EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/760/2023 
(POOL/A1/2023/760/760 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) No 432/2012 as regards the health claim on monacolin K 
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 Regulation (EU) No 432/2012 as regards the health claim on monacolin K 
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 1924/2006 of the European Parliament and of the 
Council of 20 December 2006 on nutrition and health claims made on foods1, and in 
particular Article 13(4)  thereof,  
Whereas:  
(1) Pursuant to Regulation (EC) No 1924/2006 , health claims made on foods are 
prohibited unless they are authorised by the Commission in accordance with that 
Regulation and include d in the Union list of permitted  health  claims . 
(2) Commission Regulation (EU) No 432/2012  of 16 May 2012 establishes a list of 
permitted health claims made on foods, other than those referring to the reduction of 
disease risk and to children’s development and health2. 
(3) Pursuant to Regulation (EC) No 1924/2006, scientific substantiation should b e the 
main consideration for the use of nutrition and health claims and food business 
operators using claims should justify  those claims . A claim should be scientifically 
substantiated by taking into account the totality of the available relevant scientifi c 
data, and by weig hing the evidence.  Furthermore, in order to keep up with scientific 
and technological developments, the list of permitted health claims  should be revised 
promptly whenever necessary.  
(4) A health claim on monacolin K from red yeast rice  was included in the list of health 
claims  submitted to the Commission under Article 13(2) of Regulation (EC) No 
1924/2006  and transmitted  to the European Food Safety Authority  (‘the Authority’) in 
accordance with Article 13(3) of that Regulation.  On 28 July 2011 , the Authority 
published  a scientific opinion3 on the substantiation of a health claim related to 
monacolin K from red yeast rice and the maintenance of normal blood LDL -
cholesterol concentrations. The Authority concluded that a cause -and-effect 
relationship had been established between the consumption of monacolin K from red 
yeast rice and the maintenance of normal blood LDL -cholesterol concentrations , at a 
daily intake of 10 mg of monacolin K from red yeast rice .  
(5) Based on the  opinion  of the Authority, the health claim on monacolin K from red yeast 
rice and its contribution to the maintenance of normal blood cholesterol levels  was 
authorised and included in the list of permitted health claims contained in the Annex to 
                                                 
1 OJ L 404, 30.12.2006, p. 9.  
2 OJ L 136, 25.5.2012, p. 1 –40 
3 EFSA Journal 2011;9(7):2304.   
EN 2  EN Commission Regulation  (EU) No 432/2012. The accompanying conditions  of use 
require d a daily intake of 10 mg of monacolin K from red yeast rice  preparations . 
(6) In relation to the restrictions of use of the health claim , the Authority referred  to the 
Summary of Product Characteris tics (SmPC) of lovastatin -containing medicinal 
products available on the Union market . The SmPC provides information to healthcare 
professionals on the safe and effective use of medicinal products  and specifically of 
lovastatin -containing medicinal product s. It describes the properties and officially 
approved conditions for their use which includes special warnings and precautions that 
refer to the risk of myopathy/rhabdomyolysis, which is increased by concomitant use 
of lovastatin with certain other medicinal products,  and discourages the use of 
lovastatin by pregnant and lactating women . The Authority considered that  the 
monacolin K in lactone form  was identical to lovastatin.  
(7) Following those restrictions of use,  Member States  raised potential safet y concerns 
associated with the consumption of foods containing monacolins from red yeast rice.   
(8) The Commission considered that on the basis of the information provided by the 
Member States, the necessary conditions and requirements laid down in Article 8 o f 
Regulation (EC) No 1925/ 2006 of the European Parliament and of the Council4 and 
Articles 3 and 4 of Commission Implementing Regulation (EU) No  307/20125 were 
fulfilled. Therefore, the Commission  launched the procedure under Article 8 of 
Regulation (EC) No 1925/2006 for monacolins in red yeast rice.  
(9) In that context, the Commission , in accordance with Article 8 (2) of Regulation (EC) 
No 1925/2006, requested the Authority to deliver a scientific opinion on the evaluation 
of the safety of monacolins in red ye ast rice.  
(10) On 25 June 2018, the Authority adopted  a scientific opinion6 on the safety of 
monacolins in red yeast rice. The Authority reiterated  that monacolin K in lactone 
form was identical to lovastatin, the active ingredient of several medicinal product s 
authorised for the treatment of hypercholesterolemia in the U nion. At the time, 
monacolin K from red yeast rice was available in food supplements at varying 
recommended daily intake  level s for its effect on the maintenance of normal blood 
LDL -cholesterol  levels. On the basis of the information available, the Authority 
concluded that  the intake of monacolins from red  yeast rice  through food supplements 
could lead to an estimated exposure to monacolin K within the range of the therapeutic 
doses of lovastati n. The Authority noted that the profile of adverse effects to red yeast 
rice was similar to that of lovastatin .7 
(11) In its scientific opinion, t he Authority considered that the available information on the 
adverse effects reported in humans 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 10  mg/day  and that  individual cases of severe 
adverse reactions had been reported for monacolins from red yeast rice at intake levels 
                                                 
4 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). 
5 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 su bstances to foods  
(OJ L 102, 12.4.2012, p. 2).  
6 EFSA Journal 2019;16(8): 5368.  
7 EFSA Journal 2018;16(8):5368 , page 38.   
EN 3  EN as low as 3  mg/day . 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 rise  to concerns about harmful 
effects to health, for the general population, and as appropriate, for vulnerable 
subgroups of the population , as requested by the Commission. The Authority 
explained that there are 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 (CYP3A 4) that is 
involved in the metabolism of monacolins.  
(12) Considering that  no daily intake of monacolins from red yeast rice that does not give 
rise to concerns for human health could be set, and considering the significant harmful 
effect on health associated w ith the use of monacolins from red yeast rice at levels of 
10 mg/day, a s well as  individual cases of severe adverse health reactions at levels as 
low as 3  mg/day , the use of monacolins from red yeast rice at levels of 3  mg and more 
per portion of the produ ct recommended for daily consumption has been  prohibited  by 
Commission Regulation (EU) 2022/8608. By that Regulation the Commission 
amend ed Annex III to Regulation (EC) No  1925/2006  by placing monacolins from red 
yeast rice in Part B  ‘Restricted substances’  of that Annex . Its addition to foods or its 
use in the manufacture of foods is therefore  only allowed under the conditions 
specified  in that Annex . 
(13) As there is still a possibility of harmful effects on health associated with the us e of 
monacolins from red yeast rice, but scientific uncertainty in this regard persists, and 
considering 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 b y the 
Authority,   the use of monacolins from red yeast rice in food supplements is placed 
under Union scrutiny and therefore  included in Part C of Annex III to Regulation (EC) 
No 1925/2006.  Interested parties have the possibility under Article  8(4) of Regulation 
(EC) No  1925/2006 to submit data demonstrating the safety of monacolins from red 
yeast rice to the Authority in accordance with Article  5 of Implementing Regulation 
(EU) No  307/2012 . In accordance with Article  8(5) of Regulation (EC) No  1925/200 6 
the Commission should take a decision within four years from the entry into force of 
Commission Regulation (EU) 2022/860 , whether to generally allow the use of 
monacolins from red yeast rice listed in Annex  III, Part C  or to list the substance in 
Annex I II, Part A or Part B, as appropriate, taking into account the opinion of the 
Authority on any submitted data.  
(14) In accordance with Article 1(2) of Regulation (EC) No 1925/2006, the provisions on 
the addition of certain other substances than vitamins and mine rals to food are 
applicable to food supplements covered by Directive 2002/46/EC9.  
                                                 
8 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 ). 
9 Directive 2002/46/EC o f 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. 
51–57).  
EN 4  EN (15) Therefore, in view of the current prohibition of 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 based on generally accepted scientific evidence and in view of legal 
certainty , the Commission must revoke  the health claim on monacolin K from red 
yeast rice  from the Union  list of permitted  health claims . Accordingly, the health claim 
on monacolin K from red yeast rice should  no longer be used on foods . 
(16) The Annex  to Regulation (EU) No 432/2012 should therefore be amended 
accordingly.  
(17) 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  
In the Annex to Regulation (EU) No 432/2012 , the entry for Monascus purpureus  (red yeast 
rice) is deleted . 
Article 2  
This Regulation shall enter int o 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 Presiden t 
 Ursula VON DER LEYEN