title: Commission Implementing Regulation (EU) 2018/241 of 15 February 2018 concerning the authorisation of piperine, 3-methylindole, indole, 2-acetylpyrrole and pyrrolidine as feed additives for all animal species (Text with EEA relevance. )

text:
                  23.2.2018

                  EN

                  Official Journal of the European Union

                  L 53/27

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/241
      of 15 February 2018
      concerning the authorisation of piperine, 3-methylindole, indole, 2-acetylpyrrole and pyrrolidine as feed additives for all animal species
      (Text with EEA relevance)
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
      Whereas:

                  (1)

                  Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

                  (2)

                  The substances piperine, 3-methylindole, indole, 2-acetylpyrrole and pyrrolidine, (‘the substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feeds additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

                  (3)

                  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of the substances concerned as feed additives for all animal species. The applicant requested that those additives be classified in the additive category ‘sensory additives’. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                  (4)

                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 January 2016 (3) that, under the proposed conditions of use in feed, the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for water for drinking. However, it should be possible to use the substances concerned within compound feeds which are subsequently administered via water.

                  (5)

                  Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures and on the labelling of feed materials and compound feed.

                  (6)

                  The Authority noted that for the substances concerned potential hazards for skin and eye contact and respiratory exposure are recognised. Most are classified as irritating to the respiratory system. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                  (7)

                  The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.

                  (8)

                  Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

                  (9)

                  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

            HAS ADOPTED THIS REGULATION:
      Article 1
      Authorisation
      The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.
      Article 2
      Transitional measures
      1.   The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 15 September 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 specified in the Annex which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the 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 specified in the Annex which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
      Article 3
      Entry into force
      This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

         This Regulation shall be binding in its entirety and directly applicable in all Member States.
         Done at Brussels, 15 February 2018.

               For the Commission

               The President

            Jean-Claude JUNCKER

         (1)  OJ L 268, 18.10.2003, p. 29.

         (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

         (3)  EFSA Journal 2016;14(2):4390

         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

                     2b14003

                     —

                     Piperine

                        Additive composition

                     Piperine

                        Characterisation of the active substance

                     Piperine
                     Produced by chemical synthesis
                     Purity: min. 95 %
                     Chemical formula: C17H19O3N
                     CAS number: 94-62-2
                     FLAVIS No: 14.003

                        Method of analysis
                         (1)

                     For the determination of piperine in the feed additive and in feed flavouring premixtures:
                     Gas chromatography coupled to a Flame Ionisation Detector (GC-FID).

                     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.

                                 The recommended maximum content of the active substance shall be: 0,5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 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 %: 0,5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 0,5 mg/kg.

                                 6.

                                 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

                     2b14004

                     —

                     3-Methylindole

                        Additive composition

                     3-Methylindole

                        Characterisation of the active substance

                     3-Methylindole
                     Produced by chemical synthesis
                     Purity: min. 97 %
                     Chemical formula: C9H9N
                     CAS number: 83-34-1
                     FLAVIS No:14.004

                        Method of analysis
                         (1)

                     For the identification of 3-methylindole in the feed additive and flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     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.

                                 The recommended maximum content of the active substance shall be: 0,5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 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 %: 0,5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 0,5 mg/kg.

                                 6.

                                 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

                     2b14007

                     —

                     Indole

                        Additive composition

                     Indole

                        Characterisation of the active substance

                     Indole
                     Produced by chemical synthesis
                     Purity: min. 97 %
                     Chemical formula: C8H7N
                     CAS number: 120-72-9
                     FLAVIS No: 14.007

                        Method of analysis
                         (1)

                     For the determination of indole in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     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.

                                 The recommended maximum content of the active substance shall be: 0,5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 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 %: 0,5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 0,5 mg/kg.

                                 6.

                                 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

                     2b14047

                     —

                     2-Acetylpyrrole

                        Additive composition

                     2-Acetylpyrrole

                        Characterisation of the active substance

                     2-Acetylpyrrole
                     Produced by chemical synthesis
                     Purity: min. 97 %
                     Chemical formula: C6H7ON
                     CAS number 1072-83-9
                     FLAVIS No: 14.047

                        Method of analysis
                         (1)

                     For the determination of 2-acetylpyrrole in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     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.

                                 The recommended maximum content of the active substance shall be: 0,5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 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 %: 0,5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 0,5 mg/kg.

                                 6.

                                 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

                     2b14064

                     —

                     Pyrrolidine

                        Additive composition

                     Pyrrolidine

                        Characterisation of the active substance

                     Pyrrolidine
                     Produced by chemical synthesis
                     Purity: min. 95 %
                     Chemical formula: C4H9N
                     CAS number 123-75-1
                     FLAVIS No: 14.064

                        Method of analysis
                         (1)

                     For the determination of pyrrolidine the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     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.

                                 The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %.shall be:

                                             —

                                             0,3 mg/kg for pigs and poultry,

                                             —

                                             0,5 mg/kg for other species and categories.

                                 4.

                                 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 %:

                                             —

                                             0,3 mg/kg for pigs and poultry,

                                             —

                                             0,5 mg/kg for other species and categories.’

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

                                             —

                                             0,3 mg/kg for pigs and poultry,

                                             —

                                             0,5 mg/kg for other species and categories.

                                 6.

                                 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


title: 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. )

text:
                  23.2.2018

                  EN

                  Official Journal of the European Union

                  L 53/134

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/249
      of 15 February 2018
      concerning the authorisation of taurine, beta-alanine, L-alanine, L-arginine, L-aspartic acid, L-histidine, D,L-isoleucine, L-leucine, L-phenylalanine, L-proline, D,L-serine, L-tyrosine, L-methionine, L-valine, L-cysteine, glycine, monosodium glutamate and L-glutamic acid as feed additives for all animal species and L-cysteine hydrochloride monohydrate for all species except cats and dogs
      (Text with EEA relevance)
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
      Whereas:

                  (1)

                  Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

                  (2)

                  The substances taurine, beta-alanine, L-alanine, L-arginine, L-aspartic acid, L-histidine, D,L-isoleucine, L-leucine, L-phenylalanine, L-proline, D,L-serine, L-tyrosine, L-methionine, L-valine, L-cysteine, L-cysteine hydrochloride monohydrate, glycine, monosodium glutamate and L-glutamic acid (‘substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

                  (3)

                  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of the substances concerned produced by fermentation, protein hydrolysis and chemical synthesis as feed additives for all animal species. The applicant requested those additives be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                  (4)

                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 9 April 2014 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The lack of information on the production strains does not allow concluding on the substances concerned produced by fermentation. The Authority has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for the use of the substances concerned in water for drinking.

                  (5)

                  The Authority further concluded that, in the absence of data, the substances concerned should be considered as irritating to skin and eyes and as skin sensitisers. The Authority also considered that the substances concerned are irritating to the respiratory system and have the potential to produce hazardous dust. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                  (6)

                  The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied except for the substances concerned produced by fermentation. The lack of information on the production strains does not allow assessing their safety. Accordingly, the use of the substances concerned produced by chemical synthesis and protein hydrolysis should be authorised as specified in the Annex to this Regulation.

                  (7)

                  The applicant proposed use levels for the substances concerned to the Authority. Having regard to that proposal, the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of official controls along the food chain, certain labelling requirements should be provided for. In particular, where the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of premixtures and the labelling of feed materials and compound feed containing the substances concerned include certain information including reference to the levels considered by the Authority.

                  (8)

                  The fact that the use of the substances concerned in water for drinking is not authorised does not preclude their use in compound feed which is administered via water.

                  (9)

                  Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

                  (10)

                  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

            HAS ADOPTED THIS REGULATION:
      Article 1
      Authorisation
      The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.
      Article 2
      Transitional measures
      1.   The substances taurine, beta-alanine, L-alanine, L-arginine, L-aspartic acid, L-histidine, D,L-isoleucine, L-leucine, L-phenylalanine, L-proline, D,L-serine, L-tyrosine, L-methionine, L-valine, L-cysteine, L-cysteine hydrochloride monohydrate, glycine, monosodium glutamate and L-glutamic acid, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, and premixtures containing those substances, which are produced and labelled before 15 December 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.
      2.   Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and labelled before 15 September 2019 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
      3.   Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and labelled before 15 September 2020 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
      Article 3
      Entry into force
      This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

         This Regulation shall be binding in its entirety and directly applicable in all Member States.
         Done at Brussels, 15 February 2018.

               For the Commission

               The President

            Jean-Claude JUNCKER

         (1)  OJ L 268, 18.10.2003, p. 29.

         (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

         (3)  EFSA Journal 2014;12(5):3670.

         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: C2H7O3NS
                     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: C3H7O2N
                     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: C3H7NO2

                     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: C6H14O2N4

                     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: C4H7O4N
                     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: C6H9O2N3

                     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: C6H13O2N
                     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: C6H13O2N
                     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: C9H11O2N
                     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: C5H9O2N
                     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: C3H7NO3

                     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: C9H11O3N
                     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: C5H11NO2S
                     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: C5H11NO2

                     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: C3H7O2NS
                     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: C3H8ClNO2S · H2O
                     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: C2H5O2N
                     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: C5H8 NaNO4 · H2O
                     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: C5H9O4N
                     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).