G/SPS/N/EU/511  
 
13 October 2021  
(21-7749) 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:  Draft Commission Regulation (EU) amending Annex III 
to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards 
green tea extract containing ( -)-epigallocatechin -3-gallate (Text with EEA relevance) . 
Language(s):  English . Number of pages:  6 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_6540_00_e.pdf  
6. Description of content:  This draft Commission Regulation concerns the inclusion of 
green tea catechins in Annex III of Regulation (EC) No 1925/2006 ( 'the Regulation').  
In its opinion, adopted on 14 March 2018, EFSA concluded that while catechins from green 
tea infusions prepared  in a traditional way were considered safe for use, catechins taken 
as a food supplement, at and above 800mg of ( -)-epigallocatechin -3-gallate, had been 
shown to cause elevated serum transaminases, which is indicative of liver injury. 
Therefore, pursuant t o 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 green tea catechins, and 
therefore, there is still the possibility o f harmful effects on health but scientific uncertainty 
persists in this regard, this substance should be placed under Union scrutiny (Part C of 
Annex III to the Regulation).  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protect ion, 
[ ] 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 number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  G/SPS/N/EU/511  
 
- 2 - 
 
  [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  
https://eur -lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:32006R1925&qid=1634044973427&from=EN   
10. Proposed date of adoption (dd/mm/yy) : First quarter 2022  
Proposed date of publication (dd/mm/yy) : First quarter 2022  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : Twenty days following that of its publication in the Official Jou rnal of the 
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) : 12 December 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