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)

CHAPTER 1

INTRODUCTORY PROVISIONS

Article 1

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 internal market.

Article 2

Scope

This Regulation shall apply without prejudice to other Community 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 (¹);

(d) Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (²);

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

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

(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 (⁵).

Article 3

Definitions

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.

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;

(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;

(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.

CHAPTER 2

GENERAL REQUIREMENTS

Article 4

Safety and marketing requirements

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.

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 Community 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.

Article 5

Responsibilities and obligations of feed businesses

Article 6

Restriction and prohibition

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

On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 28(5) with a view to adopting those measures.

CHAPTER 3

PLACING ON THE MARKET OF SPECIFIC TYPES OF FEED

Article 7

Characteristics of types of feed

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

Article 8

Content of feed additives

Article 9

Marketing of feed intended for particular nutritional purposes

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

Article 10

List of intended uses of feed intended for particular nutritional purposes

Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(6).

In such cases, where applicable, the Commission shall inform the applicant and the Member States directly, indicating in its letter the reasons for failing to consider the update justified.

CHAPTER 4

LABELLING, PRESENTATION AND PACKAGING

Article 11

Principles for labelling and presentation

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

(a) as to the intended use or characteristics of the feed, in particular, the nature, method of manufacture or production, properties, composition, quantity, durability, species or categories of animals for which it is intended;

(b) by attributing to the feed effects or characteristics that it does not possess or by suggesting that it possesses special characteristics when in fact all similar feeds possess such characteristics; or

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

Article 12

Responsibility

Article 13

Claims

The labelling and the presentation of feed materials and compound feed may draw particular attention to the presence or the absence of a substance in the feed, to a specific nutritional characteristic or process or to a specific function related to any of these, provided that the following conditions are met:

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

(b) the person responsible for the labelling provides, 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).

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.

Article 14

Presentation of labelling particulars

Article 15

General mandatory labelling requirements

A feed material or compound feed shall not be placed on the market unless the following particulars are indicated by labelling:

(a) the type of feed: ‘feed material’, ‘complete feed’ or ‘complementary feed’, as appropriate; — for ‘complete feed’, the designation ‘complete milk replacer feed’ may be used, if appropriate, — for ‘complementary feed’, the following designations may be used if appropriate: ‘mineral feed’ or ‘complementary milk replacer feed’, — for pets other than cats and dogs, ‘complete feed’ or ‘complementary feed’ may be replaced by ‘compound feed’;

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

(c) if available, the establishment approval number of the person responsible for the labelling granted in accordance with Article 13 of Regulation (EC) No 1774/2002 for establishments authorised 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 16

Specific mandatory labelling requirements for feed materials

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 24(5); and

(b) 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.

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 17

Specific mandatory labelling requirements for compound feed

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: — 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: — ‘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.

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.

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

Article 18

Additional mandatory labelling requirements for feed intended for particular nutritional purposes