NOTOX’ regulatory affairs department provides a complete service for the registration of biocides under the biocidal products directive 98/8/EC.

Our aim is to provide you with a high quality service which will help you in achieving product registrations in a fast and efficient way.  

We provide complete hazard characterization and exposure assessments for operators, workers, bystanders and consumers as well as for the environment (groundwater, surface water, soil, air, non-target organisms). These assessments are carried out using various modeling tools (e.g. USES, EUSES, etc.) and are based on the most up to date guidelines and emission scenario documents.

NOTOX’ experienced team consists of regulatory experts in chemistry, environmental fate and behavior, residues, ecotoxicology and human toxicology. In addition to outstanding technical knowledge, we have well-established contact with EU and national authorities and a thorough understanding of the procedures involved in obtaining registrations for biocides.

We assist you with dossier preparation at EU and Member state level. We compile complete dossiers (Documents I, II, III and study reports) in electronic format. Prior to dossier compilation, we assist you in identifying data gaps, outsourcing and study monitoring, writing data waivers to save costs and time, and discussions with authorities.

Our services are custom made to fit your needs and range from assistance with single sections and smaller regulatory questions to the preparation of complete dossiers.

Differentiated enforcement policy for biocides (BPD 98/8/EC)