Biocides Registration Services in Europe

Established Reputation within the Biocides Sector
CSI has successfully obtained listing for one of the first new active substances on Annex I to the Biocidal Products Directive (BPD). First provisional product authorization for a new active substance. Extensive experience through participation in the four existing active substance review lists. Support for existing product registration needs.

Registration Dossier Preparation & Submission
With Annex I inclusion being granted for the existing active substances, CSI can help you to prepare product dossiers within the time period permitted. CSI staff are experienced in data gap analysis, literature search and evaluation, preparation of data waivers based on (Q)SARs, read across arguments, generation of frame formulations and acceptable justifications.

Regulatory Strategy
Product registration guidance for compliance with the Biocidal Products Regulation (BPR). Advice on regulatory options to meet registration requirements for disinfectants, wood preservatives, rodenticides, insecticides, and other BPR-regulated products.

Study Monitoring / Data Development
Identification of studies required to support registration objectives. Placement and monitoring of tests at contract research organizations. Review and interpretation of study results.

Data Review & Evaluation
A multi-disciplinary team of CSI scientists support registration activities by providing expert data review and evaluation for toxicology, environmental toxicology, product chemistry, analytical chemistry and environmental fate of subject products.

Hazard, Exposure & Risk Assessments for Human Health & Environment
Extensive experience in all aspects of human health and environmental assessment. Application of various models, including: ConsExpo, BEAT, BPD TNsG, EUSES and ESD.

Task Force Management
Senior CSI staff serve in administrative and lead technical roles representing clients in industry task forces.