G/SPS/N/EU/367  
 
21 February 2020  
(20-1337) Page: 1/3 
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 products  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partner s  
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft Commission Regulation amending Annexes II and 
III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and 
the Annex to Commission Regulation (EU) No. 231/2012 as regards the use of Annatto, 
Bixin, Norbixin (E 160b) (Text wi th EEA relevance) . Language(s):  English . 
Number  of pages:  32 
https://members.wto.org/crnattachments/2020/SPS/EEC/20_1320_00_e.pdf  
https://members.wto.org/crnattachments/2020/SPS/EEC/20_1320_01_e.pdf  
6. Description of co ntent:  The Regulation aims at updating the current authorisation of 
the food additive Annatto, Bixin, Norbixin (E 160b) in the European Union, in line with the 
conclusions of the re -evaluation of the safety of this food additive by the European Food 
Safety  Authority (EFSA), which included the assessment of an application for the 
authorisation of five new annatto -based extracts and some extensions of use. 
EFSA concluded that the main pigments in annatto extracts, namely bixin and norbixin, 
have different tox icological properties and therefore a different Acceptable Daily Intake 
(ADI). Consequently, the text removes food additive Annatto, Bixin, Norbixin (E 160b) 
from the Union list   of permitted food additives in Regulation (EC) No. 1333/2008 and 
inserts inst ead in that list two new separate food additives, namely Annatto bixin 
(E 160b(i)) and Annatto norbixin (E 160b(ii)). As a consequence, the text removes the 
authorised uses and conditions of use for the food additive Annatto, Bixin, Norbixin 
(E 160b) from the list of authorised conditions of use in food in to Regulation 
(EC) No. 1333/2008, and lays down the authorised uses and use levels for the two new 
food additives Annatto bixin (E  160b(i)) and Annatto norbixin (E 160b(ii)). The Annex to 
Regulation (EU) No. 231/2012 (specifications for food additives) is amended accordingly.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage fr om pests.   G/SPS/N/EU/367  
 
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  8. Is there a relevant international standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : 
Codex General Standard for Food Additives - Codex Stan 192 -1995  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  
[X] 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:   
The safety of annatto extracts (E 160b) as a food additive (European Food Safety 
Authority, EFSA Journal 2016;14(8):4544,  
https://www.efsa.europa.eu/en/efsajournal/p ub/4544 ) 
Exposure assessment of annatto colouring principles bixin and norbixin (E 160b) when 
used as food additives (European Food Safety Authority, EFSA Journal 2017;15(8):4966, 
https://www.efsa.europa.eu/en/efsajournal/pub/4966 )  
Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin 
(E 160b) when used as a food additive (European Food Safety Authority, EFSA Journal 
2019;17(3):5626, https://www.efsa.europa.eu/en/efsajournal/pub/5626 ). (available in 
English)  
10. Proposed date of adoption (dd/mm/yy) : June 2020  
Proposed date of publication (dd/mm/yy) : June 2020  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : 20 days after publication in the Official Journal of the European 
Union (with transitional provisions for a six -month period) . 
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification an d/or (dd/mm/yy) : 21 April 2020  
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: +(322) 295 4263  
Fax: +(322) 299 8090  
E-mail: sps@ec.europa.eu  G/SPS/N/EU/367  
 
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  13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Add ress, 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: +(322) 295 4263  
Fax: +(322) 299 8090  
E-mail: sps@ec.europa.eu