bulk commodities are able to meet all the characteristics included in the definition. 13

Some delegations (DELETED) felt that the reference to the internet should be accompanied by other aspects of this issue, such as advertising, marketing etc. 14

One delegation (DELETED) expressed concerns over the use of this term in this paragraph.

(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. 15

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, Articles 15 of Regulation (EC) No.

178/2002 shall apply, mutatis mutandis, to feed for non-food producing animals;

b)

it is sound, genuine, fit for purpose and of merchantable quality ; 17
c)

it does not have a direct adverse effect on the environment or animal welfare; 18
d)

it is labelled, packaged and presented in accordance with the provisions laid down

in this Regulation, in Directive 90/167/EEC and in Regulation (EC) No 1831/2003, as applicable; for the purpose of this Regulation, Article 16 of Regulation 178/2002 shall apply mutatis mutandis to feed for non-food producing animals.

2.

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 Articles18 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.

Some delegations (DELETED) requested defining nutritional supplements in this Article. 16

Regarding the issue of "merchantable quality", one delegation (DELETED) felt that this is not sufficiently clarified and requested to delete (b); while another delegation (DELETED) stressed that there are examples in the current legislation, as well as legal precedents that provide sufficient information on this issue. 17

Two delegations (DELETED) suggested eliminating the word "direct" and using the same wording as in Article 10 (2). 18

Two delegations (DELETED) suggested adding "in particular" and/or adding reference to other relevant legislation. 19

One delegation (DELETED) requested replacing "feed business operator" with "person responsible for the labelling" while the Commission representative reminded delegations about the definition of the first concept in Article 12. Another delegation (DELETED) suggested using one and the same concept in Article 12 (1) and (2).

2.

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 they place on the market which enables the accuracy of the information given by the labelling to be verified. Article 6

2021

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.
2.

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, the Commission shall adopt a list of materials whose placing on the market or use for animal nutritional purposes is restricted or prohibited. 3. 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 the imperative grounds of urgency, the Commission may use the urgent 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(2), the Commission may adopt guidelines clarifying the distinction between feed materials, feed additives and other products such as veterinary drugs.

Some delegations queried whether this Article should include a reference to bio-proteins that are prohibited. 21

One delegation (DELETED) suggested changing the title to "Prohibition or restriction" to better reflect the content of the Article. 22

Several delegations (DELETED) suggested replacing "may" by "shall". The same comments apply for 7 (2).

2.

Where necessary, the Commission may adopt measures in order to determine whether a product constitutes a feed material, a feed additive 23 24

or a processing aid for the purposes of this Regulation.

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 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.

By way of derogation from (1) the factor 100 for feed materials or complementary feed may be

exceeded if the composition of such products meets the particular intended nutritional purpose as

authorised according to Article10. Feed business operators using such feed shall comply with the

2627

provisions in Annex 2 of Regulation 183/2005.

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 it meets the

essential nutritional characteristics for the respective particular nutritional purpose set forth in that

list.

23 Two delegations (DELETED) requested deletion of "feed additive".

24 Two delegations (DELETED) suggested including nutritional supplements as a new category, and some other delegations (DELETED) emphasised the need to clarify the status of these products using existing instruments, having in mind that they are already on the market. 25

Some delegations (DELETED) have supported the modifications to Article 7 (2) as being a step in the right direction, while one delegation (DELETED) expressed concerns on this issue.

26 New wording for this Article proposed by the Presidency taking into account delegations and EP's concerns. Modifications have been seen as a step in the right direction. However, some delegations (DELETED) felt that this paragraph was too restrictive and did not cover some category of products, such as vitamin pills. 27 One delegation (DELETED) suggested removing the last sentence. Another delegation (DELETED) called for careful consideration of whom this provision is addressed to and its effects and (DELETED) for deleting feed materials from the exemption.

Article 10

List of intended uses 28 of feed intended for particular nutritional purposes

1.

The Commission may update the list of intended uses by adding an intended use, withdrawing an intended use or by adding, removing or changing the conditions associated to 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(4).
6.

By way of derogation from paragraph 5, the Commission may 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. 29

One delegation (DELETED) queried if transitional measures are necessary. 29

Following discussion on the available procedural options to be included in Article 10(6), which provides new role for the Commission, it was agreed to re-examine the text.

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, identity, 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. (c) as to the compliance of the labelling to 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/CE of the European Parliament and of the Council ad

the mandatory

labelling particulars required by this Regulation and available at the time of their dissemination shall appear on the material supporting the distance selling.

4.

Additional general labelling provisions 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. Article 12

Responsibility

1.

The feed business operator first placing feed on the market shall be responsible for the labelling particulars and ensure their presence and substantive accuracy.

OJ L 144, 4.6.1997, p. 19. 30

Delegations (DELETED) expressed their concerns on the availability of the mandatory information at the time when the buyer makes the decision to buy. It has been discussed whether this moment should be the time of the offer or the time of the actual sale. One delegation (DELETED) expressed doubts with regard to the use of the term "dissemination". Anther delegation (DELETED) queried the monitoring mechanisms that could be used for enforcing this provision. 31

It was agreed to insert "the person".

2.

If the feed is marketed with the name or business name of a feed business operator other than the manufacturer that feed business operator 32 33

shall be responsible for the labelling particulars.

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 can be 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 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. In the case where the authority responsible for carrying out official controls has doubts whether the truthfulness of the claim is scientifically substantiated, competent authority may submit the issue to the Commission. The Commission may adopt a recommendation according to the procedure laid down in Article 29(2). 34

Three delegations (DELETED) suggested clarifying this paragraph as follows: " If the feed is marketed with the name or business name of a feed business operator other than the feed business operator mentioned in paragraph (1), this other feed business operator shall be responsible for the labelling particulars. One delegation (DELETED) emphasised that there might be a need for further clarification of this article. 33

It has been suggested to insert "the person". 34

One delegation(DELETED) felt that the current wording gives unnecessary powers to the Commission, while two other delegations (DELETED) supported this Article, as being a step towards harmonisation. One delegation (DELETED) requested clarification on the nature of the recommendation adopted by the Commission. Three delegations (DELETED) suggested including a reference to Article 26.

2.

Without prejudice to paragraph 1, claims concerning optimisation of the nutrition and support or protection of the physiological conditions are permitted if they are not based on a pharmacological or preventive immunological 35

action.

3.

The labelling or the presentation of feed shall not claim that

(a) it will prevent, treat or cure a disease, except for the prevention of nutrition related diseases or

(b) it has particular nutritional purposes and characteristics other than those provided for in the list as referred to in Article 9.

(c) a feed additive or a feed containing such additive has properties or functions other than those demonstrated in the respective legal authorisation act of the additive or those fulfilling the conditions laid down under paragraph (1). 36

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 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;

One delegation (DELETED) suggested deleting "preventive immunological" and better clarify the link between paragraphs (2) and (3). 36

Some delegations (DELETED) expressed concerns with regard to this Article, with one delegation (DELETED) entering a reservation on this issue. 37

One delegation (DELETED) suggested replacing "by labelling" with "on the label".

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 particulars;

(c) if available, the establishment approval number granted in accordance with Article 17 of Regulation (EC) No 1774/2002 or with Article 10 of Regulation (EC) No 183/2005. If a manufacturer 39

has several approval numbers he shall use the one obtained under

Regulation 183/2005; 41

(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 42

;

(f) the list of feed additives preceded by the name and the content 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. 43

(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;

(b) compulsory declaration corresponding to the respective category as set out in the list in Annex IV.2. The compulsory declaration referred to in paragraph 1 (b) may be replaced by the particulars laid down in the Community Catalogue referred to in Article 25.

One delegation (DELETED) felt that this paragraph was too limited and should be further clarified. 39

One delegation (DELETED) suggested replacing "manufacturer" with "person responsible for the labelling" or " person placing on the market". 40

Two delegations (DELETED) suggested including a reference to Article 13 of Regulation 1774/2002. Another delegation (DELETED) requested clarification on the registration number that has to be on the label. 41

Two delegations (DELETED) felt that sometimes it might be difficult to give a batch number. 42

One delegation (DELETED) suggested that this paragraph may create difficulties for bulk consignments. 43

One delegation (DELETED) expressed concerns on the proportionality of labelling detailed information for all additives subject to maximum permitted level.

If a feed material that is listed in the Community Catalogue is used and the product meets the description laid down therein, the relevant name set forth in the Community Catalogue

shall be used for this feed material in the labelling, in order not to mislead the consumer on the real identity of the product.

3.

In addition to the requirements provided for in paragraphs 1 and 2, the labelling of feed materials shall include the following when additives are incorporated in feed materials: 44
a)

the species or categories of animals for which the feed material is intended;
b)

instructions for proper use, including the maximum amount of the feed material, in order to ensure that respective maximum contents of feed additives in the daily ration are complied with. 4546

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 category of animals for which the compound feed is intended;

(b) the instructions for proper use indicating the purpose for which the feed is intended and the maximum amount of the compound feed, in order to ensure that respective maximum contents of feed additives in the daily ration are complied with ; 47

following shall be provided:

the name or business name and address of the manufacturer, or 48

the identifying number as granted according to Article 19 of Regulation (EC)

No 183/2005; if such identifying number is not available, a registration number attributed on the manufacturers 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:

44 One delegation (DELETED) expressed doubts over the use of this word.

45 Alternative wording proposed by the Presidency during Working Party on 25-26 September.

46 Three delegations (DELETED) suggested that this paragraph might be difficult to apply in practice and there might be a need to differentiate between different categories of additives.

47 Alternative wording proposed by the Presidency during Working Party on 25-26 September. Two delegations (DELETED) suggested deleting the last part of this paragraph, from "in order to...". 48 One delegation (DELETED) requested insertion of "of the manufacturer".

49 Two delegations (DELETED) felt that the use of another identification number might create difficulties, while another delegation (DELETED) felt that the identification number is important. Another delegation (DELETED) raised questions about the Italian translation of this paragraph.

`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 may be indicated 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 and listing those feed materials in descending order by weight; that list may include the percentage of weight. 50

(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 make available on request of the customer information on the quantitative composition data in a range of +/- 15% 51

of the value according to the

feed formulation, unless the person responsible for the labelling can prove that the requested information is commercially sensitive and its disclosure could infringe his intellectual property rights;

(c) in the case of compound feed intended for non-food producing 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 belongs to.

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. 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).

One delegation (DELETED) was of the opinion that the order of the weight should be calculated based on the water content in the final product. 51

Two delegations (DELETED) felt that the +/-15% figure does not add value and it should be replaced by exact figures. 52

Some delegations preferred to defer the discussion on this paragraph pending progress of negotiations in the European Parliament. One delegations (DELETED) felt that this paragraph requires further clarification. Another delegation (DELETED) requested deletion of the final part of this paragraph from "unless...". 53

Two delegations (DELETED) suggested that this paragraph should only refer to pet food. The Presidency and the Commission agreed with this point and promised to implement the consequential change to paragraph 3.

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; 55

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

Article 19

Additional mandatory labelling requirements for pet food

1.

On the label of pet food a free telephone number or other means of communication shall be indicated in order to allow the customer 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

56 5758

Additional labelling requirements for contaminated feed

1.

In addition to the requirements laid down in Articles 15, 16, 17 and 18, contaminated feed shall be labelled `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 59

in authorised establishments'. The authorisation of those

establishments shall be based on Article 10(2) or (3) of Regulation (EC) No 183/2005.

One delegation (DELETED) suggested replacing" particular nutritional purposes" by "intended uses". 55

Some delegations (DELETED) requested addition of "veterinarian" in this paragraph. 56

One delegation (DELETED) suggested adding "mandatory" for consistency reasons. 57

Some delegations (DELETED) supported expanding this article to microbiological contaminants. 58

One delegation (DELETED) suggested replacing "feed" by "material". One delegation (DELETED) suggested that the use of the term "feed" in paragraph (1) of this Article might contravene to provisions of Article 3 of Directive 2002/32. 59

One delegation (DELETED) suggested replacing "detoxification" with "decontamination".

2.

In case the contamination is intended to be reduced or eliminated by cleaning, the additional labelling of contaminated feed 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'. Article 21

Derogations 61

1.

The particulars referred to in Article 15(c), (d) (e) , 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) and (e) and Article 17(1)(c), (d) and (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) 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 63

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 customer at the latest on the invoice. 64

A number of delegations (DELETED) expressed their support for including a derogation for liquid feed. 61

Two delegations(DELETED) supported including a derrogation for paragraph 15(g). The same comment applies for paragraphs 3 and 7 of this Article. 62

Two delegations (DELETED) expressed concerns that this paragraph might be too broad. 63

Two delegations (DELETED) requested addition of "seeds and fruits" to this paragraph. 64

One delegation (DELETED) expressed concerns on the use of "invoice" as it might create problems at national level.

7.

For quantities of pet food sold in packages with several containers in which each pack is intended to meet the daily ration 65 66

of the intended animal , the particulars referred to in

Article 15(b), (c) and (f) and Article 17(1)(c), (e) and (f) may be given only on the package instead of each container.

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 may also include voluntary labelling particulars, provided that the general principles laid down in this Regulation are respected.
2.

The additional voluntary labelling may include in particular the following particulars: (a) optional declarations as laid down in Annexes V and VI; (b) the country of production or manufacture;

(d) an indication of the physical condition of the feed or the specific processing it has undergone; (e) the moisture content;

(f) the date of manufacture;

(g) special storage conditions; (h) the price of the product.

Two delegations (DELETED) requested deletion of the reference to "daily ration". 66

Four delegations (DELETED) requested clarification on the use of multi-packs that can be used for a number of animals. 67

One delegation (DELETED) expressed concerns that the use of "feed" in (2) might be too far- reaching.

Article 23

Packaging

1.

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: 68

(a) feed materials;

(b) compound feed exclusively obtained by mixing grain or whole fruit; 69

(c) deliveries between producers [and distributors] of compound feed ; (d) deliveries of compound feed directly 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. Article 24

Change of package

1.

If a batch of feed is divided, the mandatory labelling particulars provided for in this Regulation, together with a reference to the initial batch, shall be repeated on the packaging, container or accompanying document of each division of the batch. 2. Where the composition of a feed is modified after it has been placed on the market the mandatory labelling particulars shall be adapted accordingly under the responsibility of the feed business operator responsible for the modification of the feed.

Discussions focused on whether point (a) on "feed materials" should be deleted, with two delegations supporting deletion (DELETED) and another delegation being against (DELETED). 69

Discussions focused on the need to insert reference to "distributors", with some delegations supporting the original Commission proposal (DELETED).

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') is hereby created as a tool to improve the labelling of feed materials. It shall include for each feed material listed 70

(a) the name;

(b) the identification number;

(d) particulars replacing the compulsory declaration concerning the nutritional composition for the purpose of in Article 16(2); 71

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

2.

The first entries in the Catalogue are constituted by 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 is 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. Any use of the Catalogue by the feed business operators shall be voluntary. 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 [non-food producing animals] 72

and one

for feed for food producing animals.

Some delegations (DELETED) requested including "such as" in order to underline the nonexclusive nature of the list. 71

Some delegations (DELETED) requested clarification of this paragraph. 72

Some delegations (DELETED) expressed concerns about the status of fur animals and their inclusion in the Code for non-food producing animals. One delegation (DELETED) pointed out that fur animals might share more characteristics with food producing animals.

They shall refer to the presentation provided for in Article 14 and to the scope for voluntary labelling provided for in Article 22 and support to improve the appropriateness of the labelling.

2.

The procedure laid down in Article 27 shall apply for the establishment and for any amendment to be made to the Codes. 3. Any use of the Codes by the feed business operators shall be voluntary. 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. The Commission shall approve any such draft in accordance with the procedure referred to in Article 29(2) 74

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) are suitable to meet the respective objectives.

3.

The Catalogue and the Codes shall be published in the Official Journal of the European Union.

One delegation (DELETED) suggested including a reference to Article 13 in this paragraph. 74

One delegation (DELETED) entered a reservation over the use of this procedure and suggested using the procedure in Article 29(3) instead.

Chapter 6

General and final provisions

Article 28

Amendments to Annexes and implementing measures

1.

The Commission may amend Annexes II, V and VI 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).

1a. The Commission shall regularly amend Annexes I, III and IV 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(6)

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

(1) Paragraph 1 is amended as follows:

(a) Point (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*;

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

*

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

(b) The following subparagraph is added: 77

`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 must 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 in capital letters on the label and 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]*. ----------------------------------------

*

OJ L ... .'.

Some delegations (DELETED) were of the view that Regulation 183/2005 should be updated through this Regulation. Some delegations reiterated questions related to the issue of exports to third countries. One delegation (DELETED) requested clarification of the wording of this Article. 76

One delegation (DELETED) demanded clarification on the nature of the identification number requested. 77

Two delegations (DELETED) demanded insertion of "minimum storage life" in this paragraph.

Article 31

Repeal

Directives 79/373/EEC, 80/511/EEC, 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and

96/25/EC and Article 16 of Directive 70/524/EEC are repealed as of 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

Transitional measures designed to amend the non-essential elements of this Regulation inter alia by

supplementing shall be adopted in accordance with the procedure referred to in Article 29(4 ).

Products covered by this Regulation, which have been labelled before the date of application of this

Regulation following dispositions of Directives 96/25 ad 79/373 may continue to be put on the

market and used until stocks are exhausted.

Suggested by the Council Legal Service and agreed by the Commission. 79

One delegation (DELETED) raised the issue of adopting transitional measures for market players that would be ready to apply this Regulation before the given delay. Another delegation (DELETED) indicated that the pet food industry might need additional time for being able to apply this Regulation.

Article 34

Entry into force

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

Official Journal of the European Union.

It shall apply from twelve months after the date of its publication. 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.

Feed materials must, as according to the good manufacturing practices as laid down in Regulation (EC) No 183/2005 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. 80
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. 81
3.

The iron level in milk replacer feed for calves of a live weight less than or equal to 70 kilograms must 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 must 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, in the case of feed materials;

compound feed containing authorized mineral binding agents; 82

mineral compound 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.

Some delegations (DELETED) had a preference for the wording in the current legislation. 81

One delegation (DELETED) raised the issue of an increase in the purity level. 82

Two delegations (DELETED) requested deletion of the word "compound".

6.

Provided that no other level is laid in the 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; 83

14 % in the case of other feed.

Two delegations (DELETED) raised the issue of feed materials that have a moisture content higher than 50%.