G/SPS/N/EU/491  
 
26 May 2021  
(21-4381) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -
General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Food supplements  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Commission Regulation (EU) amending Annex III to 
Regulation (EC) No 192 5/2006 of the European Parliament and of the Council as regards 
monacolins from red yeast rice (Text with EEA relevance) . Language(s):  English . 
Number of pages:  8 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_3686_00_e.pdf  
6. Description of content:  This draft Commission Regulation concerns the inclusion of 
monacolins from red yeast rice (RYR) in Annex III of Regulation (EC) No 1925/2006 
('the Regulation').  
EFSA, in its scientific opinion adopted on 28 June 2018, considered that monacolin K in 
lacton e form is identical to lovastatin, the active ingredient of several medicinal products 
authorised for the treatment of hypercholesterolemia in the European Union. 
EFSA concluded that monacolins in RYR when used as food supplements were of 
significant safet y concern at the use level of 10  mg/day, and that individual cases of 
severe adverse reactions had been reported at intake levels as low as 3  mg/day. 
Furthermore, EFSA noted that the profile of adverse effects to RYR was similar to that of 
lovastatin. Ther efore, pursuant to the procedure of Article 8 of the Regulation, this 
substance should be included in Annex III (Part B) to the Regulation.  
Furthermore, as EFSA could not identify a safe dietary intake of monacolins from RYR, 
and therefore, there is still the possibility of harmful effects on health but scientific 
uncertainty persists in this regard, this substance should be placed under Union scrutiny 
(Part C of the 'Regulation').  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant p rotection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial numb er of Codex 
standard or related text) :  G/SPS/N/EU/491  
 
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  [ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:  
Regulation (EU) 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  
http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:404:0026:0038:EN:P
DF  
10. Proposed date of adoption (dd/mm/yy) : Foreseen in the fo urth quarter of 2021.  
Proposed date of publication (dd/mm/yy) : Foreseen in the fourth quarter of 2021.  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : 20 days from publication in the Official Journal of t he European 
Union.  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 25 July 2021  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if available) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu  
13. Text(s) available from: [ X] National Notification Authority, [ X] National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu