Documentation (NL=zRMS)
Highlighting specific guidance:
- GD on zonal evaluation and mutual recognition (SANCO/13169/2010)
- Beleidsregel naamgeving toegelaten biociden en gewasbeschermingsmiddelen (Besluit Collegevergadering C-292, d.d. 24 augustus 2016)
- Criteria for derogation from a European authorisation (Besluit collegevergadering C-283.1.11. 25 november 2015)
- GD on the Preparation and Submission of Dossiers for Plant Protection Products according to the “Risk Envelope Approach”(SANCO/11244/2011)
- GD on Data Protection (SANCO/12576/2012)
- GD on Transitional Measures for Data Requirements for chemical ASs and PPPs (SANTE/11509/2013)
- GD on preparing Test and Study Reports according to Article 60 of PPPR 1107/2009 (SANCO/12580/2012)
- GD on Presentation and Evaluation of Dossiers according to Annex III of PPPD 91/414 – dRR format (SANCO/6895/2009)
- GD on Presentation and Evaluation of Dossiers according to Annex III of PPPD 91/414 – dRR format - Annexes (SANTE/6895/2009)
- Draft GD om Comparative Assessment and Substitution of PPPs iaw PPPR 1107/2009 (SANCO/11507/2013)
- Explanatory Notes provide further details and examples on the data requirements related to micro-organisms laid down under Regulation (EU) No 283/2013 and Regulation (EU) No 284/2013
- Technical guidelines on the presentation and evaluation of plant protection product dossiers in the format of a (draft) Registration Report
- GD on semiochemical active substances and plant protection products
Law
- Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market
- Commission Regulation (EU) No 547/2011 as regards labelling requirements for plant protection products
- Commission Regulation (EU) No 284/2013 setting out the data requirements for plant protection products
-
Commission Regulation (EU) No 2021/383 amending Annex III to Regulation (EC) No 1107/2009 of the European Parliament and of the Council listing co-formulants which are not accepted for inclusion in plant protection products
dRR
- Form - Notification according to Art. 36(3) of PPPR 1107/2009
- Draft Registration Report - version 2015
- New dRR format micro’s (mandatory after November 2024)
- Comparison list A (chemicals) – Annex II and Annex III points (OECD vs. former EC system)
- Comparison list B (microbials) – Annex II and Annex III points (OECD vs. former EC system)