Public consultation on new data requirements for Biocides with endocrine-disrupting properties until March 12, 2020

11th March 2020

Regulation (EU) No 528/2013, in its Annexes II and III, gives the data requirements for approval or authorization of biocidal actives and products. These annexes will be amended to identify endocrine-disrupting properties of biocides. It is in accordance with ECHA/EFSA Guidance for the Identification of Endocrine Disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009.

Information to investigate potential endocrine disrupting properties in fish (EAS modalities) and amphibians (T modality) need to be provided; except if there is no indication for endocrine activity or endocrine related effects from the mammalian data set or from any other relevant information.

The ecotoxicological assessment comprises mechanistic in vivo tests (level 3 of the guidance document) or evaluation of adverse effects (levels 4 and 5). Fish and frog studies should provide data on endocrine mechanisms (OECD 229, 230, 234, 231) and on adverse effects on endocrine relevant endpoints (OECD 240, 241, OPPTS 850.1500). Short-term toxicity testing on fish is not required if sufficient other data are available (e.g. FET, OECD 236; non-animal methods). A long-term toxicity testing on fish shall be considered if the substance is poorly water soluble, i.e. below 1 mg/L.

Any testing proposals should be discussed with authorities prior to conduction and there will be an obligation to document such discussions. Do you need support for testing proposals or discussions? Our experienced ED team looks forward to assisting you, please contact Dr. Melanie Lichtenberger for further questions (melanie.lichtenberger@ibacon.com).