G/SPS/N/EU/475  
31 March 2021  
(21-2630) 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):  HS Code 2309 Prep aration of a kind used in animal nutrition  
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) 2021/507 
concerning the renewal of the authori zation of pyridoxine hydrochloride (vitamin B6) as a 
feed additive for all animal species and repealing Implementing Regulation (EU) No 
515/2011 (Text with EEA relevance) . Language(s):  English, Spanish, French . Number of 
pages:  3 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_2177_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_2177_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_2177_00_s.pdf  
6. Description of content:  Regulation (EC) No 1831/2003 provides for the authorization of 
additives for use in animal nutrition and for the grounds and procedures for granting and 
renewing such authorization. Pyridoxine hydrochloride (vitamin B6) was authorized for 10 
years as a feed additive for all animal species by Commission Implementing Reg ulation 
(EU) No 515/2011(2). In accordance with Article 14 of Regulation (EC) No 1831/2003, an 
application was submitted for the renewal of the authorization of pyridoxine hydrochloride 
as a feed additive for all animal species, requesting the additive to be classified in the 
additive category "nutritional additives". That application was accompanied by the 
particulars and documents required under Article 14(2) of that Regulation. The European 
Food Safety Authority ("the Authority") concluded in its opinion  of 30 September 2020(3) 
that the applicant has provided evidence that the additive complies with the existing 
conditions of authorization. The Authority concluded that pyridoxine hydrochloride under 
the current authorized conditions of use does not have a n adverse effect on animal health, 
consumer safety or the environment. It also concluded that the additive is non -irritant to 
skin and eyes and is not a skin sensitiser but it may cause photosensitisation and in the 
absence of inhalation toxicity studies, adverse effects in the respiratory tract could not be 
fully excluded. Therefore, the Commission considers that appropriate protective measures 
should be taken to prevent adverse effects on human health, in particular as regards to 
the users of the additive . The Authority also concluded that there is no need for assessing 
the efficacy of the additive in the context of the renewal of the authorization. The 
assessment of pyridoxine hydrochloride shows that the conditions for authori zation, as 
provided for in A rticle 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the 
authori zation of that additive should be renewed.  G/SPS/N/EU/475  
 
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  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) : 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) : 23 March 2021  
Proposed date of publication (dd/mm/yy) : 24 March 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 the twe ntieth day following that of 
its publication in the Official Journal of the European Union.  
[X] 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