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

CHAPTER IV FINAL PROVISIONS

Article 9 Implementing measures and transitional measures

Implementing measures and transitional arrangements may be laid down in accordance with the procedure referred to in Article 12(2).

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.

Article 11 Specific decisions

Without prejudice to the generality of Article 9 and Article 10(1), implementing measures may be laid down, or amendments to Annex II or III adopted, in accordance with the procedure referred to in Article 12(2):

1)

to lay down rules for the transport of meat while it is warm;

2)

to specify, in respect of MSM, which calcium content is not significantly higher than that of minced meat;

3)

to lay down other treatments that may be applied in a processing establishment to live bivalve molluscs from class B or C production areas that have not been submitted to purification or relaying;

4)

to specify recognised testing methods for marine biotoxins;

5)

to lay down additional health standards for live bivalve molluscs in cooperation with the relevant Community Reference Laboratory, including:

(a)

limit values and analysis methods for other marine biotoxins;

(b)

virus testing procedures and virological standards; and

(c)

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

6)

to lay down health standards or checks, where there is scientific evidence indicating that they are necessary to protect public health;

7)

to extend Annex III, Section VII, Chapter IX, to live bivalve molluscs other than pectinidae;

8)

to specify 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;

9)

to lay down freshness criteria and limits with regard to histamine and total volatile nitrogen for fisheries products;

10)

to permit the use for the manufacture of certain dairy products of raw milk not meeting the criteria laid down in Annex III, Section IX, as regards its plate count and somatic cell count;

11)

without prejudice to Directive 96/23/EC(2), to fix a maximum permitted value for the combined total of residues of antibiotic substances in raw milk; and

12)

to approve equivalent processes for the production of gelatine or collagen.

Article 12 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 provided for 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 13 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 to extend Annex III, Section III, to other animal species.

Article 14 Report to the European Parliament and to the Council

1. The Commission shall, not later than ...(3), submit a report to the European Parliament and the Council reviewing the experience gained from the implementation of this Regulation.

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

Article 15

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:

(a)

Regulation (EC) No.../2004(4);

(b)

Regulation (EC) No.../2004(5); and

(c)

Directive 2004/.../EC(6).

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

(1)

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

(2)

Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products (OJ L 125, 23.5.1996, p. 10). Directive as amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

(3)

Five years after the entry into force of this Regulation.

(4)

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

(5)

Official Publications Office is to insert here the official number of the Regulation referred to in Article 4(3).

(6)

Official Publications Office is to insert here the official number of the Directive referred to in recital 25.