The “Essential Use” Concept: The Commission Publishes Guiding Criteria on Limiting Most Harmful Chemicals to Essential Uses

On 22 April 2024, the Commission published a much-awaited Communication setting out guiding criteria and principles on the “essential use” concept – a key deliverable of the Chemicals Strategy for Sustainability. The “essential use” concept is intended to limit the use of the most harmful chemicals to situations where it can be demonstrated that these are necessary for health or safety or serve an essential function to society, and that there are no acceptable alternatives.

The aim of the Commission’s Communication is to provide the necessary definitions, principles and parameters of the essential use concept so that it can be introduced in future EU legislation dealing with chemicals in a harmonized way. The Communication as such has no legal effect at this stage and its impact will depend upon the extent to which the concept will be used in future EU legislation.

Important procedural aspects (e.g. who and how will assess and determine the essentiality of use) would need to be specified in each piece of EU legislation to which the essential use concept will be introduced, having regard to the specificities of that legislation.

The essential use concept represents a fundamental shift in regulatory thinking from “risk” to “hazard” and from “safety” to “essentiality”, which will have a significant impact on the availability of many substances and products currently used, if embedded in EU legislation as planned. With a very broad list of hazards that can cover thousands of chemical substances currently in use, and a very narrow definition of when their use can be deemed “essential”, the use of the essential use concept will inevitably lead to banning substances and products that are currently safely used and serve many legitimate societal goals beyond the protection of health, safety and the functioning of society. It can be also expected that, in anticipation of future EU legislation, the concept may be picked up and used by the EU Member States in their national legislations.

The most harmful chemicals

The “essential use” concept is intended to limit the use of the “most harmful” chemicals only to uses that are essential for society and for which there are no acceptable alternatives to date.

The most harmful substances are very broadly defined in the Commission’s Communication by reference only to their “hazardous” properties, and include not only carcinogens, mutagens and reproductive toxicants (CMRs) and persistent, bioaccumulative and toxic/very persistent and very bioaccumulative (PBT/vPvBs) chemicals, but also endocrine disruptors, respiratory sensitizers and specific target organ toxicants (STOT-RE).

This extensive list of hazards covers thousands of substances currently in use.

The “essential use” criteria

For a use to be considered essential, the following two criteria need to be cumulatively met:

1. The use is necessary for health or safety or is critical for the functioning of society; and
2. There are no acceptable alternatives

The Commission explains that these are guiding principles for the essential use concept and that there is flexibility to consider the specificities and objectives of each piece of legislation to which the concept would be introduced. It also indicates that where the assessment of alternatives includes a technical and/or economic feasibility assessment – as in REACH for example - it will not change the existing reference to such an assessment if and when introducing the essential use concept in that legislation.

Defining the “use” to be assessed

Before assessing whether the “use” meets the two conditions set out above, it is necessary first to comprehensively describe that use. This is particularly important because the essential use concept is applied to a specific use as determined by the final product and the service or purpose it serves for society. Therefore, it is possible that the use of a substance may be considered “essential” in one context or setting, and not in another – for example, the use of a substance for public safety would be essential, by contrast to the use of the same substance purely for decorative or convenience purposes.

Assessment of the use against the essential use criteria

The Communication provides some guidance on how to assess whether a use is essential:

• Necessity for health or safety and criticality for the functioning of society

In assessing whether a use is necessary for health or safety or is critical for the functioning of society, the following two steps need to be followed:

• First, it needs to be assessed whether the technical function of the most harmful substance (i.e. the role of the substance when used, e.g. corrosion inhibitor) is needed for the final product to deliver its service or for the product’s characteristics relating to its service. If the technical function of the substance is not necessary for the final product (i.e. the product can deliver the same service without the substance or without the technical function of the substance) the use is not essential.
• Second, if the technical function of the substance is found necessary, it needs to be assessed whether the use of the most harmful substance is necessary for health or safety, or critical for the functioning of society. In that respect, the Communication provides examples to help determine whether that criterion is met.

In particular, a use is necessary for health or safety, where it addresses health issues (e.g. hygiene in hospitals, prevention of diseases) and health emergencies (e.g. functioning of emergency services), sustains basic conditions for human or animal health (e.g. clean water and air, safe food and feed), ensures personal safety (e.g. the functioning of personal safety equipment) or public safety (e.g. infrastructure, military, anti-terrorism, cyber security services).

A use is necessary for the critical functioning of society, where it provides resources or services necessary for society to function (e.g. installation and maintenance of critical infrastructure, including for energy conversion and storage, transportation, digital communications), or to ensure defence and security (e.g. infrastructure and equipment for defence and security), manages societal risks and impacts from natural disasters, protects and restores the natural environment (e.g. to reduce greenhouse gas emissions or water, soil and air pollutants), contributes to scientific research and development, and protects cultural heritage.

• Acceptability of alternatives

According to the Commission’s Communication, the assessment of the acceptability of alternatives should (at least) consist of (i) the identification of possible alternatives that can provide the technical function needed for the final product to deliver its service as expected and (ii) the assessment of their acceptability from a societal point of view.

The assessment of alternatives is not specific to the use of a substance by a certain undertaking, but relates to the societal needs for that use and the way the substance is used at market level. Therefore, it is not necessary that alternatives to the substance have the same level of performance, as long as they have a function and level of performance that is acceptable for society (even if lower compared to the most harmful substance).

As explained above, there are more specific requirements for the assessment of alternatives in different pieces of legislation, which notably include technical and/or economic feasibility assessments. The Commission clarifies that it does not intend to change the existing requirements on the assessment of alternatives to align them with its Communication. 

Conditions on essential uses

The Communication provides that even where a use is found to be essential, there should be conditions for minimising the emissions and exposure of humans and the environment to most harmful chemicals to the lowest technically and practically possible. These conditions should seek to minimise exposure of the vulnerable population (children, pregnant women, elderly people) and to provide incentives for innovation in developing safer alternatives, by requiring specific commitments towards substitution of most harmful chemicals and time-limits for derogations of essential uses.

Conclusions

As the Communication is designed to serve as guidance, it will have no direct legal effect. Rather, its impact will depend upon the extent to which the concept will be used in future EU legislation, and in particular in the future revision of the REACH Regulation, if this remains an objective of the future European Commission, and downstream legislation on chemicals in products.

However, the essential use concept, now enshrined in the Commission’s Communication, already represents a fundamental shift in regulatory thinking from “risk” to “hazard” and from “safety” to “essentiality”, which, if embedded in EU legislation, will have a significant impact on the availability of many substances and products currently used. With a very broad list of hazards covering thousands of chemicals currently in use and a very narrow definition of when their use can be deemed “essential”, the use of this concept will inevitably lead to banning substances and products that are currently safely used and serve many legitimate societal needs beyond the protection of health, safety and the functioning of society in a pure mechanistic way, as defined in the Communication. In particular, it will be very difficult, if not impossible, to justify the use of those hazardous substances in most consumer products - not only luxurious goods, but all sorts of other products that are used by consumers for their everyday enjoyment and quality of life.