Regulation (EC) No 1137/2008 of the European Parliament and of the CouncilDangos y teitl llawn

8.4. Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements(1)

As regards Directive 2002/46/EC, the Commission should be empowered to adopt specific rules for vitamins and minerals used as food supplements, including the setting of specific values for maximum and minimum levels for vitamins and minerals present in food supplements, as well as their purity criteria. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2002/46/EC, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

When, on imperative grounds of urgency, the normal time limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of measures prohibiting the use of a vitamin or mineral the use of which was previously authorised.

Accordingly, Directive 2002/46/EC is hereby amended as follows:

1.

Article 4(2) shall be replaced by the following:

‘2. The purity criteria for substances listed in Annex II to this Directive shall be adopted by the Commission, except where such criteria apply pursuant to paragraph 3. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3).’;

2.

Article 4(5) shall be replaced by the following:

‘5. Modifications to the lists referred to in paragraph 1, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 13(4) in order to remove a vitamin or a mineral from the list referred to in paragraph 1 of this Article.’;

3.

Article 5(4) shall be replaced by the following:

‘4. The maximum and minimum amounts of vitamins and minerals referred to in paragraphs 1, 2 and 3 shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3).’;

4.

Article 12(3) shall be replaced by the following:

‘3. In order to remedy the difficulties described in paragraph 1 and to ensure the protection of human health, adaptations of this Directive or of its implementing measures shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 13(4) in order to adopt those adaptations. The Member State that has adopted safeguard measures may in that event retain such measures until the adoption of the adaptations.’;

5.

Article 13 shall be replaced by the following:

‘Article 13

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Regulation (EC) No 178/2002 of the European Parliament and of the Council(2)

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. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

4. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’.

(1)

OJ L 183, 12.7.2002, p. 51.

(2)

OJ L 31, 1.2.2002, p. 1.’.