COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/107 
of 23 Januar y 2020 
concer ning the author isation of ponceau 4R as a feed additiv e for dogs, cats and ornamental fish 
(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) Ponceau 4R 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 submitted for the re-evaluation of ponceau 4R 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’. 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 Safety Author ity (‘the Author ity’) concluded in its opinion of 6 March 2018 (3) that, under the 
proposed conditions of use, ponceau 4R does not have an adverse effect on animal health. It also concluded that the 
inhalation exposure to additive is regarded as hazardous for the user of the additive and that no conclusion could be 
drawn on the irritancy pote ntial to skin or eyes and on the skin sensitation. Theref ore, the Commission considers 
that appropr iate prot ective measures should be taken to prevent adverse effects on human health, in particular as 
regards the users of the additive. In accordance with Commission Regulation (EC) No 429/2008 (4), phase I of the 
environmental risk assessment has deter mined that ponceau 4R, as an additive intended for non-f ood producing 
animals, is exem pted from further assessment due to the unlikeli hood of a significant envi ronmental effect, there 
being no scientifi cally-based evidence for concer n having been identified by the Author ity in its abov e-mentioned 
opinion. The Author ity also stated that for this additive, which is also author ised in food, where the function is the 
same as that for feed, no further demonstration of efficacy might be necessar y. However , the Author ity, consider ing 
the wide variety of feedingstuffs, requested further demonstration. The applicant demonstrated the efficacy in a 
typical feed matr ix for 50 mg/kg but also indicated that for other matr ixes (colour in petfood may rang e from 
almost white to dark brown) lower levels may be used specially in pale matr ixes (the applicant provid ed in the 
dossier some evidence for lower levels). As the recommended maximum level proposed by the Auth ority for this 
additive is similar to the levels author ised for food in different types of products, the Commission considered that 
there is suffic ient evidence of the efficacy of this substance. The Author ity does not consider that there is a need for 
specifi c requirements of post-marke t monitori ng. 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. 
(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 2018; 16(3):5222. 
(4)Commission Regulation (EC) No 429/2008 of 25 Apr il 2008 on detailed rules for the impl ementation 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 19/18                                                                                                                                           24.1.2020   (5) The assessment of ponceau 4R shows that the conditions for author isation, as provid ed for in Article 5 of Regulation 
(EC) No 1831/2003, are satisfi ed. According ly, the use of that additive should be author ised as specifi ed 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 specifi ed in the Annex and premixtures containing that substance, whic h are produced and labelled 
before 13 August 2020 in accordance with the rules applicable before 13 Febr uary 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 13 Febr uary 2022 in accordance with the rules applicable before 13 Febr uary 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, 23 Januar y 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union 24.1.2020                                                                                                                                           L 19/19   ANNEX 
Identifica-
tion number 
of the 
additive Additive Compo sition, 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 complet e feedi ngstuff with 
a moisture conten t of 12 % 
Categor y: Sensor y additiv es. Functional group: Colourants. (i) substances that add or restore colour in feedingstuffs 
2a124 Ponceau 
4R Additive composition 
Ponceau 4R descr ibed as the sodium salt as the prin­
cipal compo nent. 
Solid form (powder or granules) Cats — — 31 1. In the directions for use of the 
additive and premixture, the sto­
rage conditions and stability to 
heat treatment 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 or re­
duced to a minimum by such pro­
cedures and measures, the addi­
tive and premixtures shall be 
used with personal protective 
equipment, including eye, skin, 
oral and breathing prot ection. 13 Febr uary 
2030 
Char acter isation of the active substance as the sodium salt 
Ponceau 4R consists essentially of trisodium 2-hy­
droxy-1-(4-sulf onato1-nap hthylazo) naphthalene- 
6,8-disulf onate and subsidiar y colour ing matters to­
gether with sodium chloride and/or sodium sul­
phate as the principal uncoloured compo nents. 
The calcium and the potassium salts are also per­
mitted 
Chemical formula: C20H11N2O10S3Na 3 
Solid form (powder or granules) produced by che­
mical synthesis 
CAS No: 2611-82-7 
Purity criteria 
— Total colour ing matte rs calculated as the sodium 
salt ≥ 80 % (assa y); 
— Subsidiar y colour ing matte r ≤ 1 %; 
—Org anic compo unds other than colour ing mat­
ters ≤ 0,5 %; 
—Unsulf onat ed primar y aromatic amines (calcu­
lated as aniline) ≤ 0,01 %. 
Analytical method  (1) 
For the quantifi cation of total colour ing matt ers 
conte nt of ponceau 4R in the feed additive: 
Spectrophotomet ry at 505 nm and titration with 
Titanous chlor ide as descr ibed in Commission Reg­
ulation (EU) No 231/2012 refer ring to FAO JECF A 
Combined Compendium for Food Additive Specifi­
cations (Analytical methods Vol. 4); and the Mono­
graph No 11 (2011) ‘Ponceau 4R’. 
For the quantification of ponceau 4R in feeding­
stuffs: Dogs — — 37 EN Offi cial Jour nal of the European Union L 19/20                                                                                                                                           24.1.2020   Identifica-
tion number 
of the 
additive Additive Compo sition, 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 complet e feedi ngstuff with 
a moisture conten t of 12 % 
High performa nce liquid chromat ography coupled 
to tandem mass spectrometr y (LC-MS/MS) 
Categor y: Sensor y additiv es. Functional group: Colourants. (iii) substances whic h favourably affect the colour of ornamental fish or birds 
2a124 Ponceau 
4R Additive composition 
Ponceau 4R descr ibed as the sodium salt as the prin­
cipal compo nent. 
Solid form (powder or granules) Ornamental 
fish — — 137 1. In the directions for use of the 
additive and premixture, the sto­
rage conditions and stability to 
heat treatment 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 or re­
duced to a minimum by such pro­
cedures and measures, the addi­
tive and premixtures shall be 
used with personal protective 
equipment, including eye, skin, 
oral and breathing prot ection. 13 Febr uary 
2030 
Char acter isation of the active substance as the sodium salt 
Ponceau 4R consists essentially of trisodium 2-hy­
droxy-1-(4-sulf onato1-nap hthylazo) naphthalene- 
6,8-disulf onate and subsidiar y colour ing matters to­
gether with sodium chloride and/or sodium sul­
phate as the principal uncoloured compo nents 
The calcium and the potassium salts are also per­
mitted 
Chemical formula: C20H11N2O10S3Na 3 
Solid form (powder or granules) produced by che­
mical synthesis 
CAS No: 2611-82-7 
Purity criteria 
— Total colour ing matte rs calculated as the sodium 
salt ≥ 80 % (assa y); 
— Subsidiar y colour ing matte r ≤ 1 %; 
—Org anic compo unds other than colour ing mat­
ters ≤ 0,5 %; 
—Unsulf onat ed primar y aromatic amines (calcu­
lated as aniline) ≤ 0,01 %. 
Analytical method  (1) 
For the quantifi cation of total colour ing matt ers 
conte nt of ponceau 4R in the feed additive: 
Spectrophotomet ry at 505 nm and titration with 
Titanous chlor ide as descr ibed in Commission Reg­
ulation (EU) No 231/2012 refer ring to FAO JECF A 
Combined Compendium for Food Additive Specifi­
cations (Analytical methods Vol. 4); and the Mono­
graph No 11 (2011) ‘Ponceau 4R’. 
For the quantification of ponceau 4R in feeding­
stuffs: EN Offi cial Jour nal of the European Union 24.1.2020                                                                                                                                           L 19/21   Identifica-
tion number 
of the 
additive Additive Compo sition, 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 complet e feedi ngstuff with 
a moisture conten t of 12 % 
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 19/22                                                                                                                                           24.1.2020