Commission Implementing Regulation (EU) 2017/57 of 14 December 2016 concerning the authorisation of 1,8-cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran as feed additives for all animal species (Text with EEA relevance. )
Commission Implementing Regulation (EU) 2017/57of 14 December 2016concerning the authorisation of 1,8-cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran 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 nutritionOJ L 268, 18.10.2003, p. 29., 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/EECCouncil Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1)..(2)1,8-Cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran 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 the substances concerned 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 opinions of 6 March 2012 and 13 November 2012EFSA Journal 2012;10(3):2622 and EFSA Journal 2012;10(11):2967 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 further concluded that the function of 1,8-cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran in feed is similar to that on food. The Authority has already concluded that for food those substances are efficacious, as they increase the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. As the use of 1,8-cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran in water for drinking is difficult to control when used simultaneously with feed, such use should be excluded. However, those substances can be used 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, compound feeds and feed materials.(6)The Authority concluded that 1,8-cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran are irritant to eyes, respiratory tract and skin. The Authority further concluded that 3,4-dihydrocoumarin is also skin sensitiser and harmful if swallowed. 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 1,8-cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran 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 1,8-cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran 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 1AuthorisationThe 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 2Transitional measures1.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 3Entry into forceThis 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 CommissionThe PresidentJean-Claude JunckerANNEX
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-reportsCategory: Sensory additives. Functional group: Flavouring compounds
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd 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)
2b03001—1,8-CineoleAdditive composition1,8-CineoleCharacterisation of the active substance1,8-CineoleProduced by distillation from Eucalyptus globulusPurity: min. 98 %Chemical formula: C10H18OCAS number 470-82-6FLAVIS No 03.001Method of analysisFor the determination of 1,8-cineole 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
2b13009—3,4-DihydrocoumarinAdditive composition3,4-DihydrocoumarinCharacterisation of the active substance3,4-DihydrocoumarinProduced by chemical synthesisPurity: min. 99 %Chemical formula: C9H8O2CAS number 119-84-6FLAVIS No 13.009Method of analysisFor the determination of 3,4-dihydrocoumarin 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
2b13037—2-(2-Methylprop-1-enyl)-4-methyltetrahydropyranAdditive composition2-(2-Methylprop-1-enyl)-4-methyltetrahydropyranCharacterisation of the active substance2-(2-Methylprop-1-enyl)-4-methyltetrahydropyranProduced by chemical synthesisPurity: min. 99 %Chemical formula: C10H18OCAS number 16409-43-1FLAVIS No 13.037Method of analysisFor the identification of 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran 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: 0,5 mg/kg, and for other species and categories: 0,3 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 %:0,5 mg/kg for pigs and poultry;0,3 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 contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded:0,5 mg/kg for pigs and poultry;0,3 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