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Related Concept Videos

Drug Regulation01:25

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Data Requirements for Implementing the "Essential-Use" Concept in Chemical Legislation.

Romain Figuière1, Zhanyun Wang2, Juliane Glüge3

  • 1Department of Environmental Science, Stockholm University, SE-10691 Stockholm, Sweden.

Environmental Science & Technology
|June 2, 2025
PubMed
Summary

The essential-use concept can guide chemical regulations like the Stockholm Convention and EU REACH. This study shows existing regulations already incorporate essentiality, requiring no major data changes for implementation.

Keywords:
Essential-use conceptMicroplasticsREACH Authorisation processREACH RegulationSound management of chemicalsStockholm Convention

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Area of Science:

  • Environmental Law
  • Chemical Regulation
  • Risk Assessment

Background:

  • The Stockholm Convention and EU REACH Regulation are key global and European chemical legislations.
  • Discussions are ongoing regarding revisions, including the "essential-use" concept for phasing out harmful chemicals.

Purpose of the Study:

  • To assess how the essential-use concept can inform decision-making on exemptions in chemical regulations.
  • To provide insights into the implementation of the essential-use concept.
  • To explore the use of existing data requirements for essentiality assessments, using a microplastics case study.

Main Methods:

  • Analysis of 34 cases under the Stockholm Convention.
  • Review of 45 restrictions and 544 applications for authorization under REACH (as of November 2023).
  • Detailed case study of the REACH restriction on intentionally added microplastics.

Main Results:

  • Elements of the essential-use concept are already present in the decision-making processes of both the Stockholm Convention and REACH.
  • Existing data requirements within regulatory frameworks are suitable for essentiality assessments.
  • No significant alterations to data requirements are needed for implementing the essential-use concept.

Conclusions:

  • The Stockholm Convention and REACH Regulation can effectively integrate the essential-use concept without substantial modifications.
  • The study provides a framework for applying the essential-use concept in chemical management.
  • The findings support the continued use and refinement of existing regulatory tools for chemical safety.