COMMISSION IMPLEMENTING REGUL ATION (EU) 2017/60 
of 14 December 2016 
concer ning the author isation of isoeugenol as a feed additiv e for pigs, ruminants and horses except 
those producing milk for human consumption and pets 
(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 9(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 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)  Isoeuge nol, was author ised without a time limit in accordance with Directive 70/524/EEC as a feed additive for 
all animal species. That product was subsequently entered in the Regist er of feed additives as existing products, 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 the isoeugenol as a feed additive for all animal species excep t 
for poultr y, ruminants producing milk for human consum ption and fish. The applicant request ed that additive to 
be classified in the additive cate gory ‘sensor y 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 Auth ority (‘the Author ity’) concluded in its opinion of 14 December 2011 (3) that, 
under the proposed conditions of use in feed, isoeugenol does not have adverse effects on animal health, human 
health or the environment. Isoeug enol should not be allowed for those categor ies of mammal species intended 
for the production of milk for human consump tion. The Author ity further concluded that the function of 
isoeuge nol in feed is similar to that on food. The Author ity has already concluded that for food isoeugenol is 
efficacious, as it increases the food smell or palatability . Theref ore, that conclusion can be extrapolat ed for feed. 
The Author ity concluded that the simultaneous use in feed and wate r for drinking should be avoided. However , 
those substances can be used within compound feeds whic h are subsequently administe red via water . 
(5)  Restr ictions and conditions should be provided for to allow better control. Since safety reasons do not require the 
setting of a maximum content and taking into account the re-evaluation performe d by the Authority, 
recommended cont ents should be indicated on the label of the additive. Where such cont ents are excee ded, 
certain information should be indicated on the label of premixtures, compound feeds and feed mate rials. 
(6)  The Authority concluded that isoeug enol is an irritant to the respirato ry tract, skin and eyes and it is also a skin 
and respirator y sensitiser . Consequently , appropr iate prot ective measures should be taken. The Authority does 
not consider that there is a need for specific requirements of post-market monit oring. It also verified the repor t 
on the method of analysis of the feed additive in feed submitte d by the Reference Laboratory set up by 
Regulation (EC) No 1831/2003. 
(7)  The assessment of the substance concer ned shows that the conditions for author isation, as provided for in 
Article 5 of Regulation (EC) No 1831/2003, are satisfi ed. According ly, the use of that substance should be 
author ised as specified in the Annex to this Regulation. 17.1.2017 L 13/177 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)Council Directive 70/524/EEC of 23 November 1970 concer ning additives in feed ingstuffs (OJ L 270, 14.12.1970, p. 1). 
(3)EFSA Journal 2012;10(1):2532. (8) Since safety reasons do not require the immediate application of the modifi cations to the conditions of author is­
ation for that substance it is appropr iate to allow a transitional period for inter ested parties to prepare themselves 
to meet the new requirements resulting from the author isation. 
(9)  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 
Author isation 
The substance specif ied in the Annex, belonging to the additive catego ry ‘sensor y additives’ and to the functional group 
‘flavouri ng compo unds ’, is author ised as a feed additive in animal nutr ition subject to the conditions laid down in that 
Annex. 
Article 2 
Transitional measures 
1. The substance specif ied in the Annex and premixtures containing that substance, which are produced and labelled 
before 6 August 2017 in accordance with the rules applicable before 6 Febr uary 2017 may continue to be placed on the 
mark et and used until the existing stoc ks are exhaust ed. 
2. Com pound feed and feed mater ials containing the substance specifi ed in the Annex whic h are produced and 
labelled before 6 Febr uary 2018 in accordance with the rules applicable before 6 Febr uary 2017 may continue to be 
placed on the mark et and used until the existing stoc ks are exhausted if they are intende d for food-producing animals. 
3. Com pound feed and feed mater ials containing the substance specifi ed in the Annex whic h are produced and 
labelled before 6 Febr uary 2019 in accordance with the rules applicable before 6 Febr uary 2017 may continue to be 
placed on the mark et and used until the existing stocks are exhaust ed if they are intende d for non-f ood-producing 
animals. 
Article 3 
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, 14 December 2016. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  17.1.2017 L 13/178 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
number of 
the additive Name of the 
holder of 
author isation Additive Compo sition, chemical 
formula, descr iption, analytical 
method Species or 
categor y of 
animal Maximum age Minimum 
content Maximum 
conten t 
Other provisions End of period 
of author is­
ation mg of active substance/kg of 
complet e feed ingstuff with 
a moisture content of 12 % 
Categor y: Sensor y additiv es. Functional group: Flavour ing compounds 
2b04004 — Isoeugenol Additiv e composition 
Isoeugenol 
Char acter isation of the activ e 
substance 
Isoeugenol 
Produced by chemical syn­
thesis 
Purity: min. 99 % 
Chemical formula: 
C10H12O2 
CAS number 97-54-1 
FLAVIS No 04.004 
Method of analy sis(1) 
For the identification of 
isoeugenol in the feed addi ­
tive and flavouring premix ­
tures: 
Gas chromatograph y mass 
spectrometr y with retention 
time locking GC-MS-RTL. Pigs 
Ruminants 
and horses 
excep t those 
producing 
milk for hu­
man con­
sump tion 
Pets — — — 1.The additive shall be incor por­
ated into the feed in the form of 
a premixture.  
2. In the directions for use of the 
additive and premixtures, the 
storag e and stability conditions 
shall be indicated .  
3. The recommended maximum 
conte nt of the active substance 
shall be: 
5 mg/kg of compl ete feeding ­
stuff with a moisture conte nt of 
12 %.  
4. On the label of the additive the 
following shall be indicated : 
‘Recommended maximum con­
tent of the active substance of 
compl ete feedingstuff with 
a moisture conte nt of 12 %: 
5 mg/kg’. 
5.The functional group, the identi ­
fication number , the name and 
the added amount of the active 
substance shall be indicate d on 
the labelling of the premixtures, 
feed mat erials and compo und 
feedingstuffs, if the following 
conte nt of the active substance 
in compl ete feedingstuff with 
a moisture content of 12 % is 
exceed ed: 5 mg/kg.  6 Febr uary 
2027 17.1.2017 L 13/179 Official Jour nal of the European Union EN     6. For users of the additive and 
premixtures, feed business oper ­
ators shall establish operational 
procedures and organisational 
measures to address poten tial 
risks by dermal contact or eyes 
contact. Where those risks can­
not be eliminated or reduced to 
a minimum by such procedures 
and measures, the additive and 
premixtures shall be used with 
personal prote ctive equipment, 
including safety glasses and 
gloves. 
(1)  Details of the analytical methods are available at the following address of the Reference Laboratory : https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor ts   17.1.2017 L 13/180 Official Jour nal of the European Union EN