Implementation of the “Essential-use” concept in chemical regulations Romain Figuièrea, Zhanyun Wangb, and Ian T. Cousinsa a: Department of Environmental Sciences, Stockholm University, SE-10691 Stockholm, Sweden b: Empa – Swiss Federal Laboratories for Materials Science and Technology, 9014 St. Gallen, Switzerland • Derogations refer mainly to the “availability of alternatives” component of the essential-use concept. • Category “Others reasons” can be divided into two sub-categories: • Reasons for which the essential-use concept would not affect the regulatory outcome, i.e., because the use already regulated, the use being out of scope, restriction not enforceable for the specific use, or substance found as impurities in the specific use; • Reasons for which the essential-use concept could affect the outcome, i.e., because negligible risk from the use, or the restriction costs outweigh the benefits, mentioned for ~20% of the derogations. Results Acknowledgements This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101036756. Partners Background Methods In the Montreal Protocol, a use is essential only if (A) it is necessary for the health and safety, or is critical for the functioning, of society; and (B) there are no available safer, technically and economically feasible alternatives. The EU Chemicals Strategy for Sustainability stipulates implementation of the essential-use concept under REACH to guide phase-out of the most harmful substances. Aims of the study To determine (1) whether the existing restriction of uses of harmful chemicals processes refer to elements of the essential-use concept; and (2) whether process changes are necessary to implement the concept in the decision-making. Analysis of the decisions on derogations to restrictions under Stockholm Convention and REACH processes following the READ approach (Dalglish et al. (2020)) to determine if relevant information to perform essential-use assessment was available. Lessons-learnt • No major changes in the REACH Restriction process are needed to implement the essential-use concept. • Previous decisions on derogations have been mainly based on the availability of alternatives. • The essential-use concept can bring a new perspective in decision- making. Components of the essential-use concept mentioned in decision-making on derogations to previous restrictions *: See separate section on REACH Authorisation process References: EU (2020), https://ec.europa.eu/environment/pdf/chemicals/2020/10/Strategy.pdf; Dalglish et al. (2020), DOI: 10.1093/heapol/czaa064; EU (2024), https://environment.ec.europa.eu/publications/communication-essential-uses-chemicals_en Contact romain.figuiere@aces.su.se REACH AUTHORISATION PROCESS • Authorisations are granted if (1a) risk is adequately controlled, or (1b) costs of ceased use outweigh the benefits, and (2) there no suitable alternatives available to the applicant (“Availability of alternatives” component) • Further work is needed to determine if enough information is provided in the applications to evaluate if the technical function is needed in final products, and whether it would fulfil the criteria to be considered as necessary for society • For 20 applications, the European Commission did not grant authorisation for part of the use applied for where “the specified key functionality is not necessary for the use” (“Technical function” component) Is the technical function needed in the final product? Technical function Does the use fulfil one of the criteria for being critical for society? Necessity for society Are acceptable alternatives lacking? Availability of alternatives Overview of the assessment of essentiality of a use as proposed by the European Commission 2% 15% 58% 40% 8% 15% 31% 88% 5% 100% 100% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Technical function Necessity for society Availability of alternatives Other reasons REACH Authorisa