G/TBT/N/EU/1026  
27 October 2023  
(23-7254) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
European Commission  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
European Comm ission,  
EU-TBT Enquiry Point,  
Fax: +(32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tbt/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Food 
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Regulation 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; 
(6 page(s), in English), (1 page(s), in English)  
6. Description of content:  This draft Commission Reg ulation concerns the refusal of 
authorisation of a health claim made on foods, other than those referring to the reduction 
of disease risk and to children's development and health in accordance with Article 18(5) 
of Regulation (EC) No 1924/2006 of the Euro pean Parliament and of the Council of 20 
December 2006 on nutrition and health claims made on foods.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The proposed measure is a draft Commission Regulation for one health claim 
as referred to above under point 6 that has been assessed by the European Food Safety 
Authority (EFSA) with a favourable outcome. The health claim included in this draft 
Commission Regulation is related to monacolin K in SYLVAN BIO red yeast rice and 
maintenance of normal blood LDL -cholesterol concentrations. The Panel considered that 
in order to obtain the claimed effect, 10 mg of monacolin K from fermented red yeast rice 
preparatio ns should be consumed daily. Commission Regulation (EU) 2022/860 amending 
Annex III to Regulation (EC) No 1925/2006 as regards monacolins from red yeast rice 
was adopted on 1 June 2022, prohibiting the addition to foods or use in the manufacture 
of foods of monacolins from red yeast rice at levels of 3 mg and more per portion of the 
product recommended for daily consumpti on. The substance is also placed under Union 
scrutiny, as scientific uncertainty persists with regard to the harmful effects on health G/TBT/N/EU/1026  
 
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  associated with its use. Therefore, the health claim included in this draft Commission 
Regulation does not comply with th e conditions set out in Regulation (EC) No 1924/2006, 
and will not be authorised for use on foods; Protection of human health or safety  
8. Relevant documents:   
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.  
http://eur -
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:404:0009:0025:EN:PDF  
9. Proposed date of adoption:  2nd quarter 2024  
Proposed date of entry into force:  20 days from publication in the Official Journal of 
the EU (about a month after adoption approx.)  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
European Commission,  
EU-TBT Enquiry Point,  
Fax: + (32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
The text is available on the EU -TBT Website : http://ec.europa.eu/growth/to ols-
databases/tbt/en/  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_13183_00_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_13183_01_e.pdf