The 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.

Do you sometimes feel overpowered?

ARCHE Consulting is constantly shifting the goalposts within the biocidal regulatory arena to create a level playing field for its clients!

Choose your preferred option here below:

Active substance dossier preparation
  • New active substance

  • Renewal of active substance dossier

  • Annex I active substance

  • Article 95

  • Technical Equivalence assessment

Biocidal product dossier preparation
  • Biocidal single product

  • Biocidal product family

  • Simplified authorisation

How can we safeguard your market?

Strategic advice
  • Analyse biocidal products, including Substances of Concern, active substances, preliminary risk assessment

  • Develop marketing strategies

Dossier preparation
  • 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

Dossier submission, follow-up, communication with authorities
  • Pre-submission meetings with ECHA and evaluating CA

  • National Authorizations, Mutual Recognitions, Union Authorisation

  • Consortia for biocides

  • IUCLID & R4BP3

  • Risk assessment


ARCHE Consulting offers a wide range of services from tailor-made strategic advice to training modules. Don’t hesitate to contact us for a competitive offer suited for your company.

Contact our experts:

Frederik Verdonck, PhD

Frederik Verdonck

Managing Director
IBERA Diplomate
+32 9 216 70 60

More about Frederik
Lieve Claeys

Lieve Claeys

Regulatory Affairs Manager
European Registered Toxicologist
+32 9 216 70 67

More about Lieve