The ongoing REACH revision seeks to reduce the risks from hazardous chemicals, especially Substances of Very High Concern (SVHCs), while streamlining regulatory procedures. Although discussions are ongoing and the political level is yet to be decided, we have summarised the proposed changes for Authorisation and Restriction, as communicated by the European Commission at their 54thmeeting of the Competent Authorities (Caracal 54) in April.
Authorisation:
Changed role of candidate list: REACH revision is expected to prioritize broader group restrictions rather than individual authorisations. This aims to accelerate phasing out of SVHC, including using the candidate list as a tool to prioritise regulatory action, rather than simply a first step to authorization. Its worth nothing while the candidate list was established as the first step in the authorisation process, it has already evolved in practice, with existing SVHCs taking an alternative pathway such as the DNEL based restriction used for the aprotic solvents.
Limiting applications for authorisations: The current authorisation system has experienced backlogs. The revision seeks to address this by reducing the number of applications. As such its proposed to limit the use of authorisation through a change to the prioritisation criteria in Article 58(3), focusing on substances used in i) high volumes, ii) limited number of users and uses iii) potential to be used as alternative for substances already on Annex XIV, and iv) not incorporated in articles. This is a change to the existing criteria focusing on substances with widespread uses. They also propose to add flexibility to restrict certain uses of an authorised substance. This would involve the removal of Article 58(5) and (6), which would allow the use of restriction and authorisation in parallel for the same substance and intrinsic property, while at the same time avoid targeting substances, which are incorporated into articles, for authorisation.
Upfront analysis and discussion of regulatory options for authorisation and restriction: It has been acknowledged that information on use, exposure and alternatives becomes available too late in the authorisation and restriction process. Earlier information can help target a more appropriate regulatory action. Therefore, the role of Regulatory Management Options Analysis (RMOA) is expected to be revised to become a more central step in the process.
Essential use concept and the role of adequate control route under discussion: The concept of “essential use” has long been considered to simplify decision-making in authorisation and restriction. The idea is that for the most hazardous substances, their use should only be allowed if it’s “essential” for society and no alternatives exist. If this concept is implemented, it could significantly limit the scope of the adequate control route under article 60(2), as many uses might not be deemed “essential” even if technical control of exposure is possible. EBB in their comments emphasised that only essential uses should be authorized, the adequate control route should be eliminated, and decisions should be based on the availability of alternatives.
Transitional period in case of refusal of authorisation. This would give companies a welcome opportunity to phase out a SVHC, in the event an authorisation application is refused
Clarifications on the key elements for applications for authorisation (AoA, Substitution plans, etc) The required information for authorisation applications is expected to be clarified, potentially aiming for more targeted and efficient assessments. Another welcome change for all stakeholders, as the process for applying for authorisation is currently complex & considered a barrier in particular for SMEs.
Restriction:
As part of the restriction presentation, the Commission reiterated the points above on better upfront prioritisation, earlier discussion on use, exposure and alternative & the simplification potential of the essential use concept. In addition, they committed to:
Take into account authorities’ capacity: This could include possible changes to legal deadlines or splitting proposals
Support substitution: They have proposed further action to support substitution, such as substitution pathways, substitution centres, innovation, safe and sustainable by design
Extending the generic risk management (GRA) approach. This is a critical aspect of REACH revision, with all stakeholders closely monitoring its development. This proposes a move away from substance specific restrictions, in favour of generic restrictions, which are currently in place for category 1 CMRs (carcinogenic, mutagenic, or reprotoxic) for consumer use. The Commission’s chemicals strategy for sustainability (CSS), proposed extending its scope to other hazard classes such as endocrine disruptors and to include professional use. However, the impact assessment for REACH revision, which was completed in 2023, indicates that the Commission is considering various scenarios for this extension. The outcomes would vary significantly, with the products impacted been reported between 1- 50%. EBB expressed their support to extend this restriction route, but accused the options presented at CARACAL 54 of abandoning the fast-track ban on professional use. In contrast CIFICs 10-point action plan outlined the primary focus of restrictions should be consumer use, final goods and end uses. With regards grouping of chemicals EBB have pushed for grouping chemicals by default as seen with microplastics, tattoos ink & PFAS, to reduce the burden on authorities. However, CIFIC have called for a robust and transparent framework for grouping chemicals that require regulatory action.
Conclusion:
In summary, the communication during Caracal 54 has sparked a harsh response from both Industry & NGOs with regards to Authorisation & Restriction. CIFIC responded with the “proposals made today will massively increase the administrative burden for industry and SMEs in particular”. Their 10-Point action plan to simplify REACH agreed with some of the points addressed by the commission, in particular limiting the use of the authorisation, an upfront analysis of available data, and to clarify the required information in the application for authorisation. However, they also called for a need to create more possibilities for granting exemptions when risks are adequately controlled. In contrast the EBB response stated “Rather than streamlining the process, the Commission is adding bureaucratic hurdles, such as the RMOA, and narrowing the scope of authorisation — pushing all regulation into the slow and burdensome “normal” restriction route”
Published May 27, 2025
This article was generated with the assistance of Artificial Intelligence.