COMMI SSION IMPLEMENTING REGUL ATION (EU) 2018/246 
of 15 Febr uary 2018 
concer ning the author isation of linalool oxide as a feed additiv e for all animal species except fish 
(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 provides for the 
re-evaluation of additives author ised pursuant to Council Directive 70/524/EEC (2). 
(2)  The substance linalool oxide was author ised by Directive 70/524/EEC as a feed additive for all animal 
species. That substance was subsequently entered in the Regist er of feed additives as 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 linalool oxide as a feed additive for all animal species excep t 
fish. The applicant requested that this additive 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 Author ity (‘the Author ity’) concluded in its opinion of 13 June 2012 (3) that, under 
the proposed conditions of use, linalool oxide does not have adverse effects on animal health, human health or 
the environment. In addition, as regards consumer safet y, the conclusions of the opinion adop ted on 5 March 
2014 (4) are applicable to linalool oxide since linalool oxide belongs to the same chemical group as the 
substances examined in that opinion. The terminal metabolism of this additive through glucuronidation among 
mammals, birds and fish allows the conjugat es of the additive to be rapidly excre ted. The Author ity has 
concluded that, since linalool is used in food as flavouri ng and its function in feed is essentially the same as in 
food, no further demonstration of efficacy is necessar y. Theref ore, that conclusion can be extrapolated to feed. 
The applicant withdrew the application for use of linalool in water for drinking. 
(5)  The Author ity further concluded that, linalool oxide should be treated as poten tially hazardous to the respirato ry 
tract, skin and eyes and also as irritating to the skin. Consequently , appropr iate protective measures should be 
take n The Author ity does not consider that there is a need for specifi c requirements of post-market monit oring. 
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. 
(6)  The assessment of linalool oxide 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 substance should be author ised as 
specified in the Annex to this Regulation. 
(7)  The applicant proposed use levels for linalool oxide to the Auth ority. Having regar d to that proposal, the 
Author ity considered that certain use levels are safe (‘levels considered by the Auth ority’). For the purpose of 
official controls along the food chain, certain labelling requirements should be provid ed for. In particular , where 
the use levels exceed the levels considered by the Author ity, it is appropr iate to require that the label of 
premixtures and the labelling of feed mater ials and compo und feed containing the substances concer ned include 
certain information including referen ce to the levels considered by the Author ity. 23.2.2018 L 53/105 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 2012;10(7):2786. 
(4)EFSA Journal 2014:12(3):3608. (8)  The fact that the use of the substance concer ned in wate r for drinking is not author ised does not preclude its use 
in compound feed which is administered via water . 
(9) Since safety reasons do not require the immediate application of the modifications to the conditions of author i­
sation for linalool oxide, 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. 
(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 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 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 compound feed containing the substance as specifi ed in the Annex whic h are produced and 
labelled before 15 March 2019 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 exhausted if they are intende d for food-producing animals. 
3. Feed mater ials and compound feed containing the substance as specifi ed in the Annex whic h are produced and 
labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 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 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 State s. 
Done at Brussels, 15 Febr uary 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  23.2.2018 L 53/106 Official Jour nal of the European Union EN     ANNEX 
Identifi ­
cation 
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 
period 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 
2b13140 — Linalool oxide Additiv e composition 
Linalool oxide 
Char acter isation of the activ e sub­
stance 
Produced by chemical synthesis 
Purity: min. 95 % assa y 
Chemical formula: C10H18O2 
CAS number: 1365-19-1 
FLAVIS No: 13.140 
Method of analy sis(1) 
For the deter mination of linalool 
oxide 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 ex­
cept fish — — — 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.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 %: 
—  0,3 mg/kg for pigs and poultr y, 
—  0,5 mg/kg for other species and 
catego ries excep t fish.’ 
4.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 premixture where the use 
levels suggest ed on the label of the 
premixture would result in exceed ­
ing the levels refer red to in point 3.  15.3.2028 23.2.2018 L 53/107 Official Jour nal of the European Union EN     Identifi ­
cation 
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 
period 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 in the 
labelling of feed mate rials and com ­
pound feedingstuffs where the con­
tent of the active substance in the 
compl ete feedingstuff with a mois ­
ture content of 12 % exceeds: 
—  0,3 mg/kg for pigs and poultr y, 
—  0,5 mg/kg for other species and 
catego ries excep t fish. 
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 elimi ­
nated 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 53/108 Official Jour nal of the European Union EN