EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11028065/2023 CIS 
(POOL/G5/2023/11028065/11028065 -
EN CIS.docx)  
[…](2024) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
withdrawing from the market star anise terpenes from Illicium verum  Hook.f. as a feed 
additive  
 
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
withdrawing from the market star anise terpenes from Illicium verum  Hook.f. as a feed 
additive  
 
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the 
Council of 22 September 2003 on additives for use in animal nutrition1, and in p articular 
Article  10(5)  thereof,  
Whereas:  
(1) 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 
particular, Article  10(2) of that Regulation provides rules for the re -evaluation of 
additives authorised pursuant to Council Directive 70/524/EEC2. 
(2) The substance star anise terpenes from Illicium verum  Hook. f. was authorised without 
a time limit in accordance with  Directiv e 70/524/EEC as a feed additive for all animal 
species. That substance was subsequently entered in the Register of Feed Additives as  
an existing product, in accordance with Article 10(1), point (b), of Regulation (EC) No 
1831/2003.  
(3) In accordance with Artic le 10(2) of Regulation (EC) No 1831/2003, in conjunction 
with Article 7 thereof, an application was submitted for the authorisation of  star anise 
terpenes from  Illicium verum  Hook. f. as a feed additive for all animal species . The 
applicant  request ed the ad ditive to be classified in the additive category ‘sensory 
additives’ and in the functional group ‘flavouring compounds’. That application was 
accompanied by the particulars and documents required under Article 7(3) of 
Regulation (EC) No 1831/ 2003.  
(4) The Euro pean Food Safety Authority (‘the Authority’) concluded in its opinion of 26 
September 20233 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 carcinogen . In this regard, the Authority stated  that this 
does not comply  with the principles outlined in the general approach to assess the 
safety for the target spe cies of botanical preparations which contain compounds that 
are genotoxic and/or carcinogenic when used as feed additives. Therefore, the 
 
1 OJ L  268, 18.10.2003 , p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj . 
2 Council Directive 70/524/EEC of 23 November 1 970 concerning additives in feedingstuffs (OJ L 270, 
14.12. 1970, p. 1) , ELI: http://data.europa.eu/eli/dir/1970/524/oj ). 
3 EFSA Journal 2023;21(10):8341.   
EN 2  EN Authority considered that it was inappropriate to perform an assessment of the safety 
and efficacy of star anise terpe nes for its use as a feed additive.  
(5) The applicant subsequently withdrew the application for authorisation of star anise 
terpenes from Illicium verum  Hook. f. for all animal species.  
(6) Article 10(5) of Regulation (EC) No 1831/2003 imposes an obligation on the 
Commission to adopt a Regulation requiring the withdrawal from the market of feed 
additives for which no applications as required by Article 10(2) of Regulation (EC) No 
1831/2003 were submitted before the deadline provided for in that provision. 
Similarly,  a Regulation should be adopted concerning feed additives for which an 
application was submitted but subsequently withdrawn.  
(7) Therefore, the feed additive star anise terpenes from Illicium verum  Hook. f. should be 
withdrawn from the market.  
(8) A transitional period should be allowed for interested parties to comply properly with 
the withdrawal obligation , providing for a limited period of time within which existing 
stocks of the additive and feed containing it may be used up.  Such period of time 
should be as sh ort as possible, taking account of the safety concerns raised by the 
Authority in its opinion of 26 September 2023 concerning the additive.  
(9) The measures provided for in this Regulation are in accordance with the opinion of the  
Standing  Committee  on Plants , Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Withdrawal from the market  
The feed additive  star anise terpenes from Illicium verum  Hook. f., as authorised pursuant to 
Directive 70/524/EEC,  shall be withdrawn from the market in respect of all animal species.  
Article  2 
Transitional measures  
1. Existing stocks of the feed additive  referred to in Article 1 may continue to be placed 
on the market and used until [ one month from  the date of entry int o force of this 
Regulation – Dated to be inserted by the Service responsible for the publication ]. 
2. Premixtures produced with the feed additive referred to in paragraph 1 may continue 
to be placed on the market and used until [ two months from  the date of entry into 
force of this Regulation – Dated to be inserted by the Service responsible for the 
publication ]. 
3. Compound feed and feed materials produced with the feed additive referred to in 
paragraph 1 or with the premixtures referred to in para graph 2 may continue to be 
placed on the market and used until [ three months from  the date of entry into force of 
this Regulation – Dated to be inserted by the Service responsible for the publication ]. 
Article 3  
Entry into force  
This Regulation shall enter  into force on the  twentieth  day following that of its publication in 
the Official Journal of the European Union .  
EN 3  EN This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The Pres ident  
 Ursula VON DER LEYEN