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, 1 June 2022.

For the Commission

The President

Ursula VON DER LEYEN

( 1 ) OJ L 404, 30.12.2006, p. 26 .

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

( 3 ) EFSA Journal 2011;9(7):2304.

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

( 5 ) Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives ( OJ L 354, 31.12.2008, p. 16 ).

( 6 ) Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 ( OJ L 327, 11.12.2015, p. 1 ).

( 7 ) Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing implementing rules for the application of Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods ( OJ L 102, 12.4.2012, p. 2 ).

( 8 ) ANSES Opinion Request No 2012-SA-0228: Opinion of the French Agency for Food, Environmental and Occupational Health & Safety on the risks associated with the presence of ‘red yeast rice’ in food supplements, 14 February 2014.

( 9 ) Avis du Conseil Superieur de la Sante N° 9312 : Compléments alimentaires à base de «levure de riz rouge », 3.2.2016.

( 10 ) Stellungnahme der Gemeinsamen Experten kommission BVL/BfArM: Einstufung von Rotschimmelreisprodukten, 8.2.2016.

( 11 ) EFSA Journal 2019;16(8):5368.

( 12 ) World Health Organisation; French Agency for Food, Environmental and Occupational Health and Safety; Italian Surveillance System of Natural Health Products; Food and Drug Administration.

( 13 ) Fogacci F, Banach M, Mikhailidis DP et al. Safety of red yeast rice supplementation: A systematic review and meta-analysis of randomized controlled trials. Pharmacological Research 143 (2019) 1–16.

( 14 ) Banach M, Bruckert E, Descamps OS et al. The role of red yeast rice (RYR) supplementation in plasma cholesterol control: A review and expert opinion. Atheroscler Suppl. 2019 Aug 17.

( 15 ) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements ( OJ L 183, 12.7.2002, p. 51 ).

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