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. )

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. (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.L 53/110 EN Official Journal of the European Union 23.2.2018 (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 authoris­ ation 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 JUNCKERANNEX Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period of Additive category of mg of active substance/kg Other provisions number of of authoris­ description, analytical method age authoris­ animal of complete feedingstuff the additive ation ation with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b15019 — 2,4,5-Tri­ Additive composition All animal — — — 1. The additive shall be incorporated into 15.3.2028 methyl­ species the feed in the form of a premixture. 2,4,5-Trimethylthiazole thiazole 2. In the directions for use of the additive Characterisation of the active sub­ and premixtures, the storage and stabil­ stance ity conditions shall be indicated. Produced by chemical synthesis 3. On the label of the additive the follow­ Purity: min. 97 % assay ing shall be indicated: Chemical formula: C H NS ‘Recommended maximum content of 6 9 the active substance of complete CAS number: 13623-11-5 feedingstuff with a moisture content of FLAVIS No: 15.019 12 %: 0,05 mg/kg.’ Method of analysis(1) 4. The functional group, the identification number, the name and the added For the determination of 2,4,5-tri­ amount of the active substance shall be methylthiazole in the feed additive indicated on the label of the premixture and in feed flavouring premix­ where the use level suggested on the la­ tures: bel of the premixture would result in Gas chromatography mass spec­ exceeding the level referred to in trometry with retention time lock­ point 3. ing GC-MS-RTL. 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 mate­ rials and compound feedingstuffs where the content of the active sub­ stance in the complete feedingstuff with a moisture content of 12 % ex­ ceeds: 0,05 mg/kg. 23.2.2018 EN Official Journal of the European Union L 53/111Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period of Additive category of mg of active substance/kg Other provisions number of of authoris­ description, analytical method age authoris­ animal of complete feedingstuff the additive ation ation with a moisture content of 12 % 6. For users of the additive and premix­ tures, feed business operators shall establish operational procedures and organisational measures to address po­ tential risks by inhalation, dermal con­ tact 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 protec­ tion, safety glasses and gloves. 2b15013 — 2-Isobu­ Additive composition All animal — — — 1. The additive shall be incorporated into 15.3.2028 tylthiazole species the feed in the form of a premixture. 2-Isobutylthiazole 2. In the directions for use of the additive Characterisation of the active sub­ and premixtures, the storage and stabil­ stance ity conditions shall be indicated. 2-Isobutylthiazole 3. On the label of the additive the follow­ Produced by chemical synthesis ing shall be indicated: Purity: min. 96 % assay ‘Recommended maximum content of the active substance of complete Chemical formula: C H NS 7 11 feedingstuff with a moisture content of CAS number: 18640-74-9 12 %: 0,05 mg/kg.’ FLAVIS No: 15.013 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 la­ bel of the premixture would result in exceeding the level referred to in point 3. L 53/112 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period of Additive category of mg of active substance/kg Other provisions number of of authoris­ description, analytical method age authoris­ animal of complete feedingstuff the additive ation ation with a moisture content of 12 % Method of analysis(1) 5. The functional group, the identification number, the name and the added For the determination of 2-isobu­ amount of the active substance shall be tylthiazole in the feed additive and indicated in the labelling of feed mate­ in feed flavouring premixtures: rials and compound feedingstuffs Gas chromatography mass spec­ where the content of the active sub­ trometry with retention time lock­ stance in the complete feedingstuff ing GC-MS-RTL. with a moisture content of 12 % ex­ ceeds: 0,05 mg/kg. 6. For users of the additive and premix­ tures, feed business operators shall establish operational procedures and organisational measures to address po­ tential risks by inhalation, dermal con­ tact 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 protec­ tion, safety glasses and gloves. 2b15014 — 5-(2-Hy­ Additive composition All animal — — — 1. The additive shall be incorporated into 15.3.2028 droxye­ species the feed in the form of a premixture. 5-(2-Hydroxyethyl)-4-methylthia­ thyl)-4- zole 2. In the directions for use of the additive methyl­ and premixtures, the storage and stabil­ thiazole Characterisation of the active sub­ ity conditions shall be indicated. stance 3. On the label of the additive the follow­ 5-(2-Hydroxyethyl)-4-methylthia­ ing shall be indicated: zole ‘Recommended maximum content of Produced by chemical synthesis the active substance of complete Purity: min. 96 % assay feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’ Chemical formula: C H ONS 6 9 CAS number: 137-00-8 FLAVIS No: 15.014 23.2.2018 EN Official Journal of the European Union L 53/113Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period of Additive category of mg of active substance/kg Other provisions number of of authoris­ description, analytical method age authoris­ animal of complete feedingstuff the additive ation ation with a moisture content of 12 % Method of analysis(1) 4. The functional group, the identification number, the name and the added For the determination of 5-(2-hy­ amount of the active substance shall be droxyethyl)-4-methylthiazole in indicated on the label of the premixture the feed additive and in feed fla­ where the use level suggested on the la­ vouring premixtures: bel of the premixture would result in Gas chromatography mass spec­ exceeding the level referred to in trometry with retention time lock­ point 3. ing GC-MS-RTL. 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 mate­ rials and compound feedingstuffs where the content of the active sub­ stance in the complete feedingstuff with a moisture content of 12 % ex­ ceeds: 0,05 mg/kg. 6. For users of the additive and premix­ tures, feed business operators shall establish operational procedures and organisational measures to address po­ tential risks by inhalation, dermal con­ tact 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 protec­ tion, safety glasses and gloves. 2b15020 — 2-Acet­ Additive composition All animal — — — 1. The additive shall be incorporated into 15.3.2028 ylthiazole species the feed in the form of a premixture. 2-Acetylthiazole 2. In the directions for use of the additive and premixtures, the storage and stabil­ ity conditions shall be indicated. L 53/114 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period of Additive category of mg of active substance/kg Other provisions number of of authoris­ description, analytical method age authoris­ animal of complete feedingstuff the additive ation ation with a moisture content of 12 % Characterisation of the active sub­ 3. On the label of the additive the follow­ stance ing shall be indicated: 2-Acetylthiazole ‘Recommended maximum content of the active substance of complete Produced by chemical synthesis feedingstuff with a moisture content of Purity: min. 97 % assay 12 %: 0,05 mg/kg.’ Chemical formula: C H ONS 4. The functional group, the identification 5 5 CAS number: 24295-03-2 number, the name and the added amount of the active substance shall be FLAVIS No: 15.020 indicated on the label of the premixture Method of analysis(1) where the use level suggested on the la­ bel of the premixture would result in For the determination of 2-acet­ exceeding the level referred to in ylthiazole in the feed additive and point 3. in feed flavouring premixtures: 5. The functional group, the identification Gas chromatography mass spec­ number, the name and the added trometry with retention time lock­ amount of the active substance shall be ing GC-MS-RTL. indicated in the labelling of feed mate­ rials and compound feedingstuffs where the content of the active sub­ stance in the complete feedingstuff with a moisture content of 12 % ex­ ceeds: 0,05 mg/kg. 6. For users of the additive and premix­ tures, feed business operators shall establish operational procedures and organisational measures to address po­ tential risks by inhalation, dermal con­ tact 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 protec­ tion, safety glasses and gloves. 23.2.2018 EN Official Journal of the European Union L 53/115Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period of Additive category of mg of active substance/kg Other provisions number of of authoris­ description, analytical method age authoris­ animal of complete feedingstuff the additive ation ation with a moisture content of 12 % 2b15033 — 2-Ethyl-4- Additive composition All animal — — — 1. The additive shall be incorporated into 15.3.2028 methyl­ species the feed in the form of a premixture. 2-Ethyl-4- methylthiazole thiazole 2. In the directions for use of the additive Characterisation of the active sub­ and premixtures, the storage and stabil­ stance ity conditions shall be indicated. 2-Ethyl-4- methylthiazole 3. On the label of the additive the follow­ Produced by chemical synthesis ing shall be indicated: Purity: min. 97 % assay ‘Recommended maximum content of the active substance of complete Chemical formula: C H NS 6 9 feedingstuff with a moisture content of CAS number:15679-12-6 12 %: 0,05 mg/kg.’ FLAVIS No: 15.033 4. The functional group, the identification number, the name and the added Method of analysis(1) amount of the active substance shall be For the determination of 2-ethyl- indicated on the label of the premixture 4- methylthiazole in the feed addi­ where the use level suggested on the la­ tive and in feed flavouring bel of the premixture would result in premixtures: exceeding the level referred to in Gas chromatography mass spec­ point 3. trometry with retention time lock­ 5. The functional group, the identification ing GC-MS-RTL. number, the name and the added amount of the active substance shall be indicated in the labelling of feed mate­ rials and compound feedingstuffs where the content of the active sub­ stance in the complete feedingstuff with a moisture content of 12 % ex­ ceeds: 0,05 mg/kg. L 53/116 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period of Additive category of mg of active substance/kg Other provisions number of of authoris­ description, analytical method age authoris­ animal of complete feedingstuff the additive ation ation with a moisture content of 12 % 6. For users of the additive and premix­ tures, feed business operators shall establish operational procedures and organisational measures to address po­ tential risks by inhalation, dermal con­ tact 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 protec­ tion, safety glasses and gloves. 2b15113 — 5,6-Dihy­ Additive composition All animal — — — 1. The additive shall be incorporated into 15.3.2028 dro-2,4,6, species the feed in the form of a premixture. 5,6-Dihydro-2,4,6,tris(2-methyl­ tris(2- propyl)4H-1,3,5-dithiazine 2. In the directions for use of the additive methylpro­ and premixtures, the storage and stabil­ pyl)4H- Characterisation of the active sub­ ity conditions shall be indicated. 1,3,5- stance dithiazine 3. On the label of the additive the follow­ 5,6-Dihydro-2,4,6,tris(2-methyl­ ing shall be indicated: propyl)4H-1,3,5-dithiazine ‘Recommended maximum content of Produced by chemical synthesis the active substance of complete Purity: min. 87 % assay feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’ Chemical formula: C H NS 15 31 2 4. The functional group, the identification CAS number: 74595-94-1 number, the name and the added FLAVIS No: 15.113 amount of the active substance shall be indicated on the label of the premixture Method of analysis(1) where the use level suggested on the la­ For the determination of 5,6-dihy­ bel of the premixture would result in dro-2,4,6,tris(2-methylpropyl)4H- exceeding the level referred to in 1,3,5-dithiazine in the feed addi­ point 3. tive and in feed flavouring premixtures: Gas chromatography mass spec­ trometry with retention time lock­ ing GC-MS-RTL. 23.2.2018 EN Official Journal of the European Union L 53/117Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period of Additive category of mg of active substance/kg Other provisions number of of authoris­ description, analytical method age authoris­ animal of complete feedingstuff the additive ation ation with a moisture content of 12 % 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 mate­ rials and compound feedingstuffs where the content of the active sub­ stance in the complete feedingstuff with a moisture content of 12 % ex­ ceeds: 0,05 mg/kg. 6. For users of the additive and premix­ tures, feed business operators shall establish operational procedures and organisational measures to address po­ tential risks by inhalation, dermal con­ tact 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 protec­ tion, safety glasses and gloves. 2b16027 — Thiamine Additive composition All animal — — — 1. The additive shall be incorporated into 15.3.2028 hydro­ species the feed in the form of a premixture. Thiamine hydrochloride chloride 2. In the directions for use of the additive Characterisation of the active sub­ and premixtures, the storage and stabil­ stance ity conditions shall be indicated. Thiamine hydrochloride 3. On the label of the additive the follow­ Produced by chemical synthesis ing shall be indicated: Purity: min.98 % assay ‘Recommended maximum content of the active substance of complete Chemical formula: C H ClN OS · 12 17 4 feedingstuff with a moisture content of HCl 12 %: 0,05 mg/kg.’ CAS number: 67-03-8 FLAVIS No: 16.027 L 53/118 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period of Additive category of mg of active substance/kg Other provisions number of of authoris­ description, analytical method age authoris­ animal of complete feedingstuff the additive ation ation with a moisture content of 12 % Method of analysis(1) 4. The functional group, the identification number, the name and the added For the determination of thiamine amount of the active substance shall be hydrochloride in the feed additive indicated on the label of the premixture and in feed flavouring premix­ where the use level suggested on the la­ tures: bel of the premixture would result in High-Performance Liquid Chroma­ exceeding the level referred to in tography (HPLC) European Phar­ point 3. macopeia (Ph. Eur. 6.0, method 5. The functional group, the identification 01/2008:0303) number, the name and the added amount of the active substance shall be indicated in the labelling of feed mate­ rials and compound feedingstuffs where the content of the active sub­ stance in the complete feedingstuff with a moisture content of 12 % ex­ ceeds: 0,05 mg/kg. 6. For users of the additive and premix­ tures, feed business operators shall establish operational procedures and organisational measures to address po­ tential risks by inhalation, dermal con­ tact 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 protec­ tion, safety glasses and gloves. (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 23.2.2018 EN Official Journal of the European Union L 53/119