Commission Implementing Regulation (EU) 2015/1107

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC^note, and in particular Article 23(5) in conjunction with Article 13(2) thereof,Whereas:

(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^note. The Commission presented the review report^note 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^note in accordance with Directive 2001/83/EC of the European Parliament and of the Council^note 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^note 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,

HAS ADOPTED THIS REGULATION:

Article 1Approval of a basic substance#

The substance Salix spp. cortex as specified in Annex I is approved as basic substance subject to the conditions laid down in that Annex.

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

Part C of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3Entry into force#

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Annex I

Common Name, Identification Numbers	IUPAC Name	Purity^note	Date of approval	Specific provisions
Salix spp. cortexCAS No: not allocatedCIPAC No: not allocated	Not applicable	European Pharmacopeia	1 July 2015	Salix cortex shall be used in accordance with the specific conditions included in the conclusions of the review report on Salix spp. cortex (SANCO/12173/2014) and in particular Appendices I and II thereof.

Annex II

In Part C of the Annex to Implementing Regulation (EC) No 540/2011, the following entry is added:

Common Name, Identification Numbers

IUPAC Name

Purity^note

Date of approval

Specific provisions

Salix spp. cortexCAS No: not allocatedCIPAC No: not allocated

Not applicable

European Pharmacopeia

1 July 2015

Salix cortex shall be used in accordance with the specific conditions included in the conclusions of the review report on Salix spp. cortex (SANCO/12173/2014) and in particular Appendices I and II thereof.

Article 1Approval of a basic substance#

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

Article 3Entry into force#

Annex I

Annex II

Key facts

Article 1Approval of a basic substance#

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

Article 3Entry into force#

Annex I

Annex II