A Regulatory Perspective on the New EU Drinking Water Guidance
The European Union (EU) has implemented new regulations to improve the protection of humans and domesticated animals used for food from the risks posed by active substances that are used in plant protection products and biocides. One crucial aspect of this regulation is the assessment of risks associated with exposure to residues in drinking water. The new guidance document published jointly by the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) on assessing risks to humans and domesticated animals from the use of active substances or their metabolites in drinking water provides a stringent framework for evaluating these risks.
Challenges in Active Substance Renewal
The renewal of the approval of active substances often faces significant challenges due to the evolving regulatory landscape and the increasing demand for safe and effective products. One key challenge is the need to demonstrate compliance with the new EU drinking water treatment processes guidance, which comes into effect for all new applications submitted on or after April 1, 2026. This will require a thorough understanding of the potential risks posed by transformation products of active substances or their environmental metabolites formed during water treatment processes.
Battelle's Comprehensive Solution
Battelle, with its extensive expertise in regulatory compliance and environmental science, offers a comprehensive solution to address the challenges faced by companies seeking to renew their active substances or that have existing approvals contingent on submitting such an assessment. Battelle’s approach involves:
Screening Assessment: Evaluating the need for a full assessment based on the presence of active substances and metabolites in surface and groundwater. We evaluate all relevant and available data to try and ascertain which, if any, substances require assessment under the guidance.
Identification and Quantification of Water Treatment Transformation Products (tTPs): Identifying potential reaction pathways and simulating water treatment processes to determine the likely formation of treatment transformation products and their likely concentrations in drinking water.
Genotoxicity Assessment: Reviewing existing toxicological data, conducting QSAR analyses, and performing in vitro or in vivo testing to assess the genotoxicity of the identified transformation products.
General Toxicity Assessment: Looking at all available evidence, both proprietary and public domain data, for any other toxic potential apart from genotoxicity. If necessary, this may involve the conduction of new in-vivo toxicology studies.
Risk Assessment: Comparing identified risks to acceptable exposure levels and developing strategies to mitigate any potential risks.
By partnering with Battelle, you can benefit from:
Deep Regulatory Expertise: Our team of multidisciplinary experts has over 35 years of experience navigating the complex regulatory landscape, providing valuable insights and guidance throughout the process.
Advanced Analytical Techniques: We utilize state-of-the-art methods to accurately identify and quantify transformation products.
Develop a Robust Regulatory Strategy: With our expertise and experience by your side, we help you prepare a regulatory submission dossier that has the best chance of a positive outcome.
Tailored Solutions: Our approach is customized to meet your specific needs and challenges. We identify potential risks associated with active substances and develop effective risk mitigation strategies.
Efficient Processes: We streamline the assessment process to minimize costs and disruptions to your business.
Conclusion
The new EU drinking water treatment processes guidance presents significant challenges for companies seeking to renew their active substances. Battelle's comprehensive solution offers a practical approach to address these challenges and ensure compliance with regulatory requirements. By leveraging our expertise, you can confidently navigate the renewal process ensuring compliance and product safety.
Download our white paper, "Understanding the New EU Drinking Water Treatment" to learn more about our approach and how we can help.
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