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

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:
 
  1. in consultation with representatives of parties whose interests may be substantially affected, such as competent authorities and consumer groups;
 
  1. having regard to relevant codes of practice of the Codex Alimentarius; and
 
 
  1. when they concern primary production and those associated operations listed in Annex I, having regard to the recommendations set out in Part B of Annex I.
 
  1. National guides may be developed under the aegis of a national standards institute referred to in Annex II to Directive 98/34/EC 1.
 
  1. Member States shall assess national guides in order to ensure that:
 
 
  1. they have been developed in accordance with paragraph 1;
 
 
  1. their contents are practicable for the sectors to which they refer; and
 
 
  1. they are suitable as guides to compliance with Articles 3, 4 and 5 in the sectors and for the foodstuffs covered.
 
  1. 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.
 
  1. Guides to good practice drawn up under Directive 93/43/EEC shall continue to apply after the entry into force of this Regulation, provided that they are compatible with its objectives.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


1          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 amended by Directive 98/48/EC (OJ L 217, 5.8.1998, p. 18).
 
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.
 
  1. When Community guides are prepared, the Commission shall ensure that they are developed and disseminated:
 
  1. by or in consultation with appropriate representatives of European food business sectors, including SMEs, and other interested parties, such as consumer groups;
 
  1. in collaboration with parties whose interests may be substantially affected, including competent authorities;
 
  1. having regard to relevant codes of practice of the Codex Alimentarius; and
 
 
  1. when they concern primary production and those associated operations listed in Annex I, having regard to the recommendations set out in Part B of Annex I.
 
  1. The Committee referred to in Article 14 shall assess draft Community guides in order to ensure that:
 
  1. they have been developed in accordance with paragraph 2;
 
 
  1. their contents are practicable for the sectors to which they refer throughout the Community; and
 
  1. they are suitable as guides to compliance with Articles 3, 4 and 5 in the sectors and for the foodstuffs covered.
 
  1. 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.
 
  1. 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:
 
  1. the need to revise the recommendations set out in Annex I, Part B, paragraph 2;
 
 
  1. the experience gained from the implementation of HACCP-based systems pursuant to Article 5;
 
  1. technological developments and their practical consequences and consumer expectations with regard to food composition;
 
  1. scientific advice, particularly new risk assessments;
 
 
  1. microbiological and temperature criteria for foodstuffs.
 
 
  1. 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.
 
  1. 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.
 
4.(a) The national measures referred to in paragraph 3 shall have the aim of:
 
 
  1. enabling the continued use of traditional methods, at any of the stages of production, processing or distribution of food; or
 
  1. accommodating the needs of food businesses situated in regions that are subject to special geographical constraints.
 
(b) In other cases, they shall apply only to the construction, layout and equipment of establishments.
 
  1. 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:
 
  1. provide a detailed description of the requirements that that Member State considers need to be adapted and the nature of the adaptation sought;
 
  1. describe the foodstuffs and establishments concerned;
 
 
  1. explain the reasons for the adaptation, including, where relevant, by providing a summary of the hazard analysis carried out and any measures to be taken to ensure that the adaptation will not compromise the objectives of this Regulation; and
 
  1. give any other relevant information.
 
 
  1. 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.
 
  1. A Member State may adopt national measures adapting the requirements of Annex II only:
 
 
  1. in compliance with a decision adopted in accordance with paragraph 6; or
 
 
  1. if, one month after the expiry of the period referred to in paragraph 6, the Commission has not informed Member States that it has received written comments or that it intends to propose the adoption of a decision in accordance with paragraph 6.
 
Article 14
 
 
Committee procedure
 
 
  1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health.
 
  1. 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.
 
 
  1. 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 .......... *, submit a report to the European Parliament and the Council.
 
  1. 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.
 
  1. The Commission shall, if appropriate, accompany the report with relevant proposals.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  • Five years after the entry into force of this Regulation.
 
Article 17
 
 
Repeal
 
 
  1. Directive 93/43/EEC shall be repealed with effect from the date of application of this Regulation.
 
  1. References to the repealed Directive shall be construed as being made to this Regulation.
 
 
  1. 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), points (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.
 
 
  1. 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 twenty days after the date 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:
 
 
  1. Regulation (EC) No .../2004 *;
 
  1. Regulation (EC) No .../2004 of the European Parliament and of the Council of ......... laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption 1; and
 

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