In 2024, ECHA issued more than 200 formal decisions asking companies to provide new information—often on long-term human health and environmental endpoints. Around 30% of these cases are now in enforcement hands, underlining a pattern: dossiers are not keeping pace with regulatory expectations. This is not about “old” dossiers anymore—every submission is under scrutiny.
Substance Identity: The Persistent Challenge for UVCBs and Complex Materials
One of the loudest signals from Helsinki is clear: “Be clear on what you register.” For substances of unknown or variable composition (UVCBs), companies are still struggling with boundary compositions, representative constituents, and consistent groupings.
Petroleum UVCBs illustrate the pain:
- Analytics above C30 remain inconclusive.
- Lack of standardised methods makes read-across increasingly difficult to defend.
- Registrants are uncertain about the granularity required for variability and impurities.
When dossiers cannot pin down substance identity, risk assessments, classification, and authorisation all start on shaky ground.
Annex XI Adaptations: When Justifications Fall Short
Many dossiers rely on adaptations instead of new testing. Regulators are clear: weak or copy-paste justifications no longer pass. Companies have seen adaptation arguments dismissed because they failed to cover:
- Boundary conditions,
- Long-term endpoint coverage,
- Scientific reliability of existing data.
The result? Unexpected testing obligations and delays in supply.
Exposure Data in CSRs: Why Regulators Still Say It’s Not Enough
Another under-reported weakness lies in the exposure scenarios and exposure data included in Chemical Safety Reports (CSRs). ECHA and sector groups like ECETOC stress that:
- Exposure scenarios are too often generic, not operational.
- Downstream users receive inconsistent ES that cannot be compared across suppliers.
- Data gaps force policymakers to gather their own monitoring evidence for restrictions or OEL setting.
Companies complain on LinkedIn about “exposure scenarios that read like cut-and-paste checklists” and “annexes that don’t match workplace reality.” These aren’t minor errors—they are becoming enforcement triggers.
The Cost of Non-Compliance: From Formal Decisions to Enforcement
Every weak dossier invites extra questions. Each extra question adds time, costs, and uncertainty. For SMEs, one badly prepared update can mean being locked out of the EU market until issues are resolved. Across sectors, compliance leaders say the same thing: “We didn’t realise until the evaluation decision hit us.”
Practical Steps to Strengthen Your Registration Dossier in 2025
- Refresh Substance Identity Files
– Document boundaries and representative constituents in line with ECHA’s recommendations.
– For UVCBs, align with sector-specific analytical guidance and invest in reproducible methods (e.g. GC×GC, FD-MS). - Upgrade Annex XI Justifications
– Re-evaluate adaptation strategies against ECHA’s most recent decision letters.
– Provide robust scientific reasoning rather than generic citations. - Rebuild Exposure Scenarios for Reality
– Ensure exposure scenarios match actual downstream conditions, not theoretical defaults.
– Harmonise ES with sector SWED codes and make use of SUMIs where available. - Monitor Evaluation Lists and IT Updates
– Track ECHA’s published evaluation lists and upcoming IUCLID changes to avoid being blindsided.
– Anticipate data requirements for long-term endpoints rather than waiting for a decision.
By embedding these actions into compliance processes now, companies can stay ahead of ECHA’s shifting baseline and reduce the cycle of “decision → update → re-decision.”