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.

Step-by-step guidance

Successful implementation requires a structured approach that addresses technical, operational, and organizational considerations. Organizations should establish dedicated implementation teams with clear responsibilities and sufficient authority to drive necessary changes across the enterprise.

Project governance should include regular status reviews, risk assessments, and stakeholder communications. Executive sponsorship is essential for securing resources and removing organizational barriers that might impede progress.

Change management practices help ensure smooth transitions and stakeholder acceptance. Training programs, communication plans, and feedback mechanisms all contribute to effective change management outcomes.

Verification steps

Compliance verification involves systematic evaluation of implemented controls against applicable requirements. Organizations should establish verification procedures that provide objective evidence of compliance status and identify areas requiring remediation.

Internal audit functions play an important role in providing independent assurance over compliance activities. Audit plans should incorporate risk-based prioritization and coordination with external audit requirements where applicable.

Continuous compliance monitoring capabilities enable early detection of control failures or compliance drift. Automated monitoring tools can provide real-time visibility into compliance status across multiple control domains.

Vendor considerations

Third-party relationships require careful management to ensure compliance obligations are properly addressed throughout the vendor ecosystem. Due diligence procedures should evaluate vendor compliance capabilities before engagement.

Contractual provisions should clearly allocate compliance responsibilities and establish appropriate oversight mechanisms. Service level agreements should address compliance-relevant performance metrics and reporting requirements.

Ongoing vendor monitoring ensures continued compliance throughout the relationship lifecycle. Periodic assessments, audit rights, and incident response procedures all contribute to effective third-party risk management.

Planning considerations

Strategic alignment ensures that compliance initiatives support broader organizational objectives while addressing regulatory requirements. Leadership should evaluate how this development affects competitive positioning, operational efficiency, and stakeholder relationships.

Resource planning should account for both immediate implementation needs and ongoing operational requirements. Organizations should develop realistic timelines that balance urgency with practical constraints on resource availability and organizational capacity for change.

Tracking performance

Effective monitoring programs provide visibility into compliance status and control effectiveness. Key performance indicators should be established for critical control areas, with regular reporting to appropriate stakeholders.

Metrics should address both compliance outcomes and process efficiency, enabling continuous improvement of compliance operations. Trend analysis helps identify emerging issues and evaluate the impact of improvement initiatives.

Summary and next steps

Organizations should prioritize assessment of their current posture against the requirements outlined above and develop actionable plans to address identified gaps. Regular progress reviews and stakeholder communications help maintain momentum and accountability throughout the implementation journey.

Continued engagement with industry peers, professional associations, and regulatory bodies provides valuable opportunities for knowledge sharing and influence on future policy developments. Organizations that address emerging requirements position themselves favorably relative to competitors and build stakeholder confidence.

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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