Regulatory Services

We have the practical, scientific and regulatory knowledge necessary to support the complete registration programme as well as considerable in-house expertise from the biocides industry. We are able to advise on regulatory strategy and scope issues, and can assess toxicology, efficacy and environmental datasets for completeness. We can prepare waivers, produce IUCLID 5 documents, manage testing requirement via independent testing facilities, undertake risk assessments, partake in taskforces and produce dossiers for submission to regulatory authorities. These services can be provided either on a project-by-project basis or for the full management of a submission through to final approval. JSC is additionally able to work on both active substance (Annex I) submissions and biocidal product authorisations.

Biocides are a diverse range of products that are used to control harmful organisms including bacteria, insects and rodents. Historically biocides have been regulated differently in each member state within the EU, but this will change as the Biocidal Products Directive (98/8/EC) becomes fully implemented. Today, both the old national systems and the BPD are in operation, but the national systems will gradually be withdrawn as the BPD takes effect. The BPD has divided biocidal products into 23 product types, each of which has unique regulatory challenges.

These 23 product types are split into 4 main groups of biocides:

• Disinfectants - Food hygiene, domestic, hospital, drinking water etc.
• Preservatives - Wood Preservatives, slimicides, film, in-can, textiles etc.
• Pest Control - Insecticides and acaricides, rodenticides, avicides, other vertebrate control products, repellents etc.
• Specialised - Antifouling products, embalming and taxidermist fluids etc.