欧盟修订肌酸的声称使用条件

(1)

Regulation (EC) No 1924/2006 provides that health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.

(2)

Pursuant to Article 13(3) of Regulation (EC) No 1924/2006 Commission Regulation (EU) No 432/2012 (2) was adopted, which establishes a list of permitted health claims made on foods other than those referring to the reduction of disease risk and to children's development and health.

(3)

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’, for a scientific assessment, as well as to the Commission and the Member States for information.

(4)

The Authority is to deliver an opinion on the health claim concerned.

(5)

The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.

(6)

In order to stimulate innovation, health claims which are based on newly developed scientific evidence and/or which include a request for the protection of proprietary data shall undergo an accelerated type of authorisation.

(7)

Following an application from AlzChem AG, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to creatine in combination with resistance training and improvement in muscle strength (Question No EFSA-Q-2015-00437 (3)). The claim proposed by the applicant was worded as follows: ‘creatine contributes to the maintenance of muscle function in the elderly’.

(8)

On 23 February 2016, the Commission and the Member States received the scientific opinion from the Authority which concluded that on the basis of the data presented, a cause and effect relationship had been established between the consumption of creatine in combination with resistance training and improvement in muscle strength. The target population is adults over the age of 55, who are engaged in regular resistance training. Accordingly, a health claim reflecting this conclusion should be considered as complying with the requirements of Regulation (EC) No 1924/2006 and should be included in the Union list of permitted claims, established by Regulation (EU) No 432/2012.

(9)

One of the objectives of Regulation (EC) No 1924/2006 is to ensure that health claims are truthful, clear and reliable and useful to the consumer, and that the wording and the presentation are taken into account in that respect. Therefore, where the wording of claims used by the applicant has the same meaning for consumers as that of an authorised health claim, because they demonstrate the same relationship that exists between a food category, a food or one of its constituents and health, these claims should be subject to the same conditions of use as those listed in the Annex to this Regulation.

(10)

In accordance with Article 20 of Regulation (EC) No 1924/2006, the Register of nutrition and health claims containing all authorised health claims should be updated in order to take into account this Regulation.

(11)

Regulation (EU) No 432/2012 should therefore be amended accordingly.

(12)

The Member States have been consulted,