Commission Regulation (EU) 2023/648 of 20 March 2023 authorising a health claim made on foods and referring to the reduction of disease risk (Text with EEA relevance)

Article 1

The health claim set out in the Annex to this Regulation shall be included in the Union list of permitted health claims as provided for in Article 14(1) of Regulation (EC) No 1924/2006 and may be made on foods in compliance with the conditions laid down in the Annex to this Regulation.

Article 2

Only Laboratoire Lescuyer  ( 7 ) is authorised to use the health claim set out in the Annex, for a period of 5 years from the date into force of this Regulation in accordance with Article 4 of this Regulation, unless a subsequent applicant obtains an authorisation to use the same claim without reference to the scientific data protected pursuant to Article 3, or with the agreement of Laboratoire Lescuyer. After the expiry of that period, that health claim may be used, in conformity with the conditions applying to it, by any food business operator.

Article 3

The scientific data of the studies included in the application, on the basis of which the health claim referred to in Article 1 has been assessed by the Authority, and fulfilling the requirements laid down in Article 21(1) of Regulation (EC) No 1924/2006, shall not be used for the benefit of a subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the prior agreement of Laboratoire Lescuyer.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Permitted health claim

ANNEXSupplementary provisions

ANNEX Permitted health claim Application – Relevant provisions of Regulation (EC) No 1924/2006 Applicant – Address Nutrient, substance, food or food category Claim Conditions of use of the claim Conditions and/or restrictions of use of the food and/or additional statement or warning EFSA opinion reference Article 14(1)(a) health claim referring to a reduction of a disease risk Laboratoire Lescuyer, ZAC de Belle Aire Nord, 15 rue le Corbusier, 17440 Aytré, France A combination of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, procyanidolic oligomers from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate A combination of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, procyanidolic oligomers from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate reduces blood LDL-cholesterol concentrations. High LDL-cholesterol is a risk factor in the development of coronary heart disease  ( 1 ) . The claim may be used only for food supplements which provide 600 mg artichoke leaf dry extract with 30-36 mg caffeoylquinic acids, 500 mg red yeast rice with 2 mg monacolin K, 10 mg sugar-cane derived policosanols, 20 mg French maritime pine bark extract with 18 mg procyanidolic oligomers, 30 mg garlic dry extract with 0,25 mg allicin, 30 mg α-tocopherol equivalents, 5 mg riboflavin and 9 mg inositol hexanicotinate divided in three daily doses to be consumed with the major meals.   Q-2012-00968 ( 1 )   Authorised on 10 April 2023 and restricted to the use by Laboratoire Lescuyer, ZAC de Belle Aire Nord, 15 rue le Corbusier, 17440 Aytré, France, for a period of 5 years.