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The Essential or Critical Use of Chemical Substances in the United States and the European Union journal article open-access

Heidi M. Guenther

International Chemical Regulatory and Law Review, Volume 5 (2022), Issue 1, Page 3 - 12

As the regulated community prepares for risk management provisions under forthcoming Toxic Substances Control Act (TSCA) rules, there is renewed focus on what exactly is a ‘critical’ or ‘essential’ use under TSCA Section 6(g). This article seeks to provide guidance on the answer to this question by focusing on the two major instruments that consider the continued use of chemical substances based on essentiality: essential use in the Montreal Protocol, as the language within the Treaty serves the basis for later applications of essentiality in chemicals regulation; and the European Commission’s Chemical Strategy for Sustainability and Essential Use (EU CSS). The article then focuses on how TSCA addresses essential use through the legislative history that led to its inclusion in the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). As discussed more below, a firm definition of what factors qualify a substance as ‘critical’ or ‘essential’ was not identified in the development of the TSCA 6(g) exemption. Rather, when looking through its legislative history, emphasis was placed more on cost and in turn the essentiality exemption mirrors much of the language housed within the Montreal Protocol. The article then addresses how the Montreal Protocol and the EU CSS apply essential use in chemicals regulation. The practical applications of essentiality within these two instruments may serve as a basis for further understanding how essentiality may be interpreted and applied to TSCA Section 6(g).

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