COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/1712 
of 7 September 2023
concer ning the author isation of Sunset Yello w FCF as a feed additiv e for cats, dogs, ornamental fish, 
grain-eating ornament al birds and small rodents 
(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 such an author isation. Article 10(2) of Regulation (EC) No 1831/2003 
provid es for the re-evaluation of additives author ised pursuant to Council Directive 70/524/EEC (2).
(2) Sunset Yellow FCF was author ised without a time limit in accordance with Directive 70/524/EEC as a feed additive 
for ornamental fish belonging to the group ‘colourants, including pigments ’ under the heading ‘other colourants’ 
and for dogs and cats under the heading ‘other colourants – colour ing agents author ised for colour ing foodstuffs by 
Community rules ’. Under the same Directive, it was author ised without a time limit for all species or catego ries of 
animals, with the excep tion of cats and dogs, in animal feedingstuffs only in products processed from: (i) waste 
products of foodstuffs; (ii) other base substances, with the excep tion of cereals and manioc flour , denaturated by 
means of these agents or coloured during technical preparation to ensure the necessar y identif ication during 
manufact ure. It was also author ised without a time limit for grain-eating ornamental birds and small rodents by 
Commission Regulation (EC) No 358/2005 (3). The additive 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 submitte d for the re-evaluation of Sunset Yellow FCF as a feed additive for dogs, cats, ornamental 
fish, grain-eating ornamental birds and small rodents. The applicant request ed the additive to be classified in the 
additive catego ry ‘sensor y additive’ and in the functional group ‘colourants’. The application was accompanied by 
the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4) The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 23 March 2022 (4)that, under the 
proposed conditions of use, Sunset Yellow FCF does not have adverse effects on animal health. Howe ver, in the 
absence of adequate information, it could not conclude on the eyes and skin irritation poten tial, and on its skin 
sensitisation poten tial. Users are likely to be exposed by inhalation. In accordance with Commission Regulation (EC) 
No 429/2008 (5), phase I of the environmental risk assessment has determined that Sunset Yellow FCF, as an additive 
intended for non-f ood producing animals, is exem pted from further assessment due to the unlikelihood of a 
signif icant environmental effect, there being no scientifi cally-based evidence for concer n having been identified by 
(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)Commission Regulation (EC) No 358/2005 of 2 March 2005 concer ning the author isations without a time limit of certain additives 
and the author isation of new uses of additives already author ised in feedingstuffs (OJ L 57, 3.3.2005, p. 3).
(4)EFSA Jour nal 2022;20(5):7266.
(5)Commission Regulation (EC) No 429/2008 of 25 Apr il 2008 on detailed rules for the implementation of Regulation (EC) 
No 1831/2003 of the European Parliament and of the Council as regar ds the preparation and the presentation of applications and the 
assessment and the author isation of feed additives (OJ L 133, 22.5.2008, p. 1).EN Offi cial Jour nal of the European Union L 221/46 8.9.2023  the Authority in its abov ementioned opinion. The Author ity could not conclude on the effic acy of Sunset Yellow 
FCF, consider ing the wide variety of feedingstuffs used in compl ete and complementary feed for the targe t species, 
and the uncer tainty of which concentration of Sunset Yellow FCF would result in a visible effect. Howe ver, the 
Authority also state d that for this additive, whic h is author ised in food and, where the function for feed is the same 
as that for food, no further demonstration of efficacy might be necessar y. The applicant also provided further 
information and the Commission considered that there is sufficient evidence of the efficacy of Sunset Yellow FCF. 
The Author ity also verified the repor t on the methods of analysis of the feed additive in feed submitted by the 
Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) The assessment of Sunset Yellow FCF shows that the conditions for author isation, as provided for in Article 5 of 
Regulation (EC) No 1831/2003, are satisfied. According ly, the use of that additive should be author ised as specified 
in the Annex to this Regulation. 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.
(6) Since safet y reasons do not require the immediate application of the modifications to the conditions of author isation 
of the additive, it is appropr iate to allow a transitional period for interest ed parties to prepare themselves to meet the 
new requirements resulting from the author isation.
(7) 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 
‘colourants’, is author ised as an additive in animal nutr ition, subject to the conditions laid down in that Annex.
Article 2
Transitional measures
1. The substance specifi ed in the Annex and premixtures containing that substance, whic h are produced and labelled 
before 28 March 2024 , in accordance with the rules applicable before 28 Septembe r 2023 , may continue to be placed on 
the mark et and used until the existing stoc ks are exhaust ed.
2. Com pound feed and feed mat erials containing the substance as specified in the Annex, which are produced and 
labelled before 28 September 2025 , in accordance with the rules applicable before 28 Sept ember 2023 , may continue to 
be placed on the market and used until the existing stoc ks are exhausted.
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.EN Offi cial Jour nal of the European Union 8.9.2023 L 221/47  This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 Sept ember 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 221/48 8.9.2023  ANNEX 
Identifica -
tion 
number of 
the 
additiveAdditiveComposition, chemical formula, descr iption, 
analytical methodSpecies or 
categ ory of 
animalMaxi -
mum ageMini -
mum 
conten tMaximum 
conten t
Other provisi onsEnd of period of 
author isation mg active substance/kg 
of compl ete feed with a 
moisture content of 
12 %
Categor y: Sensor y additiv es. Functional group: Colourants. (i) substances that add or restor e colour in feedingstuffs
2a110 Sunset Yellow FCF Additive composition
Sunset Yellow FCF
Solid form (powder or granules)Cats - - 165 1. In the directions for use of the 
additive and premixtures, the sto­
rage conditions shall be indicated.
2. For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational mea ­
sures to address poten tial risks re­
sulting from its use. Where those 
risks cannot be eliminated by such 
procedures and measures, the ad­
ditive and premixtures shall be 
used with personal eyes, skin 
and breathing protective equip ­
ment.28 Sept ember 
2033
Dogs - - 198
Char acter isation of the active substance
Sunset Yellow FCF, descr ibed as the sodium salt, 
consists essentially of disodium 2-hydro xy- 
1-(4-sulf onat ophenylazo)naphthalene- 
6-sulf onate and subsidiar y colour ing matt ers 
together with sodium chlor ide and/or sodium 
sulfa te as the principal uncoloured components. 
Calcium and potassium salts are also allowe d 
with the same charact erisation as sodium salt.
Produced by chemical synthesis
Purity criteria: content not less than 90 % total 
colour ing matt ers, calculat ed as the sodium salt 
(assa y)
Water insoluble matt er: ≤ 0,2 %
Subsidiar y colour ing matte rs: ≤ 5 %
1-(Pheny lazo)-2-naphthalenol (Sudan I): 
≤ 0,5 mg/kg)
Org anic compo unds other than colour ing 
matte rs: ≤ 0,5 %Ornamental 
fish- - 733
Grain-eating 
ornamental 
birds- - 24
Small rodents - - 750EN Offi cial Jour nal of the European Union 8.9.2023 L 221/49  Unsulf onat ed primar y aromatic amines: ≤ 0,01 % 
(calculate d as aniline)
Ether extractable matt er: ≤ 0,2 % from a solution 
of pH 7
Chemical formula: C16H10N2Na 2O7S2
CAS number: 2783-94-0
Analytical method (1)
For the determination of the total colour ing 
matte rs conte nt of Sunset Yellow FCF in the feed 
additive:
— spectrophotometr y at 485 nm and titration 
with titanic chlor ide as specified and 
descr ibed in Commission Regulation (EU) 
No 231/2012 (2)which refers to FAO JECF A 
Combined Com pendium for Food Additive 
Specifi cations (Analytical methods Vol. 4) 
and the Monograph No 11 (2011) ‘Sunset 
Yellow FCF’
For the determination of Sunset Yellow FCF in 
compo und feed:
— high performance liquid chromat ography 
coupled to tandem mass spectrometr y 
(LC- MS/MS)
(1)Details of the analytical methods are available at the following address of the Reference Laborato ry: https://joint-research-c entre.ec.europa.eu/eurl-fa-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_en .
(2)Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the 
Council (OJ L 83, 22.3.2012, p. 1).EN Offi cial Jour nal of the European Union L 221/50 8.9.2023