EN   EN  
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/2222875/2023 CIS 
(POOL/G5/2023/AN/2222875/2222875 -
EN CIS.docx)  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the authorisation of gentian tincture from Gentiana lutea L . as a feed 
additive for certain animal species  
(Text with EEA relevance)   EN 1  EN  COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the authorisation of gentian tincture from Gentiana lutea L . as a feed 
additive for certain animal species  
(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 particular 
Article 9(2) and 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. 
Article 10(2) of that Regulation provides for the re -evaluation of additives authorised 
pursuant to Council Directive 70/524/EEC2. 
(2) The substance gentian tincture from Gentiana lutea L . was authorised without a time 
limit in accordance with Directive 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 belonging to the category ‘sensory additives’ and to the functional 
group ‘flavouring compounds ’, in accordance with Article 10(1), point (b), of 
Regulation (EC) No 1831/2003 . 
(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction 
with Article 7 thereof, an application was submitted for the authorisation of  gentian 
tincture from Gentiana lutea L . as a feed additive for all animal species. The applicant 
requested the additive to be classified in the additive category ‘sensory additives’ and 
in the functional group ‘flavouring compounds’. The application was accompanied by 
the particulars and documents required under Article 7(3) of Regulation (EC) No 
1831/2003.  
(4) The applicant requested the additive to be authorised for use also in water for drinking. 
However, Regulation (EC) No 1831/2003 does not allow the authorisation of 
‘flav ouring compounds’ for use in water for drinking . Therefore, the use of the 
additive  in water for drinking should  not be allowed . 
(5) The European Food Safety Authority (‘the Authority’) concluded in it s opinion s of 18 
March 20213 and 1 February 20234 that, under the proposed conditions of use , gentian 
tincture from Gentiana lutea L . is safe for short -living animals , i.e. animal  species  for 
 
1 OJ L 268, 18.10.2003, p. 29.  
2 Council Directive 70 /524/EEC of 23 November 1970 concerning additives in feedingstuffs  
(OJ L 270, 14.12.1970, p.  1). 
3 EFSA Journal 2021;19(4):654 7. 
4 EFSA Journal 2023;21(2):78 69. EN 2  EN  fattening, for consumers and for the environment . It stated that no conclusions could 
be drawn for long -living ani mals and reproductive animals  in the absence of data on 
the in vivo  genotoxicity of xanthones  (gentisin and isogentisin)  and gentiopicroside.  
Furthermore, the Authority could not conclude  on the potential of the additive to be a 
dermal/eye irritant or a skin sensitiser , in the absence of data . It also noted that when 
handling the tincture, exposure of unprotected users to the potential genotoxicants 
xanthones (gentisin and isogentisin)  and gentiopicroside  cannot be excluded  and that  
therefore, to reduce the risk, the exposure of the users should be minimised.  In 
addition, t he Authority concluded that  since gentian tincture from Gentiana lutea L .is 
recognised to flavour food and  since  its fu nction  in feed would be essentially the same 
as that in food, no further demonstration of efficacy is considered necessary . It also 
verified the report on th e method of analysis of the feed ad ditive s in feed submitted by 
the Reference Laboratory set up by Regulation (EC) No  1831/2003.  
(6) The applicant withdrew the application for authorisation of gentian tincture from 
Gentiana Lutea  L. for all animal species except animal species for fattening.  
(7) In view of the above, the Commission consid ers that gentian tincture from Gentiana 
lutea L . satisfies the conditions provided for in Article 5 of Regulation (EC) No 
1831/2003 , as regards animal species for fattening and provided in particular that the 
additive is not used in combination with other additives containing gentisin, 
isogentisin and gentiopicroside . Accordingly, the use of that substance  should be 
authorised . In ad dition, the Commission considers that appropriate protective 
measures should be taken to prevent adverse effects on the health  of the users of the 
additive . 
(8) Article 10(5) of Regulation (EC) No 1831/2003 imposes an obligation on the 
Commission to adopt a Regulation requiring the withdraw al 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 . 
(9) In the case of feed a dditives for which an application has been withdrawn only  for 
certain animal species or categories of animals, the withdrawal from the market should 
only concern those animal species or categories of animals.  
(10) Therefore, gentian tincture from Gentiana lutea  L. should be withdrawn from the 
market as regards the animal species and categories of animals which are not the 
subject of the authorisation granted by this Regulation.  
(11) It is appropriate to provide for a transitional period for interested parties to prep are 
themselves to meet the new requirements resulting from the authorisation  of gentian 
tincture from Gentiana lutea L . for certain animal species  and to adapt to the 
withdrawal of th e additive from the market as regards the  use for  animal species and 
categories of animals  which are not the subject of the authorisation granted by this 
Regulation . That transitional period should allow using up the existing stocks of the 
additive and of products containing it.  
(12) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  EN 3  EN  HAS ADOPTED THIS REGULATION:  
Article 1  
Authorisation  
The substance  specified in the Annex, belonging to the additive category ‘ sensory additives’ 
and to the functional group ‘ flavouring compounds ’, is authorised as an additive in animal 
nutrition , subject to the conditions laid down in that Annex.  
Article 2  
Withdrawal from the market  
The feed additive referred to in Article 1  shall be withdrawn from the market in respect of the 
animal species and categories of animals other than those  mentioned in the Annex.  
Article 3 
Transitional measures  
1. Existing stocks of t he feed additive  specified in the Annex  may continue to be placed  
on the market and used in accordance with the rules applicable before [date of entry 
into force of this Regulation – Date to be inserted by the Service responsible for the 
publication]  until [12 months after the date of entry into force of this Regulation – 
Date 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  in accordance with the rules applicable before 
[date of entry into force of this Regulation – Date to be inserted by the Service 
responsible for the publication]  until [15 months after the date of entry into force of 
this Regulation – Date 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 paragraph 2 may continue to be 
placed on the market and used in accordanc e with the rules applicable before [date of 
entry into force of this Regulation – Date to be inserted by the Service responsible 
for the publication]  until [24 months after the date of entry into force of this 
Regulation – Date to be inserted by the Servic e responsible for the publication] . 
Article 4 
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.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DE R LEYEN