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The evidence base for the assessment of endocrine-disrupting chemicals: a comment on the EU criteria for pesticides and biocides

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Background: The evidence base for the regulatory assessment of endocrine-disrupting chemicals (EDC) has proved very controversial to define. The EU has been a first mover and – after years of discussions and conflicts – adopted criteria for the pesticide and biocide sectors in 2018.

Key points: The article reviews alternative regulatory options and critically discusses some of the features of the adopted EU guidelines. It argues that they are a significant and necessary step. It further argues that while EU guidelines are certainly up to date with current developments in regulatory toxicology, they are not ambitious enough to set the pace beyond internationally agreed standards and conventions in risk regulation. Specifically, the article shows that EU regulators ‘bypassed’ some of the most difficult issues on the use and interpretation of evidence around endocrine-disrupting chemicals.

Conclusions and implications: The article argues that the lack of regulatory translation of pressing scientific questions on endocrine disruption has significant consequences: it limits the applicability of EU guidelines and will likely require EU risk assessors to resort to a case-by-case approach in evaluations of pesticides and biocides. Moreover, contrary to expectations and ambitions, EU guidelines can only partially inform regulatory developments in other chemical sub-sectors and in other jurisdictions.

Key messages
  • Endocrine disruption is the adverse interference of chemicals with the hormone system.

  • After years of discussion the EU adopted guidelines on the type of evidence and criteria for its evaluation in the pesticides and biocides sectors.

  • EU guidelines avoid the regulatory translation of some of the most controversial scientific issues.

  • EU guidelines are necessary but a partial and limited regulatory response.
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Keywords: EU regulation; biocides; endocrine disruption; pesticides

Affiliations: University of Trento, Italy

Appeared or available online: December 2, 2020

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