Toxicological support to a major European hygiene company on registration of a novel biocidal active for use in the food and beverage industry

Client

A European hygiene company supporting the food and beverage industry

Background

Within the EU, biocidal products are regulated under the Biocidal Products Directive (98/8/EC). The regulatory regime will ultimately require all biocidal products to be authorised before they can be placed on the EU market through a scheduled review of notified existing active substances that were on the market when the Directive came into force (May 2000), and evaluation of new active substances. An extensive dossier of information relating to the manufacture, use, and human health and environmental hazards of active ingredient(s) and sample products must be submitted for evaluation and authorisation as part of this legislative programme.

Project goals

To provide toxicological support to the company to meet the regulatory deadline for submission of the relevant technical dossiers for authorisation of a novel chemical-reaction based biocidal active for use in the food and beverage industry.

Approach

Bibra scientists carried out literature searches to identify any relevant toxicological data on the biocidal active ingredient and evaluated proprietary data provided by the client. (Robust) Study Summaries were prepared in IUCLID format, together with supporting documentation, to satisfy the regulatory requirements relating to human health. Where scientifically justified, we were able to advise on and prepare study waivers for a number of key endpoints and suggest relevant in vitro studies to minimise the need for any additional vertebrate testing. We provided expertise in responding to a number of initial questions and comments from the regulatory Competent Authority.

Project outcome

Bibra successfully provided the technical dossier documentation relating to the human health input on the biocidal active substance and addressed initial questions and comments on the submission from the regulatory Competent Authorities

Bibra project leader

Philip Copestake



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