COMMI SSION REGUL ATION (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 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regard to 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 (1), and in particular Article 8(2)(a)(ii) and (b) 
thereof,
Whereas:
(1) Pursuant to Article 8(2) of Regulation (EC) No 1925/2006, on its own initiative or on the basis of information 
provid ed by Member State s, the Commission may initiat e a procedure to include a substance or an ingredient 
containing a substance other than a vitamin or a mineral in Annex III to that Regulation listing the substances 
whose use in foods is prohibited, restr icted or under Union scrutiny , if that substance is associated with a potential 
risk to consumers as provid ed for in Article 8(1) of Regulation (EC) No 1925/2006.
(2) In 2010, the European Food Safet y Author ity (‘the Auth ority’) was aske d to provide an opinion on scientifi c 
substantiation of a health claim relat ed to monacolin K submitted pursuant to Article 13 of Regulation (EC) 
No 1924/2006 of the European Parliament and of the Council (2). On 30 June 2011 (3), the Author ity issued a 
scientific opinion on the substantiation of a health claim related to monacolin K from red yeast rice and 
mainte nance of normal blood LDL -choleste rol concentrations. The Auth ority concluded that a cause and effect 
relationship has been established between the consum ption of monacolin K from red yeast rice and mainte nance of 
normal blood LDL-cholester ol concentrations at the level of 10 mg daily dose.
(3) In 2012, the Author ity was asked to provide an opinion on the scientific substantiation of a health claim submitte d 
pursuant to Article 14 of Regulation (EC) No 1924/2006 relat ed to the combination of ingredients, among which 
monacolin K from red yeast rice. On 12 July 2013 (4), the Authority issued a scientifi c opinion establishing a cause 
and effect relationship between the consump tion of a product containing 2 mg of monacolin K from red yeast rice 
in combination with other ingredients, and the reduction of blood LDL- choleste rol concentrations.
(4) In the abov ementioned scientifi c opinions, in relation to restr ictions of use, the Author ity refer red to the Summar y 
of Product Character istics (SmPC) for lovastatin-containing medicinal products available on the Union mark et, as 
the Authority considered that monacolin K in lactone form is identical to lovastatin. The SmPC provid es 
information to healthcare professionals on the safe and effective use of these medicinal products. The SmPC for 
lovastatin-containing medicinal products descr ibes the proper ties and officially approved conditions for their use 
and includes special warnings and precautions for use that refer to the risk of myopath y/rhabdomy olysis, which is 
increased by concomitant use of lovastatin with certain other medicinal products, and discourag es use of lovastatin 
by pregnant and lactating women.
(5) Dur ing discussions of the working group on nutr ition and health claims on the abov ementioned scientifi c opinions, 
the Member States raised poten tial safet y concer ns associated with the consum ption of foods containing monacolins 
from red yeast rice.
(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 nutr ition 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.EN Offi cial Jour nal of the European Union 2.6.2022 L 151/37  (6) Red yeast rice is made by fermentation of rice with yeasts, mainly Monascus purpureu s, resulting in the production of 
monacolins, the most abundant of whic h is monacolin K. It is traditionally used in China as a food colour ing and as a 
traditional remedy to promote dige stion and blood circulation. In the EU, it is not author ised 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 mark eted and 
consumed to a signif icant degree before 15 May 1997 and theref ore, 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 
catego ries is subject to an author isation 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 provi ded by the 
Member State s during a consultation on the safet y of monacolins from red yeast rice, the necessar y conditions and 
requirements laid down in Article 8 of that Regulation and Articles 3 and 4 of Commission Imp lementing 
Regulation (EU) No 307/2012 (7)were fulfilled. This available information included an opinion from the French 
Agen cy for Food, Environmental and Occupational Health & Safe ty (ANSES) on the risk associated with the 
presence of ‘red yeast rice’ in food supplements (8). That opinion concluded that ‘due to the compo sition of red 
yeast rice and in particular: the presence of monacolin K (also called lovastatin when mark eted as a drug) that shares 
the adverse effects of statins; the presence at varying levels of the other monacolins, compo unds whose safety has 
not been established, consump tion of “red yeast rice” exposes some consumers to a health risk’. The available 
information also included a scientifi c advisor y repor t adopt ed by the Belgian Super ior Health Council on 
13 Febr uary 2016 (9)that provided an evaluation of the supposed beneficial effects and possible toxicity of dietar y 
supplements based on red yeast rice for the Belgian population. That repor t referred to the risk associate d with the 
presence of monacolins, in particular monacolin K, in red yeast rice that includes adverse effects identical to those 
obser ved in patients taking statin drugs and referred to a higher risk of developing toxic effects for certain 
vulnerable groups such as pregnant women, people suffer ing from liver , kidne y and muscle disorders, persons aged 
over 70 years and children and adolescents. Another relevant scientific assessment was carried out by the German 
research funding orga nisation DFG in 2013 (10)that concluded that ‘red mould rice is not a safe food/f ood 
supplement’.
(8) Theref ore, the Commission in 2017, in accordance with Article 8 of Regulation (EC) No 1925/2006, requeste d the 
Authority to deliver a scientifi c opinion on the evaluation of the safety of monacolins in red yeast rice.
(9) On 25 June 2018 (11), the Author ity adopt ed a scientific opinion on the safety of monacolins in red yeast rice. The 
Authority considered that monacolin K in lacto ne form was identical to lovastatin, the active ingredient of several 
medicinal products author ised for the treatment of hypercholest erolemia in the EU. Monacolin K from red yeast rice 
is available in food supplements at varying recommended daily intakes for its effect on the maintenanc e of normal 
blood LDL-cholester ol levels. On the basis of the information available, the Author ity concluded that intake of 
monacolins from red yeast rice via food supplements could lead to estimat ed exposure to monacolin K within the 
range of the therapeutic doses of lovastatin. The Author ity note d that the prof ile 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 Apr il 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-02 28: Opinion of the French Agency for Food, Environmental and Occupational Health & 
Safet y on the risks associated with the presence of ‘red yeast rice’ in food supplements, 14 Febr uary 2014.
(9)Avis du Conseil Super ieur de la Sante N° 9312 : Compl éments alimentaires à base de «levure de riz rouge », 3.2.2016.
(10)Stellungnahme der Gemeinsamen Exper ten kommission BVL/BfArM: Einstufung von Rotschimmelreisprodukt en, 8.2.2016.
(11)EFSA Journal 2019;16(8):5368.EN Offi cial Jour nal of the European Union L 151/38 2.6.2022  was similar to that of lovastatin. It repor ted, through consultation of four sources (12)of case repor ts, that the most 
imp ortant targets for adverse events were musculoskeletal and connective tissue (including rhabdomy olysis), liver , 
nervous system, gastro-intestinal tract, skin and subcutaneous tissue, in descending order of occur rence. The 
Authority considered that the available information on the adverse effects repor ted in humans were judge d to be 
suffi cient to conclude that monacolins from red yeast rice when used as food supplements were of significant safety 
concer n at the use level of 10 mg/da y. The Author ity further considered that individual cases of severe adverse 
reactions had been repor ted for monacolins from red yeast rice at intake levels as low as 3 mg/da y taken for a 
period of between 2 weeks and 1 year, and that cases of rhabdomy olysis, hepatitis and skin disorders occur red and 
required hospitalisation.
(10) On the basis of the information available and several uncer tainties highlight ed in its opinion, the Author ity was 
unable to provid e advice on a daily intake of monacolins from red yeast rice that does not give rise to concer ns 
about harmful effects to health, for the general population, and as appropr iate, for vulnerable subgroups of the 
population as request ed by the Commission. The Auth ority explained that there are uncer tainties as to the 
compo sition and content of monacolins in food supplements containing red yeast rice and that monacolins in red 
yeast rice are used in multi-ingredient products, the components of whic h have not been fully evaluated individually 
or in combination. Further more, due to the lack of data, the safe use of monacolins in certain vulnerable groups of 
consumers cannot be evaluated and there is uncer tainty as to the effects of concomitant consump tion of red yeast 
rice-based food supplements with foods or drugs that inhibit the enzyme (CYP3A4) that is involved in the 
metabolism of monacolins.
(11) In accordance with Article 4(5) of Implementing Regulation (EU) No 307/2012 and followi ng publication by the 
Authority of its opinion on monacolins from red yeast rice, the Commission received comments from interest ed 
parties on the scientific risk assessment carried out by the Author ity. Interested parties also provided state ments to 
suppor t the safe use of monacolins from red yeast rice in combination with adequate consumer information on the 
safe use of the substance.
(12) Those comments that were of a scientific nature were clarified by the Author ity during post-adoption 
telecon ferences held with the interest ed parties. The Author ity provided clarifications on the sources of evidence for 
its scientifi c opinion and explained why certain studies submitte d by interested parties during a public call for data 
were not considered to be sufficiently reliable and scientifically robust to be included in its safety assessment. The 
Authority explained the scientific rationale for consider ing safety data for lovastatin as relevant for the safety 
assessment of monacolins and clarified how post-marketing data on adverse events provid ed by inter ested parties 
was used as suppor ting evidence in its assessment.
(13) The Commission aske d the Author ity for technical assistance on two scientific studies, a systematic review and meta- 
analysis of the safet y of red yeast rice supplementation (13), and a review and exper t opinion on the role of red yeast 
rice supplementation in plasma choleste rol control (14), that were submitte d to the Commission by an inter ested 
party follo wing adopt ion of the scientifi c opinion by the Authority. The Author ity noted that irrespective of the 
results of any inter vention study or meta-analysis on the safety of red yeast rice supplementation, repor ts of side 
effects associated with the consump tion of red yeast rice in humans exist and monacolin K in lacto ne form is 
identical to lovastatin for whic h adverse effects are well documented, and theref ore those submitt ed studies would 
have to be considered together with the whole body of evidence to draw an overall conclusion. The Author ity 
explained that the existen ce of repor ts of adverse effects cannot be neglected or invalidated by results of trials that 
were relatively small in size and not designed to detect these effects, and that studies, such as the review and exper t 
opinion study submitted, provid ing compara tive risk-benefi t ratio of products containing red yeast rice were not 
relevant to the evaluation of the safety of substances intentionally added to food.
(12)World Health Org anisation; French Agency for Food, Environmental and Occupational Health and Safety ; Italian Surveillance Syst em 
of Natural Health Products; Food and Drug Adm inistration.
(13)Fogacci F, Banach M, Mikhailidis DP et al. Safet y of red yeast rice supplementation: A systematic review and meta-analysis of 
randomized controlled trials. Phar macological Researc h 143 (2019) 1–16.
(14)Banach M, Bruckert E, Descamps OS et al. The role of red yeast rice (RYR) supplementation in plasma cholest erol control: A review 
and exper t opinion. Atheroscler Suppl. 2019 Aug 17.EN Offi cial Jour nal of the European Union 2.6.2022 L 151/39  (14) Consider ing that no daily intake of monacolins from red yeast rice that does not give rise to concer ns for human 
health could be set, and consider ing the significant harmful effect on health associated with the use of monacolins 
from red yeast rice at levels of 10 mg/da y, and individual cases of severe adverse health reactions at levels as low as 
3 mg/da y, the use of monacolins from red yeast rice at levels of 3 mg and more per portion of the product 
recommended for daily consum ption should be prohibited. That substance should theref ore be placed in Part B of 
Annex III to Regulation (EC) No 1925/2006 and its addition to foods or its use in the manufacture of foods should 
only be allowed under the conditions specified in that Annex.
(15) Food supplements are required by Article 6 of Directive 2002/46/EC of the European Parliament and of the 
Council (15)to be labelled with the portion of the product that is recommended for daily consump tion together with 
a warning not to excee d the stated recommended daily dose. As different foods or food supplements containing 
monacolins from red yeast rice may be consumed simultaneously , there is the possibility of exce eding the limit laid 
down in Annex III to Regulation (EC) No 1925/2006, theref ore, it is necessar y to provide for appropr iate labelling 
requirements for all foods containing monacolins from red yeast rice.
(16) In order to provid e compl ete information about the content of monacolins on the labels of foods containing 
monacolins from red yeast rice, it is necessar y to provi de for appropr iate labelling requirements for all foods 
containing monacolins from red yeast rice.
(17) As the Auth ority identified a risk of adverse effects due to interactions with medicinal products, it is necessar y to 
warn persons using cholest erol-lower ing medicines, to avoid concomitant use of foods containing monacolins from 
red yeast rice. The Auth ority noted that the prof ile of adverse effects to red yeast rice was similar to that of lovastatin, 
theref ore, it is appropr iate to warn persons to seek medical advice if they exper ience any health problems. 
Further more, as the Authority could not evaluate the safe use of monacolins in certain vulnerable groups of 
consumers because of the lack of data, and as theref ore, there is still the possibility of harmful effects on health 
associated with the use of monacolins from red yeast rice, it is appropr iate to advise again st the use of foods 
containing monacolins from red yeast rice for pregnant or lactating women, persons aged over 70 years, children 
and adolescents. Consider ing the abov e, it is necessar y to provid e for appropr iate labelling requirements for all 
foods containing monacolins from red yeast rice.
(18) The Authority could not identify a dietar y intak e of monacolins from red yeast rice that does not give rise to 
concer ns about harmful effects to health, for the general population, and as appropr iate, for vulnerable subgroups 
of the population. As there is still a possibility of harmful effects on health associated with the use of monacolins 
from red yeast rice, but scientific uncer tainty in this rega rd persists, and consider ing that monacolins from red yeast 
rice may only be used in food supplements and that the extent of use of those food supplements could not be 
determined by the Author ity, the use of monacolins from red yeast rice in food supplements should be placed under 
Union scrutiny and theref ore, should be included in Part C of Annex III to Regulation (EC) No 1925/2006. 
Consider ing the uncer tainties outlined by the Auth ority in its scientific opinion and consider ing the statements 
given by inter ested parties on the safety profile of monacolins from red yeast rice, those interested parties have 
under Article 8(4) of Regulation (EC) No 1925/2006 the possibility to submit data demonstrating the safety of 
monacolins from red yeast rice to the Author ity in accordance with Article 5 of Implementing Regulation (EU) 
No 307/2012. In accordance with Article 8(5) of Regulation (EC) No 1925/2006 the Commission should take a 
decision within four years from the entr y into force of this Regulation, whether to list monacolins from red yeast 
rice in Annex III, Part A or Part B, as appropr iate, taking into account the opinion of the Author ity on any 
submitted data.
(19) Regulation (EC) No 1925/2006 should theref ore be amended according ly.
(20) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
(15)Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the appro ximation of the laws of the 
Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).EN Offi cial Jour nal of the European Union L 151/40 2.6.2022  HAS ADOPTED THIS REGUL ATION:
Article 1
Annex III to Regulation (EC) No 1925/2006 is amended as follows:
1.The followi ng entr y is added in the table in Part B ‘Restr icted substances’ in alphabetical order :
Restr icted substance Conditions of use Additional requirements
‘Monacolins from red yeast rice Individual portion of the product 
for daily consum ption shall 
provid e less than 3 mg of 
monacolins from red yeast rice.The label shall provide the number of 
individual portions of the product for 
maximum daily consump tion and a 
warning not to consume a daily amount 
of 3 mg of monacolins from red yeast rice 
or more.
The label shall indicate the conte nt of 
monacolins per portion of the product.
The label shall include the follo wing 
warnings:
“Should not be consumed by pregnant or 
lactating women, children below 18 years 
old and adults above 70 years old”.
“Seek advice from a doctor on 
consum ption of this product if you 
exper ience any health problems”;
“Should not be consumed if you are taking 
cholesterol-lo wering medication”;
“Should not be consumed if you are already 
consuming other products containing red 
yeast rice”.’
2.The followi ng entr y is added in the table in Part C ‘Substances under Community scrutiny’ in alphabetical order:
‘Monacolins from red yeast rice’
Article 2
This Regulation shall enter into force on the twentieth day followi ng 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 LEYENEN Offi cial Jour nal of the European Union 2.6.2022 L 151/41