title: Commission Implementing Regulation (EU) 2018/243 of 15 February 2018 concerning the authorisation of 3-hydroxybutan-2-one, pentan-2,3-dione, 3,5-dimethyl cyclopentan-1,2-dione, hexan-3,4-dione, sec-butan-3-onyl acetate, 2,6,6-trimethylcyclohex-2-en-1,4-dione and 3-methylnona-2-,4-dione as feed additives for all animal species (Text with EEA relevance. )

text:
                  23.2.2018

                  EN

                  Official Journal of the European Union

                  L 53/69

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/243
      of 15 February 2018
      concerning the authorisation of 3-hydroxybutan-2-one, pentan-2,3-dione, 3,5-dimethyl cyclopentan-1,2-dione, hexan-3,4-dione, sec-butan-3-onyl acetate, 2,6,6-trimethylcyclohex-2-en-1,4-dione and 3-methylnona-2-,4-dione 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 3-hydroxybutan-2-one, pentan-2,3-dione, 3,5-dimethyl cyclopentan-1,2-dione, hexan-3,4-dione, sec-butan-3-onyl acetate, 2,6,6-trimethylcyclohex-2-en-1,4-dione and 3-methylnona-2-,4-dione (‘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 as feed additives for all animal species. The applicant requested that 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 19 October 2016 (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 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, a recommended content should be indicated on the label of the additive. Where such content is 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 hazards for the skin, eye contact and respiratory exposure are recognised. Most substances 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 as 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 as 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(11):4618.

         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

                     2b07051

                     —

                     3-Hydroxybutan-2-one

                        Additive composition

                     3-Hydroxybutan-2-one

                        Characterisation of the active substance

                     3-Hydroxybutan-2-one
                     Produced by chemical synthesis
                     Purity: min. 96 % assay
                     Chemical formula: C4H8O2

                     CAS number: 513-86-0
                     FLAVIS No: 07.051

                        Method of analysis
                         (1)

                     For the determination of 3-hydroxybutan-2-one 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 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 %: 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 the 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: 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

                     2b07060

                     —

                     Pentan-2,3-dione

                        Additive composition

                     Pentan-2,3-dione

                        Characterisation of the active substance

                     Pentan-2,3-dione
                     Produced by chemical synthesis
                     Purity: min. 93 % assay
                     Chemical formula: C5H8O2

                     CAS number: 600-14-6
                     FLAVIS No: 07.060

                        Method of analysis
                         (1)

                     For the determination of pentan-2,3-dione 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 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 %: 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 the 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: 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

                     2b07076

                     —

                     3,5-Dimethyl cyclopentan-1,2-dione

                        Additive composition

                     3,5-dimethyl cyclopentan-1,2-dione

                        Characterisation of the active substance

                     3,5-dimethyl cyclopentan-1,2-dione
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C7H10O2

                     CAS number: 13494-07-0
                     FLAVIS No: 07.076

                        Method of analysis
                         (1)

                     For the determination of 3,5-dimethyl cyclopentan-1,2-dione 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 the 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

                     2b07077

                     —

                     Hexan-3,4-dione

                        Additive composition

                     Hexan-3,4-dione

                        Characterisation of the active substance

                     Hexan-3,4-dione
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C6H10O2

                     CAS number: 4437-51-8
                     FLAVIS No: 07.077

                        Method of analysis
                         (1)

                     For the determination of hexan-3,4-dione 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 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 %: 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 the 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: 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

                     2b09186

                     —

                     Sec-butan-3-onyl acetate

                        Additive composition

                     Sec-butan-3-onyl acetate

                        Characterisation of the active substance

                     Sec-butan-3-onyl acetate
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C6H10O3

                     CAS number: 4906-24-5
                     FLAVIS No: 09.186

                        Method of analysis
                         (1)

                     For the determination of sec-butan-3-onyl acetate 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 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 %: 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 the 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: 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

                     2b07109

                     —

                     2,6,6-Trimethylcyclohex-2-en-1,4-dione

                        Additive composition

                     2,6,6-Trimethylcyclohex-2-en-1,4-dione

                        Characterisation of the active substance

                     2,6,6-Trimethylcyclohex-2-en-1,4-dione
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C9H12O2

                     CAS number: 1125-21-9
                     FLAVIS No: 07.109

                        Method of analysis
                         (1)

                     For the determination of 2,6,6-trimethylcyclohex-2-en-1,4-dione 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 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 the 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

                     2b07184

                     —

                     3-Methylnona-2-,4-dione

                        Additive composition

                     3-Methylnona-2-,4-dione

                        Characterisation of the active substance

                     3-Methylnona-2-,4-dione
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C10H18O2

                     CAS number: 113486-29-6
                     FLAVIS No: 07.184

                        Method of analysis
                         (1)

                     For the determination of 3-methylnona-2-,4-dione 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 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 the 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) 2018/239 of 15 February 2018 concerning the authorisation of methyl N-methylanthranilate and methylanthranilate as feed additives for all animal species except avian species (Text with EEA relevance. )

text:
                  23.2.2018

                  EN

                  Official Journal of the European Union

                  L 53/9

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/239
      of 15 February 2018
      concerning the authorisation of methyl N-methylanthranilate and methylanthranilate as feed additives for all animal species except avian 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 methyl N-methylanthranilate and methylanthranilate were authorised without a time limit in accordance with 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 methyl N-methylanthranilate and methylanthranilate as feed additives for all animal species except for avian species. The applicant requested those additives to 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 15 November 2011 (3) that, under the proposed conditions of use in feed, methyl N-methylanthranilate and methylanthranilate do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since methyl N-methylanthranilate and methylanthranilate 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 concluded that methyl N-methylanthranilate and methylanthranilate are possible eye and respiratory irritants. 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 methyl N-methylanthranilate and methylanthranilate 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 methyl N-methylanthranilate and methylanthranilate, 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 2011; 9(12):2441

         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

                     2b09781

                     —

                     Methyl N-methylanthranilate

                        Additive composition

                     Methyl N-methylanthranilate

                        Characterisation of the active substance

                     Methyl N-methylanthranilate
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C9H11O2N
                     CAS number: 85-91-6
                     FLAVIS No 09.781

                        Method of analysis
                         (1)

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

                     All species except avian 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: 4 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 %: 4 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: 4 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

                     2b09715

                     —

                     Methylanthranilate

                        Additive composition

                     Methylanthranilate

                        Characterisation of the active substance

                     Methylanthranilate
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C8H9O2N
                     CAS number: 134-20-3
                     FLAVIS No 09.715

                        Method of analysis
                         (1)

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

                     All species except avian 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: 25 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 %: 25 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: 25 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

            (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) 2018/248 of 15 February 2018 concerning the authorisation of 2,3-diethylpyrazine, 2,5 or 6-methoxy-3-methylpyrazine, 2-acetyl-3-ethylpyrazine, 2,3-diethyl-5-methylpyrazine, 2-(sec-butyl)-3-methoxypyrazine, 2-ethyl-3-methoxypyrazine, 5,6,7,8-tetrahydroquinoxaline, 2-ethylpyrazine and 5-methylquinoxaline as feed additives for all animal species (Text with EEA relevance. )

text:
                  23.2.2018

                  EN

                  Official Journal of the European Union

                  L 53/120

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/248
      of 15 February 2018
      concerning the authorisation of 2,3-diethylpyrazine, 2,5 or 6-methoxy-3-methylpyrazine, 2-acetyl-3-ethylpyrazine, 2,3-diethyl-5-methylpyrazine, 2-(sec-butyl)-3-methoxypyrazine, 2-ethyl-3-methoxypyrazine, 5,6,7,8-tetrahydroquinoxaline, 2-ethylpyrazine and 5-methylquinoxaline 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 2,3-diethylpyrazine, 2,5 or 6-methoxy-3-methylpyrazine, 2-acetyl-3-ethylpyrazine, 2,3-diethyl-5-methylpyrazine, 2-(sec-butyl)-3-methoxypyrazine, 2-ethyl-3-methoxypyrazine, 5,6,7,8-tetrahydroquinoxaline, 2-ethylpyrazine and 5-methylquinoxaline (‘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 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 6 December 2016 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. These substances increase the food smell or palatability. The Authority has concluded that since the substances concerned are 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 for feed. The applicant withdrew the application for use of the substances concerned in water for drinking.

                  (5)

                  The Authority further noted that for the substances concerned hazards for the skin, eye contact and respiratory exposure are recognised. Most substances 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.

                  (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. Accordingly, the use of those substances 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 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 as 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 as 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;15(2):4671.

         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

                     2b14005

                     —

                     2,3-Diethylpyrazine

                        Additive composition

                     2,3-Diethylpyrazine

                        Characterisation of the active substance

                     2,3-Diethylpyrazine
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C8H12N2

                     CAS number: 15707-24-1
                     FLAVIS No: 14.005

                        Method of analysis
                         (1)

                     For the determination of 2,3-diethylpyrazine 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.

                                 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 %:

                                             —

                                             0,1 mg/kg for pigs and poultry.

                                             —

                                             0,5 mg/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 levels 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:

                                             —

                                             0,1 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

                     2b14025

                     —

                     2,5 or 6-Methoxy-3-methylpyrazine

                        Additive composition

                     2,5 or 6-Methoxy-3-methylpyrazine

                        Characterisation of the active substance

                     2,5 or 6-Methoxy-3-methylpyrazine
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C6H8ON2

                     CAS number: 63450-30-6
                     FLAVIS No: 14.025

                        Method of analysis
                         (1)

                     For the determination of 2,5 or 6-methoxy-3-methylpyrazine 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.

                                 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 %:

                                             —

                                             0,1 mg/kg for pigs and poultry.

                                             —

                                             0,5 mg/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 levels 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:

                                             —

                                             0,1 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

                     2b14049

                     —

                     2-Acetyl-3-ethylpyrazine

                        Additive composition

                     2-Acetyl-3-ethylpyrazine

                        Characterisation of the active substance

                     2-Acetyl-3-ethylpyrazine
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C8H10ON2

                     CAS number: 32974-92-8
                     FLAVIS No: 14.049

                        Method of analysis
                         (1)

                     For the determination of 2-acetyl-3-ethylpyrazine 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.

                                 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 %:

                                             —

                                             0,1 mg/kg for pigs and poultry.

                                             —

                                             0,5 mg/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 levels 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:

                                             —

                                             0,1 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

                     2b14056

                     —

                     2,3-Diethyl-5-methylpyrazine

                        Additive composition

                     2,3-Diethyl-5-methylpyrazine

                        Characterisation of the active substance

                     2,3-Diethyl-5-methylpyrazine
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C9H14N2

                     CAS number: 18138-04-0
                     FLAVIS No: 14.056

                        Method of analysis
                         (1)

                     For the determination of 2,3-diethyl-5-methylpyrazine alcohol 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.

                                 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 %:

                                             —

                                             0,1 mg/kg for pigs and poultry.

                                             —

                                             0,5 mg/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 levels 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:

                                             —

                                             0,1 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

                     2b14062

                     —

                     2-(sec-Butyl)-3-methoxypyrazine

                        Additive composition

                     2-(sec-Butyl)-3-methoxypyrazine

                        Characterisation of the active substance

                     2-(sec-Butyl)-3-methoxypyrazine
                     Produced by chemical synthesis
                     Purity: min. 99 % assay
                     Chemical formula: C9H14ON2

                     CAS number: 24168-70-5
                     FLAVIS No: 14.062

                        Method of analysis
                         (1)

                     For the determination of 2-(sec-butyl)-3-methoxypyrazine 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.

                                 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 %:

                                             —

                                             0,1 mg/kg for pigs and poultry.

                                             —

                                             0,5 mg/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 levels 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:

                                             —

                                             0,1 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

                     2b14112

                     —

                     2-Ethyl-3-methoxypyrazine

                        Additive composition

                     2-Ethyl-3-methoxypyrazine

                        Characterisation of the active substance

                     2-Ethyl-3-methoxypyrazine
                     Produced by chemical synthesis
                     Purity: min. 99 % assay
                     Chemical formula: C7H10N2O
                     CAS number: 25680-58-4
                     FLAVIS No: 14.112

                        Method of analysis
                         (1)

                     For the determination of 2-ethyl-3-methoxypyrazine 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.

                                 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 %:

                                             —

                                             0,1 mg/kg for pigs and poultry

                                             —

                                             0,5 mg/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 levels 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:

                                             —

                                             0,1 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

                     2b14015

                     —

                     5,6,7,8-Tetrahydroquinoxaline

                        Additive composition

                     5,6,7,8-Tetrahydroquinoxaline

                        Characterisation of the active substance

                     5,6,7,8-Tetrahydroquinoxaline
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C8H10N2

                     CAS number: 34413-35-9
                     FLAVIS No: 14.015

                        Method of analysis
                         (1)

                     For the determination of 5,6,7,8-tetrahydroquinoxaline 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.

                                 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 %:

                                             —

                                             0,1 mg/kg for pigs and poultry.

                                             —

                                             0,5 mg/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 levels 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:

                                             —

                                             0,1 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

                     2b14022

                     —

                     2-Ethylpyrazine

                        Additive composition

                     2-Ethylpyrazine

                        Characterisation of the active substance

                     2-Ethylpyrazine
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C6H8N2

                     CAS number: 13925-00-3
                     FLAVIS No: 14.022

                        Method of analysis
                         (1)

                     For the determination of 2-ethylpyrazine 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.

                                 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 %:

                                             —

                                             0,1 mg/kg for pigs and poultry.

                                             —

                                             0,5 mg/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 levels 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:

                                             —

                                             0,1 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

                     2b14028

                     —

                     5-Methylquinoxaline

                        Additive composition

                     5-Methylquinoxaline

                        Characterisation of the active substance

                     5-Methylquinoxaline
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C9H8N2

                     CAS number: 13708-12-8
                     FLAVIS No: 14.028

                        Method of analysis
                         (1)

                     For the determination of 5-methylquinoxaline 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.

                                 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 %:

                                             —

                                             0,05 mg/kg for pigs and poultry

                                             —

                                             0,08 mg/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 levels 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:

                                             —

                                             0,05 mg/kg for pigs and poultry.

                                             —

                                             0,08 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