Guidance Document on the Assessment of the Relevance of Metabolites in Groundwater of Substances Regulated under Council Directive 91/414/EEC
All Approval Holders Letter 09/2003
4 April 2003
At the meeting of the Standing Committee for the Food Chain and Animal Health on 26 February, the guidance document (Sanco/221/2000 –rev.10) was finalised. At that meeting the European Commission made the following declaration which was supported by most Member States:
This technical guidance document, on the assessment of the relevance of metabolites in groundwater, is intended to provide guidance for notifiers and Member States in the context of the review of active substances under Council Directive 91/414/EEC. It confirms the principle laid down in the Directive that active substances and relevant metabolites thereof must not exceed a limit value of 0.1 ug/l in groundwater. It further provides for a scientifically-based assessment schemeto decide whether or not a degradation product is relevant.
It is intended that this guidance be used henceforth for substances reviewed under the Directive. The document identifies a consensus approach in regulatory decision-making concerning the inclusion of active substances in Annex I to the Directive. The Commission notes that the Guidance document is not legally binding. Neither the document itself nor its principles will force Member States to change their current practice in granting authorisations at national level. The document does not prejudice the authority of Member States in national authorisations, nor does it prejudice the application of other Community legislation, such as the Drinking Water Directive, in force.
This is the summary report of the meeting.
This document will therefore apply to all decisions on Annex I inclusion from now on, where the relevance of metabolites in groundwater is an issue. Consequently it may be necessary to revise assessments provided in dossiers already submitted or those already carried out by rapporteur Member States. Where PSD is rapporteur and the evaluation of your dossier is ongoing, we will contact you to advise if this is case. However, for dossiers where evaluations are not yet underway you may wish to consider what revisions, if any, are required to meet this new guidance. It is considered that the agreed guideline is similar to the previous version of this document (version 7b) that many applicants/notifiers may have already used in making assessments. If applicants have used version 7b then it is unlikely that a revised assessment will be necessary at this stage, pending the outcome of the initial assessment.
In the UK, for product registration/re-registration under Plant Protection Products Regulations (PPPR) then precedents already set for metabolites when the active substance was considered for Annex I listing will be followed for the product. Only if there is a major change in use, pattern of use, or different soil hydrology that might lead to a greater risk of metabolites reaching groundwater than with the uses already assessed, will there be any further consideration. In these circumstances, it is important to consider whether UK relevant FOrum for Co-ordination of pesticide fate models and their USe (FOCUS) groundwater scenarios give (or would be expected to give) metabolite estimates for the proposed use of the product in the UK, that are higher than from the example product 'safe' use patterns identified at the European level. If this is the case then the new guideline can then be used by applicants / PSD to investigate the acceptability of the new use.
Contact Information
If you have any questions about the impact of the new guidance on applications currently being processed please contact the PSD project manager dealing with your application.
If you have any queries concerning the technical content of the guidance document, please contact us.