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. )

L 53/14 EN Official Journal of the European Union 23.2.2018 COMMISSION IMPLEMENTING REGULATION (EU) 2018/240 of 15 February 2018 concerning the authorisation of trimethylamine, trimethylamine hydrochloride, 3-methylbutyl­ amine 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) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof, Whereas: (1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). (2) The substances 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 for all animal species (‘the substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10 (1) of Regulation (EC) No 1831/2003. (3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation as feed additives 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 for all animal species. The applicant requested those additives to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 25 April 2012 (3) that, under the proposed conditions of use in feed, the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for water for drinking, however, it should be possible to use the substances concerned within compound feeds which are subsequently administered via water. (5) Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures and on the labelling of feed materials and compound feed. (6) The Authority noted that trimethylamine, trimethylamine hydrochloride, 3-methylbutylamineare recognised as being corrosive to the eye, strongly irritant or corrosive to the skin and irritant to respiratory tract. Asthma like (1) OJ L 268, 18.10.2003, p. 29. (2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1). (3) EFSA Journal 2012;10(5):2678 and EFSA Journal 2012;10(5):2679.23.2.2018 EN Official Journal of the European Union L 53/15 symptoms may occur after inhalation. For 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy- benzene, 1-isopropyl-2-methoxy-4-methylbenzene potential hazards for skin and eye contact and respiratory exposure are recognised. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. (7) The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation. (8) Since safety reasons do not require the immediate application of the modifications to the conditions of authori­ sation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. (9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, HAS ADOPTED THIS REGULATION: Article 1 Authorisation 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. Article 2 Transitional measures 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. Article 3 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.L 53/16 EN Official Journal of the European Union 23.2.2018 This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 15 February 2018. For the Commission The President Jean-Claude JUNCKERANNEX Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age of authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b11009 — Trimethyla­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 mine species ex­ into the feed in the form of a pre­ Trimethylamine cept laying mixture. Characterisation of the active sub­ hens 2. In the directions for use of the ad­ stance ditive and premixtures, the storage Trimethylamine and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 98 % tent of the active substance shall Chemical formula: C H N be: 5 mg/kg of complete feeding­ 3 9 CAS number: 75-50-3 stuff with a moisture content of 12 %. FLAVIS No: 11.009 4. On the label of the additive the fol­ Method of analysis(1) lowing shall be indicated: For the determination of trimethyl­ ‘Recommended maximum content amine in the feed additive and in of the active substance of complete feed flavouring premixtures: feedingstuff with a moisture con­ Gas chromatography mass spectro­ tent of 12 %: 5 mg/kg’. metry with retention time locking 5. The functional group, the identifi­ GC-MS-RTL. cation number, the name and the added amount of the active sub­ stance shall be indicated on the la­ bel of the premixtures and on the labelling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture con­ tent of 12 % exceeds: 5 mg/kg. 23.2.2018 EN Official Journal of the European Union L 53/17Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age of authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes con­ tact. Where those risks cannot be eliminated or reduced to a mini­ mum by such procedures and measures, the additive and premix­ tures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. 2b11024 — Trimethyl­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 amine hydro­ species ex­ into the feed in the form of a pre­ Trimethylamine hydrochloride chloride cept laying mixture. Characterisation of the active sub­ hens 2. In the directions for use of the ad­ stance ditive and premixtures, the storage Trimethylamine hydrochloride and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 98.5 % tent of the active substance shall Chemical formula: C H N · HCl be: 5 mg/kg of complete feeding­ 3 9 CAS number: 593-81-7 stuff with a moisture content of 12 %. FLAVIS No: 11.024 4. On the label of the additive the fol­ Method of analysis(1) lowing shall be indicated: For the determination of trimethyl­ ‘Recommended maximum content amine hydrochloride in the feed of the active substance of complete additive and in feed flavouring pre­ feedingstuff with a moisture con­ mixtures: tent of 12 %: 5 mg/kg’. Gas chromatography mass spectro­ metry with retention time locking GC-MS-RTL. L 53/18 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age of authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % 5. The functional group, the identifi­ cation number, the name and the added amount of the active sub­ stance shall be indicated on the label of premixtures and on the la­ belling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture con­ tent of 12 % exceeds: 5 mg/kg. 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes con­ tact. Where those risks cannot be eliminated or reduced to a mini­ mum by such procedures and measures, the additive and premix­ tures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. 2b11001 — 3-Methyl­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 butylamine species ex­ into the feed in the form of a pre­ 3-Methylbutylamine cept laying mixture. Characterisation of the active sub­ hens 2. In the directions for use of the ad­ stance ditive and premixtures, the storage 3-Methylbutylamine and stability conditions shall be in­ dicated. Produced by chemical synthesis Purity: min. 98 % Chemical formula: C H N 5 13 CAS number: 107-85-7 FLAVIS No:11.001 23.2.2018 EN Official Journal of the European Union L 53/19Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age of authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % Method of analysis(1) 3. The recommended maximum con­ tent of the active substance of com­ For the determination of 3-methyl­ plete feedingstuff with a moisture butylamine in the feed additive content of 12 % shall be: and in feed flavouring premixtures: — 1 mg/kg for pigs and poultry, Gas chromatography mass spectro­ except laying hens; metry with retention time locking GC-MS-RTL. — 1,5 mg/kg for other species and categories. 4. On the label of the additive the fol­ lowing shall be indicated: ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture con­ tent 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 identifi­ cation number, the name and the added amount of the active sub­ stance shall be indicated on the label of premixtures and on the la­ belling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture con­ tent of 12 % exceeds: — 1 mg/kg for pigs and poultry, except laying hens; — 1,5 mg/kg for other species and categories. L 53/20 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age of authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes con­ tact. Where those risks cannot be eliminated or reduced to a mini­ mum by such procedures and measures, the additive and premix­ tures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. 2b03006 — 2-Methoxy­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 ethyl benzene species into the feed in the form of a pre­ 2-Methoxyethyl benzene mixture. Characterisation of the active sub­ 2. In the directions for use of the ad­ stance ditive and premixtures, the storage 2-Methoxyethyl benzene and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 99 % tent of the active substance of com­ Chemical formula: C H O plete feedingstuff with a moisture 9 12 CAS number: 3558-60-9 content of 12 % shall be: FLAVIS No: 03.006 — 0,3 mg/kg for pigs and poultry; — 0,5 mg/kg for other species and Method of analysis(1) categories. For the determination of 2-meth­ oxyethyl benzene in the feed addi­ tive and in feed flavouring premix­ tures: Gas chromatography mass spectro­ metry with retention time locking GC-MS-RTL. 23.2.2018 EN Official Journal of the European Union L 53/21Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age of authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % 4. On the label of the additive the fol­ lowing shall be indicated: ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture con­ tent of 12 %: — 0,3 mg/kg for pigs and poultry; — 0,5 mg/kg for other species and categories.’. 5. The functional group, the identifi­ cation number, the name and the added amount of the active sub­ stance shall be indicated on the label of premixtures and on the la­ belling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture con­ tent 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 pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes con­ tact. Where those risks cannot be eliminated or reduced to a mini­ mum by such procedures and measures, the additive and premix­ tures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. L 53/22 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age of authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % 2b04016 — 1,3-Di­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 methoxy-ben­ species into the feed in the form of a pre­ 1,3-Dimethoxy-benzene zene mixture. Characterisation of the active sub­ 2. In the directions for use of the ad­ stance ditive and premixtures, the storage 1,3-Dimethoxy-benzene and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 98 % tent of the active substance shall Chemical formula: C H O be: 1 mg/kg of complete feeding­ 8 10 2 CAS number: 151-10-0 stuff with a moisture content of 12 %. FLAVIS No: 04.016 4. On the label of the additive the fol­ Method of analysis(1) lowing shall be indicated: For the determination of 1,3-di­ ‘Recommended maximum content methoxy-benzene in the feed addi­ of the active substance of complete tive and in feed flavouring premix­ feedingstuff with a moisture con­ tures: tent of 12 %: 1 mg/kg’. Gas chromatography mass spectro­ 5. The functional group, the identifi­ metry with retention time locking cation number, the name and the GC-MS-RTL. added amount of the active sub­ stance shall be indicated on the label of premixtures and on the la­ belling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture con­ tent of 12 % exceeds: 1 mg/kg. 23.2.2018 EN Official Journal of the European Union L 53/23Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age of authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes con­ tact. Where those risks cannot be eliminated or reduced to a mini­ mum by such procedures and measures, the additive and premix­ tures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. 2b04034 — 1,4-Di­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 methoxy-ben­ species into the feed in the form of a pre­ 1,4-Dimethoxy-benzene zene mixture. Characterisation of the active sub­ 2. In the directions for use of the ad­ stance ditive and premixtures, the storage 1,4-Dimethoxy-benzene and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 98 % tent of the active substance shall Chemical formula: C H O be: 1 mg/kg of complete feeding­ 8 10 2 CAS number: 150-78-7 stuff with a moisture content of 12 %. FLAVIS No: 04.034 4. On the label of the additive the fol­ Method of analysis(1) lowing shall be indicated: For the determination of 1,4-di­ ‘Recommended maximum content methoxy-benzene in the feed addi­ of the active substance of complete tive and in feed flavouring premix­ feedingstuff with a moisture con­ tures: tent of 12 %: 1 mg/kg’. Gas chromatography mass spectro­ metry with retention time locking GC-MS-RTL. L 53/24 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age of authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % 5. The functional group, the identifi­ cation number, the name and the added amount of the active sub­ stance shall be indicated on the label of premixtures and on the la­ belling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture con­ tent of 12 % exceeds: 1 mg/kg. 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes con­ tact. Where those risks cannot be eliminated or reduced to a mini­ mum by such procedures and measures, the additive and premix­ tures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. 2b04043 — 1-Isopropyl-2- Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 methoxy-4- species into the feed in the form of a pre­ 1-Isopropyl-2-methoxy-4-methyl­ methylben­ mixture. benzene zene 2. In the directions for use of the ad­ Characterisation of the active sub­ ditive and premixtures, the storage stance and stability conditions shall be in­ 1-Isopropyl-2-methoxy-4-methyl­ dicated. benzene 3. The recommended maximum con­ Produced by chemical synthesis tent of the active substance shall be: 1 mg/kg of complete feeding­ Purity: min. 98 % stuff with a moisture content of 12 %. 23.2.2018 EN Official Journal of the European Union L 53/25Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age of authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % Chemical formula: C H O 4. On the label of the additive the fol­ 11 16 lowing shall be indicated: CAS number: 1076-56-8 ‘Recommended maximum content FLAVIS No: 04.043 of the active substance of complete Method of analysis(1) feedingstuff with a moisture con­ tent of 12 %: 1 mg/kg’. For the determination of 1-isopro­ pyl-2-methoxy-4-methylbenzene in 5. The functional group, the identifi­ the feed additive and in feed fla­ cation number, the name and the vouring premixtures: added amount of the active sub­ stance shall be indicated on the Gas chromatography mass spectro­ label of premixtures and on the la­ metry with retention time locking belling of feed materials and com­ GC-MS-RTL. pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture con­ tent of 12 % exceeds: 1 mg/kg. 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes con­ tact. Where those risks cannot be eliminated or reduced to a mini­ mum by such procedures and measures, the additive and premix­ tures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. (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 L 53/26 EN Official Journal of the European Union 23.2.2018