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, 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)
Dry grape extract of Vitis vinifera spp. vinifera, was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That product was 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 dry grape extract of Vitis vinifera spp. vinifera as feed additives for all animal species except for dogs. The applicant requested that additive 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 20 April 2016 that, under the proposed conditions of use in feed, the substance concerned does not have adverse effect on animal health, human health or the environment. The Authority further concluded that the function of dry grape extract of Vitis vinifera spp. vinifera in feed is similar to that on food. The Authority has already concluded that for food dry grape extract of Vitis vinifera spp. vinifera is efficacious, as it increases the food smell or palatability. Therefore, that conclusion can be extrapolated for feed.
(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, a recommended content should be indicated on the label of the additive. Where such content is 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 on user safety, dry grape extract of Vitis vinifera spp. vinifera should be considered as potentially hazardous to the respiratory tract, skin and eyes and as a skin and respiratory 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 additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(7)
The assessment of the substance 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 that substance 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 substance 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: