Acta EU focuses on biocides and biocidal products regulation and support services to assist industry in tackling the intimidating landscape of increasing chemical regulation. Acta EU’s experience in the biocide, industrial chemical, agrochemical, biotechnology, and nanotechnology sector allows it to offer a complete package of consultancy services for the European Union’s (EU) regulatory framework. Acta EU professionals, working closely with their U.S. affiliates, The Acta Group, L.L.C. and Bergeson & Campbell, P.C., offer a full range of biocides and biocidal products regulatory services.
- Assess the need for registration under BPD, including the identification of the need for Annex 1 listing or the possibility of application by “Letters of Access” - Identify data gaps - Prepare summaries, partial or full dossiers, and International Uniform Chemical Information Database (IUCLID) files and management for both active substances and biocidal products - Submit dossiers to relevant Member States for Application for Annex 1 listing of an active and/or biocidal product authorisation - Identify companies with structurally similar products or products of a similar nature to create and manage a consortia for testing and data submission - Provide hazard data appraisal and literature reviews (toxicology, environmental, physical/chemical) - Prepare risk assessments and appraisals for all exposure groups via all routes of exposure - Offer study design and management (human health and environmental) - Prepare safety data sheets, product labels, chemical safety assessments, and reports - Provide product support from concept to approval - Prepare risk management proposals - Design, implement, and complete a cost-effective testing program - Discuss specific needs and issues with appropriate legislators and regulators - Act as the “Only Representative” for companies that are not legal entities in the EU - Offer post-regulatory product support |