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 be 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:
- A new part (B.0) was added which should contain general information.
- The cover 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 to be used from 1 November 2019
- Part B Section 9 Ecotoxicology to be used from 1 September 2019
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.