Consideration of substances of concern in a biocidal product

Client

A regulatory consultancy, specialising in biocidal products.

Background

Substances of concern (SoCs) in biocidal products are defined as those substances, other than the active, which have an inherent capacity to cause an adverse effect on humans, animals or the environment and are present/produced in a biocidal product in sufficient concentrations to create such an effect. Under the Biocidal Products Regulation, such substances should be evaluated, with acceptable exposure levels (AELs) derived, or a lack of AELs justified.

Project goals

Bibra was provided with details on SoCs (identified by the relevant Competent Authority) in a biocidal product. We were asked to consider these SoCs with respect to AEL derivation.

Approach

Bibra evaluated the SoCs in compliance with regulatory guidance from the European Chemicals Agency. ECHA recommends a tiered approach be taken, accounting for the nature and severity of the hazards identified, and assigning SoCs to one of four possible product hazard classification bands (from A to D) of increasing evaluation and risk management requirements. Bibra identified the correct band for each of the SoCs and evaluated them appropriately.

Project outcome

Bibra considered the relevant toxicity data on each of the SoCs in the biocide, and justified why AELs were not necessary in this case.

Project Team

Pete Watts

 

Biocidal Products

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