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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 (1), 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 (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,
HAS ADOPTED THIS REGULATION:
Article 1
Approval 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 2
Amendments 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 3
Entry 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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 July 2015.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 309, 24.11.2009, p. 1.
(2) Outcome of the consultation with Member States and EFSA on the basic substance application for Salix alba bark and the conclusions drawn by EFSA on the specific points raised. 2014:EN-609.34 pp.
(3) http://ec.europa.eu/sanco_pesticides/public/?event=homepage
(4) Assessment report on Salicis cortex (willow bark) and herbal preparation(s) thereof with well-established use and traditional use; EMEA/HMPC/295337/2007.
(5) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(6) Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).
ANNEX I
Common Name, Identification Numbers
IUPAC Name
Purity (1)
Date of approval
Specific provisions
Salix spp. cortex
CAS No: not allocated
CIPAC 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 I
Common Name, Identification Numbers |
IUPAC Name |
Purity(1) |
Date of approval |
Specific provisions |
Salix spp. cortex CAS No: not allocated CIPAC 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. |
Number |
Common Name, Identification Numbers |
IUPAC Name |
Purity(1) |
Date of approval |
Specific provisions |
7 |
Salix spp. cortex CAS No: not allocated CIPAC 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 onSalix spp. cortex (SANCO/12173/2014) and in particular Appendices I and II thereof. |
(1) Further details on identity, specification and manner of use of basic substance are provided in the review report.
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