Regulation (EC) No 853/2004 of the European Parliament and of the CouncilShow full title

[X1 Article 10 U.K. Amendment and adaptation of Annexes II and III

[F1 1. The Commission is empowered to adopt delegated acts in accordance with Article 11a amending Annexes II and III. The amendments shall have the aim of ensuring and facilitating the achievement of the objectives of this Regulation, taking into account the relevant risk factors, and shall be justified on the basis of:

(a) the experience gained by food business operators and/or competent authorities, in particular on the implementation of HACCP-based systems pursuant to Article 5;

(b) the experience gained by the Commission, in particular on the outcome of its audits;

(c) 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.

The amendments referred to in the first subparagraph shall concern:

(a) the requirements on the identification marking of products of animal origin;

(b) the objectives of HACCP-based procedures;

(c) the requirements on the food chain information;

(d) the specific hygiene requirements for the premises, including means of transport, where products of animal origin are produced, handled, processed, stored or distributed;

(e) the specific hygiene requirements for the operations involving the production, handling, processing, storage, transport or distribution of products of animal origin;

(f) the rules for the transport of meat while it is warm;

(g) the health standards or checks, where there is scientific evidence indicating that they are necessary to protect public health;

(h) the extension of Annex III, Section VII, Chapter IX, to live bivalve molluscs other than pectinidae;

(i) the criteria for determining when epidemiological data indicate that a fishing ground does not present a health hazard with regard to the presence of parasites and, consequently, for determining when the competent authority may authorise food business operators not to freeze fishery products in accordance with Annex III, Section VIII, Chapter III, Part D;

(j) the additional health standards for live bivalve molluscs in cooperation with the relevant Union Reference Laboratory, including:

(i)

limit values and analysis methods for other marine biotoxins;

(ii)

virus testing procedures and virological standards; and

(iii)

sampling plans and the methods and analytical tolerances to be applied to check compliance with the health standards.

2. The Commission is empowered to adopt delegated acts in accordance with Article 11a in order to supplement this Regulation by granting derogations from Annex II and III, taking into account the relevant risk factors and provided that such derogations do not affect the achievement of the following objectives of this Regulation:

(a) to facilitate the fulfilment, by small businesses, of the requirements laid down in the Annexes;

(b) to enable the continued use of traditional methods at any of the stages of production, processing or distribution of food;

(c) to accommodate the needs of food businesses situated in regions that are subject to special geographic constraints;

(d) to facilitate the work of establishments producing raw material which is intended for the production of highly refined food products and which has undergone a treatment ensuring its safety.]

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 IX, 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.]

Editorial Information

X1 Substituted by Corrigendum to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (Official Journal of the European Union L 139 of 30 April 2004).

Textual Amendments

F1 Substituted by Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (Text with EEA relevance).