COMMI SSION IMPLEMENTING REGUL ATION (EU) 2018/244 
of 15 Febr uary 2018 
concer ning the author isation of vanillyl acetone and 4-(4-metho xyphen yl) butan-2-one as feed 
additiv es for all animal species and the denial of 1-phenyletha n-1-ol 
(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 provi des 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 provid es for the re- 
evaluation of additives author ised pursuant to Council Directive 70/524/EEC (2). 
(2)  The substances vanillyl acet one, 4-(4-metho xyphen yl) butan-2-one and 1-phenylethan-1-ol were author ised 
without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances were 
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 vanillyl aceton e, 4-(4-metho xyphenyl) butan-2-one and 
1-phen ylethan-1-ol as feed additives for all animal a species. The applicant requeste d that those additives be 
classified in the additive catego ry ‘sensor y 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 Safety Auth ority (‘the Authority’) concluded in its opinion of 12 July 2016 (3) that, under the 
proposed conditions of use, vanillyl aceton e and 4-(4-metho xyphenyl) butan-2-one do not have adverse effects 
on animal health, human health or the envi ronment. The Authority could not conclude on the safety of 
1-phen ylethan-1-ol in the terrestr ial compar tment. The Auth ority has concluded that, since vanillyl acetone and 
4-(4-metho xyphen yl) butan-2-one are efficacious when used in food as flavourings and their function in feed is 
essentially the same as in food, no further demonstration of efficacy was necessar y. Theref ore, that conclusion 
can be extrapolated to feed. The applicant withdrew the application for water for drinking. However , it should be 
possible to use vanillyl acetone and 4-(4-metho xyphen yl) butan-2-one within compound feeds which are 
subsequently administe red via water . 
(5)  Restr ictions and conditions should be provid ed 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, 
a recommended content should be indicated on the label of the additive. Where such cont ent is excee ded, certain 
information should be indicated on the label of premixtures, and on the labelling of feed mat erials and 
compo und feed. 
(6)  The Author ity note d that, vanillyl aceton e and 4-(4-metho xyphenyl) butan-2-one should be recognised as 
hazardous to the respirator y tract, skin and eyes and also as irritating to the respirato ry system . Consequently , 
appropr iate prot ective measures should be taken The Authority does not consider that there is a need for specifi c 
requirements of post-market monitori ng. It also verified the repor t on the method of analysis of the feed 
additives in feed submitt ed by the Reference Laboratory set up by Regulation (EC) No 1831/2003. 
(7) The assessment of vanillyl acet one and 4-(4-metho xyphen yl) butan-2-one shows that the conditions for author is­
ation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfi ed. According ly, the use of those 
substances should be author ised as specifi ed in the Annex to this Regulation. 23.2.2018 L 53/81 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 feedingstuffs (OJ L 270, 14.12.1970, p. 1). 
(3)EFSA Journal 2016;14(8):4557. (8)  The assessment of 1-phenylethan-1-ol shows that the conditions for author isation, as provid ed for in Article 5 of 
Regulation (EC) No 1831/2003, are not satisfied. The Author ity could not conclude on the safety of 
1-phen ylethan-1-ol for the terrestr ial compar tment, as no exper imental data was provid ed by the applicant and 
theref ore application of the Ecological Structure Activity Relationships (ECOS AR) Predictive Model was not able 
to provi de the needed parameters. 
(9) Since safety reasons do not require the immediate application of the modifi cations to the conditions of author is­
ation for vanillyl acetone, 4-(4-metho xyphen yl) butan-2-one and 1-phen ylethan-1-ol, 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 and denial. 
(10)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Author isation 
The substances specifi ed in the Annex, belonging to the additive catego ry ‘sensor y additives ’ and to the functional group 
‘flavouri ng compounds’, are author ised as feed additives in animal nutr ition subject to the conditions laid down in that 
Annex. 
Article 2 
Denial 
The author isation of 1-phenylethan-1-ol, as additive belonging to the additive catego ry ‘sensor y additives’ and to the 
functional group ‘flavouring compo unds ’ is denied. 
Article 3 
Transitional measures 
1. Vanillyl acet one, 4-(4-metho xyphen yl) butan-2-one and 1-phen ylethan-1-ol and premixtures containing those 
substances, which are produced and labelled before 15 Sept ember 2018 in accordance with the rules applicable before 
15 March 2018 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 vanillyl aceton e, 4-(4-metho xyphen yl) butan-2-one and 
1-phen ylethan-1-ol which are produced and labelled before 15 Marc h 2019 in accordance with the rules applicable 
before 15 March 2018 may continue to be placed on the market and used until the existing stoc ks are exhaust ed if they 
are intende d for food-producing animals. 
3. Feed mater ials and compo und feed containing vanillyl aceton e, 4-(4-metho xyphen yl) butan-2-one and 
1-phen ylethan-1-ol which are produced and labelled before 15 Marc h 2020 in accordance with the rules applicable 
before 15 March 2018 may continue to be placed on the market and used until the existing stoc ks are exhaust ed if they 
are intende d for non-f ood-producing animals. 
Article 4 
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. 23.2.2018 L 53/82 Official Jour nal of the European Union EN     This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 15 Febr uary 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  23.2.2018 L 53/83 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author i­
sation Additive Composition, chem ical formula, 
descr iption, analytical method Species or 
category of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of pe­
riod 
of author i­
sation mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
Categor y: Sensor y additiv es. Functional group: Flavour ing compounds 
2b07005 — Vanillyl acet ­
one Additiv e composition 
Vanillyl aceton e 
Char acter isation of the activ e sub­
stance 
Vanillyl aceton e 
Produced by chemical synthesis 
Purity: min. 95 % assa y 
Chemical formula: C11H14O3 
CAS number: 122-48-5 
FLAVIS No: 07.005 
Method of analy sis(1) 
For the deter mination of vanillyl 
aceton e in the feed additive and in 
feed flavouring premixtures: 
Gas chromat ography mass spec ­
trometr y with retention time lock ­
ing GC-MS-RTL. All animal 
species — — — 1.  The additive shall be incor porated 
into the feed in the form of a pre­
mixture. 
2.In the directions for use of the addi ­
tive and premixtures, the storag e 
and stability conditions shall be in­
dicated. 
3.The recommended maximum con­
tent of the active substance shall be 
5 mg/kg of compl ete feedingstuff 
with a moisture conte nt of 12 %. 
4.On the label of the additive the fol­
lowing shall be indicated : 
‘Recommended maximum cont ent 
of the active substance of compl ete 
feedingstuff with a moisture cont ent 
of 12 %: 5 mg/kg.’ 
5.The functional group, the identif ica­
tion number , the name and the 
added amount of the active sub­
stance shall be indicated on the la­
bel of the premixtures and on the 
labelling of feed mate rials and com ­
pound feedingstuffs, if the cont ent 
of the active substance in compl ete 
feedingstuff with a moisture cont ent 
of 12 % exce eds: 5 mg/kg.  15.3.2028 23.2.2018 L 53/84 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author i­
sation Additive Composition, chem ical formula, 
descr iption, analytical method Species or 
category of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of pe­
riod 
of author i­
sation mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
6.For users of the additive and pre­
mixtures, feed business operators 
shall establish operational proce ­
dures and organisational measures 
to address poten tial risks by inhala ­
tion, dermal contact or eyes contact. 
Where those risks cannot be elimin ­
ated or reduced to a minimum by 
such procedures and measures, the 
additive and premixtures shall be 
used with personal prot ective equip ­
ment, including breathing prot ec­
tion, safety glasses and gloves .           
2b07029 — 4-(4-Metho xy­
pheny l) bu­
tan-2-one Additiv e composition 
4-(4-Metho xyphen yl) butan-2-one 
Char acter isation of the activ e sub­
stance 
4-(4-Metho xyphen yl) butan-2-one 
Produced by chemical synthesis 
Purity: min. 96 % assa y 
Chemical formula: C11H14O2 
CAS number 104-20-1 
FLAVIS No 07.029 
Method of analy sis(1) 
For the determination of 4-(4- 
metho xyphen yl) butan-2-one in 
the feed additive and in feed fla­
vouring premixtures: 
Gas chromat ography mass spec ­
trometr y with retention time lock ­
ing GC-MS-RTL. All animal 
species — — — 1.  The additive shall be incor porated 
into the feed in the form of a pre­
mixture. 
2.In the directions for use of the addi ­
tive and premixtures, the storag e 
and stability conditions shall be in­
dicated. 
3.The recommended maximum con­
tent of the active substance shall be 
5 mg/kg of compl ete feedingstuff 
with a moisture conte nt of 12 %. 
4.On the label of the additive the fol­
lowing shall be indicated : 
‘Recommended maximum cont ent 
of the active substance of compl ete 
feedingstuff with a moisture cont ent 
of 12 %: 5 mg/kg.’  15.3.2028 23.2.2018 L 53/85 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author i­
sation Additive Composition, chem ical formula, 
descr iption, analytical method Species or 
category of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of pe­
riod 
of author i­
sation mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
5.The functional group, the identif ica­
tion number , the name and the 
added amount of the active sub­
stance shall be indicated on the la­
bel of the premixtures and on the 
labelling of feed mate rials and com ­
pound feedingstuffs, if the cont ent 
of the active substance in compl ete 
feedingstuff with a moisture cont ent 
of 12 % exce eds: 5 mg/kg. 
6.For users of the additive and pre­
mixtures, feed business operators 
shall establish operational proce ­
dures and organisational measures 
to address poten tial risks by inhala ­
tion, dermal contact or eyes contact. 
Where those risks cannot be elimin ­
ated or reduced to a minimum by 
such procedures and measures, the 
additive and premixtures shall be 
used with personal prot ective equip ­
ment, including breathing prot ec­
tion, safety glasses and gloves .           
(1)  Details of the analytical methods are available at the following address of the Reference Laborato ry: https://ec.europa.eu/jrc/en/eurl/feed-addi tives/evaluation-repor ts.   23.2.2018 L 53/86 Official Jour nal of the European Union EN