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Commission Implementing Regulation (EU) 2018/241Show full title

Commission Implementing Regulation (EU) 2018/241 of 15 February 2018 concerning the authorisation of piperine, 3-methylindole, indole, 2-acetylpyrrole and pyrrolidine as feed additives for all animal species (Text with EEA relevance)

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ANNEX

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
^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		Species or category of animal	Maximum age	mg of active substance/kg of complete feedingstuff with a moisture content of 12 %		Other provisions	End of period of authorisation
Category: Sensory additives. Functional group: Flavouring compounds
2b14003	—	Piperine	Additive composition Piperine Characterisation of the active substance Piperine Produced by chemical synthesis Purity: min. 95 % Chemical formula: C₁₇H₁₉O₃N CAS number: 94-62-2 FLAVIS No: 14.003 Method of analysis ^a For the determination of piperine in the feed additive and in feed flavouring premixtures: Gas chromatography coupled to a Flame Ionisation Detector (GC-FID).	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 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
2b14004	—	3-Methylindole	Additive composition 3-Methylindole Characterisation of the active substance 3-Methylindole Produced by chemical synthesis Purity: min. 97 % Chemical formula: C₉H₉N CAS number: 83-34-1 FLAVIS No:14.004 Method of analysis ^a For the identification of 3-methylindole 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: 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 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
2b14007	—	Indole	Additive composition Indole Characterisation of the active substance Indole Produced by chemical synthesis Purity: min. 97 % Chemical formula: C₈H₇N CAS number: 120-72-9 FLAVIS No: 14.007 Method of analysis ^a For the determination of indole 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 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
2b14047	—	2-Acetylpyrrole	Additive composition 2-Acetylpyrrole Characterisation of the active substance 2-Acetylpyrrole Produced by chemical synthesis Purity: min. 97 % Chemical formula: C₆H₇ON CAS number 1072-83-9 FLAVIS No: 14.047 Method of analysis ^a For the determination of 2-acetylpyrrole 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 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
2b14064	—	Pyrrolidine	Additive composition Pyrrolidine Characterisation of the active substance Pyrrolidine Produced by chemical synthesis Purity: min. 95 % Chemical formula: C₄H₉N CAS number 123-75-1 FLAVIS No: 14.064 Method of analysis ^a For the determination of pyrrolidine 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: 0,3 mg/kg for pigs and poultry, 0,5 mg/kg for other species and categories. 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 %: 0,3 mg/kg for pigs and poultry, 0,5 mg/kg for other species and categories.’ 5. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of 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: 0,3 mg/kg for pigs and poultry, 0,5 mg/kg for other species and categories. 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