G/SPS/N/EU/504  
 
1 September 2021  
(21-6526) 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) 2021/1409 
of 27 August 2021  concerning the authorisation of phytomenadione as a feed additive for 
horses (Text with EEA relevance) . Language(s):  English, French and Spanish . Number 
of pages:  3 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_5501_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_5501_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_5501_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 such 
authorisation. In accordance with Article 7 of Regulation (EC) No 1831/2003 an application  
was submitted for the authorisation of phytomenadione. That application was accompanied 
by the particulars and documents required under Article 7(3) of Regulation (EC) 
No 1831/2003. The application concerns the authorisation of phytomenadione as a feed 
additive for horses. The applicant requested this additive to be classified in the additive 
category 'nutritional additives'. The European Food Safety Authority ( 'the Authority') 
concluded in its opinion of 17 March 2021 that, under the proposed conditions o f use, 
phytomenadione does not have adverse effects on animal health, consumer safety or the 
environment. The Authority concluded that users will not be exposed by inhalation when 
the additive is presented in solid form or viscous liquid. Data from the Sci entific Committee 
on Consumer Safety indicates that vitamin K 1 can be categorised as a dermal sensitiser. 
For preparations, the Authority could not conclude on their potential to be toxic by 
inhalation or on their potential as skin/eye irritant. Therefore,  the Commission considers 
that appropriate protective measures should be taken to prevent adverse effects on human 
health, in particular as regards the users of the additive and its preparations. 
The Authority concluded that phytomenadione is considered as  an efficacious source of 
vitamin K 1 for horses, when added to feed. The Authority does not consider that there is a 
need for specific requirements of post -market monitoring. It also verified the report on the 
method of analysis of the feed additives in fe ed submitted by the Reference Laboratory set 
up by Regulation (EC) No 1831/2003. The assessment of phytomenadione shows that the 
conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, 
are satisfied. Accordingly, the use  of phytomenadione should be authorised. The measures 
provided for in this Regulation are in accordance with the opinion of the Standing 
Committee on Plants, Animals, Food and Feed.  G/SPS/N/EU/504  
 
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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 n umber) :  
[ ] 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 
intern ational standard:   
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : 27 August 2021  
Proposed date of publication (dd/mm/yy) : 30 August 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 twentieth day following that of 
its publication in the Official Journal of the European Union.  
[X] Trade facilitating measure   
12. Final date for comment s: [ ] 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