Commission Regulation (EC) No 1024/2009
of 29 October 2009
on the authorisation and refusal of authorisation of certain health claims made on food and referring to the reduction of disease risk and to children’s development and health
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Whereas:
Pursuant to Regulation (EC) No 1924/2006 health claims made on food are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.
Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as the Authority.
Following receipt of an application the Authority is to inform without delay the other Member States and the Commission of the application, and to deliver an opinion on a health claim concerned.
The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.
On 14 November 2008 the Commission and the Member States received two opinions on applications for health claim authorisation from the Authority. On 10 December 2008, the Commission and the Member States received five opinions on applications for health claim authorisation from the Authority. On 19 December 2008, the Commission and the Member States received nine opinions on applications for health claim authorisation from the Authority. On 15 January 2009, the Commission and the Member States received one opinion on an application for health claim authorisation from the Authority. Meanwhile one application for health claim authorisation was subject to a previous decision.
One opinion was related to an application for reduction of disease risk claim, as referred to in Article 14(1)(a) of Regulation (EC) No 1924/2006, and 15 opinions were related to applications for health claims referring to children’s development and health, as referred to in Article 14(1)(b) of Regulation (EC) No 1924/2006.
On the basis of the data presented, the Authority concluded that a cause and effect relationship was established between the consumption of chewing gum sweetened with 100 % xylitol and the claimed effect. However, it concluded that a cause and effect relationship had not been established between the consumption of pastilles sweetened with at least 56 % xylitol and the claimed effect. Subject to a revised wording, the claim should be considered as complying with the requirements of Regulation (EC) No 1924/2006 and in particular Article 14(1)(a) thereof, and it should be included in the Community list of permitted claims.
On the basis of the data presented, the Authority concluded that a cause and effect relationship was established between the consumption of calcium, vitamin D, phosphorus and protein and the claimed effect. Subject to a revised wording and taking into account that health claims for the same claimed effect are authorised for calcium, vitamin D and protein, the claim for phosphorus should be considered as complying with the requirements of Regulation (EC) No 1924/2006, and it should be included in the Community list of permitted claims.
Article 16(4) of Regulation (EC) No 1924/2006 provides that an opinion in favour of authorising a health claim should include certain particulars. Accordingly, those particulars should be set out in the Annex I to the present Regulation as regards the two authorised claims and include, as the case may be, the revised wording of the claim, specific conditions of use of the claim, and, where applicable, conditions or restrictions of use of the food and/or an additional statement or warning, in accordance with the rules laid down in Regulation (EC) No 1924/2006 and in line with the opinions of the Authority.
One of the objectives of the Regulation (EC) No 1924/2006 is to ensure that health claims are truthful, clear and reliable and useful to the consumer, and that wording and presentation have to be taken into account in that respect; that therefore where the wording of claims has the same meaning for consumers as that of an authorised health claim as they demonstrate the same relationship that exists between a food category, a food or one of its constituents and health, included in Annex I to the present Regulation, they should be subject to the same conditions of use indicated therein.
On the basis of the data presented, the Authority concluded that the constituents of Lactoral are insufficiently characterised, and that a cause and effect relationship had not been established between the consumption of Lactoral and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
On the basis of the data presented, the Authority concluded that the constituents of Lactoral are insufficiently characterised, and that a cause and effect relationship had not been established between the consumption of Lactoral and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
On the basis of the data presented, the Authority concluded that the constituents of Lactoral are insufficiently characterised, and that a cause and effect relationship had not been established between the consumption of Lactoral and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
On the basis of the data presented, the Authority concluded that the constituents of Lactoral are insufficiently characterised, and that a cause and effect relationship had not been established between the consumption of Lactoral and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
On the basis of the data presented, the Authority concluded that the constituents of Lactoral are insufficiently characterised, and that the claimed effect had not been shown. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
On the basis of the data presented, the Authority concluded that a cause and effect relationship had not been established between the consumption of the food and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
On the basis of the data presented, the Authority concluded that a cause and effect relationship had not been established between the consumption of Efalex® and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
On the basis of the data presented, the Authority concluded that a cause and effect relationship had not been established between the consumption of Efalex® and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
On the basis of the data presented, the Authority concluded that a cause and effect relationship had not been established between the consumption of Efalex® and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
On the basis of the data presented, the Authority concluded that a cause and effect relationship had not been established between the consumption of Efalex® and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
On the basis of the data presented, the Authority concluded that a cause and effect relationship had not been established between the consumption of Efalex® and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
On the basis of the data presented, the Authority concluded that a cause and effect relationship had not been established between the intake of Eye q baby® and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
On the basis of the data presented, the Authority concluded that a cause and effect relationship had not been established between the intake of Eye q® and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
On the basis of the data presented, the Authority concluded that a cause and effect relationship had not been established between the intake of Eye q® and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
The comments from the applicants and the members of the public received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the measures provided for in this Regulation.
In accordance with Article 28(6) of Regulation (EC) No 1924/2006 health claims referred to in Article 14(1)(b) of Regulation (EC) No 1924/2006 and not authorised by this Regulation may continue to be used for six months after the adoption of a decision pursuant to Article 17(3) of Regulation (EC) No 1924/2006. However, for applications which were not made before 19 January 2008 the requirement provided for in Article 28(6)(b) is not fulfilled, and the transition period laid down in that Article is not applicable. Accordingly, a transition period of six months should be provided for, to enable food business operators to adapt to the requirements laid down in this Regulation.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION: