G/SPS/N/EU/716  
6 February 2024  
(24-0933) 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):  Preparations of a kind used in animal feeding (HS code(s): 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:  Draft Commission Implementing Regulation withdrawing 
from the market star anise terpenes from Illicium verum  Hook.f. as a feed  additive (Text 
with EEA relevance) . Language(s):  English . Number of pages:  4 
https://members.wto.org/crnattachments/2024/SPS/EEC/24_01145_00_e.pdf  
6. Description of content:  The draft act concerns the withdrawal from the EU market of 
star anise terpenes from Illicium verum  Hook.f. as a feed additive belonging to the 
functional group of 'flavouring compounds'. That additive was allowed on the EU market 
under the previous legisl ation (Directive 70/524/EEC), as part of a generic entry within the 
group of 'flavouring and appetising substances' and was the subject of an application for 
re-authorization submitted under Article 10(2) of Regulation (EC) No 1831/2003. In its 
opinion of 26 September 2023, the European Food Safety Authority ('EFSA') concluded 
that the additive star anise terpenes contains up to 25% estragole by specification and is 
obtained by a manufacturing process which results in the enrichment of this genotoxic 
carcin ogen. EFSA further stated that this does not comply with the principles outlined in 
the general approach to assess the safety for the target species of botanical preparations 
which contain compounds that are genotoxic and/or carcinogenic when used as feed 
additives. Therefore, EFSA considered that it was inappropriate to perform an assessment 
of the safety and efficacy of star anise terpenes for its use as a feed additive. 
The applicant subsequently withdrew the application for re -authorization of that feed  
additive for all animal species. As a result of the withdrawal of the application, 
Article  10(5) of Regulation (EC) No 1831/2003 imposes the adoption of a measure 
requiring the withdrawal from the market of the additive concerned. It is proposed to 
provid e a limited period of time – which is kept to a minimum due to the safety concerns 
raised in the relevant EFSA opinion - in order to allow operators to comply properly with 
the measure.  
7. Objective and rationale: [X]  food safety, [X]  animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   G/SPS/N/EU/716  
 
- 2 - 
 
  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 
international standard:   
9. Other relevant documents and language(s) in which these are available:  
EFSA scientific opinion of 26 September 2023 on the safety and efficacy of a feed additive 
consisting of a fraction of the essential oil from the fruit and leaves of Illicium verum  
Hook.f. (star anise terpenes) for use in all animal species. EFSA Journal 
2023;21(10):8341. https://doi.org/10.2903/j.efsa.2023.8341  (availab le in English)  
10. Proposed date of adoption (dd/mm/yy) : April 2024  
Proposed date of publication (dd/mm/yy) : April 2024  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : Twenty days after publication of the act 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) : 30 days after publicati on of this notification.  
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 A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu  
13. Text(s) available from: [X]  National Notifi cation 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 A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu