10 May 2024, 2:11 pm
The European Commission has clarified the criteria and principles for the ‘essential use’ concept in EU legislation dealing with chemicals, which could see the single market phase out the most harmful chemicals, including per- and polyfluoroalkyl substances (PFAS) – the so-called ‘forever chemicals’ – from non-essential uses, such as use in consumer products.
The guidance (22-page PDF/318KB) provides clarification on the ‘essential use’ criteria and principles that are important and applicable when implementing several pieces of EU legislation governing the use and production of chemicals. It sets out that two criteria must be met when determining whether a use of “a most harmful substance” is essential for society. The first is that the use is necessary for health or safety or is critical for the functioning of society, and the second is that there are no acceptable alternatives. The guidance includes non-exhaustive direction on what is meant by various terms, including “most harmful substance”.
As an example given in the document, the persistent, bioaccumulative and toxic/very persistent and very bioaccumulative substances (PBT/vPvB) are listed as most harmful substances. The use of these chemicals should be phased out from consumer products and minimised and substituted as far as possible in all uses. However, their use is permitted for the purpose of addressing sickness and health issues, such as to prevent transmission of diseases, and for providing resources or services that are critical for society to function, including enabling installation of energy supply and transport systems, as long as there are no suitable substitutes.
Katie Hancock of Pinsent Masons said that the guidance shows that the EU’s aim of phasing out the use of the most harmful substances is moving forward, albeit cautiously.
“That caution is however justified by the essential nature in a variety of scenarios of some substances considered to be harmful, and that wholesale banning is neither practical nor possible. This is particularly so given the critical use of some such substances – for example, in the green transition. A balancing exercise will have to be carried out, to encourage advances and innovation to find alternatives and at the same time to limit the harm which may be caused while that is done,” she said.
The clarification by the Commission on essential use is set to ensure the protection of health and the environment by accelerating the phase-out of the uses of the most harmful substance that are non-essential, while allowing uses still essential for society, such as climate change mitigation and digital transition, and for products that serve human and animal health needs.
According to the Commission, the ‘essential use’ concept can give companies certainty that substances otherwise targeted for phase-out can continue to be used to fulfil societal needs until alternatives are available. It is designed as a tool to help industries in the EU to determine when a use of a most harmful substance is justified from a societal point of view.
The document was published as a response to previous calls on the Commission to develop an action plan to eliminate all non-essential uses of PFAS, which refers to the class of approximately 10,000 fluorinated chemicals that degrade very slowly and are very persistent in the environment. In 2020, the European Parliament adopted a resolution on the Chemicals Strategy for Sustainability, in which, it asked the Commission to define the concept of and criteria for the ‘essential use’ of hazardous chemicals, to provide a harmonised approach for regulatory measures on non-essential uses.
The chemical strategy specifically committed to: “[…] define criteria for essential uses to ensure that the most harmful chemicals are only allowed if their use is necessary for health, safety or is critical for the functioning of society and if there are no alternatives that are acceptable from the standpoint of environment and health. These criteria will guide the application of essential uses in all relevant EU legislation for both generic and specific risk assessments”.
PFAS is mentioned in the strategy as requiring special reference, but the strategy and the ‘essential use’ guidance goes beyond PFAS to include other harmful chemicals. Hancock said that the guidance will have a bearing on the chemical strategy’s commitment to “ban all PFAS as a group in fire-fighting forms as well as in other uses, allowing their use only where they are essential for society”.