
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.

Slovenia has announced its intention to classify n-hexane as a Substance of Very High Concern (SVHC) under the REACH Regulation (EC) 1907/2006, citing its neurotoxic effects and serious risks to human health. The proposal, submitted to the European Chemicals Agency (ECHA), is expected for formal evaluation on 4 August 2025. This development could lead to stricter regulatory controls, impacting industries that rely on n-hexane in adhesives, coatings, lubricants, pharmaceuticals, and cosmetics.
n-Hexane (EC: 203-777-6, CAS: 110-54-3) is a widely used industrial solvent found in multiple applications:
Industrial solvents – Essential in adhesives, coatings, rubber, and plastics manufacturing.Paints and coatings – Found in surface treatments and chemical formulations.Automotive industry – Used in lubricants, greases, and hydraulic fluids.Pharmaceutical and laboratory use – Applied in scientific research and healthcare.Cosmetics and personal care – Present in fragrances, waxes, and beauty products.
With its classification under REACH Article 57(f), businesses using n-hexane may need to reassess formulations, explore alternatives, or adjust compliance strategies.
ECHA classifies n-hexane as a highly flammable liquid and vapour, with additional concerns over chronic health effects:
Neurotoxic properties – Long-term exposure can cause nerve damage.Suspected reproductive toxicity – Potential risk to fertility and foetal development.Organ damage – Repeated exposure may affect the central nervous system.Environmental hazard – Toxic to aquatic life with long-lasting effects.
Businesses across the manufacturing, automotive, and chemical sectors must evaluate workplace exposure limits, ventilation systems, and employee protective measures to comply with potential future restrictions.
The formal SVHC proposal submission is scheduled for 4 August 2025, allowing time for stakeholder engagement and consultation. If approved, n-hexane could be added to the Candidate List for Authorisation, restricting its availability and requiring authorisation for continued use. Companies should:
Review supply chains – Identify dependencies on n-hexane and explore alternatives.Assess workplace safety – Ensure compliance with occupational exposure limits (OELs).Monitor regulatory updates – Stay informed on the consultation process and potential classification.




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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