Commission Implementing Regulation (EU) 2017/63 of 14 December 2016 concerning the authorisation of benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate as feed additives for all animal a species and of veratraldehyde and gallic acid as feed additives for certain animal species (Text with EEA relevance. )
Commission Implementing Regulation (EU) 2017/63of 14 December 2016concerning the authorisation of benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate as feed additives for all animal a species and of veratraldehyde and gallic acid as feed additives for certain 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)Benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, veratraldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, gallic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate ("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. Veratraldehyde for poultry and fish and gallic acid for fish will not be re-authorised as they were withdrawn by the applicant.(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 benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate as feed additives for all animal a species and of veratraldehyde and gallic acid as feed additives for certain animal species. The applicant requested those additives 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 June 2012EFSA Journal 2012;10(7):2785. that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. 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 they increase the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The Authority cannot conclude on the safety of the concerned substances 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. Since safety reasons do not require the setting of a maximum content, except for benzoic acid, 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 in the absence of data the substances concerned should be considered as potentially hazardous to the respiratory tract, skin and eyes, skin sensitisers 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 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: