L 151/38
EN
Official Journal of the European Union
2.6.2022
(6)
Red yeast rice is made by fermentation of rice with yeasts, mainly Monascus purpureus, resulting in the production of monacolins, the most abundant of which is monacolin K.
It is traditionally used in China as a food colouring and as a traditional remedy to promote digestion and blood circulation.
In the EU, it is not authorised for use as a food colour as it is not included in the Union list of Regulation (EC) No 1333/2008 of the European Parliament and of the Council (5) on food additives.
Food supplements containing red yeast rice preparations have been marketed and consumed to a significant degree before 15 May 1997 and therefore, are not subject to Regulation (EU) 2015/2283 of the European Parliament and of the Council (6) on novel foods.
The use of red yeast rice preparations in other food categories is subject to an authorisation under Regulation (EU) 2015/2283 on novel foods.
The application of the provisions of this Regulation is without prejudice to Regulations (EU) 2015/2283 and (EC) No 1333/2008.
(7)
The Commission, on its own initiative, started the procedure under Article 8 of Regulation (EC) No 1925/2006 for monacolins in red yeast rice as it considered that on the basis of the available information that was provided by the Member States during a consultation on the safety of monacolins from red yeast rice, the necessary conditions and requirements laid down in Article 8 of that Regulation and Articles 3 and 4 of Commission Implementing Regulation (EU) No 307/2012 (7) were fulfilled.
This available information included an opinion from the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) on the risk associated with the presence of ‘red yeast rice’ in food supplements (8).
That opinion concluded that ‘due to the composition of red yeast rice and in particular: the presence of monacolin K (also called lovastatin when marketed as a drug) that shares the adverse effects of statins; the presence at varying levels of the other monacolins, compounds whose safety has not been established, consumption of “red yeast rice” exposes some consumers to a health risk’.
The available information also included a scientific advisory report adopted by the Belgian Superior Health Council on 13 February 2016 (9) that provided an evaluation of the supposed beneficial effects and possible toxicity of dietary supplements based on red yeast rice for the Belgian population.
That report referred to the risk associated with the presence of monacolins, in particular monacolin K, in red yeast rice that includes adverse effects identical to those observed in patients taking statin drugs and referred to a higher risk of developing toxic effects for certain vulnerable groups such as pregnant women, people suffering from liver, kidney and muscle disorders, persons aged over 70 years and children and adolescents.
Another relevant scientific assessment was carried out by the German research funding organisation DFG in 2013 (10) that concluded that ‘red mould rice is not a safe food/food supplement’.
(8)
Therefore, the Commission in 2017, in accordance with Article 8 of Regulation (EC) No 1925/2006, requested the Authority to deliver a scientific opinion on the evaluation of the safety of monacolins in red yeast rice.
(9)
On 25 June 2018 (11), the Authority adopted a scientific opinion on the safety of monacolins in red yeast rice.
The Authority considered that monacolin K in lactone form was identical to lovastatin, the active ingredient of several medicinal products authorised for the treatment of hypercholesterolemia in the EU.
Monacolin K from red yeast rice is available in food supplements at varying recommended daily intakes for its effect on the maintenance of normal blood LDL-cholesterol levels.
On the basis of the information available, the Authority concluded that intake of monacolins from red yeast rice via food supplements could lead to estimated exposure to monacolin K within the range of the therapeutic doses of lovastatin.
The Authority noted that the profile of adverse effects to red yeast rice
(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.