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. )
Commission Implementing Regulation (EU) 2018/247of 15 February 2018concerning 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 nutritionOJ L 268, 18.10.2003, p. 29., 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/EECCouncil Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1)..(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 2016EFSA Journal 2016;14(4):4441. 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 1AuthorisationThe 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 2Transitional measures1.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 3Entry into forceThis 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 CommissionThe PresidentJean-Claude JunckerANNEX
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-reportsCategory: Sensory additives. Functional group: Flavouring compounds
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
2b15019—2,4,5-TrimethylthiazoleAdditive composition2,4,5-TrimethylthiazoleCharacterisation of the active substanceProduced by chemical synthesisPurity: min. 97 % assayChemical formula: C6H9NSCAS number: 13623-11-5FLAVIS No: 15.019Method of analysisFor 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-IsobutylthiazoleAdditive composition2-IsobutylthiazoleCharacterisation of the active substance2-IsobutylthiazoleProduced by chemical synthesisPurity: min. 96 % assayChemical formula: C7H11NSCAS number: 18640-74-9FLAVIS No: 15.013Method of analysisFor 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-methylthiazoleAdditive composition5-(2-Hydroxyethyl)-4-methylthiazoleCharacterisation of the active substance5-(2-Hydroxyethyl)-4-methylthiazoleProduced by chemical synthesisPurity: min. 96 % assayChemical formula: C6H9ONSCAS number: 137-00-8FLAVIS No: 15.014Method of analysisFor 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-AcetylthiazoleAdditive composition2-AcetylthiazoleCharacterisation of the active substance2-AcetylthiazoleProduced by chemical synthesisPurity: min. 97 % assayChemical formula: C5H5ONSCAS number: 24295-03-2FLAVIS No: 15.020Method of analysisFor 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- methylthiazoleAdditive composition2-Ethyl-4- methylthiazoleCharacterisation of the active substance2-Ethyl-4- methylthiazoleProduced by chemical synthesisPurity: min. 97 % assayChemical formula: C6H9NSCAS number:15679-12-6FLAVIS No: 15.033Method of analysisFor 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-dithiazineAdditive composition5,6-Dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazineCharacterisation of the active substance5,6-Dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazineProduced by chemical synthesisPurity: min. 87 % assayChemical formula: C15H31NS2CAS number: 74595-94-1FLAVIS No: 15.113Method of analysisFor 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 hydrochlorideAdditive compositionThiamine hydrochlorideCharacterisation of the active substanceThiamine hydrochlorideProduced by chemical synthesisPurity: min.98 % assayChemical formula: C12H17ClN4OS · HClCAS number: 67-03-8FLAVIS No: 16.027Method of analysisFor 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