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Biocides (concerning Endocrine Disruptors): Draft Delegated Regulation Amending Regulation (EU) No 528/2013 Published

 

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 account for recent developments, in example to identify endocrine-disrupting properties of biocides, 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.

The revised data requirements now include a more detailed way forward to skin/eye irritation or skin sensitisation in vitro testing and changes for reproduction toxicity testing, where the extended one-generation reproduction toxicity study (OECD 443) is now preferred replacing the two-generation study (OECD 416),  developmental toxicity testing in a second species should be performed and developmental neurotoxicity testing has become a core data requirement.

 

As regards endocrine disrupting properties mammalian toxicology requirements comprise, but are not limited to, beside information from a detailed literature search data from repeated dose toxicity in rodents and non-rodents, prenatal developmental toxicity, extended one-generation reproductive toxicity, developmental neurotoxicity studies and combined chronic and long-term repeated dose toxicity studies as assigned to level 4 of the guidance document.

 

If there is any evidence that the substance may have endocrine-disrupting properties or no conclusion can be drawn on ED additional information needs to be provided. This information comprises mechanistic in vitro and in vivo tests (level 2 or 3 of the guidance document) or evaluation of adverse effects (level 4). According to the regulation level 2 may be assessed providing, i.e. estrogen/androgen receptor transactivation (OECD 455, $58), aromatase (OPPTS 890.1200) and steroidogenesis assays (OECD 456). Further testing to gather in vivo mechanistic data (level 3) and evidence for adverse effects may include uterotrophic and Hershberger assays (OECD 440, 441) or pubertal development testing (i.e. OPPTS 890.1500).

 

Short-term toxicity testing on fish is not required if sufficient other data is 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.

 

Information to investigate potential endocrine disrupting properties in fish (EAS modalities) and amphibians (T modality) need to be provided except there is no indication for endocrine activity or endocrine related effects from the mammalian data set or from any other relevant information. This may include level 3 studies (FSTRA, OECD TG 229; 21-days fish assay, OECD TG 230; FSDT, OECD TG 234; AMA, OECD 231) and/or level 4/5 studies (MEOGRT, OECD 240; FLCTT, OPPTS 850.1500; LAGDA, OECD 241).

Any testing proposals should be discussed with authorities prior to conduction and there will be an obligation to document such discussions.

 

Revised Annexes can be found here:

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12184-Adapting-data-requirements-in-the-Annexes-to-the-BPR-to-the-ED-criteria

 

For further information please contact: Dr. Nadja Schweizer