Product Safety & Regulatory Support

Biocides

The world of biocidal products is complex. For example, the EU Biocidal Products Directive identifies 23 different product types, ranging from disinfectants to wood preservatives to pest control agents. These products have in common that they are all intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on harmful organisms by chemical or biological means.

Agencies around the world regulate and classify these products differently. In the US, for example, most biocides are regulated under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), although a few are not—personal health care disinfectants, for example, are regulated as drugs. In many parts of the world biocide regulation is still developing.

Our services encompass:

• strategic and techical support related to the authorization of biocidal products in all jurisdictions
• evaluation of data requirements, identification of data gaps, evaluation of the necessity of additional experimental studies, and literature surveys.
• outsourcing and monitoring of experimental studies.
• expert advice in human toxicology, ecotoxicology, environmental chemistry, toxicokinetics, mathematical modelling, QSARs, statistics, and experimental design, including the formulation of expert statements.
• preparation of complete registration dossiers, including necessary summaries, evaluations and risk assessments.
• guidance on addressing specific issues, such as possible local effects and differences between professional and nonprofessional use.