Do you use biocidal products containing ethanol (CAS No. 64-17-5)? If so, please pay close attention! Biocidal products containing ethanol as an active substance currently benefit from national transitional measures that simplify the marketing process. In Germany, for example, such products can currently be marketed without authorisation. However, this situation could soon change. The competent Greek authority has been evaluating ethanol for product types PT1, PT2 and PT4 for over 15 years. As a 'backlog dossier', it still falls under the transitional provisions of the old Biocidal Products Directive (BPD, Directive 98/8/EC). In October 2024, the BPC Human Health Working Group concluded that ethanol potentially exhibits carcinogenic and reprotoxic properties. This means that the active substance meets the ‘exclusion criteria’ of the Biocidal Products Regulation (BPR, Regulation (EU) No 528/2012) and is considered a candidate for substitution in accordance with Article 10(1). A public consultation was then launched. Public consultation and decision-making From 25 February to 28 April 2025, the European Chemicals Agency (ECHA) conducted a public consultation to gather information on possible alternatives to ethanol and any potential exemptions. In response to this call, the Agency received 365 submissions from industry, associations, and institutions. The BPC's opinion is expected at the end of November 2025. The decision on approval of ethanol by the Standing Committee on Biocidal Products, consisting of representatives from the Member States, is expected in spring 2026 at the earliest. What are your next steps? If the EU Commission approves ethanol for the relevant product types, a two-year transition period will begin. This means that, from today's perspective, manufacturers must submit their product dossiers to the ECHA by 2027/28 at the latest if they want to continue selling their products. If you manufacture or sell ethanol-containing products and are unsure about the steps you need to take, Dr. Brill Regulatory Services can support you. We can help you to understand the regulatory requirements, evaluate options for action, and design the entire authorisation process for your affected products strategically and efficiently. We are planning to establish a consortium to coordinate the approval of ethanol-based disinfectants for use in the European healthcare sector. If you are interested, please feel free to contact us. Please click here to contact us directly.

With rich participation of the DR. BRILL INSTITUTES Group, the SETAC Europe Annual Meeting will take place in Vienna from May 11-15, 2025 - under the overall theme “Innovation for Tomorrow: Progress in Safe and Sustainable Concepts.” For our part, Dr. Brill Regulatory Services GmbH and Hydrotox GmbH are both involved, both in terms of personnel and content - and for the first time even with their own exhibition stand! Our commitment in detail: Session 6.07: “Environmental Risk Assessment under Biocides and other EU legislations” with presentation by Heike Schimmelpfennig, Dr. Brill Regulatory Services GmbH, on “Comparison of Environmental Exposure Assessment Strategies across Different EU Legislation” Chair: Andrea Brunswik-Titze, Hydrotox GmbH Co-chair: Aiga Latsone, ECHA, Heike Schimmelpfennig, Dr. Brill Regulatory Services GmbH Poster contributions from Hydrotox GmbH: Elena Perabo, Dr. Christoph Hafner: "Sustainable green roofs for the implementation of the sponge city: Determination of ecotoxicologically safe construction products for green roofs" Andrea Brunswik-Titze, Stefan Gartiser: "Consolidation of OECD tests for ready biodegradability on the example of OECD 310" Exhibition booth - Booth No. 3: For the first time, Hydrotox and Dr. Brill Regulatory Services will be represented with a joint booth at the SETAC Europe Annual Meeting.   Our colleagues on site are already looking forward to welcoming a hopefully large number of our customers and, of course, potential new customers to the beautifully styled stand - Booth No. 3. If you would like to make an appointment in advance, please contact us, e.g. by email here: info@brillhygiene.com One-day free tickets: A small number of SETAC one-day free tickets are still available at Hydrotox, which we will be happy to pass on to you. If you are interested, please contact Dr. Christoph Hafner directly by email at hafner@hydrotox.de. Use your participation in the SETAC Europe Annual Meeting for a personal meeting with us! The following colleagues will be present in Vienna: 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), Marie Bechstein (Test Leader Biodegradability), Elene Perabo (Test Leader Ecotoxicology, Third Party Research Projects) and Dr. Christoph Hafner (Head of GLP Test Facility, Customer Support).   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 35th Annual Meeting

With a real "dream team", Dr. Brill Institutes will be able to offer customers from industry its own Regulatory Service in the future. Heike Schimmelpfennig and Dr. Gunnar Kleist, each with two decades of regulatory experience in different areas of industry and public authorities, offer a 360-degree view of chemical testing and approval of biocides (active substances and products). "With our wealth of experience from different perspectives, we are unique on the market," explains Dr. Gunnar Kleist confidently. "We offer our customers holistic project management, which can take five years from the first kick-off meeting to approval, depending on the process." The two are more than trustworthy sparring partners in a process that demands complete transparency and honesty from the customer. Thanks to its many years of experience, the Regulatory Services team is also able to master critical situations at short notice when companies get lost in the complex European chemicals legislation or miss important deadlines, which can sometimes threaten their existence. However, both prefer to work with the customer from the start of the process in order to avoid precisely such crisis situations. "In our role, we also see ourselves as a mediator between the needs of industry and the expectations of the authorities," says Heike Schimmelpfennig. "We know what the authorities want, but we also know the needs of industrial customers." Heike Schimmelpfennig has ten years of experience in the environmental risk assessment of chemicals in both a consultancy firm and an EU regulatory authority. Dr. Gunnar Kleist contributes his more than 20 years of corporate experience in industrial research, test method development and Regulatory Affairs. Their joint core competence is to incorporate all relevant information from their profound knowledge of internal company processes into an approval application in such a way that a smooth and successful completion of the entire procedure is guaranteed. The Regulatory Services are an independent island in the Dr. Brill family because their services can be booked independently of laboratory operations. The efficacy tests required for product approval can, but of course do not have to, be commissioned from Dr. Brill + Partner. However, the short line to the technical expertise of the associated test laboratories and the possibility of commissioning time-critical data packages at short notice within the network can be a decisive advantage for the customer in the approval process. Dr. Florian Brill, Owner and Managing Director of Dr. Brill Institutes, sums it up: "With the integration of Dr. Brill Regulatory Services GmbH into the Dr. Brill Institutes Group, we have gained a decisive new building block that will help us strategically. We are bringing regulatory expertise in-house. A large part of our work in the various laboratories results in an approval dossier according to BPR, for example, and now we can deliver this. Dr. Brill Regulatory Services was the missing component - and with Gunnar and Heike we have gained two superstars of the scene. I want them in my team and so do our customers. I'm really looking forward to everything else." In the coming weeks and months, the new Dr. Brill Regulatory Services team will be presenting itself to clients at conferences and presentations. Dr. Gunnar Kleist: "It is important that clients build up a basis of trust with us and also realize what makes us special. That we don't do anything by the book, but always create the best case for the customer. As a rather small team, we deliver what we promise with our personal expertise!" If you would like more information about our new service, please contact Heike Schimmelpfennig (heike.schimmelpfennig@brillregulatory.com) or Dr. Gunnar Kleist (gunnar.kleist@brillregulatory.com).