ECHA Considers Adding n-Hexane to SVHC Candidate List

On February 18, 2025, the European Chemicals Agency (ECHA) proposed adding n-hexane to the Substances of Very High Concern (SVHC) Candidate List due to its probable serious effects on human health. Currently, the relevant dossier for n-hexane is being actively prepared by the proposer and is expected to be submitted by August 4, 2025.

Currently, the List contains a total of 247 substances. You can access the complete substance of very high concern (SVHC) list here.

After submission, ECHA will initiate a public consultation to determine whether n-hexane should be officially listed as an SVHC. During this period, all stakeholders will have the right to submit feedback to ECHA. Once the feedback is reviewed and accepted, n-hexane will be formally added to the SVHC Candidate List.

CIRS Insights

Companies exporting products to the EU containing SVHCs above 0.1% must fulfill the following obligations:

1. Information Transfer: Suppliers must provide recipients with safety information for safe use if SVHC content exceeds 0.1%.
2. Consumer Requests: Provide sufficient information (e.g., substance name and concentration) free of charge within 45 days upon consumer request.
3. SVHC Notification: If annual exports exceed 1 tonne per year (t/y), importers/producers must notify ECHA within 6 months.
4. SCIP Notification: Since January 5, 2021, submit SVHC-related information to ECHA’s SCIP database if content exceeds 0.1%.
5. Future Compliance: SVHC-listed substances may later be added to the Authorisation List. Companies must apply for authorization to continue their use.

About CIRS

CIRS Group is a leading provider of comprehensive regulatory compliance services and solutions for chemicals, cosmetics, food and food-related products, agrochemicals, and medical devices. Its chemical team consists of experts with extensive knowledge in chemistry, toxicology, environmental science, and related fields. They are well-versed in various international regulations, including but not limited to EU REACH, CLP, GHS, TSCA, and K-REACH. Our chemical compliance services in the EU cover:

• EU REACH Registration (including OR services);
• EU REACH Evaluation Compliance Services;
• SVHC Testing;
• EU CLP Compliance;
• EU Poison Center Notification; and 
• EU BPR Compliance.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

ECHA