The technical guideline on the evaluation of extraction efficiency of residue analytical methods (SANTE/2017/10632 Rev.3) was noted at the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) Section Phytopharmaceuticals – Residues 21 – 22 November 2017. The Commission confirmed the application date to be 22 November 2019, two years of the date of note taking.
It is now understood that in France, Anses will take this guideline into account for applications submitted from December 1st, 2019. Other member states are also likely to follow these timings.
The purpose of this guidance document is to give advice on when and how to assess the suitability of the extraction procedures applied in pesticide residue analytical methods, e.g. as required for post-registration monitoring methods in the guidance document SANCO/825/00. However, it is not restricted to post-registration monitoring methods and is also applicable for residue analytical methods used for the quantification of residues in supervised field trials (pre-registration or data generation methods). The guidance document was developed primarily for the evaluation of extraction efficiency of analytical methods for plant matrices, but the basic principles are also applicable for products of animal origin. The suitability of extraction procedures should be evaluated based on information from metabolism studies performed with radiolabelled pesticides (if needed in combination with radio cross validation studies). The guidance also provides suggestions regarding the design of new studies with respect to extraction efficiency and on how to approach cases where samples with incurred radiolabelled residues are no longer available.
Anses highlight that any study submitted in the residue section must now be in accordance with this guideline. Crucially, this will apply to both new studies and also previously submitted studies. Studies will be re-assessed on the specific point of extraction efficiency. If the extraction efficiency is not appropriately demonstrated, the available residue dataset could be insufficiently supported with possible consequences regarding the acceptability of the corresponding intended use.
The final version of the guidance document is available online at https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_wrkdoc_2017-10632.pdf
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 ERM on +44 (0) 1423 520245, or contact firstname.lastname@example.org.
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