Commission Regulation (EU) No 1154/2014
of 29 October 2014
refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
Pursuant to Regulation (EC) No 1924/2006 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.
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.
The Authority is to deliver an opinion on the health claim concerned.
The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.
On 1 June 2011, the Commission and the Member States received the scientific opinion, from the Authority, which concluded that the claim ‘prevents bad breath by neutralising of volatile sulphur compounds in the mouth and oral cavity’ is related to breath odour rather than to a function of the body as required by Article 13 of Regulation (EC) No 1924/2006. During the evaluation of the claim, the applicant was requested to clarify how the proposed claim is linked to a function of the body. The applicant argued that the production of volatile sulphur compounds and halitosis as part of the bacterial flora of the mouth and oral cavity is related to the function of the mouth and oral cavity, and thus to a function of the body. However, the Authority noted that the evidence provided did not demonstrate that the chemical neutralisation of volatile sulphur compounds in the mouth, in order to improve bad breath, constitutes a physiological effect in relation to a function of the body. Therefore, the applicant did not provide evidence that zinc has a physiological effect in relation to a function of the body as required by Article 13(1)(a) of Regulation (EC) No 1924/2006. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
On 8 April 2013 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 could not be established between the consumption of Yestimun® ((1,3)-(1,6)-β-D-glucans from brewer's yeast cell wall) 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 13 June 2013, 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 not been established between the consumption of Transitech® 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 18 June 2013, 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 not been established between the consumption of Lactobacillus rhamnosus GG 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 20 June 2013, 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 could not be established between the consumption of Verisol®P 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 26 July 2013, 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 could not be established between the consumption of proanthocyanidins in Urell® 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 26 July 2013, the Commission and the Member States received the scientific opinion from the Authority, which concluded that the claimed effect indicated by the applicant is general and non-specific, and that the references provided by the applicant did not provide information which could be used to define a specific beneficial physiological effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
The health claims subject to this Regulation are health claims as referred to in Article 13(1)(a) of Regulation (EC) No 1924/2006, which are subject to the transitional period laid down in Article 28(5) of that Regulation until the adoption of the list of permitted health claims provided that they comply with that Regulation.
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.
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:
Article 1
1.
F32.
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F4Article 2
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This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 October 2014.
For the Commission
The President
José Manuel Barroso
ANNEXREJECTED HEALTH CLAIMS
Application — Relevant provisions of Regulation (EC) No 1924/2006 | Nutrient, substance, food or food category | Claim | EFSA opinion reference |
|---|---|---|---|
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | Zinc | Prevents bad breath by neutralising of volatile sulphur compounds (VSC) in the mouth and oral cavity. | Q-2010-01092 |
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | Yestimun® | Daily administration of Yestimun® helps to maintain the body's defence against pathogens. | Q-2012-00761 |
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | Transitech® | Improves transit and durably regulates it. | Q-2013-00087 |
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | Bimuno® GOS | Regular daily consumption of 1,37 g galacto-oligosaccharides from Bimuno® may reduce abdominal discomfort. | Q-2012-01007 |
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | Lactobacillus rhamnosus GG | Lactobacillus rhamnosus GG for maintaining normal defecation during oral antibiotic treatment. | Q-2013-00015 |
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | VeriSol®P | Characteristic collagen peptide mixture (collagen hydrolysate) having a beneficial physiological effect on the maintenance of skin health, as indicated by an increased skin elasticity and a reduction of wrinkles volume, by contributing to a normal collagen and elastin synthesis. | Q-2012-00839 |
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | Proanthocyanidins in Urell® | Proanthocyanidins from Urell® contribute to support defence against bacterial pathogens in the lower urinary tract | Q-2012-00700 |
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | Preservation® | Improves the physiological response to stress by accelerating the appearance of heat shock proteins (HSPs) and maintains an effective level of HSPs to ensure that the organism is primed should the cell encounter further stress. | Q-2013-00021 |