ECHA Adds Five Substances to REACH Candidate List

On 23 January 2024 the European Chemicals Agency added five new substances of very high concern to the REACH Candidate List, bringing the total to 240 entries. Companies placing articles containing these substances above 0.1% w/w on the EU market must notify ECHA and provide safety information to downstream users within six months of listing. This update reflects ongoing efforts to identify and regulate chemicals that pose serious risks to human health and the environment.

Newly Added Substances of Very High Concern

The January 2024 update adds substances identified as carcinogenic, mutagenic, reproductive toxicants, or persistent, bioaccumulative, and toxic under REACH Article 57. Each substance underwent extensive evaluation by ECHA's Member State Committee before addition to the Candidate List.

• 2,4,6-tri-tert-butylphenol (EC 211-989-5). Added due to endocrine disrupting properties affecting human health. This antioxidant is used in lubricants, fuels, and rubber products.
• 2-(4-tert-butylbenzyl)propionaldehyde (EC 201-289-8). Listed for very persistent and very bioaccumulative properties. Found in fragrances and cosmetic formulations.
• Oligomerisation products. Several oligomerisation and reaction products added based on persistence and bioaccumulation characteristics relevant to environmental protection.

Compliance Obligations for EU Market Participants

Companies affected by this Candidate List update must assess their product portfolios and supply chains for the presence of newly listed substances. The 0.1% weight-by-weight threshold applies to individual substances within articles, requiring detailed composition analysis for complex products.

• Communication requirements. Suppliers of articles containing Candidate List substances above threshold must provide sufficient information to allow safe use, at minimum including the substance name. This obligation triggers immediately upon listing.
• SCIP database notification. Within six months, suppliers must submit notifications to ECHA's Substances of Concern In articles database, providing information about the article, substance identity, and safe use conditions.
• Supply chain due diligence. Companies should request declarations from suppliers regarding Candidate List substance content, updating supplier questionnaires and contractual requirements to capture new entries.

Business Impact and Strategic Considerations

Candidate List substances face potential authorization requirements if added to REACH Annex XIV, which would require specific permission for continued use. Companies should evaluate reformulation opportunities and alternative substances early rather than waiting for authorization deadlines.

The regulatory trajectory from Candidate List to Authorization List typically spans several years, providing lead time for substance substitution programs. However, downstream users now specify Candidate List-free requirements in procurement specifications, creating market pressure beyond strict regulatory obligations.

Implementation Steps for Compliance Teams

• Product screening. Review bill of materials and material declarations for products sold in the EU market against the updated Candidate List. Automated screening tools can accelerate this process for organizations with large product portfolios.
• Supplier engagement. Update supplier surveys and certificates of compliance to include newly listed substances. Request updated declarations from suppliers within affected supply chains.
• SCIP notification preparation. Gather required data elements for SCIP submissions, including article identifiers, substance concentrations, and safe use instructions. Consider implementing IUCLID-compatible data management systems for simplified submissions.
• Customer communication. Prepare responses for customer inquiries about Candidate List substance content. early communication shows regulatory awareness and supports downstream compliance programs.

Future Regulatory Developments

ECHA typically updates the Candidate List twice annually, with additional substances under evaluation for future additions. If you are affected, monitor ECHA's Registry of Intentions for advance notice of upcoming proposals and participate in public consultations when substances relevant to their operations are under consideration. The European Commission's Chemicals Strategy for Sustainability signals continued expansion of substance restrictions, making early compliance program development essential for long-term market access.

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Coverage intelligence

Published

January 23, 2024

Coverage pillar

Infrastructure

Source credibility

87/100 — high confidence

Topics

REACH · ECHA · SVHC · Compliance

Sources cited

3 sources (echa.europa.eu, iso.org)

Reading time

5 min

References

1. ECHA — Five New Substances Added to the Candidate List (January 23, 2024) — echa.europa.eu
2. ECHA — Candidate List — echa.europa.eu
3. ISO/IEC 27017:2015 — Cloud Service Security Controls — International Organization for Standardization