First IUCLID dossier for plant protection products prepared
Having been involved in EFSA’s pilot project on testing suitability of IUCLID for conventional plant protection products (PPP) and biological products that was completed in 2020, knoell now prepared the first ever re-registration dossier in the new IUCLID format for plant protection products that was submitted to EFSA in July 2021.
The dossier consists of the active substance data set and two data sets for representative formulations containing the active substance. The client received the IUCLID data set electronically and transferred the dossier to EFSA.
The project started at the beginning of 2021 and included the following main activities
- Strategic creation of the dataset structure in IUCLID;
- Implementation of study reports, OECD study summaries and endpoint summaries including metadata into IUCLID;
- Redaction of hundreds of confidentially relevant documents, justification of redactions; and
- Attachment of documents and justifications into IUCLID;
- Not to forget the participation in EFSA Hypercare sessions on behalf of the client, where EFSA provided a targeted support to Member States and applicants involved in the 1st submission and evaluation of renewal dossiers in IUCLID.
It is worth mentioning the main obstacles we had to overcome
- EFSA IUCLID manual and a respective manual for conventional plant protection active substances and representative products were still under development during the course of the project;
- IUCLID report-generator, print options and validation assistant were under development and are still not fully operational;
- The EFSA Hypercare events took place as intended alongside the project, the implementation of the most recent information from the sessions was sometimes challenging;
- Best practices from BPR, CLP and REACH IUCLID work were very helpful but we still dealt with some specific issues in the preparation of the PPP dossier;
- The client, EFSA and ECHA had to solve the problem of data size limitations for data export and submission.
We are proud to have prepared this very first IUCLID PPP dossier for our client! With this step we extended our portfolio of IUCLID services that currently covers preparation of IUCLID dossiers for REACH, UK-REACH, CLP, BPR, UK-BPR, SCIP, Australia (AICIS) and PPP. Our team will be happy to support you - just get in touch with Dr Katarzyna Bucior.
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