Biocides – assessment and authorization

Biocidal products are used daily in a broad range of application areas: to protect human health, improve hygiene, extend the shelf life of numerous products, or help sustain smooth production processes. This is achieved by targeted use of biocides against harmful organisms, such as fungi, bacteria, algae, viruses, insects or other organisms.

The authorization of biocidal products and their active ingredients is subject to a systematic but complex authorization procedure according to the Biocidal Product Regulation (EU) 528/2012 (BPR).

We have more than 20 years' experience preparing dossiers for biocidal active substances and biocidal products in different product categories on behalf of our clients. Fraunhofer ITEM can support its clients with any scientific and regulatory issues. This includes the evaluation of all data, identification and assessment of critical substances, and dossier preparation and submission.

For questions beyond standard toxicology, we develop tailored solutions for our clients by applying read-across/bridging principles or integrated testing strategies, such as in-vitro methods.

Our aim is to point out risks to health and the environment, to reduce these, and at the same time not to lose sight of the desired efficacy against harmful target organisms.

Our services – regulatory support for biocide authorization

Scientific and regulatory support

Development of a registration strategy and support for the implementation of regulatory requirements

Communication with competent authorities

Letter of access negotiations (LoA)

Notification of biocides in different countries

Data collection and study monitoring

Identification of data gaps

Development of testing strategies and use of (Q)SAR

Commissioning and monitoring of analytical studies and in-vitro and in-vivo studies

Efficacy assessment and consultancy on label claims

Risk assessment of active substances, biocidal products/families

Assessment of the hazard profile including classification and labeling

Substance of concern (SoC) identification and evaluation

Evaluation of endocrine disrupting criteria (ED assessment)

Exposure and risk assessment for humans and the environment

In-house exposure measurements and analytics

Dossier preparation and submission

Dossier preparation for authorization of biocidal active substances and biocidal products/families according to the BPR (including IUCLID file; draft risk assessment (DRA) and summary of product characteristics (SPC))

Dossier submission via R4BP

Response to further inquiries and additional data requests by the authorities

Expertise in human and environmental toxicology

Many years of experience in the preparation of dossiers for biocidal active substances and biocidal products/families

Exposure and risk assessment

Consulting and support in related regulatory areas including REACH, veterinary medicinal products, food additives, and cosmetics

Development and evaluation of concepts and methods for chemical risk assessment, including development of (quantitative) structure-activity relationships ((Q)SAR) or exposure models