The Essential-Use Concept for Harmful Chemicals: A Framework for Safer Substitution

Key Takeaways

• The essential-use concept restricts harmful chemicals to uses that are necessary for health, safety, or critical societal functions and for which no safer alternatives are available.
• It shifts the regulatory approach from risk management of individual chemicals to a systemic phase-out of non-essential uses, promoting innovation in safer alternatives.
• Originally developed under the Montreal Protocol to eliminate ozone-depleting substances, the concept is now being adapted for broader chemical regulation, including per- and polyfluoroalkyl substances (PFAS).
• Implementing the essential-use concept requires clear criteria for what constitutes an “essential” use, balancing societal benefits against potential risks, and ensuring a just transition for affected industries and communities.

What Is The Essential-Use Concept for Harmful Chemicals?

The essential-use concept is a regulatory and policy principle that proposes restricting the use of harmful chemicals to only those applications that are truly necessary for health, safety, or the functioning of society, and for which no safer alternatives are available. Under this framework, a chemical is not automatically permitted simply because it is useful or profitable; instead, its continued use must be justified by demonstrating that it provides a critical benefit and that no viable, less hazardous substitute exists. The concept aims to move beyond traditional risk assessment, which often manages rather than eliminates hazardous substances, toward a proactive phase-out of non-essential uses.

This approach is rooted in the idea that many harmful chemicals are used in products and processes where safer alternatives could be employed, but market forces and regulatory inertia allow their continued presence. By defining what constitutes an “essential” use, regulators can prioritize the elimination of unnecessary exposures, protect vulnerable populations, and drive innovation toward inherently safer chemistry. The essential-use concept is not a ban on all uses of a chemical, but a strategic tool to ensure that when hazardous substances are used, they are used only when truly needed and under controlled conditions.

Overview

The essential-use concept provides a structured decision-making framework for managing chemicals of concern. It originated in international environmental law and has been most successfully applied to ozone-depleting substances under the Montreal Protocol. In recent years, the concept has gained traction as a potential tool to address other persistent, bioaccumulative, and toxic substances, such as per- and polyfluoroalkyl substances (PFAS), and to support broader sustainable chemistry goals. The framework typically involves two key questions: Is the use of the chemical necessary for health, safety, or critical societal functions? And, are there available safer alternatives that can fulfill the same function? If the answer to the first is no, or if a safer alternative exists, the use is considered non-essential and should be phased out.

The essential-use concept is distinct from traditional risk-based chemical regulation, which often permits continued use of hazardous substances as long as exposure is controlled or deemed “acceptable.” Instead, it focuses on the inherent necessity of the use itself, encouraging substitution and innovation. This approach aligns with the principles of green chemistry and the circular economy, aiming to design out hazards rather than manage them indefinitely. While the concept is straightforward in theory, its practical implementation requires clear definitions, robust assessment methodologies, and consideration of socioeconomic factors.

How It Works

Implementing the essential-use concept involves a stepwise evaluation process. First, a chemical or class of chemicals is identified as being of high concern due to its hazardous properties, such as persistence, bioaccumulation, toxicity, or potential for widespread exposure. Next, all current uses of the chemical are catalogued. Each use is then assessed against two core criteria: necessity and availability of alternatives. A use is considered necessary only if it is critical for health, safety, or the functioning of society, and if the specific function cannot be achieved by other means. For example, a use might be essential if it is required for medical devices, safety equipment, or national security where no substitute exists.

If a use is deemed necessary, the second criterion examines whether a safer and technically feasible alternative is available. If such an alternative exists, the use is not essential and should be substituted. If no alternative is available, the use may be considered essential, but it is often subject to ongoing review and requirements to find alternatives. This process can be applied at different regulatory levels—from individual product design to national or international chemical management. The essential-use concept can also be integrated into broader sustainability assessments, considering the overall environmental and social footprint of alternatives to avoid regrettable substitutions.

Importance and Impact

The essential-use concept is important because it addresses a fundamental weakness in current chemical management systems: the slow pace of phasing out hazardous substances. Traditional risk-based regulation often results in long delays, contested science, and continued exposure while alternatives are developed. By shifting the default assumption that a chemical can be used unless proven unacceptably risky, the essential-use approach places the burden on proponents to demonstrate that a use is truly necessary. This can accelerate the transition to safer chemicals and reduce the overall chemical burden on human health and the environment.

The impact of adopting an essential-use framework can be profound. It can drive innovation by creating market demand for safer alternatives, reduce regulatory complexity by focusing on uses rather than individual chemicals, and enhance protection for vulnerable populations, such as children and workers, who are often disproportionately exposed. Moreover, it can help prevent regrettable substitutions—where one hazardous chemical is replaced by another with similar risks—by requiring a comprehensive assessment of alternatives. The concept also supports the circular economy by ensuring that materials and products are designed to be safe and sustainable from the outset, rather than relying on end-of-pipe controls.

Examples

The most well-known application of the essential-use concept is under the Montreal Protocol on Substances that Deplete the Ozone Layer. The Protocol allowed continued production and consumption of ozone-depleting substances only for uses deemed “essential” by the Parties, such as metered-dose inhalers for asthma and some laboratory and analytical uses. All other uses were phased out. This approach was instrumental in the successful global elimination of chlorofluorocarbons (CFCs) and other ozone-depleting chemicals, demonstrating that an essential-use framework can work on a large scale.

More recently, the concept has been proposed for managing per- and polyfluoroalkyl substances (PFAS), a class of persistent chemicals used in a wide range of products from non-stick cookware to firefighting foams. In 2020, the European Chemicals Agency (ECHA) and other EU bodies published a report outlining how the essential-use concept could be applied to PFAS, identifying many uses as non-essential and calling for their phase-out. Some uses, such as in certain medical devices or safety-critical industrial applications, were considered potentially essential, but the report emphasized the need for innovation to find safer alternatives even for those uses. The concept is also being discussed for other substances of concern, such as endocrine disruptors and very persistent chemicals.

Benefits, Limitations and Trade-offs

The essential-use concept offers several benefits. It provides a clear, principled basis for chemical restrictions, reducing the need for lengthy risk assessments on a chemical-by-chemical basis. It can accelerate the phase-out of harmful substances, stimulate green chemistry innovation, and align chemical policy with broader sustainability goals. By focusing on the function a chemical serves, it encourages the development of safer alternatives and can lead to more comprehensive protection of human health and the environment.

However, the concept also has limitations and trade-offs. Defining what is “essential” can be subjective and context-dependent, leading to potential disputes among stakeholders. For example, a use that is essential for one industry or region may be considered non-essential by another. There is also a risk that an overly rigid application could disrupt supply chains or eliminate beneficial uses of chemicals where risks are adequately managed. Additionally, the framework requires robust data on alternatives to avoid regrettable substitutions, and it may impose higher short-term costs on businesses and consumers. Balancing these factors requires transparent, inclusive decision-making processes and careful consideration of socioeconomic impacts.

What Businesses and Governments Can Do

Businesses can proactively adopt the essential-use concept as part of their chemical management and sustainability strategies. This involves assessing their product portfolios to identify chemicals of concern, evaluating whether their uses are truly essential, and investing in research and development of safer alternatives. Companies can also collaborate with supply chain partners to phase out non-essential uses and communicate transparently with consumers and regulators about their progress. By doing so, they can reduce regulatory risks, enhance brand reputation, and drive innovation.

Governments can integrate the essential-use concept into chemical regulations and policies. This may include establishing legal definitions of essential use, developing guidance for industry, and creating incentives for substitution. Regulatory agencies can apply the concept when authorizing or restricting chemicals, requiring manufacturers to demonstrate that a use is essential and that no safer alternatives exist. International cooperation is also crucial to harmonize approaches and prevent the transfer of non-essential uses to regions with weaker regulations. Additionally, governments can support research into safer alternatives and provide assistance to small and medium-sized enterprises to facilitate the transition.