II 
(Non-legislative acts) 
REGUL ATIONS 
COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/228 
of 19 Febr uary 2020 
concer ning the author isation of erythrosine as a feed additiv e for dogs and cats 
(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). 
(2) Erythrosine 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’. It 
was also author ised without a time limit as a feed additive for dogs and cats belonging to the group ‘colourants, 
including pigments’, under the heading ‘colour ing agents author ised for colour ing foodstuffs by Community rules’. 
The additive was subsequently entered in the Regist er of feed additives as an existing product, in accordance with 
Article 10(1)(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 submitt ed for the re-evaluation of erythrosine as a feed additive for ornamental fish and for dogs 
and cats. The applicant requeste d the additive to be classif ied in the additive catego ry ‘sensor y additive’ and in the 
functional group ‘colourants’. In accordance with Article 7 of Regulation (EC) No 1831/2003, the applicant also 
requeste d the author isation of erythrosine as a feed additive for a new use in reptiles, to be classif ied in the additive 
catego ry ‘sensor y additive’ and in the functional group ‘colourants’. Latel y, the applicant withdrew the application 
for ornamental fish and for reptiles. The application was accompan ied by the particulars and documents required 
under Article 7(3) of Regulation (EC) No 1831/2003. 
(4) The European Food Safet y Auth ority (‘the Auth ority’) concluded in its opinions of 16 November 2011 (3), 
8 Sept ember 2015 (4) and 3 Apr il 2019 (5) that, under the proposed conditions of use, erythrosine does not have an 
adverse effect on animal health. It also concluded that dermat ological reactions, including photosensitivity , 
erythroder ma and desquamation have been attributed to erythrosine and that an exposure of the lowe r respirato ry 
tract is considered a hazard for the user of the additive. Theref ore, the Commission considers that appropr iate 
prote ctive measures should be taken to prevent adverse effects on human health, in particular as regar ds the users 
(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 2011;9(12):2447. 
(4)EFSA Jour nal 2015;13(9):4233. 
(5)EFSA Jour nal 2019;17(5):5699 EN Offi cial Jour nal of the European Union 20.2.2020                                                                                                                                            L 47/1   of the additive. In accordance with Commission Regulation (EC) No 429/2008 (6), phase I of the environmental risk 
assessment has determined that erythrosine, 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 scientifically- 
based evidence for concer n having been identified by the Authority in its abov e-mentioned opinions. The Author ity 
further concluded that the substance concer ned is effective in adding colour to feedingstuffs and in favourably 
affecting the colour of ornamental fish. The Author ity does not consider that there is a need for specifi c 
requirements of post-market monitor ing. It also verified the repor t on the method 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 the erythrosine 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 that additive should be author ised as specified 
in the Annex to this Regulation. 
(6) 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. 
(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 specified in the Annex and premixtures containing that substance, whic h are produced and labelled 11 
Sept ember 2020 in accordance with the rules applicable before 11 March 2020 may continue to be placed on the mark et 
and used until the existing stoc ks are exhausted. 
2. Feed mater ials and compo und feed containing the substance specifi ed in the Annex which are produced and labelled 
before 11 March 2022 in accordance with the rules applicable before 11 March 2020 may continue to be placed on the 
mark et and used until the existing stoc ks are exhaust ed. 
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. 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, 19 Febr uary 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     
(6)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 regards 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 47/2                                                                                                                                            20.2.2020   ANNEX 
Identification 
number of the 
additive Additive Composition, chemical formula, descr iption, analytical 
method Species or 
category of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of period 
of 
author isation mg of active substance of kg of 
compl ete feedingstuff with a 
moisture content of 12 % 
Categor y: Sensor y additiv es. Functional group: Colourants. (i) substances that add or restore colour in feedingstuffs 
2a127 Erythrosine Additiv e composition: 
Erythrosine descr ibed as the sodium salt as the 
principal compo nent. 
Solid form Dogs 
Cats - 
- - 
- 16 
13 1. In the directions for use 
of the additive and pre­
mixture, the storage 
conditions and stability 
to heat treatment shall 
be indicated. 
2. For users of the additive 
and premixtures, feed 
business operat ors shall 
establish operational 
procedures and orga ni­
sational measures to ad­
dress pote ntial risks re­
sulting from its use. 
Where those risks can­
not be eliminated or re­
duced to a minimum by 
such procedures and 
measures, the additive 
and premixtures shall 
be used with personal 
prote ctive equipment, 
including breathing pro­
tectio n. 11.3.2030 
Character isation of the activ e subst ance as the 
sodium salt: 
Erythrosine consists essentially of disodium 2- 
(2,4,5,7-te traiodo-3- oxido-6-o xoxanthen-9-yl) 
benzoate monoh ydrate and subsidiar y colour ing 
matte rs together with water , sodium chlor ide an­
d/or sodium sulphat e as the principal uncoloured 
compo nents. 
The calcium and the potassium salts are also per­
mitted. 
Chemical formula: C20H6I4Na 2O5·H2O 
CAS number: 16423-68-0 
Solid form produced by chemical synthesis. 
Purity criteria 
—Total colour ing matters, calculat ed as the anhy­
drous sodium salt ≥ 87 % (assa y) 
— Inorg anic iodides ≤ 0,1 % (calculat ed as sodium 
iodide) 
— Water insoluble matt er ≤ 0,2 % 
—Subsidiar y colour ing matte rs (excep t fluores­
cein) ≤ 4,0 % 
— Fluorescein ≤ 20 mg/kg 
—Org anic compo unds other than colour ing mat­
ters: 
— Tri-iodoresorcinol ≤ 0,2 % 
—2-(2,4-dihy droxy-3,5-diiodobenzo yl) ben­
zoic acid ≤ 0,2 % EN Offi cial Jour nal of the European Union 20.2.2020                                                                                                                                            L 47/3   Identification 
number of the 
additive Additive Composition, chemical formula, descr iption, analytical 
method Species or 
category of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of period 
of 
author isation mg of active substance of kg of 
compl ete feedingstuff with a 
moisture content of 12 % 
— Ether extractable matte r from a solution of 
pH from 7 through 8 ≤ 0,2 % 
Analytical method (1) 
For the quantification of erythrosine in the feed 
additive: 
— spectrophotometr y at 526 nm (Commission 
Regulation (EU) No 231/2012 refers to FAO 
JECF A monographs n. 1 (Vol. 4)) 
For the quantifi cation of erythrosine in feeding­
stuffs: 
— high performa nce liquid chromat ography 
coupled to tandem mass spectrometr y (LC- 
MS/MS) 
(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 ts   EN Offi cial Jour nal of the European Union L 47/4                                                                                                                                            20.2.2020