An Applicant’s guide for environmental data submission to HSE under the BPD

This guidance is intended to help Applicants to submit ‘sufficient’ environmental data and reduce the unnecessary and excessive submission of study summary documents and justifications for non-submission.

Applicants are reminded that the environmental data requirements are based on a tiered approach of core data, product type specific data and any additional data as required to address the risk of the active substance and/or its major metabolites.  For each data requirement that is triggered, either the available study report(s) (Documents IV-A or IV-B) and study summary(ies) (Document III-A or III-B) or a justification for non-submission is needed.

Study summaries or justifications for non-submission are not required for every environmental endpoint, this approach results in unnecessary effort and expense in preparing the dossier and will increase the evaluation fee. For example; Many biocidal active substances are also used in agricultural pesticide products and as a result are data rich (i.e. there are extensive data/endpoints available). In these circumstances Applicants have been known to submit all their data with summary documents, regardless of the fact that these data are not required for the exposure or risk assessment presented. Or an Applicant may submit data with study summaries for all the required endpoints (as triggered by the guidance) but also complete lengthy justifications for every remaining endpoint despite not being triggered by the product or use pattern being supported.

The core and product type specific data requirements are clearly laid down in the TNG on data requirements (accessible below) and should be addressed through data or reasoned argument (justification).  However, Applicants need to also consider the need for additional data requirements to support the product risk assessment because of the envisaged pattern of use or as a consequence of the results from available studies. The basic premise is that; if there is a route to the environment as a consequence of use, the route and fate (degradation and mobility) of the active substance (and/or its metabolites) in the relevant environmental compartments will have to be quantified and a predicted exposure concentration (PEC) calculated.

Simple statements that the exposure ‘will be low’ will not be sufficient for defence in the EU but should be demonstrated by calculating the PEC based on reasonable worst-case assumptions. For each compartment where a PEC has been calculated, effects data will be required so that a predicted no effect concentration (PNEC) can be derived so that a risk quotient (PEC:PNEC) can be determined.  It is particularly important to be able to assess the long-term risk to the environment where repeated use/exposure is envisaged.

Where numerous studies are available for the same endpoint, it is not necessary for the Applicant to produce study summaries for all these studies and the ‘Key study’ approach should be taken as outlined in the available TNG on dossier preparation.
It is therefore VERY important that the dossier is compiled ‘intelligently’ using all the available guidance to build up a dossier which supports the risk assessment of the associated biocidal product;

• TNG on Dossier Preparations and TNG on Data Requirements
• Environmental Exposure Scenario Documents – where these are not available, the Applicant should rely on the known use patterns with knowledge of the ESD approaches taken for similar product types.