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.
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
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
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
Inhouse exposure measurements and analytics
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
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