Biocide Risk Assessment

Biocides are a diverse range of products that are used to control harmful organisms including bacteria, insects and rodents. Two European Union (EU) regulatory legislations regulate the use of biocides:

1) The Biocidal Products Directive 98/8/EC (BPD) and

2) The Biocidal Product Regulation (BPR)

The BPD has divided biocidal products into 23 product types (PT), each of which has unique regulatory challenges. The PTs are further subdivided into 4 main groups of biocides (i.e. priority lists). All active substances are being reviewedat EU level according to the priority lists. The review dossierscontain detailed information on efficacy, physical chemical properties,analytical methods, mammalian toxicology, ecotoxicology,environmental fate, exposure assessments, risk assessments andrisk management measures.

Those active substances deemed to be sufficiently efficacious and having an acceptable risk profile are included in Annex 1, 1A or 1B of the directive. Once an active substance is included in Annex 1 of the directive, products belonging to the product type reviewed containing that active substance has to be authorised nationally.

The BPD and BPR require a rigours evaluation process of both biocidal active substances and biocidal product, ensuring biocide pose no unacceptable risk to human health, animal or the environment. Enviresearch is able to offer help on both active substance (Annex I) submissions and biocidal product authorisations. We have the scientific and technical expertise necessary to offer support in assessing toxicology, efficacy and environmental datasets for completeness, prepare waivers, manage testing requirement via independent testing facilities and undertake environmental risk assessments and human health risk assessments