EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/6522196/2023 CIS 
(POOL/G5/2023/6522196/6522196 -EN 
CIS.docx)  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the denial of authorisation of a preparation of astaxanthin -rich Phaffia 
rhodozyma (ATCC SD -5340) for salmon and trout  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the denial of authorisation of a preparation of astaxanthin -rich Phaffia 
rhodozyma (ATCC SD -5340) as a feed additive for salmon and trout  
(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)  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 or denying  such 
authorisation . Article 10 of that Regulation provides for the re -evaluation of additives 
authorised pursuant to Council Directive 70/524/EEC2. 
(2) A preparation of astaxanthin -rich Phaffia rhodozyma  (ATCC SD -5340) was 
authorised  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 
Register of feed additives as an existing  product, in accordance with Article 10(1) of 
Regulation (EC) No 1831/2003.  
(3) In accordan ce with Article 10( 2) of Regulation (EC) No 1831/2003 , in conjunction 
with Article 7 thereof, an application was submitted for the authorisation  of a 
preparation of astaxanthin -rich Phaffia rhodozyma  (ATCC SD -5340) as a feed 
additive for salmon and trout , requesting that additive to be classified in the category 
‘sensory 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 particu lars and documents required under Article 7(3) of 
Regulation (EC) No 1831/2003.  
(4) The European Food Safety Authority (‘the Authority’) noted in its opinion of 27 
January 202 23 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 
Authority could not conclude on the safety of the additive for the consumer  either , due 
to a lack of adequate toxicity and residue data. The Authority concluded that the 
additive is  irritant to skin and eyes, is a skin and respiratory sensitiser, although 
 
1 OJ L 268, 18.10.2003 , p. 29.  
2 Council Directive 70/524/EEC of 23 N ovember 1970 concerning additives in feedingstuffs (OJ L 270, 
14.12.1970, p. 1).  
3 EFSA Journal 202 2;20(2):7161.  
EN 2  EN exposure by inhalation is likely low. Furthermore, in the absence of adequate 
evidence, no conclusions could be drawn by the Authority  on the efficacy of the 
additive.  The Authority  also verified the report 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 opportunity to 
submit supplementary information to address the inconclusive opinion of the 
Authority. In the absence of a reply, a new letter  was sent to the applicant on 20 April 
2023 , asking for a clarification of  the intention with the application, but no reaction 
was communicated to the Commission.  
(6) As provided for by Article 5(1) of Regulation (EC) No 1831/2003, it is for the 
applicant for an authorisation of a feed additive to adequately and sufficiently 
demonstrate, in accordance with the implementing rules refer red to in Article 7 of that 
Regulation, that the conditions for authorisation set out in Article 5(2) and (3) of that 
Regulation are satisfied.  
(7) It derives from t he Authority’s opinion of 27 January 202 2 that it has not been 
established that the preparatio n of astaxanthin -rich Phaffia 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 category 
‘sensory 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 -rich 
Phaffia rhodozyma  (ATCC SD -5340)  satisfies  the conditions for the authorisation, as 
provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the 
authorisation of that preparation as a feed additive belonging to  the category ‘sensory 
additives’  and the  functional group ‘colourants: (ii)  substances which, when fed to 
animals, add colours to food of animal origin ’ for use for salmon and trout,  should be 
denied.  
(9) Therefore, the preparation of astaxanthin -rich Phaffia rhodozyma  (ATCC SD -5340)  
and feed containing it should be withdrawn from the  market as soon  as possible as far 
as the use for salmon and trout  is concerned. However , a limited  period should be 
allowed for the withdrawal from the market of the existing stocks of those products, in 
order to enable operators to comply properly with t he withdrawal obligation . 
(10) 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  
Denial of authorisation  
The authorisation of the preparation of astaxanthin -rich Phaffia rhodozyma  (ATCC SD -5340) 
(E 161y) as an additive in animal nutrition belonging to the category ‘sensory additives’, 
functional group ‘colourants: (ii) substances which, when fed to animals, a dd colours to food 
of animal origin’ f or use for salmon and trout, is denied . 
Article 2 
Transitional provisions   
EN 3  EN 1. Existing stocks of the additive referred to in Article 1, which are intended  for salmon 
and trout , and of premixtures containing it , shall be  withdrawn from the market by  
[OP please insert the date = 3 months after the date of entry into force of this 
Regulation ]. 
2. Feed materials and c ompound feed which have been produced with the additive or 
premixtures referred to in paragraph 1 before [OP please insert the date = 3 months 
after the date of entry into force of this Regulation ] and which  are intended for 
salmon and trout , shall be withdrawn from the market by  [OP please insert the date 
= 6 months after the date of entry into force of this Regulation ]. 
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 . 
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 DER LEYEN