REGULATION & COMPLIANCE
In short, any dossier that has not been updated for a few years is unlikely to satisfy current requirements. Addressing this might take time and require new data.
Our advice is to identify dossiers that may be at risk of being revoked and make an early start on updating them. If the ten-year proposal goes ahead, updating all registration dossiers routinely on a regular basis will be essential. Even if it does not, time spent future-proofing your portfolio is never wasted.
Prioritising restriction
One of the most publicised aspects of recent EU chemicals policy is the commitment to tighter management of hazardous chemicals such as PFAS and hexavalent chromium( Cr( VI)) using REACH tools including authorisation and restriction. Based on the proposals presented at CARACAL-54, both will remain part of the chemical regulatory toolbox.
Nevertheless, there may be modifications to the way they are applied, with significant implications for industry. For instance, inclusion on the candidate list of substances of very high concern( SVHCs) may lead to restriction( or other regulatory actions) as well as authorisation – or possibly both, to cover different uses of the same substance.
Proposals suggest restrictions will be increasingly favoured to manage the risks chemicals pose to workers, consumers, public and the environment. There is also an implied shift towards using restriction more broadly and, in many cases, in place of authorisation.
This increased emphasis on restriction coupled with faster, simpler regulation could be problematic for industry when restrictions are not fit for purpose. A restricted substance cannot be used outside the conditions of that restriction. Industry lacks the autonomy to refine or negotiate
Assessment of regulatory needs
Regulatory management option analysis
Regulatory proposal
Public consultation
Formal opinions from ECHA committees
Regulation updated
ECHA activity
Proposal
Proposal
Proposal
Proposal
Proposal
Proposal
Ongoing optimisation of dossiers
Track and assess developments
Provide data to inform outcome
Prepare to comply
Comply
Industry activity
Figure 3- Industry role in shaping emerging REACH obligations
terms once they are established. While the authorisation process, as implemented, creates its own challenges for industry, it allows some flexibility for continued use of important substances( in principle at least) if companies demonstrate stringent risk management measures and clear socioeconomic benefits.
Coupled with recent changes to the Classification, Labelling and Packaging( CLP) regulation this signals an emergence of broad restrictions across groups of similar chemicals. Industry will need to be alert and highly responsive, tracking and influencing regulatory developments that may curtail or prevent certain applications.
For example, increased use of restrictions could have implications for bisphenols. This family of chemicals is largely used as building blocks in the production of plastics and resins, including speciality coatings and composites, and the chemicals are often used in highperformance applications.
Commission proposes new REACH obligations
Ensure dossiers are up-to-date; any emerging data gaps must be
Monitor emerging obligations; prepare information to inform regulatory development
Compile data for substance properties, grouping, and use, including release and exposure across the lifecycle
Address new requirements for substances affected by the changes
Submit documentation and data to ECHA; update dossiers if substance status changes
Bisphenol A( BPA) has already received much regulatory and public attention for its endocrine disruption and reprotoxic properties. A recent Assessment of Regulatory Needs( ARN) by ECHA included 148 bisphenol substances, and concluded that a group restriction would be the best way forward.
ECHA noted that this would avoid‘ regrettable substitution’, where one bisphenol is replaced with another that is just as harmful but not( yet) subject to regulatory controls. Such broad approaches could have very significant consequences for downstream users who rely on specific substances for niche formulations.
Our advice is to stay tuned and engage with relevant authorities at the first sign that an important substance could be restricted. With REACH moving towards broader rules, general assumptions and grouping of chemicals, industry needs to scrutinise emerging obligations, taking steps to influence their development as necessary.
JUL / AUG 2025 SPECCHEMONLINE. COM
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