   
  
G/SPS/N/EU/487  
 
30 April 2021  
(21-3721) 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) 2021/658 
concerning the authorisation of essential oil from Origanum vulgare  L. subsp. hirtum  
(Link) letsw. Var. Vulkan (DOS 00001) as a feed additive for all animal species (Text with 
EEA relevance) . Language(s):  English, French and Spanish . Number of pages:  4 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_3175_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_3175_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_3175_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. Article 4(1) of that Regulation provides for the authorisation of 
additives. In accordance with Article 4(1) of Regulation (EC) No 1831/2003 in conjunc tion 
with Article 7 thereof, an application was submitted for the authorisation of essential oil 
from Origanum vulgare  L. subsp. hirtum  (Link) letsw. Var. Vulkan (DOS 00001) as a feed 
additive for all animal species. The applicant requested the additive to  be classified in the 
additive category 'sensory additives'. That 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') concluded in it s opinions of 
29 November 2017  and 4 July 2019  that, under the proposed conditions of use, the 
essential oil from Origanum vulgare  L. subsp. hirtum  (Link) letsw. Var. Vulkan 
(DOS  00001) does not have an adverse effect on animal health, consumer health or t he 
environment. It also concluded that the additive is considered as a potential irritant to 
skin and eye and a potential respiratory and skin sensitiser in susceptible individuals. 
Therefore, the Commission considers that appropriate protective measures s hould be 
taken to prevent adverse effects on human health, in particular as regards the users of 
the additive. The Authority does not consider that there is a need for specific requirements 
of post -market monitoring. It also verified the report on the meth ods of analysis of the 
feed additives in feed submitted by the Reference Laboratory set up by Regulation 
(EC) No 1831/2003.  G/SPS/N/EU/487  
 
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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) : 21 April 2021  
Proposed date of publication (dd/mm/yy) : 22 April 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 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  
 