Toxicity support for EU Authorisation of a biocidal product family

Client

A regulatory consultancy, specialising in biocidal products.

Background

Under the Biocidal Products Regulation, registrants in the EU must demonstrate that there is sufficient toxicity information available on the skin and eye irritation, skin sensitization, and acute toxicity (by the oral, inhalation and dermal routes) of each ingredient to conclude on the classification and labelling of the product. Bibra was asked to prepare expert statements on the toxicity of each ingredient of a biocidal product family.

Project Goals

The two biocidal products in the family in question contained different levels of the active substance and eight co-formulants in water. We collected data on each component and made a recommendation for the classification and labelling of both products, considering the relative concentrations of each ingredient.

Approach

Data searches were carried out by bibra scientists on each component of the two products using the TRACE database. Searching was limited to expert reviews of authoritative bodies, with additional insights on classification and labelling obtained from ECHA’s C&L Inventory and MSDSs made available online by chemical manufacturers.

Project Outcome

Having considered the available toxicity information on the endpoints of interest, bibra provided our client with the appropriate toxicity summaries and classification and labelling proposals, in support of their biocidal product registrations, among the first under the new regulation.

Project Team

Phil Copestake

Chris Waine

Pete Watts

Richard Young

 

Biocidal Products Regulation

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