EU Commission Adopts Criteria for 'Essential Uses' of Harmful Chemicals

On 22 April 2024, the European Commission adopted criteria outlining what constitutes ‘essential uses’ of the most harmful chemicals (‘Guiding Criteria and Principles for the Essential Use Concept in EU Legislation Dealing with Chemicals’). This move aims to improve health and environmental protection by accelerating the phase-out of non-essential uses while allowing time for substitution in essential cases.

What is an essential use

In the Communication published on 22 April, the Commission defines that a use of a most harmful substance is essential only if both of the following two criteria are met:

1. Its use is necessary for health or safety or is critical for the functioning of society.

2. There are no acceptable alternatives.

The concept of essential use will only have legal effect if it is included in specific legislation which is currently not the case in the EU.

Most harmful chemicals

A most harmful substance has one or more of the following hazard properties:

• Carcinogenicity Category 1A and 1B.

• Germ cell mutagenicity Category 1A and 1B.

• Reproductive/developmental toxicity Category 1A and 1B.

• Endocrine disruption Category 1 (human health).

• Endocrine disruption Category 1 (environment).

• Respiratory sensitisation Category 1.

• Specific target organ toxicity – repeated exposure (STOT-RE) Category 1, including immunotoxicity and neurotoxicity.

• Persistent, bioaccumulative and toxic/very persistent and very bioaccumulative (PBT/vPvB).

• Persistent, mobile and toxic/very persistent and mobile (PMT/vPvM).

• Hazardous to the ozone layer Category 1.

Use necessary for health and safety

The use of a most harmful substance is necessary for health or safety if the use and the technical function of the substance in that use are necessary in order to:

• Prevent, monitor or treat disease and similar health conditions.

• Maintain essential conditions for human or animal life and health.

• Manage health crises and emergencies.

• Ensure personal safety.

• Ensure public safety.

These elements are described in the Annex to the Communication (Table 2).

Uses critical for the functioning of society

The use of a most harmful substance is critical for the functioning of society if the use and the technical function of the substance in that use are critical in order to:

• Provide resources or services that need to be maintained for society to function (e.g. ensure the supply of energy and critical raw materials or resilience to supply disruptions).

• Manage societal risks and impacts of natural crises and disasters.

• Protect and restore the natural environment.

• Undertake scientific research and development.

• Protect cultural heritage.

These elements are described in the Annex to the Communication (Table 3).

Definition of ‘use’

In the context of the essential use concept, 'use' applies to substances in various forms, including mixtures, articles, products or processes. It covers activities such as processing, formulation, consumption, storage, treatment and production. The assessment of essentiality takes into account both the technical function of the substance and the context of its use. A substance may be essential for one product, but not for another.

Integrating essential use into legislation

The Communication outlines the guiding principles and criteria for the concept of essential use, with the aim of incorporating it into EU legislation in a harmonised way. The legal effect of the concept will only be achieved through its inclusion in legislation, a process which depends on impact assessments.

At present, the essential use concept is not part of the REACH regulation and therefore does not influence initiatives such as the restriction of PFAS. Nevertheless, the Communication reaffirms the Commission's commitment to phasing out harmful substances while recognising their essential societal role, particularly in the green and digital transition.