G/TBT/N/EU/1027  
27 October 2023  
(23-7256) 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 addit ion, where applicable):  Food 
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Regulation amending Regulation (EU) No 432/2012 as regards the health 
claim on monacolin K from red yeast rice; (5 page(s), in English)  
6. Description of content:  This draft Commission Regulation concerns the revocation of 
authorisation of a health claim made on foods, in accordance with Article 13(4) of 
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.  
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 had been assessed by the European Food Safety 
Authority (EFSA) with a favourable outcome and was authorised on 16 May 2012 with 
Commission Re gulation (EU) No 432/2012 for the inclusion in the list of permitted health 
claims. The existing health claim relates to monacolin K from red yeast rice and the 
contribution to the maintenance of normal blood cholesterol levels at a daily intake of 10 
mg o f monacolin K in order to obtain the claimed effect. 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 produ ct recommended for daily consumption. The substance is also 
placed under Union scrutiny, as scientific uncertainty persists with regard to the harmful 
effects on health associated with its use. Therefore, the health claim included in this draft G/TBT/N/EU/1027  
 
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  should be r evoked and deleted from the list of permitted health claims to be made 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 h ealth 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_13184_00_e.pdf