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) - Main contents

EN

Official Journal of the European Union

L 229/1

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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,

Directive 90/167/EEC;

Directive 2002/32/EC;

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);

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);

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

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);

Regulation (EC) No 1831/2003; and

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

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

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

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

‘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;

‘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;

‘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;

‘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;

‘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;

‘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;

‘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;

‘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;

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

‘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;

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

‘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;

‘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;

‘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;

‘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;

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

‘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;

‘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;

‘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;

‘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

‘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.

it is safe; and

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

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

is labelled, packaged and presented in accordance with the provisions laid down in this Regulation and other applicable Community legislation.

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;

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

as to the compliance of the labelling with the Community Catalogue and the Community Codes referred to in Articles 24 and 25.

the claim is objective, verifiable by the competent authorities and understandable by the user of the feed; and

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 shall be available at the time the feed is placed on the market. Purchasers shall have the right to bring to the attention of the competent authority their doubts in respect of the truthfulness of the claim. Where the conclusion is reached that the claim is not sufficiently substantiated, the labelling in respect of such claim shall 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 Commission. The Commission may adopt a decision, where appropriate after obtaining an opinion from the Authority, in accordance with the advisory procedure laid down in Article 28(2).

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;

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.

the type of feed: ‘feed material’, ‘complete feed’ or ‘complementary feed’, as appropriate;

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

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;

the batch or lot reference number;

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;

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

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

the name of the feed material; the name shall be used in compliance with Article 24(5); and

the compulsory declaration corresponding to the respective category as set out in the list in Annex V; the compulsory declaration may be replaced by the particulars laid down in the Community Catalogue referred to in Article 24 for each feed material in the respective category.

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;

instructions for proper use in accordance with point 4 of Annex II, where a maximum content of the additives in question is set; and

the minimum storage life for additives other than technological additives.

the species or categories of animals for which the compound feed is intended;

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;

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

the indication of the minimum storage life in accordance with the following requirements:

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’;

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

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

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;

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

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.

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);

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

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.

the feed additives contained in the pet food; and

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

feed materials;

compound feed obtained exclusively by mixing grain or whole fruit;

deliveries between producers of compound feed;

deliveries of compound feed directly from the producer to the feed user;

deliveries from producers of compound feed to packaging firms;

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

blocks or licks.

the name;

the identification number;

a description of the feed material including information on the manufacturing process, if appropriate;

particulars replacing the compulsory declaration for the purpose of Article 16(1)(b); and

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

in consultation with other concerned parties, such as feed users;

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

taking into account relevant experience from opinions issued by the Authority and scientific or technological developments.

they have been developed in accordance with paragraph 1;

their content is capable of being applied throughout the Community in the sectors to which they refer; and

they are suitable for meeting the objectives of this Regulation.

paragraph 1 is amended as follows:

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.’;

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.

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.

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.

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 %.

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.

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:

provided that the level is declared on the label.

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:

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

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’.

Synonymic expressions in certain languages;

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

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

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

Chapter 1: Prohibited materials

Chapter 2: Restricted materials

The tolerances laid down in this Annex include technical and analytical deviations. Once analytical tolerances covering measurement uncertainties and procedural variations are fixed at Community level, the values set out in paragraph 2 should be adapted accordingly in order to cover only the technical tolerances.

Where the composition of a feed material or compound feed is found to depart from the labelled composition in a manner such as to reduce its value, the following tolerances are permitted:

As long as the fixed maximum level for each feed additive is not exceeded, the variation from the declared content may be up to three times the relevant tolerance laid down in paragraph 2.

For feed additives belonging to the group of micro-organisms the acceptable upper limit shall correspond to the fixed maximum level.

The following additives shall be listed with their specific names as defined in the relevant legal act authorising the feed additive in question, added amount, identification number and 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:

The name as laid down in the relevant legal act authorising the feed additive in question and the added amount of the feed additive shall be indicated if its presence is emphasised on the labelling in words, pictures or graphics.

The person responsible for the labelling shall disclose the names, the identification number and the functional group of the feed additives not mentioned in paragraph 1 to the purchaser at his request.

Feed additives not mentioned in paragraph 1 may be voluntarily indicated in the form laid down in paragraph 1 or partially.

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

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.

The analytical constituents of compound feed for food producing animals shall be labelled as follows:

If amino acids, vitamins and/or trace elements are indicated under the heading of analytical constituents, they shall be declared, along with the total amount thereof.

If the energy value and/or protein value are indicated, such indication shall be in accordance with the EC method, if available or with the respective official national method in the Member State where the feed is placed on the market, if available.

The following additives shall be listed, along with their specific names as defined in the relevant legal act authorising the feed additive in question and/or its identification number, 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:

By way of derogation from paragraph 1, for additives of the functional groups ‘preservatives’, ‘antioxidants’ and ‘colourants’ as laid down in Annex I to Regulation (EC) No 1831/2003, only the functional group in question need be indicated.

In this case the information pursuant to paragraph 1 shall be disclosed by the person responsible for the labelling to the purchaser at his request.

The name as laid down in the relevant legal act authorising the feed additive in question and the added amount of the feed additive shall be indicated if its presence is emphasised on the labelling in words, pictures or graphics.

The person responsible for the labelling shall disclose the names, the identification number and the functional group of the feed additives not mentioned in paragraph 1 to the purchaser at his request.

Feed additives not mentioned in paragraph 1 may be voluntarily indicated in the form laid down in paragraph 1 or partially.

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

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.

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

The analytical constituents of compound feed for non-food producing animals shall be labelled as follows:

If amino acids, vitamins and/or trace elements are indicated under the heading of analytical constituents, they shall be declared, along with the total amount thereof.

If the energy value and/or protein value are indicated, such indication shall be in accordance with the EC method, if available, or with the respective official national method in the Member State where the feed is placed on the market, if available.

Contaminated materials shall be labelled as ‘feed with excessive level(s) of … (designation of the undesirable substance(s) in accordance with Annex I to Directive 2002/32/EC), only to be used as feed after detoxification in authorised establishments’. The authorisation of such establishments shall be in accordance with Article 10(2) or (3) of Regulation (EC) No 183/2005.

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’.