REGULATION & COMPLIANCE
Do EU REACH revisions spell overload for industry?
Sue Bullock, principal at Sagentia Regulatory( formerly TSG Consulting), says planned changes present challenges, but forewarned is forearmed *
REACH is a centrepin of the European Commission’ s commitment to protecting human health and the environment. So, when the Commission heralded some REACH revisions as a‘ simplification’ we were immediately sceptical. Addressing the regulation’ s well-documented shortcomings without compromising its core objectives was unlikely to reduce the burden on industry.
The proposals discussed by the Competent Authorities of EU Member States in April 2025 appear to confirm our instinct was correct. The emphasis seems to be on simplification for regulatory authorities while accelerating progress towards tighter rules for harmful chemicals.
Industry’ s direct obligations would increase, but this is probably just the tip of the iceberg, because the indirect burden is even more significant( Figure 1). Industry will also face a high level of additional work if it is to effectively steward the range of chemistries currently used in many critical and noncritical applications. Unless a strong, watertight case is made for safe use, some chemicals could be taken off the market altogether.
Status of REACH revisions
The new European Parliament said it would‘ make business easier’ and focus on sustainable prosperity under the 2024-2029 strategic agenda, encouraging industry hopes
REACH revisions
• Ten-year revocation of substance registration if dossier not updated
• Increased use of broad restrictions
• Endocrine disruption data required as standard
• PMT, vPvM and endocrine disruption assessment required
• Polymer introduced and registration
Figure 1- Additional industry burden created by new REACH obligations
for a simpler REACH. Yet, despite lengthy delays to the revision process, very little was revealed about the scope of changes being discussed until recently.
After the proposals were eventually presented at CARACAL-54 on 3 April, CEFIC expressed shock. In a LinkedIn post, it warned that the proposals“ will massively increase the administrative burden for industry and SMEs in particular.” 1
As envisaged, simplifying and expediting core regulatory decisions regarding hazardous chemicals will make lighter work for the authorities. However, in practice, this only serves to transfer a heavier burden to industry( Figure 2).
Industry actions
• Review existing registration dossiers
• Check dossiers regularly and keep updated
• Track and assess emerging and evolving regulatory activity and priorities
• Respond to emerging obligations and engage in public consultations
• Conduct new studies( e. g. to assess substances’ endocrine disruption, PMT, vPvM status)
• Demonstrate chemical safety and value
• Review and optimise data and dossiers to meet new obligations structural identity of polymers
Following consultation with Member States, the EC is now finalising the revisions and publication of its proposals is expected in Q4. Meanwhile, there is a window of opportunity to get a head start on likely new requirements. Given the scale of the potential impact, it is prudent to consider the implications for your business if they come into force as currently foreseen. This will facilitate early consideration of business risk, helping to determine whether the budget, resources and systems necessary for an effective response are in place.
Notable revisions presented at CARACAL-54, include the revocation of chemical registrations after ten years if dossiers have not
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