COMMISSION IMPLEMENTING REGUL ATION (EU) 2022/1375 
of 5 August 2022
concer ning the denial of author isation of etho xyquin as a feed additiv e belonging to the functional 
group of antio xidants and repealing Implementing Regulation (EU) 2017/962 
(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 Articles 9(2) and 13(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 or denying such author isation. Article 10 of that Regulation provides for the 
re-evaluation of additives author ised pursuant to Council Directive 70/524/EEC (2).
(2) Etho xyquin was author ised without a time limit by Directive 70/524/EEC as a feed additive for use for all animal 
species. The additive was subsequently entered in the Regist er of feed additives as an existing product, in accordance 
with Article 10(1) 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 etho xyquin as a feed additive for all animal species, requesting 
the additive to be classified in the catego ry ‘technological additives’. That 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 Author ity (‘the Author ity’) note d in its opinion of 21 Octobe r 2015 (3)that it could not 
conclude on the efficacy and safety of the additive etho xyquin for animals, consumers and the environment, due to 
an overall lack of data submitted by the applicant. In particular , no conclusion was possible on the absence of 
genoto xicity of the metabolite etho xyquin quinone imine and concer ns were raised as to the possible mutagenicity 
of the impur ity p-phenetidine. Consequently , it had not been established that the additive etho xyquin does not have 
an adverse effect on animal health, human health and the environment. Theref ore, the existing author isation of the 
additive etho xyquin was suspended by Commission Imp lementing Regulation (EU) 2017/962 (4).
(5) The author isation of the additive etho xyquin was suspended pending the submission and assessment of 
supplementar y data to be produced by the applicant, in accordance with a time sche dule listing the necessar y 
studies to be carried out. According to that time sched ule, the outcome of the last of those studies had to be 
available by July 2018.
(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 2015;13(11):4272.
(4)Commission Implementing Regulation (EU) 2017/962 of 7 June 2017 suspending the author isation of etho xyquin as a feed additive 
for all animal species and categ ories (OJ L 145, 8.6.2017, p. 13).EN Offi cial Jour nal of the European Union 8.8.2022 L 206/39  (6) In accordance with Implementing Regulation (EU) 2017/962, the suspension measure is to be reviewed by 
31 December 2022 and in any event after the adopt ion by the Author ity of a non-fa vour able opinion on the safet y 
and efficacy of the additive etho xyquin.
(7) Since the adoptio n of the Author ity’s opinion of 21 Octobe r 2015 , the applicant submitted to the Commission 
successive packag es of supplementar y data on 11 March 2016 , 15 December 2017 , 20 Apr il 2018 and 23 June 
2021 , whic h were forwarded to the Author ity. Further supplementar y data was submitted by the applicant to the 
Authority in the course of the data assessment, as well as on 24 Sept ember 2020 .
(8) On 27 Januar y 2022 , the Authority adopt ed an opinion (5)following the assessment of the supplementar y data 
submitted by the applicant, taking into account in particular the modifi ed specifi cations of the additive etho xyquin, 
in which the conte nt of the impur ity p-phenetidine was reduced to a level lowe r than 2,5 ppm, and consider ing the 
proposed inclusion level of 50 mg of the additive per kg in compl ete feed. In its opinion, the Author ity could not 
conclude on the safet y of the additive etho xyquin at any level for long-living and reproductive animals, consider ing 
that the additive contains p-phenetidine, a recognised possible mutagen which remains as an impur ity in the 
additive, but in regards to which the applicant did not provid e additional information addressing this safet y 
concer n. Concer ning the safet y of the use of etho xyquin for the consumers, no conclusion could be drawn due to 
the presence of p-phenetidine and in the absence of data on the residues of p-phenetidine in tissues and products of 
animal origin. In addition, in the absence of residue data in milk, the Auth ority could not conclude on the 
consumers’ safet y of etho xyquin, when used in feed for milk -producing animals. With regard to the safety for the 
user , the Author ity concluded that users’ exposure should be minimised in order to reduce the risk of exposure to p- 
phenetidine by inhalation. Regarding the safety for the environment, the Authority state d that supplementar y data 
would be needed to conclude on the safet y of etho xyquin for the terrestrial compar tment when fed to terrestrial 
animals. In addition, the Author ity considered that a risk for the aquatic compar tment could not be excl uded when 
the additive is used in terrestr ial animals and that a risk of secondar y poisoning via the aquatic food chain could not 
be excl uded either . Further more, the Author ity concluded that a risk could not be excluded for etho xyquin used in 
sea-cag es for mar ine sediment-dwelling organisms.
(9) The Author ity’s opinion of 27 Januar y 2022 shows , theref ore, that it has not been established that etho xyquin does 
not have an adverse effect on animal health, human health or the environment, when used as a feed additive in the 
functional group ‘antio xidants’.
(10) The assessment of etho xyquin thus shows that the conditions for author isation, as provided for in Article 5 of 
Regulation (EC) No 1831/2003, are not satisfied and according ly, the author isation of etho xyquin as a feed additive 
belonging to the functional group ‘antio xidants’ should be denied.
(11) It derives from the abov e review that Implemen ting Regulation (EU) 2017/962 should be repealed.
(12) 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
Denial of author isation
The author isation of etho xyquin (E 324) as an additive in animal nutr ition belonging to the additive catego ry ‘technological 
additives ’ and to the functional group ‘antio xidants’, is denied.
(5)EFSA Jour nal 2022;20(3):7166.EN Offi cial Jour nal of the European Union L 206/40 8.8.2022  Article 2
Repeal of Implementing Regulation (EU) 2017/962
Implementing Regulation (EU) 2017/962 is repealed.
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, 5 August 2022 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 8.8.2022 L 206/41