
EU Set to Debate ‘One Substance, One Assessment’ Chemicals Package to Overhaul Safety Rules
MEPs to debate 'one substance, one assessment' rule to simplify EU chemical safety laws. Industry must prepare for regulatory change.

The European Chemicals Agency (ECHA) has released its annual evaluation statistics, revealing key compliance gaps in REACH registration dossiers. Since 2009, ECHA has assessed 15,500 registrations covering 3,200 substances. In 2024, 313 compliance checks were conducted, leading to 208 decisions requesting additional data from registrants. Around 30% of companies failed to provide the required information, resulting in referrals to national enforcement authorities. Manufacturers, importers, and downstream users must address these regulatory demands to avoid enforcement actions and ensure continued market access.
In 2024, ECHA evaluated nearly 2,000 registrations, prioritising high-volume chemicals (≥100 tonnes per year) and substances with potential hazards. The agency issued:
208 compliance check decisions targeting data gaps in hazard assessments.161 testing proposal reviews, leading to 92 adopted decisions.241 follow-up evaluations, with 30% of cases escalated to national enforcement authorities due to non-compliance.
For high-volume substances, ECHA checked 34% of dossiers to ensure safety data remains up to date. Businesses dealing with these chemicals must reassess their registration dossiers and respond to ECHA’s data requests promptly.
ECHA’s findings signal stricter enforcement of REACH compliance. The agency has adopted three substance evaluation decisions requesting further data on substances of concern. Additionally, the Joint Evaluation Action Plan (2019–2024) has concluded, shifting focus to enforcement and follow-up measures.
Industries relying on chemicals under scrutiny—such as manufacturing, coatings, and plastics—should prepare for possible regulatory restrictions or reclassification. Companies failing to meet data submission deadlines risk market exclusion, supply chain disruptions, and reputational damage.
To stay compliant, businesses should:
Review and update REACH dossiers to address data gaps.Monitor ECHA’s follow-up actions on the Joint Evaluation Action Plan.Engage with regulatory bodies and ensure timely responses to information requests.
As enforcement efforts increase, proactive compliance strategies will be critical in maintaining market access and avoiding penalties.




MEPs to debate 'one substance, one assessment' rule to simplify EU chemical safety laws. Industry must prepare for regulatory change.

The EU’s 2025 Work Programme will introduce a chemicals industry package in Q4 2025, aiming to simplify compliance, reduce administrative burdens, and enhance digital reporting.

This strategy aims to advance chemical safety through science, collaboration, and knowledge, emphasising the protection of human health and the environment.
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