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

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.

Again with strong participation from the DR. BRILL INSTITUTES Group, the SETAC Europe 36th Annual Meeting will take place in Maastricht from May 17-21, 2026, under the theme "Embrace the Outlier: In Science, Regulations, and Networks." Dr. Brill Regulatory Services GmbH and Hydrotox GmbH will both be involved, both in terms of personnel and content – and, following last year's great success, we will once again have our own exhibition stand! Our commitment in detail: Exhibition booth - Booth No. 37: Hydrotox and Dr. Brill Regulatory Services will once again be represented with a joint booth at the SETAC Europe Annual Meeting. Presentation title: Assessment of Endocrine Effects of Construction Products in the Environment Presentation type: Poster Session title: 6.04 - Endocrine Disruption: Scientific and Regulatory Challenges Presentation day: Monday, 18 May 2026 Authors: Elena Perabo, Martina Springmann - Hydrotox GmbH, Freiburg i.Br.  Co-Author: Dr. Peter Behnisch - BioDetection Systems b.v., Amsterdam Presentation title: Biodegradability of Polymers in Aquatic Test Systems: ISO 14852 - Feasibility Study for Different Concentrations of Test Item and Inoculum Presentation type: Poster Session title: 3.18 - Microplastics Research: Beyond Fear-Mongering, Towards Trustworthy Science Presentation day: Monday, 18 May 2026 Authors: Andrea Brunswik-Titze, Jessica Bühler, Marie Canon - Hydrotox GmbH, Freiburg i.Br., Germany Presentation title: Sustainable green roofs for the implementation of the sponge city: Determination of ecotoxicologically safe construction products for green roofs Presentation type: Poster Session title: 3.09 - Environmental Forensics: Tracking Sources and Evaluating the Effects of Chemicals in Urban and Other Environments Presentation day: Tuesday, 19 May 2026 Authors: Elena Perabo, Dr. Christoph Hafner - Hydrotox GmbH, Freiburg i.Br., Germany Presentation title: Round Robin Test to prepare for consolidation of tests for ready biodegradability according to OECD 301/310 Presentation type: Poster & Poster Corner Discussion Session title: 3.04 - Advancing Understanding of Environmental Persistence of Chemicals Presentation day: Tuesday, 19 May 2026 Authors: Ulrich Jöhncke - UBA, Section IV 2.3. Chemicals  Andrea Brunswik-Titze - Hydrotox GmbH, Freiburg i.Br.  Stefan Gartiser - Hydrotox GmbH, Freiburg i.Br. Daniel Sättler - UBA, Section IV 2.3. Chemicals Monika Ratte - ToxRat Solutions GmbH & Co. KG, Alsdorf Benjamin Daniels - ToxRat Solutions GmbH & Co. KG, Alsdorf Presentation title: Comparison of exposure modelling tools used in different regulatory areas Presentation type: Poster Session title: 3.02 - Advances in Exposure Modelling: Closing the Gap between Scientific Innovation and Regulatory Relevance Presentation day: Wednesday, 20 May 2026 Presenter: Heike Schimmelpfennig   Our colleagues on site are already looking forward to welcoming what we hope will be a large number of our customers, as well as potential new customers, to our attractive booth - Booth No. 37. If you would like to arrange an appointment in advance, please feel free to contact us, e.g., by email here: info@brillhygiene.com Use your participation in the SETAC Europe Annual Meeting for a personal meeting with us! The following colleagues will be present in Maastricht: From Dr. Brill Regulatory Services Dr. Gunnar Kleist (Director Regulatory Services) and Heike Schimmelpfennig (Senior Manager Regulatory Affairs), as well as from Hydrotox Andrea Brunswik-Titze (Team Leader and Test Leader Biodegradability), Jessica Bühler (Study Director Biodegradation), Elene Perabo (Test Leader Ecotoxicology, Third Party Research Projects) and Dr. Christoph Hafner (Head of GLP Test Facility, Customer Support). One-day free tickets: Hydrotox has a small number of SETAC one-day free tickets available, which we would be happy to pass on to you. If you are interested, please contact Dr. Christoph Hafner directly by email at hafner@hydrotox.de. 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