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Commission Implementing Regulation (EU) 2018/240 of 15 February 2018 concerning the authorisation of trimethylamine, trimethylamine hydrochloride, 3-methylbutylamine for all animal species except laying hens and 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy-benzene, 1-isopropyl-2-methoxy-4-methylbenzene as feed additives for all animal species (Text with EEA relevance. )

Commission Implementing Regulation (EU) 2018/240 of 15 February 2018 concerning the authorisation of trimethylamine, trimethylamine hydrochloride, 3-methylbutylamine for all animal species except laying hens and 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy-benzene, 1-isopropyl-2-methoxy-4-methylbenzene as feed additives for all animal species (Text with EEA relevance. )

Implementing Regulation (EU) 2018/240 · Regulation · 4 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

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 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 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 .

Supplementary provisions

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 2b11009 — Trimethylamine Additive composition Trimethylamine Characterisation of the active substance Trimethylamine Produced by chemical synthesis Purity: min. 98 % Chemical formula: C 3 H 9 N CAS number: 75-50-3 FLAVIS No: 11.009 Method of analysis  ( 1 ) For the determination of trimethylamine in the feed additive and in feed flavouring premixtures: Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. All animal species except laying hens — — — 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 2b11024 — Trimethylamine hydrochloride Additive composition Trimethylamine hydrochloride Characterisation of the active substance Trimethylamine hydrochloride Produced by chemical synthesis Purity: min. 98.5 % Chemical formula: C 3 H 9 N · HCl CAS number: 593-81-7 FLAVIS No: 11.024 Method of analysis  ( 1 ) For the determination of trimethylamine hydrochloride in the feed additive and in feed flavouring premixtures: Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. All animal species except laying hens — — — 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 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 2b11001 — 3-Methylbutylamine Additive composition 3-Methylbutylamine Characterisation of the active substance 3-Methylbutylamine Produced by chemical synthesis Purity: min. 98 % Chemical formula: C 5 H 13 N CAS number: 107-85-7 FLAVIS No:11.001 Method of analysis  ( 1 ) For the determination of 3-methylbutylamine in the feed additive and in feed flavouring premixtures: Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. All animal species except laying hens — — — 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: — 1 mg/kg for pigs and poultry, except laying hens; — 1,5 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 %: — 1 mg/kg for pigs and poultry, except laying hens; — 1,5 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: — 1 mg/kg for pigs and poultry, except laying hens; — 1,5 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 2b03006 — 2-Methoxyethyl benzene Additive composition 2-Methoxyethyl benzene Characterisation of the active substance 2-Methoxyethyl benzene Produced by chemical synthesis Purity: min. 99 % Chemical formula: C 9 H 12 O CAS number: 3558-60-9 FLAVIS No: 03.006 Method of analysis  ( 1 ) For the determination of 2-methoxyethyl benzene 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: — 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 2b04016 — 1,3-Dimethoxy-benzene Additive composition 1,3-Dimethoxy-benzene Characterisation of the active substance 1,3-Dimethoxy-benzene Produced by chemical synthesis Purity: min. 98 % Chemical formula: C 8 H 10 O 2 CAS number: 151-10-0 FLAVIS No: 04.016 Method of analysis  ( 1 ) For the determination of 1,3-dimethoxy-benzene 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: 1 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 %: 1 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: 1 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 2b04034 — 1,4-Dimethoxy-benzene Additive composition 1,4-Dimethoxy-benzene Characterisation of the active substance 1,4-Dimethoxy-benzene Produced by chemical synthesis Purity: min. 98 % Chemical formula: C 8 H 10 O 2 CAS number: 150-78-7 FLAVIS No: 04.034 Method of analysis  ( 1 ) For the determination of 1,4-dimethoxy-benzene 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: 1 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 %: 1 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: 1 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 2b04043 — 1-Isopropyl-2-methoxy-4-methylbenzene Additive composition 1-Isopropyl-2-methoxy-4-methylbenzene Characterisation of the active substance 1-Isopropyl-2-methoxy-4-methylbenzene Produced by chemical synthesis Purity: min. 98 % Chemical formula: C 11 H 16 O CAS number: 1076-56-8 FLAVIS No: 04.043 Method of analysis  ( 1 ) For the determination of 1-isopropyl-2-methoxy-4-methylbenzene 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: 1 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 %: 1 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: 1 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 ( 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

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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