June 19, 2018 by Becky Brown
The new endocrine disrupter criteria for biocides apply from the 7th June 2018 under Regulation (EU) No 528/2012¹. This means that new biocides and biocides currently going through the authorisation process will need to have an endocrine disrupter assessment included as part of their application.
The criteria apply to humans and non-target organisms. According to the ED criteria a substance has endocrine disrupting properties if it meets all the following criteria (prefaced from the regulation):
- It shows an adverse effect;
- It has an endocrine mode of action i.e. it alters the function(s) of the endocrine system;
- The adverse effect is a consequence of the endocrine mode of action.
Identification of a substance should be based on all relevant scientific information, the assessment of the information should follow a weight of evidence approach, and the weight of evidence should consider the biological plausibility of the link between the endocrine mode of action and the adverse effect.
The European Chemicals Agency (ECHA) and the European Food Standards Authority (EFSA) have recently published their guidance for identification of endocrine disrupters². The scope of the guidance is limited to vertebrates and specifically covers endocrine disruption via the estrogenic, androgen, thyroid and steroidogenesis (EATS) pathways. It does not however rule out investigation of alternative endocrine modes of action if there is sufficient evidence to support one.
In theory the endocrine assessment can be made based on the available data generated under the biocides directive, however if there are data gaps or the existing data is not of sufficient quality then additional data may be required to reach a conclusion.
If a biocide is identified as an endocrine disrupter in humans it will fulfil exclusion criteria and will not be approved (unless it meets one of the derogation criteria). If the biocide is an endocrine disrupter only in non-target organisms it can be approved but not for use by the general public and only if there is no alternative substance.
At a webinar hosted by ECHA on the 19th June 2018, Simon Gutierrez Alonso confirmed that even for products that are already authorised, if the conditions for authorisation are no longer met authorisation may be amended or cancelled. For biocide assessments submitted after 1st September 2013 the evaluating authority may request new information for endocrine disrupter evaluation. For assessments submitted before the 1st September 2013 the product authorisation holder has obligation to inform ECHA if new information is available. ECHA are therefore encouraging product authorisation holders to reconsider their data following the new guidance³.
wca’s mammalian toxicologists and ecotoxicologists are highly experienced at conducting endocrine assessments for biocides, plant protection products and industrial chemicals, including Weight of Evidence evaluations. Please contact us if you would like further information on our services in this area or if you have a specific enquiry concerning the assessment of endocrine disruption potential of one of your products.
¹Regulation (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://eur-lex.europa.eu/eli/reg/2012/528/oj
²Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009; https://www.efsa.europa.eu/en/efsajournal/pub/5311