Revision of extrapolation guidance for residue assessment
For the assessment of residue tests, a guidance document can be used (SANCO 7525/VI/95 Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs). This document not only contains the accepted extrapolations between crops, but also aspects such as guidelines for the minimum number of residue tests that are required for a complete dataset. On 23 September the Commission adopted Revision 10.2, which became effective immediately.
Revision 9 of this guidance document was adopted in 2011. Revision 10.1 went into force in December 2015. In that document, the format of the extrapolation tables was changed – to make the document easier to read – and some existing extrapolations were also clarified. Making substantive changes to the extrapolations was not planned. However, after version 10.1 came into force, a number of mistakes/errors were detected in the extrapolations, which resulted in substantive changes in Revision 10.1 compared to Revision 9. This discrepancy has now been put right as much as possible and the guidance been clarified in Revision 10.2
The extrapolation guidance in Revision 10.2 is part of the assessment framework and is being used in the assessment of residues for applications submitted after 23 September 2016.For MRL applications, the Commission ruled that Revision 10.2 not only applies to new applications from 23 September 2016, but also to previous applications for which the assessment is still pending.