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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.
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.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEX
Identification number of the additive
Name of the holder of authorisation
Additive
Composition, chemical formula, description, analytical method
Species or category of animal
Maximum age
Minimum content
Maximum content
Other provisions
End of period of authorisation
mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
Category: Sensory additives. Functional group: Flavouring compounds
2b16056
—
Taurine
Additive composition
Taurine
Characterisation of the active substance
Taurine
Produced by chemical synthesis or protein hydrolysis
Purity: min. 98 % assay
Chemical formula: C 2 H 7 O 3 NS
CAS number 107-35-7
FLAVIS No 16.056
Method of analysis
( 1 )
For identification of taurine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of taurine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Commission Regulation (EC) No 152/2009 ( 2 ) (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b17001
—
Beta-alanine
Additive composition
Beta-alanine
Characterisation of the active substance
Beta-alanine
Produced by chemical synthesis or protein hydrolysis
Purity: min. 97 % assay
Chemical formula: C 3 H 7 O 2 N
CAS number 107-95-9
FLAVIS No 17.001
Method of analysis
( 1 )
For identification of beta-alanine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of beta-alanine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b17002
—
L-Alanine
Additive composition
L-Alanine
Characterisation of the active substance
L-Alanine
Produced by chemical synthesis or protein hydrolysis
Purity: min. 98,5 % assay
Chemical formula: C 3 H 7 NO 2
CAS number 56-41-7
FLAVIS No 17.002
Method of analysis
( 1 )
For identification of L-Alanine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of L-alanine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b17003
—
L-Arginine
Additive composition
L-Arginine
Characterisation of the active substance
L-Arginine
Produced by chemical synthesis or protein hydrolysis
Purity: min. 98 % assay
Chemical formula: C 6 H 14 O 2 N 4
CAS number 74-79-3
FLAVIS No 17.003
Method of analysis
( 1 )
For identification of L-arginine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of L-arginine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b17005
—
L-Aspartic acid
Additive composition
L-Aspartic acid
Characterisation of the active substance
L-Aspartic acid
Produced by chemical synthesis or protein hydrolysis
Purity: min. 98 % assay
Chemical formula: C 4 H 7 O 4 N
CAS number 56-84-8
FLAVIS No 17.005
Method of analysis
( 1 )
For identification of L-aspartic acid in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of L-aspartic acid in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b17008
—
L-Histidine
Additive composition
L-Histidine
Characterisation of the active substance
L-Histidine
Produced by chemical synthesis or protein hydrolysis
Purity: min. 98 % assay
Chemical formula: C 6 H 9 O 2 N 3
CAS number 71-00-1
FLAVIS No 17.008
Method of analysis
( 1 )
For identification of L-histidine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of L-histidine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b17010
—
D,L-Isoleucine
Additive composition
D,L-Isoleucine
Characterisation of the active substance
D,L-Isoleucine
Produced by chemical synthesis or protein hydrolysis
Purity: min. 98 % assay
Chemical formula: C 6 H 13 O 2 N
CAS number 443-79-8
FLAVIS No 17.010
Method of analysis
( 1 )
For identification of D,L-isoleucine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of D, L-isoleucine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b17012
—
L-Leucine
Additive composition
L-Leucine
Characterisation of the active substance
L-Leucine
Produced by chemical synthesis or protein hydrolysis
Purity: min. 98 % assay
Chemical formula: C 6 H 13 O 2 N
CAS number 61-90-5
FLAVIS No 17.012
Method of analysis
( 1 )
For identification of L-leucine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of L-leucine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b17018
—
L-Phenylalanine
Additive composition
L-Phenylalanine
Characterisation of the active substance
L-Phenylalanine
Produced by chemical synthesis or protein hydrolysis
Purity: min. 98 % assay
Chemical formula: C 9 H 11 O 2 N
CAS number 63-91-2
FLAVIS No 17.018
Method of analysis
( 1 )
For identification of L-phenylalanine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of L-phenylalanine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b17019
—
L-Proline
Additive composition
L-Proline
Characterisation of the active substance
L-Proline
Produced by chemical synthesis or protein hydrolysis
Purity: min. 98 % assay
Chemical formula: C 5 H 9 O 2 N
CAS number 147-85-3
FLAVIS No 17.019
Method of analysis
( 1 )
For identification of L-proline in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of L-proline in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b17020
—
D,L-Serine
Additive composition
D,L-Serine
Characterisation of the active substance
D,L-Serine
Produced by chemical synthesis or protein hydrolysis
Purity: min. 95 % assay
Chemical formula: C 3 H 7 NO 3
CAS number 302-84-1
FLAVIS No 17.020
Method of analysis
( 1 )
For identification of D,L-serine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of D, L-serine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b17022
—
L-Tyrosine
Additive composition
L-Tyrosine
Characterisation of the active substance
L-Tyrosine
Produced by chemical synthesis or protein hydrolysis
Purity: min. 98 % assay
Chemical formula: C 9 H 11 O 3 N
CAS number 60-18-4
FLAVIS No 17.022
Method of analysis
( 1 )
For identification of L-tyrosine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of L-tyrosine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b17027
—
L-Methionine
Additive composition
L-Methionine
Characterisation of the active substance
L-Methionine
Produced by chemical synthesis or protein hydrolysis
Purity: min. 98,5 % assay
Chemical formula: C 5 H 11 NO 2 S
CAS number 63-68-3
FLAVIS No 17.027
Method of analysis
( 1 )
For identification of L-methionine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of L-methionine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b17028
—
L-Valine
Additive composition
L-Valine
Characterisation of the active substance
L-Valine
Produced by chemical synthesis or protein hydrolysis
Purity: min. 98,5 % assay
Chemical formula: C 5 H 11 NO 2
CAS number 72-18-4
FLAVIS No 17.028
Method of analysis
( 1 )
For identification of L-valine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of L-valine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b17033
—
L-Cysteine
Additive composition
L-Cysteine
Characterisation of the active substance
L-Cysteine
Produced by chemical synthesis or protein hydrolysis
Purity: min. 98 % assay
Chemical formula: C 3 H 7 O 2 NS
CAS number 52-90-4
FLAVIS No 17.033
Method of analysis
( 1 )
For identification of L-cysteine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of L-cysteine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b920
—
L-Cysteine hydrochloride monohydrate
Additive composition
L-Cysteine hydrochloride monohydrate
Characterisation of the active substance
L-Cysteine hydrochloride monohydrate
Produced by chemical synthesis or protein hydrolysis
Purity: min. 98,5 % assay
Chemical formula: C 3 H 8 ClNO 2 S · H 2 O
CAS number 7048-04-6
Method of analysis
( 1 )
For identification of L-cysteine hydrochloride monohydrate in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of L-cysteine hydrochloride monohydrate in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species except cats and dogs
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg for all species except cats and dogs’.
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b17034
—
Glycine
Additive composition
Glycine
Characterisation of the active substance
Glycine
Produced by chemical synthesis or protein hydrolysis
Purity: min. 98 % assay
Chemical formula: C 2 H 5 O 2 N
CAS number 56-40-6
FLAVIS No 17.034
Method of analysis
( 1 )
For identification of glycine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of glycine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:
—
20 g/kg for cats and dogs;
—
25 g/kg for other species and categories.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the levels referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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.
6.
For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b621
—
Monosodium glutamate
Additive composition
Monosodium glutamate
Characterisation of the active substance
Monosodium glutamate
Produced by chemical synthesis or protein hydrolysis
Purity: min. 99 % assay
Chemical formula: C 5 H 8 NaNO 4 · H 2 O
CAS number 142-47-2
Method of analysis
( 1 )
For identification of monosodium glutamate in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of monosodium glutamate in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
2b620
—
L-Glutamic acid
Additive composition
L-Glutamic acid
Characterisation of the active substance
L-Glutamic acid
Produced by chemical synthesis or protein hydrolysis
Purity: min. 98 % assay
Chemical formula: C 5 H 9 O 4 N
CAS number 56-86-0
Method of analysis
( 1 )
For identification of L-glutamic acid in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
For the determination of L-glutamic acid in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).
All animal species
—
—
—
1.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound 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 hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.
7.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
15.3.2028
( 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 ).
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. ) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32018R0249
© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.
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