Customised support across the biocidal regulatory landscape
Biocides
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The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) establishes the rules for placing biocidal products on the EU market. These products are used to protect people, animals, materials, or articles from harmful organisms - such as bacteria, insects, or fungi - by means of the active substances they contain.
The BPR aims to harmonise the principles for the evaluation of biocidal products and to improve the efficiency of authorisation procedures while ensuring a high level of protection for human health and the environment. Under the BPR, active substances must first receive approval, before a biocidal product authorisation can be applied for. Only authorised products can be placed on the market.
Understanding regulatory challenges under the BPR
For companies developing or marketing biocidal products, navigating evolving regulatory requirements can be complex. Compliance involves multiple processes, detailed documentation, and ongoing communication with regulatory authorities at both national and EU level.
ARCHE Consulting offers in-depth support for companies involved in the biocides sector, providing regulatory expertise, scientific evaluations, dossier development, and strategic advice aligned with the latest guidance from ECHA and other competent authorities.
Services and areas of support
Regulatory and strategic advice
To support decision-making and risk management, ARCHE Consulting offers the following services:
Continuous monitoring of regulatory developments
Detailed support and follow-up for EU and GB regulations both under transitional law and BPR
Substance analysis (e.g. hazard profiling for active substances, evaluation of potential endocrine disrupting (ED) properties, screening for Substances of Concern)
Preliminary risk assessments to evaluate claim feasibility
Development of compliance-oriented marketing strategies
Proactive portfolio management to anticipate regulatory impacts
Scientific and technical expertise
ARCHE Consulting’s multidisciplinary team includes over 40 specialists with expertise in:
Toxicology (including ED assessments)
Ecotoxicology and environmental fate
Physico-chemical properties
Hazard classification
Risk assessment (human health, environmental, dietary, livestock)
Efficacy assessment
CLP classification (Regulation (EC) No 1272/2008)
Consortium and project management
Support for various authorisation procedures (national, Union, Mutual Recognition, Same Biocidal Product)
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General dossier preparation and submission
End-to-end regulatory dossier support includes:
Data gap analysis
Study monitoring and coordination with CROs
Preparation of expert opinions and development of waiving justifications
Compilation of regulatory formats: IUCLID, draft CAR, SPC, PAR, etc.
Submission of dossiers and ongoing liaison with regulatory authorities
Pre- and post-submission meetings with ECHA and national agencies
Active substance specific support
ARCHE Consulting assists with all aspects of active substance approval and management, including:
New active substances (including in situ generated and Annex I substances)
Renewal of active substances
Article 95 compliance
Technical Equivalence assessments
ED assessments (mammalian and non-target species)
Biocidal Product (Family) specific support
Comprehensive services are provided for the preparation, submission, and management of biocidal product authorisations, including:
Portfolio planning and management
Single biocidal product applications
Applications for Biocidal Product Families (including BPF assessments)
Applications for simplified authorisation
Comparative assessments
National transitional procedures under Article 89 of the BPR
Extensive experience and thorough understanding of country-specific requirements and guidance
Expert regulatory support tailored to the unique requirements of the Benelux region (Belgium, the Netherlands, Luxembourg), Germany, France, and the Iberian Peninsula (Spain and Portugal).
Network of local partners who are knowledgeable about the requirements in other EU countries.
High-quality, customised support to help companies successfully register their products and remain compliant with national regulations.
Smooth and efficient registration process.
Training
Tailored training modules are available to support internal teams, covering topics such as:
Introduction to BPR
IUCLID usage and dossier compilation
Risk assessment methodology and practice
Contact our experts:
Lieve Claeys
Regulatory Affairs Manager
European Registered Toxicologist
lieve.claeys@arche-consulting.be
+32 9 216 70 67
An Vanden Bosch
Regulatory Affairs Manager
European Registered Toxicologist
IBERA Diplomate
an.vandenbosch@arche-consulting.be
+32 16 28 49 03