Reasons and aims of this analysis
Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA), the competent authority for REACH of Germany, and Umweltbundesamt (UBA), hereafter referred to as ‘the authorities’, are currently preparing a REACH Annex XV Restriction Dossier for bisphenol A (BPA) + bisphenols of similar concern (as defined under Section II.) since all these substances are considered to have endocrine disrupting properties in the environment.
Endocrine disrupting substances (EDs) in the environment interfere with the hormone system of wildlife animals and can thereby cause adverse and population relevant effects. Thus, exposure to EDs endanger the survival of populations or subpopulations in the affected ecosystems. Due to the still limited knowledge on e.g. the endocrine system of invertebrates and hence their sensitivities to EDs exposure, the decoupling of exposure and adverse effects (even transient exposure during sensitive juvenile life stages can result in adverse effects in adult animals or in subsequent generations) and missing test systems to address specific endocrine mediated modes of action (e.g. thyroid active chemicals in fish) it is not possible to predict and derive a safe threshold for EDs in the environment that is sufficiently protective.
BPA, BPB and the other bisphenols of similar concern (BosC) act via several endocrine pathways that are conserved among a broad range of species and taxa. Hence, environmental exposure to these chemicals not only affects single species and populations but directly whole ecosystems.
Based on these considerations any exposure of the environment with BPA and BosC is subject to the minimization requirement.
BAUA, 28 October 2021