title: Commission Implementing Regulation (EU) 2020/1396 of 5 October 2020 concerning the authorisation of geraniol, citral, 3,7,11-trimethyldodeca-2,6,10-trien-1-ol, (Z)-nerol, geranyl acetate, geranyl butyrate, geranyl formate, geranyl propionate, neryl propionate, neryl formate, neryl acetate, neryl isobutyrate, geranyl isobutyrate and prenyl acetate as feed additives for all animal species except for marine animals (Text with EEA relevance)

text:
                  6.10.2020

                  EN

                  Official Journal of the European Union

                  L 324/6

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1396
         of 5 October 2020
         concerning the authorisation of geraniol, citral, 3,7,11-trimethyldodeca-2,6,10-trien-1-ol, (Z)-nerol, geranyl acetate, geranyl butyrate, geranyl formate, geranyl propionate, neryl propionate, neryl formate, neryl acetate, neryl isobutyrate, geranyl isobutyrate and prenyl acetate as feed additives for all animal species except for marine animals
         (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(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

                     (2)

                     The substances geraniol, citral, 3,7,11-trimethyldodeca-2,6,10-trien-1-ol, (Z)-nerol, geranyl acetate, geranyl butyrate, geranyl formate, geranyl propionate, neryl propionate, neryl formate, neryl acetate, neryl isobutyrate, geranyl isobutyrate and prenyl acetate (‘the substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those additives substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1)(b) 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 to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. The 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 25 May 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 concluded that for the marine environment, the safe use level is estimated to be 0,05 mg/kg feed. The levels of use proposed for the substances concerned exceeds the safe level for the marine environment, therefore, the use for marine animals is not authorised. The Authority also concluded in the opinion that, since the substances concerned are efficacious when used as flavourings in food and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion could be extrapolated to feed. Although the applicant withdrew the application for water for drinking, it should be possible to use the substances concerned within compound feeds which are subsequently administered via water.

                     (5)

                     The Authority concluded that in the absence of data the substances concerned should be considered hazardous for the skin, and eye contact and for respiratory exposure. Geraniol, citral and 3,7,11-trimethyldodeca-2,6,10-trien-1-ol, are also reported to be skin sensitisers. 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 the substances concerned should be authorised as specified in the Annex to this Regulation.

                     (7)

                     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 feed additive. Where such content is exceeded, certain information should be indicated on the label of premixtures.

                     (8)

                     Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of 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 26 April 2021 in accordance with the rules applicable before 26 October 2020 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 26 October 2021 in accordance with the rules applicable before 26 October 2020 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 26 October 2022 in accordance with the rules applicable before 26 October 2020 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, 5 October 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (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(6):4512.

            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

                        2b02012

                        -

                        Geraniol

                           Additive composition

                        Geraniol

                           Characterisation of the active substance

                        Geraniol
                        Produced by fractional distillation of an essential oil or by chemical synthesis
                        Purity: min. 95 % assay
                        Chemical formula: C10H18O
                        CAS number: 106-24-1
                        FLAVIS No: 02.012

                           Method of analysis
                            (1)

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

                        All animal species except marine animals

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture of flavourings.

                                    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 the premixtures, 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.

                           26.10.2030

                        2b02029

                        -

                        3,7,11-Trimethyldodeca-2,6,10-trien-1-ol

                           Additive composition

                        3,7,11-Trimethyldodeca-2,6,10-trien-1-ol

                           Characterisation of the active substance

                        3,7,11-Trimethyldodeca-2,6,10-trien-1-ol
                        Produced by chemical synthesis
                        Purity: min. 96 % assay
                        Chemical formula: C15H26O
                        CAS number: 4602-84-0
                        FLAVIS No: 02.029

                           Method of analysis
                            (1)

                        For the determination of 3,7,11-Trimethyldodeca-2,6,10-trien-1-ol in the feed additive and in feed flavouring premixtures:
                        Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                        All animal species except marine animals

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture of flavourings.

                                    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, 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.

                           26.10.2030

                        2b02058

                        -

                        (Z)-Nerol

                           Additive composition

                        (Z)-Nerol

                           Characterisation of the active substance

                        (Z)-Nerol
                        Produced by chemical synthesis
                        Purity: min. 95 % assay
                        Chemical formula: C10H18O
                        CAS number: 106-25-2
                        FLAVIS No: 02.058

                           Method of analysis
                            (1)

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

                        All animal species except marine animals

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture of flavourings.

                                    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, 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.

                           26.10.2030

                        2b05020

                        -

                        Citral

                           Additive composition

                        Citral

                           Characterisation of the active substance

                        Citral
                        Produced by chemical synthesis
                        Purity: min. 96 % assay
                        Chemical formula: C10H16O
                        CAS number: 5392-40-5
                        FLAVIS No: 05.020

                           Method of analysis
                            (1)

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

                        All animal species except marine animals

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture of flavourings.

                                    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 the premixtures, 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.

                           26.10.2030

                        2b09011

                        -

                        Geranyl acetate

                           Additive composition

                        Geranyl acetate

                           Characterisation of the active substance

                        Geranyl acetate
                        Produced by chemical synthesis
                        Purity: min. 90 % assay
                        Chemical formula: C12H20O2

                        CAS number: 105-87-3
                        FLAVIS No: 09.011

                           Method of analysis
                            (1)

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

                        All animal species except marine animals

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture of flavourings.

                                    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, 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.

                           26.10.2030

                        2b09048

                        -

                        Geranyl butyrate

                           Additive composition

                        Geranyl butyrate

                           Characterisation of the active substance

                        Geranyl butyrate
                        Produced by chemical synthesis
                        Purity: min. 92 % assay
                        Chemical formula: C14H24O2

                        CAS number: 106-29-6
                        FLAVIS No: 09.048

                           Method of analysis
                            (1)

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

                        All animal species except marine animals

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture of flavourings.

                                    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, 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.

                           26.10.2030

                        2b09076

                        -

                        Geranyl formate

                           Additive composition

                        Geranyl formate

                           Characterisation of the active substance

                        Geranyl formate
                        Produced by chemical synthesis
                        Purity: min. 94 % assay
                        Chemical formula: C11H18O2

                        CAS number: 105-86-2
                        FLAVIS No: 09.076

                           Method of analysis
                            (1)

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

                        All animal species except marine animals

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture of flavourings.

                                    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, 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.

                           26.10.2030

                        2b09128

                        -

                        Geranyl propionate

                           Additive composition

                        Geranyl propionate

                           Characterisation of the active substance

                        Geranyl propionate
                        Produced by chemical synthesis
                        Purity: min. 92 % assay
                        Chemical formula: C13H22O2

                        CAS number: 105-90-8
                        FLAVIS No: 09.128

                           Method of analysis
                            (1)

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

                        All animal species except marine animals

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture of flavourings.

                                    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, 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.

                           26.10.2030

                        2b09169

                        -

                        Neryl propionate

                           Additive composition

                        Neryl propionate

                           Characterisation of the active substance

                        Neryl propionate
                        Produced by chemical synthesis
                        Purity: min. 95 % assay
                        Chemical formula: C13H22O2

                        CAS number: 105-91-9
                        FLAVIS No: 09.169

                           Method of analysis
                            (1)

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

                        All animal species except marine animals

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture of flavourings.

                                    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, 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.

                           26.10.2030

                        2b09212

                        -

                        Neryl formate

                           Additive composition

                        Neryl formate

                           Characterisation of the active substance

                        Neryl formate
                        Produced by chemical synthesis
                        Purity: min. 90 % assay
                        Chemical formula: C11H18O2

                        CAS number: 2142-94-1
                        FLAVIS No: 09.212

                           Method of analysis
                            (1)

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

                        All animal species except marine animals

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture of flavourings.

                                    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, 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.

                           26.10.2030

                        2b09213

                        -

                        Neryl acetate

                           Additive composition

                        Neryl acetate

                           Characterisation of the active substance

                        Neryl acetate
                        Produced by chemical synthesis
                        Purity: min. 93 % assay
                        Chemical formula: C12H20O2

                        CAS number: 141-12-8
                        FLAVIS No: 09.213

                           Method of analysis
                            (1)

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

                        All animal species except marine animals

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture of flavourings.

                                    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.

                           26.10.2030

                        2b09424

                        -

                        Neryl isobutyrate

                           Additive composition

                        Neryl isobutyrate

                           Characterisation of the active substance

                        Neryl isobutyrate
                        Produced by chemical synthesis
                        Purity: min. 92 % assay
                        Chemical formula: C14H24O2

                        CAS number: 2345-24-6
                        FLAVIS No: 09.424

                           Method of analysis
                            (1)

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

                        All animal species except marine animals

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture of flavourings.

                                    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, 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.

                           26.10.2030

                        2b09431

                        -

                        Geranyl isobutyrate

                           Additive composition

                        Geranyl isobutyrate

                           Characterisation of the active substance

                        Geranyl isobutyrate
                        Produced by chemical synthesis
                        Purity: min. 95 % assay
                        Chemical formula: C14H24O2

                        CAS number: 2345-26-8
                        FLAVIS No: 09.431

                           Method of analysis
                            (1)

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

                        All animal species except marine animals

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture of flavourings.

                                    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, 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.

                           26.10.2030

                        2b09692

                        -

                        Prenyl acetate

                           Additive composition

                        Prenyl acetate

                           Characterisation of the active substance

                        Prenyl acetate
                        Produced by chemical synthesis
                        Purity: min. 95 % assay
                        Chemical formula: C7H12O2

                        CAS number: 1191-16-8
                        FLAVIS No: 09.692

                           Method of analysis
                            (1)

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

                        All animal species except marine animals

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture of flavourings.

                                    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 1 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 %: 1 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, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds 1 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.

                           26.10.2030

               (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) 2020/1397 of 5 October 2020 concerning the renewal of the authorisation of L-isoleucine produced by Escherichia coli FERM ABP-10641 as a nutritional additive, its extension of use and the authorisation of L-isoleucine produced by Corynebacterium glutamicum KCCM 80189 as a feed additive for all animal species, and repealing Regulation (EU) No 348/2010 (Text with EEA relevance)

text:
                  6.10.2020

                  EN

                  Official Journal of the European Union

                  L 324/19

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1397
         of 5 October 2020
         concerning the renewal of the authorisation of L-isoleucine produced by Escherichia coli FERM ABP-10641 as a nutritional additive, its extension of use and the authorisation of L-isoleucine produced by Corynebacterium glutamicum KCCM 80189 as a feed additive for all animal species, and repealing Regulation (EU) No 348/2010
         (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 and renewing such authorisation.

                     (2)

                     L-isoleucine produced by Escherichia coli FERM ABP-10641 was authorised for 10 years as a feed additive for all animal species by Commission Regulation (EU) No 348/2010 (2).

                     (3)

                     In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of L-isoleucine produced by Escherichia coli FERM ABP-10641 as a feed additive for all animal species, requesting this additive to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’. This application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. Moreover, the application requested, in accordance with Article 7 of Regulation (EC) No 1831/2003, L-isoleucine produced by Escherichia coli FERM ABP-10641 to be authorised for use in water for drinking in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’ for all animal species, and for use in feed to be classified in the additive category ‘sensory additives’, functional group ‘flavouring compounds’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (4)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-isoleucine produced by Corynebacterium glutamicum KCCM 80 189 as a feed additive for use in feed and in water for drinking for all animal species. The application concerns the authorisation of L-isoleucine produced by Corynebacterium glutamicum KCCM 80 189 as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (5)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 28 January 2020 (3) (4) that, under the proposed conditions of use, L-isoleucine produced by Escherichia coli FERM ABP-10641 or Corynebacterium glutamicum KCCM 80 189 does not have an adverse effect on animal health, consumer health or the environment. It also stated that L-isoleucine produced by Escherichia coli FERM ABP-10641 was hazardous by inhalation for persons handling the additive. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of this additive. No adverse effects on user safety were stated for L-isoleucine produced by Corynebacterium glutamicum KCCM 80 189. The Authority also concluded that the additive is an efficacious source of the essential amino acid isoleucine for non-ruminant animals and that for the supplemental L-isoleucine to be fully efficacious in ruminants, it should be protected against degradation in the rumen. The Authority expressed concerns on the simultaneous oral administration of the amino acid via water for drinking and feed. However, the Authority did not propose a maximum content for L-isoleucine. Thus, in the case of supplementation with L-isoleucine via water for drinking, it is appropriate to alert the user to take into account the dietary supply with all the essential and conditionally essential amino acids.

                     (6)

                     Restrictions and conditions should be provided for to allow for a better control for L-isoleucine when used as flavouring. For L-isoleucine used as flavouring, the recommended content should be indicated on the label. Where such content is exceeded, certain information should be indicated on the label of the additive and premixtures. As regards the use of L-isoleucine as a flavouring, the Authority states that no further demonstration of efficacy is necessary when the substance is used at the recommended dose level. The use of L-isoleucine as a flavouring compound is not authorised in water for drinking. The fact that the use of the L-isoleucine is not authorised for use as a flavouring in water for drinking, does not preclude its use in compound feed, which is administered via water.

                     (7)

                     The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (8)

                     The assessment of L-isoleucine produced by Escherichia coli FERM ABP-10641 and by Corynebacterium glutamicum KCCM 80 189 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as specified in the Annex to this Regulation.

                     (9)

                     As a consequence of the renewal of the authorisation of L-isoleucine produced by Escherichia coli FERM ABP-10641 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EU) No 348/2010 should be repealed.

                     (10)

                     Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for L-isoleucine produced by Escherichia coli FERM ABP-10641, it is appropriate to provide a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.

                     (11)

                     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

               1.   The authorisation of L-isoleucine produced by Escherichia coli FERM ABP-10641, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is renewed, extended to its use via water for drinking, subject to the conditions laid down in the Annex.
               L-isoleucine produced by Escherichia coli FERM ABP-10641 belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as an additive in animal nutrition, subject to the conditions laid down in the Annex.

               2.   L-isoleucine produced by Corynebacterium glutamicum KCCM 80 189, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is authorised as an additive in animal nutrition, subject to the conditions laid down in the Annex.

            Article 2

               1.   L-isoleucine produced by Escherichia coli FERM ABP-10641 and premixtures containing it, which are produced and labelled before 26 April 2021 in accordance with the rules applicable before 26 October 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

               2.   Feed materials and compound feed containing L-isoleucine produced by Escherichia coli FERM ABP-10641 and premixtures containing it, which are produced and labelled before 26 October 2021 in accordance with the rules applicable before 26 October 2020 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 L-isoleucine produced by Escherichia coli FERM ABP-10641 and premixtures containing it, which are produced and labelled before 26 October 2022 in accordance with the rules applicable before 26 October 2020 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
            Regulation (EU) No 348/2010 is repealed.

            Article 4
            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, 5 October 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Regulation (EU) No 348/2010 of 23 April 2010 concerning the authorisation of L-isoleucine as a feed additive for all animal species (OJ L 104, 24.4.2010, p. 29).

            (3)  EFSA Journal 2020;18(2):6022.

            (4)  EFSA Journal 2020;18(2):6021.

            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/kg of complete feed with a moisture content of 12 %

                           Category: nutritional additives. Functional group: amino acids, their salts and analogues.

                        3c381

                        -

                        L-isoleucine

                           Additive composition

                        Powder with a minimum content of L-isoleucine of 93,4 % (on a dry matter basis)

                        All animal species

                        -

                        -

                        -

                                    1.

                                    L-isoleucine may be placed on the market and used as an additive consisting of a preparation.

                                    2.

                                    In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment and in water shall be indicated.

                                    3.

                                    The additive may be used via water for drinking.

                                    4.

                                    Declaration to be made on the label of the additive and premixture:

                                                —

                                                ‘The supplementation with L-isoleucine, in particular via water for drinking, shall take into account all essential and conditionally essential amino acids in order to avoid imbalances.’

                                                —

                                                L-isoleucine content.

                                    5.

                                    The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600  IU endotoxins/m3 air  (3).

                                    6.

                                    For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with personal protective equipment.

                        26 October 2030

                           Characterisation of the active substance

                        L-isoleucine produced by fermentation with Escherichia coli FERM ABP-10641
                        IUPAC name: (2S,3S)-2-amino-3-methylpentanoic acid
                        Chemical formula: C6H13NO2
                        CAS number: 73-32-5

                           Analytical method
                            (1)

                        For the identification of L-isoleucine in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-isoleucine monograph’

                              For the quantification of isoleucine in the feed additive:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) or

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

                              For the quantification of isoleucine in premixtures:

                                    —

                                    ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) or

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Regulation (EC) No 152/2009 (2) (Annex III, F)

                              For the quantification of isoleucine in compound feed and feed materials:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Regulation (EC) No 152/2009 (Annex III, F)

                              For the quantification of isoleucine in water:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

                        3c383

                        -

                        L-isoleucine

                           Additive composition

                        Powder with a minimum content of L-isoleucine of 90 %

                        All animal species

                        -

                        -

                        -

                                    1.

                                    L-isoleucine may be placed on the market and used as an additive consisting of a preparation.

                                    2.

                                    In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment and in water shall be indicated.

                                    3.

                                    The additive may be used via water for drinking.

                                    4.

                                    Declaration to be made on the label of the additive and premixture:

                                                —

                                                ‘The supplementation with L-isoleucine, in particular via water for drinking, shall take into account all essential and conditionally essential amino acids in order to avoid imbalances.’

                                                —

                                                L-isoleucine content.

                        26 October 2030

                           Characterisation of the active substance

                        L-isoleucine produced by fermentation with Corynebacterium glutamicum KCCM 80189
                        IUPAC name: (2S,3S)-2-amino-3-methylpentanoic acid
                        Chemical formula: C6H13NO2
                        CAS number: 73-32-5

                           Analytical method
                            (1)

                        For the identification of L-isoleucine in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-isoleucine monograph’

                              For the quantification of isoleucine in the feed additive:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) or

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

                              For the quantification of isoleucine in premixtures:

                                    —

                                    ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) or

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Regulation (EC) No 152/2009 (Annex III, F)

                              For the quantification of isoleucine in compound feed and feed materials:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Regulation (EC) No 152/2009 (Annex III, F)

                              For the quantification of isoleucine in water:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

                           Category: Sensory additives. Functional group: Flavouring compounds

                        3c381

                        -

                        L-isoleucine

                           Additive composition

                        Powder with a minimum content of L-isoleucine of 93,4 % (on a dry matter basis)

                        All animal species

                        -

                        -

                                    1.

                                    L-isoleucine may be placed on the market and used as an additive consisting of a preparation.

                                    2.

                                    The additive shall be incorporated into the feed in the form of a premixture.

                                    3.

                                    In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.

                                    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 the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 25 mg/kg.

                                    6.

                                    The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600  IU endotoxins/m3 air (3).

                                    7.

                                    For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential by inhalation. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with personal protective equipment.

                        26 October 2030

                           Characterisation of the active substance

                        L-isoleucine) produced by fermentation with Escherichia coli FERM ABP-10641
                        IUPAC name: (2S,3S)-2-amino-3-methylpentanoic acid
                        Chemical formula: C6H13NO2
                        CAS number: 73-32-5

                           Analytical method
                            (1)

                        For the identification of L-isoleucine in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-isoleucine monograph’

                              For the quantification of isoleucine in the feed additive:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) or

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

                              For the quantification of isoleucine in premixtures:

                                    —

                                    ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) or

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Regulation (EC) No 152/2009 (Annex III, F))

               (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).

               (3)  Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2020;18(2):6022); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).


title: Commission Implementing Regulation (EU) 2020/1399 of 5 October 2020 concerning the authorisation of butylated hydroxyanisole as a feed additive for all animal species except cats (Text with EEA relevance)

text:
                  6.10.2020

                  EN

                  Official Journal of the European Union

                  L 324/29

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1399
         of 5 October 2020
         concerning the authorisation of butylated hydroxyanisole as a feed additive for all animal species except cats
         (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)

                     Butylated hydroxyanisole was authorised without a time limit as a feed additive for all animal species in accordance with Council Directive 70/524/EEC. This additive was subsequently entered in the Register of feed additives as an existing product, 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 butylated hydroxyanisole as a feed additive for all animal species. The applicant has later withdrawn the application with regard to cats.

                     (4)

                     The applicant requested the additive to be classified in the additive category ‘technological additives’ and in the functional group ‘antioxidants’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (5)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 6 March 2018 (3) and 12 November 2019 (4) that, under the proposed conditions of use, butylated hydroxyanisole does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive should be considered a skin, eye irritant and a potential skin sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that since butylated hydroxyanisole is authorised as an antioxidant for use in food at comparable use levels, no studies are required to demonstrate the efficacy of butylated hydroxyanisole as an antioxidant in feedingstuffs for all animal species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods 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 butylated hydroxyanisole shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of butylated hydroxyanisole should be authorised as specified in the Annex to this Regulation.

                     (7)

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

                     (8)

                     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 substance specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘antioxidants’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

            Article 2
            Transitional measures

               1.   The substance specified in the Annex and premixtures containing this substance, which are produced and labelled before 26 April 2021 in accordance with the rules applicable before 26 October 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

               2.   Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 26 October 2021 in accordance with the rules applicable before 26 October 2020 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   Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 26 October 2022 in accordance with the rules applicable before 26 October 2020 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, 5 October 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (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 2018; 16(3):5215.

            (4)  EFSA Journal 2019;17(12):5913.

            ANNEX

                           Identification number of the additive

                           Additive

                           Chemical formula, description, methods of analysis

                           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: Technological additives. Functional group: antioxidants

                        1b320

                        Butylated hydroxyanisole

                           Additive composition

                        Butylated hydroxyanisole (BHA)
                        (≥98,5%)
                        Waxy solid form

                        All animal species other than cats

                        -

                        -

                        150

                                    1.

                                    In the directions for use of the additive and premixture, the storage conditions shall be indicated.

                                    2.

                                    BHA can be used in combination with butylated hydroxytoluene (BHT) up to 150 mg of the mixture/kg of complete feed.

                                    3.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. 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.

                        26.10.2030

                           Characterisation of the active substance

                        Mixture of:

                                    —

                                    2-tert-butyl-4-hydroxyanisole

                                    —

                                    3-tert-butyl-4-hydroxyanisole (≥85%)

                              CAS No: 25013-16-5
                        C11H16O2

                           Analytical method
                            (1)

                        For the quantification of BHA in the feed additive :

                                    —

                                    Gas Chromatography coupled to Flame Ionization Detection (GC-FID) (FCC7 method)

                              For the quantification of BHA in premixtures and feedingstuffs:

                                    —

                                    Reversed Phase High Performance Liquid Chromatography coupled to UltraViolet-Diode-Array Detection (RP-HPLC-UV-DAD, 285 nm)

               (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) 2020/1400 of 5 October 2020 concerning the authorisation of ethyl ester of β-apo-8’-carotenoic acid as a feed additive for chickens for fattening, laying hens and minor poultry species for laying and for fattening (Text with EEA relevance)

text:
                  6.10.2020

                  EN

                  Official Journal of the European Union

                  L 324/32

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1400
         of 5 October 2020
         concerning the authorisation of ethyl ester of β-apo-8’-carotenoic acid as a feed additive for chickens for fattening, laying hens and minor poultry species for laying and for fattening
         (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(2) of Regulation (EC) No 1831/2003 provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2) and Article 4 of the same Regulation for the authorisation of a new use of an additive.

                     (2)

                     Ethyl ester of β-apo-8’-carotenoic acid was authorised without a time limit in accordance with Directive 70/524/EEC as feed additive for poultry belonging to the functional group ‘colourants, including pigments’, under the heading ‘carotenoids and xanthophylls’. The additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.

                     (3)

                     In accordance with Articles 4 and 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of ethyl ester of β-apo-8’-carotenoic acid in water for drinking and the re-evaluation of ethyl ester of β-apo-8’-carotenoic acid as feed additive for chickens for fattening, laying hens and minor poultry species for laying and for fattening. The applicant requested the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘colourants’. The 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 opinions of 8 March 2016 (3) and of 12 November 2019 (4) that, under the proposed conditions of use, ethyl ester of β-apo-8’-carotenoic acid does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that ethyl ester of β-apo-8'-carotenoic acid is not an irritant to skin and eyes, and not a dermal sensitiser. On the inhalation toxicity of ethyl ester of β-apo-8’-carotenoic acid, the Authority cannot conclude on the risk of users by inhalation. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health. The Authority further concluded that the additive concerned is effective in adding colour to food of animal origin. 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 additive in feed submitted by the European Union Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (5)

                     As regards the use in water for drinking, the Commission considers that the simultaneous use of the additive in water for drinking and feed is difficult to manage, as there are maximum levels established for safety reasons and there are also other additives containing xanthophylls and carotenoids that may be used in feed. The simultaneous use of ethyl ester of β-apo-8’-carotenoic acid in water for drinking and feed increases the ways of administration and the risk to exceed the maximum levels authorised for additives containing carotenoids and xanthophylls. Consequently, the use in water for drinking should be denied.

                     (6)

                     The assessment shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of ethyl ester of β-apo-8’-carotenoic acid should be authorised as specified in the Annex to this Regulation.

                     (7)

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

                     (8)

                     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
            The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘colourants’, is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

            Article 2
            The authorised substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘colourants’, shall not be used in water for drinking.

            Article 3

               1   The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 26 April 2021 in accordance with the rules applicable before 26 October 2020 may continue to be placed on the market and used until 26 October 2021.

               2.   Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 26 October 2021 in accordance with the rules applicable before 26 October 2020 may continue to be placed on the market and used until 26 April 2022.

            Article 4
            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, 5 October 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (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(4):4439

            (4)  EFSA Journal 2019;17(12):5911

            ANNEX

                           Identification number of the additive

                           Additive

                           Composition, chemical formula, description, analytical method

                           Species or category of animal

                           Maximum age

                           Minimum content

                           Maximum content

                           Maximum residue levels

                           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: Colourants. (ii) substances which, when fed to animals, add colours to food of animal origin

                        2a160f

                        Ethyl ester of β-apo-8’-carotenoic acid;

                           Additive composition:

                        Ethyl ester of β-apo-8’-carotenoic acid.
                        Triphenyl phosphine oxide (TPPO) ≤ 100 mg/kg.

                        Chickens for fattening and minor poultry for fattening.

                        -

                        -

                        15

                                    —

                                    20 mg ethyl ester of β-apo-8’-carotenoic acid /kg egg yolk (wet tissue).

                                    —

                                    8 mg ethyl ester of β-apo-8’-carotenoic acid/kg liver (wet tissue).

                                    —

                                    2.5 mg ethyl ester of β-apo-8’-carotenoic acid/kg skin/fat (wet tissue).

                                    1.

                                    In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment. shall be indicated.

                                    2.

                                    Ethyl ester of β-apo-8’-carotenoic acid shall be placed on the market and used as an additive consisting of a preparation.

                                    3.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. 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 eye skin and breathing protection.

                        26.10.2030

                           Characterisation of the active substance:

                        Ethyl ester of β-apo-8’-carotenoic acid.
                        Chemical formula: C32H44O2

                        CAS number: 1109-11-1
                        Solid form produced by chemical synthesis.
                        Purity criteria: ≥ 97% all isomers.

                        Laying hens and minor poultry for laying.

                        -

                        -

                        5

                           Analytical method

                                    —

                                    For the quantification of ethyl ester of β-apo-8’-carotenoic acid in the feed additive preparation: spectrophotometry at 446 nm.

                                    —

                                    For the quantification of ethyl ester of β-apo-8’-carotenoic acid in the premixtures and feedingstuffs: Normal Phase High Performance Liquid Chromatography coupled to visible detection (NP-HPLC-VIS, 446 nm).

                        -

                        -