REGULATION & COMPLIANCE
In many cases companies will need to advocate for specific use cases, using detailed and compelling information. This may have to be prepared within very short timescales, and in circumstances that are not heavily publicised, so effective monitoring and assessment will be key.
Proactive engagement with public consultations will be of vital importance. Figure 3 offers a high-level view of how this will work in practice.
Registration requirements
The REACH proposals also outline revised data requirements that would impact both new and existing chemical registration dossiers. For example, while endocrine disruption data is not a standard requirement at present, this is expected to change. If the proposed changes go ahead, new studies to assess endocrine disruptor impact will become a core requirement of a registration and inform the chemical safety assessment.
Under the revisions presented at CARACAL-54, registrants would have to proactively investigate and report endocrine activity. This will demand specialist advice and new studies. It will likely lead to many challenging discussions with regulators too.
Substance reclassifications could be triggered, with implications for authorisation and / or restriction. The revision will also require companies to assess risks when substances are persistent, mobile and toxic( PMT) or very persistent, very mobile( vPvM), and address combined exposure, with similar implications for regulatory risk management measures.
In addition, the proposals outline the expansion of registration requirements to include polymers, which are generally exempt from REACH at present. All entities manufacturing or importing a polymer at a volume of more than 1 tonne / year would have to submit a notification to ECHA.
It is likely that hundreds of thousands of polymers would be affected by this requirement. Certain polymers would also have to be registered, based on hazard criteria. These are referred to in the proposals as Polymers Requiring Registration( PRRs).
This proposal would create obligations for companies that have never had to engage with REACH compliance before. Polymers’ structural identity will have to be precisely defined to determine whether they are classified as PRRs. Companies handling PRRs would then have to satisfy new testing and registration requirements, potentially working within complex groupings.
Forming consortia for joint registration and notification of polymers could be a pragmatic response to these escalating requirements. When managed effectively, this approach can lower costs and reduce risks.
Monitor, assess, plan
Until the REACH revisions are finalised, their full impact on business operations, supply chains, and product portfolios cannot be determined. Nevertheless, the EC is clearly serious about expanding requirements, enforcing compliance and accelerating reduced use of harmful chemicals.
Monitoring activity that is indicative of future policy will aid industry foresight, planning and risk mitigation. Right now, all eyes are on the imminent re-draft of ECHA’ s PFAS restriction proposal. This will show how the agency responded to the evidence presented by industry during public consultation, how it intends to implement the essential use concept, and how such broad restrictions might operate.
ECHA’ s restriction proposal for Cr( VI) substances also warrants close attention. This proposal is the first to suggest the removal of substances from Annex XIV of REACH( authorisation) for placement
on Annex XVII( restriction) using a group approach.
It aligns with the Commission’ s aim to enhance the scientific basis for decision-making, streamline the restriction process and use restriction rather than authorisation to regulate SVHCs. And it may set a precedent for how future restrictions and authorisations are handled under the revised REACH framework.
Assessing dossiers to check they meet current requirements is a vital interim measure. Screening substances for endocrine disruptor and persistence concerns, and planning for potential new requirements, is highly advisable too. Early engagement with suppliers, customers and the wider industry is also key to minimise disruption if certain proposals come into effect.
With REACH poised for significant overhaul, it is time to get set for change. Strategic measures taken now will reduce the risk of regulatory overload and aid better management of business impacts later. ●
*- The author would like to thank Richard Bishop, Karen Cooksey, John Albaya, Rebecca Miller, Mike Padgham and Ewen Wright from Sagentia Regulatory for expert contributions to this article
Reference: 1: https:// tinyurl. com / ws6r6xwm
j
Sue Bullock
HEAD OF CHEMICAL COMPLIANCE STEWARDSHIP & SUSTAINABILITY
SAGENTIA REGULATORY sue. bullock @ sagentiaregulatory. com
38 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981