Regulation (EC) No 107/2008 of the European Parliament and of the Council of 15 January 2008 amending Regulation (EC) No 1924/2006 on nutrition and health claims made on foods as regards the implementing powers conferred on the Commission

4 For generic descriptors (denominations) which have traditionally been used to indicate a particularity of a class of foods or beverages which could imply an effect on human health, a derogation from paragraph 3 designed to amend non-essential elements of this Regulation by supplementing it may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3), on application by the food business operators concerned. The application shall be sent to the national competent authority of a Member State which will forward it to the Commission without delay. The Commission shall adopt and make public the rules for food business operators according to which such applications shall be made, so as to ensure that the application is dealt with transparently and within a reasonable time.;

1 By 19 January 2009, the Commission shall establish specific nutrient profiles, including exemptions, which food or certain categories of food must comply with in order to bear nutrition or health claims and the conditions for the use of nutrition or health claims for foods or categories of foods with respect to the nutrient profiles. Such measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3).;

5 Measures determining the foods or categories of foods other than those referred to in paragraph 3 for which nutrition or health claims are to be restricted or prohibited and designed to amend non-essential elements of this Regulation may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3) and in the light of scientific evidence.;

2 Amendments to the Annex shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3) and, where appropriate, after consulting the Authority. Where appropriate, the Commission shall involve interested parties, in particular food business operators and consumer groups, in order to evaluate the perception and understanding of the claims in question.;

3 After consulting the Authority, the Commission shall adopt, in accordance with the regulatory procedure with scrutiny referred to in Article 25(3), a Community list, designed to amend non-essential elements of this Regulation by supplementing it, of permitted claims as referred to in paragraph 1 and all necessary conditions for the use of these claims by 31 January 2010 at the latest.;

4 Any changes to the list referred to in paragraph 3, based on generally accepted scientific evidence and designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3), after consulting the Authority, on the Commission's own initiative or following a request by a Member State.;

3 A final decision on the application, designed to amend non essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). However, where at the applicant's request for the protection of proprietary data, the Commission proposes to restrict the use of the claim in favour of the applicant: (a) a decision on the authorisation of the claim shall be taken in accordance with the regulatory procedure referred to in Article 25(2). In such case, the authorisation, if granted, shall expire after five years; (b) before the expiry of the five-year period, if the claim still meets the conditions laid down in this Regulation, the Commission shall submit a draft of measures designed to amend non-essential elements of this Regulation by supplementing it for authorisation of the claim without restriction for use which shall be decided on in accordance with the regulatory procedure with scrutiny referred to in Article 25(3).;

5 Where the Authority issues an opinion that does not support the inclusion of the claim in the list referred to in paragraph 4, a decision on the application designed to amend non-essential elements of this Regulation by supplementing it shall be taken in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). However, where at the applicant's request for the protection of proprietary data the Commission proposes to restrict the use of the claim in favour of the applicant: (a) a decision on the authorisation of the claim shall be taken in accordance with the regulatory procedure referred to in Article 25(2). In such case, the authorisation, if granted, shall expire after five years; (b) before the expiry of the five-year period, if the claim still meets the conditions laid down in this Regulation, the Commission shall submit a draft of measures designed to amend non-essential elements of this Regulation by supplementing it for authorisation of the claim without restriction of use which shall be decided on in accordance with the regulatory procedure with scrutiny referred to in Article 25(3).;

1 The Commission shall be assisted by the Committee.

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 laid down 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.;

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.