PURPOSE : to amend the Regulation on nutrition and health claims made on foods, in order to align it with the new Council Decision 2006/512/EC amending Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission (comitology).

LEGISLATIVE ACT: Regulation (EC) N° 107/2008 of the European Parliament and of the Council amending Regulation (EC) N° 1924/2006 on nutrition and health claims made on foods as regards the implementing powers conferred on the Commission.

CONTENT: Decision 1999/468/EC has been amended by Decision 2006/512/EC, which introduced a regulatory procedure with scrutiny (see CNS/2002/0298 ) to be used for the adoption of implementing measures of general scope which seek to amend non-essential elements of a basic instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty, including by deleting some of those elements or by supplementing the instrument by the addition of new non-essential elements.

It is recalled that on 19 January 2007, Regulation 1924/2006 on nutrition and health claims made on foods entered into force. The Regulation contained a list of permitted nutrition claims, including a description of their conditions of use. However, it foresaw the development of an additional list of health claims based on generally accepted scientific evidence via the Article 13 procedure. This involves the submission of health claims (under the form of concise dossiers providing references on substantiation data for specific ingredient health effects and conditions of use) to national authorities, which will then send their national lists of health claims to the European Commission by 31 January 2008. Following EFSA evaluation, the European Commission will set up the ‘Community list’ of permitted health claims by end January 2010.

Moreover, additional procedures had been established for the approval of health claims based on newly developed scientific evidence or including a request for the protection of proprietary data, reduction of disease risk claims and claims referring to children's development and health.

Regulation 1924/2006 contained a variety of transition periods which applied to products already on the market, or certain claims already in use. It had no transition period for claims referring to children's development and health

This Regulation provides that the regulatory procedure with scrutiny should apply to the following:

to adopt Community measures concerning the labelling, presentation and advertising of certain foods; to establish derogations from certain provisions of Regulation (EC) N° 1924/2006; to establish and update nutrient profiles and the conditions and exemptions under which they can be used; to establish and/or amend lists of nutrition and health claims; to amend the list of foods in respect of which the making of claims is restricted or prohibited.

Furthermore it provides that when data protection provisions apply, the authorisation restricted to use by an individual operator should not prevent other applicants from applying for authorisation to use the same claim. 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 decision on the authorisation of the claim shall be taken in accordance with the regulatory procedure (i.e. the new regulatory procedure with scrutiny does not apply at this point). In such case, the authorisation, if granted, shall expire after five years; before the expiry of the five-year period, if the claim still meets the conditions laid down in the Regulation, the Commission shall submit a proposal for authorisation of the claim without restriction for use which shall be decided on in accordance with the regulatory procedure with scrutiny.

ENTRY INTO FORCE: 04/03/2008.

Regulation 2008/107
OJ L 039 13.02.2008, p. 0008

03628/2007/LEX

SP(2007)3798/2

Results of vote in Parliament

The European Parliament adopted a resolution drafted by Adriana POLI BORTONE (UEN, IT) and made some amendments to the Commission’s proposal. These amendments are aimed at reinforcing Parliament's role by extending the areas in which the regulatory procedure with scrutiny should be applied. Negotiations conducted with the Commission and the Council with a view to reaching an agreement ahead of the plenary vote have resulted in a compromise package supported by all the political groups. Compared to the Commission's original proposal, Parliament's role in the execution of the Regulation has been strengthened considerably.

It is recalled that on 19 January 2007, Regulation 1924/2006 on nutrition and health claims made on foods entered into force. The Regulation currently only contains a list of permitted nutrition claims, including a description of their conditions of use. However, it foresees the development of an additional list of health claims based on generally accepted scientific evidence via the Article 13 procedure. This involves the submission of health claims (under the form of concise dossiers providing references on substantiation data for specific ingredient health effects and conditions of use) to national authorities, which will then send their national lists of health claims to the European Commission by 31 January 2008. Following EFSA evaluation, the European Commission will set up the ‘Community list’ of permitted health claims by end January 2010.

Moreover, additional procedures have been established for the approval of health claims based on newly developed scientific evidence or including a request for the protection of proprietary data, reduction of disease risk claims and claims referring to children's development and health.

The Regulation contains a variety of transition periods which apply to products already on the market, or certain claims already in use. It has currently no transition period for claims referring to children's development and health

Parliament provided in its amendments that the regulatory procedure with scrutiny should apply to the following:

- to adopt Community measures concerning the labelling, presentation and advertising of certain foods;

- to establish derogations from certain provisions of Regulation (EC) No 1924/2006;

- to establish and update nutrient profiles and the conditions and exemptions under which they can be used;

- to establish and/or amend lists of nutrition and health claims;

- to amend the list of foods in respect of which the making of claims is restricted or prohibited.

Furthermore it provided that when data protection provisions apply, the authorisation restricted to use by an individual operator should not prevent other applicants from applying for authorisation to use the same claim. Parliament stipulated that, 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 decision on the authorisation of the claim shall be taken in accordance with the regulatory procedure (i.e the new regulatory procedure with scrutiny does not apply at this point). In such case, the authorisation, if granted, shall expire after five years;

- before the expiry of the five-year period, if the claim still meets the conditions laid down in the Regulation, the Commission shall submit a proposal for authorisation of the claim without restriction for use which shall be decided on in accordance with the regulatory procedure with scrutiny.

T6-0226/2007

CES1571/2006

A6-0404/2006

A6-0404/2006

The committee adopted the report by Adriana POLI BORTONE (UEN, IT) approving the proposal amending the new regulation on nutrition and health claims made on foods. The proposal was aimed at introducing into the regulation the new regulatory procedure with scrutiny that is now applicable for the exercise of implementing powers. The committee adopted just three amendments - under the 1st reading of the codecision procedure - designed to ensure that the new procedure should also apply to national measures considered necessary by a Member State.

PE380.844

PE380.722

PURPOSE: to amend the European Parliament and Council Regulation on nutrition and health claims made on foods, in order to align it with the new Council Decision 2006/512/EC amending Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission (comitology).

PROPOSED ACT: Regulation of the European Parliament and of the Council.

CONTENT: Decision 1999/468/EC has been amended by Decision 2006/512/EC, which introduced a regulatory procedure with scrutiny (see CNS/2002/0298 ) to be used for the adoption of implementing measures of general scope which seek to amend non-essential elements of a basic instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty, including by deleting some of those elements or by supplementing the instrument by the addition of new non-essential elements.

The regulatory procedure with scrutiny should therefore be followed for measures of general scope designed to amend non-essential elements of this Regulation.

The present proposal aims to introduce in the Regulation a reference to the new regulatory procedure with scrutiny procedure in all cases where the Commission is empowered to adopt quasi-legislative measures within the meaning of Article 2 of Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred to the Commission, as amended by Decision 2006/512/EC.

Due to the urgency of the matter it will be necessary that the adoption of this proposal by the Parliament and Council take place by December 2006.

COM(2006)0607
EUR-Lex

PURPOSE: to amend the European Parliament and Council Regulation on nutrition and health claims made on foods, in order to align it with the new Council Decision 2006/512/EC amending Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission (comitology).

PROPOSED ACT: Regulation of the European Parliament and of the Council.

CONTENT: Decision 1999/468/EC has been amended by Decision 2006/512/EC, which introduced a regulatory procedure with scrutiny (see CNS/2002/0298 ) to be used for the adoption of implementing measures of general scope which seek to amend non-essential elements of a basic instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty, including by deleting some of those elements or by supplementing the instrument by the addition of new non-essential elements.

The regulatory procedure with scrutiny should therefore be followed for measures of general scope designed to amend non-essential elements of this Regulation.

The present proposal aims to introduce in the Regulation a reference to the new regulatory procedure with scrutiny procedure in all cases where the Commission is empowered to adopt quasi-legislative measures within the meaning of Article 2 of Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred to the Commission, as amended by Decision 2006/512/EC.

Due to the urgency of the matter it will be necessary that the adoption of this proposal by the Parliament and Council take place by December 2006.

COM(2006)0607
EUR-Lex

COM(2003)0424
EUR-Lex