Commission Implementing Regulation (EU) No 359/2012
of 25 April 2012
approving the active substance metam, 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, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Regulation (EC) No 33/2008.
The application was submitted to Belgium, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as those that were the subject of Decision 2009/562/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.
Belgium evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 31 August 2010.
The additional report by the rapporteur Member State and the new conclusions by the Authority concentrate on the concerns that led to the non-inclusion. Those concerns were in particular that it was not possible to demonstrate the acceptability of consumer exposure and lack of data with respect to the behaviour in the environment of the impurity N,N-dimethylthiourea (DMTU).
The new information submitted by the applicant shows that the exposure of consumers may be considered acceptable and the behaviour of DMTU in the environment will not result in unacceptable effects.
Consequently, the additional information provided by the applicant permits to eliminate the specific concerns that led to the non-inclusion.
It has appeared from the various examinations made that plant protection products containing metam may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular as regards the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve metam in accordance with Regulation (EC) No 1107/2009.
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 and restrictions.
Without prejudice to the conclusion that metam should be approved, it is, in particular, appropriate to require further confirmatory information.
A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.
Without prejudice to the obligations defined by Regulation (EC) No 1107/2009 as a consequence of the approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009 the following should, however, apply. Member States should be allowed a period after approval to review authorisations of plant protection products containing metam which have been maintained for certain uses in accordance with Article 3 of Decision 2009/562/EC. For the calculation of that period that provision is to be taken into account. Member States should, as appropriate, vary, replace or withdraw existing authorisations.
For plant protection products containing metam, where Member States grant any period of grace in accordance with Article 46 of Regulation (EC) No 1107/2009, Article 4 of Decision 2009/562/EC should be taken into account for the calculation of that period. Hence, such a period of grace should expire at the latest by 31 December 2014.
In the interest of clarity, Decision 2009/562/EC should be repealed.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION: