title: Commission Implementing Regulation (EU) 2018/245 of 15 February 2018 concerning the authorisation of menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate as feed additives for all animal species (Text with EEA relevance. )

text:
                  23.2.2018

                  EN

                  Official Journal of the European Union

                  L 53/87

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/245
      of 15 February 2018
      concerning the authorisation of menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate as feed additives for all animal species
      (Text with EEA relevance)
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
      Whereas:

                  (1)

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

                  (2)

                  The substances menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate (‘substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

                  (3)

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

                  (4)

                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 20 April 2016 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for the use of the substances concerned in water for drinking.

                  (5)

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

                  (6)

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

                  (7)

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

                  (8)

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

                  (9)

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

                  (10)

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

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

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

               For the Commission

               The President

            Jean-Claude JUNCKER

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

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

         (3)  EFSA Journal 2016;14(6):4475.

         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

                     2b02015

                     —

                     Menthol

                        Additive composition

                     Menthol

                        Characterisation of the active substance

                     Menthol
                     Produced by chemical synthesis
                     Purity: min. 95 % assay
                     Chemical formula: C10H20O
                     CAS number: 89-78-1
                     FLAVIS No: 02.015

                        Method of analysis
                         (1)

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

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     15.3.2028

                     2b07146

                     —

                     d-Carvone

                        Additive composition

                     d-Carvone

                        Characterisation of the active substance

                     d-Carvone
                     Produced by chemical synthesis
                     Purity: min. 95 % assay
                     Chemical formula: C10H14O
                     CAS number: 2244-16-8
                     FLAVIS No: 07.146

                        Method of analysis
                         (1)

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

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3

                                 5.

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

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     15.3.2028

                     2b09016

                     —

                     Menthyl acetate

                        Additive composition

                     Menthyl acetate

                        Characterisation of the active substance

                     Menthyl acetate
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C12H22O2

                     CAS number: 29066-34-0
                     FLAVIS No: 09.016

                        Method of analysis
                         (1)

                     For the determination of menthyl 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.

                                 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.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3

                                 5.

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

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     15.3.2028

                     2b07078

                     —

                     d,l-Isomenthone

                        Additive composition

                     d,l-Isomenthone

                        Characterisation of the active substance

                     d,l-Isomenthone
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C10H18O
                     CAS number: 491-07-6
                     FLAVIS No: 07.078

                        Method of analysis
                         (1)

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

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

                                             —

                                             0,3 mg/kg for pigs and poultry;

                                             —

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

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the levels referred to in point 3

                                 5.

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

                                             —

                                             0,3 mg/kg for pigs and poultry;

                                             —

                                             0,5 mg/kg for other species and categories

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     15.3.2028

                     2b07094

                     —

                     3-Methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one

                        Additive composition

                     3-Methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one

                        Characterisation of the active substance

                     3-Methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C11H16O
                     CAS number: 488-10-8
                     FLAVIS No: 07.094

                        Method of analysis
                         (1)

                     For the determination of 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

                                             —

                                             0,3 mg/kg for pigs and poultry;

                                             —

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

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the levels referred to in point 3

                                 5.

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

                                             —

                                             0,3 mg/kg for pigs and poultry;

                                             —

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

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     15.3.2028

                     2b07126

                     —

                     3,5,5-Trimethylcyclohex-2-en-1-one

                        Additive composition

                     3,5,5-Trimethylcyclohex-2-en-1-one

                        Characterisation of the active substance

                     3,5,5-Trimethylcyclohex-2-en-1-one
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C9H14O
                     CAS number: 78-59-1
                     FLAVIS No: 07.126

                        Method of analysis
                         (1)

                     For the determination of 3,5,5-trimethylcyclohex-2-en-1-one in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

                                             —

                                             0,3 mg/kg for pigs and poultry;

                                             —

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

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

                                 5.

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

                                             —

                                             0,3 mg/kg for pigs and poultry;

                                             —

                                             0,5 mg/kg for other species and categories

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and glove.

                     15.3.2028

                     2b07159

                     —

                     d-Fenchone

                        Additive composition

                     d-Fenchone

                        Characterisation of the active substance

                     d-Fenchone
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C10H16O
                     CAS number: 4695-62-9
                     FLAVIS No: 07.159

                        Method of analysis
                         (1)

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

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

                                             —

                                             0,3 mg/kg for pigs and poultry;

                                             —

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

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the levels referred to in point 3

                                 5.

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

                                             —

                                             0,3 mg/kg for pigs and poultry;

                                             —

                                             0,5 mg/kg for other species and categories

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves

                     15.3.2028

                     2b02038

                     —

                     Fenchyl alcohol

                        Additive composition

                     Fenchyl alcohol

                        Characterisation of the active substance

                     Fenchyl alcohol
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C10H18O
                     CAS number: 1632-73-1
                     FLAVIS No: 02.038

                        Method of analysis
                         (1)

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

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3

                                 5.

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

                     15.3.2028

                     2b09215

                     —

                     Carvyl acetate

                        Additive composition

                     Carvyl acetate

                        Characterisation of the active substance

                     Carvyl acetate
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C12H18O2

                     CAS number: 97-42-7
                     FLAVIS No: 09.215

                        Method of analysis
                         (1)

                     For the determination of carvyl 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.

                                 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.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3

                                 5.

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

                     15.3.2028

                     2b09216

                     —

                     Dihydrocarvyl acetate

                        Additive composition

                     Dihydrocarvyl acetate

                        Characterisation of the active substance

                     Dihydrocarvyl acetate
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C12H20O2

                     CAS number: 20777-49-5
                     FLAVIS No: 09.216

                        Method of analysis
                         (1)

                     For the determination of dihydrocarvyl 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.

                                 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.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3

                                 5.

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

                     15.3.2028

                     2b09269

                     —

                     Fenchyl acetate

                        Additive composition

                     Fenchyl acetate

                        Characterisation of the active substance

                     Fenchyl acetate
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C12H20O2

                     CAS number: 13851-11-1
                     FLAVIS No: 09.269

                        Method of analysis
                         (1)

                     For the determination of fenchyl 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.

                                 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.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3

                                 5.

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

                     15.3.2028

            (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports


title: Commission Implementing Regulation (EU) 2018/250 of 15 February 2018 concerning the authorisation of methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate as feed additives for all animal species (Text with EEA relevance. )

text:
                  23.2.2018

                  EN

                  Official Journal of the European Union

                  L 53/166

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/250
      of 15 February 2018
      concerning the authorisation of methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate as feed additives for all animal species
      (Text with EEA relevance)
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
      Whereas:

                  (1)

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

                  (2)

                  The substances methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate (‘substances concerned’) were authorised without a time limit by 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.

                  (3)

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

                  (4)

                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 January 2016 (3) that under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. These substances increase the food smell or palatability. The Authority has concluded that since the substances concerned are used in food as flavourings and their function in feed is essentially the same as in food no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated for feed. The applicant withdrew the application for use of the substances concerned in water for drinking.

                  (5)

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

                  (6)

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

                  (7)

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

                  (8)

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

                  (9)

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

                  (10)

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

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

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

               For the Commission

               The President

            Jean-Claude JUNCKER

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

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

         (3)  EFSA Journal 2016;14(2):4389.

         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

                     2b13002

                     —

                     Methyl 2-furoate

                        Additive composition

                     Methyl 2-furoate

                        Characterisation of the active substance

                     Methyl 2-furoate
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C6H6O3

                     CAS number: 611-13-2
                     FLAVIS No: 13.002

                        Method of analysis
                         (1)

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

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,5 mg/kg.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

                                 5.

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

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     15.3.2028

                     2b13016

                     —

                     Bis-(2-methyl-3-furyl) disulfide

                        Additive composition

                     Bis-(2-methyl-3-furyl) disulfide

                        Characterisation of the active substance

                     Bis-(2-methyl-3-furyl) disulfide
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C10H10O2 S2

                     CAS number: 28588-75-2
                     FLAVIS No: 13.016

                        Method of analysis
                         (1)

                     For the determination of bis-(2-methyl-3-furyl) disulfide in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     15.3.2028

                     2b13018

                     —

                     Furfural

                        Additive composition

                     Furfural

                        Characterisation of the active substance

                     Furfural
                     Produced by chemical synthesis
                     Purity: min. 95 % assay
                     Chemical formula: C5H4O2

                     CAS number: 98-01-1
                     FLAVIS No: 13.018

                        Method of analysis
                         (1)

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

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

                                 5.

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

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     15.3.2028

                     2b13019

                     —

                     Furfuryl alcohol

                        Additive composition

                     Furfuryl alcohol

                        Characterisation of the active substance

                     Furfuryl alcohol
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C5H6O2

                     CAS number: 98-00-0
                     FLAVIS No: 13.019

                        Method of analysis
                         (1)

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

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

                                 5.

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

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     15.3.2028

                     2b13026

                     —

                     2-Furanmethanethiol

                        Additive composition

                     2-Furanmethanethiol

                        Characterisation of the active substance

                     2-Furanmethanethiol
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C5H6OS
                     CAS number: 98-02-2
                     FLAVIS No: 13.026

                        Method of analysis
                         (1)

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

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     15.3.2028

                     2b13033

                     —

                     S-Furfuryl acetothioate

                        Additive composition

                     S-furfuryl acetothioate

                        Characterisation of the active substance

                     S-furfuryl acetothioate
                     Produced by chemical synthesis
                     Purity: min. 95 % assay
                     Chemical formula: C7H8O2S
                     CAS number: 13678-68-7
                     FLAVIS No: 13.033

                        Method of analysis
                         (1)

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

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     15.3.2028

                     2b13050

                     —

                     Difurfuryl disulfide

                        Additive composition

                     Difurfuryl disulfide

                        Characterisation of the active substance

                     Difurfuryl disulfide
                     Produced by chemical synthesis
                     Purity: min. 96 % assay
                     Chemical formula: C10H10O2S2

                     CAS number: 4437-20-1
                     FLAVIS No: 13.050

                        Method of analysis
                         (1)

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

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     15.3.2028

                     2b13053

                     —

                     Methyl furfuryl sulfide

                        Additive composition

                     Methyl furfuryl sulfide

                        Characterisation of the active substance

                     Methyl furfuryl sulfide
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C6H8OS
                     CAS number: 1438-91-1
                     FLAVIS No: 13.053

                        Method of analysis
                         (1)

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

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     15.3.2028

                     2b13055

                     —

                     2-Methylfuran-3-thiol

                        Additive composition

                     2-Methylfuran-3-thiol

                        Characterisation of the active substance

                     2-Methylfuran-3-thiol
                     Produced by chemical synthesis
                     Purity: min. 95 % assay
                     Chemical formula: C5H6OS
                     CAS number: 28588-74-1
                     FLAVIS No: 13.055

                        Method of analysis
                         (1)

                     For the determination of 2-methylfuran-3-thiol in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     15.3.2028

                     2b13064

                     —

                     Methyl furfuryl disulfide

                        Additive composition

                     Methyl furfuryl disulfide

                        Characterisation of the active substance

                     Methyl furfuryl disulfide
                     Produced by chemical synthesis
                     Purity: min. 95 % assay
                     Chemical formula: C6H8OS2

                     CAS number: 57500-00-2
                     FLAVIS No: 13.064

                        Method of analysis
                         (1)

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

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     15.3.2028

                     2b13079

                     —

                     Methyl 2-methyl-3-furyl disulfide

                        Additive composition

                     Methyl 2-methyl-3-furyl disulfide

                        Characterisation of the active substance

                     Methyl 2-methyl-3-furyl disulfide
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C6H8OS2

                     CAS number: 65505-17-1
                     FLAVIS No: 13.079

                        Method of analysis
                         (1)

                     For the determination of methyl 2-methyl-3-furyl disulfide in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     15.3.2028

                     2b13128

                     —

                     Furfuryl acetate

                        Additive composition

                     Furfuryl acetate

                        Characterisation of the active substance

                     Furfuryl acetate
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C7H8O3

                     CAS number: 623-17-6
                     FLAVIS No: 13.128

                        Method of analysis
                         (1)

                     For the determination of furfuryl 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.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,5 mg/kg.’

                                 4.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

                                 5.

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

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                     15.3.2028

            (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