Tailor-made solutions for authorisation of your biocidal products
Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to
protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment. All biocidal products require an
authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved.
The BPR aims to harmonise the market at Union level; simplify the approval of active substances and authorisation of biocidal products.
Flexible to add products later
Provides additional support to your customers
Prepare joint product family dossier
Opportunity for data sharing at a larger scale
Gives SME's the opportunity to stay on the market at low costs
(*) ARCHE Consulting offers a one-stop for preparing biocidal product family dossiers in a consortium. This can significantly reduce the costs for dossier preparation and fees to ECHA and the evaluating Competent Authority.
Cost Reduction: More than 50% cost savings possible!
Develop marketing strategies
Data gap analysis, coordination of tests, waivers
Risk assessment (human health, environment)
Active substance dossier and Article 95 inclusion, TE
Biocidal products: single product and product family dossiers
Pre-submission meetings with ECHA and evaluating CA
National Authorizations, Mutual Recognitions, Union Authorisation
Consortia for biocides
IUCLID & R4BP3