Commission Regulation (EU) 2019/651
of 24 April 2019
refusing to authorise a health claim made on foods and referring 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 are 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 thereof, and 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 30 January 2017, the Commission and the Member States received the scientific opinion from the Authority, which concluded that on the basis of the data presented, the scientific evidence is insufficient to establish a cause and effect relationship between the consumption of ‘Nutrimune®’ (a pasteurised cow's skim milk fermented with Lactobacillus paracasei CBA L74) and the immune defence against pathogens in the gastrointestinal and upper respiratory tracts. 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 applicant received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting out 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 Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
The health claim listed in the Annex to this Regulation F1may not be made on foods on the Great Britain market.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
F2...
Done at Brussels, 24 April 2019.
For the Commission
The President
Jean-Claude Juncker
ANNEXRejected health claim
Application — Relevant provisions of Regulation (EC) No 1924/2006 | Nutrient, substance, food or food category | Claim | EFSA opinion reference |
|---|---|---|---|
Article 14(1)(b) health claim referring to children's development and health | ‘Nutrimune®’ (a pasteurised cow's skim milk fermented with Lactobacillus paracasei CBA L74) | ‘Nutrimune®’ supports the immune defence in the gastrointestinal and upper respiratory tract of young children | Q-2016-00008 |