As part of the Chemicals Strategy for Sustainability, on April 22, 2024 the European Commission adopted “Guiding criteria and principles for the essential use concept in EU legislation dealing with chemicals”. The Communication stresses the importance of phasing out these substances and states that no use can be considered essential if alternatives exist.
Harmful Substances
The Communication provides a broad definition of substances with hazardous properties, including not only carcinogenic, mutagenic and toxic for reproduction (CMR) substances, but also persistent, bioaccumulative and toxic/very persistent and very bioaccumulative (PBT/vPvB) substances, endocrine disruptors, respiratory sensitizers and toxic to target organs (STOT-RE).
Concept of ‘Essential Uses’
The Commission defines the concept of “essential use” to ensure that the most harmful chemicals are authorised only for specific purposes and for a limited period, provided that:
- the use is necessary for health or safety or serve an essential function to society; and
- there are no acceptable alternatives.
These criteria serve as guiding principles, to adapt with some flexibility to the specificities and objectives of each legislation in which the concept will be applied. The Commission clarifies that, although technical and economic feasibility will be considered in the analysis of alternatives, existing references in legislation such as REACH will not be changed.
Aim of the Communication
The main aim is to improve the protection of health and the environment by accelerating the decision-making process to phase out non-essential uses of hazardous substances and, where necessary, allowing a transition period for their substitution.
Application of Concept of “Essential Use”
The use of a substance may be essential in one product or context. The Commission specifies that an entire sector, such as healthcare or food packaging, will not be exempted from the essential use concept. Instead, specific individual uses within these sectors will be assessed. The assessment will be “per use” and not “per user”.
Evaluation of alternatives
According to the Commission’s Communication, the assessment of the acceptability of alternatives should consist of:
- identifying possible alternatives that can provide the technical function needed for the final product to deliver the intended service and
- assessing their acceptability from a social point of view.
It is therefore not necessary that the alternatives offer the same level of performance, as long as they have a function and a level of performance that are acceptable to society (even if lower than the most harmful substance). There are specific requirements for the assessment of alternatives in several pieces of legislation, including technical and economic feasibility. The Commission clarifies that it does not intend to change the existing requirements to align them with its Communication.
Conclusions
The EU Communication has no direct legal effect, but will serve as a guide for future legislation, in particular for the revision of REACH regulation and other chemicals legislation. However, the concept of essential use represents a significant change, shifting the attention from risk assessment to hazard and from safety to essentiality. If integrated into EU legislation, this concept will impact the accessibility of many substances and products currently in use.
