EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/759/2023 
(POOL/A1/2023/759/759 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
refusing to authorise a health claim made on foods, other than those referring to the 
reduction of disease risk and to children’s development and health  
(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  
refusing to authorise a health claim made on foods, other than those referring to the 
reduction of disease risk and to children’s development and health  
(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 18(5) thereof,  
Whereas:  
(1) Pursuant to Regulation (EC) No 1924/2006 , health claims made on foods are 
prohibited unless they are authorised by the Commi ssion in accordance with that 
Regulation and included in the Union list of permitted health claims.  
(2) Pursuant to Regulation (EC) No 1924/2006, scientific substantiation should be the 
main aspect to be taken into account for the use of nutrition and health claims and food 
business operators using those claims should justify them. A claim should be 
scientif ically substantiated by taking into account the totality of the available scientific 
data, and by weighing the evidence.  
(3) Article 18 of Regulation (EC) No 1924/2006 provides that applications for the 
inclusion of health claims in the list of permitted claim s must be submitted by food 
business operators to the national competent authority of a Member State. The national 
competent authority is to forward valid applications to the European Food Safety 
Authority (‘the Authority ’) for a scientific assessment, as well as to the Commission 
and the Member States for information.  
(4) The Authority is to deliver an opinion on t he health claim concerned  within 5 months 
from the receipt of a request . 
(5) The Commission is to decide on the authorisation of the health claims taki ng into 
account the opinion delivered by the Authority.  However, in accordance with Article  
17 of the Regulation (EC) No 1924/2006, in that consideration the Co mmission must 
take into account  also any relevant provisions of Union law and  other legitimate 
factors relevant to the matter.  
(6) Following an application from Sylvan Bio Europe BV  ('the applicant’) , submitted 
pursuant to Article 18(1) of Regulation (EC) No 1924/2006 , the Authority was 
required to deliver an opinion on a health claim related to monacolin K in SYLVAN 
BIO red yeast rice and the maintenance of normal blood LDL -cholesterol 
concentrations  (Question No EFSA -Q-2012 -00736 ). The claim proposed by the 
applicant was worded as follows: ‘A daily intake of at least 2.4 g of SYLVAN BIO 
                                                 
1 OJ L 404, 30.12.2006, p. 9.   
EN 2  EN red y east rice, corresponding to 4.08 mg of monacolin K, contributes to the 
maintenance of normal blood LDL -cholesterol. ’. 
(7) On 24 January 2013, the Authority adopted the Scientific Opinion2 on the 
substantiation of a health claim related to monacolin K in SYLVAN  BIO red yeast rice 
and maintenance of normal blood LDL -cholesterol concentrations pursuant to Article 
13(5) of Regulation (EC) No 1924 /2006. On 13  February 2013 , the Commission  and 
the Member States  received the scientific opinion from the  Authority.  
(8) The Authority noted in its scientific opinion that according to the study of Myers et 
al., 20063, the content of monacolin  K in 2.4 g of SYLVAN BIO  red yeast rice  should 
have been higher than 4.08 mg. Upon a request from the Authority,  the applicant 
clarif ied that the red yeast rice preparation used in th at study complied with the 
specifications provided for SYLVAN BIO  red yeast rice , and that , taking into  account 
all the active forms , 2.4 g of SYLVAN  BIO contained 8.96 mg of monacolin K . The 
Authority considered  that this study,  with some methodological limitations , showed  an 
effect of monacolin K in SYLVAN BIO red yeast rice on blood LDL -cholesterol 
concen trations , at doses of about 9 mg  per d ay. 
(9) With regard to the studies of Becker et al ., 20094 and Halbert et al ., 20105, the 
Authority noted that th ose studies showed an effect of monacolin K in SYLVAN BIO 
red yeast rice at doses of about 10 mg and 14 mg per day, respectively.  
(10) In its opinion, the Authority also considered that  the evidence provide d by the 
applicant does not establish that mo nacolin K in SYLVAN BIO red yeast rice  is 
different from that in other red yeast rice preparations with respect to its effect on 
blood LDL -cholesterol concentrations .  
(11) The Authority concluded that a cause -and-effect relationship had  been  established 
between the consump tion of monacolin K in red yeast rice preparations, which  include 
SYLVAN BIO red yeast rice, and the maintenance of normal blood LDL -cholesterol 
concentrations . In order to obtain the claimed effect , 10 mg of monacolin K from 
fermented red yeast rice preparations should be consumed daily . 
(12) The Authority found that it could  have reached this  conclusion  without  th human  
intervention  study  by Myers et al.,  2006,  claimed as proprietary by the applicant . 
(13) The Authority noted in its opinion, that a claim on  monacolin K from red yeast rice 
and the maintenance of normal blood LDL -cholesterol concentrations had already 
been assessed with a favourable outcome by the EFSA Panel on Dietetic Products 
Nutriti on and Allergies (NDA), in 20116. The conditions of use for the claim subject to 
that opinion also provide d for a daily intake of 10 mg monacolin K from any red yeast 
rice preparation (which would include SYLVAN BIO red yeast rice) in order to obtain 
the claimed effect . 
                                                 
2 EFSA Journal 2013;11(2):3084.  
3 Myers SP, Cheras PA, Brooks L and O'Connor J, 2006, unpublished. Study on the Safety and Efficacy 
of Sylvan Red  Yeast Rice in Adults with Primary Hy percholesteremia . 
4 Becker DJ, Gordon RY, Halbert SC, French B, Morris PB and Rader DJ, 2009. Red yeast rice for 
dyslipidemia in statin -intolerant patients: a randomized trial. Annals of Internal Medicine, 150, 830 -
839, W147 -839. 
5 Halbert SC, French B, Gordon RY, Farrar JT, Schmitz K, Morris PB, Thompson PD, Rader DJ and 
Becker DJ,  2010. Tolerability of red yeast rice (2,400 mg twice daily) versus pravastatin (20 mg twice 
daily) in  patients with previous statin intolerance. American Journal o f Cardiology, 1 05, 198 -204. 
6 EFSA Journal 2011;9(7):2304 .  
EN 3  EN (14) In relation to the restrictions of use of both of the above -mentioned  health claims , the 
Authority in its scientific opinions referred to the Summary of Product Characteristics 
(SmPC) of lovastatin -containing medicinal products available on the Uni on market . 
The SmPC provides information to healthcare professionals on the safe and effective 
use of medicinal products  and specifically of lovastatin -containing medicinal products . 
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 the concomitant use of lovastatin 
with certain other medicinal products and  discourages the use of lovastatin by 
pregnant and lacta ting women . The Authority considered that  the monacolin K in 
lactone form  was identical to lovastatin . 
(15) Following those restrictions of use, Member States  raised potential safety concerns 
associated with the consumption of foods containing monacolins from red yeast rice.  
(16) 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 of 
Regulation (EC) No 1925/ 2006 of the European Parliament and of the Council7 and 
Articles 3 and 4 of Commission Implementing Regulation (EU) No  307/20128 were 
fulfilled. Therefore, the Commission, launched the procedure under Article 8 of 
Regulation (EC) No 1925/2006 for monacolins in red yeast rice.  
(17) 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 yeast rice.  
(18) On 25 June 2018 , the Authority adopted  a scientific opinion9 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 products 
authorised in the Union for the treatment of hypercholesterolemia. 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 
concl uded that  the intake of monacolins from red yeast rice through 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 was similar to that of lovastatin10.  
(19) 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 supplement 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 
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 
                                                 
7 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). 
8 Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing implementing 
rules for the application of Article 8 of Regulation (EC) N o 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).  
9 EFSA Journal 2019;16(8):5368.  
10 EFSA Journal 2018;16(8):5368 , page 38   
EN 4  EN 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 mon acolins 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 consumer s 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 monacolins.  
(20) 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 with the use of monacolins from red yeast rice at levels of 
10 mg/day, and  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 product recommended for daily consumption has been  prohibited  by 
Commission Regulatio n (EU) 2022/86011. By that Regulation the Commission 
amended 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 th at Annex.  
(21) As there is still a possibility of harmful effects on health associated with the use of 
monacolins from red yeast rice, but scientific uncertainty in this regard persists, and 
considerin g 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 
Authority,   the use of monacolins from red yeast rice in food supplements is placed 
under Union s crutiny 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 t he Authority 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 entry into force of 
Commission Regulatio n (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 III, Part A or Part B, as appropriate, taking into account the opinion of the 
Authority on any submitted dat a.  
(22) Therefore, the proposed health claim should not be authorised and included  in the 
Union list of permitted health claims.  
(23) The comments of the applicant received by the Commission pursuant to Article 16(6) 
of Regulation (EC) No 1924/2006, have been considered when adopting this 
Regulation.  
(24) On 4 March 2013 the applicant submitted comm ents to the Commission  indicating that 
the conditions of use for the claim set in the scientific opinion, did not take into 
                                                 
11 Commission Regulation (EU) 2022/860 of 1 June 2022 amending Annex III to Regulation (EC) No 
1925/2006 of the European Parliament an d of the Council as regards monacolins from red yeast rice 
(OJ L 151, 2.6.2022, p. 37).   
EN 5  EN account evidence of a potential effect on bloo d LDL -cholesterol of concentrations of 
monacolin K below a daily dose of 10 mg . 
(25) Following a request from the Commission, the Authority was asked to review the 
scientific comments received  and on 13 May 2013, the Authority published the 
technical report12 as a response to the comments of the applicant.  
(26) In its report, the Authority noted that  the studies of Myers et al.,  2006 and Becker et 
al., 2009  showed an effect of monacolin K in SYLVAN BIO red yeast rice on blood 
LDL -cholesterol concentrations at doses of  about 9  and 10  mg per day respectively. 
As stated in the opinion, this is in the range of the doses used in the two human 
intervention studies (Heber et al.,  1999; Lin et al.,  2005) which were evaluated by the 
Authority  to set conditions of use of 10 mg monacolin K per day for a claim on 
monacolin K from red yeast rice preparations in general and maintenance of normal 
blood LDL -cholesterol concentrations (EFSA NDA Panel, 2011).  The Authority also 
noted that when setting conditions of use, it takes into account and weighs the totality 
of the available scientific evidence. In this specific case, the  Authority  took into 
account the evidence provided by two human intervention studies (Heber et al.,  1999; 
Lin et al.,  2005) at doses of around 7.5 and 11.5 mg/day monacolin K, as well as the 
lowest dose of lovastatin (pure monacolin K) which has been shown consistently to 
reduce LDL -cholesterol concentrations in the target population (i.e. 10 mg/day).  The 
Authority concluded that the comments received did not change its conclusions  and 
reconfirmed its opinion.  
(27) 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  
The proposed health claim  set out in the Annex to this Regulation shall not be included in the 
Union list of permitted health claims  as provided for in Article 13(3) of Regulation (EC) 
No 1924/2006.  
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  
                                                 
12 Technical report from EFSA - Response to comments on the Scientific Opinion of the EFSA Panel on 
Dietetic Products, Nutrition and Allergies (NDA) on the scientific su bstantiation of health claims 
related to monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL -
cholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/2006