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

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.