• Regulation and Compliance

Authorisation of biocidal products in Europe

The Biocidal Product 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, by the action of the active substances contained in the biocidal product. It entered into force on 1 September 2013. Being compliant with this Regulation is the legal prerequisite that allows marketing of  your biocidal products in Europe or Switzerland, which has implemented similar provisions in the framework of the Ordinance on Biocidal Products (OBP). However, obtaining an authorisation for marketing your biocidal products is not the only concern; under the BPR also treated articles are regulated.

Biocides

Obtaining compliance with the BPR is often a time consuming and costly process, demanding various kinds of expertise.

Arcadis can support companies to:


Introduce you to the requirements
  • Tailor-made BPR training for e.g. regulatory teams, EHS teams, users of biocidal products 
  • Support with the interpretation of the legislation, clarification of grey zones, e.g. assess if products are subject to another, closely related regulation like MDR, IVDR, PPP, REACH
  • Develop compliance strategies
  • Act as helpdesk or Trustee

Define your strategy:
  • Identify products that need authorization vs. the ones that will be phased-out
  • List the compliant uses
  • Follow the review of your active substance
  • Complete national authorization to ensure market continuation in EU and Switzerland
  • Consider participation to consortia for dossier preparation in order to share costs
  • Install a consortium if relevant

Prepare your dossier:
  • Support in getting access to the active substance dossier for the creation of a European product dossier
  • Gather relevant information from suppliers and confirm whether they meet current biocidal requirements
  • Demonstrate technical equivalence when buying an active substance form a ‘new’ source
  • Review available data and compare with data required for a biocidal product dossier (incl. phys-chem, efficacy, (eco)toxicological information) 
  • Study monitoring in case new tests are to be performed, writing of waivers, perform risk assessments
  • Create your IUCLID dossier and submit it via R4BP (single product or product families / national – mutual recognition – union authorization)
  • Support the authorization of your treated articles

Communication and follow-up after submission:
  • Communicate with the competent authorities 
  • Organize pre-submission meetings
  • Help with the response to questions raised by the authorities
  • Act as helpdesk
 

Find out more about our services:

 

 



Questions about this capability

Maaike Bilau

Manager Product Stewardship Solutions Belgium +32 492 73 04 89 Ask me a question

Dr. Karina Urmann

Department Head Product Stewardship Solutions Switzerland  +41 44 73292 81 Ask me a question