See Full Document Text
L 53/134 EN Official Journal of the European Union 23.2.2018
COMMISSION IMPLEMENTING REGULATION (EU) 2018/249
of 15 February 2018
concerning the authorisation of taurine, beta-alanine, L-alanine, L-arginine, L-aspartic acid,
L-histidine, D,L-isoleucine, L-leucine, L-phenylalanine, L-proline, D,L-serine, L-tyrosine,
L-methionine, L-valine, L-cysteine, glycine, monosodium glutamate and L-glutamic acid as feed
additives for all animal species and L-cysteine hydrochloride monohydrate for all species except
cats and dogs
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003
on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the
grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-
evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).
(2) The substances taurine, beta-alanine, L-alanine, L-arginine, L-aspartic acid, L-histidine, D,L-isoleucine, L-leucine,
L-phenylalanine, L-proline, D,L-serine, L-tyrosine, L-methionine, L-valine, L-cysteine, L-cysteine hydrochloride
monohydrate, glycine, monosodium glutamate and L-glutamic acid (‘substances concerned’) were authorised
without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances 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 concerned produced by fermentation, protein
hydrolysis and chemical synthesis as feed additives for all animal species. The applicant requested those additives
be classified in the additive category ‘sensory 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 Authority (‘the Authority’) concluded in its opinion of 9 April 2014 (3) that, under the
proposed conditions of use the substances concerned 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 concerned produced by fermentation. The Authority has concluded that, since the substances
concerned 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 is necessary. Therefore, that conclusion can be extrapolated to feed.
The applicant withdrew the application for the use of the substances concerned in water for drinking.
(5) The Authority further concluded that, in the absence of data, the substances concerned should be considered as
irritating to skin and eyes and as skin sensitisers. The Authority also considered that the substances concerned
are irritating to the respiratory system and have the potential to produce hazardous dust. Consequently,
appropriate protective measures should be taken. The Authority does not consider that there is a need for
specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed
additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(6) The assessment of the substances concerned shows that the conditions for authorisation, as provided for in
Article 5 of Regulation (EC) No 1831/2003, are satisfied except for the substances concerned produced by
fermentation. The lack of information on the production strains does not allow assessing their safety.
Accordingly, the use of the substances concerned produced by chemical synthesis and protein hydrolysis should
be authorised as specified in the Annex to this Regulation.
(1) OJ L 268, 18.10.2003, p. 29.
(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
(3) EFSA Journal 2014;12(5):3670.23.2.2018 EN Official Journal of the European Union L 53/135
(7) The applicant proposed use levels for the substances concerned to the Authority. Having regard to that proposal,
the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of
official controls along the food chain, certain labelling requirements should be provided for. In particular, where
the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of
premixtures and the labelling of feed materials and compound feed containing the substances concerned include
certain information including reference to the levels considered by the Authority.
(8) The fact that the use of the substances concerned in water for drinking is not authorised does not preclude their
use in compound feed which is administered via water.
(9) Since safety reasons do not require the immediate application of the modifications to the conditions of authoris
ation for the substances concerned, it is appropriate to allow a transitional period for interested parties to
prepare themselves to meet the new requirements resulting from the authorisation.
(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
Authorisation
The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group
‘flavouring compounds’, are authorised as feed additives in animal nutrition subject to the conditions laid down in that
Annex.
Article 2
Transitional measures
1. The substances taurine, beta-alanine, L-alanine, L-arginine, L-aspartic acid, L-histidine, D,L-isoleucine, L-leucine,
L-phenylalanine, L-proline, D,L-serine, L-tyrosine, L-methionine, L-valine, L-cysteine, L-cysteine hydrochloride
monohydrate, glycine, monosodium glutamate and L-glutamic acid, belonging to the additive category ‘sensory additives’
and to the functional group ‘flavouring compounds’, 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 market and used until the existing stocks are exhausted.
2. Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and
labelled before 15 September 2019 in accordance with the rules applicable before 15 March 2018 may continue to be
placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
3. Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and
labelled before 15 September 2020 in accordance with the rules applicable before 15 March 2018 may continue to be
placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing
animals.
Article 3
Entry 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.L 53/136 EN Official Journal of the European Union 23.2.2018
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 February 2018.
For the Commission
The President
Jean-Claude JUNCKERANNEX
Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff the additive tion tion
with a moisture content of
12 %
Category: Sensory additives. Functional group: Flavouring compounds
2b16056 — Taurine Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a pre
Taurine
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
Taurine and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98 % assay
‘Recommended maximum content
Chemical formula: C H O NS
2 7 3 of the active substance of complete
CAS number 107-35-7 feedingstuff with a moisture content
FLAVIS No 16.056 of 12 %: 25 mg/kg.’
4. The functional group, the identifica
Method of analysis(1)
tion number, the name and the
For identification of taurine in added amount of the active sub
premixtures of flavourings: Ion- stance shall be indicated on the la
exchange chromatography with bel of the premixture where the use
post column ninhydrin derivatisa level suggested on the label of the
tion (Ph.Eur. 6.6-2.2.56-Method 1). premixture would result in exceed
For the determination of taurine ing the level referred to in point 3.
in premixtures: Ion-exchange 5. The functional group, the identifica
chromatography with post col tion number, the name and the
umn ninhydrin derivatisation and added amount of the active sub
photometric detection: based on stance shall be indicated in the la
Commission Regulation (EC) belling of feed materials and com
No 152/2009(2) (Annex III, pound feedingstuffs where the
part F). content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg.
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/137Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
2b17001 — Beta-alanine Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a pre
Beta-alanine
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
Beta-alanine and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 97 % assay
‘Recommended maximum content
Chemical formula: C H O N
3 7 2 of the active substance of complete
CAS number 107-95-9 feedingstuff with a moisture content
FLAVIS No 17.001 of 12 %: 25 mg/kg.’
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53/138
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
Method of analysis(1) 4. The functional group, the identifica
tion number, the name and the
For identification of beta-alanine
added amount of the active sub
in premixtures of flavourings: Ion-
stance shall be indicated on the la
exchange chromatography with
bel of the premixture where the use
post column ninhydrin derivatisa
level suggested on the label of the
tion (Ph.Eur. 6.6-2.2.56-Method 1).
premixture would result in exceed
For the determination of beta-ala ing the level referred to in point 3.
nine in premixtures: Ion-exchange
5. The functional group, the identifica
chromatography with post col
tion number, the name and the umn ninhydrin derivatisation and
added amount of the active sub
photometric detection: based on
stance shall be indicated in the la
Regulation (EC) No 152/2009
belling of feed materials and com (Annex III, part F).
pound feedingstuffs where the
content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg.
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
23.2.2018
EN
Official
Journal
of
the
European
Union
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53/139Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
2b17002 — L-Alanine Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a pre
L-Alanine
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
L-Alanine and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98,5 % assay
‘Recommended maximum content
Chemical formula: C H NO
3 7 2 of the active substance of complete
CAS number 56-41-7 feedingstuff with a moisture content
FLAVIS No 17.002 of 12 %: 25 mg/kg.’
4. The functional group, the identifica
Method of analysis(1)
tion number, the name and the
For identification of L-Alanine in added amount of the active sub
premixtures of flavourings: Ion- stance shall be indicated on the la
exchange chromatography with bel of the premixture where the use
post column ninhydrin derivatisa level suggested on the label of the
tion (Ph.Eur. 6.6-2.2.56-Method 1). premixture would result in exceed
For the determination of L-alanine ing the level referred to in point 3.
in premixtures: Ion-exchange 5. The functional group, the identifica
chromatography with post col tion number, the name and the
umn ninhydrin derivatisation and added amount of the active sub
photometric detection: based on stance shall be indicated in the la
Regulation (EC) No 152/2009 belling of feed materials and com
(Annex III, part F). pound feedingstuffs where the
content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg.
L
53/140
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
2b17003 — L-Arginine Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a pre
L-Arginine
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
L-Arginine and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98 % assay
‘Recommended maximum content
Chemical formula: C H O N
6 14 2 4 of the active substance of complete
CAS number 74-79-3 feedingstuff with a moisture content
FLAVIS No 17.003 of 12 %: 25 mg/kg.’
23.2.2018
EN
Official
Journal
of
the
European
Union
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53/141Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
Method of analysis(1) 4. The functional group, the identifica
tion number, the name and the
For identification of L-arginine in
added amount of the active sub
premixtures of flavourings: Ion-
stance shall be indicated on the la
exchange chromatography with
bel of the premixture where the use
post column ninhydrin derivatisa
level suggested on the label of the
tion (Ph.Eur. 6.6-2.2.56-Method 1).
premixture would result in exceed
For the determination of L-argi ing the level referred to in point 3.
nine in premixtures: Ion-exchange
5. The functional group, the identifica
chromatography with post col
tion number, the name and the umn ninhydrin derivatisation and
added amount of the active sub
photometric detection: based on
stance shall be indicated in the la
Regulation (EC) No 152/2009
belling of feed materials and com (Annex III, part F).
pound feedingstuffs where the
content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg.
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
L
53/142
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Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
2b17005 — L-Aspartic Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
acid species into the feed in the form of a pre
L-Aspartic acid
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
L-Aspartic acid and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98 % assay
‘Recommended maximum content
Chemical formula: C H O N
4 7 4 of the active substance of complete
CAS number 56-84-8 feedingstuff with a moisture content
FLAVIS No 17.005 of 12 %: 25 mg/kg.’
4. The functional group, the identifica
Method of analysis(1)
tion number, the name and the
For identification of L-aspartic added amount of the active sub
acid in premixtures of flavou stance shall be indicated on the la
rings: Ion-exchange chromatogra bel of the premixture where the use
phy with post column ninhydrin level suggested on the label of the
derivatisation (Ph.Eur. 6.6-2.2.56- premixture would result in exceed
Method 1). ing the level referred to in point 3.
For the determination of L-aspar 5. The functional group, the identifica
tic acid in premixtures: Ion-ex tion number, the name and the
change chromatography with post added amount of the active sub
column ninhydrin derivatisation stance shall be indicated in the la
and photometric detection: based belling of feed materials and com
on Regulation (EC) No 152/2009 pound feedingstuffs where the
(Annex III, part F). content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg.
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/143Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
2b17008 — L-Histidine Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a pre
L-Histidine
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
L-Histidine and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98 % assay
‘Recommended maximum content
Chemical formula: C H O N
6 9 2 3 of the active substance of complete
CAS number 71-00-1 feedingstuff with a moisture content
FLAVIS No 17.008 of 12 %: 25 mg/kg.’
L
53/144
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
Method of analysis(1) 4. The functional group, the identifica
tion number, the name and the
For identification of L-histidine in
added amount of the active sub
premixtures of flavourings: Ion-
stance shall be indicated on the la
exchange chromatography with
bel of the premixture where the use
post column ninhydrin derivatisa
level suggested on the label of the
tion (Ph.Eur. 6.6-2.2.56-Method 1).
premixture would result in exceed
For the determination of L-histi ing the level referred to in point 3.
dine in premixtures: Ion-exchange
5. The functional group, the identifica
chromatography with post col
tion number, the name and the umn ninhydrin derivatisation and
added amount of the active sub
photometric detection: based on
stance shall be indicated in the la
Regulation (EC) No 152/2009
belling of feed materials and com (Annex III, part F).
pound feedingstuffs where the
content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg.
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
23.2.2018
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Official
Journal
of
the
European
Union
L
53/145Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
2b17010 — D,L-Isoleucine Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a pre
D,L-Isoleucine
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
D,L-Isoleucine and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98 % assay
‘Recommended maximum content
Chemical formula: C H O N
6 13 2 of the active substance of complete
CAS number 443-79-8 feedingstuff with a moisture content
FLAVIS No 17.010 of 12 %: 25 mg/kg.’
4. The functional group, the identifica
Method of analysis(1)
tion number, the name and the
For identification of D,L-isoleucine added amount of the active sub
in premixtures of flavourings: Ion- stance shall be indicated on the la
exchange chromatography with bel of the premixture where the use
post column ninhydrin derivatisa level suggested on the label of the
tion (Ph.Eur. 6.6-2.2.56-Method 1). premixture would result in exceed
For the determination of D, L-iso ing the level referred to in point 3.
leucine in premixtures: Ion-ex 5. The functional group, the identifica
change chromatography with post tion number, the name and the
column ninhydrin derivatisation added amount of the active sub
and photometric detection: based stance shall be indicated in the la
on Regulation (EC) No 152/2009 belling of feed materials and com
(Annex III, part F). pound feedingstuffs where the
content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg.
L
53/146
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
2b17012 — L-Leucine Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a pre
L-Leucine
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
L-Leucine and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98 % assay
‘Recommended maximum content
Chemical formula: C H O N
6 13 2 of the active substance of complete
CAS number 61-90-5 feedingstuff with a moisture content
FLAVIS No 17.012 of 12 %: 25 mg/kg.’
23.2.2018
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Official
Journal
of
the
European
Union
L
53/147Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
Method of analysis(1) 4. The functional group, the identifica
tion number, the name and the
For identification of L-leucine in
added amount of the active sub
premixtures of flavourings: Ion-
stance shall be indicated on the la
exchange chromatography with
bel of the premixture where the use
post column ninhydrin derivatisa
level suggested on the label of the
tion (Ph.Eur. 6.6-2.2.56-Method 1).
premixture would result in exceed
For the determination of L-leucine ing the level referred to in point 3.
in premixtures: Ion-exchange
5. The functional group, the identifica
chromatography with post col
tion number, the name and the umn ninhydrin derivatisation and
added amount of the active sub
photometric detection: based on
stance shall be indicated in the la
Regulation (EC) No 152/2009
belling of feed materials and com (Annex III, part F).
pound feedingstuffs where the
content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg.
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
L
53/148
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
2b17018 — L-Phenylala Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
nine species into the feed in the form of a pre
L-Phenylalanine
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
L-Phenylalanine and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98 % assay
‘Recommended maximum content
Chemical formula: C H O N
9 11 2 of the active substance of complete
CAS number 63-91-2 feedingstuff with a moisture content
FLAVIS No 17.018 of 12 %: 25 mg/kg.’
4. The functional group, the identifica
Method of analysis(1)
tion number, the name and the
For identification of L-phenylala added amount of the active sub
nine in premixtures of flavour stance shall be indicated on the la
ings: Ion-exchange chromatogra bel of the premixture where the use
phy with post column ninhydrin level suggested on the label of the
derivatisation (Ph.Eur. 6.6-2.2.56- premixture would result in exceed
Method 1). ing the level referred to in point 3.
For the determination of L-pheny 5. The functional group, the identifica
lalanine in premixtures: Ion-ex tion number, the name and the
change chromatography with post added amount of the active sub
column ninhydrin derivatisation stance shall be indicated in the la
and photometric detection: based belling of feed materials and com
on Regulation (EC) No 152/2009 pound feedingstuffs where the
(Annex III, part F). content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg.
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/149Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
2b17019 — L-Proline Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a pre
L-Proline
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
L-Proline and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98 % assay
‘Recommended maximum content
Chemical formula: C H O N
5 9 2 of the active substance of complete
CAS number 147-85-3 feedingstuff with a moisture content
FLAVIS No 17.019 of 12 %: 25 mg/kg.’
L
53/150
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
Method of analysis(1) 4. The functional group, the identifica
tion number, the name and the
For identification of L-proline in
added amount of the active sub
premixtures of flavourings: Ion-
stance shall be indicated on the la
exchange chromatography with
bel of the premixture where the use
post column ninhydrin derivatisa
level suggested on the label of the
tion (Ph.Eur. 6.6-2.2.56-Method 1).
premixture would result in exceed
For the determination of L-proline ing the level referred to in point 3.
in premixtures: Ion-exchange
5. The functional group, the identifica
chromatography with post col
tion number, the name and the umn ninhydrin derivatisation and
added amount of the active sub
photometric detection: based on
stance shall be indicated in the la
Regulation (EC) No 152/2009
belling of feed materials and com (Annex III, part F).
pound feedingstuffs where the
content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg.
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/151Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
2b17020 — D,L-Serine Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a pre
D,L-Serine
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
D,L-Serine and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 95 % assay
‘Recommended maximum content
Chemical formula: C H NO
3 7 3 of the active substance of complete
CAS number 302-84-1 feedingstuff with a moisture content
FLAVIS No 17.020 of 12 %: 25 mg/kg.’
4. The functional group, the identifica
Method of analysis(1)
tion number, the name and the
For identification of D,L-serine in added amount of the active sub
premixtures of flavourings: Ion- stance shall be indicated on the la
exchange chromatography with bel of the premixture where the use
post column ninhydrin derivatisa level suggested on the label of the
tion (Ph.Eur. 6.6-2.2.56-Method 1). premixture would result in exceed
For the determination of D, L-ser ing the level referred to in point 3.
ine in premixtures: Ion-exchange 5. The functional group, the identifica
chromatography with post col tion number, the name and the
umn ninhydrin derivatisation and added amount of the active sub
photometric detection: based on stance shall be indicated in the la
Regulation (EC) No 152/2009 belling of feed materials and com
(Annex III, part F). pound feedingstuffs where the
content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg.
L
53/152
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
2b17022 — L-Tyrosine Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a pre
L-Tyrosine
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
L-Tyrosine and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98 % assay
‘Recommended maximum content
Chemical formula: C H O N
9 11 3 of the active substance of complete
CAS number 60-18-4 feedingstuff with a moisture content
FLAVIS No 17.022 of 12 %: 25 mg/kg.’
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/153Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
Method of analysis(1) 4. The functional group, the identifica
tion number, the name and the
For identification of L-tyrosine in
added amount of the active sub
premixtures of flavourings: Ion-
stance shall be indicated on the la
exchange chromatography with
bel of the premixture where the use
post column ninhydrin derivatisa
level suggested on the label of the
tion (Ph.Eur. 6.6-2.2.56-Method 1).
premixture would result in exceed
For the determination of L-tyro ing the level referred to in point 3.
sine in premixtures: Ion-exchange
5. The functional group, the identifica
chromatography with post col
tion number, the name and the umn ninhydrin derivatisation and
added amount of the active sub
photometric detection: based on
stance shall be indicated in the la
Regulation (EC) No 152/2009
belling of feed materials and com (Annex III, part F).
pound feedingstuffs where the
content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg.
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
L
53/154
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
2b17027 — L-Methionine Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a pre
L-Methionine
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
L-Methionine and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98,5 % assay
‘Recommended maximum content
Chemical formula: C H NO S
5 11 2 of the active substance of complete
CAS number 63-68-3 feedingstuff with a moisture content
FLAVIS No 17.027 of 12 %: 25 mg/kg.’
4. The functional group, the identifica
Method of analysis(1)
tion number, the name and the
For identification of L-methionine added amount of the active sub
in premixtures of flavourings: Ion- stance shall be indicated on the la
exchange chromatography with bel of the premixture where the use
post column ninhydrin derivatisa level suggested on the label of the
tion (Ph.Eur. 6.6-2.2.56-Method 1). premixture would result in exceed
For the determination of L- ing the level referred to in point 3.
methionine in premixtures: Ion- 5. The functional group, the identifica
exchange chromatography with tion number, the name and the
post column ninhydrin derivatisa added amount of the active sub
tion and photometric detection: stance shall be indicated in the la
based on Regulation (EC) belling of feed materials and com
No 152/2009 (Annex III, part F). pound feedingstuffs where the
content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg.
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/155Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
2b17028 — L-Valine Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a pre
L-Valine
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
L-Valine and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98,5 % assay
‘Recommended maximum content
Chemical formula: C H NO
5 11 2 of the active substance of complete
CAS number 72-18-4 feedingstuff with a moisture content
FLAVIS No 17.028 of 12 %: 25 mg/kg.’
L
53/156
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
Method of analysis(1) 4. The functional group, the identifica
tion number, the name and the
For identification of L-valine in
added amount of the active sub
premixtures of flavourings: Ion-
stance shall be indicated on the la
exchange chromatography with
bel of the premixture where the use
post column ninhydrin derivatisa
level suggested on the label of the
tion (Ph.Eur. 6.6-2.2.56-Method 1).
premixture would result in exceed
For the determination of L-valine ing the level referred to in point 3.
in premixtures: Ion-exchange
5. The functional group, the identifica
chromatography with post col
tion number, the name and the umn ninhydrin derivatisation and
added amount of the active sub
photometric detection: based on
stance shall be indicated in the la
Regulation (EC) No 152/2009
belling of feed materials and com (Annex III, part F).
pound feedingstuffs where the
content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg.
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/157Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
2b17033 — L-Cysteine Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a pre
L-Cysteine
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
L-Cysteine and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98 % assay
‘Recommended maximum content
Chemical formula: C H O NS
3 7 2 of the active substance of complete
CAS number 52-90-4 feedingstuff with a moisture content
FLAVIS No 17.033 of 12 %: 25 mg/kg.’
4. The functional group, the identifica
Method of analysis(1)
tion number, the name and the
For identification of L-cysteine in added amount of the active sub
premixtures of flavourings: Ion- stance shall be indicated on the la
exchange chromatography with bel of the premixture where the use
post column ninhydrin derivatisa level suggested on the label of the
tion (Ph.Eur. 6.6-2.2.56-Method 1). premixture would result in exceed
For the determination of L-cy ing the level referred to in point 3.
steine in premixtures: Ion-ex 5. The functional group, the identifica
change chromatography with post tion number, the name and the
column ninhydrin derivatisation added amount of the active sub
and photometric detection: based stance shall be indicated in the la
on Regulation (EC) No 152/2009 belling of feed materials and com
(Annex III, part F). pound feedingstuffs where the
content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg.
L
53/158
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
2b920 — L-Cysteine hy Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
drochloride species ex into the feed in the form of a pre
L-Cysteine hydrochloride mono
monohydrate cept cats mixture.
hydrate
and dogs
2. In the directions for use of the addi
Characterisation of the active sub
tive and premixtures, the storage
stance
and stability conditions shall be in
L-Cysteine hydrochloride mono dicated.
hydrate
3. On the label of the additive the fol
Produced by chemical synthesis or lowing shall be indicated:
protein hydrolysis
‘Recommended maximum content
Purity: min. 98,5 % assay of the active substance of complete
feedingstuff with a moisture content
Chemical formula: C H ClNO S ·
3 8 2 of 12 %: 25 mg/kg for all species
H O
2 except cats and dogs’.
CAS number 7048-04-6
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/159Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
Method of analysis(1) 4. The functional group, the identifica
tion number, the name and the
For identification of L-cysteine hy
added amount of the active sub
drochloride monohydrate in pre
stance shall be indicated on the la
mixtures of flavourings: Ion-ex
bel of the premixture where the use
change chromatography with post
level suggested on the label of the
column ninhydrin derivatisation
premixture would result in exceed
(Ph.Eur. 6.6-2.2.56-Method 1).
ing the level referred to in point 3.
For the determination of L-cy
5. The functional group, the identifica
steine hydrochloride monohydrate
tion number, the name and the in premixtures: Ion-exchange
added amount of the active sub
chromatography with post col
stance shall be indicated in the la
umn ninhydrin derivatisation and
belling of feed materials and com photometric detection: based on
pound feedingstuffs where the
Regulation (EC) No 152/2009
content of the active substance in
(Annex III, part F).
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg for all species except cats
and dogs.
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
L
53/160
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
2b17034 — Glycine Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a pre
Glycine
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
Glycine and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98 % assay
‘Recommended maximum content
Chemical formula: C H O N
2 5 2 of the active substance of complete
CAS number 56-40-6 feedingstuff with a moisture content
FLAVIS No 17.034 of 12 %:
— 20 g/kg for cats and dogs;
Method of analysis(1)
— 25 g/kg for other species and
For identification of glycine in
categories.’
premixtures of flavourings: Ion-
exchange chromatography with 4. The functional group, the identifica
post column ninhydrin derivatisa tion number, the name and the
tion (Ph.Eur. 6.6-2.2.56-Method 1). added amount of the active sub
stance shall be indicated on the la
For the determination of glycine
bel of the premixture where the use
in premixtures: Ion-exchange
level suggested on the label of the
chromatography with post col
premixture would result in exceed
umn ninhydrin derivatisation and
ing the levels referred to in point 3.
photometric detection: based on
Regulation (EC) No 152/2009 5. The functional group, the identifica
(Annex III, part F). tion number, the name and the
added amount of the active sub
stance shall be indicated in the la
belling of feed materials and com
pound feedingstuffs where the
content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
— 20 g/kg for cats and dogs;
— 25 g/kg for other species and
categories.
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/161Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
2b621 — Monosodium Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
glutamate species into the feed in the form of a pre
Monosodium glutamate
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
Monosodium glutamate and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 99 % assay
‘Recommended maximum content
Chemical formula: C H NaNO ·
5 8 4 of the active substance of complete
H O
2 feedingstuff with a moisture content
CAS number 142-47-2 of 12 %: 25 mg/kg.’
L
53/162
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
Method of analysis(1) 4. The functional group, the identifica
tion number, the name and the
For identification of monosodium
added amount of the active sub
glutamate in premixtures of fla
stance shall be indicated on the la
vourings: Ion-exchange chromato
bel of the premixture where the use
graphy with post column ninhy
level suggested on the label of the
drin derivatisation (Ph.Eur. 6.6-
premixture would result in exceed
2.2.56-Method 1).
ing the level referred to in point 3.
For the determination of monoso
5. The functional group, the identifica
dium glutamate in premixtures:
tion number, the name and the Ion-exchange chromatography
added amount of the active sub
with post column ninhydrin deri
stance shall be indicated in the la
vatisation and photometric detec
belling of feed materials and com tion: based on Regulation (EC)
pound feedingstuffs where the
No 152/2009 (Annex III, part F).
content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg.
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, safety glasses and gloves.
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/163Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
2b620 — L-Glutamic Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
acid species into the feed in the form of a pre
L-Glutamic acid
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
L-Glutamic acid and stability conditions shall be in
dicated.
Produced by chemical synthesis or
protein hydrolysis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98 % assay
‘Recommended maximum content
Chemical formula: C H O N
5 9 4 of the active substance of complete
CAS number 56-86-0 feedingstuff with a moisture content
of 12 %: 25 mg/kg.’
Method of analysis(1)
4. The functional group, the identifica
For identification of L-glutamic
tion number, the name and the
acid in premixtures of flavourings:
added amount of the active sub
Ion-exchange chromatography
stance shall be indicated on the la with post column ninhydrin
bel of the premixture where the use
derivatisation (Ph.Eur. 6.6-2.2.56-
level suggested on the label of the
Method 1).
premixture would result in exceed
For the determination of L-gluta ing the level referred to in point 3.
mic acid in premixtures: Ion-ex
5. The functional group, the identifica
change chromatography with post
tion number, the name and the
column ninhydrin derivatisation
added amount of the active sub
and photometric detection: based
stance shall be indicated in the la
on Regulation (EC) No 152/2009
belling of feed materials and com
(Annex III, part F).
pound feedingstuffs where the
content of the active substance in
the complete feedingstuff with
a moisture content of 12 % exceeds:
25 mg/kg.
L
53/164
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
6. For additives produced from hydro
lysis of animal protein, 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 potential 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 protective equip
ment, including breathing protec
tion, 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-reports
(2) Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/165