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Commission Implementing Regulation (EU) 2018/247Dangos y teitl llawn
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)
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ANNEXU.K.
| a 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 | |||||||||
| 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 composition2,4,5-Trimethylthiazole Characterisation of the active substanceProduced by chemical synthesis Purity: min. 97 % assay Chemical formula: C6H9NS CAS number: 13623-11-5 FLAVIS No: 15.019 Method of analysis aFor 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 composition2-Isobutylthiazole Characterisation of the active substance2-Isobutylthiazole Produced by chemical synthesis Purity: min. 96 % assay Chemical formula: C7H11NS CAS number: 18640-74-9 FLAVIS No: 15.013 Method of analysis aFor 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 composition5-(2-Hydroxyethyl)-4-methylthiazole Characterisation of the active substance5-(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 aFor 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 composition2-Acetylthiazole Characterisation of the active substance2-Acetylthiazole Produced by chemical synthesis Purity: min. 97 % assay Chemical formula: C5H5ONS CAS number: 24295-03-2 FLAVIS No: 15.020 Method of analysis aFor 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 composition2-Ethyl-4- methylthiazole Characterisation of the active substance2-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 aFor 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 composition5,6-Dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazine Characterisation of the active substance5,6-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 aFor 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 compositionThiamine hydrochloride Characterisation of the active substanceThiamine 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 aFor 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 |
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