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, 20 March 2023.

For the Commission

The President

Ursula VON DER LEYEN

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

( 2 ) Question No EFSA-Q-2012-00968.

( 3 ) EFSA Journal 2013;11(7):3327.

( 4 ) Barrat E, Zaïr Y, Chauveau P, Maudet C, Housez B, Derbord E, Lescuyer JF, Bard JM, Cazaubiel M and Peltier SL, 2012, unpublished; Effect on LDL-cholesterol of a large dose of a dietary portfolio supplement in subjects with untreated moderate hypercholesterolaemia: a double-blind, placebo-controlled study, published as : Barrat E, Zaïr Y, Sirvent P, Chauveau P, Maudet C, Housez B, Derbord E, Lescuyer JF, Bard JM, Cazaubiel M and Peltier SL, 2012; Effect on LDL-cholesterol of a large dose of a dietary supplement with plant extracts in subjects with untreated moderate hypercholesterolaemia: a randomised, double-blind, placebo-controlled study, European Journal of Nutrition, Dec 25. [Epub ahead of print]; Barrat E, Zaïr Y, Ogier N, Housez B, Vergara C, Maudet C, Lescuyer JF, Bard JM, Carpentier YA, Cazaubiel M and Peltier SL, 2012, unpublished; A dietary portfolio supplement substantially lowers LDL-cholesterol in subjects with moderate untreated hypercholesterolaemia: a randomised controlled study, published as : Barrat E, Zaïr Y, Ogier N, Housez B, Vergara C, Maudet C, Lescuyer JF, Bard JM, Carpentier YA, Cazaubiel M and Peltier SL, 2013; A combined natural supplement lowers LDL cholesterol in subjects with moderate untreated hypercholesterolemia: a randomized placebo-controlled trial. International Journal of Food Sciences and Nutrition, Jul 2. [Epub ahead of print]; Ogier N, Amiot MJ, Georgé S, Maillot M, Mallmann C, Maraninchi M, Morange S, Lescuyer JF, Peltier SL and Cardinault N, 2013; LDL-cholesterol-lowering effect of a dietary supplement with plant extracts in subjects with moderate hypercholesterolemia, European Journal of Nutrition, 52, p. 547.

( 5 ) Commission Regulation (EU) 2022/860 of 1 June 2022 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice. OJ L 151, 2.6.2022, p. 37 .

( 6 ) Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods. OJ L 404, 30.12.2006, p. 26 .

( 7 ) Address: ZAC de Belle Aire Nord, 15 rue le Corbusier, 17440 Aytré, France.

COMMISSION REGULATION (EU) 2023/648 of 20 March 2023 authorising a health claim made on foods and referring to the reduction of disease risk ANNEX Permitted health claim