COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/197 
of 13 Febr uary 2020 
concer ning the author isation of allura red AC as a feed additiv e for cats and dogs 
(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) Allura red AC was author ised without a time limit in accordance with Directive 70/524/EEC 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 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 Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an 
application was submitted for the re-evaluation of allura red AC as a feed additive for dogs and cats. The applicant 
requeste d the additive to be classified in the additive categor y ‘sensor y additive’ and in the functional group 
‘colourants’. 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 Safe ty Auth ority (‘the Authority’) concluded in its opinions of 24 Apr il 2012 (3), 15 May 
2013 (4) and 20 October 2015 (5) that, under the proposed conditions of use, allura red AC does not have an 
adverse effect on animal health or the envi ronment. It also concluded that the substance should be considered 
poten tially harmful for the user of the additive as a result of skin, eye, or inhalation exposure. Theref ore, the 
Commission considers that appropr iate prot ective measures should be take n to prevent adverse effects on human 
health, in particular as rega rds the users of the additive. In accordance with Commission Regulation (EC) No 
429/2008 (6), phase I of the environmental risk assessment has determined that allura red AC, 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 
the Authority in its abov e-mentioned opinions. The Auth ority further concluded that the additive concer ned is 
effective in adding colour to feedingstuffs. The Author ity does not consider that there is a need for specific 
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 Laborator y set up by Regulation (EC) No 1831/2003. 
(5) The assessment of allura red AC 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. 
(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. 
(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 Journal 2012; 10(5):2675. 
(4)EFSA Journal 2013;11(6):3234. 
(5)EFSA Journal 2015; 13(11):4270. 
(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 42/4                                                                                                                                            14.2.2020   (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 5 Sept ember 2020 in accordance with the rules applicable before 5 March 2020 may continue to be placed on the 
mark et and used until the existing stoc ks are exhaust ed. 
2. Feed mater ials and compo und feed containing the substance specifi ed in the Annex which are produced and labelled 
before 5 March 2022 in accordance with the rules applicable before 5 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, 13 Febr uary 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union 14.2.2020                                                                                                                                            L 42/5   ANNEX 
Identifica-
tion number 
of the 
additive Additive Compo sition, chemical formula, descr iption, analytical 
method Species or 
categor y of 
animal Maximum 
age Minimum 
conten t Maximum 
conten t 
Other provisions End of period 
of 
author isa-
tion mg of active substance of kg 
of complet e feed ingstuff 
with a moisture content of 
12 % 
Categor y: Sensor y additiv es. Functional group: Colourants. (i) substances that add or restore colour in feedingstuffs 
2a129 Allura Red AC Additiv e composition 
Allura Red AC descr ibed as the sodium salt as the princi­
pal compo nent. 
Solid form (powd er or granules) 
Char acter isation of the active substance as the sodium salt 
Allura Red AC consists essentially of disodium 2-hydro xy- 
1-(2- metho xy-5-methyl-4-sulf onato-phen ylazo) 
naphthalene-6-sulf onate and subsidiar y colour ing mat­
ters together with sodium chlor ide and/or sodium sul­
phate as the principal uncoloured components. 
The calcium and the potassium salts are also permitted 
Solid form (powd er or granules) produced by chemical 
synthesis 
Chemical formula: C18H14N2Na 2O8S2 
CAS number: 25956-17-6 
Purity criteria 
Content not less than 85 % total colour ing matt ers, calcu­
lated as the sodium salt (assa y) 
Water insoluble matter: ≤ 0,2 % 
Subsidiar y colour ing matters: ≤ 3 % 
Organic compounds other than 
colour ing matters: 
—6-hydro xy-2-naphthalene sulfonic acid, so­
dium salt: ≤ 0,3 % 
—4-amino-5-metho xy-2- meth ylbenezene sulfo­
nic acid: ≤ 0,2 % 
—6,6-o xybis (2-naphthalene sulfonic acid) diso­
dium salt: ≤ 1 % Cats - - 308 1. In the directions for use of the additive 
and premixture, the storage conditions 
and stability to heat treatment shall be 
indicated . 
2.For users of the additive and premix­
tures, feed business operat ors shall es­
tablish operational procedures and or­
gani sational measures to address 
poten tial risks resulting from its use. 
Where those risks cannot be eliminated 
or reduced to a minimum by such pro­
cedures and measures, the additive and 
premixtures shall be used with personal 
prote ctive equipment, including breath­
ing protection, safety glasses and gloves. 5.3.2030 
Dogs - - 370 EN Offi cial Jour nal of the European Union L 42/6                                                                                                                                            14.2.2020   Identifica-
tion number 
of the 
additive Additive Compo sition, chemical formula, descr iption, analytical 
method Species or 
categor y of 
animal Maximum 
age Minimum 
conten t Maximum 
conten t 
Other provisions End of period 
of 
author isa-
tion mg of active substance of kg 
of complet e feed ingstuff 
with a moisture content of 
12 % 
Unsu lfonated primar y aromatic amines: ≤ 0,01 % (calcu­
lated as aniline) 
Ether extractable matter: ≤ 0,2 % from a solution of pH 7 
Analytical method (1) 
For the quantification of Allura Red AC in the feed addi­
tive: 
— spectrophotometr y at 504 nm (Commission 
Regulation (EU) No 231/2012 refer ring to 
FAO JECF A monographs n. 1 (Vol. 4)) 
—For the quantification of Allura Red AC in fee­
dingstuffs: 
— high performance 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 14.2.2020                                                                                                                                            L 42/7