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Introducing a novel chemical substance to the EU is both a major growth opportunity and a regulatory challenge. Under REACH, full registration obligations apply once annual manufacture or import reaches 1 tonne, unless exemptions or alternative EU frameworks govern the substance.

For leadership teams, the real question is not whether registration is required, but how proactively and strategically their organizations approach it. The right preparation can accelerate market access, reduce regulatory risk, and protect capital investment.

This newsletter outlines a strategic and technical roadmap for companies preparing to bring a new substance to the EU market, from early evaluation to post-registration compliance.

The First-Mover Advantage (and Responsibility)

When a substance has never been registered with the European Chemicals Agency (ECHA), your company steps into a unique position. There is no consortium, no existing datasets, and no cost-sharing opportunities. This means you must act as the Lead Registrant, taking responsibility for generating and submitting the full set of required data.

Being the first registrant comes with both responsibility and opportunity. You gain full data ownership, first-mover advantage, and potential market exclusivity, all of which can strengthen pricing power and competitive differentiation. At the same time, your organization becomes the legal duty holder under REACH, accountable for dossier accuracy, compliance, and ongoing regulatory obligations.

Key Steps to Successful Registration

1. Understand the Regulatory Landscape

Before investing in testing or dossier preparation, evaluate which regulations apply to your new substance. Consider:

• REACH obligations and potential exemptions
• Other relevant EU legislation (e.g., CLP, BPR, Cosmetics, Food Contact, Fertilisers)
• Reduced data requirements or special derogations

This upfront assessment informs market-entry planning, budget allocation, and project feasibility, ensuring your strategy is grounded in regulatory reality.

2. Engage with ECHA Early via an Inquiry Dossier

Submitting an inquiry dossier through REACH-IT is mandatory before registration. This step confirms substance identity, checks for existing registrations, and identifies any shareable data.

For novel substances, no existing data on your specific substance is typically available. This means you must fulfill REACH information requirements by generating substance-specific data. In addition, it is essential to collect relevant information on structurally similar substances to support read-across approaches and, where applicable, gather data on individual constituents in the case of multi-constituent or UVCB substances. This comprehensive strategy not only ensures regulatory compliance but also significantly reduces testing costs and minimizes the use of vertebrate animals by leveraging waivers, read-across, and existing data sources. Early inquiry also signals your intent to ECHA and helps avoid delays later.

3. Generate the Full REACH Data Package

As Lead Registrant, you are responsible for compiling a comprehensive dataset required under REACH Annexes VII-X which typically include:

• Analytical and identity data
• Physicochemical properties
• Toxicology and ecotoxicology studies
• Environmental fate and behavior data
• Chemical Safety Report (for annual volumes ≥10 t)
• Exposure scenarios and operational conditions

Strategic Considerations

1. Budget early: Testing costs can exceed €100,000/substance for higher tonnage bands.
2. Explore read-across and waivers: Reduce unnecessary studies where scientifically justified.
3. Engage experts: Regulatory consultants can optimize study design and avoid costly mistakes.

4. Prepare and Submit the IUCLID Dossier

Once the required data is ready, the IUCLID dossier should be submitted via REACH-IT, including all study summaries, classification, CSR, exposure scenarios, and tonnage-specific data. Following submission, ECHA conducts a completeness check, and registration fees vary depending on company size and annual volumes.

Timeline and Planning Considerations

From inquiry to registration, a novel substance registration project typically spans 9–24 months:

• Analytical Data Generation: Analytical and identity data must be finalized before preparation of the inquiry dossier. This step is critical for substance identification and can take additional time for complex substances (e.g., UVCBs or multi-constituent substances).
• Inquiry Dossier Preparation and Submission: 1–2 months for straightforward substances, but longer for complex substances requiring detailed composition and identity clarification. ECHA uses this dossier to confirm substance identity and check for existing registrations.
• Data Generation and Testing: 4–18 months, depending on tonnage band and testing requirements. Higher tonnage bands require more extensive studies, which significantly increases preparation time.
• IUCLID Dossier Preparation: 2–4 months, with higher tonnage bands typically taking longer due to additional data, Chemical Safety Report, and exposure scenarios.
• ECHA Completeness Check: Approximately 3 weeks, assuming no technical issues.

Integrating this timeline into product launch planning and supply chain strategies is crucial to avoid delays or disruptions.

Non-EU Manufacturers: The Role of an Only Representative (OR)

Non-EU manufacturers or formulators can appoint an EU-based Only Representative to manage registration, maintain dossiers, interface with ECHA, and handle ongoing compliance. The OR acts as the legal duty holder on behalf of the foreign supplier, shielding EU importers from direct obligations.

Strategic Planning Is Essential: Preparing for Continuous Compliance

The key cost drivers include registration fees, laboratory testing, expert support for dossier preparation, Only Representative fees, and ongoing compliance maintenance. Without cost-sharing opportunities, proactive strategic planning is crucial to minimize unnecessary studies and protect your investment.

Business must understand that registration is not the endpoint. Companies must update dossiers, respond to evaluation requests, and maintain compliance to avoid enforcement actions, supply chain disruption, or loss of EU market access.

Note that even if your novel substance is a safer alternative to a hazardous chemical, REACH obligations may still apply. Thus, starting early ensures compliance, reduces risks, and safeguards your business.

Need support for registering your novel substance under EU REACH?

REACHLaw provides comprehensive support for registering new substances under EU REACH, serving either as your Only Representative or as a dedicated service provider. For expert assistance, please contact us at sales@reachlaw.fi.