G/SPS/N/EU/468  
 
17 March 2021  
(21-2232) 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) 2021/421 
of 9 March 2021 concerning the authorisation of tincture derived from Artemisia 
vulgaris  L. (mugwort tincture) 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_1973_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_1973_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_1973_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 a tincture derived from 
Artemisia  vulgaris  L. (mugwort tincture) as a feed additive for all animal species. 
This 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 a tincture  derived from Artemisia vulgaris  L. (mugwort tincture) as a feed additive for 
all animal species. The applicant requested this additive to be classified in the additive 
category "sensory additives". The European Food Safety Authority ("the Authority") 
concluded in its opinions of 4 October 2019 and 1 July 2020 that, under the proposed 
conditions of use the tincture derived from Artemisia vulgaris  L. (mugwort tincture) does 
not have adverse effects on animal health, consumer health or the environment. 
The Authority indicated that no conclusions can be drawn on the additive's potential to be 
a dermal/eye irritant or a skin sensitiser. 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.  
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.   G/SPS/N/EU/468  
 
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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) : 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 st andard?  
[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) : 9 March 2021  
Proposed date of publication (dd/mm/yy) : 10 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 twentieth day 
following that of its publi cation 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