ELI: http://data.europa.eu/eli/reg_impl/2024/824/oj 1/5COMMISSION IMPLEMENTING REGUL ATION (EU) 2024/824 
of 8 March 2024
concer ning the author isation of gentian tincture from Gentiana lutea L. as a feed additiv e for certain 
animal species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng rega rd to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on 
additives for use in animal nutr ition (1), and in particular Article 9(2) and Article 10(5) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provid es for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such author isation. Article 10(2) of that Regulation provides for the 
re-evaluation of additives author ised pursuant to Council Directive 70/524/EEC (2).
(2) The substance gentian tincture from Gentiana lutea L. was author ised 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 
Registe r 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 Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an 
application was submitted for the author isation 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 catego ry ‘sensor y additives’ and 
in the functional group ‘flavouri ng compo unds ’. 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 author ised for use also in wate r for drinking. However , Regulation (EC) 
No 1831/2003 does not allow the author isation of ‘flavouri ng compounds’ for use in water for drinking. Theref ore, 
the use of the additive in water for drinking should not be allowed.
(5) The European Food Safety Authority (‘the Author ity’) concluded in its opinions of 18 March 2021 (3)and 1 Febr uary 
2023 (4)that, under the proposed conditions of use, gentian tincture from Gentiana lutea L. is safe for shor t-living 
animals, i.e., animal species for fattening, for consumers and for the environment. It stated that no conclusions 
could be drawn for long-living animals and reproductive animals in the absence of data on the in vivo genoto xicity 
of xanthones (gentisin and isogen tisin) and gentio picroside. Further more, the Author ity could not conclude on the 
poten tial of the additive to be a dermal/ey e irritant or a skin sensitiser , in the absence of data. It also noted that 
when handling the tincture, exposure of unprot ecte d users to the potential genoto xicants xanthones (gentisin and 
isogen tisin) and gentiopicroside cannot be excl uded and that theref ore, to reduce the risk, the exposure of the users 
should be minimised. In addition, the Author ity concluded that since gentian tincture from Gentiana lutea L. is 
recognised to flavour food and since its function in feed would be essentially the same as that in food, no further 
demonstration of efficacy is considered necessar y. It also verified the repor t on the method of analysis of the feed 
additives in feed submitted by the Reference Laborat ory set up by Regulation (EC) No 1831/2003.
(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 1970 concer ning additives in feedi ngstuffs (OJ L 270, 14.12.1970, p. 1, ELI: http:// 
data.europa.eu/eli/dir/1970/524/oj ).
(3)EFSA Journal 2021;19(4):6547.
(4)EFSA Journal 2023;21(2):7869.
Offi cial Jour nal  
of the European Union EN 
L series    
2024/824  11.3.2024ELI: http://data.europa.eu/eli/reg_im pl/2024/824/oj 2/5(6) Subsequently , the applicant withdrew the application for author isation of gentian tincture from Gentiana Lutea L. for 
all animal species and cate gories excep t: animal species for fattening (other than Equidae) and salmonids and minor 
fin fish other than brood stoc k.
(7) In view of the above, the Commission considers that gentian tincture from Gentiana lutea L. satisfies the conditions 
provid ed for in Article 5 of Regulation (EC) No 1831/2003, as regar ds animal species for fattening (except Equidae), 
salmonids and fin fish excep t brood stoc k, and provid ed in particular that the additive is not used in combination 
with other additives containing gentisin, isogen tisin and gentiopicroside. According ly, the use of that substance 
should be author ised. In addition, the Commission considers that appropr iate prot ective 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 
requir ing the withdrawal from the mark et of feed additives for which no applications as required by Article 10(2) of 
Regulation (EC) No 1831/2003 were submitted before the deadline provid ed for in that provision. Similarly , a 
Regulation should be adopt ed concer ning feed additives for whic h an application was submitted but subsequently 
withdra wn.
(9) In the case of feed additives for which an application has been withdrawn only for certain animal species or 
catego ries, the withdra wal from the market should only concer n those animal species or cate gories.
(10) Theref ore, gentian tincture from Gentiana lutea L. should be withdrawn from the market as regards the animal species 
and cate gories whic h are not the subject of the author isation granted by this Regulation.
(11) In so far as this Regulation author ises gentian tincture from Gentiana lutea L. as a feed additive, safety reasons do not 
require the immediate application of the modifications to the conditions of author isation of that substance in respect 
of the animal species and cate gories which are covered by the author isation grant ed by this Regulation. It is theref ore 
appropr iate to provide for a transitional period for inter ested parties to prepare themselves to meet the new 
requirements resulting from the author isation.
(12) In addition, in so far as the feed additive is withdra wn from the mark et, it is also appropr iate to allow for a 
transitional period within which existing stoc ks of the additive, premixtures, feed mate rials and compo und feed 
which have been produced with that additive, may be used up also in respect of the animal species and categor ies of 
animals which are not covered by the author isation grant ed by this Regulation, in order to allow interested parties to 
adapt to the oblig ation to withdra w those products from the mark et.
(13) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
Article 1
Author isation
The substance specified in the Annex, belonging to the additive cate gory ‘sensor y additives’ and to the functional group 
‘flavouring compounds,’ is author ised as an additive in animal nutr ition, subject to the conditions laid down in that Annex.
Article 2
Withdra wal from the market
The feed additive gentian tincture from Gentiana lutea L., as author ised pursuant to Directive 70/524/EEC, shall be 
withdra wn from the mark et in respect of the animal species and categor ies other than those mentioned in the Annex.OJ L, 11.3.2024 EN  ELI: http://data.europa.eu/eli/reg_impl/2024/824/oj 3/5Article 3
Transitional measures related to the author isation
1. The feed additive referred to in Article 2 and premixtures containing that additive, whic h are produced and labelled 
before 30 September 2024 in accordance with the rules applicable before 31 March 2024 , may continue to be placed on 
the mark et and used in respect of the animal species and cate gories mentioned in the Annex until the stoc ks concer ned are 
exhaust ed.
2. Com pound feed and feed mate rials containing the feed additive referred to in Article 2, which are produced and 
labelled before 31 Marc h 2025 in accordance with the rules applicable before 31 March 2024 , may continue to be placed 
on the market and used in respect of the animal species and catego ries mentioned in the Annex until the stoc ks concer ned 
are exhaust ed.
Article 4
Transitional measures related to the withdraw al from the market
1. Existing stoc ks of the feed additive referred to in Article 2 may continue to be placed on the mark et and used in 
respect of the animal species and categor ies other than those mentioned in the Annex until 31 Marc h 2025 .
2. Premixtures produced with the feed additive refer red to in paragraph 1 may continue to be placed on the mark et and 
used in respect of the animal species and cate gories other than those mentioned in the Annex until 30 June 2025 .
3. Com pound feed and feed mat erials produced with the feed additive referred to in paragraph 1 or with the premixtures 
refer red to in paragraph 2 may continue to be placed on the mark et and used in respect of the animal species and cate gories 
other than those mentioned in the Annex until 31 March 2026 .
Article 5
Entr y into force
This Regulation shall enter into force on the twentieth day followi ng 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, 8 March 2024 .
For the Commission
The President
Ursula VON DER LEYENOJ L, 11.3.2024 EN  ELI: http://data.europa.eu/eli/reg_im pl/2024/824/oj 4/5ANNEX 
Identifica -
tion 
number of 
the feed 
additiveAdditiveComposition, chemical formula, descr iption, 
analytical method.Species or categor y of 
animalMaximum 
ageMinimum 
conten tMaximum 
conten t
Other provisi onsEnd of period of 
author isationmg active substance/kg 
of complet e feed with a 
moisture content of 
12 %
Categor y: sensor y additiv es. Functional group: flavour ing compounds
2b2506-t Gentian 
tinctureAdditive composition
Tincture from roots of Gentiana lutea L.
Liquid form
Char acter isation of the active substance
Tincture obtained from the roots of Gentiana 
lutea L. by extended extraction with 
a water/ethanol mixture as defined the 
Council of Europe (1).
FEMA number: 2506
Specif ications
Dry matt er: 3,5-5 %
Total polyphenols: 0,05-0,11 %
Total flavonoids:0,03-0,06 %
Xanthones: maximum 0,004 %
— Gentisin
— Isogentis in
Gentiopicroside: maximum 0,006 %Pigs for fattening 
and pigs for 
fattening of minor 
Suidae
Cattle for fattening, 
sheep for fattening, 
minor ruminants 
for fattening and 
calves for fattening
Chick ens for 
fattening, turke ys 
for fattening and 
minor poultr y for 
fattening
Salmonids and 
minor finfish 
excep t brood stoc k
Other minor 
species for fattening 
excep t Equidae— — 50 1.The additive shall be incor porated 
into the feed in the form of a premix ­
ture.
2.In the directions for use of the additive 
and premixtures, the storage condi ­
tions and the stability to heat treat ­
ment shall be indicated.
3.This additive shall not be used in com ­
bination with other additives contain ­
ing gentisin, isogen tisin and gentiopi ­
croside.
4.For users of the additive and premix ­
tures, feed business operat ors shall es­
tablish operational procedures and 
organisational measures to address 
the pote ntial risks resulting from their 
use. Where those risks cannot be 
eliminated by such procedures and 
measures, the additive and premix ­
tures shall be used with personal 
breathing, eye and skin prot ective 
equipment.31 March 2034OJ L, 11.3.2024 EN  ELI: http://data.europa.eu/eli/reg_impl/2024/824/oj 5/5Analytical method (2)
For the identification and characteri sation of 
the feed additive:
— Gravimetr y for the determination of dry 
matte r and ash content ;
— Spectrophotomet ry for the determination 
of tota l polyphenols content ; and
—High performa nce thin-la yer chromat o­
graphy (HPTL C) for the determination of 
conte nts of total flavonoid s, xanthones 
(genti sin and isogen tisin) and gentiopicro ­
side.
(1)Natural sources of flavourings – Repor t No 2 (2007).
(2)Details of the analytical methods are avail able at the follo wing address of the Reference Laboratory : https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor tsOJ L, 11.3.2024 EN