COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/420 
of 9 March 2021 
correcting Implementing Regulation (EU) 2020/1097 concer ning the author isation of lutein-r ich and 
lutein/zeaxanth in extracts from Tagetes erecta as feed additiv es for poultr y (excep t turke ys) for 
fattening and laying and for minor poultr y species for fattening and laying 
(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 for the 
author isation of a new use of an additive. 
(2) Lutein-r ich and lutein/zeaxanthin extracts from Tagetes erecta were author ised by Commission Imp lementing 
Regulation (EU) 2020/1097 (3) concer ning the author isation of lutein-r ich and lutein/zeaxanthin extracts from 
Tagetes erecta as feed additives for poultr y (excep t turke ys) for fattening and laying and for minor poultr y species 
for fattening and laying. 
(3) The European Food Safety Author ity (‘the Auth ority’) concluded in its opinion of 3 Apr il 2019 (4) that the maximum 
proposed use level of 80 mg total carot enoids/kg of compl ete feed for lutein-r ich and lutein/zeaxanthin extracts is 
safe for poultr y for fattening (except turk eys), minor poultr y for fattening , poultr y for laying (except turk eys) and 
minor poultr y for laying. By mistake , the heading of the sixth and seventh columns of the Annex to Implementing 
Regulation (EU) 2020/1097 refers to ‘mg of activ e substance of kg of complete feedingstuf f with a moisture content of 12 %’. 
That referen ce is not correct as the EFSA opinion refers to the ‘total carotenoids’. It is theref ore appropr iate to correct 
the heading of the sixth and seventh columns of the table in the Annex to that Implementing Regulation to reflect 
the wording appear ing in the EFSA opinion of 3 Apr il 2019. 
(4) The references to ‘poultr y for fattening (except turk eys)’ and ‘poultr y for laying, (except turke ys)’ have been modifi ed 
to ‘chic kens for fattening’ and ‘laying hens ’. This change does not affect or modify the catego ries of animals currently 
author ised, as the term ‘poultr y’ covers turke ys for laying and fattening, chick ens for fattening and laying hens. 
Theref ore, it is more appropr iate to refer directly to chick ens for fattening and laying hens. 
(5) The EFSA opinion also indicate d that the maximum use level of the lutein/zeaxanthin extract is 80 mg total 
carotenoids/kg of complet e feed in poultr y for fattening (except turk eys), minor poultr y for fattening, poultr y for 
laying (except turk eys) and minor poultr y for laying. In addition, the EFSA opinion state d that in breeding minor 
poultr y the maximum level should not excee d 50 mg total carotenoids/kg complet e feed, consider ing the 
toxicological poten tial of zeaxanthin on reproduction. The EFSA opinion further stated that, since the breeding 
husbandr y in minor poultr y species does not differentiat e between laying and breeding, it cannot be excl uded that 
the additive contained in a layer diet would be given to minor breeding poultr y. By mistak e, the table in the Annex 
(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 Implementing Regulation (EU) 2020/1097 of 24 July 2020 concer ning the author isation of lutein-rich and lutein/ 
zeaxanthin extracts from Taget es erecta as feed additives for poultr y (excep t turke ys) for fattening and laying and for minor poultr y 
species for fattening and laying (OJ L 241, 27.7.2020, p. 23).
(4)EFSA Journal 2019; 17(5):5698.EN Offi cial Jour nal of the European Union L 83/16                                                                                                                                           10.3.2021   to Imple menting Regulation (EU) 2020/1097 set the maximum level of carotenoids of lutein/zeaxanthin extract for 
poultr y for fattening (excep t turke ys), minor poultr y for fattening , poultr y for laying (except turke ys) and minor 
poultr y for laying at 50 mg total carotenoids/kg feed, while this level should apply only to minor poultr y for laying, 
to prevent any misuse on breeding animals. The rest of the poultr y catego ries should have a maximum level of use of 
80 mg total carot enoids/kg of complet e feed. 
(6) Implementing Regulation (EU) 2020/1097 should theref ore be corrected. 
(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 
The Annex to Regulation (EU) 2020/1097 is replaced by the Annex to this Regulation. 
Article 2 
This Regulation shall enter into force on the day 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, 9 March 2021.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union 10.3.2021                                                                                                                                           L 83/17   ANNEX 
‘ANNEX                                                                
Identification 
number of 
the additive Additive Composition, chemical formula, descr iption, analytical 
method Species or 
categ ory of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of period 
of 
author isation mg of total  
carotenoi ds/kg of 
complet e feedingstuff 
with a moisture conten t 
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 
2a161b Lutein-r ich 
extract Additive composition 
Lutein-r ich extract of Tagetes erecta 
Benzene ≤ 2mg/kg Chick ens for 
fattening and 
minor poultr y 
for fattening - - 80 1.In the directions for use of the addi ­
tive and premixture, the storage con­
ditions and stability to heat treat ­
ment shall be indicated. 
2. Lutein-r ich extract must be placed on 
the market and used as an additive 
consisting of a preparation. 
3. The mixture of lutein-r ich extract 
with other author ised carot enoids 
and xanthophy lls shall not excee d a 
total carot enoids and xanthophy lls 
conte nt of 80 mg/kg of compl ete 
feed. 
4.For users of the additive and premix ­
tures, feed business operat ors shall 
establish operational procedures 
and organisational measures to ad­
dress poten tial risks resulting from 
its use. Where those risks cannot be 
eliminated or reduced to a minimum 
by such procedures and measures, 
the additive and premixtures shall 
be used with personal prot ective 
equipment, including eye and skin 
prote ction 30.3.2031 
Char acter isation of the active substance 
Lutein from a saponified extract of Tagetes erecta (dried 
flowers petals) obtained via extraction and 
saponif ication: 
— Total carot enoids (TC):≥ 60g/kg 
— Lutein ≥ 75 % of total carotenoids (TC) 
— Zeaxanthin≥ 4 % of total carotenoids (TC) 
Chemical formula: C40H56O2 
CAS number 127-40-2 (lutein) 
CAS number 144-68-3 (zeaxanthin) 
CoE number: 494 
Liquid form Laying hens and 
minor poultr y 
for laying. - - 80 
Analytical method (1) 
— For the determination of lutein (all-trans-lutein 
isomer only), zeaxanthin and total carotenoids 
and xanthophy lls in the feed additive: high Perfor ­
mance Liquid Chromat ography (HPL C) with spec ­
trophot ometr y – Commission Regulation (EU) 
No 231/2012 referring to FAO JECF A monograph 
“lutein from Tagetes erecta” monograph No 3 
(2006), Combined Com pendium for Food Addi­
tive Specifi cations EN Offi cial Jour nal of the European Union L 83/18                                                                                                                                           10.3.2021   — For the determination of lutein (all-trans-lutein 
isomer only) in premixtures and feedingstuffs: 
high Performan ce Liquid Chromatograph y with 
visible detection (HPLC- Vis) 
— For the deter mination of total carotenoids and 
xanthophy lls in premixtures and feedingstuffs: 
liquid chromat ography with visible detection 
(LC- Vis) – AOAC official method 970.64 
2a161bi Lutein/ 
zeaxanthin 
extract Additive composition 
Lutein/zeaxanthin extract of Tagetes erecta. 
Benzene ≤ 2mg/kg Chick ens for 
fattening and 
minor poultr y 
for fattening - - 80 1.In the directions for use of the addi ­
tive and premixture, the storage con­
ditions and stability to heat treat ­
ment shall be indicated. 
2. Lutein/zeaxanthin extract must be 
placed on the mark et and used as 
an additive consisting of a prepara ­
tion. 
3.The mixture of lutein/zeaxanthin ex­
tract with other author ised carote ­
noids and xanthophylls shall not ex­
ceed a total carotenoids and 
xanthophy lls content of: 
a. 80 mg/kg of compl ete feed for 
chickens for fattening , minor 
poultr y for fattening and laying 
hens. 
b. 50 mg/kg of compl ete feed for 
minor poultr y for laying. 
4.For users of the additive and premix ­
tures, feed business operat ors shall 
establish operational procedures 
and organisational measures to ad­
dress poten tial risks resulting from 
its use. Where those risks cannot be 
eliminated or reduced to a minimum 
by such procedures and measures, 
the additive and premixtures shall 
be used with personal prot ective 
equipment, including eye and skin 
prote ction. 30.3.2031 
Char acter isation of the active substance 
Lutein/zeaxanthin saponif ied/isomer ised extract of 
Tagetes erecta (dried flowers petals) obtained via 
extraction, saponif ication and isomer isation: 
— Total carot enoids (TC):≥ 60g/kg 
— Lutein ≥ 37 % of TC; 
— Zeaxanthin ≥ 36 % of TC. 
Liquid form 
CAS number 127-40-2(lut ein) 
CAS number 144-68-3 (zeaxanthin) 
CoE number: 494 
Chemical formula: C40H56O2 Laying hens 80 
Minor poultr y 
for laying. 50 
Analytical method (1) 
For the determination of lutein (all-trans-lute in 
isomer only), zeaxanthin and total carotenoids and 
xanthophy lls in the feed additive: 
— High Performance Liquid Chromatograph y 
(HPL C) with spectrophotometr y – Commission 
Directive 2008/128/EC refer ring to FAO JECF A 
monograph “lutein from Tagetes erecta” mono ­
graph No 3 (2006), Combined Compendium for 
Food Additive Specifications  - -’  EN Offi cial Jour nal of the European Union 10.3.2021                                                                                                                                           L 83/19   For the determination of lutein (all-trans-lute in 
isomer only) in premixtures and feedingstuffs: 
— High Performan ce Liquid Chromat ography with 
visible detection (HPLC- Vis) 
For the determination of tota l carotenoids and 
xanthophy lls in premixtures and feedingstuffs: 
— Liquid chromat ography with visible detection 
(LC- Vis) – AOAC official method 970.64 
(1) 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 tsEN Offi cial Jour nal of the European Union L 83/20                                                                                                                                           10.3.2021