The Essential Use Concept
Guiding principles and criteria
Summary of the EPPA analysis
The background
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Commission Communication published on 22/04/2024 but announced already by the Chemicals strategy for sustainability in 2020
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Guide the application of essential uses in all relevant EU legislation for both generic and specific risk assessments’ and authorisations
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Encourage companies to be proactive in phasing out the most harmful substances and focus R&I on safe and sustainable by design alternatives
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Facilitate decision-making and increase regulatory efficiency to achieve a fast phase-out of the most harmful substances:
Carc. Cat. 1A and 1B; Germ cell mut. Cat. 1A and 1B; Reprotox. Cat. 1A and 1B; ED Cat. 1 human health & Cat. 1 environment; Resp. sensitization Cat. 1 (STOT-RE) Cat. 1 incl. immunotoxicity and neurotoxicity; PBT/vPvB; Dangerous for the ozone layer Cat.1
EPPA assessment: Proactive engagement in the consultation process influenced the design of the EUC which will de facto become the only possibility to justify a derogation under EU law. The EUC heads towards a fast-track ban of the most harmful chemicals and will be a condition sine qua non for granting derogations.
Criteria for essential use
For a use to be proven essential, both criteria must be met (cumulatively)
Necessity
Addressing sickness and comparable health issues
Sustaining basic conditions for human or animal life and health
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Managing health crises and emergencies
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Ensuring Personal safety
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Ensuring Public safety
Criticality
Need for critical infrastructure
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Services for society to function
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Defense and security of society
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Key equipment and components
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Societal risks from natural crises and disasters
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Critical resources
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Protect the natural environment and cultural heritage
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Perform scientific R&D
Acceptability
Substances, materials, technologies, processes or products which, from a public point of view are:
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Providing function and level of productivity (even with a lower performance) that society can accept as sufficient; And
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Safer: their overall chemical risks to human or animal health and the environment throughout the life cycle are lower than the most harmful substance
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Definitions existing in legislative acts, technical and/or economic feasibility, should be taken into account if and when applying the concept of essential use.
Phase out and substitution where the use is not critical, regardless how critical the sector is; Technical function = particular use and the context of that use; The use of the most harmful substance itself should not generate adverse effects. Convenience, leisure, decoration or luxury to the user of the final product should normally not be deemed essential
EPPA assessment:
While “technical and/or economic feasibility of alternatives” is not included as a standalone criterion for assessment of Acceptable Alternatives, it should be considered if so required in the legislation. The burden of proof for lack of alternatives is always with the industry. Life-cycle safety assessment needed - data related to use, potential exposure/releases, risk management measures, alternative substances, materials, technologies, processes or products and potential risks. Challenging for all players in the value chain.
Application of the EUC
Applies to uses of substances on their own, in mixtures, articles, products or processes
Both the technical function of the substance in the specific use and the context of that use in final product or service
For essential uses, conditions must be laid down to minimise emissions and exposure of humans and the environment
Substitution plan with commitments, deadlines and steps envisaged to move to alternatives could be requested
The concept of essential use will have legal effect only when it is introduced into specific legislation
Flexibility to take into account specificities and existing definitions in legislation in which the concept can be integrated and applied
What is next?
REACH Restriction & Authorisation? Generic approach to risk management (GRA)? Cosmetics, food contact materials, toys?
What is still missing?
Which legislation will integrate the EUC and will the social economic aspect be added as a second tier to the criteria of EUC? Who should be responsible for the evaluation of the essentiality? EUC derogation will be time limited? How to determine the duration - substitution plan will prove to be a necessity? How often the EUC criteria should be implemented or revised? How the EUC would apply to broad restrictions that cover variety of hazards?
How to prepare – EPPA recommendations
Screen your portfolio of chemicals, materials, products, processes using the most hazardous substances
Analyse market developments and alternatives; assess the feasibility of substitution
Identify applications that could be qualified as necessary for health and safety and critical for the functioning of society
For substances with critical functions:
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Perform life cycle assessment
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Assess the information on alternative substances and processes
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Prepare comparative performance and life cycle risk assessments
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Assess the socio-economic impacts of substation and time needed to transition
Be active industry - participate proactively in the consultation processes and engage constructively with the authorities with input on how EUC could be applied in current and future legislation.
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Particular focus on maintaining the technical and economic feasibility of the alternatives
