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Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption

Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof,

Having regard to the proposal from the Commission(1),

Having regard to the opinion of the European Economic and Social Committee(2),

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),

Whereas:

  1. Regulation (EC) No 852/2004 of the European Parliament and of the Council(4) lays down general hygiene rules applying to all foodstuffs and Regulation (EC) No 853/2004 of the European Parliament and of the Council(5) lays down specific hygiene rules for products of animal origin.

  2. Specific rules for official controls on products of animal origin are necessary to take account of specific aspects associated with such products.

  3. The scope of the specific control rules should mirror the scope of the specific hygiene rules for food business operators laid down in Regulation (EC) No 853/2004. However, Member States should also carry out appropriate official controls to enforce national rules established in accordance with Article 1(4) of that Regulation. They may do so by extending the principles of this Regulation to such national rules.

  4. Official controls on products of animal origin should cover all aspects that are important for protecting public health and, where appropriate, animal health and animal welfare. They should be based on the most recent relevant information available and it should therefore be possible to adapt them as relevant new information becomes available.

  5. Community legislation on food safety should have a sound scientific basis. To that end, the European Food Safety Authority should be consulted whenever necessary.

  6. The nature and intensity of the official controls should be based on an assessment of public health risks, animal health and welfare, where appropriate, the type and throughput of the processes carried out and the food business operator concerned.

  7. It is appropriate to provide for the adaptation of certain specific control rules, through the transparent procedure provided for in Regulation (EC) No 852/2004 and Regulation (EC) No 853/2004, to provide flexibility in order to accommodate the specific needs of establishments which use traditional methods, have a low throughput or are located in regions that are subject to special geographical constraints. The procedure should also allow pilot projects to take place in order to try out new approaches to hygiene controls on meat. However, such flexibility should not compromise food hygiene objectives.

  8. Official controls on the production of meat are necessary to verify that food business operators comply with hygiene rules and respect criteria and targets laid down in Community legislation. These official controls should comprise audits of food business operators ‘activities and inspections, including checks on food business operators’ own controls.

  9. In view of their specific expertise, it is appropriate for official veterinarians to carry out audits and inspections of slaughterhouses, game handling establishments and certain cutting plants. Member States should have discretion to decide which are the most appropriate staff for audits and inspections of other types of establishments.

  10. Official controls on the production of live bivalve molluscs and on fishery products are necessary to check for compliance with the criteria and targets laid down in Community legislation. Official controls on the production of live bivalve molluscs should in particular target relaying and production areas for bivalve molluscs and the end product.

  11. Official controls on the production of raw milk are necessary to check for compliance with criteria and targets laid down in Community legislation. Such official controls should in particular target milk production holdings and raw milk upon collection.

  12. The requirements of this Regulation should not apply until all parts of the new legislation on food hygiene have entered into force. It is also appropriate to provide for at least 18 months to elapse between entry into force and the application of the new rules, to allow competent authorities and the industries affected time to adapt.

  13. 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(6),

HAVE ADOPTED THIS REGULATION:

CHAPTER I GENERAL PROVISIONS

Article 1 Scope

1.

This Regulation lays down specific rules for the organisation of official controls on products of animal origin.

1a.

This Regulation shall apply in addition to 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(7).

2.

It shall apply only in respect of activities and persons to which Regulation (EC) No 853/2004 applies.

3.

The performance of official controls pursuant to this Regulation shall be without prejudice to food business operators' primary legal responsibility for ensuring food safety, 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(8), and any civil or criminal liability arising from the breach of their obligations.

Article 2 Definitions

1.

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

  1. ‘competent authority’ means the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence;

  2. ‘official veterinarian’ means a veterinarian qualified, in accordance with this Regulation, to act in such a capacity and appointed by the competent authority;

  3. ‘approved veterinarian’ means a veterinarian designated by the competent authority to carry out specific official controls on holdings on its behalf;

  4. ‘official auxiliary’ means a person qualified, in accordance with this Regulation, to act in such a capacity, appointed by the competent authority and working under the authority and responsibility of an official veterinarian;

    and

  5. ‘health mark’ means a mark indicating that, when it was applied, official controls had been carried out in accordance with this Regulation.

2.

The definitions laid down in the following Regulations shall also apply as appropriate:

  1. Regulation (EC) No 178/2002;

  2. the definitions of ‘animal by-products’, ‘TSEs’ (transmissible spongiform encephalopathies) and ‘specified risk material’ laid down in 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(9);

  3. Regulation (EC) No 882/2004;

  4. Regulation (EC) No 852/2004, except for the definition of ‘competent authority’;

    and

  5. Regulation (EC) No 853/2004.

CHAPTER II OFFICIAL CONTROLS IN RELATION TO COMMUNITY ESTABLISHMENTS

Article 3 Approval of establishments

Article 4 General principles for official controls in respect of all products of animal origin falling within the scope of this Regulation

Article 5 Fresh meat

Article 6 Live bivalve molluscs

Article 7 Fishery products

Article 8 Raw milk and dairy products

CHAPTER III PROCEDURES CONCERNING IMPORTS

Article 10

Article 11 Lists of third countries and parts of third countries from which imports of specified products of animal origin are permitted

Article 12 List of establishments from which imports of specified products of animal origin are permitted

Article 13 Live bivalve molluscs, echinoderms, tunicates and marine gastropods

Article 14 Documents

Article 15 Special provisions for fishery products

CHAPTER IV FINAL PROVISIONS

Article 16

Article 17 Amendment and adaptation of the Annexes

Article 18 Specific decisions

Article 19 Committee procedure

Article 20 Consultation of the European Food Safety Authority

Article 21 Report to the European Parliament and to the Council

Article 22 Entry into force

ANNEX IFRESH MEAT

ANNEX IILIVE BIVALVE MOLLUSCS

ANNEX IIIFISHERY PRODUCTS

ANNEX IVRAW MILK, COLOSTRUM, DAIRY PRODUCTS AND COLOSTRUM BASED PRODUCTS

ANNEX VESTABLISHMENTS NOT SUBJECT TO THE LISTING REQUIREMENT OF ARTICLE 12(1)

ANNEX VIREQUIREMENTS FOR CERTIFICATES ACCOMPANYING IMPORTS