Commission Regulation (EU) 2018/199

of 9 February 2018

refusing to authorise a health claim 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,

Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods1, and in particular Article 18(5) thereof,

Whereas:

(1)

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.

(2)

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.

(3)

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

(4)

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

(5)
Following an application from Probi AB, 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 Lactobacillus plantarum 299v (Lp299v) and an increase of non-haem iron absorption (Question No EFSA- Q-2015-006962). The claim proposed by the applicant was worded as follows: ‘Lactobacillus plantarum 299v increases non-haem iron absorption’.
(6)

On 25 July 2016, the Commission and the Member States received the scientific opinion from the Authority, which concluded that the evidence provided was insufficient to establish a cause and effect relationship between the consumption of Lp299v and an increase of non-haem iron absorption. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

(7)

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 the measures provided for in this Regulation.

(8)

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 shall not be included in the F1... list of permitted claims F2in the Annex to Regulation (EU) 432/2012.

F3Article 2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 9 February 2018.

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 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data

Lactobacillus plantarum 299v (Lp299v)

Lactobacillus plantarum 299v (Lp299v) increases non-haem iron absorption

Q-2015-00696