COMMISSION IMPLEMENTING REGULATION (EU) 2017/58

17.1.2017 | EN | Official Journal of the European Union | L 13/159 ---|---|---|--- * * * COMMISSION IMPLEMENTING REGULATION (EU) 2017/58 of 14 December 2016 concerning the authorisation of alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate 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) | Alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products 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 alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate as feed additives 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 opinion of 13 November 2012 (3) that, under the proposed conditions of use in feed of alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate do not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate in feed is similar to that on food. The Authority has already concluded that for food alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate are efficacious, as it increases the food smell or palatability. The Authority concluded that for nerolidol and 2-(4-methylphenyl) propan-2-ol the absence of margin of safety would not allow simultaneous administration in feed and water. For alpha-terpineol, terpineol and linalyl acetate the exact ratio for the inclusion in feed and water is not available. However, those substances can be used within a compound feed subsequently administered via water. ---|--- (5) | Restrictions and conditions should be provided for to allow better control. For practical reasons and taking into account the re-evaluation performed by the Authority, maximum recommended contents should be set up. Where the recommended content of the additive in complete feedingstuff is exceeded, the identification number of the feed additive, its name and added amount should be indicated on the label of premixtures, compound feeds and feed materials. ---|--- (6) | The Authority concluded that in the absence of data on user safety alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate should be considered as irritant to skin, eyes and respiratory tract and as a skin sensitizer. 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 alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate 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 authorisation for alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate 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 as specified in the Annex and premixtures containing those substances, which are produced and labelled before 6 August 2017 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted. 2\. Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 6 February 2018 in accordance with the rules applicable before 6 February 2017 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\. Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 6 February 2019 in accordance with the rules applicable before 6 February 2017 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, 14 December 2016. For the Commission The President Jean-Claude JUNCKER * * * (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(11):2966. * * * 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 % (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) Category: Sensory additives. Functional group: Flavouring compounds 2b02014 | — | alpha-Terpineol | Additive composition alpha-Terpineol Characterisation of the active substance alpha-Terpineol Produced by chemical synthesis Purity: min. 96 % Chemical formula: C10H18O CAS No 98-55-5 FLAVIS No: 02.014 Method of analysis (1) For the determination of alpha-Terpineol 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 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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. ---|--- 6 February 2027 2b02018 | — | Nerolidol | Additive composition Nerolidol Characterisation of the active substance Nerolidol Produced by chemical synthesis Purity: min. 97 % Chemical formula: C15H26O CAS No 7212-44-4 FLAVIS No: 02.018 Method of analysis (1) For the identification of Nerolidol in the feed additive and 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: for pigs and poultry: 1 mg/kg, and for other species and categories: 1,5 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 %: | — | 1 mg/kg for pigs and poultry; ---|--- — | 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: | — | 1 mg/kg for pigs and poultry; ---|--- — | 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. ---|--- 6 February 2027 2b02042 | — | 2-(4-Methylphenyl)propan-2-ol | Additive composition 2-(4-Methylphenyl)propan-2-ol Characterisation of the active substance 2-(4-Methylphenyl)propan-2-ol Produced by chemical synthesis Purity: min. 90 % Chemical formula: C10H14O CAS No 1197-01-9 FLAVIS No: 02.042 Method of analysis (1) For the identification of 2-(4-Methylphenyl)propan-2-ol in the feed additive and 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: for pigs and poultry: 1 mg/kg, and for all other species and categories: 1,5 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 %: | — | 1 mg/kg for pigs and poultry; ---|--- — | 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: | — | 1 mg/kg for pigs and poultry; ---|--- — | 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. ---|--- 6 February 2027 2b02230 | — | Terpineol | Additive composition Terpineol Characterisation of the active substance Terpineol Produced by chemical synthesis Purity: min. 91 % Chemical formula: C10H18O CAS No 8000-41-7 FLAVIS No: 02.230 Method of analysis (1) For the determination of Terpineol 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 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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. ---|--- 6 February 2027 2b09013 | — | Linalyl acetate | Additive composition Linalyl acetate Characterisation of the active substance Linalyl acetate Produced by chemical synthesis Purity: min. 95 % Chemical formula: C12H20O2 CAS No 115-95-7 FLAVIS No: 09.013 Method of analysis (1) For the determination of Linalyl acetate 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 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 labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 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. ---|--- 6 February 2027 * * * (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 * * *