JSC have asked EFSA for clarification on some aspects of this ongoing topic and the responses suggest that we must all wait a bit longer for clear guidance on the finalised version and a decision on when to use this as a tool for non-dietary exposure assessment.
Regarding instructions for how to use the model and a definition of the reference value end-points, EFSA say it is under discussion and they intend to prepare a document defining the most appropriate reference values to be used for the non-dietary risk assessment.
JSC have identified apparent discrepancies in the use of the model compared to earlier versions and asked EFSA if it is accepted that further changes are required. The EFSA response noted that before entry into force of the Guidance, the calculator will be tested and revised if needed. All stakeholders and the Commission will be informed by EFSA of any updates to the published guidance document.
When asked about implementation of the model for regulatory submissions and any transitional measures for imminent dossier submissions (either at EU level or zonal dRR) EFSA confirmed that the decision is the Commissions responsibility, after discussion with Member States.
For all of these aspects, no timeline for the next steps can currently be anticipated – Watch this space!
JSC can advise you on the appropriate non-dietary exposure models to use for your active substance and product requirements. However, the latest version of the EFSA guidance is clearly not ready for use in regulatory submissions and is currently also unreliable for use in an impact assessment.
The EFSA guidance and model can be viewed here.
For more information please contact JSC on +44 (0)1423 520245, firstname.lastname@example.org
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