The final draft of the EFSA “Guidance document on the establishment of the residue definition for dietary risk assessment“ was made available in advance of a technical meeting with stakeholders held in Parma, 26 September 2016.

JSC attended this meeting. The presentations gave more information and clarification on the processes outlined in the final draft guideline.  The topics included a number of important areas of interest including residue definition setting process, Quantitative Structure-Activity Relationships (QSAR), Threshold of Toxicological Concern (TTC), toxicology testing strategies and the assessment of conjugates. Industry and the MS also gave their views on the proposed guidelines.  It is clear that when the guideline is implemented, close collaboration between toxicologists and residue specialists will be required to address possible concerns regarding the potential toxicity of metabolites.  Furthermore, the consumer risk assessment may become more complex as a result of the changes.  There was no definite indication of timescale for approval but informal expectations are that the guideline will be discussed and voted on during 2016.

The agenda, list of participants and the presentations from the meeting are available at: https://www.efsa.europa.eu/en/events/event/160926

For advice on risk assessment and further information on the registration of plant protection products, biocides or general chemicals, or any other regulatory issues, please contact JSC on +44 (0)1423 520245, enquiries@jsci.co.uk.