European Chemicals Agency Requires Endocrine Disruptor Assessment for all Biocidal Product Co-formulants
June 10, 2019
On June 7, 2018, the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) published “Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009.”[1] Under the Biocidal Products Regulation (EU No 528/2012; BPR), active substances considered to have endocrine-disrupting (ED) properties will not be approved unless the risk from exposure to the active substance is shown to be negligible or unless there is evidence that the active substance is essential to prevent or control a serious danger to human health, animal health, or the environment.

Further to this, in accordance with the BPR, specific non-active substances currently need to be evaluated if there are indications that the substance may have ED properties based on the existing knowledge and the available scientific information (CA-March18-Doc.7.3.b-final). To address this requirement the UK competent authority (Heath and Safety Executive) has proposed a step-wise approach for targeted determination of whether a non-active substance (a.k.a. “co-formulant”) in a biocidal product is an ED or has “indications” of ED properties.

How Exponent Can Help

Exponent can assess your product portfolio to determine the endocrine-disrupting properties of your co-formulants and provide ED assessments in support of your biocidal products and biocidal product families for authorisations in accordance with the draft guidance. Exponent can further provide higher-tier recommendations and solutions to questions that may arise from the results of the ED assessment.

Exponent is a multi-disciplinary science and engineering consulting firm that brings together more than 90 different disciplines to solve important technical, regulatory, and business issues facing our clients. Our team of health, food, and chemical safety consultants has over 20 years’ experience in all aspects of non-dietary exposure and risk assessments related to pesticides and are well versed in the development of risk assessment and refinements that incorporate both tailored exposure and hazard assessments.

Exponent’s scientific and regulatory experts have successfully supported clients in the submission of active substance and plant protection product dossiers and can provide up-front information critical to potential pesticide risk issues before dossier submission.

[1] ECHA (European Chemicals Agency) and EFSA (European Food Safety Authority) with the technical support of the Joint Research Centre (JRC), Andersson N, Arena M, Auteri D, Barmaz S, Grignard E, Kienzler A, Lepper P, Lostia AM, Munn S, Parra Morte JM, Pellizzato F, Tarazona J, Terron A, and Van der Linden S, 2018. Guidance for the identiļ¬cation of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA Journal 2018;16(6):5311, 135 pp. ECHA-18-G-01-EN.