title: Commission Implementing Regulation (EU) 2018/246 of 15 February 2018 concerning the authorisation of linalool oxide as a feed additive for all animal species except fish (Text with EEA relevance. )

text:
                  23.2.2018

                  EN

                  Official Journal of the European Union

                  L 53/105

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/246
      of 15 February 2018
      concerning the authorisation of linalool oxide as a feed additive for all animal species except fish
      (Text with EEA relevance)
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
      Whereas:

                  (1)

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

                  (2)

                  The substance linalool oxide was authorised by Directive 70/524/EEC as a feed additive for all animal species. That substance was subsequently entered in the Register of feed additives as existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

                  (3)

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

                  (4)

                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 June 2012 (3) that, under the proposed conditions of use, linalool oxide does not have adverse effects on animal health, human health or the environment. In addition, as regards consumer safety, the conclusions of the opinion adopted on 5 March 2014 (4) are applicable to linalool oxide since linalool oxide belongs to the same chemical group as the substances examined in that opinion. The terminal metabolism of this additive through glucuronidation among mammals, birds and fish allows the conjugates of the additive to be rapidly excreted. The Authority has concluded that, since linalool is used in food as flavouring and its function in feed is essentially the same as in food, no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for use of linalool in water for drinking.

                  (5)

                  The Authority further concluded that, linalool oxide should be treated as potentially hazardous to the respiratory tract, skin and eyes and also as irritating to the skin. 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 additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                  (6)

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

                  (7)

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

                  (8)

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

                  (9)

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

                  (10)

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

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

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

               For the Commission

               The President

            Jean-Claude JUNCKER

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

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

         (3)  EFSA Journal 2012;10(7):2786.

         (4)  EFSA Journal 2014:12(3):3608.

         ANNEX

                     Identification number of the additive

                     Name of the holder of authorisation

                     Additive

                     Composition, chemical formula, description, analytical method

                     Species or category of animal

                     Maximum age

                     Minimum content

                     Maximum content

                     Other provisions

                     End of period of authorisation

                     mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

                        Category: Sensory additives. Functional group: Flavouring compounds

                     2b13140

                     —

                     Linalool oxide

                        Additive composition

                     Linalool oxide

                        Characterisation of the active substance

                     Produced by chemical synthesis
                     Purity: min. 95 % assay
                     Chemical formula: C10H18O2

                     CAS number: 1365-19-1
                     FLAVIS No: 13.140

                        Method of analysis
                         (1)

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

                     All animal species except fish

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

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

                                             —

                                             0,3 mg/kg for pigs and poultry,

                                             —

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

                                 4.

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

                                 5.

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

                                             —

                                             0,3 mg/kg for pigs and poultry,

                                             —

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

                                 6.

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

                     15.3.2028

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


title: Commission Implementing Regulation (EU) 2018/240 of 15 February 2018 concerning the authorisation of trimethylamine, trimethylamine hydrochloride, 3-methylbutylamine for all animal species except laying hens and 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy-benzene, 1-isopropyl-2-methoxy-4-methylbenzene as feed additives for all animal species (Text with EEA relevance. )

text:
                  23.2.2018

                  EN

                  Official Journal of the European Union

                  L 53/14

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/240
      of 15 February 2018
      concerning the authorisation of trimethylamine, trimethylamine hydrochloride, 3-methylbutylamine for all animal species except laying hens and 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy-benzene, 1-isopropyl-2-methoxy-4-methylbenzene as feed additives for all animal species
      (Text with EEA relevance)
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
      Whereas:

                  (1)

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

                  (2)

                  The substances trimethylamine, trimethylamine hydrochloride, 3-methylbutylamine for all animal species, except laying hens and 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy-benzene, 1-isopropyl-2-methoxy-4-methylbenzene for all animal species (‘the substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10 (1) of Regulation (EC) No 1831/2003.

                  (3)

                  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation as feed additives of trimethylamine, trimethylamine hydrochloride, 3-methylbutylamine for all animal species, except laying hens and 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy-benzene, 1-isopropyl-2-methoxy-4-methylbenzene 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 opinions of 25 April 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 has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for water for drinking, however, it should be possible to use the substances concerned within compound feeds which are subsequently administered via water.

                  (5)

                  Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures and on the labelling of feed materials and compound feed.

                  (6)

                  The Authority noted that trimethylamine, trimethylamine hydrochloride, 3-methylbutylamineare recognised as being corrosive to the eye, strongly irritant or corrosive to the skin and irritant to respiratory tract. Asthma like symptoms may occur after inhalation. For 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy-benzene, 1-isopropyl-2-methoxy-4-methylbenzene potential hazards for skin and eye contact and respiratory exposure are recognised. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                  (7)

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

                  (8)

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

                  (9)

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

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

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

               For the Commission

               The President

            Jean-Claude JUNCKER

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

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

         (3)  EFSA Journal 2012;10(5):2678 and EFSA Journal 2012;10(5):2679.

         ANNEX

                     Identification number of the additive

                     Name of the holder of authorisation

                     Additive

                     Composition, chemical formula, description, analytical method

                     Species or category of animal

                     Maximum age

                     Minimum content

                     Maximum content

                     Other provisions

                     End of period of authorisation

                     mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

                        Category: Sensory additives. Functional group: Flavouring compounds

                     2b11009

                     —

                     Trimethylamine

                        Additive composition

                     Trimethylamine

                        Characterisation of the active substance

                     Trimethylamine
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C3H9N
                     CAS number: 75-50-3
                     FLAVIS No: 11.009

                        Method of analysis
                         (1)

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

                     All animal species except laying hens

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

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

                                 4.

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

                                 5.

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

                                 6.

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

                     15.3.2028

                     2b11024

                     —

                     Trimethylamine hydrochloride

                        Additive composition

                     Trimethylamine hydrochloride

                        Characterisation of the active substance

                     Trimethylamine hydrochloride
                     Produced by chemical synthesis
                     Purity: min. 98.5 %
                     Chemical formula: C3H9N · HCl
                     CAS number: 593-81-7
                     FLAVIS No: 11.024

                        Method of analysis
                         (1)

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

                     All animal species except laying hens

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

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

                                 4.

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

                                 5.

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

                                 6.

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

                     15.3.2028

                     2b11001

                     —

                     3-Methylbutylamine

                        Additive composition

                     3-Methylbutylamine

                        Characterisation of the active substance

                     3-Methylbutylamine
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C5H13N
                     CAS number: 107-85-7
                     FLAVIS No:11.001

                        Method of analysis
                         (1)

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

                     All animal species except laying hens

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

                                             —

                                             1 mg/kg for pigs and poultry, except laying hens;

                                             —

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

                                 4.

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

                                             —

                                             1 mg/kg for pigs and poultry, except laying hens;

                                             —

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

                                 5.

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

                                             —

                                             1 mg/kg for pigs and poultry, except laying hens;

                                             —

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

                                 6.

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

                     15.3.2028

                     2b03006

                     —

                     2-Methoxyethyl benzene

                        Additive composition

                     2-Methoxyethyl benzene

                        Characterisation of the active substance

                     2-Methoxyethyl benzene
                     Produced by chemical synthesis
                     Purity: min. 99 %
                     Chemical formula: C9H12O
                     CAS number: 3558-60-9
                     FLAVIS No: 03.006

                        Method of analysis
                         (1)

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

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

                                 The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

                                             —

                                             0,3 mg/kg for pigs and poultry;

                                             —

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

                                 4.

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

                                             —

                                             0,3 mg/kg for pigs and poultry;

                                             —

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

                                 5.

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

                                             —

                                             0,3 mg/kg for pigs and poultry;

                                             —

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

                                 6.

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

                     15.3.2028

                     2b04016

                     —

                     1,3-Dimethoxy-benzene

                        Additive composition

                     1,3-Dimethoxy-benzene

                        Characterisation of the active substance

                     1,3-Dimethoxy-benzene
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C8H10O2

                     CAS number: 151-10-0
                     FLAVIS No: 04.016

                        Method of analysis
                         (1)

                     For the determination of 1,3-dimethoxy-benzene 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: 1 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

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

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg.

                                 6.

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

                     15.3.2028

                     2b04034

                     —

                     1,4-Dimethoxy-benzene

                        Additive composition

                     1,4-Dimethoxy-benzene

                        Characterisation of the active substance

                     1,4-Dimethoxy-benzene
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C8H10O2

                     CAS number: 150-78-7
                     FLAVIS No: 04.034

                        Method of analysis
                         (1)

                     For the determination of 1,4-dimethoxy-benzene 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: 1 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

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

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg.

                                 6.

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

                     15.3.2028

                     2b04043

                     —

                     1-Isopropyl-2-methoxy-4-methylbenzene

                        Additive composition

                     1-Isopropyl-2-methoxy-4-methylbenzene

                        Characterisation of the active substance

                     1-Isopropyl-2-methoxy-4-methylbenzene
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C11H16O
                     CAS number: 1076-56-8
                     FLAVIS No: 04.043

                        Method of analysis
                         (1)

                     For the determination of 1-isopropyl-2-methoxy-4-methylbenzene 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: 1 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

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

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg.

                                 6.

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

                     15.3.2028

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


title: Commission Implementing Regulation (EU) 2018/247 of 15 February 2018 concerning the authorisation of 2,4,5-trimethylthiazole, 2-isobutylthiazole, 5-(2-hydroxyethyl)-4-methylthiazole, 2-acetylthiazole, 2-ethyl-4- methylthiazole, 5,6-dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazine and thiamine hydrochloride as feed additives for all animal species (Text with EEA relevance. )

text:
                  23.2.2018

                  EN

                  Official Journal of the European Union

                  L 53/109

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/247
      of 15 February 2018
      concerning the authorisation of 2,4,5-trimethylthiazole, 2-isobutylthiazole, 5-(2-hydroxyethyl)-4-methylthiazole, 2-acetylthiazole, 2-ethyl-4- methylthiazole, 5,6-dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazine and thiamine hydrochloride as feed additives for all animal species
      (Text with EEA relevance)
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
      Whereas:

                  (1)

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

                  (2)

                  The substances 2,4,5-trimethylthiazole, 2-isobutylthiazole, 5-(2-hydroxyethyl)-4-methylthiazole, 2-acetylthiazole, 2-ethyl-4- methylthiazole, 5,6-dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazine and thiamine hydrochloride (‘substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

                  (3)

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

                  (4)

                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 April 2016 (3) that, under the proposed conditions of use, the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since the substances concerned are used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for use of the substances concerned in water for drinking.

                  (5)

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

                  (6)

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

                  (7)

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

                  (8)

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

                  (9)

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

                  (10)

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

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

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

               For the Commission

               The President

            Jean-Claude JUNCKER

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

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

         (3)  EFSA Journal 2016;14(4):4441.

         ANNEX

                     Identification number of the additive

                     Name of the holder of authorisation

                     Additive

                     Composition, chemical formula, description, analytical method

                     Species or category of animal

                     Maximum age

                     Minimum content

                     Maximum content

                     Other provisions

                     End of period of authorisation

                     mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

                        Category: Sensory additives. Functional group: Flavouring compounds

                     2b15019

                     —

                     2,4,5-Trimethylthiazole

                        Additive composition

                     2,4,5-Trimethylthiazole

                        Characterisation of the active substance

                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C6H9NS
                     CAS number: 13623-11-5
                     FLAVIS No: 15.019

                        Method of analysis
                         (1)

                     For the determination of 2,4,5-trimethylthiazole in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

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

                                 4.

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

                                 5.

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

                                 6.

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

                     15.3.2028

                     2b15013

                     —

                     2-Isobutylthiazole

                        Additive composition

                     2-Isobutylthiazole

                        Characterisation of the active substance

                     2-Isobutylthiazole
                     Produced by chemical synthesis
                     Purity: min. 96 % assay
                     Chemical formula: C7H11NS
                     CAS number: 18640-74-9
                     FLAVIS No: 15.013

                        Method of analysis
                         (1)

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

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

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

                                 4.

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

                                 5.

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

                                 6.

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

                     15.3.2028

                     2b15014

                     —

                     5-(2-Hydroxyethyl)-4-methylthiazole

                        Additive composition

                     5-(2-Hydroxyethyl)-4-methylthiazole

                        Characterisation of the active substance

                     5-(2-Hydroxyethyl)-4-methylthiazole
                     Produced by chemical synthesis
                     Purity: min. 96 % assay
                     Chemical formula: C6H9ONS
                     CAS number: 137-00-8
                     FLAVIS No: 15.014

                        Method of analysis
                         (1)

                     For the determination of 5-(2-hydroxyethyl)-4-methylthiazole in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

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

                                 4.

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

                                 5.

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

                                 6.

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

                     15.3.2028

                     2b15020

                     —

                     2-Acetylthiazole

                        Additive composition

                     2-Acetylthiazole

                        Characterisation of the active substance

                     2-Acetylthiazole
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C5H5ONS
                     CAS number: 24295-03-2
                     FLAVIS No: 15.020

                        Method of analysis
                         (1)

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

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

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

                                 4.

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

                                 5.

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

                                 6.

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

                     15.3.2028

                     2b15033

                     —

                     2-Ethyl-4- methylthiazole

                        Additive composition

                     2-Ethyl-4- methylthiazole

                        Characterisation of the active substance

                     2-Ethyl-4- methylthiazole
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C6H9NS
                     CAS number:15679-12-6
                     FLAVIS No: 15.033

                        Method of analysis
                         (1)

                     For the determination of 2-ethyl-4- methylthiazole in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

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

                                 4.

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

                                 5.

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

                                 6.

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

                     15.3.2028

                     2b15113

                     —

                     5,6-Dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazine

                        Additive composition

                     5,6-Dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazine

                        Characterisation of the active substance

                     5,6-Dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazine
                     Produced by chemical synthesis
                     Purity: min. 87 % assay
                     Chemical formula: C15H31NS2

                     CAS number: 74595-94-1
                     FLAVIS No: 15.113

                        Method of analysis
                         (1)

                     For the determination of 5,6-dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazine in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

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

                                 4.

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

                                 5.

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

                                 6.

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

                     15.3.2028

                     2b16027

                     —

                     Thiamine hydrochloride

                        Additive composition

                     Thiamine hydrochloride

                        Characterisation of the active substance

                     Thiamine hydrochloride
                     Produced by chemical synthesis
                     Purity: min.98 % assay
                     Chemical formula: C12H17ClN4OS · HCl
                     CAS number: 67-03-8
                     FLAVIS No: 16.027

                        Method of analysis
                         (1)

                     For the determination of thiamine hydrochloride in the feed additive and in feed flavouring premixtures:
                     High-Performance Liquid Chromatography (HPLC) European Pharmacopeia (Ph. Eur. 6.0, method 01/2008:0303)

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

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

                                 3.

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

                                 4.

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

                                 5.

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

                                 6.

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

                     15.3.2028

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


title: Commission Implementing Regulation (EU) 2018/238 of 15 February 2018 concerning the authorisation of disodium 5′-ribonucleotides, disodium 5′-guanylate and disodium 5′-inosinate as feed additives for all animal species (Text with EEA relevance. )

text:
                  23.2.2018

                  EN

                  Official Journal of the European Union

                  L 53/1

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/238
      of 15 February 2018
      concerning the authorisation of disodium 5′-ribonucleotides, disodium 5′-guanylate and disodium 5′-inosinate 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)

                  Disodium 5′-ribonucleotides, disodium 5′-guanylate and disodium 5′-inosinate (‘substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

                  (3)

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

                  (4)

                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 4 March 2014 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of the substances concerned in feed is similar to that in food. The Authority has already concluded that for food the substances concerned are efficacious, as they increase the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The applicant withdrew the application for water for drinking. However, the substances concerned 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 and on the labelling of compound feeds and feed materials.

                  (6)

                  The Authority also concluded that in the absence of data the substances concerned should be considered as potentially hazardous to workers by skin, eyes and mucous membranes or inhalation exposure. 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 except for the substances concerned produced by fermentation. The applicant asked for the authorisation of the substances concerned produced by fermentation and RNA hydrolysis. The lack of information on the production strains does not allow to assess the safety of the substances concerned produced by fermentation despite they are ‘per se’ safe. Accordingly, the use of the substances concerned should be authorised as specified in the Annex to this Regulation and the authorisation of those additives produced by fermentation should be denied.

                  (8)

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

                  (9)

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

            HAS ADOPTED THIS REGULATION:
      Article 1
      Authorisation
      The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.
      Article 2
      Denial
      The authorisation of disodium 5′-ribonucleotides, disodium 5′-guanylate and disodium 5′-inosinate produced by fermentation is denied.
      Article 3
      Transitional measures
      1.   The substances specified in the Annex and the substances mentioned in Article 2, and premixtures containing those substances and which are produced and labelled before 15 December 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.
      2.   Compound feed and feed materials containing the substances as specified in the Annex and the substances mentioned in Article 2 which are produced and labelled before 15 September 2019 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
      3.   Compound feed and feed materials containing the substances as specified in the Annex and the substances mentioned in Article 2 which are produced and labelled before 15 September 2020 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
      Article 4
      Entry into force
      This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

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

               For the Commission

               The President

            Jean-Claude JUNCKER

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

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

         (3)  EFSA Journal 2014;12(3):3606.

         ANNEX

                     Identification number of the additive

                     Name of the holder of authorisation

                     Additive

                     Composition, chemical formula, description, analytical method

                     Species or category of animal

                     Maximum age

                     Minimum content

                     Maximum content

                     Other provisions

                     End of period of authorisation

                     mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

                        Category: Sensory additives. Functional group: Flavouring compounds

                     2b635

                     —

                     Disodium 5′-ribonucleotide

                        Additive composition

                     Disodium 5′-ribonucleotides

                        Characterisation of the active substance

                     Disodium 5′-ribonucleotides: a mixture of disodium 5′-guanylate (GMP) and disodium 5′-inosinate (IMP).
                     Produced by RNA hydrolysis
                     Purity: min.: 97 % assay
                     Chemical formula:

                                 —

                                 C10H11N4O8P · nH2O

                                 —

                                 C10H12N5Na2O8P · nH2O

                        Method of analysis
                         (1)

                     For the identification of GMP and IMP in the feed additive:
                     JECFA monograph, Specifications for food additives: Disodium 5′-Ribonucleotides.
                     For the determination of GMP and IMP in the feed additive and premixtures of flavourings:
                     High performance Liquid Chromatography coupled to UV detection (HPLC-UV).

                     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 or the combination of disodium 5′-ribonucleotide (2b635), disodium 5′-guanylate (2b627) and disodium 5′-inosinate (2b631) shall be:
                                 50 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 or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate of complete feedingstuff with a moisture content of 12 %: 50 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the following content of the active substance or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate in complete feedingstuff with a moisture content of 12 % is exceeded: 50 mg/kg.

                                 6.

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

                     15.3.2028

                     2b627

                     —

                     Disodium 5′-guanylate

                        Additive composition

                     Disodium 5′-guanylate (GMP)

                        Characterisation of the active substance

                     Disodium 5′-guanylate
                     Produced by RNA hydrolysis
                     Purity: min.: 97 % assay
                     Chemical formula: C10H12N5Na2O8P · n H2O
                     CAS number: 5550-12-9

                        Method of analysis
                         (1)

                     For the identification of GMP in the feed additive:
                     JECFA monograph, Specifications for food additives: Disodium 5′-Ribonucleotides.
                     For the determination of GMP in the feed additive and premixtures of flavourings:
                     High performance Liquid Chromatography coupled to UV detection (HPLC-UV).

                     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 or the combination of disodium 5′-ribonucleotide (2b635), disodium 5′-guanylate (2b627) and disodium 5′-inosinate (2b631) shall be:
                                 50 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 or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate of complete feedingstuff with a moisture content of 12 %: 50 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the following content of the active substance or the combination of disodium 5′-ribonucleotide disodium 5′-guanylate and disodium 5′-inosinate in complete feedingstuff with a moisture content of 12 % is exceeded: 50 mg/kg.

                                 6.

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

                     15.3.2028

                     2b631

                     —

                     Disodium 5′-inosinate

                        Additive composition

                     Disodium 5′-inosinate (IMP)

                        Characterisation of the active substance

                     Disodium 5′-inosinate
                     Produced by RNA hydrolysis
                     Purity: min. 97 % assay
                     Chemical formula: C10H11 N4O8P · nH2O
                     CAS number 4691-65-0

                        Method of analysis
                         (1)

                     For the identification of IMP in the feed additive:
                     JECFA monograph, Specifications for food additives: Disodium 5′-Ribonucleotides.
                     For the determination of IMP in the feed additive and premixtures of flavourings:
                     High performance Liquid Chromatography coupled to UV detection (HPLC-UV).

                     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 or the combination of disodium 5′-ribonucleotide (2b635), disodium 5′-guanylate (2b627) and disodium 5′-inosinate (2b631) shall be:
                                 50 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 or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate of complete feedingstuff with a moisture content of 12 %: 50 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the following content of the active substance or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate in complete feedingstuff with a moisture content of 12 % is exceeded: 50 mg/kg.

                                 6.

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

                     15.3.2028

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