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. )

23.2.2018 EN Official Journal of the European Union L 53/27 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) 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 piperine, 3-methylindole, indole, 2-acetylpyrrole and pyrrolidine, (‘the substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feeds 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 of the substances concerned as feed additives for all animal species. The applicant requested that those additives be classified in the additive category ‘sensory additives’. This 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 opinion of 26 January 2016 (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 for the substances concerned potential hazards for skin and eye contact and respiratory exposure are recognised. Most are classified as irritating to the respiratory system. 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. (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 2016;14(2):4390L 53/28 EN Official Journal of the European Union 23.2.2018 (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. 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 of Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b14003 — Piperine Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 species into the feed in the form of a pre­ Piperine mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Piperine and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 95 % tent of the active substance shall be: Chemical formula: C H O N 0,5 mg/kg of complete feedingstuff 17 19 3 CAS number: 94-62-2 with a moisture content of 12 %. FLAVIS No: 14.003 4. On the label of the additive the fol­ lowing shall be indicated: Method of analysis(1) ‘Recommended maximum content For the determination of piperine of the active substance of complete in the feed additive and in feed feedingstuff with a moisture content flavouring premixtures: of 12 %: 0,5 mg/kg’. Gas chromatography coupled 5. The functional group, the identifica­ to a Flame Ionisation Detector tion number, the name and the (GC-FID). 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 content of 12 % exceeds: 0,5 mg/kg. 23.2.2018 EN Official Journal of the European Union L 53/29Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period of Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age 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 contact. Where those risks cannot be elimi­ nated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b14004 — 3-Methyl­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 indole species into the feed in the form of a pre­ 3-Methylindole mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage 3-Methylindole and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 97 % tent of the active substance shall be: Chemical formula: C H N 0,5 mg/kg of complete feedingstuff 9 9 CAS number: 83-34-1 with a moisture content of 12 %. FLAVIS No:14.004 4. On the label of the additive the fol­ lowing shall be indicated: Method of analysis(1) ‘Recommended maximum content For the identification of 3-methyl­ of the active substance of complete indole in the feed additive and fla­ feedingstuff with a moisture content vouring premixtures: of 12 %: 0,5 mg/kg’. Gas chromatography mass spec­ trometry with retention time lock­ ing GC-MS-RTL. L 53/30 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 of Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % 5. The functional group, the identifica­ tion 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 content of 12 % exceeds: 0,5 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 contact. Where those risks cannot be elimi­ nated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b14007 — Indole Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 species into the feed in the form of a pre­ Indole mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Indole and stability conditions shall be in­ dicated. Produced by chemical synthesis Purity: min. 97 % Chemical formula: C H N 8 7 23.2.2018 EN Official Journal of the European Union L 53/31Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period of Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % CAS number: 120-72-9 3. The recommended maximum con­ tent of the active substance shall be: FLAVIS No: 14.007 0,5 mg/kg of complete feedingstuff Method of analysis(1) with a moisture content of 12 %. For the determination of indole 4. On the label of the additive the fol­ in the feed additive and in feed lowing shall be indicated: flavouring premixtures: ‘Recommended maximum content Gas chromatography mass spec­ of the active substance of complete trometry with retention time lock­ feedingstuff with a moisture content ing GC-MS-RTL. of 12 %: 0,5 mg/kg’. 5. The functional group, the identifica­ tion 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 content of 12 % exceeds: 0,5 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 contact. Where those risks cannot be elimi­ nated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. L 53/32 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 of Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % 2b14047 — 2-Acetyl­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 pyrrole species into the feed in the form of a pre­ 2-Acetylpyrrole mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage 2-Acetylpyrrole and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 97 % tent of the active substance shall be: Chemical formula: C H ON 0,5 mg/kg of complete feedingstuff 6 7 CAS number 1072-83-9 with a moisture content of 12 %. FLAVIS No: 14.047 4. On the label of the additive the fol­ lowing shall be indicated: Method of analysis(1) ‘Recommended maximum content For the determination of 2-acetyl­ of the active substance of complete pyrrole in the feed additive and in feedingstuff with a moisture content feed flavouring premixtures: of 12 %: 0,5 mg/kg’. Gas chromatography mass spec­ 5. The functional group, the identifica­ trometry with retention time lock­ tion number, the name and the ing 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 content of 12 % exceeds: 0,5 mg/kg. 23.2.2018 EN Official Journal of the European Union L 53/33Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period of Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age 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 contact. Where those risks cannot be elimi­ nated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b14064 — Pyrrolidine Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 species into the feed in the form of a pre­ Pyrrolidine mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Pyrrolidine and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 95 % tent of the active substance of com­ Chemical formula: C H N plete feedingstuff with a moisture 4 9 CAS number 123-75-1 content of 12 %.shall be: FLAVIS No: 14.064 — 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 pyrrol­ 4. On the label of the additive the fol­ idine the feed additive and in feed lowing shall be indicated: flavouring premixtures: ‘Recommended maximum content Gas chromatography mass spec­ of the active substance of complete trometry with retention time lock­ feedingstuff with a moisture content ing GC-MS-RTL. of 12 %: — 0,3 mg/kg for pigs and poultry, — 0,5 mg/kg for other species and categories.’ L 53/34 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 of Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % 5. The functional group, the identifica­ tion 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 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 pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimi­ nated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, 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 23.2.2018 EN Official Journal of the European Union L 53/35