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Corrigendum to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs

(Official Journal of the European Union L 139 of 30 April 2004)

Regulation (EC) No 852/2004 should read as follows:

                        REGULATION (EC) No 852/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL                     

of 29 April 2004                     

on the hygiene of foodstuffs

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 95 and 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:

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

1.   This Regulation lays down general rules for food business operators on the hygiene of foodstuffs, taking particular account of the following principles:

This Regulation shall apply to all stages of production, processing and distribution of food and to exports, and without prejudice to more specific requirements relating to food hygiene.

2.   This Regulation shall not apply to:

3.   Member States shall establish, under national law, rules governing the activities referred to in paragraph 2(c). Such national rules shall ensure the achievement of the objectives of this Regulation.

Article 2

Definitions

1.   For the purposes of this Regulation:

2.   The definitions laid down in Regulation (EC) No 178/2002 shall also apply.

3.   In the Annexes to this Regulation the terms ‘where necessary’, ‘where appropriate’, ‘adequate’ and ‘sufficient’ shall mean respectively where necessary, where appropriate, adequate or sufficient to achieve the objectives of this Regulation.

CHAPTER II

FOOD BUSINESS OPERATORS' OBLIGATIONS

Article 3

General obligation

Food business operators shall ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in this Regulation.

Article 4

General and specific hygiene requirements

1.   Food business operators carrying out primary production and those associated operations listed in Annex I shall comply with the general hygiene provisions laid down in part A of Annex I and any specific requirements provided for in Regulation (EC) No 853/2004.

2.   Food business operators carrying out any stage of production, processing and distribution of food after those stages to which paragraph 1 applies shall comply with the general hygiene requirements laid down in Annex II and any specific requirements provided for in Regulation (EC) No 853/2004.

3.   Food business operators shall, as appropriate, adopt the following specific hygiene measures:

4.   The criteria, requirements and targets referred to in paragraph 3 shall be adopted in accordance with the procedure referred to in Article 14(2).

Associated sampling and analysis methods shall be laid down in accordance with the same procedure.

5.   When this Regulation, Regulation (EC) No 853/2004 and their implementing measures do not specify sampling or analysis methods, food business operators may use appropriate methods laid down in other Community or national legislation or, in the absence of such methods, methods that offer equivalent results to those obtained using the reference method, if they are scientifically validated in accordance with internationally recognised rules or protocols.

6.   Food business operators may use the guides provided for in Articles 7, 8 and 9 as an aid to compliance with their obligations under this Regulation.

Article 5

Hazard analysis and critical control points

1.   Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles.

2.   The HACCP principles referred to in paragraph 1 consist of the following:

When any modification is made in the product, process, or any step, food business operators shall review the procedure and make the necessary changes to it.

3.   Paragraph 1 shall apply only to food business operators carrying out any stage of production, processing and distribution of food after primary production and those associated operations listed in Annex I.

4.   Food business operators shall:

5.   Detailed arrangements for the implementation of this Article may be laid down in accordance with the procedure referred to in Article 14(2). Such arrangements may facilitate the implementation of this Article by certain food business operators, in particular by providing for the use of procedures set out in guides for the application of HACCP principles, in order to comply with paragraph 1. Such arrangements may also specify the period during which food business operators shall retain documents and records in accordance with paragraph 4(c).

Article 6

Official controls, registration and approval

1.   Food business operators shall cooperate with the competent authorities in accordance with other applicable Community legislation or, if it does not exist, with national law.

2.   In particular, every food business operator shall notify the appropriate competent authority, in the manner that the latter requires, of each establishment under its control that carries out any of the stages of production, processing and distribution of food, with a view to the registration of each such establishment.

Food business operators shall also ensure that the competent authority always has up-to-date information on establishments, including by notifying any significant change in activities and any closure of an existing establishment.

3.   However, food business operators shall ensure that establishments are approved by the competent authority, following at least one on-site visit, when approval is required:

Any Member State requiring the approval of certain establishments located on its territory under national law, as provided for in subparagraph (a), shall inform the Commission and other Member States of the relevant national rules.

CHAPTER III

GUIDES TO GOOD PRACTICE

Article 7

Development, dissemination and use of guides

Member States shall encourage the development of national guides to good practice for hygiene and for the application of HACCP principles in accordance with Article 8. Community guides shall be developed in accordance with Article 9.

The dissemination and use of both national and Community guides shall be encouraged. Nevertheless, food business operators may use these guides on a voluntary basis.

Article 8

National guides

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

2.   National guides may be developed under the aegis of a national standards institute referred to in Annex II to Directive 98/34/EC (10).

3.   Member States shall assess national guides in order to ensure that:

4.   Member States shall forward to the Commission national guides complying with the requirements of paragraph 3. The Commission shall set up and run a registration system for such guides and make it available to Member States.

5.   Guides to good practice drawn up pursuant to Directive 93/43/EEC shall continue to apply after the entry into force of this Regulation, provided that they are compatible with its objectives.

Article 9

Community guides

1.   Before Community guides to good practice for hygiene or for the application of the HACCP principles are developed, the Commission shall consult the Committee referred to in Article 14. The objective of this consultation shall be to consider the case for such guides, their scope and subject matter.

2.   When Community guides are prepared, the Commission shall ensure that they are developed and disseminated:

3.   The Committee referred to in Article 14 shall assess draft Community guides in order to ensure that:

4.   The Commission shall invite the Committee referred to in Article 14 periodically to review any Community guides prepared in accordance with this Article, in cooperation with the bodies mentioned in paragraph 2.

The aim of this review shall be to ensure that the guides remain practicable and to take account of technological and scientific developments.

5.   The titles and references of Community guides prepared in accordance with this Article shall be published in the C series of the Official Journal of the European Union.

CHAPTER IV

IMPORTS AND EXPORTS

Article 10

Imports

As regards the hygiene of imported food, the relevant requirements of food law referred to in Article 11 of Regulation (EC) No 178/2002 shall include the requirements laid down in Articles 3 to 6 of this Regulation.

Article 11

Exports

As regards the hygiene of exported or re-exported food, the relevant requirements of food law referred to in Article 12 of Regulation (EC) No 178/2002 shall include the requirements laid down in Articles 3 to 6 of this Regulation.

CHAPTER V

FINAL PROVISIONS

Article 12

Implementing measures and transitional arrangements

Implementing measures and transitional arrangements may be laid down in accordance with the procedure referred to in Article 14(2).

Article 13

Amendment and adaptation of Annexes I and II

1.   Annexes I and II may be adapted or updated in accordance with the procedure referred to in Article 14(2), taking into account:

2.   Derogations from Annexes I and II may be granted, in particular in order to facilitate the implementation of Article 5 for small businesses, in accordance with the procedure referred to in Article 14(2), taking into account the relevant risk factors, provided that such derogations do not affect the achievement of the objectives of this Regulation.

3.   Member States may, without compromising achievement of the objectives of this Regulation, adopt, in accordance with paragraphs 4 to 7 of this Article, national measures adapting the requirements laid down in Annex II.

5.   Any Member State wishing to adopt national measures as referred to in paragraph 3 shall notify the Commission and other Member States. The notification shall:

6.   The other Member States shall have three months from the receipt of a notification referred to in paragraph 5 to send written comments to the Commission. In the case of the adaptations arising from paragraph 4(b), this period shall, at the request of any Member State, be extended to four months. The Commission may, and when it receives written comments from one or more Member States shall, consult Member States within the committee referred to in Article 14(1). The Commission may decide, in accordance with the procedure referred to in Article 14(2), whether the envisaged measures may be implemented, subject, if necessary, to appropriate amendments. Where appropriate, the Commission may propose general measures in accordance with paragraph 1 or 2.

7.   A Member State may adopt national measures adapting the requirements of Annex II only:

Article 14

Committee procedure

1.   The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health.

2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

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

3.   The Committee shall adopt its Rules of Procedure.

Article 15

Consultation of the European Food Safety Authority

The Commission shall consult the European Food Safety 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, requirements or targets in accordance with Article 4(4).

Article 16

Report to the European Parliament and the Council

1.   The Commission shall, not later than 20 May 2009, submit a report to the European Parliament and the Council.

2.   The report shall, in particular, review the experience gained from the application of this Regulation and consider whether it would be desirable and practicable to provide for the extension of the requirements of Article 5 to food business operators carrying out primary production and those associated operations listed in Annex I.

3.   The Commission shall, if appropriate, accompany the report with relevant proposals.

Article 17

Repeal

1.   Directive 93/43/EEC shall be repealed with effect from the date of application of this Regulation.

2.   References to the repealed Directive shall be construed as being made to this Regulation.

3.   However, decisions adopted pursuant to Articles 3(3) and 10 of Directive 93/43/EEC shall remain in force pending their replacement by decisions adopted in accordance with this Regulation or Regulation (EC) No 178/2002. Pending the setting of the criteria or requirements referred to in Article 4(3)(a) to (e) of this Regulation, Member States may maintain any national rules establishing such criteria or requirements that they had adopted in accordance with Directive 93/43/EEC.

4.   Pending the application of new Community legislation laying down rules for official controls on food, Member States shall take all appropriate measures to ensure the fulfilment of the obligations laid down in or under this Regulation.

Article 18

Entry into force

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

It shall apply 18 months after the date on which all of the following acts have entered into force:

However, it shall apply no earlier than 1 January 2006.

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

Done at Strasbourg, 29 April 2004.

For the European Parliament

The President

P. COX                        

For the Council

The President

P. M. McDOWELL                        

ANNEX I

PRIMARY PRODUCTION

PART A: GENERAL HYGIENE PROVISIONS FOR PRIMARY PRODUCTION AND ASSOCIATED OPERATIONS

I.   Scope

II.   Hygiene provisions

III.   Record-keeping

PART B: RECOMMENDATIONS FOR GUIDES TO GOOD HYGIENE PRACTICE

ANNEX II

GENERAL HYGIENE REQUIREMENTS FOR ALL FOOD BUSINESS OPERATORS (EXCEPT WHEN ANNEX I APPLIES)

INTRODUCTION

Chapters V to XII apply to all stages of production, processing and distribution of food and the remaining Chapters apply as follows:

CHAPTER I

General requirements for food premises (other than those specified in chapter iii)

CHAPTER II

Specific requirements in rooms where foodstuffs are prepared, treated or processed (excluding dining areas and those premises specified in chapter III)

CHAPTER III

Requirements for movable and/or temporary premises (such as marquees, market stalls, mobile sales vehicles), premises used primarily as a private dwelling-house but where foods are regularly prepared for placing on the market and vending machines

CHAPTER IV

Transport

CHAPTER V

Equipment requirements

CHAPTER VI

Food waste

CHAPTER VII

Water supply

CHAPTER VIII

Personal hygiene

CHAPTER IX

Provisions applicable to foodstuffs

CHAPTER X

Provisions applicable to the wrapping and packaging of foodstuffs

CHAPTER XI

Heat treatment

The following requirements apply only to food placed on the market in hermetically sealed containers:

CHAPTER XII

Training

Food business operators are to ensure:

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(1)OJ C 365 E, 19.12.2000, p. 43.

(2)OJ C 155, 29.5.2001, p. 39.

(3)  Opinion of the European Parliament of 15 May 2002 (OJ C 180 E, 31.7.2003, p. 267), Council Common Position of 27 October 2003 (OJ C 48 E, 24.2.2004, p. 1), Position of the European Parliament of 30 March 2004 (not yet published in the Official Journal) and Council Decision of 16 April 2004.

(4)  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 (OJ L 31, 1.2.2002, p. 1). Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

(5)OJ L 175, 19.7.1993, p. 1. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

(6)  See page 22 of this Official Journal.

(7)OJ L 37, 13.2.1993, p. 1. Regulation as amended by Regulation (EC) No 1882/2003.

(8)OJ L 184, 17.7.1999, p. 23.

(9)OJ L 330, 5.12.1998, p. 32. Directive as amended by Regulation (EC) No 1882/2003.

(10)  Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (OJ L 204, 21.7.1998, p. 37). Directive as last amended by the 2003 Act of Accession.

(11)  See page 83 of this Official Journal.

(12)OJ L 157, 30.4.2004, p. 33.

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