G/SPS/N/EU/388  
 
2 June 2020  
(20-3888) 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 the Annex to 
Regulation (EU) No 231/2012 laying down specifications for food additives listed in 
Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of 
the Council as regards specification s for titanium dioxide (E 171) (Text with EEA 
relevance) . Language(s):  English . Number of pages:  8 
https://members.wto.org/crnattachments/2020/SPS/EEC/20_3452_00_e.pdf  
https://members.wto.org/crnattachments/2020/SPS/EEC/20_3452_01_e.pdf  
6. Description of content:  The text aims at updating the current specifications for the food 
additive titanium dioxide (E 171) in the Annex to Regulation (EU) No 231/2012, in line 
with the conclusions and the recommendations of the re -evaluation of the safety of this 
food additive by the European Food Safety Authority (EFSA), as well as a later EFSA 
scientific opinion on the specifications for E 171 with respect to its particle size 
characteristics.  
The main proposed amendment to the current specifications for the food additive titanium 
dioxide (E 171) concerns the inclusion of particle size parameters, which are specific for 
titanium dioxide used as a food additive. In addition, the  definition of the food additive 
titanium dioxide (E 171) in the current specifications is amended to remove the option for 
its coating with silica and/or alumina, since according to the information provided by 
business operators titanium dioxide used as a  food additive does not have coatings or 
surface treatments.  
Moreover, new technically achievable limits for the impurities of lead, mercury, cadmium 
and antimony in titanium dioxide (E171) are included, which are lower than the current 
limits.  
7. Object ive and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   G/SPS/N/EU/388  
 
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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 d eviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:  
Re‐evaluation of titanium dioxide (E 171) as a food additive (European Food Safety 
Authority, EFSA Journal 2016;14(9):4545, 
https://efsa.onlinelibrary.wiley.com/ doi/pdf/10.2903/j.efsa.2016.4545 ) 
Language(s):  English  
Scientific opinion on the proposed amendment of the EU specifications for titanium dioxide 
(E 171) with respect to the inclusion of additional parameters related to its particle size 
distribution (Euro pean Food Safety Authority, EFSA Journal 2019;17(7):5760, 
https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2019.5760 ) 
Language(s):  English   
10. Proposed date of adoption (dd/mm/yy) : Foreseen for September 2020.  
Proposed date of publication (dd/mm/yy) : Foreseen for September 2020.  
11. Proposed date of entry into force: [X]  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) : 1 August 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/388  
 
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  13. Text(s) available from: [X]  National Notification A uthority, [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