Endocrine Disrupters and Biocides
The new endocrine disrupter criteria for biocides apply from the 7th of June 2018 under Regulation (EU) No 528/2012. This means that new biocides and biocides currently going through the authorisation process will need to have endocrine disrupter assessment included as part of their application.
According to the criteria, a substance is considered to have endocrine-disrupting properties if:
- it shows an adverse effect in an intact organism or its offspring, which changes the morphology, physiology, growth, development, reproduction or life span of the organism and impairs its functional capacity, its ability to compensate for stress or increases its susceptibility to other influences;
- it has the potential to alter the functions of the endocrine system; and
- there is a biologically plausible link between the adverse effect and the endocrine activity.
Conclusions on whether the criteria are met must be drawn separately for humans and for non-target organisms.
Under biocides legislation, the ED criteria are either exclusion criteria (for effects on human health) or substitution criteria (for effects on the environment). Derogations exist, for example, if there are public health concerns, negligible exposure or disproportionate negative impacts on society.
The European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA), with support from the Joint Research Centre (JRC), have recently developed a common guidance for the identification of endocrine disruptors. The guidance mainly addresses the effects caused by EATS modalities and focus on vertebrate organisms, i.e. mammals, birds, fish and amphibians.
The guidance describes how to gather, evaluate and consider all relevant information to the assessment, conduct a mode of action (MoA) analysis, and apply a weight of evidence (WoE) approach, in order to establish whether the ED criteria are fulfilled.
For applications submitted before 1 September 2013, there is an opportunity for companies to submit additional information on ED properties. In other words, the product authorisation holder has the obligation to inform ECHA if new information is available. ECHA are therefore encouraging product authorisation holder to reconsider their data following the new guidance. If the conditions for product authorisations are no longer met, authorisation will be amended or cancelled.
Substances with an assessment report submitted after 1 September 2013 – when the biocidal products Regulation (BPR) entered effect – will no longer be approved, if the new criteria identify them as endocrine disrupting. The national authority can request new information for endocrine disrupter evaluation.
Enviresearch’s scientists have considerable skills at conducting endocrine assessment for biocides, plant protection products and industrial chemicals including Weight of Evidence evaluations following the evaluation steps (Links ED-PPP).
We offer an independent weight of evidence evaluation of substances for potential endocrine disrupting effects in mammalian and wildlife species, which makes full use of existing internal company (eco)toxicity data and any relevant information in the published literature. The review will cover evaluated data from agreed test guidelines for endocrine effects (following the OECD Conceptual Framework for Testing and Assessment of Endocrine Disrupting Chemicals, revised 2017), as well as endpoints from standard toxicity tests that may be related to endocrine disruption.
Please contact us if you would like further information about our services in this area or if you have a specific enquiry concerning the assessment of endocrine disruption potential of one of your products. Explore our other related articles: Weight of Evidence Reviews for Endocrine Disrupting Properties, Endocrine Disrupters and Plant Protection Products.
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products:https://eurlex.europa.eu/eli/reg/2012/528/oj
Guidance for the identification of endocrine disrupters in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009:https://www.efsa.europa.eu/en/efsajournal/pub/5311