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. )

Authorisation

Article 1

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.

Transitional measures

Article 2

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.

Entry into force

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

ANNEXSupplementary provisions

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 ).