Commission Regulation (EU) 2016/372 of 15 March 2016 refusing to authorise a health claim made on foods and referring to the reduction of disease risk (Text with EEA relevance)
Date: 2016-03-15
Institutions: European Commission
Subjects: cardiovascular disease, consumer information, food inspection, foodstuff, health control, labelling, market approval








L_2016070EN.01001601.xml










16.3.2016   


EN


Official Journal of the European Union


L 70/16








            COMMISSION REGULATION (EU) 2016/372
of 15 March 2016
         
refusing to authorise a health claim made on foods and referring to the reduction of disease risk
(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 17(3) 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’.












(3)


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.












(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 Lycotec Ltd, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to L-tug lycopene and reduction of blood low-density lipoprotein (LDL)-cholesterol (Question No EFSA-Q-2014-00590 (2)). The claim proposed by the applicant was worded as follows: ‘L-tug lycopene has been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease’.












(6)


On 26 February 2015, 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 L-tug lycopene and reduction of blood LDL-cholesterol concentrations. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.












(7)


The measure provided for in this Regulation is 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 14(1) 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, 15 March 2016.


For the Commission


The President

Jean-Claude JUNCKER
            





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

(2)  
            EFSA Journal 2015;13(2):4025.




ANNEX

Rejected health claim









Application — Relevant provisions of Regulation (EC) No 1924/2006


Nutrient, substance, food or food category


Claim


EFSA opinion reference




Article 14(1)(a) health claim referring to a reduction of a disease risk.


L-tug lycopene


L-tug lycopene has been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease


Q-2014-00590