Updates on the EFSA User Guide on Confidentiality
Updates on the EFSA User Guide on Confidentiality
The European Food Safety Authority (EFSA) step-by-step practical Guide on the submission and processing of confidentiality requests has had several updates recently. The guide details the confidentiality requirements under Regulation (EU) 2019/1381 (Transparency Regulation) for those involved (applicants and Member State authorities) in the confidentiality assessment regarding pesticides risk assessment. A confidentiality assessment is defined as “the process of assessing confidentiality requests on confidential business information (CBI) or personal data (PD)”, while confidentiality requests are requests to treat certain information, i.e., CBI or PD, as confidential. Confidentiality requests may be made on scientific data, studies and other information, including supplementary information, supporting an application, generic mandate or call for data falling under the Transparency Regulation.
The updates to the guide include:
- An updated General Requirements Section (Section A) with an expanded glossary, stronger focus on confidentiality and clearer instructions on how to prepare both confidential (earmarked) and non-confidential (sanitised) document versions.
- Simplified E-Submission Food Chain (ESFC) platform and Portalino Sections (Sections B & D) which have been revised with the removal of outdated information and replaced with easier to understand and accessible information.
- An enhanced IUCLID Section (Section C) providing guidance on the meaning of “pesticide confidentiality” which is outlined in both Regulation (EC) No 1107/2009 and Regulation (EC) 178/2002. Moreover, additional instructions have been added to aid Member State authorities who conduct confidentiality assessments for plant protection product dossiers.
If you need any support with the registration of plant protection products in Europe, please do not hesitate in contacting one of our regulatory consultants at info@kerona.ie