Commission Implementing Regulation (EU) 2017/62 of 14 December 2016 concerning the authorisation of 3-(methylthio) propionaldehyde, methyl 3-(methylthio) propionate, allylthiol, dimethyl sulfide, dibutyl sulfide, diallyl disulfide, diallyl trisulfide, dimethyl trisulfide, dipropyl disulfide, allyl isothiocyanate, dimethyl disulfide, 2-methylbenzene-1-thiol, S-methyl butanethioate, allyl methyl disulfide, 3-(methylthio) propan-1-ol, 3-(methylthio) hexan-1-ol, 1-propane-1-thiol, diallyl sulfide, 2,4-dithiapentane, 2-methyl-2-(methyldithio) propanal, 2-methylpropane-1-thiol, methylsulfinyl methane, propane-2-thiol, 3,5-dimethyl-1,2,4-trithiolane and 2-methyl-4-propyl-1,3-oxathiane as feed additives for all animal species (Text with EEA relevance. )
Commission Implementing Regulation (EU) 2017/62of 14 December 2016concerning the authorisation of 3-(methylthio) propionaldehyde, methyl 3-(methylthio) propionate, allylthiol, dimethyl sulfide, dibutyl sulfide, diallyl disulfide, diallyl trisulfide, dimethyl trisulfide, dipropyl disulfide, allyl isothiocyanate, dimethyl disulfide, 2-methylbenzene-1-thiol, S-methyl butanethioate, allyl methyl disulfide, 3-(methylthio) propan-1-ol, 3-(methylthio) hexan-1-ol, 1-propane-1-thiol, diallyl sulfide, 2,4-dithiapentane, 2-methyl-2-(methyldithio) propanal, 2-methylpropane-1-thiol, methylsulfinyl methane, propane-2-thiol, 3,5-dimethyl-1,2,4-trithiolane and 2-methyl-4-propyl-1,3-oxathiane 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 feeding-stuffs (OJ L 270, 14.12.1970, p. 1)..(2)3-(Methylthio) propionaldehyde, methyl 3-(methylthio) propionate, allylthiol, dimethyl sulfide, dibutyl sulfide, diallyl disulfide, diallyl trisulfide, dimethyl trisulfide, dipropyl disulfide, allyl isothiocyanate, dimethyl disulfide, 2-methylbenzene-1-thiol, S-methyl butanethioate, allyl methyl disulfide, 3-(methylthio) propan-1-ol, 3-(methylthio) hexan-1-ol, 1-propane-1-thiol, diallyl sulfide, 2,4-dithiapentane, 2-methyl-2-(methyldithio) propanal, 2-methylpropane-1-thiol, methylsulfinyl methane, propane-2-thiol, 3,5-dimethyl-1,2,4-trithiolane and 2-methyl-4-propyl-1,3-oxathiane ("the substances concerned") 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 opinion of 17 April 2013EFSA Journal 2013;11(5):3208. 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. For allyl isothiocyanate, the Authority stated that, although additional exposure to that substance through its low use level in animal feeds would not substantially increase consumer exposure, the estimated exposure of consumers is already higher than the acceptable daily intake. For allyl isothiocyanate and 2-methylpropane-1-thiol maximum contents should be set up to ensure consumer safety and environmental protection, respectively. The Authority further concluded that the function of the substances concerned in feed is similar to that on food. The Authority has already concluded that for food the substances concerned are efficacious, as it increases the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The Authority could not conclude on the safety of the substances concerned used in water for drinking. 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. For all the substances except allyl isothiocyanate and 2-methylpropane-1-thiol, 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 the substances concerned are to be considered as being irritant to skin, eyes and respiratory tract and as a skin sensitiser. 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 authorisation 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: