
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 Commission has proposed significant changes to the REACH Fee Regulation (EC) No 340/2008, targeting both the financial and procedural dimensions of chemical registration in the EU.
The amendment introduces inflation-indexed fee increases and a new system of pre-verification for SMEs, set to reshape compliance obligations across the chemicals value chain.
To stabilise funding for the European Chemicals
Agency (ECHA), the Commission proposes raising standard REACH fees by 19.5%, covering cumulative inflation for 2021–2023.
These fees apply to all major activities—registrations, updates, authorisations, and appeals—but SMEs are exempt, maintaining previous fee levels to support their market participation.
This adjustment reflects the broader goal of enhancing ECHA’s financial sustainability amid declining registration volumes and increasing responsibilities under the Chemicals Strategy for Sustainability.
Checks
A key procedural shift is the move from retrospective to advance SME verification.
Companies seeking reduced fees must now apply for SME status at least two months before a fee-liable submission. ECHA will issue decisions valid for three years, covering all relevant EU legislation—not just REACH.
An administrative charge may apply for the verification process, but it is waived if the SME status is confirmed.
This change aims to reduce delays, prevent fee disputes, and ensure fair treatment among registrants.
Once adopted, the regulation will enter into force 20 days after publication in the Official Journal of the European Union. However, the SME verification rules will only apply 15 months later, giving companies time to adjust systems and processes.
Pending submissions on the date of entry into force will remain under current rules, offering some transitional clarity.
The REACH Committee is currently reviewing the proposal through a written procedure, after which the Commission may adopt the measure.




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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