COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/1400 
of 5 Oct ober 2020 
concer ning the author isation of ethyl ester of β-apo-8’-carotenoic acid as a feed additiv e for chickens 
for fattening, laying hens and minor poultr y species for laying and for fattening 
(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 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) and Article 4 of the same 
Regulation for the author isation of a new use of an additive. 
(2) Ethyl ester of β-apo-8’-carotenoic acid was author ised without a time limit in accordance with Directive 70/524/EEC 
as feed additive for poultr y belonging to the functional group ‘colourants, including pigments’, under the heading 
‘caroten oids and xanthophy lls’. The additive was subsequently entered in the Registe r of feed additives as an existing 
product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. 
(3) In accordance with Articles 4 and 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an 
application was submitted for the author isation of ethyl ester of β-apo-8’-carote noic acid in water for drinking and 
the re-evaluation of ethyl ester of β-apo-8’-carotenoic acid as feed additive for chick ens for fattening, laying hens and 
minor poultr y species for laying and for fattening. The applicant request ed the additive to be classif ied in the additive 
catego ry ‘sensor y additives ’ 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 Auth ority (‘the Author ity’) concluded in its opinions of 8 March 2016 (3) and of 
12 Novem ber 2019 (4) that, under the proposed conditions of use, ethyl ester of β-apo-8’-carotenoic acid does not 
have an adverse effect on animal health, consumer safety or the environment. It also concluded that ethyl ester of  
β-apo-8'-carot enoic acid is not an irritant to skin and eyes, and not a dermal sensitiser . On the inhalation toxicity of 
ethyl ester of β-apo-8’-carotenoic acid, the Authority cannot conclude on the risk of users by inhalation. Theref ore, 
the Commission considers that appropr iate prot ective measures should be taken to prevent adverse effects on 
human health. The Authority further concluded that the additive concer ned is effective in adding colour to food of 
animal origin. The Authority does not consider that there is a need for specifi c requirements of post-market 
monitori ng. It also verified the repor t on the method of analysis of the feed additive in feed submitte d by the 
European Union Reference Laboratory set up by Regulation (EC) No 1831/2003. 
(5) As regards the use in water for drinking, the Commission considers that the simultaneous use of the additive in wate r 
for drinking and feed is difficult to manage, as there are maximum levels established for safety reasons and there are 
also other additives containing xanthophy lls and carote noids that may be used in feed. The simultaneous use of ethyl 
ester of β-apo-8’-carotenoic acid in water for drinking and feed increases the ways of administration and the risk to 
exceed the maximum levels author ised for additives containing carote noids and xanthophy lls. Consequently , the 
use in water for drinking should be denied. 
(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 2016;14(4):4439 
(4)EFSA Jour nal 2019;17(12):5911 EN Offi cial Jour nal of the European Union L 324/32                                                                                                                                         6.10.2020   (6) The assessment shows that the conditions for author isation, as provi ded for in Article 5 of Regulation (EC) 
No 1831/2003, are satisfied. According ly, the use of ethyl ester of β-apo-8’-carote noic acid should be author ised as 
specifi ed in the Annex to this Regulation. 
(7) Since safet y reasons do not require the immediate application of the modifications to the conditions of author isation 
of the substance concer ned, 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. 
(8) 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 
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 a feed additive in animal nutr ition subject to the conditions laid down in that Annex. 
Article 2 
The author ised substance specifi ed in the Annex, belonging to the additive catego ry ‘sensor y additives ’ and to the functional 
group ‘colourants’, shall not be used in water for drinking. 
Article 3 
1 The substances specifi ed in the Annex and premixtures containing those substances, which are produced and labelled 
before 26 Apr il 2021 in accordance with the rules applicable before 26 October 2020 may continue to be placed on the 
mark et and used until 26 October 2021. 
2. Com pound feed and feed mat erials containing the substances as specifi ed in the Annex which are produced and 
labelled before 26 October 2021 in accordance with the rules applicable before 26 October 2020 may continue to be 
placed on the market and used until 26 Apr il 2022. 
Article 4 
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, 5 October 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union 6.10.2020                                                                                                                                         L 324/33   ANNEX 
Identif i-
cation 
number 
of the 
additiv e Additiv e Composition, chemical form ula, 
descr iption, analytical method Species or 
categor y of 
animal Maxi-
mum 
age Mini-
mum 
content Maxi-
mum 
content 
Maximum residue levels Other provisions End of period of 
author isation mg of activ e 
subst ance / kg of 
complete 
feedingst uff with a 
moistu re content 
of 12 %  
Categor y: Sensor y additiv es. Functional group: Colourants. (ii) substances which, when fed to animals, add colours to food of animal origin 
2a160f Ethyl ester of 
β-apo-8’- 
carot enoic 
acid; Additiv e composition: 
Ethyl ester of β-apo-8’-carot enoic acid. 
Triphenyl phosphine oxide (TPPO) ≤ 
100 mg/kg. Chic kens for 
fatteni ng and 
minor poultr y 
for fattening. - - 15 — 20 mg ethyl ester of β- 
apo-8’-carot enoic  
acid /kg egg yolk (wet 
tissue). 
— 8 mg ethyl ester of 
β-apo-8’-carot enoic 
acid/kg liver (wet tissue). 
— 2.5 mg ethyl ester of 
β-apo-8’-carot enoic 
acid/kg skin/fat (wet 
tissue). 1. In the directions for use of the 
additive and premixture, the 
stora ge conditions and stability 
to heat treatment. shall be indi
cated . 
2.Ethyl ester of β-apo-8’-carote­
noic acid shall be placed on the 
mark et and used as an additive 
consisting of a preparation. 
3. For users of the additive and 
premixtures, feed business op
erators shall establish opera
tional procedures and orga nisa
tional measures to address 
poten tial risks resulting from 
its use. Where those risks can
not be eliminated or reduced to 
a minimum by such proce
dures and measures, the addi
tive and premixtures shall be 
used with personal protect ive 
equipment, including eye skin 
and breathing protection. 26.10.2030 
Character isation of the activ e sub­
stance: 
Ethyl ester of β-apo-8’-carot enoic acid. 
Chemical formula: C32H44O2 
CAS number: 1109-11-1 
Solid form produced by chemical 
synthesis. 
Purity criteria: ≥ 97% all isomers. Laying hens and 
minor poultr y 
for laying. - - 5 
Analytical method 
— For the quantific ation of ethyl ester 
of β-apo-8’-carotenoic acid in the 
feed additive preparation: spectro
photomet ry at 446 nm. 
— For the quantific ation of ethyl ester 
of β-apo-8’-carotenoic acid in the 
premixtures and feedingstuffs: Nor
mal Phase High Performan ce Liquid 
Chromatograph y coupled to visible 
detection (NP-HPL C-VIS, 446 nm).  - -    EN Offi cial Jour nal of the European Union L 324/34                                                                                                                                         6.10.2020