COMMI SSION IMPLEMENTING REGUL ATION (EU) 2018/241 
of 15 Febr uary 2018 
concer ning the author isation of piper ine, 3-methylindole, indole, 2-acetylp yrrole and pyrrolidine 
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 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 substances piper ine, 3-methyl indole, indole, 2-acetylp yrrole and pyrrolidine, (‘the substances concer ned’) 
were author ised without a time limit by Directive 70/524/EEC as feeds 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 the substances concer ned as feed additives for all animal 
species. The applicant request ed that those additives be classifie d in the additive catego ry ‘sensor y additives ’. This 
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 26 Januar y 2016 (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 Auth ority has concluded that, since the substances concer ned 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 extrapolat ed to feed. The 
applicant withdrew the application for water for drinking. However , it should be possible to use the substances 
concer ned within compo und feeds which are subsequently administered via water . 
(5)  Restr ictions and conditions should be provid ed 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 indicate d on the label of premixtures and on the labelling of feed mat erials and 
compo und feed. 
(6)  The Authority noted that for the substances concer ned poten tial hazards for skin and eye contact and respirato ry 
exposure are recognised. Most are classif ied as irritating to the respirato ry system . Consequently , appropr iate 
prot ective measures should be take n. The Auth ority 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 the substances concer ned 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. 23.2.2018 L 53/27 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(2):4390 (8) Since safety reasons do not require the immediate application of the modifications to the conditions of author i­
sation for the substances concer ned, 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. 
(9)  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 
Transitional measures 
1. The substances specifi ed in the Annex and premixtures containing those substances, whic h 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 exhausted. 
2. Feed mat erials and compo und feed containing the substances specified 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 mat erials and compo und feed containing the substances specified 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 53/28 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 
2b14003 — Piper ine Additiv e composition 
Piper ine 
Char acter isation of the activ e sub­
stance 
Piper ine 
Produced by chemical synthesis 
Purity: min. 95 % 
Chemical formula: C17H19O3N 
CAS number: 94-62-2 
FLAVIS No: 14.003 
Method of analy sis(1) 
For the deter mination of piper ine 
in the feed additive and in feed 
flavouring premixtures: 
Gas chromat ography coupled 
to a Flame Ionisation Detector 
(GC-FID). 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: 
0,5 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 %: 0,5 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 
label of premixtures and on the la­
belling of feed mat erials 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: 0,5 mg/kg.  15.3.2028 23.2.2018 L 53/29 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 % 
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 .           
2b14004 — 3-Methy l­
indole Additiv e composition 
3-Methy lindole 
Char acter isation of the activ e sub­
stance 
3-Methy lindole 
Produced by chemical synthesis 
Purity: min. 97 % 
Chemical formula: C9H9N 
CAS number: 83-34-1 
FLAVIS No:14.004 
Method of analy sis(1) 
For the identif ication of 3-methyl ­
indole in the feed additive and 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: 
0,5 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 %: 0,5 mg/kg’.  15.3.2028 23.2.2018 L 53/30 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 on the 
label of premixtures and on the la­
belling of feed mat erials 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: 0,5 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 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 .           
2b14007 — Indole Additiv e composition 
Indole 
Char acter isation of the activ e sub­
stance 
Indole 
Produced by chemical synthesis 
Purity: min. 97 % 
Chemical formula: C8H7N  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.  15.3.2028 23.2.2018 L 53/31 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 % 
CAS number: 120-72-9 
FLAVIS No: 14.007 
Method of analy sis(1) 
For the determination of indole 
in the feed additive and in feed 
flavouring premixtures: 
Gas chromat ography mass spec ­
trometr y with retention time lock ­
ing GC-MS-RTL. 3.The recommended maximum con­
tent of the active substance shall be: 
0,5 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 %: 0,5 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 
label of premixtures and on the la­
belling of feed mat erials 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: 0,5 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 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 .           23.2.2018 L 53/32 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 % 
2b14047 — 2-Acetyl ­
pyrrole Additiv e composition 
2-Acetylp yrrole 
Char acter isation of the activ e sub­
stance 
2-Acetylp yrrole 
Produced by chemical synthesis 
Purity: min. 97 % 
Chemical formula: C6H7ON 
CAS number 1072-83-9 
FLAVIS No: 14.047 
Method of analy sis(1) 
For the determination of 2-acetyl ­
pyrrole 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: 
0,5 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 %: 0,5 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 
label of premixtures and on the la­
belling of feed mat erials 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: 0,5 mg/kg.  15.3.2028 23.2.2018 L 53/33 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 % 
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 .           
2b14064 — Pyrrolidine Additiv e composition 
Pyrrolidine 
Char acter isation of the activ e sub­
stance 
Pyrrolidine 
Produced by chemical synthesis 
Purity: min. 95 % 
Chemical formula: C4H9N 
CAS number 123-75-1 
FLAVIS No: 14.064 
Method of analy sis(1) 
For the deter mination of pyrrol­
idine 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 of com ­
plete feedingstuff with a moisture 
content of 12 %.shall be: 
—  0,3 mg/kg for pigs and poultr y, 
—  0,5 mg/kg for other species and 
catego ries. 
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 %: 
—  0,3 mg/kg for pigs and poultr y, 
—  0,5 mg/kg for other species and 
catego ries.’  15.3.2028 23.2.2018 L 53/34 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 on the 
label of premixtures and on the la­
belling of feed mat erials 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: 
—  0,3 mg/kg for pigs and poultr y, 
—  0,5 mg/kg for other species and 
catego ries. 
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 53/35 Official Jour nal of the European Union EN