Commission Implementing Regulation (EU) 2018/248 of 15 February 2018 concerning the authorisation of 2,3-diethylpyrazine, 2,5 or 6-methoxy-3-methylpyrazine, 2-acetyl-3-ethylpyrazine, 2,3-diethyl-5-methylpyrazine, 2-(sec-butyl)-3-methoxypyrazine, 2-ethyl-3-methoxypyrazine, 5,6,7,8-tetrahydroquinoxaline, 2-ethylpyrazine and 5-methylquinoxaline as feed additives for all animal species (Text with EEA relevance. )

Authorisation

Article 1

The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.

Transitional measures

Article 2

1.   The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted. 2.   Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals. 3.   Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

Entry into force

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

ANNEXSupplementary provisions

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 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: C 8 H 12 N 2 CAS number: 15707-24-1 FLAVIS No: 14.005 Method of analysis  ( 1 ) 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: C 6 H 8 ON 2 CAS number: 63450-30-6 FLAVIS No: 14.025 Method of analysis  ( 1 ) 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: C 8 H 10 ON 2 CAS number: 32974-92-8 FLAVIS No: 14.049 Method of analysis  ( 1 ) 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: C 9 H 14 N 2 CAS number: 18138-04-0 FLAVIS No: 14.056 Method of analysis  ( 1 ) 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: C 9 H 14 ON 2 CAS number: 24168-70-5 FLAVIS No: 14.062 Method of analysis  ( 1 ) 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: C 7 H 10 N 2 O CAS number: 25680-58-4 FLAVIS No: 14.112 Method of analysis  ( 1 ) 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: C 8 H 10 N 2 CAS number: 34413-35-9 FLAVIS No: 14.015 Method of analysis  ( 1 ) 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: C 6 H 8 N 2 CAS number: 13925-00-3 FLAVIS No: 14.022 Method of analysis  ( 1 ) 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: C 9 H 8 N 2 CAS number: 13708-12-8 FLAVIS No: 14.028 Method of analysis  ( 1 ) 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 ( 1 )   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