CELEX: 32017R0056
Language: en
Date: 2016-12-14 00:00:00
Title: Commission Implementing Regulation (EU) 2017/56 of 14 December 2016 concerning the authorisation of lactic acid, 4-oxovaleric acid, succinic acid, fumaric acid, ethyl acetoacetate, ethyl lactate, butyl lactate, ethyl 4-oxovalerate, diethyl succinate, diethyl malonate, butyl-O-butyryllactate, hex-3-enyl lactate, hexyl lactate, butyro-1,4-lactone, decano-1,5-lactone, undecano-1,5-lactone, pentano-1,4-lactone, nonano-1,5-lactone, octano-1,5-lactone, heptano-1,4-lactone and hexano-1,4-lactone as feed additives for all animal species (Text with EEA relevance. )

17.1.2017   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 13/129
               
            COMMISSION IMPLEMENTING REGULATION (EU) 2017/56
      of 14 December 2016
      concerning the authorisation of lactic acid, 4-oxovaleric acid, succinic acid, fumaric acid, ethyl acetoacetate, ethyl lactate, butyl lactate, ethyl 4-oxovalerate, diethyl succinate, diethyl malonate, butyl-O-butyryllactate, hex-3-enyl lactate, hexyl lactate, butyro-1,4-lactone, decano-1,5-lactone, undecano-1,5-lactone, pentano-1,4-lactone, nonano-1,5-lactone, octano-1,5-lactone, heptano-1,4-lactone and hexano-1,4-lactone 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)
               
               
                  Lactic acid, 4-oxovaleric acid, succinic acid, fumaric acid, ethyl acetoacetate, ethyl lactate, butyl lactate, ethyl 4-oxovalerate, diethyl succinate, diethyl malonate, butyl-O-butyryllactate, hex-3-enyl lactate, hexyl lactate, butyro-1,4-lactone, decano-1,5-lactone, undecano-1,5-lactone, pentano-1,4-lactone, nonano-1,5-lactone, octano-1,5-lactone, heptano-1,4-lactone and hexano-1,4-lactone (‘the 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.
               
            
                  (3)
               
               
                  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of the substances concerned as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘sensory additives’. 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 17 October 2012 (3) that, under the proposed conditions of use in feed the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority 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 it increases the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The Authority is not in a position to evaluate the use of the substances concerned 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 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 the substances concerned are considered as potentially hazardous to the respiratory tract skin, eyes and skin sensitisers. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
               
            
                  (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.
               
            
                  (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(10):2928.
      
         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
                     
                  
               
                     2b08004
                  
                  
                     —
                  
                  
                     Lactic acid
                  
                  
                     
                        Additive composition
                     
                     Lactic acid
                     
                        Characterisation of the active substance
                     
                     Lactic acid
                     Produced by chemical synthesis
                     Purity: min. 95 %
                     Chemical formula: C3H6O3
                     
                     CAS number 598-82-3 and
                     50-21-5 for DL-lactic acid
                     79-33-4 for L-lactic acid
                     FLAVIS No 08.004
                     
                        Method of analysis
                         (1)
                     
                     For the determination of lactic acid 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
                  
               
                     2b08023
                  
                  
                     —
                  
                  
                     4-Oxovaleric acid
                  
                  
                     
                        Additive composition
                     
                     4-Oxovaleric acid
                     
                        Characterisation of the active substance
                     
                     4-Oxovaleric acid
                     Produced by chemical synthesis
                     Purity: min. 97 %
                     Chemical formula: C5H8O3
                     
                     CAS number 123-76-2
                     FLAVIS No 08.023
                     
                        Method of analysis
                         (1)
                     
                     For the determination of 4-oxovaleric acid 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
                  
               
                     2b08024
                  
                  
                     —
                  
                  
                     Succinic acid
                  
                  
                     
                        Additive composition
                     
                     Succinic acid
                     
                        Characterisation of the active substance
                     
                     Succinic acid
                     Produced by chemical synthesis
                     Purity: min. 99 %
                     Chemical formula: C4H6O4
                     
                     CAS number 110-15-6
                     FLAVIS No 08.024
                     
                        Method of analysis
                         (1)
                     
                     For the determination of succinic acid 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
                  
               
                     2b08025
                  
                  
                     —
                  
                  
                     Fumaric acid
                  
                  
                     
                        Additive composition
                     
                     Fumaric acid
                     
                        Characterisation of the active substance
                     
                     Fumaric acid
                     Produced by chemical synthesis
                     Purity: min. 99,5 %
                     Chemical formula: C4H4O4
                     
                     CAS number 110-17-8
                     FLAVIS No 08.025
                     
                        Method of analysis
                         (1)
                     
                     For the determination of fumaric acid 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
                  
               
                     2b09402
                  
                  
                     —
                  
                  
                     Ethyl acetoacetate
                  
                  
                     
                        Additive composition
                     
                     Ethyl acetoacetate
                     
                        Characterisation of the active substance
                     
                     Ethyl acetoacetate
                     Produced by chemical synthesis
                     Purity: min. 97,5 %
                     Chemical formula: C6H10O3
                     
                     CAS number 141-97-9
                     FLAVIS No 09.402
                     
                        Method of analysis
                         (1)
                     
                     For the determination of ethyl acetoacetate 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
                  
               
                     2b09433
                  
                  
                     —
                  
                  
                     Ethyl lactate
                  
                  
                     
                        Additive composition
                     
                     Ethyl lactate
                     
                        Characterisation of the active substance
                     
                     Ethyl lactate
                     Produced by chemical synthesis
                     Purity: min. 97 %
                     Chemical formula: C5H10O3
                     
                     CAS number 97-64-3
                     FLAVIS No 09.433
                     
                        Method of analysis
                         (1)
                     
                     For the determination of ethyl lactate 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
                  
               
                     2b09434
                  
                  
                     —
                  
                  
                     Butyl lactate
                  
                  
                     
                        Additive composition
                     
                     Butyl lactate
                     
                        Characterisation of the active substance
                     
                     Butyl lactate
                     Produced by chemical synthesis
                     Purity: min. 95 %
                     Chemical formula: C7H14O3
                     
                     CAS number 138-22-7
                     FLAVIS No 09.434
                     
                        Method of analysis
                         (1)
                     
                     For the determination of butyl lactate 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
                  
               
                     2b09435
                  
                  
                     —
                  
                  
                     Ethyl 4-oxovalerate
                  
                  
                     
                        Additive composition
                     
                     Ethyl 4-oxovalerate
                     
                        Characterisation of the active substance
                     
                     Ethyl 4-oxovalerate
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C7H12O3
                     
                     CAS number 539-88-8
                     FLAVIS No 09.435
                     
                        Method of analysis
                         (1)
                     
                     For the determination of ethyl 4-oxovalerate 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
                  
               
                     2b09444
                  
                  
                     —
                  
                  
                     Diethyl succinate
                  
                  
                     
                        Additive composition
                     
                     Diethyl succinate
                     
                        Characterisation of the active substance
                     
                     Diethyl succinate
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C8H14O4
                     
                     CAS number 123-25-1
                     FLAVIS No 09.444
                     
                        Method of analysis
                         (1)
                     
                     For the determination of diethyl succinate 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
                  
               
                     2b09490
                  
                  
                     —
                  
                  
                     Diethyl malonate
                  
                  
                     
                        Additive composition
                     
                     Diethyl malonate
                     
                        Characterisation of the active substance
                     
                     Diethyl malonate
                     Produced by chemical synthesis
                     Purity: min. 97 %
                     Chemical formula: C7H12O4
                     
                     CAS number 105-53-3
                     FLAVIS No 09.490
                     
                        Method of analysis
                         (1)
                     
                     For the determination of diethyl malonate 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
                  
               
                     2b09491
                  
                  
                     —
                  
                  
                     Butyl-O-butyryllactate
                  
                  
                     
                        Additive composition
                     
                     Butyl-O-butyryllactate
                     
                        Characterisation of the active substance
                     
                     Butyl-O-butyryllactate
                     Produced by chemical synthesis
                     Purity: min. 95 %
                     Chemical formula: C11H20O4
                     
                     CAS number 7492-70-8
                     FLAVIS No 09.491
                     
                        Method of analysis
                         (1)
                     
                     For the determination of butyl-O-butyryllactate 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
                  
               
                     2b09545
                  
                  
                     —
                  
                  
                     Hex-3-enyl lactate
                  
                  
                     
                        Additive composition
                     
                     Hex-3-enyl lactate
                     
                        Characterisation of the active substance
                     
                     Hex-3-enyl lactate
                     Produced by chemical synthesis
                     Purity: min. 96 %
                     Chemical formula: C9H16O3
                     
                     CAS number 61931-81-5
                     FLAVIS No 09.545
                     
                        Method of analysis
                         (1)
                     
                     For the determination of hex-3-enyl lactate 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
                  
               
                     2b09580
                  
                  
                     —
                  
                  
                     Hexyl lactate
                  
                  
                     
                        Additive composition
                     
                     Hexyl lactate
                     
                        Characterisation of the active substance
                     
                     Hexyl lactate
                     Produced by chemical synthesis
                     Purity: min. 95 %
                     Chemical formula: C9H18O3
                     
                     CAS number 20279-51-0
                     FLAVIS No 09.580
                     
                        Method of analysis
                         (1)
                     
                     For the determination of hexyl lactate 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
                  
               
                     2b10006
                  
                  
                     —
                  
                  
                     Butyro-1,4-lactone
                  
                  
                     
                        Additive composition
                     
                     Butyro-1,4-lactone
                     
                        Characterisation of the active substance
                     
                     Butyro-1,4-lactone
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C4H6O2
                     
                     CAS number 96-48-0
                     FLAVIS No 10.006
                     
                        Method of analysis
                         (1)
                     
                     For the determination of butyro-1,4-lactone 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
                  
               
                     2b10007
                  
                  
                     —
                  
                  
                     Decano-1,5-lactone
                  
                  
                     
                        Additive composition
                     
                     Decano-1,5-lactone
                     
                        Characterisation of the active substance
                     
                     Decano-1,5-lactone
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C10H18O2
                     
                     CAS number 705-86-2
                     FLAVIS No 10.007
                     
                        Method of analysis
                         (1)
                     
                     For the determination of decano-1,5-lactone 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
                  
               
                     2b10011
                  
                  
                     —
                  
                  
                     Undecano-1,5-lactone
                  
                  
                     
                        Additive composition
                     
                     Undecano-1,5-lactone
                     
                        Characterisation of the active substance
                     
                     Undecano-1,5-lactone
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C11H20O2
                     
                     CAS number 710-04-3
                     FLAVIS No 10.011
                     
                        Method of analysis
                         (1)
                     
                     For the determination of undecano-1,5-lactone 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
                  
               
                     2b10013
                  
                  
                     —
                  
                  
                     Pentano-1,4-lactone
                  
                  
                     
                        Additive composition
                     
                     Pentano-1,4-lactone
                     
                        Characterisation of the active substance
                     
                     Pentano-1,4-lactone
                     Produced by chemical synthesis
                     Purity: min. 95 %
                     Chemical formula: C5H8O2
                     
                     CAS number 108-29-2
                     FLAVIS No 10.013
                     
                        Method of analysis
                         (1)
                     
                     For the determination of pentano-1,4-lactone 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
                  
               
                     2b10014
                  
                  
                     —
                  
                  
                     Nonano-1,5-lactone
                  
                  
                     
                        Additive composition
                     
                     Nonano-1,5-lactone
                     
                        Characterisation of the active substance
                     
                     Nonano-1,5-lactone
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C9H16O2
                     
                     CAS number 3301-94-8
                     FLAVIS No 10.014
                     
                        Method of analysis
                         (1)
                     
                     For the determination of nonano-1,5-lactone 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
                  
               
                     2b10015
                  
                  
                     —
                  
                  
                     Octano-1,5-lactone
                  
                  
                     
                        Additive composition
                     
                     Octano-1,5-lactone
                     
                        Characterisation of the active substance
                     
                     Octano-1,5-lactone
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C8H14O2
                     
                     CAS number 698-76-0
                     FLAVIS No 10.015
                     
                        Method of analysis
                         (1)
                     
                     For the determination of octano-1,5-lactone 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
                  
               
                     2b10020
                  
                  
                     —
                  
                  
                     Heptano-1,4-lactone
                  
                  
                     
                        Additive composition
                     
                     Heptano-1,4-lactone
                     
                        Characterisation of the active substance
                     
                     Heptano-1,4-lactone
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C7H12O2
                     
                     CAS number 105-21-5
                     FLAVIS No 10.020
                     
                        Method of analysis
                         (1)
                     
                     For the determination of heptano-1,4-lactone 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
                  
               
                     2b10021
                  
                  
                     —
                  
                  
                     Hexano-1,4-lactone
                  
                  
                     
                        Additive composition
                     
                     Hexano-1,4-lactone
                     
                        Characterisation of the active substance
                     
                     Hexano-1,4-lactone
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C6H10O2
                     
                     CAS number 695-06-7
                     FLAVIS No 10.021
                     
                        Method of analysis
                         (1)
                     
                     For the determination of hexano-1,4-lactone 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