COMMISSION IMPLEMENTING REGUL ATION (EU) 2017/57 
of 14 December 2016 
concer ning the author isation of 1,8-cineole, 3,4-dihydrocoumar in and 2-(2-meth ylprop-1-enyl)-4- 
methyltetrah ydrop yran as feed additiv es for all animal species 
(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)  1,8-Cineole, 3,4-dih ydrocoumar in and 2-(2-methylprop-1-en yl)-4-meth yltetrah ydrop yran were author ised without 
a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products 
were subsequently entered in the Register 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 substances concer ned as feed additives for all animal 
species. The applicant requested those additives to be classified in the additive categor y ‘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 opinions of 6 Marc h 2012 and 
13 November 2012 (3) that, under the proposed conditions of use in feed, the substances concer ned do not have 
adverse effects on animal health, human health or the environment. The Author ity further concluded that the 
function of 1,8-cineole, 3,4-dih ydrocoumar in and 2-(2-meth ylprop-1-enyl)-4-meth yltetrahydrop yran in feed is 
similar to that on food. The Auth ority has already concluded that for food those substances are efficacious, as 
they increase the food smell or palatability . Theref ore, that conclusion can be extrapolat ed for feed. As the use of 
1,8-cineole, 3,4-dihydroc oumar in and 2-(2-methylprop-1-en yl)-4-methylt etrahydrop yran in water for drinking is 
difficult to control when used simultaneously with feed, such use should be excl uded. However , those substances 
can be used within compo und feeds whic h are subsequently administ ered via wate r. 
(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 1,8-cineole, 3,4-dih ydrocoumar in and 2-(2-methylprop-1-en yl)-4-methylt etrahy ­
drop yran are irritant to eyes, respirator y tract and skin. The Author ity further concluded that 3,4-dih ydro ­
coumar in is also skin sensitiser and harmful if swallo wed. Consequently , appropr iate protective measures should 
be take n. The Auth ority does not consider that there is a need for specific requirements of post-market 
monitoring. It also verified the repor t on the method of analysis of the feed additives in feed submitted by the 
Reference Laboratory set up by Regulation (EC) No 1831/2003. 17.1.2017 L 13/153 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(3):2622 and EFSA Journal 2012;10(11):2967 (7)  The assessment of 1,8-cineole, 3,4-dih ydrocoumar in and 2-(2-methylprop-1-en yl)-4-methylt etrahydrop yran 
shows that the conditions for author isation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are 
satisfied. According ly, the use of those substances should be author ised as specified in the Annex to this 
Regulation. 
(8) Since safety reasons do not require the immediate application of the modifi cations to the conditions of author is­
ation for 1,8-cineole, 3,4-dih ydrocoumar in and 2-(2-methylprop-1-en yl)-4-methylt etrahydrop yran it is 
appropr iate to allow a transitional period for interested 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 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 
Transitional measures 
1. The substances as specified in the Annex and premixtures containing those substances, 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 exhausted. 
2. Com pound feed and feed mater ials containing the substances as specif ied in the Annex which 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 substances as specif ied in the Annex which 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 13/154 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
number of 
the additive Name of the 
holder of 
author isation Additive Composition, chem ical 
formula, descr iption, analyti ­
cal 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 % 
(1) (2) (3) (4) (5) (6) (7) (8) (9) 
Categor y: Sensor y additiv es. Functional group: Flavour ing compounds 
2b03001 — 1,8-Cineole Additiv e composition 
1,8-Cineole 
Char acter isation of the activ e 
substance 
1,8-Cineole 
Produced by distillation 
from Eucalyptus globulus 
Purity: min. 98 % 
Chemical formula: 
C10H18O 
CAS number 470-82-6 
FLAVIS No 03.001 
Method of analy sis(1) 
For the determination of 
1,8-cineole in the feed ad­
ditive and in feed flavour­
ing premixtures. 
Gas chromat ography 
mass spectrometr y with 
retention time locking 
GC-MS-RT L. 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 ad­
ditive and premixtures, the storage 
and stability conditions shall be 
indicated. 
3.The recommended maximum con­
tent of the active substance shall 
be: 5 mg/kg of compl ete feeding ­
stuff with a moisture content of 
12 %.  
4. On the label of the additive the 
following shall be indicated : 
‘Recommended maximum conte nt 
of the active substance: of com ­
plete feedingstuff with a moisture 
content of 12 %: 5 mg/kg’. 
5.The functional group, the identif i­
cation number , the name and the 
added amount of the active sub­
stance shall be indicated on the la­
belling of the premixtures, feed 
mater ials and compo und feeding ­
stuffs, if the following content of 
the active substance in compl ete 
feedingstuff with a moisture con­
tent of 12 % is excee ded: 5 mg/kg.  6 Febr uary 
2027 17.1.2017 L 13/155 Official Jour nal of the European Union EN     (1) (2) (3) (4) (5) (6) (7) (8) (9) 
6.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational measures 
to address poten tial risks by inha ­
lation, dermal contact or eyes con­
tact. Where those risks cannot be 
eliminated or reduced to a mini ­
mum by such procedures and 
measures, the additive and pre­
mixtures shall be used with per­
sonal protective equipment, in­
cluding breathing protection, 
safety glasses and gloves. 
2b13009 — 3,4-Dihy ­
drocou ­
mar in Additiv e composition 
3,4-Dih ydrocoumar in 
Char acter isation of the activ e 
substance 
3,4-Dih ydrocoumar in 
Produced by chemical 
synthesis 
Purity: min. 99 % 
Chemical formula: 
C9H8O2 
CAS number 119-84-6 
FLAVIS No 13.009 
Method of analy sis(1) 
For the determination of 
3,4-dih ydrocoumar in in 
the feed additive and in 
feed flavouring premix ­
tures. 
Gas chromat ography 
mass spectrometr y with 
retention time locking 
GC-MS-RT L. 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 ad­
ditive and premixtures, the storage 
and stability conditions shall be 
indicated. 
3.The recommended maximum con­
tent of the active substance shall 
be: 5 mg/kg of compl ete feeding ­
stuff with a moisture content of 
12 %.  
4. On the label of the additive the 
following shall be indicated : 
‘Recommended maximum conte nt 
of the active substance of com ­
plete feedingstuff with a moisture 
content of 12 %: 5 mg/kg’ 
5.The functional group, the identif i­
cation number , the name and the 
added amount of the active sub­
stance shall be indicated on the la­
belling of the premixtures, feed 
mater ials and compo und feeding ­
stuffs, if the following content of 
the active substance in compl ete 
feedingstuff with a moisture con­
tent of 12 % is excee ded: 5 mg/kg.  6 Febr uary 
2027 17.1.2017 L 13/156 Official Jour nal of the European Union EN     (1) (2) (3) (4) (5) (6) (7) (8) (9) 
6.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational measures 
to address poten tial risks by inha ­
lation, dermal contact or eyes con­
tact. Where those risks cannot be 
eliminated or reduced to a mini ­
mum by such procedures and 
measures, the additive and pre­
mixtures shall be used with per­
sonal protective equipment, in­
cluding breathing protection, 
safety glasses and gloves. 
2b13037 — 2-(2-Methyl ­
prop-1- 
enyl)-4- 
methylt etra­
hydrop yran Additiv e composition 
2-(2-Methylprop-1- enyl)- 
4-methyl tetrah ydrop yran 
Char acter isation of the activ e 
substance 
2-(2-Methylprop-1- enyl)- 
4-methyl tetrah ydrop yran 
Produced by chemical 
synthesis 
Purity: min. 99 % 
Chemical formula: 
C10H18O 
CAS number 16409-43-1 
FLAVIS No 13.037 
Method of analy sis(1) 
For the identif ication of 
2-(2-meth ylprop-1-enyl)- 
4-methyl tetrah ydrop yran 
in the feed additive and 
flavouring premixtures. 
Gas chromat ography 
mass spectrometr y with 
retention time locking 
GC-MS-RT L. 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 ad­
ditive and premixtures, the storage 
and stability conditions shall be 
indicated. 
3.The recommended maximum con­
tent of the active substance shall 
be: 
For pigs and poultr y: 0,5 mg/kg, 
and for other species and cat­
egor ies: 0,3 mg/kg of compl ete 
feedingstuff with a moisture con­
tent of 12 %.  
4. On the label of the additive the 
following shall be indicated : 
‘Recommended maximum conte nt 
of the active substance of com ­
plete feedingstuff with a moisture 
content of 12 %: 
—0,5 mg/kg for pigs and poult ­
ry; 
—  0,3 mg/kg for other species 
and cate gories.’  6 Febr uary 
2027 17.1.2017 L 13/157 Official Jour nal of the European Union EN     (1) (2) (3) (4) (5) (6) (7) (8) (9) 
5.The functional group, the identif i­
cation number , the name and the 
added amount of the active sub­
stance shall be indicated on the la­
belling of the premixtures, feed 
mater ials and compo und feeding ­
stuffs, if the following contents of 
the active substance in compl ete 
feedingstuff with a moisture con­
tent of 12 % are excee ded: 
—0,5 mg/kg for pigs and poult ­
ry; 
—  0,3 mg/kg for other species 
and cate gories. 
6.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational measures 
to address poten tial risks by inha ­
lation, dermal contact or eyes con­
tact. Where those risks cannot be 
eliminated or reduced to a mini ­
mum by such procedures and 
measures, the additive and pre­
mixtures shall be used with per­
sonal protective equipment, in­
cluding breathing protection, 
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 13/158 Official Jour nal of the European Union EN