European Chemicals Agency (ECHA) proposed adding n-hexane to the Substances of Very High Concern (SVHC) Candidate List. This decision is based on scientific evidence indicating that n-hexane exposure may pose significant health risks, particularly in occupational settings. Potential effects include neurotoxicity, reproductive toxicity, and other long-term health concerns.

This proposal is part of the REACH regulation, which aims to protect human health and the environment while promoting the use of safer alternatives.

Scientific and Regulatory Justification

The proposal to include n-hexane on the SVHC list is supported by several scientific findings:

• Neurotoxicity: Research has shown that prolonged exposure to n-hexane can lead to peripheral neuropathy, causing nerve damage and muscle weakness, especially in workers handling the substance.
• Reproductive Toxicity: Long-term exposure to n-hexane has been associated with adverse effects on fertility and fetal development.
• Widespread Industrial Use: N-hexane is commonly used in various industrial applications, including adhesives, degreasers, printing inks, and cleaning agents, presenting health risks to workers exposed to the substance.

Next Steps in the Regulatory Process

ECHA is in the process of compiling the official dossier, which is expected to be submitted by August 4, 2025. Once submitted, the proposal will enter a public consultation phase, providing an opportunity for industry stakeholders, regulatory bodies, and other interested parties to submit feedback.

If n-hexane is added to the SVHC Candidate List, it could eventually be included in the Authorisation List (Annex XIV of REACH). This would require companies to apply for explicit authorization to continue using n-hexane.

Potential Impact on Industries

The inclusion of n-hexane in the SVHC Candidate List could significantly impact several industries that rely on the substance:

• Manufacturing & Industrial Cleaning: N-hexane is commonly used as a solvent in adhesives and degreasing applications.
• Electronics & Automotive: The substance is used in cleaning solutions for precision components.
• Printing & Textiles: N-hexane is found in certain printing inks and textile processing methods.
• Pharmaceutical & Laboratory Applications: It is employed in extraction and purification processes.

Recommended Actions for Companies

To prepare for potential regulatory changes, companies should take the following actions:

1. Assess Current Usage: Review all products and processes where n-hexane is used.
2. Explore Safer Alternatives: Investigate substitute chemicals that are safer and meet performance standards.
3. Stay Informed: Monitor ECHA's regulatory updates regarding the status of n-hexane.
4. Participate in the Consultation Process: If your industry is impacted, provide feedback during the public consultation phase.
5. Develop a Compliance Strategy: Should n-hexane be added to the Authorisation List, prepare for authorization applications or consider phased substitution of the substance.

The proposed inclusion of n-hexane in the SVHC Candidate List represents a significant regulatory change. Companies using n-hexane should begin evaluating their usage and exploring alternative solutions to ensure compliance and mitigate any potential operational disruptions.

For more details, visit ECHA SVHC Proposal.

 

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