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Commission Implementing Regulation (EU) 2017/57 of 14 December 2016 concerning the authorisation of 1,8-cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran as feed additives for all animal species (Text with EEA relevance)
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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 % | |||||||||
(1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | |
Category: Sensory additives. Functional group: Flavouring compounds | |||||||||
2b03001 | — | 1,8-Cineole | Additive composition1,8-Cineole Characterisation of the active substance1,8-Cineole Produced by distillation from Eucalyptus globulus Purity: min. 98 % Chemical formula: C10H18O CAS number 470-82-6 FLAVIS No 03.001 Method of analysis aFor the determination of 1,8-cineole in the feed additive and in feed flavouring premixtures. Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. | All animal species | — | — | 1. The additive shall be incorporated into the feed in the form of a premixture. 2. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. 3. The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %. 4. On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance: of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’. 5. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg. 6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by 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. | 6 February 2027 | |
2b13009 | — | 3,4-Dihydrocoumarin | Additive composition3,4-Dihydrocoumarin Characterisation of the active substance3,4-Dihydrocoumarin Produced by chemical synthesis Purity: min. 99 % Chemical formula: C9H8O2 CAS number 119-84-6 FLAVIS No 13.009 Method of analysis aFor the determination of 3,4-dihydrocoumarin in the feed additive and in feed flavouring premixtures. Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. | All animal species | — | — | 1. The additive shall be incorporated into the feed in the form of a premixture. 2. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. 3. The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %. 4. On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’ 5. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg. 6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by 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. | 6 February 2027 | |
2b13037 | — | 2-(2-Methylprop-1-enyl)-4-methyltetrahydropyran | Additive composition2-(2-Methylprop-1-enyl)-4-methyltetrahydropyran Characterisation of the active substance2-(2-Methylprop-1-enyl)-4-methyltetrahydropyran Produced by chemical synthesis Purity: min. 99 % Chemical formula: C10H18O CAS number 16409-43-1 FLAVIS No 13.037 Method of analysis aFor the identification of 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran in the feed additive and 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: For pigs and poultry: 0,5 mg/kg, and for other species and categories: 0,3 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. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded:
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. | 6 February 2027 |
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