Data Requirements for Implementing the "Essential-Use" Concept in Chemical Legislation

Abstract

The Stockholm Convention and the EU REACH Regulation are two key pieces of legislation on chemicals at the global and European levels, respectively. Discussions have taken place on revising them. For instance, the European Commission is considering implementing the "essential-use" concept in the REACH Regulation to guide decision-making for phasing-out the use of the most harmful chemicals. By assessing 34 existing cases under the Stockholm Convention and 45 restrictions and 544 applications for authorization under the REACH regulation (as of November 2023), this study aims to capture how the essential-use concept may inform decision-making on exemptions and provide insights on its implementation. By conducting a detailed case study of the REACH restriction on intentionally added microplastics, this study also aims to explore how the existing data requirements in regulatory processes could be used in an essentiality assessment. Overall, this study suggests that the Stockholm Convention and the REACH Regulation already consider elements of the concept in their decision-making and that no drastic changes in the data requirements are necessary to apply the concept in decision-making processes.