G/SPS/N/EU/512  
 
13 October 2021  
(21-7750) 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 products  
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 amending Annexes II and 
III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as 
regards the food additive titanium di oxide (E 171) (Text with EEA relevance) . 
Language(s):  English . Number of pages:  8 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_6541_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_6541_01_e.pdf  
6. Description of content:  The text removes the authorisation to use titanium dioxide 
(E 171) in foods based on the recent scientific opinion of the European Food Safety 
Authority (EFSA) concluding that titanium dioxide can no longer be considered as safe 
when used as a food additive. The text also includes a commitment to review the necessity 
to maintain titanium dioxide (E 171) or otherwise delete it from the Union list of food 
additives for exclusive use as a colour in medicinal products within three years after the 
date of entering into force of this Regulation.  
In order to allow for a smooth  transition, the text lays down that foods that contain 
titanium dioxide (E 171) used in accordance with the rules applicable before the date of 
entry into force of the Regulation may be placed on the market until six months after that 
date. Those foods ma y then continue to be marketed until their date of minimum durability 
or 'use by' date.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] 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:  
[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) :  G/SPS/N/EU/512  
 
- 2 - 
 
  [ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international standard:  The measure banning the use of titanium dioxide in foods 
follows up on the recent EFSA scientific opinion on titanium dioxide (E 171), which 
concluded that titanium dioxide can no longer be considered as safe when used as a food 
additive.  
9. Other relevant documents and language(s) in which these are available:  
Safety  assessment of titanium dioxide (E171) as a food additive (European Food Safety 
Authority, EFSA Journal 2021;19(5):6585,  
https://www.efsa.europa.eu/en/efsajourn al/pub/6585  (available in English)  
10. Proposed date of adoption (dd/mm/yy) : Foreseen for January 2021.  
Proposed date of publication (dd/mm/yy) : Foreseen for January 2021.  
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 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: +(322) 295 4263  
Fax: +(322) 299 8090  
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: +(322) 295 4263  
Fax: +(322) 299 8090  
E-mail: sps@ec.europa.eu