Commission Implementing Regulation (EU) 2017/63 of 14 December 2016 concerning th... (32017R0063)
    EU - Rechtsakte: 03 Agriculture

    COMMISSION IMPLEMENTING REGULATION (EU) 2017/63

    of 14 December 2016

    concerning the authorisation of benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate as feed additives for all animal a species and of veratraldehyde and gallic acid as feed additives for certain animal species

    (Text with EEA relevance)

    THE EUROPEAN COMMISSION,
    Having regard to the Treaty on the Functioning of the European Union,
    Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition(1), and in particular Article 9(2) thereof,
    Whereas:
    (1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC(2).
    (2) Benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, veratraldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, gallic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate (‘substances concerned’) were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. Veratraldehyde for poultry and fish and gallic acid for fish will not be re-authorised as they were withdrawn by the applicant.
    (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 benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate as feed additives for all animal a species and of veratraldehyde and gallic acid as feed additives for certain animal species. The applicant requested those additives be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
    (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 June 2012(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 further concluded that the function of the substances concerned in feed is similar to that on food. The Authority has already concluded that for food the substances concerned are efficacious, as they increase the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The Authority cannot conclude on the safety of the concerned substances in water for drinking. However, those substances can be used within compound feeds which are subsequently administered via water.
    (5) Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content, except for benzoic acid, and taking into account the re-evaluation performed by the Authority, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials.
    (6) The Authority concluded that in the absence of data the substances concerned should be considered as potentially hazardous to the respiratory tract, skin and eyes, skin sensitisers and harmful if swallowed. Consequently, appropriate protective measures should be taken The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
    (7) The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.
    (8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
    (9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
    HAS ADOPTED THIS REGULATION:

    Article 1

    Authorisation

    The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.

    Article 2

    Transitional measures

    1.   The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 6 August 2017 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted.
    2.   Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 6 February 2018 in accordance with the rules applicable before 6 February 2017 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 6 February 2019 in accordance with the rules applicable before 6 February 2017 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, 14 December 2016.
    For the Commission
    The President
    Jean-Claude JUNCKER
    (1)  
    OJ L 268, 18.10.2003, p. 29
    .
    (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (
    OJ L 270, 14.12.1970, p. 1
    ).
    (3)  
    EFSA Journal
    2012;10(7):2785.

    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 %

    (1)

    (2)

    (3)

    (4)

    (5)

    (6)

    (7)

    (8)

    (9)

    Category: Sensory additives. Functional group: Flavouring compounds

    2b02010

    Benzyl alcohol

    Additive composition

    Benzyl alcohol

    Characterisation of the active substance

    Benzyl alcohol

    Produced by chemical synthesis

    Purity: min. 98 %

    Chemical formula: C7H8O

    CAS number 100-51-6

    FLAVIS No 02.010

    Method of analysis (1)

    For the determination of benzyl alcohol in the feed additive and in feed flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

    The recommended maximum content of the active substance shall be: 125 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 %: 125 mg/kg’.

    5.

    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 125 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 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 safety glasses and gloves.

    6 February 2027

    2b02039

    4-Isopropylbenzyl alcohol

    Additive composition

    4-Isopropylbenzyl alcohol

    Characterisation of the active substance

    4-Isopropylbenzyl alcohol

    Produced by chemical synthesis

    Purity: min. 97 %

    Chemical formula: C10H14O

    CAS number 536-60-7

    FLAVIS No 02.039

    Method of analysis (1)

    For the determination of 4-isopropylbenzyl alcohol in the feed additive and in feed flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

    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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b05013

    Benzaldehyde

    Additive composition

    Benzaldehyde

    Characterisation of the active substance

    Benzaldehyde

    Produced by chemical synthesis

    Purity: min. 98 %

    Chemical formula: C7H6O

    CAS number 100-52-7

    FLAVIS No 05.013

    Method of analysis (1)

    For the determination of benzaldehyde in the feed additive and in feed flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

    The recommended maximum content of the active substance shall be: 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b05017

    Veratraldehyde

    Additive composition

    Veratraldehyde

    Characterisation of the active substance

    Veratraldehyde

    Produced by chemical synthesis

    Purity: min. 95 %

    Chemical formula: C9H10O3

    CAS number 120-14-9

    FLAVIS No 05.017

    Method of analysis (1)

    For the identification of veratraldehyde in the feed additive and flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species except poultry and fish

    1.

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

    2.

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

    3.

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

    4.

    On the label of the additive the following shall be indicated:

    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

    5.

    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b05022

    4-Isopropylbenzaldehyde

    Additive composition

    4-Isopropylbenzaldehyde

    Characterisation of the active substance

    4-Isopropylbenzaldehyde

    Produced by chemical synthesis

    Purity: min. 95 %

    Chemical formula: C10H12O

    CAS number 122-03-2

    FLAVIS No 05.022

    Method of analysis (1)

    For the determination of 4-isopropylbenzaldehyde in the feed additive and in feed flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

     

    1.

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

    2.

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

    3.

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

    4.

    On the label of the additive the following shall be indicated:

    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

    5.

    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b05055

    Salicylaldehyde

    Additive composition

    Salicylaldehyde

    Characterisation of the active substance

    Salicylaldehyde

    Produced by chemical synthesis

    Purity: min. 95 %

    Chemical formula: C7H6O2

    CAS number 90-02-8

    FLAVIS No 05.055

    Method of analysis (1)

    For the identification of salicylaldehyde in the feed additive and flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

    The recommended maximum content of the active substance shall be: 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b05029

    p-Tolualdehyde

    Additive composition

    p-Tolualdehyde

    Characterisation of the active substance

    p-Tolualdehyde

    Produced by chemical synthesis

    Purity: min. 97 %

    Chemical formula: C8H8O

    CAS number 104-87-0

    FLAVIS No 05.029

    Method of analysis (1)

    For the determination of p-tolualdehyde in the feed additive and in feed flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

    The recommended maximum content of the active substance shall be:

    5 mg/kg of complete feedingstuff with a moisture content of 12 %.

    4.

    On the label of the additive the following shall be indicated:

    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

    5.

    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b05129

    2-Methoxybenzaldehyde

    Additive composition

    2-Methoxybenzaldehyde

    Characterisation of the active substance

    2-Methoxybenzaldehyde

    Produced by chemical synthesis

    Purity: min. 97 %

    Chemical formula: C8H8O2

    CAS number 135-02-4

    FLAVIS No 05.129

    Method of analysis (1)

    For the identification of 2-methoxybenzaldehyde in the feed additive and flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

    The recommended maximum content of the active substance shall be: 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b08021

    Benzoic acid

    Additive composition

    Benzoic acid

    Characterisation of the active substance

    Benzenecarboxylic acid, phenylcarboxylic acid

    Produced by chemical synthesis

    Purity: min. 99 %

    Chemical formula: C7H6O2

    CAS number 65-85-0

    FLAVIS No 08.021

    Maximum level of impurities

    Phthalic acid: ≤ 100 mg/kg;

    Biphenyl: ≤ 100 mg/kg

    Method of analysis (1)

    For the determination of benzoic acid in the feed additive and in feed flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    125

    1.

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

    2.

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

    3.

    For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalatory or eyes exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

    6 February 2027

    2b08080

    Gallic acid

    Additive composition

    Gallic acid

    Characterisation of the active substance

    Gallic acid

    Produced by chemical synthesis

    Purity: min. 95 %

    Chemical formula: C7H6O5

    CAS number 149-91-7

    FLAVIS No 08.080

    Method of analysis (1)

    For the identification of gallic acid in the feed additive and flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species except fish

    1.

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

    2.

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

    3.

    The recommended maximum content of the active substance shall be: 25 mg/kg of complete feedingstuff with a moisture content of 12 %.

    4.

    On the label of the additive the following shall be indicated:

    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg’.

    5.

    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b09014

    Benzyl acetate

    Additive composition

    Benzyl acetate

    Characterisation of the active substance

    Benzyl acetate

    Produced by chemical synthesis

    Purity: min. 98 %

    Chemical formula: C9H10O2

    CAS number 140-11-4

    FLAVIS No 09.014

    Method of analysis (1)

    For the determination of benzyl acetate in the feed additive and in feed flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

    The recommended maximum content of the active substance shall be: 125 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 %: 125 mg/kg’.

    5.

    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 125 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 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 safety glasses and gloves.

    6 February 2027

    2b09051

    Benzyl butyrate

    Additive composition

    Benzyl butyrate

    Characterisation of the active substance

    Benzyl butyrate

    Produced by chemical synthesis

    Purity: min. 98 %

    Chemical formula: C11H14O2

    CAS number 103-37-7

    FLAVIS No 09.051

    Method of analysis (1)

    For the determination of benzyl butyrate in the feed additive and in feed flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

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

    4.

    On the label of the additive the following shall be indicated:

    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

    5.

    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b09077

    Benzyl formate

    Additive composition

    Benzyl formate

    Characterisation of the active substance

    Benzyl formate

    Produced by chemical synthesis

    Purity: min. 95 %

    Chemical formula: C8H8O2

    CAS number 104-57-4

    FLAVIS No 09.077

    Method of analysis (1)

    For the determination of benzyl formate in the feed additive and in feed flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

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

    4.

    On the label of the additive the following shall be indicated:

    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

    5.

    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b09132

    Benzyl propionate

    Additive composition

    Benzyl propionate

    Characterisation of the active substance

    Benzyl propionate

    Produced by chemical synthesis

    Purity: min. 98 %

    Chemical formula: C10H12O2

    CAS number 122-63-4

    FLAVIS No 09.132

    Method of analysis (1)

    For the determination of benzyl propionate in the feed additive and in feed flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

    The recommended maximum content of the active substance shall be: 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b09316

     

    Benzyl hexanoate

    Additive composition

    Benzyl hexanoate

    Characterisation of the active substance

    Benzyl hexanoate

    Produced by chemical synthesis

    Purity: min. 99 %

    Chemical formula: C13H18O2

    CAS number 6938-45-0

    FLAVIS No 09.316

    Method of analysis (1)

    For the identification of benzyl hexanoate in the feed additive and flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

    The recommended maximum content of the active substance shall be:

    for pigs and poultry: 1 mg/kg, and for other species and categories: 1,5 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 %:

    1 mg/kg for pigs and poultry;

    1,5 mg/kg for other species and categories’.

    5.

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

    1 mg/kg for pigs and poultry;

    1,5 mg/kg for other species and categories.'

    6.

    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by 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 safety glasses and gloves.

    6 February 2027

    2b09426

    Benzyl isobutyrate

    Additive composition

    Benzyl isobutyrate

    Characterisation of the active substance

    Benzyl isobutyrate

    Produced by chemical synthesis

    Purity: min. 97 %

    Chemical formula: C11H14O2

    CAS number 103-28-6

    FLAVIS No 09.426

    Method of analysis (1)

    For the determination of benzyl isobutyrate in the feed additive and in feed flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

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

    4.

    On the label of the additive the following shall be indicated:

    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

    5.

    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b09458

    Benzyl isovalerate

    Additive composition

    Benzyl isovalerate

    Characterisation of the active substance

    Benzyl isovalerate

    Produced by chemical synthesis

    Purity: min. 98 %

    Chemical formula: C12H16O2

    CAS number 103-38-8

    FLAVIS No 09.458

    Method of analysis (1)

    For the determination of benzyl isovalerate in the feed additive and in feed flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

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

    4.

    On the label of the additive the following shall be indicated:

    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

    5.

    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b09581

    Hexyl salicylate

    Additive composition

    Hexyl salicylate

    Characterisation of the active substance

    Hexyl salicylate

    Produced by chemical synthesis

    Purity: min. 99 %

    Chemical formula: C13H18O3

    CAS number 6259-76-3

    FLAVIS No 09.581

    Method of analysis (1)

    For the identification of hexyl salicylate in the feed additive and flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

    The recommended maximum content of the active substance shall be: 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b09705

    Benzyl phenylacetate

    Additive composition

    Benzyl phenylacetate

    Characterisation of the active substance

    Benzyl phenylacetate

    Produced by chemical synthesis

    Purity: min. 98 %

    Chemical formula: C15H14O2

    CAS number 102-16-9

    FLAVIS No 09.705

    Method of analysis (1)

    For the determination of benzyl phenylacetate in the feed additive and in feed flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

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

    4.

    On the label of the additive the following shall be indicated:

    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

    5.

    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b09725

    Methyl benzoate

    Additive composition

    Methyl benzoate

    Characterisation of the active substance

    Methyl benzoate

    Produced by chemical synthesis

    Purity: min. 98 %

    Chemical formula: C8H8O2

    CAS number 93-58-3

    FLAVIS No 09.725

    Method of analysis (1)

    For the determination of methyl benzoate in the feed additive and in feed flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

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

    4.

    On the label of the additive the following shall be indicated:

    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

    5.

    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b09726

    Ethyl benzoate

    Additive composition

    Ethyl benzoate

    Characterisation of the active substance

    Ethyl benzoate

    Produced by chemical synthesis

    Purity: min. 98 %

    Chemical formula: C9H10O2

    CAS number 93-89-0

    FLAVIS No 09.726

    Method of analysis (1)

    For the determination of ethyl benzoate in the feed additive and in feed flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

     

    1.

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

    2.

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

    3.

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

    4.

    On the label of the additive the following shall be indicated:

    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

    5.

    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b09755

    Isopentyl benzoate

    Additive composition

    Isopentyl benzoate

    Characterisation of the active substance

    Isopentyl benzoate

    Produced by chemical synthesis

    Purity: min. 98 %

    Chemical formula: C12H16O2

    CAS number 94-46-2

    FLAVIS No 09.755

    Method of analysis (1)

    For the determination of isopentyl benzoate in the feed additive and in feed flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

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

    4.

    On the label of the additive the following shall be indicated:

    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’

    5.

    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b09762

    Pentyl salicylate

    Additive composition

    Pentyl salicylate

    Characterisation of the active substance

    Pentyl salicylate

    Produced by chemical synthesis

    Purity: min. 95 %

    Chemical formula C12H16O3

    CAS number 2050-08-0

    FLAVIS No 09.762

    Method of analysis (1)

    For the identification of pentyl salicylate in the feed additive and flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

    The recommended maximum content of the active substance shall be: 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    2b09757

    Isobutyl benzoate

    Additive composition

    Isobutyl benzoate

    Characterisation of the active substance

    Isobutyl benzoate

    Produced by chemical synthesis

    Purity: min. 98 %

    Chemical formula: C11H14O2

    CAS number 120-50-3

    FLAVIS No 09.757

    Method of analysis (1)

    For the determination of isobutyl benzoate in the feed additive and in feed flavouring premixtures.

    Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

    All animal species

    1.

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

    2.

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

    3.

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

    4.

    On the label of the additive the following shall be indicated:

    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

    5.

    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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 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 safety glasses and gloves.

    6 February 2027

    (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
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