Commission Communication on "Essential Use" The future of the chemical industry
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The introduction of the 'essential use' concept
On Monday 23rd April 2024, the Commission published its long-awaited Communication on the essential use criterion, titled "Guiding criteria and principles for the essential use concept in EU legislation dealing with chemicals".
This non-binding document illustrates the core principles of the essential use concept and how it should be used applied and incorporated into sector-specific legislation on chemicals.
In brief, the 'essential use' criterion will help accelerating the phase-out of the uses of the most harmful substance that are 'non-essential', while allowing uses still 'essential'. Also, specific conditions for 'essential uses' will be set to ensure that emissions and exposure of humans and the environment that are minimized for a certain period of time.
Regulatory background and history
The Commission already in 2020, in its Communication on the Chemical Strategy for Sustainability ('CSS'), announced its intention 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’ (p. 10). This concept was also recognized as a key element in delivering the CSS by the Parliament in its Resolution of 2020 and by the Council in its Conclusions of March 2021.
However, the concept is not completely new in the legal landscape. Indeed, this concept was already introduced in 1992 with Decision IV/25 under the 1987 Montreal Protocol ('the Protocol'), on substances that deplete the ozone layer, an international treaty to which the EU is a Party. This treaty phases out most emissive uses of ozone depleting substances except for certain essential uses, such as substances in medicines, mainly asthma inhalers, laboratory and analytical uses, process agent uses, in firefighting and as solvents in aerospace applications.
Under the Protocol, the use of a substance should qualify as 'essential' only if: a) it is necessary for the health, safety or is critical for the functioning of society (encompassing cultural and intellectual aspects); and b) there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health. Yet, the essential use criteria in the Montreal Protocol are not further defined in the Protocol nor in any guidance.
The 'essential use' concept
The aim of this concept is to increase the protection by accelerating the phase-out of the uses of the most harmful substance that are non-essential.
By way of background, according to the Commission, a 'most harmful substance' is a substance having one or more of the following hazard properties: carcinogenicity Cat. 1A and 1B; germ cell mutagenicity Cat. 1A and 1B; reproductive/developmental toxicity Cat. 1A and 1B; endocrine disruption Cat. 1 (human health) • Endocrine disruption Cat. 1 (environment); respiratory sensitisation Cat. 1; specific target organ toxicity – repeated exposure (STOT-RE) Cat. 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 Cat. 1.
However, the inclusion of all PMT and vPvM in the subgroup of most harmful substances will be subject to further assessment.
What is defined as 'essential'
According to the Communication, a most harmful substance is essential only if the following two cumulative criteria are met:
1) that use is necessary for health or safety or is critical for the functioning of society, and
2) there are no acceptable alternatives.
Once an essential use will be identified, specific conditions for the use should be set to ensure that emissions and exposure of humans and the environment that are minimized for a certain period of time. Indeed, the essentiality is seen as an 'evolving' rather than a 'static' concept. This means in practice that substitution plans with commitments, timelines and steps envisaged towards transition to alternatives could be required for uses of substances that are deemed essential as well as possible inclusion into research and innovation agendas.
The procedure to identify an essential use
To identify an essential use, a two steps approach is required:
- Step 1 – Assessment of necessity for health or safety and criticality for the functioning of society
This step requires to consider the particular use to be addressed and the technical function provided by the substance in the use, i.e. the role that the substance fulfils when it is used by itself, in a mixture, article or manufacturing process; (such as for instance processing aid, extraction solvent, degreasing agent, corrosion inhibitor, plasticizer, antioxidant, colorant and others). In particular, it should be assessed if the technical function of the most harmful substance needed for the final product to deliver its service.
Furthermore, it requires to understand if the use of the most harmful substance is necessary for health or necessary for safety or critical for the functioning of society in the particular use.
In that respect, please note that 'necessary for health or safety' is interpreted as: addressing sickness and comparable health issues; sustaining basic conditions for human or animal life and health; managing health crises and emergencies; ensuring personal safety; ensuring public safety (as further specified in Annex section III.b, table 2 of the Communication).
On the contrary, 'critical for the functioning of society' is interpreted as: providing resources or services that must remain in service for society to function; providing resources such as infrastructure and equipment to ensure defense and security to society in the face of conventional, non-conventional and hybrid threats; managing societal risks and impacts from natural crises and disasters; protecting and restoring the natural environment; performing scientific research and development; protecting cultural heritage (as further specified in Annex section III.b, table 3 of the Communication);
- Step 2 – Alternatives assessment
In this step, it is necessary to understand if alternatives are lacking. In that respect, it is required to identify possible alternatives for the use, looking at whether the use of the substance that is being assessed can be replaced by an alternative substance, material, product, process or technology and understand if they are acceptable.
The assessment of alternatives will be defined with specific requirements in each piece of legislation, and for most pieces of legislation, it also includes a technical and/or economic feasibility assessment. For instance, in restrictions under Regulation 1907/2006 ("REACH"), the assessment is based on information on alternatives including their availability and technical and economic feasibility (cfr. Article 68 and Annex XV to REACH).
Some legal considerations
Essentially, with this non-binding Communication, the Commission aims to guide considerations on introducing in the future the concept of essential use in EU legislation dealing with chemicals, while respecting the specificities of each piece of legislation.
In the implementation into sector-specific legislation, careful consideration will be given to the peculiarities of that particular piece of legislation (e.g. the assessment of alternatives under the REACH). However, it is still yet not clear how this concept will be applied in practice, for instance who shall perform an assessment of the 'essentiality', whether new EU bodies will be established to conduct such assessment and how companies will have to prove to meet the 'essentiality'.
Also, this concept will have to interact with other ongoing legislative initiatives such as the REACH restriction of PFAS and the revision of REACH. So far, the Commission has clarified in its Q&As that "the concept is not part of the REACH regulation, and hence not of current initiatives like the PFAS restriction". However, in the CSS, the Commission committed to "ban all PFAS as a group in fire-fighting foams as well as in other uses, allowing their use only where they are essential for society".
Therefore, more clarity should be provided by the Commission to ensure efficiency and predictability for the industry.