Commission Implementing Regulation (EU) 2018/243 of 15 February 2018 concerning the authorisation of 3-hydroxybutan-2-one, pentan-2,3-dione, 3,5-dimethyl cyclopentan-1,2-dione, hexan-3,4-dione, sec-butan-3-onyl acetate, 2,6,6-trimethylcyclohex-2-en-1,4-dione and 3-methylnona-2-,4-dione as feed additives for all animal species (Text with EEA relevance)
| 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 | |||||||||
| 2b07051 | — | 3-Hydroxybutan-2-one | Additive composition3-Hydroxybutan-2-one Characterisation of the active substance3-Hydroxybutan-2-one Produced by chemical synthesis Purity: min. 96 % assay Chemical formula: C4H8O2 CAS number: 513-86-0 FLAVIS No: 07.051 Method of analysis aFor the determination of 3-hydroxybutan-2-one 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 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 |
| 2b07060 | — | Pentan-2,3-dione | Additive compositionPentan-2,3-dione Characterisation of the active substancePentan-2,3-dione Produced by chemical synthesis Purity: min. 93 % assay Chemical formula: C5H8O2 CAS number: 600-14-6 FLAVIS No: 07.060 Method of analysis aFor the determination of pentan-2,3-dione 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 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 |
| 2b07076 | — | 3,5-Dimethyl cyclopentan-1,2-dione | Additive composition3,5-dimethyl cyclopentan-1,2-dione Characterisation of the active substance3,5-dimethyl cyclopentan-1,2-dione Produced by chemical synthesis Purity: min. 97 % assay Chemical formula: C7H10O2 CAS number: 13494-07-0 FLAVIS No: 07.076 Method of analysis aFor the determination of 3,5-dimethyl cyclopentan-1,2-dione 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 0,5 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 %: 0,5 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: 0,5 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 |
| 2b07077 | — | Hexan-3,4-dione | Additive compositionHexan-3,4-dione Characterisation of the active substanceHexan-3,4-dione Produced by chemical synthesis Purity: min. 97 % assay Chemical formula: C6H10O2 CAS number: 4437-51-8 FLAVIS No: 07.077 Method of analysis aFor the determination of hexan-3,4-dione 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 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 |
| 2b09186 | — | Sec-butan-3-onyl acetate | Additive compositionSec-butan-3-onyl acetate Characterisation of the active substanceSec-butan-3-onyl acetate Produced by chemical synthesis Purity: min. 98 % assay Chemical formula: C6H10O3 CAS number: 4906-24-5 FLAVIS No: 09.186 Method of analysis aFor the determination of sec-butan-3-onyl acetate 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 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 |
| 2b07109 | — | 2,6,6-Trimethylcyclohex-2-en-1,4-dione | Additive composition2,6,6-Trimethylcyclohex-2-en-1,4-dione Characterisation of the active substance2,6,6-Trimethylcyclohex-2-en-1,4-dione Produced by chemical synthesis Purity: min. 98 % assay Chemical formula: C9H12O2 CAS number: 1125-21-9 FLAVIS No: 07.109 Method of analysis aFor the determination of 2,6,6-trimethylcyclohex-2-en-1,4-dione 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:
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 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:
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 |
| 2b07184 | — | 3-Methylnona-2-,4-dione | Additive composition3-Methylnona-2-,4-dione Characterisation of the active substance3-Methylnona-2-,4-dione Produced by chemical synthesis Purity: min. 97 % assay Chemical formula: C10H18O2 CAS number: 113486-29-6 FLAVIS No: 07.184 Method of analysis aFor the determination of 3-methylnona-2-,4-dione 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:
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 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:
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 |
