ECHA expands responsibilities under OSOA package, strengthening EU chemical safety through integrated data, collaboration, science-based assessments, and enhanced regulatory coherence.
The European chemicals regulatory landscape is set to become more robust and future-ready as European Chemicals Agency (ECHA) assumes a broader range of responsibilities aimed at enhancing chemical safety across Europe. Through the implementation of the “one substance, one assessment” (OSOA) legislative package, the Agency is reinforcing its central role in ensuring that chemical assessments within the European Union are coherent, transparent, and scientifically sound. ECHA has underlined its commitment to delivering these expanded tasks efficiently while maintaining openness and accountability.
Dr Sharon McGuinness, Executive Director of ECHA, highlighted the strategic importance of the OSOA initiative, describing it as a major advancement toward a more streamlined and anticipatory chemical safety framework in Europe. She emphasised that closer cooperation among EU institutions and authorities will allow regulators to better identify emerging risks, consolidate existing scientific knowledge, and foster innovation. According to her, the overarching objective is to safeguard human health and the environment through collaborative, science-based decision-making, ultimately contributing to a safer and more sustainable Europe.
Under the new legislation, ECHA is entrusted with a range of additional responsibilities that further strengthen its mandate. These changes are designed to improve efficiency and consistency across EU chemical legislation by reducing duplication of assessments and ensuring predictable regulatory outcomes. By centralising and coordinating evaluations, ECHA will help create a more integrated regulatory system that benefits authorities, industry stakeholders, and citizens alike.
A cornerstone of the OSOA package is the creation of a common data platform on chemicals. This initiative is formalised through a new regulation establishing a shared data infrastructure, along with a monitoring and outlook framework for chemicals. ECHA will oversee the development and operation of this platform, working in close collaboration with other EU agencies, including the European Environment Agency, European Food Safety Authority, European Medicines Agency, and the European Agency for Safety and Health at Work. Governance and implementation will follow a framework adopted by the European Commission.
The common data platform will consolidate chemical information from numerous sources and offer a suite of services, including an information platform for chemical monitoring, a repository of reference values, and a study notifications database. It will also host databases covering standard formats, controlled vocabularies, regulatory processes, legal obligations, chemicals in articles or products, alternatives to substances of concern, and data related to environmental sustainability. Together, these elements will form a comprehensive one-stop-shop for chemical data, significantly improving accessibility and transparency for regulators, businesses, researchers, and the general public.
In addition to managing the data platform, ECHA will develop a monitoring and outlook framework to track trends and emerging issues in chemical safety. The Agency will support early warning systems and risk identification, generate new scientific data where gaps exist, and actively promote the use of research to underpin regulatory decisions.
ECHA will also take over several scientific and regulatory functions previously handled by other bodies. These include preparing restriction proposals and managing exemption requests under the RoHS Directive, setting and reviewing limit values for persistent organic pollutants in waste under the POPs Regulation, and updating guidance on benefit-risk assessments for hazardous substances used in medical devices under the Medical Devices Regulation. Collectively, these new tasks further position ECHA at the centre of Europe’s chemical safety system.
