Draft Registration Report (dRR)
The EU Member States cooperate intensively on zonal applications for plant protection products. To ensure a uniform reporting method for the assessment, an EU format is available for the draft Registration Report (dRR).
When submitting an application for authorisation of a plant protection product, applicants must use the draft Registration Report (dRR). The procedural guidance is published on the EU site. For products based on micro-organisms a separate dRR template must be used. Ctgb has adapted the National Guidances to the situation in the Netherlands, this lists the Netherlands-specific aspects,
For the aspect of ecotoxicology the latest template must bu used (since January,1, 2017). The templates have been aligned with the new data requirements (Regulation (EU) No 284/2013) for products which will apply from the 1st of January 2016 as well. The main changes to the dRR templates are as follows (see the guidance on how to use te dRR):
- A new part (B.0) was added which should contain general information.
- The covers sheets are adapted.
- The numbering has been brought in line with the numbering of the DAR (SANCO/12592/2012).
- The templates are brought in line with the new data requirements (Regulation (EU) No. 284/2013).
- A summary should be added to the beginning of each dRR and the study evaluation should be added to the Appendix of each section.
- An overview of data gaps should be added to the summary in each section of the dRR.
- The presentation of the GAP has been changed.
Besides the core dRR templates the following Dutch national addenda are also modified to be in accordance with the core dRR:
- Part B Section 3 Efficacy Data and Information
- Part B Section 8 Environmental Fate
- Part B Section 9 Ecotoxicology
From 1 January 2016 the Dutch National addenda for the aspects of human toxicology (Section B.6) and residues (Section B.7) no longer have to be submitted.