Commission Implementing Regulation (EU) 2018/248Show full title

ANNEX

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
2b14005	—	2,3-Diethylpyrazine	Additive composition 2,3-Diethylpyrazine Characterisation of the active substance 2,3-Diethylpyrazine Produced by chemical synthesis Purity: min. 97 % assay Chemical formula: C8H12N2 CAS number: 15707-24-1 FLAVIS No: 14.005 Method of analysis a For the determination of 2,3-diethylpyrazine 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 %: 0,1 mg/kg for pigs and poultry. 0,5 mg/kg for other species and categories’. 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 levels suggested on the label of the premixture would result in exceeding the levels 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: 0,1 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
2b14025	—	2,5 or 6-Methoxy-3-methylpyrazine	Additive composition 2,5 or 6-Methoxy-3-methylpyrazine Characterisation of the active substance 2,5 or 6-Methoxy-3-methylpyrazine Produced by chemical synthesis Purity: min. 97 % assay Chemical formula: C6H8ON2 CAS number: 63450-30-6 FLAVIS No: 14.025 Method of analysis a For the determination of 2,5 or 6-methoxy-3-methylpyrazine 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 %: 0,1 mg/kg for pigs and poultry. 0,5 mg/kg for other species and categories’. 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 levels suggested on the label of the premixture would result in exceeding the levels 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: 0,1 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
2b14049	—	2-Acetyl-3-ethylpyrazine	Additive composition 2-Acetyl-3-ethylpyrazine Characterisation of the active substance 2-Acetyl-3-ethylpyrazine Produced by chemical synthesis Purity: min. 98 % assay Chemical formula: C8H10ON2 CAS number: 32974-92-8 FLAVIS No: 14.049 Method of analysis a For the determination of 2-acetyl-3-ethylpyrazine 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 %: 0,1 mg/kg for pigs and poultry. 0,5 mg/kg for other species and categories’. 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 levels suggested on the label of the premixture would result in exceeding the levels 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: 0,1 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
2b14056	—	2,3-Diethyl-5-methylpyrazine	Additive composition 2,3-Diethyl-5-methylpyrazine Characterisation of the active substance 2,3-Diethyl-5-methylpyrazine Produced by chemical synthesis Purity: min. 98 % assay Chemical formula: C9H14N2 CAS number: 18138-04-0 FLAVIS No: 14.056 Method of analysis a For the determination of 2,3-diethyl-5-methylpyrazine alcohol 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 %: 0,1 mg/kg for pigs and poultry. 0,5 mg/kg for other species and categories’. 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 levels suggested on the label of the premixture would result in exceeding the levels 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: 0,1 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
2b14062	—	2-(sec-Butyl)-3-methoxypyrazine	Additive composition 2-(sec-Butyl)-3-methoxypyrazine Characterisation of the active substance 2-(sec-Butyl)-3-methoxypyrazine Produced by chemical synthesis Purity: min. 99 % assay Chemical formula: C9H14ON2 CAS number: 24168-70-5 FLAVIS No: 14.062 Method of analysis a For the determination of 2-(sec-butyl)-3-methoxypyrazine 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 %: 0,1 mg/kg for pigs and poultry. 0,5 mg/kg for other species and categories’. 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 levels suggested on the label of the premixture would result in exceeding the levels 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: 0,1 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
2b14112	—	2-Ethyl-3-methoxypyrazine	Additive composition 2-Ethyl-3-methoxypyrazine Characterisation of the active substance 2-Ethyl-3-methoxypyrazine Produced by chemical synthesis Purity: min. 99 % assay Chemical formula: C7H10N2O CAS number: 25680-58-4 FLAVIS No: 14.112 Method of analysis a For the determination of 2-ethyl-3-methoxypyrazine 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 %: 0,1 mg/kg for pigs and poultry 0,5 mg/kg for other species and categories’. 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 levels suggested on the label of the premixture would result in exceeding the levels 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: 0,1 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
2b14015	—	5,6,7,8-Tetrahydroquinoxaline	Additive composition 5,6,7,8-Tetrahydroquinoxaline Characterisation of the active substance 5,6,7,8-Tetrahydroquinoxaline Produced by chemical synthesis Purity: min. 98 % assay Chemical formula: C8H10N2 CAS number: 34413-35-9 FLAVIS No: 14.015 Method of analysis a For the determination of 5,6,7,8-tetrahydroquinoxaline 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 %: 0,1 mg/kg for pigs and poultry. 0,5 mg/kg for other species and categories’. 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 levels suggested on the label of the premixture would result in exceeding the levels 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: 0,1 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
2b14022	—	2-Ethylpyrazine	Additive composition 2-Ethylpyrazine Characterisation of the active substance 2-Ethylpyrazine Produced by chemical synthesis Purity: min. 98 % assay Chemical formula: C6H8N2 CAS number: 13925-00-3 FLAVIS No: 14.022 Method of analysis a For the determination of 2-ethylpyrazine 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 %: 0,1 mg/kg for pigs and poultry. 0,5 mg/kg for other species and categories’. 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 levels suggested on the label of the premixture would result in exceeding the levels 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: 0,1 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
2b14028	—	5-Methylquinoxaline	Additive composition 5-Methylquinoxaline Characterisation of the active substance 5-Methylquinoxaline Produced by chemical synthesis Purity: min. 98 % assay Chemical formula: C9H8N2 CAS number: 13708-12-8 FLAVIS No: 14.028 Method of analysis a For the determination of 5-methylquinoxaline 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 for pigs and poultry 0,08 mg/kg for other species and categories.’ 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 levels suggested on the label of the premixture would result in exceeding the levels 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 for pigs and poultry. 0,08 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