Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (Text with EEA relevance)

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter

This Regulation lays down:

(a) general rules on feed hygiene;

(b) conditions and arrangements ensuring traceability of feed;

(c) conditions and arrangements for registration and approval of establishments.

Article 2

Scope

This Regulation shall apply to:

(a) the activities of feed business operators at all stages, from and including primary production of feed, up to and including, the placing of feed on the market;

(b) the feeding of food-producing animals;

(c) imports and exports of feed from and to third countries.

This Regulation shall not apply to:

(a) the private domestic production of feed: (i) for food-producing animals kept for private domestic consumption; and (ii) for animals not kept for food production;

(b) the feeding of food-producing animals kept for private domestic consumption or for the activities mentioned in Article 1(2)(c) of Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (¹);

(c) the feeding of animals not kept for food production;

(d) the direct supply of small quantities of primary production of feed at local level by the producer to local farms for use on those farms;

(e) the retailing of pet food.

Article 3

Definitions

For the purposes of this Regulation, the definitions in Regulation (EC) No 178/2002 shall apply, subject to the following specific definitions:

(a) ‘feed hygiene’ means the measures and conditions necessary to control hazards and to ensure fitness for animal consumption of a feed, taking into account its intended use;

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

(c) ‘feed additives’ means substances or micro-organisms authorised under Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (²);

(d) ‘establishment’ means any unit of a feed business;

(e) ‘competent authority’ means the authority of a Member State or of a third country designated to carry out official controls;

(f) ‘primary production of feed’ means the production of agricultural products, including in particular growing, harvesting, milking, rearing of animals (prior to their slaughter) or fishing resulting exclusively in products which do not undergo any other operation following their harvest, collection or capture, apart from simple physical treatment.

CHAPTER II

OBLIGATIONS

Article 4

General obligations

Article 5

Specific obligations

For operations at the level of primary production of feed and the following associated operations:

(a) transport, storage and handling of primary products at the place of production;

(b) transport operations to deliver primary products from the place of production to an establishment;

(c) mixing of feed, for the exclusive requirements of their own holdings, without using veterinary medicinal products or intermediate products as defined in Regulation (EU) 2019/4 (³) or additives or premixtures of additives, with the exception of silage additives,

feed business operators shall comply with the provisions in Annex I, where relevant for the operations carried out.

Feed business operators shall:

(a) comply with specific microbiological criteria;

(b) take measures or adopt procedures necessary to meet specific targets.

The Commission is empowered to adopt delegated acts in accordance with Article 30a in order to supplement this Regulation by defining the criteria and targets referred to in points (a) and (b) of the first subparagraph.

Article 6

Hazard analysis and critical control points (HACCP) system

The principles referred to in paragraph 1 are the following:

(a) identify any hazards that must be prevented, eliminated or reduced to acceptable levels;

(b) identify the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or reduce it to acceptable levels;

(c) establish critical limits at critical control points which separate acceptability from unacceptability, for the prevention, elimination or reduction of identified hazards;

(d) establish and implement effective monitoring procedures at critical control points;

(e) establish corrective action when monitoring indicates that a critical control point is not under control;

(f) establish procedures to verify that the measures outlined in points (a) to (e) are complete and working effectively. Verification procedures shall be carried out regularly;

(g) establish documents and records commensurate with the nature and size of the feed businesses to demonstrate the effective application of the measures set out in points (a) to (f).

Article 7

Documents concerning the HACCP system

Feed business operators shall:

(a) provide the competent authority with evidence of their compliance with Article 6 in the form requested by the competent authority;

(b) ensure that any documents describing the procedures developed in accordance with Article 6 are up-to-date at all times;

Article 8

Financial guarantees

Article 9

Official controls, notification and registration

Feed business operators shall:

(a) notify the appropriate competent authority of any establishments under their control, active in any of the stages of production, processing, storage, transport or distribution of feed, in the form required by the competent authority with a view to registration;

(b) provide the competent authority with up-to-date information on any establishments under their control as referred to in point (a), including notifying the competent authority of any significant change in activities and any closure of an existing establishment.

Article 10

Approval of feed business establishments

Feed business operators shall ensure that establishments under their control and covered by this Regulation are approved by the competent authority, where:

(1) such establishments carry out one of the following activities: (a) manufacturing and/or placing on the market of feed additives covered by Regulation (EC) No 1831/2003 or products covered by Directive 82/471/EEC and referred to in Chapter 1 of Annex IV to this Regulation; (b) manufacturing and/or placing on the market of premixtures prepared using feed additives referred to in Chapter 2 of Annex IV to this Regulation; (c) manufacturing for placing on the market, or producing for the exclusive requirements of their holdings, compound feedingstuffs using feed additives or premixtures containing feed additives and referred to in Chapter 3 of Annex IV to this Regulation;

(2) approval is required under the national law of the Member State where the establishment is located; or

(3) approval is required by a Delegated Regulation that the Commission is empowered to adopt in accordance with Article 30a in order to supplement this Regulation.

Article 11

Requirements

Feed business operators shall not operate without:

(a) registration as provided for in Article 9; or

(b) approval, when required in accordance with Article 10.

Article 12

Information on national rules on approval

Any Member State requiring the approval under Article 10(2) of certain establishments located on its territory shall inform the Commission and the other Member States of the relevant national rules.

Article 13

Approval of establishments

Article 14

Suspension of registration or approval

The competent authority shall temporarily suspend the registration or the approval of an establishment for one, more or all of its activities, where it is shown that the establishment no longer fulfils the conditions applicable to those activities.

Such suspension shall last until the establishment again meets those conditions. Where such conditions are not met within one year, Article 15 shall apply.

Article 15

Revocation of registration or approval

The competent authority shall revoke the registration or the approval of an establishment, for one or more of its activities, where:

(a) the establishment ceases one or more of its activities;

(b) it is shown that the establishment has not fulfilled the conditions applicable to its activities, for a period of one year;

(c) it identifies serious deficiencies or has had to stop production at an establishment repeatedly and the feed business operator is still not able to provide adequate guarantees regarding future production.

Article 16

Amendments to registration or approval of an establishment

Upon request, the competent authority shall amend the registration or approval of an establishment, where it has demonstrated its capacity to develop activities which are additional to those for which it was first registered or approved, or which replace them.

Article 17

Exemption from on-site visits

Article 18

Transitional measures

Article 19

List of registered and approved establishments

CHAPTER III

GUIDES TO GOOD PRACTICE

Article 20

Development, dissemination and use of guides

Where necessary, Member States shall encourage the development of national guides in accordance with Article 21.

Article 21

National guides

When national guides to good practice are developed, they shall be developed and disseminated by feed business sectors:

(a) in consultation with representatives of parties whose interests may be substantially affected, such as competent authorities and user groups;

(b) having regard to relevant codes of practice of the Codex Alimentarius; and

(c) when they concern primary production of feed, having regard to the requirements set out in Annex I.

Member States shall assess national guides to ensure that:

(a) they have been developed in accordance with paragraph 1;

(b) their contents are practicable for the sectors to which they refer; and

(c) they are suitable as guides for compliance with Articles 4, 5 and 6, in the sectors and/or for the feeds concerned.

Article 22

Community guides

Where Community guides are prepared, the Commission shall ensure that they are developed and disseminated:

(a) by or in consultation with appropriate representatives of European feed business sectors and other interested parties, such as consumer groups;

(b) in collaboration with parties whose interests may be substantially affected, including competent authorities.

Community guides shall be developed and disseminated taking into account:

(a) relevant codes of practice of the Codex Alimentarius, and

(b) when they concern primary production of feed, the requirements set out in Annex I.

The Committee referred to in Article 31(1) shall assess draft Community guides to ensure that:

(a) they have been developed in accordance with paragraphs 2 and 3;

(b) their contents are practicable throughout the Community for the sectors to which they refer; and

(c) they are suitable as guides for compliance with Articles 4, 5 and 6, in the sectors and/or for the feeds concerned.

CHAPTER IV

IMPORTS AND EXPORTS

Article 23

Imports

Feed business operators importing feed from third countries shall ensure that importation takes place only in accordance with the following conditions:

(a) the third country of dispatch appears on a list, drawn up in accordance with Article 48 of Regulation (EC) No 882/2004, of third countries from which imports of feed are permitted;

(b) the establishment of dispatch appears on a list, drawn up and kept updated by the third country in accordance with Article 48 of Regulation (EC) No 882/2004, of establishments from which imports of feed are permitted;

(c) the feed was produced by the establishment of dispatch or by another establishment appearing on the list referred to in point (b) or in the Community; and

(d) the feed satisfies: (i) the requirements laid down in this Regulation, and in any other Community legislation laying down rules for feed; or (ii) those conditions recognised by the Community to be at least equivalent thereto; or (iii) where a specific agreement between the Community and the exporting country exists, the requirements contained therein.

Article 24

Interim measures

By way of derogation from Article 33 and pending the drawing up of the lists provided for in Article 23(1)(a) and (b), imports shall continue to be authorised under the conditions laid down in Article 6 of Directive 98/51/EC.

Article 25

Exports

Feed, including feed for animals not kept for food production, which is produced in the Community for placing on the market in third countries, must satisfy the provisions of Article 12 of Regulation (EC) No 178/2002.

CHAPTER V

FINAL PROVISIONS

Article 26

Implementing measures

Implementing measures may be laid down in accordance with the procedure referred to in Article 31(2).

Article 27

Amendments to Annexes I, II and III

Annexes I, II and III may be amended to take account of:

(a) the development of codes of good practice;

(b) the experience gained from the implementation of HACCP-based systems pursuant to Article 6;

(c) technological developments;

(d) scientific advice, particularly new risk assessments;

(e) the setting of feed safety targets; and

(f) the development of requirements relating to specific operations.

The Commission is empowered to adopt delegated acts in accordance with Article 30a to amend Annexes I, II and III.

Article 28

Derogations from Annexes I, II and III

The Commission is empowered to adopt delegated acts in accordance with Article 30a in order to supplement this Regulation by granting derogations from Annexes I, II and III for particular reasons, provided that such derogations do not affect the achievement of the objectives of this Regulation.

Article 29

Rapid Alert System

Should a specific feed, including feed for animals not kept for food production, present a serious risk to human or animal health or to the environment, Article 50 of Regulation (EC) No 178/2002 shall apply mutatis mutandis.

Article 30

Penalties

The Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take the measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 8 February 2007, and shall notify it without delay of any subsequent amendment affecting them.

Article 30a

Exercise of the delegation

Article 31

Committee Procedure

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

Article 32

Consultation of the European Food Safety Authority

The Commission shall consult the European Food Authority on any matter, falling within the scope of this Regulation, that could have a significant impact on public health and, in particular, before proposing criteria or targets in accordance with Article 5(3).

Article 33

Repeal

The following Directives are repealed, without prejudice to the obligations of the Member States concerning the deadlines for transposition, with effect from 1 January 2006:

(a) Council Directive 95/69/EC;

(b) Commission Directive 98/51/EC.

Article 34

Entry into force

This Regulation shall enter into force on the date of its publication in the Official Journal of the European Union.

It shall apply as from 1 January 2006.

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

ANNEX I

PART A

Requirements for feed businesses at the level of primary production of feed referred to in Article 5(1)

I. Hygiene provisions

1.Feed business operators responsible for primary production of feed shall ensure that operations are managed and carried out in such a way as to prevent, eliminate or minimise hazards with the potential to compromise feed safety.

2.Feed business operators shall ensure, as far as possible, that primary products produced, prepared, cleaned, packed, stored and transported under their responsibility are protected against contamination and spoilage.

3.Feed business operators shall meet the obligations set out in points 1 and 2 by complying with appropriate Community and national legislative provisions relating to the control of hazards, including:

(i) measures to control hazardous contamination such as that arising from the air, soil, water, fertilisers, plant protection products, biocides, veterinary medicinal products and handling and disposal of waste, and

(ii) measures relating to plant health, animal health and the environment that have implications for feed safety, including programmes for the monitoring and control of zoonoses and zoonotic agents.

4.Where appropriate, feed business operators shall take adequate measures, in particular:

(a) to keep clean and, where necessary after cleaning, to disinfect in an appropriate manner, facilities, equipment, containers, crates and vehicles used for producing, preparing, grading, packing, storing and transporting feed;

(b) to ensure, where necessary, hygienic production, transport and storage conditions for, and the cleanliness of, feed;

(c) to use clean water whenever necessary to prevent hazardous contamination;

(d) to prevent, as far as possible, animals and pests from causing hazardous contamination;

(e) to store and handle wastes and hazardous substances, separately and securely, so as to prevent hazardous contamination;

(f) to ensure that packaging materials are not a source of hazardous contamination of feed;

(g) to take account of the results of any relevant analyses carried out on samples taken from primary products or other samples relevant to feed safety.

II.   Record-keeping

1.Feed business operators shall keep records relating to measures put in place to control hazards, in an appropriate manner and for an appropriate period, commensurate with the nature and size of the feed business. Feed business operators must make relevant information contained in these records available to the competent authority.

2.Feed business operators must, in particular, keep records on: