Abstract: The European Union’s Chemicals Strategy for Sustainability (CSS), first published in October 2020, is supported by five objectives. One key goal, “Simplifying and consolidating the legal frameworks concerning chemicals in the EU“, relates to the One substance, one assessment (1S1A). Built on four pillars ―safety assessment initiation, allocation of tasks, data and methodologies―, the 1S1A envisages to improve scientific robustness, efficiency, transparency and coherence of chemicals’ risk assessment and regulation. EFSA is actively implementing the 1S1A concepts with several activities, including: ‘Early identification of cross-cutting substances’​​, ‘Piloting the 1S1A approach’, ‘Study to map Data Requirements (DR) and Risk Assessment Methodologies (RAM)’, ‘Contribution to the EU- Common Data Platform on Chemicals (EU-CDPC)’. The early identification of cross-cutting substances is being tested with those chemicals (on on-going or finished assessments) behind ECHA, EMA, the EC Scientific Committees and the food/feed assessments of EU Member States; the searching strategies and the application of 1S1A concepts (e.g. data sharing) are being examined. Whilst piloting the 1S1A approach, some misalignments in data requirements between chemicals regulatory framework were identified. That was the main driver for the study to map the DR and RAM across the various regulatory areas on chemicals in the EU, aiming to identify commonalities and differences across the operating frameworks. The establishment of the EU-CDPC containing chemical data is a major objective of the 1S1A. Several building blocks will compose the platform such as a repository of health-based-guidance values, a central database on regulatory submissions (IUCLID) and an occurrence data (IPCHEM). Legislation supporting the 1S1A ―focusing on the CLP revision, the re-attribution of tasks to EU Agencies, and the regulation on data― along with its likely impact to EFSA, will also be presented.   read more...   read less

Abstract: Current approaches for the assessment of environmental and human health risks due to exposure to chemical substances have served their purpose reasonably well so far. Nevertheless, the assessment systems in place for different chemical regulations are faced with several challenges, ranging from a growing number of chemicals to changes in the types of chemicals and materials produced. This has triggered awareness of the need for a paradigm shift, notably appearing in the CSS, requiring new concepts for chemical risk assessment. As a result, new approach methods (NAM) and next-generation risk assessment (NGRA) are generally regarded as the way forward. However, incorporating new scientific insights and innovative approaches into hazard assessment in such a way that regulatory needs are adequately met has appeared to be challenging. The European Partnership for the Assessment of Risks from Chemicals (PARC) has been designed to address various challenges associated with innovating chemical risk assessment. Its overall goal is to consolidate and strengthen the European research and innovation capacity for chemical risk assessment to protect human health and the environment. With around 200 participating organisations from all over Europe, including three European agencies, and a total budget of over 400 million euro, PARC is one of the largest projects of its kind. It has a duration of seven years and is coordinated by ANSES, the French Agency for Food, Environmental and Occupational Health & Safety. The WP hazard assessment focusses on closing data gaps for substances where data are lacking, development of new approach methods as well as increasing their regulatory robustness.   read more...   read less