COMMI SSION IMPLEMENTING REGUL ATION (EU) 2018/249 
of 15 Febr uary 2018 
concer ning the author isation of taurine, beta-alanine, L-alanine, L-arginine, L-aspar tic acid, 
L-hist idine, D,L -isoleucine, L-leucine, L-pheny lalanine, L-proline, D,L -ser ine, L-tyrosine, 
L-methionine, L-valine, L-cyst eine, glycine, monosodium glut amate and L-glutamic acid as feed 
additiv es for all animal species and L-cyst eine hydrochlorid e monohydrat e for all species except 
cats and dogs 
(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 taur ine, beta-alanine, L-alan ine, L-argi nine, L-aspar tic acid, L-histi dine, D,L-isoleucine, L-leucine, 
L-phenylalanine, L-proline, D,L-serine, L-tyrosine , L-methionine, L-valine, L-cysteine, L-cyst eine hydroch loride 
monoh ydrate, glycine, monosodium glutamat e and L-glutamic acid (‘substances concer ned’) 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 submitte d for the re-evaluation of the substances concer ned produced by fermentation, protein 
hydrolysis and chemical synthesis as feed additives for all animal species. The applicant request ed those additives 
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 Author ity (‘the Author ity’) concluded in its opinion of 9 Apr il 2014 (3) that, under the 
proposed conditions of use the substances concer ned do not have adverse effects on animal health, human health 
or the environment. The lack of information on the production strains does not allow concluding on the 
substances concer ned produced by fermentation. The Author ity has concluded that, since the substances 
concer ned are efficacious when used in food as flavouri ngs and their 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 the use of the substances concer ned in water for drinking. 
(5)  The Authority further concluded that, in the absence of data, the substances concer ned should be considered as 
irritating to skin and eyes and as skin sensitisers. The Author ity also considered that the substances concer ned 
are irritating to the respirato ry system and have the poten tial to produce hazardous dust. Consequently , 
appropr iate prote ctive measures should be taken. The Author ity does not consider that there is a need for 
specific 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. 
(6)  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 satisfi ed exce pt for the substances concer ned produced by 
fermentation. The lack of information on the production strains does not allow assessing their safety . 
According ly, the use of the substances concer ned produced by chemical synthesis and protein hydrolysis should 
be author ised as specifi ed in the Annex to this Regulation. 23.2.2018 L 53/134 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 2014;12(5):3670. (7)  The applicant proposed use levels for the substances concer ned to the Author ity. Having regard to that proposal, 
the Author ity considered that certain use levels are safe (‘levels considered by the Author ity’). 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. 
(8)  The fact that the use of the substances concer ned in water for drinking is not author ised does not preclude their 
use in compo und feed which is administ ered via water . 
(9) Since safety reasons do not require the immediate application of the modifi cations to the conditions of author is­
ation for the substances concer ned, 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 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 taur ine, beta-alanine, L-alan ine, L-arginine, L-aspar tic acid, L-hi stidine, D,L-isoleucine, L-leucine, 
L-phenylalanine, L-proli ne, D,L-ser ine, L-tyrosine, L-methionine, L-valine, L-cysteine, L-cyst eine hydroch loride 
monoh ydrate, glycine, monosodium glutamate and L-glutamic acid, belonging to the additive catego ry ‘sensor y additives ’ 
and to the functional group ‘flavouri ng compo unds ’, and premixtures containing those substances, which are produced 
and labelled before 15 December 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 mate rials and compo und feed containing the substances referred to in paragraph 1 which are produced and 
labelled before 15 Sept ember 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 mate rials and compo und feed containing the substances referred to in paragraph 1 which are produced and 
labelled before 15 Sept ember 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. 23.2.2018 L 53/135 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 53/136 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion 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 
2b16056 — Taurine Additiv e composition 
Taurine 
Char acter isation of the activ e sub­
stance 
Taurine 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 98 % assa y 
Chemical formula: C2H7O3NS 
CAS number 107-35-7 
FLAVIS No 16.056 
Method of analy sis(1) 
For identif ication of taur ine in 
premixtures of flavouri ngs: Ion- 
exchange chromat ography with 
post column ninhydr in derivatisa ­
tion (Ph.Eur . 6.6-2.2.56-Method 1). 
For the deter mination of taur ine 
in premixtures: Ion-exc hange 
chromatograph y with post col­
umn ninh ydrin derivatisation and 
photomet ric detec tion: based on 
Commission Regulation (EC) 
No 152/2009 (2) (Annex III, 
part F). 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.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 %: 25 mg/kg.’ 
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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg.  15.3.2028 23.2.2018 L 53/137 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           
2b17001 — Beta-alanine Additiv e composition 
Beta-alanine 
Char acter isation of the activ e sub­
stance 
Beta-alanine 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 97 % assa y 
Chemical formula: C3H7O2N 
CAS number 107-95-9 
FLAVIS No 17.001  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.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 %: 25 mg/kg.’  15.3.2028 23.2.2018 L 53/138 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
Method of analy sis(1) 
For identification of beta-alanine 
in premixtures of flavouri ngs: Ion- 
exchange chromat ography with 
post column ninhydr in derivatisa ­
tion (Ph.Eur . 6.6-2.2.56-Method 1). 
For the deter mination of beta-ala ­
nine in premixtures: Ion-exc hange 
chromatograph y with post col­
umn ninh ydrin derivatisation and 
photomet ric detec tion: based on 
Regulation (EC) No 152/2009  
(Annex III, part F). 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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg. 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           23.2.2018 L 53/139 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
2b17002 — L-Alanine Additiv e composition 
L-Alanine 
Char acter isation of the activ e sub­
stance 
L-Alanine 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 98,5 % assa y 
Chemical formula: C3H7NO2 
CAS number 56-41-7 
FLAVIS No 17.002 
Method of analy sis(1) 
For identif ication of L-Alanine in 
premixtures of flavouri ngs: Ion- 
exchange chromat ography with 
post column ninhydr in derivatisa ­
tion (Ph.Eur . 6.6-2.2.56-Method 1). 
For the determi nation of L-alanine 
in premixtures: Ion-exc hange 
chromatograph y with post col­
umn ninh ydrin derivatisation and 
photomet ric detec tion: based on 
Regulation (EC) No 152/2009  
(Annex III, part F). 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.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 %: 25 mg/kg.’ 
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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg.  15.3.2028 23.2.2018 L 53/140 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           
2b17003 — L-Arginine Additiv e composition 
L-Arginine 
Char acter isation of the activ e sub­
stance 
L-Arginine 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 98 % assa y 
Chemical formula: C6H14O2N4 
CAS number 74-79-3 
FLAVIS No 17.003  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.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 %: 25 mg/kg.’  15.3.2028 23.2.2018 L 53/141 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
Method of analy sis(1) 
For identif ication of L-arginine in 
premixtures of flavouri ngs: Ion- 
exchange chromat ography with 
post column ninhydr in derivatisa ­
tion (Ph.Eur . 6.6-2.2.56-Method 1). 
For the deter mination of L-argi ­
nine in premixtures: Ion-exc hange 
chromatograph y with post col­
umn ninh ydrin derivatisation and 
photomet ric detec tion: based on 
Regulation (EC) No 152/2009  
(Annex III, part F). 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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg. 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           23.2.2018 L 53/142 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
2b17005 — L-Aspar tic 
acid Additiv e composition 
L-Aspar tic acid 
Char acter isation of the activ e sub­
stance 
L-Aspar tic acid 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 98 % assa y 
Chemical formula: C4H7O4N 
CAS number 56-84-8 
FLAVIS No 17.005 
Method of analy sis(1) 
For identification of L-aspar tic 
acid in premixtures of flavou­
rings: Ion-exc hange chromat ogra ­
phy with post column ninh ydrin 
derivatisation (Ph.Eur . 6.6-2.2.56- 
Method 1). 
For the determination of L-aspar ­
tic acid in premixtures: Ion-ex ­
change chromatograph y with post 
column ninh ydrin derivatisation 
and photometr ic detection: based 
on Regulation (EC) No 152/2009  
(Annex III, part F). 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.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 %: 25 mg/kg.’ 
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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg.  15.3.2028 23.2.2018 L 53/143 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           
2b17008 — L-Histidine Additiv e composition 
L-Histidi ne 
Char acter isation of the activ e sub­
stance 
L-Histidi ne 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 98 % assa y 
Chemical formula: C6H9O2N3 
CAS number 71-00-1 
FLAVIS No 17.008  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.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 %: 25 mg/kg.’  15.3.2028 23.2.2018 L 53/144 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
Method of analy sis(1) 
For identification of L-hi stidine in 
premixtures of flavouri ngs: Ion- 
exchange chromat ography with 
post column ninhydr in derivatisa ­
tion (Ph.Eur . 6.6-2.2.56-Method 1). 
For the deter mination of L-histi ­
dine in premixtures: Ion-exc hange 
chromatograph y with post col­
umn ninh ydrin derivatisation and 
photomet ric detec tion: based on 
Regulation (EC) No 152/2009  
(Annex III, part F). 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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg. 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           23.2.2018 L 53/145 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
2b17010 — D,L-Isoleucine Additiv e composition 
D,L-Is oleucine 
Char acter isation of the activ e sub­
stance 
D,L-Is oleucine 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 98 % assa y 
Chemical formula: C6H13O2N 
CAS number 443-79-8 
FLAVIS No 17.010 
Method of analy sis(1) 
For identification of D,L-isoleucine 
in premixtures of flavouri ngs: Ion- 
exchange chromat ography with 
post column ninhydr in derivatisa ­
tion (Ph.Eur . 6.6-2.2.56-Method 1). 
For the determination of D, L-iso ­
leucine in premixtures: Ion-ex ­
change chromatograph y with post 
column ninh ydrin derivatisation 
and photometr ic detection: based 
on Regulation (EC) No 152/2009  
(Annex III, part F). 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.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 %: 25 mg/kg.’ 
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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg.  15.3.2028 23.2.2018 L 53/146 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           
2b17012 — L-Leucine Additiv e composition 
L-Leucine 
Char acter isation of the activ e sub­
stance 
L-Leucine 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 98 % assa y 
Chemical formula: C6H13O2N 
CAS number 61-90-5 
FLAVIS No 17.012  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.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 %: 25 mg/kg.’  15.3.2028 23.2.2018 L 53/147 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
Method of analy sis(1) 
For identif ication of L-leucine in 
premixtures of flavouri ngs: Ion- 
exchange chromat ography with 
post column ninhydr in derivatisa ­
tion (Ph.Eur . 6.6-2.2.56-Method 1). 
For the deter mination of L-leucine 
in premixtures: Ion-exc hange 
chromatograph y with post col­
umn ninh ydrin derivatisation and 
photomet ric detec tion: based on 
Regulation (EC) No 152/2009  
(Annex III, part F). 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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg. 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           23.2.2018 L 53/148 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
2b17018 — L-Phenylala ­
nine Additiv e composition 
L-Phenylalanine 
Char acter isation of the activ e sub­
stance 
L-Phenylalanine 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 98 % assa y 
Chemical formula: C9H11O2N 
CAS number 63-91-2 
FLAVIS No 17.018 
Method of analy sis(1) 
For identif ication of L-phen ylala ­
nine in premixtures of flavour ­
ings: Ion-exc hange chromat ogra ­
phy with post column ninh ydrin 
derivatisation (Ph.Eur . 6.6-2.2.56- 
Method 1). 
For the deter mination of L-phen y­
lalanine in premixtures: Ion-ex ­
change chromatograph y with post 
column ninh ydrin derivatisation 
and photometr ic detection: based 
on Regulation (EC) No 152/2009  
(Annex III, part F). 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.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 %: 25 mg/kg.’ 
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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg.  15.3.2028 23.2.2018 L 53/149 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           
2b17019 — L-Proline Additiv e composition 
L-Proline 
Char acter isation of the activ e sub­
stance 
L-Proline 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 98 % assa y 
Chemical formula: C5H9O2N 
CAS number 147-85-3 
FLAVIS No 17.019  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.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 %: 25 mg/kg.’  15.3.2028 23.2.2018 L 53/150 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
Method of analy sis(1) 
For identif ication of L-proline in 
premixtures of flavouri ngs: Ion- 
exchange chromat ography with 
post column ninhydr in derivatisa ­
tion (Ph.Eur . 6.6-2.2.56-Method 1). 
For the determination of L-proline 
in premixtures: Ion-exc hange 
chromatograph y with post col­
umn ninh ydrin derivatisation and 
photomet ric detec tion: based on 
Regulation (EC) No 152/2009  
(Annex III, part F). 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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg. 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           23.2.2018 L 53/151 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
2b17020 — D,L-Ser ine Additiv e composition 
D,L-Ser ine 
Char acter isation of the activ e sub­
stance 
D,L-Ser ine 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 95 % assa y 
Chemical formula: C3H7NO3 
CAS number 302-84-1 
FLAVIS No 17.020 
Method of analy sis(1) 
For identif ication of D,L-ser ine in 
premixtures of flavouri ngs: Ion- 
exchange chromat ography with 
post column ninhydr in derivatisa ­
tion (Ph.Eur . 6.6-2.2.56-Method 1). 
For the deter mination of D, L-ser ­
ine in premixtures: Ion-exc hange 
chromatograph y with post col­
umn ninh ydrin derivatisation and 
photomet ric detec tion: based on 
Regulation (EC) No 152/2009  
(Annex III, part F). 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.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 %: 25 mg/kg.’ 
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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg.  15.3.2028 23.2.2018 L 53/152 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           
2b17022 — L-Tyrosine Additiv e composition 
L-Tyrosine 
Char acter isation of the activ e sub­
stance 
L-Tyrosine 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 98 % assa y 
Chemical formula: C9H11O3N 
CAS number 60-18-4 
FLAVIS No 17.022  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.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 %: 25 mg/kg.’  15.3.2028 23.2.2018 L 53/153 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
Method of analy sis(1) 
For identification of L-tyrosine in 
premixtures of flavouri ngs: Ion- 
exchange chromat ography with 
post column ninhydr in derivatisa ­
tion (Ph.Eur . 6.6-2.2.56-Method 1). 
For the determi nation of L-ty ro­
sine in premixtures: Ion-exc hange 
chromatograph y with post col­
umn ninh ydrin derivatisation and 
photomet ric detec tion: based on 
Regulation (EC) No 152/2009  
(Annex III, part F). 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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg. 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           23.2.2018 L 53/154 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
2b17027 — L-Methionine Additiv e composition 
L-Meth ionine 
Char acter isation of the activ e sub­
stance 
L-Meth ionine 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 98,5 % assa y 
Chemical formula: C5H11NO2S 
CAS number 63-68-3 
FLAVIS No 17.027 
Method of analy sis(1) 
For identif ication of L-methionine 
in premixtures of flavouri ngs: Ion- 
exchange chromat ography with 
post column ninhydr in derivatisa ­
tion (Ph.Eur . 6.6-2.2.56-Method 1). 
For the determination of L- 
methionine in premixtures: Ion- 
exchange chromat ography with 
post column ninhydr in derivatisa ­
tion and photom etric detection: 
based on Regulation (EC) 
No 152/2009 (Annex III, part F). 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.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 %: 25 mg/kg.’ 
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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg.  15.3.2028 23.2.2018 L 53/155 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           
2b17028 — L-Valine Additiv e composition 
L-Valine 
Char acter isation of the activ e sub­
stance 
L-Valine 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 98,5 % assa y 
Chemical formula: C5H11NO2 
CAS number 72-18-4 
FLAVIS No 17.028  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.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 %: 25 mg/kg.’  15.3.2028 23.2.2018 L 53/156 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
Method of analy sis(1) 
For identif ication of L-valine in 
premixtures of flavouri ngs: Ion- 
exchange chromat ography with 
post column ninhydr in derivatisa ­
tion (Ph.Eur . 6.6-2.2.56-Method 1). 
For the determination of L-valine 
in premixtures: Ion-exc hange 
chromatograph y with post col­
umn ninh ydrin derivatisation and 
photomet ric detec tion: based on 
Regulation (EC) No 152/2009  
(Annex III, part F). 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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg. 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           23.2.2018 L 53/157 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
2b17033 — L-Cysteine Additiv e composition 
L-Cysteine 
Char acter isation of the activ e sub­
stance 
L-Cysteine 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 98 % assa y 
Chemical formula: C3H7O2NS 
CAS number 52-90-4 
FLAVIS No 17.033 
Method of analy sis(1) 
For identif ication of L-cyst eine in 
premixtures of flavouri ngs: Ion- 
exchange chromat ography with 
post column ninhydr in derivatisa ­
tion (Ph.Eur . 6.6-2.2.56-Method 1). 
For the deter mination of L-cy­
steine in premixtures: Ion-ex ­
change chromatograph y with post 
column ninh ydrin derivatisation 
and photometr ic detection: based 
on Regulation (EC) No 152/2009  
(Annex III, part F). 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.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 %: 25 mg/kg.’ 
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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg.  15.3.2028 23.2.2018 L 53/158 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           
2b920 — L-Cysteine hy­
droc hlor ide 
monoh ydrate Additiv e composition 
L-Cysteine hydrochlori de mono ­
hydrate 
Char acter isation of the activ e sub­
stance 
L-Cysteine hydrochlori de mono ­
hydrate 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 98,5 % assa y 
Chemical formula: C3H8ClNO2S · 
H2O 
CAS number 7048-04-6  All animal 
species ex­
cept cats 
and dogs — — — 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 %: 25 mg/kg for all species 
excep t cats and dogs ’.  15.3.2028 23.2.2018 L 53/159 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
Method of analy sis(1) 
For identif ication of L-cysteine hy­
droch loride monoh ydrate in pre­
mixtures of flavouri ngs: Ion-ex ­
change chromatograph y with post 
column ninh ydrin derivatisation  
(Ph.Eur . 6.6-2.2.56-Method 1). 
For the deter mination of L-cy­
steine hydroc hlor ide monoh ydrate 
in premixtures: Ion-exc hange 
chromatograph y with post col­
umn ninh ydrin derivatisation and 
photomet ric detec tion: based on 
Regulation (EC) No 152/2009  
(Annex III, part F). 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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg for all species excep t cats 
and dogs. 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           23.2.2018 L 53/160 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
2b17034 — Glycine Additiv e composition 
Glycine 
Char acter isation of the activ e sub­
stance 
Glycine 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 98 % assa y 
Chemical formula: C2H5O2N 
CAS number 56-40-6 
FLAVIS No 17.034 
Method of analy sis(1) 
For identif ication of glycine in 
premixtures of flavouri ngs: Ion- 
exchange chromat ography with 
post column ninhydr in derivatisa ­
tion (Ph.Eur . 6.6-2.2.56-Method 1). 
For the determination of glycine 
in premixtures: Ion-exc hange 
chromatograph y with post col­
umn ninh ydrin derivatisation and 
photomet ric detec tion: based on 
Regulation (EC) No 152/2009  
(Annex III, part F). 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.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 %: 
—  20 g/kg for cats and dogs; 
—  25 g/kg for other species and 
catego ries.’ 
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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the levels refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture conte nt of 12 % exceed s: 
—  20 g/kg for cats and dogs; 
—  25 g/kg for other species and 
catego ries.  15.3.2028 23.2.2018 L 53/161 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           
2b621 — Monosodium 
glutamat e Additiv e composition 
Monosodium glutamate 
Char acter isation of the activ e sub­
stance 
Monosodium glutamate 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 99 % assa y 
Chemical formula: C5H8 NaNO4 · 
H2O 
CAS number 142-47-2  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.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 %: 25 mg/kg.’  15.3.2028 23.2.2018 L 53/162 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
Method of analy sis(1) 
For identif ication of monosodium 
glutamate in premixtures of fla­
vourings: Ion-exc hange chromat o­
graphy with post column ninh y­
drin derivatisation (Ph.Eur . 6.6- 
2.2.56-Method 1). 
For the determi nation of monoso ­
dium glutamat e in premixtures: 
Ion-exc hang e chromat ography 
with post column ninh ydrin deri­
vatisation and photometr ic detec­
tion: based on Regulation (EC) 
No 152/2009 (Annex III, part F). 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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg. 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 .           23.2.2018 L 53/163 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
2b620 — L-Glutamic 
acid Additiv e composition 
L-Glutam ic acid 
Char acter isation of the activ e sub­
stance 
L-Glutam ic acid 
Produced by chemical synthesis or 
prote in hydrolysis 
Purity: min. 98 % assa y 
Chemical formula: C5H9O4N 
CAS number 56-86-0 
Method of analy sis(1) 
For identif ication of L-glutamic 
acid in premixtures of flavourings: 
Ion-exc hang e chromat ography 
with post column ninh ydrin 
derivatisation (Ph.Eur . 6.6-2.2.56- 
Method 1). 
For the deter mination of L-gluta­
mic acid in premixtures: Ion-ex ­
change chromatograph y with post 
column ninh ydrin derivatisation 
and photometr ic detection: based 
on Regulation (EC) No 152/2009  
(Annex III, part F). 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.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 %: 25 mg/kg.’ 
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 
level sugge sted on the label of the 
premixture would result in exceed ­
ing the level refer red to in point 3. 
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 la­
belling of feed mat erials and com ­
pound feedingstuffs where the 
content of the active substance in 
the compl ete feedingstuff with 
a moisture content of 12 % exceeds: 
25 mg/kg.  15.3.2028 23.2.2018 L 53/164 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author isa­
tion 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 isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
6.For additives produced from hydro­
lysis of animal prote in, the animal 
species shall be indicated on the la­
bel of the additive and premixtures. 
7.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 
(2)  Commission Regulation (EC) No 152/2009 of 27 Januar y 2009 laying down the methods of samplin g and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).   23.2.2018 L 53/165 Official Jour nal of the European Union EN