ELI: http://data.europa.eu/eli/reg_impl/2024/752/oj 1/3COMMISSION IMPLEMENTING REGUL ATION (EU) 2024/752 
of 29 Febr uary 2024
concer ning the denial of author isation of a preparation of astaxanthin-r ich Phaffia rhodozyma (ATCC 
SD-5340) as a feed additiv e for salmon and trout 
(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) 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 or denying such author isation. Article 10 of that Regulation provides for the 
re-evaluation of additives author ised pursuant to Council Directive 70/524/EEC (2).
(2) A preparation of astaxanthin-r ich Phaff ia rhodozyma (ATCC SD-5340) was author ised for four years in accordance 
with Directive 70/524/EEC as a feed additive belonging to the group ‘colourants, including pigments’ for use for 
salmon and trout with the additive number E 161y . That additive was subsequently entered in the Registe r of feed 
additives as an existing product, in accordance with Article 10(1) 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 a preparation of astaxanthin-r ich Phaff ia rhodozyma (ATCC 
SD-5340) as a feed additive for salmon and trout, requesting that additive to be classif ied in the cate gory ‘sensor y 
additives ’ and in the functional group ‘colourants: (ii) substances which, when fed to animals, add colours to food of 
animal origin’ . That application was accompanied by the particulars and documents required under Article 7(3) of 
Regulation (EC) No 1831/2003.
(4) The European Food Safety Auth ority (‘the Auth ority’) noted in its opinion of 27 Januar y 2022 (3)that it could not 
conclude on the safety of the additive for the target species in the absence of a tolerance study with the additive 
under assessment. The Author ity could not conclude on the safety of the additive for the consumer either , due to a 
lack of adequate toxicity and residue data. The Auth ority concluded that the additive is irritant to skin and eyes, is a 
skin and respirato ry sensitiser , although exposure by inhalation is likely low. Further more, in the absence of adequat e 
evidence, no conclusions could be drawn by the Author ity on the efficacy of the additive. The Author ity also verified 
the repor t on the method of analysis of the additive in feed submitted by the Reference Laboratory set up by 
Regulation (EC) No 1831/2003.
(5) By letter of 13 May 2022 , the Commission gave the applicant the oppor tunity to submit supplementar y information 
to address the inconclusive opinion of the Author ity. In the absence of a reply , a new letter was sent to the applicant 
on 20 Apr il 2023 , asking for a clarification of the intention with the application, but no reaction was communicate d 
to the Commission.
(6) As provided for by Article 5(1) of Regulation (EC) No 1831/2003, it is for the applicant for an author isation of a feed 
additive to adequat ely and suffi ciently demonstrate, in accordance with the implementing rules refer red to in 
Article 7 of that Regulation, that the conditions for author isation set out in Article 5(2) and (3) of that Regulation 
are satisfied.
(1)OJ L 268, 18.10.2003, p. 29.
(2)Council Directive 70/524/EEC of 23 November 1970 concer ning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
(3)EFSA Jour nal 2022;20(2):7161.
Offi cial Jour nal  
of the European Union EN 
L series    
2024/752  1.3.2024ELI: http://data.europa.eu/eli/reg_im pl/2024/752/oj 2/3(7) It derives from the Author ity’s opinion of 27 Januar y 2022 that it has not been established that the preparation of 
astaxanthin-r ich Phaff ia rhodozyma (ATCC SD-5340) does not have an adverse effect on animal health and human 
health, and that it is efficacious when used as a feed additive for salmon and trout in the additive categor y ‘sensor y 
additives ’ and the functional group ‘colourants: (ii) substances which , when fed to animals, add colours to food of 
animal origin’ .
(8) In view of the above, it cannot be considered that the preparation of astaxanthin-r ich Phaff ia rhodozyma (ATCC 
SD-5340) satisfies the conditions for the author isation, as provid ed for in Article 5 of Regulation (EC) 
No 1831/2003. According ly, the author isation of that preparation as a feed additive belonging to the catego ry 
‘sensor y additives ’ and the functional group ‘colourants: (ii) substances whic h, when fed to animals, add colours to 
food of animal origin’ for use for salmon and trout, should be denied.
(9) Theref ore, the preparation of astaxanthin-r ich Phaff ia rhodozyma (ATCC SD-5340) and feed containing it should be 
withdra wn from the mark et as soon as possible as far as the use for salmon and trout is concer ned. Howe ver, a 
limited period should be allowed for the withdrawal from the market of the existing stoc ks of those products, in 
order to enable operat ors to comply properly with the withdrawal obligation.
(10) 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
Denial of author isation
The author isation of the preparation of astaxanthin-r ich Phaff ia rhodozyma (ATCC SD-5340) (E 161y) as an additive in 
animal nutr ition belonging to the cate gory ‘sensor y additives ’, functional group ‘colourants: (ii) substances whic h, when 
fed to animals, add colours to food of animal origin’ for use for salmon and trout, is denied.
Article 2
Transitional provisions
1. Existing stoc ks of the additive refer red to in Article 1, which are intended for salmon and trout, and of premixtures 
containing it, shall be withdra wn from the market by 21 June 2024 .
2. Feed mate rials and compound feed whic h have been produced with the additive or premixtures refer red to in 
paragraph 1 before 21 June 2024 and whic h are intended for salmon and trout, shall be withdrawn from the market by 
21 Sept ember 2024 .
Article 3
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.OJ L, 1.3.2024 EN  ELI: http://data.europa.eu/eli/reg_impl/2024/752/oj 3/3This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 Febr uary 2024 .
For the Commission
The President
Ursula VON DER LEYENOJ L, 1.3.2024 EN