
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 adopted Implementing Regulation (EU) 2025/2067, updating the fees and charges payable to ECHA under REACH. The Regulation, which enters into force on 5 November 2025, introduces a 19.5% fee increase for standard registrants, while small and medium-sized enterprises (SMEs) remain exempt. It also replaces ECHA’s ex post SME verification with a mandatory pre-submission (ex ante) system starting 5 February 2027.
The European Commission said the change aims to improve ECHA’s long-term financial sustainability after declining fee income since the final registration deadline in 2018. Standard REACH fees are now adjusted in line with cumulative inflation rates for 2021–2023. For example, the base fee for an individual registration in the 1–10 tonne range is set at EUR 2,078, while fees for authorisation applications start at EUR 64,650.
SMEs remain protected from the inflation-based adjustment. Reduced fees for medium, small, and micro enterprises continue to apply under Commission Recommendation 2003/361/EC.
ECHA’s SME verification process will move from retrospective checks to advance validation. Companies claiming SME reductions must apply for official recognition at least two months before submission. ECHA will decide within two months of receiving complete documentation, and its decision will remain valid for three years.
An administrative charge may be introduced to cover verification costs but will be waived when SME status is confirmed. Temporary fee reductions may be granted if a decision is pending, though full fees will be recovered if the SME claim is later rejected.
The Regulation takes effect on 5 November 2025, but the new SME verification provisions will only apply from 5 February 2027, providing a 15-month transition period. Pending submissions made before entry into force are unaffected.
The Commission advises companies to prepare early by aligning internal processes with the new timeline, budgeting for higher registration and authorisation costs, and planning SME recognition applications well ahead of 2027 submissions.




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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