9.7.2015   

EN

Official Journal of the European Union

L 181/72

(1)

In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 26 April 2013 an application from the Institut Technique de l'Agriculture Biologique (ITAB) for the approval of Salix alba bark as basic substance. That application was accompanied by the information required by the second subparagraph of Article 23(3).

(2)

The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance. The Authority presented to the Commission a Technical Report on the substance concerned on 3 June 2014 (2). The Commission presented the review report (3) and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 14 November 2014 and finalised them for the meeting of that Committee of 29 May 2015.

(3)

The documentation provided by the applicant and the results of examination carried out by the European Medicine Agency (4) in accordance with Directive 2001/83/EC of the European Parliament and of the Council (5) show that Salix cortex fulfils the criteria of a traditional herbal medicine. It was therefore considered appropriate to extend the scope of the application from Salix alba bark to Salix spp. cortex. Moreover, it is not predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water.

(4)

The Commission considers that Salix spp. cortex is a basic substance pursuant to Article 23 of Regulation (EC) No 1107/2009. Salix spp. cortex is part of a plant and is ubiquitous in the environment. The additional exposure of humans, animals and the environment by the uses as detailed in the review report is expected to be negligible compared to exposure expected through realistic natural situations.

(5)

Therefore, Salix spp. cortex may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve Salix spp. cortex as a basic substance.

(6)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions for the approval which are detailed in Annex I to this Regulation.

(7)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (6) should be amended accordingly.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,