New BPR Data Requirements for Endocrine Disruption
In May this year, following the end of the feedback period, the final version of the proposed data requirements for assessing endocrine disrupting (ED) properties of biocides was agreed. The European Commission is expected to publish the final regulation this autumn.
In terms of non-target organisms, the draft regulation contains specific new data requirements for fish and amphibians.
For fish, the preferred tests are the medaka extended one-generation test (MEOGRT) or the Fish life cycle toxicity test (FLCTT). However, other in vivo tests (Fish short term reproduction assay, the 21-days fish assay, or the Fish sexual developmental test) would be accepted if they provide no indication of effects potentially related to endocrine activity and if the results from the mammalian data set is also negative. The requirements do state that if other data is available covering the estrogenic, androgenic & steroidogenic (EAS) modalities or parameters investigated in the above tests, then those data may be used instead.
For amphibians, the regulations recommend the LAGDA (Larval amphibian growth and development assay). The AMA (Amphibian metamorphosis assay) may be accepted if the results prove negative for ED and if there are no indications of endocrine activity or endocrine-related effects from the mammalian dataset. However, unlike the data requirements for fish, the regulations do not state that data from studies other than the LAGDA or the AMA would be considered as acceptable substitutes.
Together with the requirement to assess all co-formulants in biocidal products, this BPR regulation update providing specific data requirements is another indication that, despite their shared guidance document (EFSA, ECHA, 2018), there are important differences in the assessment and regulation of EDs between plant protection products and biocides. We need to remain vigilant and where appropriate, participate in the discussions in the development of ED assessment and regulations.
Enviresearch is here to help you fulfill your global regulatory requirements for the assessment of potential endocrine disrupting properties, not only for biocides but also for pesticides and general chemicals.