MSC Confirms n-Hexane as SVHC Due to Neurotoxic Effects

The substance will be formally added to the Candidate List by February 2026, impacting manufacturers, downstream users and suppliers handling n-hexane across the EU chemicals value chain.

Why n-hexane is now an SVHC

n-Hexane (EC 203-777-6) was proposed by the Slovenian competent authority for SVHC identification due to its irreversible neurotoxic effects upon prolonged exposure. The justification relied on its harmonised classification as STOT RE 1 H372 (causing damage to the nervous system through prolonged or repeated exposure), in combination with case-specific data demonstrating long-term health impacts.

ECHA’s MSC confirmed that n-hexane meets the criteria of equivalent level of concern, considering evidence such as the irreversibility of effects, societal impacts, and lack of a safe concentration. Data from patient follow-ups showed persistent symptoms even four years after exposure ceased, strengthening the argument for ELoC.

Implications across the chemicals supply chain

The identification of n-hexane as an SVHC will bring additional legal obligations under REACH. Suppliers of articles containing the substance above 0.1% weight-by-weight will need to notify ECHA and inform recipients under Article 33 duties. Substitution planning, reformulation and exposure control may become necessary, particularly in sectors where n-hexane is widely used — such as solvents in adhesives, cleaning agents, and chemical synthesis.

Furthermore, inclusion in the Candidate List is often a precursor to authorisation or restriction, which could have commercial and operational implications for businesses relying on the substance.

Growing momentum behind ELoC-based regulation

This case represents a first-of-its-kind SVHC identification for a neurotoxic substance under the ELoC route. While not the first use of Article 57(f), the inclusion of n-hexane reflects increasing focus on emerging hazard categories, beyond CMRs and PBTs. Three NGO observers voiced strong support, while one MSC member abstained, citing data limitations on irreversibility and societal concern.

During the meeting, ECHA also called for further development of guidance on ELoC determinations, signalling potential expansion of this regulatory pathway for future SVHCs.