COMMI SSION IMPLEMENTING REGUL ATION (EU) 2017/962 
of 7 June 2017 
suspending the author isation of etho xyquin as a feed additiv e for all animal species and categor ies 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutr ition (1), and in particular Article 13(2) thereof, 
Whereas: 
(1)  Regulation (EC) No 1831/2003 provides for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting, deny ing or suspending 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)  The additive etho xyquin was author ised without a time limit in accordance with Directive 70/524/EEC as a feed 
additive for use for all animal species and categor ies. 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 on 21 Sept ember 2010 for the author isation of etho xyquin as a feed additive for all 
animal species, requesting the additive to be classif ied in the catego ry ‘technological additives’. That application 
was accompanied 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’) stated in its opinion of 21 October 2015 (3) that the 
assessment of the particulars and documents submitted by the applicant make s it impos sible to conclude on the 
safety of the additive etho xyquin for any target animals, for consumers and for the environment. This is due to 
an overall lack of data submitt ed to assess the exposure and the safet y of etho xyquin for animals, consumers and 
the environment. In particular , no conclusion is possible on the absence of genot oxicity of one of the metabolites 
of the additive etho xyquin, etho xyquin quinone imine. In addition, p-phenetidine, an impur ity of the additive 
etho xyquin, is recognised as a possible mutagen. The Author ity considered the additive etho xyquin as a poten t 
antio xidant in feed but efficacy at the proposed use level, which has been reduced as compare d with the currently 
author ised maximum conte nt in feed, could not be conf irmed by the submitted data. The Author ity also verified 
the repor t on the method of analysis of the feed additive in feed submitte d by the Reference Laborat ory set up by 
Regulation (EC) No 1831/2003. 
(5)  Consequently , it has not been established that the additive does not have an adverse effect on animal health, 
human health or the environment when used under the proposed conditions. 
(6)  The existing author isation of the additive etho xyquin theref ore no long er meets the conditions set out by 
Article 5 of Regulation (EC) No 1831/2003. 
(7)  It is possible that supplementar y data concer ning the safety of use and the efficacy of the additive etho xyquin 
bring new elements that would allow a re-consideration of the assessment carried out for that additive. In this 
respect, the applicant for the author isation of the additive etho xyquin argues that additional studies may be 
performed in order to demonstrate the safety and efficacy of the additive. To this end, the applicant committe d 8.6.2017 L 145/13 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)OJ L 270, 14.12.1970, p. 1. 
(3)EFSA Journal 2015; 13(11):4272. itself to produce supplementar y data according to a time schedule listing in order of priority the studies to be 
carried out successively and planning that the outcome of the last of them would be available by July 2018. The 
prioritisation in the process of the planned data generation is based on the level of importance of the issues 
identified in the Author ity's opinion. Those studies would consist essentially of an update of the additive's charac ­
terisation, in particular as regards relevant impur ities and degradation products, of toxicological studies, in 
particular relat ed to the genot oxicity of etho xyquin quinone imine, of metabolism and residue studies in target 
animal species (including levels of residues in tissues and animal products), of targe t animals' safety studies and of 
an environmental risk assessment. 
(8) In addition, as the presence in the additive etho xyquin of the impur ity p-phenetidine results from the manufactur ­
ing process of the additive, the applicant committed itself to take steps in order to reduce progressively the 
cont ent of that impur ity in the additive to the level of 2,5 ppm p-phenetidine in etho xyquin by June 2017. For 
that purpose, an appropr iate method of analysis for the detec tion of p-phenetidine in the additive etho xyquin and 
in feed containing the additive should be submitted by the applicant and accept ed by the Authority on the basis 
of a repor t of the Reference Laboratory set up by Regulation (EC) No 1831/2003. 
(9)  In accordance with Article 13(2) of Regulation (EC) No 1831/2003, the author isation of the additive etho xyquin 
should theref ore be suspended, pending the submission and assessment of the supplementar y data. The 
suspension measure should be reviewed after due assessment of those data by the Author ity. In any event, 
a review of the suspension measure should be adopt ed where, during the process of the submission and 
assessment of the supplementar y data, the Author ity adop ts a non-fa vourable opinion on the safet y or efficacy of 
the additive etho xyquin. 
(10)  Since further use of the additive etho xyquin might cause a risk to human, animal health and the environment, 
the additive and feed containing it should be withdrawn from the mark et as soon as possible. For practical 
reasons, however , a limited transitional period should be allowed for the withdrawal from the mark et of the 
products concer ned in order to enable operat ors to comply properly with the withdrawa l obligation. 
(11)  Feed mate rials from mar ine origin, whic h contain high levels of fatty acids, are very sensitive to oxidation and 
high temperature and need to be stabilised by an antio xidant, in particular where the feed mater ials are subject to 
a long shipping or storag e period. Due to that high risk of oxidation, etho xyquin is widely used to prot ect the 
feed mater ials concer ned in an effective manner . Those feed mat erials, in particular fish meal and fish oil, are of 
high nutr itional value and contain an impor tant concentration of easily dige stible prote ins, which are required in 
aquaculture animals' and in young animals' diet, but are also used for other animal species, especially for pigs and 
poultr y. In addition, the high conte nt in those feed mater ials of poly-unsaturat ed fatty acids, which are transferr ed 
to animal products, is recognised to provide health benefits to livest ock and to the consumers of animal 
products. Theref ore, an immediate withdra wal from the market of etho xyquin could lead to nega tive 
consequences for animal health and welfare and to an inability to meet the animals' specif ic nutr itional 
requirements until suitable altern atives are in place. 
(12)  Etho xyquin is also widely used as constituent of certain feed additives preparations containing an active substance 
whic h is particularly sensitive to oxidation and heat treatment and needs to be stabilised by an antio xidant in 
order to maintain its proper ties. Those feed additives consist in preparations of certain essential vitamins, 
carote noids and colourants whic h are lipo-soluble and need to be prot ected during the manufactur ing process, 
storage and transpor t of the preparations and of feed containing them, until the deliver y to animals. Due to the 
wide use of etho xyquin in those feed additives preparations, an immediate withdra wal from the mark et of 
etho xyquin would negativ ely impa ct animal health and welf are, as a result of a lack of essential micronutr ients in 
the feed for several species of both food-producing and non-f ood producing animals. In addition, a shor tage in 
the Union of the feed additives preparations concer ned could lead to lower feed efficiency and lower livest ock 
performa nce, but also to the inability to meet market specifi cations for certain animal products. 
(13)  It appears that a substitution of etho xyquin by suitable alternative antio xidants could not be under taken 
immediate ly, as the currently author ised alternative antio xidants — several of them being still under re-evaluation 
process in accordance with Regulation (EC) No 1831/2003 — do not possess the same charact eristics as 
etho xyquin, in particular as regar ds effectiveness and the concentration of active substance needed, duration of 
action, process behaviour but also in terms of production costs. Consequently , a certain time is needed in order 
to allow operat ors to evaluate and test the functionality of alternative antio xidants through new formulations and 
to adapt the production process to the inclusion of those poten tial alternative substances. A specif ic definite 
transition period should theref ore be provided for the withdrawal from the mark et of the products referred to in 
recitals 11 and 12, in order to enable operators to adapt themselves to the new situation and thereby to comply 
properly with the withdra wal obligation. Due to the specific method of production and storage of the feed 8.6.2017 L 145/14 Official Jour nal of the European Union EN     additives preparations mentioned under recital 12, altern ative antio xidant substances for those preparations may 
be made available in a shor ter period than for the feed mat erials refer red to in recital 11, allowing the provision 
of a shor ter transitional period. 
(14)  The measures provided 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 
Suspension of the author isation 
The author isation provided by Directive 70/524/EEC and exte nded by Regulation (EC) No 1831/2003, concer ning the 
additive etho xyquin specified in entr y E 324 of the Regist er of feed additives refer red to in Article 17 of that Regulation  
(‘the additive etho xyquin’), is suspended. 
Article 2 
Transitional measures 
1. Existing stoc ks of the additive etho xyquin and of premixtures containing it may continue to be placed on the 
mark et until 28 Sept ember 2017 and may be used until 28 December 2017 in accordance with the rules applicable 
before 28 June 2017. 
2. Feed mater ials and compo und feed produced with the additive etho xyquin or with premixtures containing it may 
continue to be placed on the mark et until 28 December 2017 and may be used until 28 March 2018 in accordance 
with the rules applicable before 28 June 2017. 
Article 3 
Specif ic transitional measures for certain feed mater ials and related products 
1. By way of deroga tion from Article 2: 
(a)  the additive etho xyquin and premixtures containing it, intended to be incor porate d in the feed mater ials listed under 
entr y 7.1.2 and under Chapt er 10 of the Catalogue of feed mater ials established by Commission Regulation (EU) 
No 68/2013 (1), may continue to be placed on the mark et in accordance with the rules applicable before 28 June 
2017 until 30 Sept ember 2019, provided that the label of the additive etho xyquin or of premixtures containing it 
mentions the intended incor poration in those feed mater ials; 
(b)  feed mat erials referred to in point (a) produced with the additive etho xyquin or with premixtures containing it may 
continue to be placed on the market in accordance with the rules applicable before 28 June 2017 until 
31 December 2019; 
(c)  compo und feed produced with the feed mate rials refer red to in point (b) may continue to be placed on the mark et 
in accordance with the rules applicable before 28 June 2017 until 31 March 2020. 8.6.2017 L 145/15 Official Jour nal of the European Union EN     
(1)Commission Regulation (EU) No 68/2013 of 16 Januar y 2013 on the Catalogue of feed materials (OJ L 29, 30.1.2013, p. 1). 2. The products refer red to in points (a), (b) and (c) of paragraph 1 may be used in accordance with the rules 
applicable before 28 June 2017 until 3 months after the dates specified respectively in those points. 
Article 4 
Specif ic transitional measures for certain additiv es preparations and related products 
1. By way of deroga tion from Article 2: 
(a)  the additive etho xyquin intended to be incor porat ed in the following additives preparations which have been 
author ised in accordance with Regulation (EC) No 1831/2003, may continue to be placed on the mark et in 
accordance with the rules applicable before 28 June 2017 until 31 March 2018, provided that the label of the 
additive etho xyquin mentions the intended incor poration in those additives preparations: 
—  preparations of vitamin A; 
—  preparations of vitamin D; 
—  preparations of vitamin E; 
—  preparations of vitamin K; 
—  preparations of lutein; 
—  preparations of zeaxanthin; 
—  preparations of ethyl ester of beta-apo-8′-caroten oic acid; 
—  preparations of citranaxanthin; 
—  preparations of capsanthin; 
—  preparations of astaxanthin; 
—  preparations of astaxanthin dimethyldisuccinat e; 
—  preparations of canthaxanthin; 
—  preparations of beta-carot ene; 
(b)  the additives preparations referred to in point (a) whic h contain the additive etho xyquin and premixtures containing 
those additives preparations may continue to be placed on the mark et in accordance with the rules applicable before 
28 June 2017 until 30 June 2018; 
(c)  feed mater ials and compo und feed containing the products referred to in point (b) may continue to be placed on the 
mark et in accordance with the rules applicable before 28 June 2017 until 30 September 2018. 
2. The products refer red to in points (a), (b) and (c) of paragraph 1 may be used in accordance with the rules 
applicable before 28 June 2017 until 3 months after the dates specified respectively in those points. 
Article 5 
Review 
This Regulation shall be reviewed by 31 December 2020 at the lates t and in any event after the adoption by the 
Author ity of a non-fa vour able opinion on the safety or efficacy of the additive etho xyquin. 8.6.2017 L 145/16 Official Jour nal of the European Union EN     Article 6 
Entr y into force 
This Regulation shall enter into force on the twentieth day following 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 State s. 
Done at Brussels, 7 June 2017. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  8.6.2017 L 145/17 Official Jour nal of the European Union EN