G/SPS/N/EU/519  
 
1 December 2021  
(21-9061) 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):  Preparation of a kind used in animal nutrition (HS Code: 2309)  
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:  Commission Implementing Regulation (EU) 2021/2090 
of 25 November 2021 concerning the denial of authorisation of titanium dioxide as a feed 
additive for all animal species (Text with EEA relevance) . Language(s):  English, French 
and Spanish . Number of pages:  2 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7419_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7419_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7419_00_s.pdf  
6. Description of content:  Regulation (EC) No 1831/2003 provides for the authorisation of 
additives for use in animal nutrition and for the grounds and procedures for granting or 
denying such authorisation. Article 10 of that Regulation provides for the re -evaluation of 
additives authorised pursuant to Council Directive 70/524/EEC. Titanium diox ide was 
authorised without a time limit by Directive 70/524/EEC as a colourant additive (colouring 
agents authorised for colouring foodstuffs by Community rules) for cats and dogs. It was 
also authorised without a time limit for all animal species, with th e exception of cats and 
dogs, for animal feedingstuffs under certain conditions. That product was subsequently 
entered in the Register of feed additives as an existing product, in accordance with 
Article  10(1) of Regulation (EC) No 1831/2003. In accordance  with Article 10(2) of 
Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an application was 
submitted for the re -evaluation of titanium dioxide as a feed additive for all animal 
species. The applicant requested the additive to be classif ied in the additive category 
'sensory additives' and the functional group 'colourants: substances that add or restore 
colour in feedingstuffs'. The application was accompanied by the particulars and 
documents required under Article 7(3) of Regulation (EC) No 1831/2003. The European 
Food Safety Authority ('the Authority') noted in its opinion of 5 May 2021 that it could not 
conclude on the safety of titanium dioxide for the target species, consumers and 
environment, given the absence of specific data related  to its use as a feed additive and 
considering that the genotoxicity of particles of titanium dioxide could not be ruled out, 
raising potential concerns on the safety of the additive for the target species (especially for 
long-living animals and reproducti ve animals), consumers and users. In the absence of 
studies with titanium dioxide, the Authority could not conclude on the assessment of the 
effects of the additive on eyes and skin. The Authority further noted that titanium dioxide 
is potentially carcinog enic to workers if inhaled and that, as the genotoxicity of particles of G/SPS/N/EU/519  
 
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  titanium dioxide cannot be ruled out, it should be considered as an additional potential 
concern to users handling the additive. The Authority also verified the report on the 
method o f analysis of the feed additive in feed submitted by the Reference Laboratory set 
up by Regulation (EC) No 1831/2003.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or diseas e, [ ] 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) : Code of practice on Good Animal Feeding 
CAC/RCP  54-2004 
[ ] 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:    
10. Proposed date of adoption (dd/mm/yy) : 25 November 2021  
Proposed date of publication (dd/mm/yy) : 30 November 2021  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : This Regulation shall enter into force on t he twentieth day following its 
publication in the Official Journal of the European Union.  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable  
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