Regulation (EC) No 853/2004 of the European Parliament and of the CouncilDangos y teitl llawn

Article 10 Amendment and adaptation of Annexes II and III

1. Annexes II and III may be adapted or updated in accordance with the procedure referred to in Article 12(2), taking into account:

(a) the development of guides to good practice;

(b) the experience gained from the implementation of HACCP-based systems pursuant to Article 5 of Regulation (EC) No /2004(1);

(c) the technological developments and their practical consequences and consumer expectations with regard to food composition;

(d) scientific advice, particularly new risk assessments;

(e) microbiological and temperature criteria for foodstuffs;

(f) changes in patterns of consumption.

2. Exemptions from Annex II and III may be granted in accordance with the procedure referred to in Article 12(2), provided that they 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 8, national measures adapting the requirements laid down in Annex III.

4. (a) The national measures referred to in paragraph 3 shall have the aim of:

(i)

enabling the continued use of traditional methods at any of the stages of production, processing or distribution of food; or

(ii)

accommodating the needs of food businesses situated in regions that are subject to special geographic constraints.

(b) In other cases, they shall apply only to the construction, layout and equipment of establishments.

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

(a) provide a detailed description of the requirements that that Member State considers need to be adapted and the nature of the adaptation sought;

(b) describe the foodstuffs and establishments concerned;

(c) 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

(d) give any other relevant information.

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 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 12(1). The Commission may decide, in accordance with the procedure referred to in Article 12(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 of this Article.

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

(a) in compliance with a decision adopted in accordance with paragraph 6;

(b) 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; or

(c) in accordance with paragraph 8.

8. A Member State may, of its own initiative and subject to the general provisions of the Treaty, maintain or establish national rules:

(a) prohibiting or restricting the placing on the market within its territory of raw milk or raw cream intended for direct human consumption; or

(b) permitting the use, with the authorisation of the competent authority, of raw milk not meeting the criteria laid down in Annex III, Section DC, as regards plate count and somatic cell count of the manufacture of cheeses with an ageing or ripening period of at least 60 days, and dairy products obtained in connection with the manufacture of such cheeses, provided that this does not prejudice the achievement of the objectives of this Regulation.

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Official Publications Office is to insert the official number of the Regulation on the hygiene of foodstuffs.