Towards a new EU Plant Protection Regime – Legal Problems arising out of the Transition with Regard to Regulatory Approvals and Authorisations

The plant protection law within the European Union has been continuously developed over the past two decades. Harmonized provisions for the placing of plant protection products on the common market were introduced by Council Directive 91/414/EEC of 15 July 19911 (hereinafter the “Directive”). Based on a progress report issued by the Commission under this Directive2, the need for a revision of the Directive was identified which should, in order to ensure consistency throughout the Member States and to provide for simplification, take the form of a regulation.

On 21 October 2009, the European Parliament and the Council of the European Union adopted Regulation (EC) No. 1107/2009 concerning the placing of plant protection products on the market (hereinafter the “Regulation”). According to Article 84(1) of the Regulation, the Regulation entered into force on the 20th day following its publication in the Official Journal of the European Union, i.e. entry into force was on 14 December, 2009. However, the Regulation was not applicable from this date. Article 84, ast sentence of the Regulation states that the Regulation shall apply from 14 June 2011 (hereinafter the “Application Date”). Article 83(1) of the Regulation therefore provides that the Directive is repealed with effect from 14 June 2011. The Directive and the plant protection laws of the Member States transposing the Directive into their national law as well as the Regulation lay down the rules for the approval of active substances and for the authorisation of plant protection products containing such active substances which are intended to be placed on the market in the EU, including rules on the mutual recognition of authorisations and for provisional authorisations. The following analysis examines how the transition from the Directive to the Regulation is implemented in terms of the validity of approvals and authorisations which have already been granted under the Directive. Moreover, it is assessed which law regime, i.e. the law regime under the Directive or the provisions of the Regulation, shall apply to any applications for such approvals and authorisations which have been filed prior to the Application Date but are still pending on that date. The analysis first focuses on the questions arising out of the transition as regards the approval of active substances contained in plant protection products. The second part deals with similar questions regarding authorisations of plant protection products, including applications for national provisional authorisations and for mutual recognition.



Copyright: © Lexxion Verlagsgesellschaft mbH
Source: StoffR 01/2011 (Januar 2011)
Pages: 11
Price: € 20,00
Autor: Dr. jur. Gérardine Garçon

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