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Regulation (EC) No 767/2009 of the European Parliament and of the CouncilShow full title

Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (Text with EEA relevance)

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Regulation (EC) No 767/2009 of the European Parliament and of the Council

of 13 July 2009

on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC

(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,

Having regard to the opinion of the European Economic and Social Committee(1),

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),

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(3). That Regulation also established the farm-to-fork approach designating feed as a sensitive stage at the beginning of the food chain. To ensure a high level of protection of public health is one of the fundamental objectives of this Regulation.

(2) The production of feed is an important end for European agricultural products, given that most of the materials used for the production of feed are agricultural products listed in Annex I to the Treaty. Furthermore, feed is of crucial significance for the 5 million livestock farmers in the Community because it represents the greatest expense.

(3) Feed may take the form of feed materials, compound feed, feed additives, premixtures or 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(4) 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(5).

(4) 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(6), Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes(7) (dietetic feed), Council Directive 96/25/EC of 29 April 1996 on the circulation and use of feed materials(8) and Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition(9) (bio-proteins), needs to be updated and replaced by a single regulation. In the interests of clarity, Council Directive 83/228/EEC of 18 April 1983 on the fixing of guidelines for the assessment of certain products used in animal nutrition(10) and Commission Directive 80/511/EEC of 2 May 1980 authorising, in certain cases, the marketing of compound feedingstuffs in unsealed packages or containers(11) should be repealed.

(5) As a consequence of the repeal of Directive 79/373/EEC by this Regulation, Council Directive 93/113/EC of 14 December 1993 concerning the use and marketing of enzymes, micro-organisms and their preparations in animal nutrition(12) should also be repealed. Also, in view of the repeal of Directive 79/373/EEC, and given that this Regulation includes rules concerning the labelling of feed containing additives, Article 16 of Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs(13), which remained in force after the repeal of Directive 70/524/EEC by Regulation (EC) No 1831/2003, should be repealed.

(6) 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. It should, however, apply to feed administered in water. 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(14), which stipulates that clean water should be used whenever necessary in order to prevent contamination that could prove hazardous and that water used in feed manufacture should be of suitable quality.

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

(8) The responsibilities of the feed business operators laid down in Regulation (EC) No 178/2002 and Regulation (EC) No 183/2005 should apply, mutatis mutandis, in respect of feed for non-food producing animals.

(9) 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(15). Those controls should include not only the mandatory but also the voluntary labelling particulars. In order to allow control of the compositional data, acceptable tolerances for the labelled values should be determined.

(10) 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(16), together with a list of materials whose placing on the market for animal nutrition purposes is restricted, should be included in an Annex to this Regulation. The existence of such an Annex should not, however, be interpreted to mean that all products not listed can, as such, be considered safe.

(11) The distinction between feed materials, feed additives, and other products such as veterinary drugs has implications for the conditions for the placing of such products on the market. Feed materials are primarily 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 which can be justified by scientific assessment and which are exclusive to feed additives or veterinary drugs should be excluded from the objective uses of feed materials. It is, therefore, appropriate to draw up non-binding guidelines for distinguishing between these kinds of products. In duly justified cases, the Commission should be empowered to clarify whether a product constitutes feed for the purposes of this Regulation.

(12) The definition of complementary feedingstuffs in Directive 79/373/EEC gave rise to application problems in various Member States. It is appropriate to clarify the distinction between complementary feedingstuffs and premixtures for the purposes of applying Regulation (EC) No 183/2005.

(13) 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. Conditions governing the use of such feed should appear on the labelling in order to ensure that the rules regarding the content of feed additives in the daily ration are complied with.

(14) Directive 82/471/EEC aims to improve the supply of feed used as direct and indirect protein sources 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 to date and the shortage of protein-rich feed is still evident. Thus, the general pre-market authorisation requirement has 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 is negative, its circulation or use should be prohibited. Hence, the special requirement of a general pre-market authorisation procedure for bio-proteins should be abolished, with the consequence that the safety system for such products be the same as for all other feed materials. The existing restrictions or prohibition of certain bio-proteins should not be affected.

(15) The provisions of Directive 93/74/EEC implemented by Commission Directive 2008/38/EC of 5 March 2008 establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes(17) have proved to be working well. The list of intended uses thus established should, therefore, be maintained and provision should be made in this Regulation for its updating. In particular, the European Food Safety Authority should be consulted on the efficacy and the safety of such feed when, on the basis of available scientific and technological information, there are reasons to believe that the use of the feed in question may not meet the particular intended nutritional purpose or may have adverse effects on animal health, human health, the environment or animal welfare.

(16) Scientific substantiation should be the main factor to be taken into account for the purpose of making claims in respect of feed, and feed business operators making such claims should be able to substantiate them. A claim may be scientifically substantiated by taking into account the totality of the available scientific data, and by weighing the evidence.

(17) Labelling serves enforcement, traceability and control purposes. In addition, labelling should provide the necessary information to purchasers to enable them to make the optimal choice for their needs, and it should be consistent, coherent, transparent and understandable. As purchasers, in particular livestock farmers, make their choices not only at the point of sale where they can inspect the packaging of the feed, the requirements concerning information provided on the labelling must apply, not only to the labels which appear on the products, but also to other kinds of communication between the vendor and the purchaser. Furthermore, those principles should apply also to the presentation and the advertising of feed.

(18) Mandatory and voluntary information is provided on labelling. The mandatory information should combine general labelling requirements and specific requirements for feed materials or compound feed respectively, and additional requirements in the case of dietetic feed, contaminated material and pet food.

(19) 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 a high level of feed safety, and thus a high level of protection of public health, and in order to improve transparency, provisions should be adopted laying down acceptable levels of such chemical impurities in accordance with good practice as referred to in Regulation (EC) No 183/2005.

(20) The principle that only certain feed additives have to be labelled once they are used in feed materials and compound feed is working well. However, the categorisation resulting from Regulation (EC) No 1831/2003 needs to be updated and modernised, due also to the fact that pet owners, in particular, might be confused by some additive labelling.

(21) As a consequence of the bovine spongiform encephalopathy (BSE) and the dioxin crises, the obligation to indicate the percentage by weight of all feed materials incorporated in compound feed was introduced in 2002 by Directive 2002/2/EC of the European Parliament and of the Council of 28 January 2002 amending Council Directive 79/373/EEC on the circulation of compound feedingstuffs(18), at the initiative of the European Parliament. Furthermore, the level of food and feed safety has been significantly improved as a result of Regulation (EC) No 178/2002 and Regulation (EC) No 183/2005 and their implementing measures, in particular as a result of the focus put on the responsibility placed on feed and food business operators, the improved traceability system, the introduction of the hazard analysis and critical control points (HACCP) principle in feed businesses and the creation of guides to good hygiene practice in feed businesses. In light of these positive achievements, mirrored in the notifications to the Rapid Alert System for Food and Feed (RASFF), the obligation to indicate the percentage by weight of all feed materials incorporated in compound feed on the labelling is no longer necessary for the purpose of ensuring a high level of feed safety and thus a high level of protection of public health. The exact percentages may, however, be provided on a voluntary basis for the purpose of providing adequate information to purchasers. Furthermore, given that the competent authorities have access to information on the exact percentages by weight of all feed materials incorporated in compound feed, they should be able, on the ground of any urgency relating to human or animal health or to the environment, and in accordance with Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights(19), to provide further information to purchasers.

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

(23) 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 such cases, a margin of +/– 15 % of the declared value should be maintained.

(24) The intellectual property rights of producers should be protected. For the enforcement of such intellectual property rights, Directive 2004/48/EC should apply. It should also be acknowledged that the quantitative composition of compound feed, unlike the names of feed materials contained therein, can, under certain conditions, be considered confidential information to be protected.

(25) Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed(20) does not apply to the labelling of feed with excessive levels of undesirable substances. Provisions should therefore be laid down in order to ensure adequate labelling and proper implementation of the dilution ban provided for in Article 5 of that Directive, until such contaminated materials have been detoxified by a detoxification establishment, approved in accordance with Article 10(2) or (3) of Regulation (EC) No 183/2005, or until they have been cleaned.

(26) Derogations from the general labelling requirements should be provided for in so far as the application of such requirements is not necessary to protect human or animal health or consumer interests and would unduly burden the producer or the feed business operators responsible for the labelling. On the basis of experience, such derogations should be provided for, in particular with respect to feed delivered by one farmer to another for use on his farm, for small quantities, for compound feed not containing more than three feed materials and for mixes of whole plant grains, seeds and fruits.

(27) As a general rule, compound feed should be marketed in sealed containers, but appropriate derogations should be provided for in so far as the application of that requirement is not necessary to protect human or animal health or consumer interests and would represent an excessive burden for the feed business operators.

(28) Part B of the Annex to Directive 96/25/EC and columns 2 to 4 of the Annex to Directive 82/471/EEC contain lists of 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 of encouraging stakeholders to set voluntary standards by means of Community guidelines in the field of feed hygiene has been positive throughout. A more extensive listing could be achieved more flexibly, and could be better adapted to the information needs of the user, if undertaken by the stakeholders rather than by the legislator. The stakeholders can decide on the efforts they expend depending on the value of a list of feed materials. It is desirable, therefore, to establish a non-exhaustive Catalogue of feed materials to be used by feed business operators on a voluntary basis, except as regards use of the name of the feed material.

(29) The current lists of feed materials contained in Part B of the Annex to Directive 96/25/EC and columns 2 to 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 supplemented at the initiative of the stakeholders in accordance with their interests, including by the addition of emerging feed materials.

(30) In the interests of transparency, it is appropriate that the representatives of the stakeholders are notified of a feed material which is not listed in the catalogue as soon as such feed material is placed on the market for the first time.

(31) 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 relationship in the marketing of livestock feed and the relationship between the producer and the purchaser of pet food, Codes of good labelling for these two areas could be a 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 assist in the interpretation of the framework for voluntary labelling or the presentation of mandatory labelling. The Codes should be used on a voluntary basis, except in cases where use of the Codes is indicated on the labelling.

(32) Involvement of all parties concerned is the crucial element for ensuring the quality and appropriateness of the Catalogue and the Codes for good labelling. In order to strengthen the rights of users to proper information, their interests must be taken into consideration. This can be ensured by approval by the Commission of the Catalogue and the Codes, provided that the content thereof is practicable and that they are suitable for meeting the objectives of this Regulation.

(33) The Member States should lay down penalties for infringement of the provisions of this Regulation and should take all measures necessary to ensure that they are implemented. Such penalties should be effective, proportionate and dissuasive.

(34) A transitional period is necessary, in particular in respect of feed which fulfils a particular nutritional purpose and in respect of the acceptable level of chemical impurities resulting from the manufacturing process and from processing aids. The marketing of existing stock should also be permitted until it is exhausted. 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.

(35) Since the objective of this Regulation, namely harmonisation of the conditions for the placing on the market and the use of feed, in order to ensure a high level of feed safety and thus a high level of protection of public health as well as to provide adequate information for users and consumers and to strengthen the effective functioning of the internal market, 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 that objective.

(36) 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(21).

(37) In particular, the Commission should be empowered 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 the maximum content of chemical impurities or levels of botanical purity or the levels of moisture content or particulars replacing the compulsory declaration, to adapt the Annexes in light of scientific and technological developments 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 with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(38) On grounds of efficiency, the normal time limits for the regulatory procedure with scrutiny should be curtailed for the adoption of updates to the list of intended uses. When, on 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 adoption of amendments to the list of materials whose placing on the market or use for animal nutritional purposes is restricted or prohibited.

(39) Article 16 of Regulation (EC) No 1831/2003 lays down provisions for the labelling and packaging of feed additives and premixtures. Implementation of the rules concerning premixtures has, in particular, caused practical problems for the industry and the competent authorities. In order to allow for a more consistent labelling of premixtures, that Article should be amended,

HAVE ADOPTED THIS REGULATION:

CHAPTER 1U.K.INTRODUCTORY PROVISIONS

Article 1U.K.Objective

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 the use of feed, in order to ensure a high level of feed safety and thus a high level of protection of public health, as well as to provide adequate information for users and consumers and to strengthen the effective functioning of the F1... market.

Article 2U.K.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 [F2Great Britain], including requirements for labelling, packaging and presentation.

2.This Regulation shall apply without prejudice to other F3... provisions applicable in the field of animal nutrition, in particular:

(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(22);

(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(23);

(e)Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(24);

(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(25);

(g)Regulation (EC) No 1831/2003; and

(h)Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products(26).

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 3U.K.Definitions

1.For the purposes of this Regulation, the following definitions shall apply:

(a)the definitions of ‘feed’, ‘feed business’, and ‘placing on the market’ as laid down in Regulation (EC) No 178/2002;

(b)the definitions of ‘feed additive’, ‘premixture’, ‘processing aids’ and ‘daily ration’ as laid down in Regulation (EC) No 1831/2003; and

(c)the definitions of ‘establishment’ and ‘competent authority’ as laid down in Regulation (EC) No 183/2005.

2.The following definitions shall also apply:

(a)‘feed-business operator’ means any natural or legal person responsible for ensuring that the requirements of this Regulation are met within the feed business under their control;

(b)‘oral feeding of animals’ means the introduction of feed into an animal’s gastrointestinal tract through the mouth with the aim of meeting the animal’s nutritional needs and/or maintaining the productivity of normally healthy animals;

(c)‘food-producing animal’ means any animal that is fed, bred or kept for the production of food for human consumption, including animals that are not used for human consumption, but that belong to a species that is normally used for human consumption in the Community [F4or the United Kingdom];

(d)‘non-food producing animals’ means any animal that is fed, bred or kept but that is not used for human consumption, such as fur animals, pets and animals kept in laboratories, zoos or circuses;

(e)‘fur animals’ means any non-food producing animal fed, bred or kept for the production of fur, and which is not used for human consumption;

(f)‘pet’ or ‘pet animal’ means any non-food producing animal belonging to species fed, bred or kept, but not normally used for human consumption in the Community [F5or the United Kingdom];

(g)‘feed materials’ means products of vegetable or animal origin, whose principal purpose is to meet animals’ nutritional needs, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, whether or not containing feed additives, which are intended for use in oral animal-feeding either directly as such, or after processing, or in the preparation of compound feed, or as carrier of premixtures;

(h)‘compound feed’ means a 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;

(i)‘complete feed’ means compound feed which, by reason of its composition, is sufficient for a daily ration;

(j)‘complementary feed’ means 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;

(k)‘mineral feed’ means complementary feed containing at least 40 % crude ash;

(l)‘milk replacer’ means 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;

(m)‘carrier’ means a 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 itself;

(n)‘particular nutritional purpose’ means the purpose of meeting the specific nutritional needs of animals whose process of assimilation, absorption or metabolism is, or could be, temporarily or irreversibly impaired and who can therefore benefit from the ingestion of feed appropriate to their condition;

(o)‘feed intended for particular nutritional purposes’ means feed which can satisfy a particular nutritional purpose by virtue of its particular composition or method of manufacture, which clearly distinguishes it from ordinary feed. Feed intended for particular nutritional purposes does not include medicated feedingstuffs within the meaning of Directive 90/167/EEC;

(p)‘contaminated materials’ means feed containing a level of undesirable substances in excess of that which is acceptable under Directive 2002/32/EC;

(q)‘minimum storage life’ means the 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 it is determined on the basis of the minimum storage life of each of its components;

(r)‘batch’ or ‘lot’ means an identifiable quantity of feed determined to have common characteristics, such as origin, variety, type of packaging, packer, consignor or labelling, and, in the 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;

(s)‘labelling’ means the attribution of any words, particulars, trade marks, brand name, pictorial matter or symbol to a feed by placing this information on any medium referring to or accompanying such feed, such as packaging, container, notice, label, document, ring, collar or the Internet, including for advertising purposes;

(t)‘label’ means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed, impressed on, or attached to the packaging or the container of feed; and

(u)‘presentation’ means 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.

[F6(v)prescribe” means prescribe by regulations;

(w)appropriate authority” means—

(i)in relation to England, the Secretary of State;

(ii)in relation to Wales, the Welsh Ministers;

(iii)in relation to Scotland, the Scottish Ministers;

(x)Food Safety Authority” means—

(i)as regards England and Wales, the Food Standards Agency;

(ii)as regards Scotland, Food Standards Scotland.]

CHAPTER 2U.K.GENERAL REQUIREMENTS

Article 4U.K.Safety and marketing requirements

1.Feed may only be placed on the market and used if:

(a)it is safe; and

(b)it does not have a direct adverse effect on the environment or animal welfare.

The requirements set out in Article 15 of Regulation (EC) No 178/2002 shall apply, mutatis mutandis, to feed for non-food producing animals.

2.In addition to the requirements set out in paragraph 1 of this Article, feed business operators placing feed on the market shall ensure that the feed:

(a)is sound, genuine, unadulterated, fit for its purpose and of merchantable quality; and

(b)is labelled, packaged and presented in accordance with the provisions laid down in this Regulation and other applicable F7... legislation.

The requirements set out in Article 16 of Regulation (EC) No 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 to this Regulation.

Article 5U.K.Responsibilities and obligations of feed businesses

1.Feed business operators shall comply, mutatis mutandis, with obligations set out in Articles 18 and 20 of Regulation (EC) No 178/2002 and Article 4(1) of Regulation (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 competent authorities any information concerning the composition or claimed properties of the feed placed on the market by that person, which allows the accuracy of the information given by the labelling to be verified, including the exact percentages by weight of feed materials used in compound feed.

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

Article 6U.K.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 III.

[F82.The appropriate authority may prescribe 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 developments or intelligence sharing systems or results of official controls pursuant to Regulation (EC) No 882/2004.]

CHAPTER 3U.K.PLACING ON THE MARKET OF SPECIFIC TYPES OF FEED

[F9Article 7U.K.Characteristics of types of feed

The appropriate authority may, where necessary, prescribe whether a certain product constitutes feed for the purposes of this Regulation.]

Article 8U.K.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 levels of feed additives that are higher than 100 times the relevant fixed maximum content in complete feed or five times in case of coccidiostats and histomonostats.

2.The level of 100 times the relevant fixed maximum content in complete feed referred to in paragraph 1 may only be exceeded if the composition of the products concerned fulfils the particular nutritional purpose in respect of the relevant intended use under Article 10 of this Regulation. The conditions of use for such feed shall be further specified in the list of intended uses. Establishments under the control of a producer of such feed who uses feed additives referred to in Chapter 2 of Annex IV to Regulation (EC) No 183/2005 must be approved in accordance with point 1(b) of Article 10 of that Regulation.

Article 9U.K.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.

[F10Article 10U.K.List of intended uses of feed intended for particular nutritional purposes

The appropriate authority may prescribe how the list of intended uses set out in Directive 2008/38/EC may be updated, to include—

(a)how an intended use is to be assessed;

(b)how the conditions of use should be determined;

(c)the procedure by which—

(i)an application for adding a new use may be made;

(ii)an amendment to a use or one or more of its conditions may be authorised; and

(iii)a use may be removed.]

CHAPTER 4U.K.LABELLING, PRESENTATION AND PACKAGING

Article 11U.K.Principles for labelling and presentation

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

[F11(c)as to the compliance of the labelling with the Catalogue of Feed Materials and the Codes referred to in Articles 24 and 25.]

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 required under 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 of 20 May 1997 on the protection of consumers in respect of distance contracts(27) the mandatory labelling particulars required by this Regulation, except for the particulars provided for in Articles 15(b), (d), (e), and 16(2)(c) or 17(1)(d), shall appear on the material supporting the distance selling or they shall be provided through other appropriate means prior to the conclusion of a distance contract. The particulars referred to 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 IV to this Regulation.

Article 12U.K.Responsibility

1.The person responsible for the labelling shall ensure the presence and substantive accuracy of the labelling particulars.

2.The person responsible for the labelling shall be the feed business operator who first places feed on the market or, where applicable, the feed business operator under whose name or business name the feed is marketed.

3.To the extent that 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 ensure compliance with the labelling requirements, in particular by refraining from supplying feed which they know or should have presumed, on the basis of the information in their possession and as professionals, does not comply with those requirements.

5.Within the businesses under their control feed business operators shall ensure that mandatory labelling particulars are transmitted throughout the food chain in order to allow the information to be provided to the final feed user in accordance with this Regulation.

Article 13U.K.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

[F12(b)the person responsible for the labelling provides, at the request of the competent authority, scientific substantiation of the claim, either by reference to publicly available scientific evidence or through documented company research. The scientific substantiation must be available at the time the feed is placed on the market. Purchasers must have the right to bring to the attention of the competent authority their doubts in respect of the truthfulness of the claim. Where the conclusion is reached that the claim is not sufficiently substantiated, the labelling in respect of such claim must be considered misleading for the purposes of Article 11. Where the competent authority has doubts regarding the scientific substantiation of the claim concerned, it may submit the issue to the appropriate authority.]

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 of the type referred to 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 (EC) No 1831/2003; this point shall not, however, apply to claims concerning nutritional imbalances provided that there is no pathological symptom associated therewith;

(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.

F134.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F14Article 14U.K.Presentation of labelling particulars

1.The mandatory labelling particulars must be given in their entirety in a prominent place on the packaging, the container, on a label attached to it or on the accompanying document provided for in Article 11(2), in a conspicuous, clearly legible and indelible manner, in English or in English and Welsh.

2.The mandatory labelling particulars must be easily identifiable and must not be obscured by any other information. They must be displayed in a colour, font and size that does not obscure or emphasise any part of the information, unless such variation is to draw attention to precautionary statements.]

Article 15U.K.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 in accordance with Article 23(2)(a), (b) and (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 granted in accordance with Regulation (EC) No 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 VI or VII, as applicable, and without prejudice to labelling provisions laid down in the legal act authorising the respective feed additive; and

(g)

the moisture content in accordance with point 6 of Annex I.

Article 16U.K.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 [F1524(2)]; and

[F16(b)the compulsory declaration corresponding to the respective category as set out in the list in Annex 5; the compulsory declaration may be replaced by the particulars laid down in the Catalogue of Feed Materials referred to in Article 24 for each feed material in the respective category.]

2.In addition to the requirements provided for in paragraph 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 additives in question 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 point 4 of Annex II, where a maximum content of the additives in question is set; and

(c)the minimum storage life for additives other than technological additives.

Article 17U.K.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 point 4 of Annex II;

(c)in cases where the producer is not the person responsible for the labelling, the following shall be provided:

  • (c)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 in accordance with Articles 9, 23 or 24 of Regulation (EC) No 183/2005; if such number is not available, an identifying number allocated at the request of the producers or the importing feed business operator, which shall be 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:

  • (d)‘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 indicated on the label, the date indicating minimum storage life may be provided as well as ‘… (time period in days or months) after the date of manufacture’;

(e)a 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 by weight; and

(f)the compulsory declarations provided for in Chapter II of Annex VI or VII, as applicable.

2.As regards the list provided for in paragraph 1(e), the following requirements shall apply:

(a)the name and percentage by 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 by weight of the feed materials contained in compound feed for food-producing animals are not indicated on the labelling, the person responsible for the labelling shall, without prejudice to Directive 2004/48/EC, make available to the purchaser, on request, information on the quantitative composition data within a range of +/– 15 % of the value according to the feed formulation; and

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

3.In the event of any urgency relating to human or animal health or to the environment, and without prejudice to Directive 2004/48/EC, the competent authority may provide the purchaser with information that is available to it under Article 5(2), provided that, after having balanced the respective legitimate interests of the manufacturers and the purchasers, it concludes that the provision of such information is justified. If appropriate, the competent authority shall provide such information subject to the signing of a confidentiality clause by the purchaser.

F174.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 18U.K.Additional mandatory labelling requirements for feed intended for particular nutritional purposes

In addition to the general mandatory requirements laid down in Articles 15, 16 and 17, as applicable, the labelling of feed intended for particular nutritional purposes shall also include:

(a)

the qualifying expression ‘dietetic’, in the case, exclusively, of 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 to 6 of the list of intended uses referred to in Article 9; and

(c)

an indication that the opinion of a nutrition expert or veterinarian should be sought before using the feed or before extending its period of use.

Article 19U.K.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 contained in the pet food; and

(b)

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

[F18Article 20U.K.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 requirements set out in Annex 8, such as contaminated materials, must bear the labelling particulars laid down in that Annex.

2.The appropriate authority may prescribe amendments to Annex 8 in order to bring it into line with the development of standards.]

Article 21U.K.Derogations

1.The particulars referred to in Article 15(c), (d), (e), and (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) and (e) and Article 16(2)(c) or Article 17(1)(c), (d), and (e) may be given on the packaging 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 (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 in accordance with Article 5(1) of Regulation (EC) No 183/2005 to a feed user involved in primary production for use within his 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 fruit.

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 are clearly indicated 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 such cases, 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) and (g) and Article 17(1)(b), (c), (e) and (f) may be given only on the outer packaging instead of on each container, provided that the combined total weight of the package does not exceed 10 kg.

[F198.The appropriate authority may derogate from the provisions of this Regulation in respect of of feed intended for animals kept for scientific or experimental purposes on condition that such purpose is clearly indicated on the label.]

Article 22U.K.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 complied with.

F202.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 23U.K.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 obtained exclusively 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; and

(g)blocks or licks.

CHAPTER 5U.K.F21... CATALOGUE OF FEED MATERIALS AND F21... CODES OF GOOD LABELLING PRACTICE

[F22Article 24U.K. Catalogue of feed materials

1.A Catalogue of Feed Materials (the Catalogue) must be maintained by the appropriate authority. The Catalogue must 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); and

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

2.Use of the Catalogue by the feed business operators is voluntary. However, the name of a feed material listed in the Catalogue may be used only on condition that all relevant provisions of the Catalogue are complied with.

3.The person who, for the first time, places on the market a feed material that is not listed in the Catalogue must immediately notify its use to the representatives of feed businesses in Great Britain.

4.The appropriate authority may prescribe amendments to the Catalogue.]

[F23Article 25U.K. Codes of good labelling practice

1.The Food Safety Authority is to develop Codes of good labelling practice (the 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 must aim to improve the appropriateness of the labelling. They must, 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.Use of the Codes by the feed business operators is voluntary. However, use of any of the Codes may be indicated on the labelling only on condition that all relevant provisions of such Code are complied with.]

F24Article 26U.K.Establishment of the Codes and amendments to the Community Catalogue and the Community Codes

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

CHAPTER 6U.K.GENERAL AND FINAL PROVISIONS

[F25Article 27U.K.Implementing measures

The appropriate authority may prescribe amendments to the Annexes in order to adapt them in light of scientific and technological developments.]

F26Article 28U.K.Committee procedure

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F27Article 28AU.K.Regulations and devolved powers

1.Any power to make regulations under this Regulation—

(a)so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;

(b)so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument.

2.For regulations made under this Regulation by the Scottish Ministers, see also section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010 (Scottish statutory instruments).

3.Any power to make regulations under this Regulation includes power—

(a)to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business);

(b)to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.

4.Any statutory instrument or Scottish statutory instrument containing regulations under this Regulation is subject to annulment in pursuance of a resolution—

(a)in the case of England, of either House of Parliament;

(b)in the case of Wales, of Senedd Cymru;

(c)in the case of Scotland, of the Scottish Parliament;

5.In this Regulation, any power—

(a)of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;

(b)of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;

(c)of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only.]

Article 29U.K.Amendment to Regulation (EC) No 1831/2003

Article 16 of Regulation (EC) No 1831/2003 shall be 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 of 12 January 2005 laying down requirements for feed hygiene(28) or, as applicable, to Article 5 of Directive 95/69/EC;;

(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 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed(29), 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..

Article 30U.K.Repeal

Article 16 of Directive 70/524/EEC and Directives 79/373/EEC, 80/511/EEC, 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC, and Decision 2004/217/EC are repealed with effect from 1 September 2010.

References to the repealed Directives and to the repealed Decision shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex IX.

F28Article 31U.K.Penalties

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 32U.K.Transitional measures

1.By way of derogation from the second subparagraph of Article 33, feed placed on the market or labelled in accordance with Directives 79/373/EEC, 82/471/EEC, 93/74/EEC and 96/25/EC before 1 September 2010 may be placed or remain on the market until stocks are exhausted.

2.By way of derogation from Article 8(2), types of feed referred to in that Article that have already been legally placed on the market before 1 September 2010 may be placed or remain 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 before 1 September 2010.

3.By way of derogation from point 1 of Annex I to this Regulation, 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 out in point 1 of Part A, Title II of the Annex to Directive 96/25/EC. This derogation shall cease to apply, however, on 1 September 2012.

4.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. Such measures, designed to amend the non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(4).

Article 33U.K.Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply from 1 September 2010.

However, Articles 31 and 32 shall apply from the date of entry into force of this Regulation.

F29...

ANNEX IU.K. Technical provisions on impurities, milk replacer, feed materials for binding or denaturising, the ash level and moisture content as referred to in Article 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 24.U.K.

2.The botanical purity of feed materials shall not be less than 95 %, unless a different level has been laid down in the Catalogue referred to in Article 24. Botanical impurities comprise impurities of plant materials which do not have 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.U.K.

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 %.U.K.

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.U.K.

5.The level of ash insoluble in hydrochloric acid shall not exceed 2,2 % of the dry matter. The 2,2 % level may, however, be exceeded for:U.K.

  • feed materials,

  • compound feed containing authorised 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 V or the Catalogue referred to in Article 24 the moisture content of the feed must be stated if it exceeds:U.K.

  • 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 IIU.K.General provisions on labelling as 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.U.K.

2.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’.U.K.

[F303.In the designation of feed for pets, the expression ‘pet food’ shall be allowed.]U.K.

4.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:U.K.

  • 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 the respective maximum contents of feed additives in the daily ration are complied with.

5.Without affecting the analytical methods, for pet food the expression ‘crude protein’ may be replaced by ‘protein’, ‘[F31crude fat]’ may be replaced by ‘fat content’ and ‘crude ash’ may be replaced by ‘incinerated residue’ or ‘inorganic matter’.U.K.

ANNEX IIIU.K. 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 and separated digestive tract content resulting from the 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 by-products derived therefrom.

    4.

    Wood, including sawdust or other materials derived from wood, which has been treated with wood preservatives as defined in Annex V to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market(30).

    5.

    [F32All waste obtained from the various phases of the treatment of the urban, domestic and industrial waste water, as defined in Article 2 of Council Directive 91/271/EEC of 21 May 1991 concerning urban waste water treatment (31) , irrespective of any further processing of that waste and irrespective of the origin of the waste waters (32) .

    6.

    Solid urban waste (33) , such as household waste.]

    7.

    Packaging from the use of products from the agri-food industry, and parts thereof.

    8.

    [F33Protein products obtained from yeasts of the Candida variety cultivated on n-alkanes.]

  • Chapter 2: Restricted materials

[F34ANNEX IV U.K. Permitted tolerances for the compositional labelling of feed materials or compound feed provided for in Article 11(5)

[F35Part A: Tolerances for the analytical constituents set out in Annexes I, V, VI and VII U.K.

(1) The tolerances laid down in this Part include technical and analytical deviations. Once analytical tolerances covering measurement uncertainties and procedural variations are fixed F36..., the values set in point 2 should be adapted accordingly in order to cover only the technical tolerances. U.K.

Textual Amendments

F36Words in Annex 4 Pt. A point (1) omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 120; 2020 c. 1, Sch. 5 para. 1(1)

(2) Where the composition of a feed material or compound feed is found to deviate from the labelled value of the analytical constituents set out in Annexes I, V, VI and VII the following tolerances shall apply: U.K.

a

The tolerances are given either as an absolute percentage value (this value must be subtracted from/added to the declared content) or as a relative value marked with ‘ % ’ after the value (this percentage must be applied to the declared content to calculate the acceptable deviation).

b

The tolerances are applicable where no tolerance has been laid down in accordance with an EU method or in accordance with an official national method in the Member State in which the feed is placed on the market or in accordance with an method adopted by the European Committee for Standardisation (https://standards.cen.eu/dyn/www/f?p=204:32:0::::FSP_ORG_ID,FSP_LANG_ID:6308,25&cs=1C252307F473504B6354F4EE56B99E235). ]

Constituent Declared content of the constituent Tolerance a
[%] Below the labelled value Above the labelled value
crude fat < 8 1 2
8 - 24 12,5 % 25 %
> 24 3 6
crude fat, feed for non-food producing animals < 16 2 4
16 - 24 12,5 % 25 %
> 24 3 6
crude protein < 8 1 1
8 - 24 12,5 % 12,5 %
> 24 3 3
crude protein, feed for non-food producing animals < 16 2 2
16 - 24 12,5 % 12,5 %
> 24 3 3
crude ash < 8 2 1
8 - 32 25 % 12,5 %
> 32 8 4
crude fibre < 10 1,75 1,75
10 - 20 17,5 % 17,5 %
> 20 3,5 3,5
sugar < 10 1,75 3,5
10 - 20 17,5 % 35 %
> 20 3,5 7
starch < 10 3,5 3,5
10 - 20 35 % 35 %
> 20 7 7
calcium < 1 0,3 0,6
1 - 5 30 % 60 %
> 5 1,5 3
magnesium < 1 0,3 0,6
1 - 5 30 % 60 %
> 5 1,5 3
sodium < 1 0,3 0,6
1 - 5 30 % 60 %
> 5 1,5 3
total phosphorus < 1 0,3 0,3
1 - 5 30 % 30 %
> 5 1,5 1,5
ash insoluble in hydrochloric acid < 1 no limits are set 0,3
[F311 - 5] 30 %
> 5 1,5
potassium < 1 0,2 0,4
1 - 5 20 % 40 %
> 5 1 2
moisture < 2 no limits are set 0,4
2 - < 5 20 %
5 - 12,5 1
> 12,5 8 %
energy value b 5 % 10 %
protein value b 10 % 20 %

Part B: U.K. Tolerances for feed additives labelled according to Annexes I, V, VI and VII

1. The tolerances laid down in this Part include technical deviation only. They shall apply to feed additives in the list of feed additives and in the list of analytical constituents. U.K.

As regards feed additives listed as analytical constituents, the tolerances shall apply to the total amount labelled as the guaranteed quantity at the end of the minimum storage life of the feed.

Where the content of a feed additive in a feed material or compound feed is found to be below the declared content, the following tolerances shall apply (34) :

(a)

10 % of the declared content if the declared content is 1 000 units or more;

(b)

100 units if the declared content is less than 1 000 units but not less than 500 units;

(c)

20 % of the declared content if the declared content is less than 500 units but not less than 1 unit;

(d)

0,2 units if the declared content is less than 1 unit but not less than 0,5 units;

(e)

40 % of the declared content if the declared content is less than 0,5 units.

2. Where a minimum and/or a maximum content of an additive in a feed is laid down in the respective authorisation act for that feed additive, the technical tolerances laid down in point 1 shall only apply above a minimum content or below a maximum content, where appropriate. U.K.

3. As long as the fixed maximum content of an additive as referred to in point 2 is not exceeded, the deviation above the declared content may go up to three times the tolerance laid down in point 1. However, if for feed additives belonging to the group of micro-organisms a maximum content is laid down in the respective authorising act for that feed additive, the maximum content shall constitute the upper permitted value.] U.K.

ANNEX VU.K.

Compulsory declaration for feed materials as referred to in Article 16(1)(b)

Feed material consisting ofCompulsory 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 %

[F31Crude fat], if > 5 %

Crude fibre

4.Oil seeds, oil fruits
5.Products and by-products of oil seeds, oil fruits

Crude protein, if > 10 %

[F31Crude fat], 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 mentioned in 2-7

Crude protein

Crude fibre

[F31Crude fat], if > 10 %

13.Other plants, their products and by-products, except those mentioned in 8-11

Crude protein, if > 10 %

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 %

[F31Crude fat], if > 5 %

Moisture, if > 8 %

16.Fish, other marine animals, their products and by-products

Crude protein, if > 10 %

[F31Crude fat], if > 5 %

Moisture, if > 8 %

17.Minerals

Calcium

Sodium

Phosphorus

Other relevant minerals

18.Miscellaneous

Crude protein, if > 10 %

Crude fibre

[F31Crude fat], if > 10 %

Starch, if > 30 %

Total sugar, as sucrose, if > 10 %

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

[F35ANNEX VI U.K. Labelling particulars for feed materials and compound feed for food-producing animals

Chapter I: Compulsory and voluntary labelling of feed additives as referred to in Article 15(f) and 22(1) U.K.

1. The following additives shall be listed, along with their specific names, identification numbers, added amount and the name of the functional group as laid down in Annex I to Regulation (EC) No 1831/2003 or the category referred to in Article 6(1) of that Regulation: U.K.

(a)

additives where a maximum content is set for at least one food producing animal;

(b)

additives belonging to the categories zootechnical additives and coccidiostats and histomonostats ;

(c)

additives for which the recommended maximum contents established in the legal act authorising the feed additive are exceeded.

The labelling particulars shall be indicated in accordance with the legal act authorising the feed additive in question.

The added amount referred to in the first paragraph shall be expressed as the amount of the feed additive except where the legal act authorising the respective feed additive indicates a substance in the column minimum/maximum content . In this latter case, the added amount shall be expressed as the amount of that substance.

2. For feed additives of the functional group vitamins, pro-vitamins and chemically well-defined substances having similar effect which must be listed pursuant to point 1, the labelling may indicate the total amount guaranteed during the complete shelf-life under the heading Analytical constituents instead of indicating the added amount under the heading Additives . U.K.

3. The name of the functional group as referred to in point 1, 4 and 6 may be replaced by the following abbreviation, if such abbreviation is not established in Annex I to Regulation (EC) No 1831/2003: U.K.

Functional group Name and description Abbreviated name
1h Substances for control of radionuclide contamination: substances that suppress absorption of radionuclides or promote their excretion Radionuclide controllers
1m Substances for reduction of the contamination of feed by mycotoxins: substances than can suppress or reduce the absorption, promote the excretion of mycotoxins or modify their mode of action Mycotoxin reducers
1n Hygiene condition enhancers: substances or, when applicable, microorganisms which favourably affect the hygienic characteristics of feed by reducing a specific microbiological contamination Hygiene improvers
2b Flavouring compounds: substances the inclusion of which in feedingstuffs increase feed smell or palatability. Flavourings
3a Vitamins, pro-vitamins and chemically well-defined substances having similar effect Vitamins
3b Compounds of trace elements Trace elements
3c Amino acids, theirs salts and analogues Amino acids
3d Urea and its derivatives Urea
4c Substances affecting favourably the environment Environment improvers

4. Feed additives emphasised on the labelling in words, pictures or graphics shall be indicated in accordance with point 1 or 2, as applicable. U.K.

5. The person responsible for the labelling shall disclose the names, the identification number and the functional group of the feed additives not mentioned in point 1, 2 and 4 to the purchaser at his request. This provision shall not apply to flavouring compounds. U.K.

6. Feed additives not mentioned in points 1, 2 and 4 may be voluntarily indicated at least with their name or, in the case of flavouring compounds, at least with their functional group. U.K.

[F317. Without prejudice to point 6, where a sensory or nutritional feed additive is labelled on a voluntary basis, the added amount shall be indicated in accordance with point 1 or in case of feed additives of the functional group vitamins, pro-vitamins and chemically well-defined substances having similar effect, the total amount guaranteed during the complete shelf-life shall be indicated in accordance with point 2.] U.K.

8. 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. U.K.

9. Labelling particulars concerning the proper use of feed materials and compound feed which are laid down in the legal act authorising the feed additive in question shall be indicated. U.K.

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

1. The analytical constituents of compound feed for food producing animals shall be indicated on the label, preceded by the heading Analytical constituents’(35) , as follows: U.K.

Compound feed Target species Analytical constituents and levels
Complete feed

All species

All species

All species

All species

All species

All species

All species

Pigs and poultry

Pigs and poultry

  • Crude protein

  • Crude fibre

  • Crude fat

  • Crude ash

  • Calcium

  • Sodium

  • Phosphorus

  • Lysine

  • Methionine

Complementary feed — Mineral

All species

All species

All species

Pigs and poultry

Pigs and poultry

Ruminants

  • Calcium

  • Sodium

  • Phosphorus

  • Lysine

  • Methionine

  • Magnesium

Complementary feed — Other

All species

All species

All species

All species

All species

All species

All species

Pigs and poultry

Pigs and poultry

Ruminants

  • Crude protein

  • Crude fibre

  • Crude fat

  • Crude ash

  • Calcium ≥ 5 %

  • Sodium

  • Phosphorus ≥ 2 %

  • Lysine

  • Methionine

  • Magnesium ≥ 0,5 %

2. Substances indicated under this heading, which are also sensory or nutritional additives, shall be declared along with the total amount thereof. U.K.

3. If the energy value and/or protein value are indicated, such indication shall be in accordance with Article 11 of Regulation (EC) No 882/2004.] U.K.

[F35ANNEX VII U.K. Labelling particulars for feed materials and compound feed for non-food producing animals

Chapter I: Compulsory and voluntary labelling of feed additives as referred to in Articles 15(f) and 22(1) U.K.

1. The following additives shall be listed, along with their specific names and/or identification numbers, added amount and the name of the functional group as laid down in Annex I to Regulation (EC) No 1831/2003 or the category referred to in Article 6(1) of that Regulation: U.K.

(a)

additives where a maximum content is set for at least one non-food producing animal;

(b)

additives belonging to the categories zootechnical additives and coccidiostats and histomonostats ;

(c)

additives for which the recommended maximum contents established in the legal act authorising the feed additive are exceeded.

The labelling particulars shall be indicated in accordance with the legal act authorising the feed additive in question.

The added amount referred to in the first paragraph shall be expressed as the amount of the feed additive except where the legal act authorising the respective feed additive indicates a substance in the column minimum/maximum content . In this latter case, the added amount shall be expressed as the amount of that substance.

2. For feed additives of the functional group vitamins, pro-vitamins and chemically well-defined substances having similar effect which must be listed pursuant to point 1, the labelling may indicate the total amount guaranteed during the complete shelf-life under the heading Analytical constituents instead of indicating the added amount under the heading Additives . U.K.

3. The name of the functional group as referred to in point 1, 5 and 7 may be replaced by the abbreviation in accordance with the table in point 3 of Annex VI, if such abbreviation is not established in Annex I to Regulation (EC) No 1831/2003. U.K.

4. Feed additives emphasised on the labelling in words, pictures or graphics shall be indicated in accordance with point 1 or 2, as applicable. U.K.

5. By way of derogation from point 1, for additives of the functional groups preservatives , antioxidants , colourants and flavouring compounds , only the functional group in question needs to be indicated. In this case the information referred to in point 1 and 2 shall be disclosed by the person responsible for the labelling to the purchaser at his request. U.K.

6. The person responsible for the labelling shall disclose the names, the identification number and the functional group of the feed additives not mentioned in point 1, 2 and 4 to the purchaser at his request. This provision shall not apply to flavouring compounds. U.K.

7. Feed additives not mentioned in point 1, 2 and 4 may be voluntarily indicated at least with their name or, in the case of flavouring compounds, at least with their functional group. U.K.

[F318. Without prejudice to point 7, where a sensory or nutritional feed additive is labelled on a voluntary basis, the added amount shall be indicated in accordance with point 1 or in case of feed additives of the functional group vitamins, pro-vitamins and chemically well-defined substances having similar effect, the total amount guaranteed during the complete shelf-life shall be indicated in accordance with point 2.] U.K.

9. 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. U.K.

10. Labelling particulars concerning the proper use of feed materials and compound feed which are laid down in the legal act authorising the feed additive in question shall be indicated. U.K.

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

1. The analytical constituents of compound feed for non-food producing animals shall be listed under the heading Analytical constituents’(36) and shall be labelled as follows: U.K.

Compound feed Target species Analytical constituents
Complete feed

Cats, dogs and fur animals

Cats, dogs and fur animals

Cats, dogs and fur animals

Cats, dogs and fur animals

  • Crude protein

  • Crude fibres

  • Crude fat

  • Crude ash

Complementary feed — Mineral

All species

All species

All species

  • Calcium

  • Sodium

  • Phosphorus

Complementary feed — Other

Cats, dogs and fur animals

Cats, dogs and fur animals

Cats, dogs and fur animals

Cats, dogs and fur animals

  • Crude protein

  • Crude fibres

  • Crude fat

  • Crude ash

2. Substances indicated under this heading, which are also sensory or nutritional additives, shall be declared along with the total amount thereof. U.K.

3. If the energy value and/or protein value are indicated, such indication shall be in accordance with Article 11 of Regulation (EC) No 882/2004.] U.K.

ANNEX VIIIU.K.Specific provisions for the labelling of feed which does not comply with safety and marketing requirements under [F37retained EU] law as referred to in Article 20(1)

Textual Amendments

[F351. 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 approved establishments ’ . The approval of such establishments shall be in accordance with Article 10(2) or (3) of Regulation (EC) No 183/2005.] U.K.

2.Where the contamination is intended to be reduced or eliminated by cleaning, the labelling of contaminated materials shall contain the following addition: ‘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’.U.K.

[F383. Without prejudice to point 1 and 2, former foodstuffs that need to be processed before they can be used as feed, shall be labelled as: ‘ former food, only to be used as feed material after … (designation of the adequate process in accordance with part B of the Annex to Regulation (EU) No 68/2013) ’ .] U.K.

ANNEX IXU.K.

CORRELATION TABLE

Directive 79/373/EECDirective 96/25/ECOther acts: Directives 80/511/EEC (1), 82/471/EEC (2), 93/74/EEC (3), 93/113 EC (4), or Decision 2004/217/EC (5)This Regulation
Article 1
Article 1Article 1

(2), (4): Article 1

(3): Article 4

Article 2
Article 2Article 2(2), (3): Article 2Article 3
Article 4(1)
Article 3Article 3(3): Article 1(2)Article 4(2)
Article 4Article 4(3)
Article 5(1)
Article 12(3): Article 10(2)Article 5(2)
Article 10a(3)Article 11(b)(2): Article 8Article 6
Article 7
Article 8
(3): Article 3Article 9
(3): Article 6Article 10
Article 5eArticle 11(1)
Article 5(2)Article 5(1)(2): Article 5(2)Article 11(2)
Article 11(3)
Article 5(6)Articles 4 and 6(4)Article 11(4)
Article 6Article 4Article 11(5)
Article 5(1)Article 5(1)Article 12
Article 5eArticle 5(2)(3): Article 5(6)Article 13
Article 5(1), Article 11Article 5(1), Article 9Article 14
Articles 5(1) and 5(5)(c)Article 5(1)(4): Article 7(1)E and Directive 70/524/EEC: Article 16Article 15
Article 5(1)(c), (d) and 7Article 16
Articles 5(1), 5c and 5dArticle 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 8Article 20
Article 6(1)(a)Article 21(1)
Article 5(5)(d)Article 21(2)
Article 6(3)(a)Article 21(3)
Article 5(5)(b)Article 21(4)
Article 5(5)(a)Article 21(5)
Article 5(2)Article 5(3), 6(1)(b)Article 21(6)
Article 21(7)
Article 14(c)Article 21(8)
Article 5(3), 5c(4) and 5eArticle 5(2)Article 22
Article 4(1)(1): Article 1Article 23
Article 24
Article 25
Article 26
Article 10Article 11Article 27
Article 13Article 13

(2): Articles 13 and 14

(3): Article 9

Article 28
Article 29
Article 30
Article 31
Article 32
Article 33
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
(5): AnnexAnnex III
Annex Part A(5), (6)Annex Part A(VII)Annex IV
Annex Part CAnnex V
Annex Part BAnnex VI
Annex Part BAnnex VII
(2)

Opinion of the European Parliament of 5 February 2009 (not yet published in the Official Journal) and Council Decision of 22 June 2009.

(32)

[F32The term waste water does not refer to process water , i.e. water from independent conduits integrated in food or feed industries; where these conduits are supplied with water, no water may be used for animal nutrition unless it is wholesome and clean water as specified in Article 4 of Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption ( OJ L 330, 5.12.1998, p. 32 ). In the case of fish industries, the conduits concerned may also be supplied with clean seawater as defined in Article 2 of Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs ( OJ L 139, 30.4.2004, p. 1 ). Process water may not be used for animal nutrition unless it carries feed or food material and is technically free from cleaning agents, disinfectants or other substances not authorised by the animal nutrition legislation.]

(33)

[F32The term solid urban waste does not refer to catering waste as defined by Regulation (EC) No 1774/2002.]

(34)

[F341 unit in this point means 1 mg, 1 000 IU, 1 × 10 9 CFU or 100 enzyme activity units of the respective feed additive per kg feed, as appropriate.]

(35)

[F35In German language analytische Bestandteile may be replaced by Inhaltsstoffe . In Swedish language Analytiska beståndsdelar may be replaced by Analyserat innehåll .]

(36)

[F35In German language analytische Bestandteile may be replaced by Inhaltsstoffe . In Swedish language Analytiska beståndsdelar may be replaced by Analyserat innehåll .]

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