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. )
Date: 2018-02-09
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: consumer information, food inspection, foodstuff, gastrointestinal disease, health control, labelling, market approval, trace element








L_2018038EN.01000901.xml










10.2.2018   


EN


Official Journal of the European Union


L 38/9








            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 foods (1), 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-2015-00696 (2)). 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 Union list of permitted claims as provided for in Article 13(3) of Regulation (EC) No 1924/2006.


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.




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
            





(1)  
            OJ L 404, 30.12.2006, p. 9.

(2)  
            EFSA Journal 2016;14(7):4550.




ANNEX

Rejected 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