Client
Confidential client
Background
The recently revised European legislation on plant protection products (Regulation (EC) No. 1107/2009) sets out new, stricter, criteria for approval of active substances and includes the assessment of endocrine disrupting properties. Active substances that are endocrine disruptors will not be approved under the new regulation unless there is negligible exposure to humans and non-target species. In addition to this, endocrine disrupting substances approved because of negligible exposure will become candidates for substitution with less hazardous substances during the authorisation stage at Member State level. The burden of proof is placed on the notifier. However, there is currently no agreed guidance on how to identify and evaluate endocrine activity and disruption. One way of determining whether a substance is an endocrine disrupter is to use a weight of evidence (WoE) approach to evaluate all available data.
Objectives
To adopt a WoE approach, which makes use of endpoints available in standard regulatory toxicity and ecotoxicity studies required for dossier submission and any relevant information in the open literature, and evaluate these for indications of endocrine effects.
Methodology
Two published WoE frameworks for the assessment of the endocrine disrupting properties of chemicals were evaluated and elements of each combined into a practical WoE evaluation for PPP active substances. The combined framework consists of four evaluation steps: 1) Study reliability — quality of work undertaken, 2) Study relevance — endpoint relevance to endocrine disruption, 3) Study significance — based on the earlier assessments made for reliability and relevance, and 4) Balance of the weight of evidence, coherence and gap assessment.
Outcome
A report for each active substance was produced for the client. The method and some general conclusions were presented in a poster at the 2nd SETAC Europe Special Science Symposium 17-18 September 2009 in Brussels, Belgium.
Value
Confidential
Start and completion dates
November 2008 – April 2010
wca environment project co-ordinator
Melanie Gross
