EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10408/2020 
(POOL/E1/2020/10408/10408 -EN.docx)  
[…](2021) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
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)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
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 EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1925/2006 of the European Parliament and of the 
Council of 20 Decemb er 2006 on the addition of vitamins and minerals and of certain other 
substances to foods1, 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 provided by Member States, the Commission may initiate 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 pro hibited, restricted or under Union scrutiny, if that substance is 
associated with a potential risk to consumers as provided for in Article 8(1) of 
Regulation (EC) No 1925/2006.  
(2) In 2010 , the European Food Safety Authority (‘the Authority`) was asked to provide 
an opinion on scientific substantiation of a health claim  related to monacolin K  
submitted pursuant to Article 13 of Regulation (EC) No 1924/20062. On 30 June 
20113, the Authority issued  a scientific opinion on the substantiation of a health claim 
related to monacolin K from red yeast rice and maintenance of normal blood LDL -
cholesterol concentrations. The Authority concluded that a cause and effect 
relationship has been established between the consumption of monacolin K from red 
yeast rice and main tenance of normal blood LDL - cholesterol concentrations at the 
level of 10 mg daily dose.   
(3) In 2012 , the Authority was asked to provide an opinion on the scientific substantiation 
of a health claim submitted pursuant to Article 14 of Regulation (EC) No 1924 /2006  
related to the combination of  ingredients, among which monacolin K in red yeast rice. 
On 12 July 20134, the Authority issued a scientific opinion establishing a cause and 
effect relationship between the consumption of a product containing 2mg of 
mona colin K from  red yeast rice in combination with other ingredients, and the 
reduction of blood LDL -cholesterol concentrations.  
                                                 
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 .  
EN 2  EN (4) In the above -mentioned scientific opinions, i n relation to restrictions of use, the 
Authority referred to the Summary of Product Characteristics (SmPC)  for lovastatin -
containing medicinal products available on the Union market , as the Authority 
considered that monacolin K in lactone form is identical  to lovastatin . The SmPC  
provides information to healthcare professionals on the safe and effective use of these 
medicinal products . The SmPC for lovastatin -containing medicinal products describe s 
the properties and officially approved conditions for their  use and includes special 
warnings and precautions for use that refer to the risk of myopathy/rhabdomyolysis, 
which is increased by concomitant use of lovastatin with certain other medicinal 
products, and discourag es use of lovastatin by pregnant and lacta ting women.  
(5) During discussions of the working group on nutrition and health claims on the above -
mentioned scientific opinion s, the Member States raised potential safety concerns 
associated with the consumption of foods containing monacolins from red yeast rice.  
(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 on food additives. Food supplements containing red yeast rice preparations 
have been marketed and consumed to a significant deg ree before 15 May 1997 and 
therefore, are not subject to Regulation (EU) 2015/22835 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 applicati on of the provisions of this 
Regulation is without prejudice to Regulations (EU) 2015/2283  and (EC) No 
1333/20086. 
(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 Regulati on and Articles 3 
and 4 of Commission Implementing Regulation (EU) No  307/20127 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 supplements8. 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 
                                                 
5 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 ) 
6 Regulation (EC) No 1333/2008 of the European Parlia ment and of the Council of 16 December 2008 on 
food additives  (OJ L 354, 31.12.2008 ) 
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 o f the French Agency for Food, Environmental 
and Occu pational Health & Safety  on the risks associated with the presence of “red yeast rice” in food 
supplements , 14 February 2014.   
EN 3  EN 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 rep ort adopted by the Belgian Superior Health Council on 13 February 20169 
that provided an evaluation of the supposed beneficial effects and possible toxicity of 
dietary supplements based on red yeast rice for the Belgian population. Th at 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 certai n 
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 
organisatio n DFG in 201310 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 201811, the Authority adopted a scientific opinion on the safety of 
monacolins in red yeast rice . The Authority considered tha t 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 fro m 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 i ntake of monacolins fr om 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 adve rse effects to red yeast rice was  similar to that of lovastatin . It reported, 
through consultation of four sources12 of case reports, that the most important targets 
for adverse events were muscul oskeletal and connective tissue  (including 
rhabdomyolysis ), liver, nervous system, gastro -intestinal tract, skin and subcutaneous  
tissue, in descending order of occurrence . The Authority considered that the available 
information on the adverse effects reported in human s were judged to be sufficient to 
conclude that monacolins from red yeast rice when used as food supplements were of  
significant safety concern at the use level of 10mg/day. The Authority further 
considered that individual cases of severe adverse reactions had been reported for 
monacolins from red yeast rice at intake levels as low as 3mg/day  taken for a period of 
betwe en 2 weeks and 1 year, and that cases of rhabdomyolysis, hepatitis and skin 
disorders occurred and required hospitalisation .  
(10) On the basis of the information available and several uncertainties  highlighted in its 
opinion , the Authority  was unable to provide advice on a daily intake of monacolins 
from red yeast rice that does not give ris e to concerns about  harmful effects to health , 
for the general population, and as appropriate, for vulnerable subgroups of the 
population  as requested by the Commissio n. The Authority  explained that there are 
                                                 
9 Avis du Conseil Superieur de la Sante N° 9312  : Compléments alimentaires à base de « levure de riz 
rouge »,  3 février 2016  
10 Stellungnahme der Gemeinsamen Experten kommission BVL/BfArM: Einstufung von 
Rotschimmelreisprodukten, 08.02.2016  
11 EFSA Journal 2019;16(8):5368  
12 World Health Organisation; French Agency for Food, Environmental and Occupational Health and 
Safety; Italian Surveillance System; Food and Drug Administration.   
EN 4  EN uncertainties as to the composition 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 which have not been fully evaluated 
individually or in combination. Furthermore, due to the lack of data, the safe use of 
monacolins in certain vulnerable groups of consumers cannot be evaluated and there is 
uncertainty as to the effects of concomitant consumption of  red yeast rice -based food 
supplements with foods or drugs that inhibit the enzyme (CYP3A4) that is involved in 
the metabolism of monacolin s.  
(11) In accordance with Article 4(5) of Commission Implementing Regulation (EU) No 
307/2012  and following publication by the Authority of its opinion on monacolins 
from red yeast rice , the Commission received comments from interested parties on the 
scientific risk assessment carried out by the Authority . Interested parties also provided 
statements to support the safe use of monacolins in 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 Authority during 
post-adoption teleconferences held with the interest ed parties. The Authority provided 
clarifications on  the sources of evidence for its scientific opinion and explained why 
certain studies submitted by interested parties during a public call for data  were not 
considered to be sufficiently reliable and scie ntifically robust to be included in its 
safety assessment . The Authority explained the scientific rationale for considering 
safety data for lovastatin as relevant for the safety assessment of monacolins  and 
clarified how post-marketing data on adverse events provided by interested parties was 
used as supporting evidence in its assessment . 
(13) The Commission asked the Authority  for technical assistance on two scientific studies , 
a systematic review and meta -analysis of the safety of red yeast rice  
supplementation13, and a review and expert opinion on the role of red yeast rice 
supplementation in plasma cholesterol control14, that were submitted to the 
Commission by an interested party following adoption of the scientific opinion by the 
Authority. The Authority noted that irrespective of the results of any intervention 
study or meta -analysis on the safety of red yeast rice supplementation, reports of side 
effects associated with the consumption of red yeast rice in humans exist and 
monacolin K in lacto ne form is identical to lovastatin for which adverse effects are 
well documented, and therefore those submitted studies would have to be considered 
together with the whole body of evidence to draw an overall conclusion. The 
Authority exp lained that the exi stence of re ports 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 expert opinion study 
submitted, providing com parative risk -benefit ratio of products containing red yeast 
rice were not relevant to the evaluation of the safety of substances intentionally added 
to food.  
(14) Considering that no daily intake of monacolins from red yeast rice that does not give 
rise to co ncerns for human health could be set , and considering the significant harmful 
effect on health associated with the use of monacolins from red yeast rice at levels of 
10mg/ day, and individual cases of severe adverse health reactions at levels as low as 
                                                 
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   
EN 5  EN 3mg/ day, the use  of monacolins from red yeast rice at levels of 3mg and more  per 
portion of the product rec ommended for daily consumption should be prohibited. That 
substance should therefore 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 to b e labelled 
with the portion of the product that is re commended for daily consumption together 
with a warning not to exceed the st ated recommended daily dose. As d ifferent 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, therefore, it is necessary to provide for appropriate 
labelling requirements for all foods containing monacolins from red yeast rice.  
(16) In order to provide complete information about the cont ent of monacolins on the labels 
of foods containing monacolins from red yeast rice, it is necessary to provide for 
appropriate labelling requirements for all foods containing  monacolins from red yeast 
rice. 
(17) As the Authority identified a risk of adverse eff ects due to interaction s with medicinal 
products , it is necessary to warn persons using cholesterol -lowering medicines, to 
avoid concomitant use of foods and food supplements  containing monacolins from red 
yeast rice. The Authority noted that the profile of adverse effects to red yeast rice was 
similar to that of lovastatin, therefore, it is appropriate to warn persons to seek medical 
advice if they experience any health problems . Furthermore, 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 therefore, there is still the possibility of harmful effects on 
health associated with the use of monacolins from red yeast rice, it is appropria te to 
advise against the use of foods and food supplements containing monacolins from red 
yeast rice for pregnant or lactating women , persons aged over 70 years, children and 
adolescents.  Considering the above, it is necessary to provide for appropriate labelling 
requirements for all foods  containing monacolins from red yeast rice.  
(18) The Authority could not identify a dietary intake of monacolins from red yeast rice 
that does not give rise to concerns about harmful effects to health, for the general 
populati on, and as appropriate, 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 r ice, but scientific  uncertainty  in this regard persists , and considering  
that monacolins from red yeast rice may o nly be used in food supplements  and that the 
extent of use of those food supplements  could not be determined by the Authority , the 
use of monacolins from red yeast rice in food supplements should be placed under 
Union scrutiny and therefore, should be included in Part C of Annex III to Regulation 
(EC) No 1925/2006. Considering the uncertainties outlined by the Authority in its 
scientific opinion and considering the statements given by interested parties on the 
safet y 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 Authority in 
accordance with Arti cle 5 of Commission Implementing Regulation (EU) No 
307/2012. In accordance with Article 8(5) the Commission should take a decision 
within four years from the entry into force of this Regulation, whether to list 
monacolins from red yeast rice in Annex III,  Part A or Part B, as appropriate, taking 
into account the opinion of the Authority on any submitted data.   
EN 6  EN (19) Regulation (EC) No 1925/2006 should therefore be amended accordingly.  
(20) The measures provided for in this Regulation are in accordance with the opinion  of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex III to Regulation (EC) No 1925/2006 is amended as follows:  
1. The following entry is  added in the table in P art B in alphabetical order : 
 
‘PART B - Restricted substances  
 
Restricted substance  Conditions of use  Additional requirements  
Monacolins from red yeast 
rice added to foods or used 
in food supplements as 
defined by Directive 
2002/46/ EC. Individual p ortion of food 
or food supplement  for 
daily consumption shall 
provide less than 3mg of 
monacolins from red yeast 
rice. The label shall provide the  
number of individual 
portion s of the product for 
maximum daily 
consumption and a warning 
not to exceed daily amount  
of less than 3mg .  
 
The label shall indicate the 
content of monacolins per 
portion of the product .  
 
The label shall include the  
following  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 
consumption of this 
product if you experience 
any health problems”;  
 
“Should not be consumed  if 
you are  taking cholesterol -
lowering medication ”; 
 
“Should not be consumed if 
you are already consuming 
other products containing 
red ye ast rice ”.  
EN 7  EN  
2. The following entry is added in the table in part C in alphabetical order : 
 
‘PART C  - Substances under Community scrutiny  
 
Monacolins from red yeast rice added to foods or used in food supplements as 
defined by Directive 2002/46/EC’  
Article  2 
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,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN