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When dealing with regulatory and scientific issues, we always keep an eye on what is economically feasible. Our contribution can range from individual components to a complete package.

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Dr. Gunnar Kleist Director Regulatory Services
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Regulatory Affairs

Here you will find information about our regulatory services for biocides, REACH, and medical devices.

Regulatory Science

Here you will find information about our scientific services such as study monitoring and risk assessments for biocides, REACH, and pharmaceuticals.


News from our company

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June 8, 2026
Review: SETAC Europe 36th Annual Meeting with Hydrotox and Dr. Brill Regulatory Services
The Hydrotox Labor für Ökotoxikologie und Gewässerschutz GmbH team was represented with a booth at the annual meeting of SETAC Europe (Society of Environmental Toxicology and Chemistry) in Maastricht, the Netherlands, from May 17-21, 2026, together with colleagues from Dr. Brill Regulatory GmbH. Among the more than 2,500 participants from more than 60 countries, we were able to meet many of our long-standing customers and colleagues, but also make many new contacts. The scientific program was again very comprehensive with several thousand posters and up to ten parallel sessions and included topics such as persistence assessment, animal-free replacement methods, endocrine effects and regulatory issues, which were particularly interesting for us. Elena Perabo gave a presentation on our project on the sponge city, which is about to be completed, entitled "Sustainable green roofs for the implementation of the sponge city: Determination of ecotoxicologically safe construction products for green roofs", which met with great interest. Andrea Brunswik-Titze, together with Ulrich Jöhncke and colleagues from the Federal Environment Agency, presented a poster with the titel "Round Robin Test: consolidation of OECD ready biodegradability tests", which was also presented in a Poster Corner. It illustrated the actual status of our project to organize that round robin test. Furthermore, Andrea Brunswik-Titze, Jessica Bühler and Marie Canon presented a poster on methodological approaches in the testing of the biodegradability of polymers entitled "Biodegradability of polymers in aquatic test systems: ISO 14852 - feasibility study for different concentrations of test item and inoculum". In a third poster, first results of the project on the assessment of endocrine effects induced by construction products were presented with the title "Assessment of endocrine effects of construction products in the environment" by Elena Perabo and Martina Springmann together with Peter Behnisch from BioDetection Systems in Amsterdam. And in a fourth poster, Heike Schimmelpfennig, Andrea Brunswik-Titze, and Elena Perabo presented a comparison of exposure models used to simulate the entry of substances into various environmental compartments within the risk assessments under the legal frameworks of biocides, plant protection products, and chemicals under REACH, titled "Comparison of exposure modelling tools used in different regulatory areas." We are very happy about the successful participation in this conference and look forward to next year, when the conference will take place in Geneva. If you are interested in learning more about any of the topics presented in Maastricht or about the other services offered by our institutes, we would be happy to assist you! Contact: HERE   The SETAC Europe Annual Meeting is an annual conference of the Society of Environmental Toxicology and Chemistry (SETAC) Europe that brings together scientists, policy makers and industry representatives to discuss current issues in the fields of environmental toxicology, ecotoxicology and environmental chemistry. Main features of the conference: Topics: Environmental risk research, life cycle assessment, regulatory developments and scientific policy advice Formats: Scientific sessions, plenary lectures, training sessions and networking events Participants: 2,000-2,500 experts from over 60 countries The conference serves as a platform for the exchange of new findings and promotes cooperation between research, industry and authorities. Link: SETAC Europe 36th Annual Meeting
March 30, 2026
Are Your Data Compliant? New ERA Guideline for Human Medicinal Products in Force Since September 2024
The revised Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00 Rev. 1 – Corr.) came into force in September 2024. For pharmaceutical companies, it introduces additional requirements for Environmental Risk Assessments (ERA). We can support you in meeting these expectations – efficiently, scientifically robust, and fully aligned with the latest regulatory standards.   Our Services for Pharmaceutical Companies Systematic literature review in accordance with the current ERA guideline Gap analysis: identification of missing studies and data gaps Evaluation and conduct of Phase I/II ERAs Support in responding to authority queries Why choose Dr. Brill Regulatory Services? With more than 20 years of experience in environmental risk assessment, Heike Schimmelpfennig brings extensive expertise from industry, regulatory authorities, and international regulatory frameworks – including over 10 years at ECHA and collaborations with EMA. You will benefit from a unique combination of regulatory know how, scientific expertise, and hands on dossier experience.   Want to Ensure Full ERA Compliance? We support you from initial screening to developing complete assessment documents – compliant, efficient, and strategically sound.   Contact us for a non binding consultation - here: Contact.   Dr. Brill Regulatory Services – Your Partner for Regulatory Excellence in the Pharmaceutical Sector
March 18, 2026
Focus on ethanol – what manufacturers need to know
BPC confirms safe use of ethanol (CAS No. 64‑17‑5) in biocidal products. On February 23, 2026, the BPC finally adopted, by simple majority, the view that the safe use of ethanol as a disinfectant in product types 1, 2, and 4 has been demonstrated. However, the decisive issue remains unresolved: The committee did not reach a final toxicological conclusion regarding a possible classification as carcinogenic or reprotoxic. Uncertainty therefore continues with regard to a future CLP classification—although the CMR classification, originally based on the oral consumption of alcoholic beverages, is, for the time being, off the table. Consequently, ethanol will also not be considered a candidate for substitution under Article 10 of the BPR for the time being. It is expected that the Standing Committee on Biocidal Products will follow the BPC’s recommendation and approve the active substance for disinfection purposes. The ongoing new studies addressing more realistic exposure routes also offer further hope that a CMR classification can also be avoided in the future. What might your next steps be?  Should the European Commission approve ethanol for the relevant product types as anticipated, manufacturers will—based on the current situation—be required to submit their product dossiers to ECHA no earlier than March 2028 in order to continue marketing their ethanol-containing biocidal products. If you market ethanol-containing products and are unsure which requirements you will face, we at Dr. Brill Regulatory Services are here as your reliable partner. We support you in understanding regulatory requirements, developing strategic options, and efficiently planning and implementing the entire authorisation process for your products. In addition, we are planning to establish a consortium to coordinate the product authorisation of ethanol-based disinfectants in the European healthcare sector. If you are interested, please feel free to contact us. Please click here to contact us directly.