Emergency

Expert Services

Biocides (BPR)

From testing to authorization: guiding biocides through BPR

Bringing your product to the market and remaining compliant is an almost continuous complex regulatory process.
The development of new active substances and the related product authorisation is a long and costly trajectory. We have experience with both and successfully achieved various substance approvals and product authorisations.

INTRODUCTION

Safety, efficacy and regulatory trust

Biocidal products help safeguard hygiene and health, but their use comes with strict legal requirements. Under the EU Biocidal Products Regulation (BPR, Regulation EU No 528/2012), companies must prove both safety and efficacy.
We help you meet these requirements.

Biocides (BPR)

Introduction
Legislation
What we do
Triskelion benefits
Case
Deep dive information
Relevant for

Legislation

What rules apply

BPR regulates both active substances and biocidal products. Two steps are required to gain EU market access.
First, biocidal active substances must be approved EU-wide. And then all individual products containing such approved substances have to be authorized in the countries they will be marketed.
Product authorization can be done through either:
  • Union authorization for EU-wide access
  • National BPR authorization via one EU member state followed by mutual recognition in other member states.
The process includes toxicological and efficacy testing, a robust risk assessment, and a full dossier submitted through ECHA’s R4BP system. We help navigate the differences between existing and new active substances, bridging scientific data with strategic dossier planning.

What we do

From data to dossier

We support manufacturers, formulators and suppliers with:
  • Strategic advice for your dossier set-up and substance registration.
  • Data gap analysis and preliminary risk assessment, including check for substances of concern.
  • Developing the testing strategy for physico-chemical, human and environmental hazard as well as efficacy.
  • Risk assessment for human health, animal health and environment according to the latest guidance and models.
  • Preparation of IUCLID dossiers, including SPC.
  • Assessment of endocrine disrupting properties for co-formulants.
  • Preparation and submission of complete product dossiers via R4BP.
  • Tailored support during Member State or Union evaluations.

Triskelion Expertise

Why clients choose us

We combine scientific expertise with regulatory insight. What sets us apart:

  • Extensive experience with both national submissions and echa submissions
  • Efficient project coordination and time management
  • Strategic advice on authorization route and data requirements (feasibility)
  • Transparent reporting and proactive communication

Case Example

From data gap to market entry

We bring more than 20 years of experience with a broad knowledge on most of the categorised product types.
However, we do have specific expertise on disinfectants, preservatives and antifouling products e.g. the PTs: 1, 2, 3, 4, 6, 7, 8, 9, 11, 18 & 21.
Specific tasks and services we offer: Strategic partnerships, regulatory support and set-up of registration strategy, dossier preparation for active substances and biocidal products, In house GLP analytical lab, coordination of test packages (efficacy), incl. study monitoring, preparation of risk assessment reports for active substance & product (families), dossier submission and follow-up (as EU Representative), communication with active substance manufacturers, Ad-hoc consultancy with regard to product development, substance of concern, ED assessment of active substances & co-formulants

Learn more

Insights and methods

BPR Dossier Preparation & Submission

Ready to verify your packaging safety?

Need to confirm compliance or solve an urgent safety issue?
Contact us or request a test quotation.

Relevancy

Who we support

Our BPR support services are designed for:

  • Manufacturers of biocidal active substances and products.
  • Formulators of biocides (i.e disinfectants, preservatives, insecticides and repellents.
  • Distributors and importers needing EU market access.
  • Companies listed on the Article 95 list.
  • Regulatory affairs and product stewardship teams.
  • Businesses facing dossier rejection, data gaps or evaluation questions.
Emergency
info@triskelion.nl
+31 88 382 2737