EU Regulation Plant Protection
The authorization of plant protection products (end use products) is governed by Regulation (EC) No 1107/2009 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", introducing the zonal evaluation procedure which is further detailed in SANCO/13169/2010 rev. 5; 11 March 2011: Guidance document on zonal evaluation and mutual recognition under Regulation (EC) No 1107/2009. Three political zones (northern, central and southern zone) are established, with one Member State evaluating the plant protection product for the whole zone and thus acting as zonal Rapporteur Member State. This process is intended to enable work sharing between Member States as further illustrated for the Northern Zone in the "Guidance Document on the Process For Work-Sharing in the Northern Zone in the Registration of Plant Protection Products Following Inclusion of an Active Substance in Annex I of Council Directive 91/414/EEC July 2011".
Draft Registration Report
The format of the dossier to be employed in authorizations of plant protection products (end-use products) is stipulated in SANCO/12592/2012, which repeals SANCO/6895/2009 rev 1 of 10 September 2009, "Guideline on the Presentation and Evaluation of Dossiers According to Annex III of Directive 91/414/EEC in the Format of a (draft) Registration Report" The new format of the draft registration report (dRR) according to SANCO/12592/2012 is to be used from 01.01.2016 onwards, with the numbering now aligned according to the numbering of the DAR. The risk envelop approach as given in SANCO/11244/2011 rev. 5 14 March 2011, "Guidance Document on the Preparation and Submission of Dossiers for Plant Protection Products According to the ‘Risk Envelope Approach'" is to be employed in the risk assessments.
As the evaluation of new active substance data (Annex II data) is a matter of the EU evaluation as stipulated in Regulation (EC) No 1107/2009 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", the use of new active substance data in the evaluation of the protection products (end use products) is further clarified in SANCO/10328/2004- rev 8, 24.1.2012, "Guidance Document on the Evaluation of New Active Substance Data Post Approval". Finally, the renewal, withdrawal and amendment of authorizations are detailed in SANCO/2010/13170 rev. 7; 11 March 2011, "Guidance document on renewal, withdrawal and amendment of authorizations under Regulation (EC) No 1107/2009".
For further information please refer to SCC's home page: http://www.scc-gmbh.de/business-units/agrochemicals-biopesticides