COMMISSION IMPLEMENTING REGULATION (EU) 2015/707
of 30 April 2015
concerning the non-approval of
Rheum officinale
root extract as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
(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 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 for the approval of
Rheum officinale
root extract 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 12 June 2014(2). The Commission presented the review report(3) and the draft of this Regulation on the non-approval of
Rheum officinale
root extract to the Standing Committee on Plants, Animals, Food and Feed on 20 March 2015.
(3) The documentation provided by the applicant shows that
Rheum officinale
root extract does not fulfil the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council(4).
(4) Specific concerns were identified in the Technical Report, regarding the risk to operators, workers, bystanders, consumers and non-target organisms.
(5) The Commission invited the applicant to submit its comments on the examination of the Authority and on the draft review report. The applicant submitted its comments, which have been carefully examined.
(6) However, despite the arguments put forward by the applicant, the concerns related to the substance cannot be eliminated.
(7) Consequently, it has not been established, with respect to the uses which were examined and detailed in the Commission review report, that the requirements laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to approve
Rheum officinale
root extract as basic substance.
(8) This Regulation does not prejudice the submission of a further application for the approval of
Rheum officinale
root extract as basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.
(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:
Article 1
Non-approval as a basic substance
The substance
Rheum officinale
root extract is not approved as basic substance.
Article 2
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, 30 April 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
Rheum officinale
and the conclusions drawn by EFSA on the specific points raised. 2014:EN-617. 31 pp.
(3) http://ec.europa.eu/sanco_pesticides/public/?event=activesubstance.selection&language=EN
(4) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (
OJ L 31, 1.2.2002, p. 1
).
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