Under the EU REACH Regulation, registrants carry a continuous responsibility to keep dossiers accurate, up to date, and compliant. Over time, some registrants may assume that once a registration has been accepted, the work is “done.” In reality, that’s rarely the case.

Today, the bar for dossier quality is higher than ever. Technical completeness checks (TCC) are more stringent, and manual verifications by ECHA experts can highlight deficiencies that would have passed through older screening systems. For dossiers prepared years ago, this means previously unnoticed gaps may now be flagged.

So why does this create a business risk:

• ECHA Decisions: If your substance is selected for evaluation or compliance check, you may face strict deadlines to provide additional information.
• Urgent updates: Changes in registrant circumstances, substance classification, new data, or customer demands may require spontaneous dossier updates.

In either case, if hidden deficiencies surface, your time dependent resubmission may be rejected or be subject to unexpected resubmission demands. That takes time, resources, and often additional cost—none of which may be available when the clock is ticking.

Our perspective:

At Blue Frog Scientific, we’ve seen first-hand how dossier weaknesses can become critical pain points at the worst possible moment. The key is to identify and resolve them early—before an ECHA deadline or business-critical update forces your hand.

How we help:

• Dossier health checks: We review existing submissions against current TCC and ECHA expectations to spot weaknesses before they become problems.
• Targeted remediation: Where gaps exist, we help you resolve them efficiently—whether through improved justifications, updated substance identity information, or additional data strategies.
• Ongoing support: We work with clients to maintain dossier quality over time, reducing regulatory risk and ensuring readiness for any urgent updates.

Why it matters:

Maintaining high-quality dossiers isn’t just about compliance. It’s about business resilience—protecting your market access, avoiding costly last-minute fixes, and ensuring you can respond to regulators and customers with confidence.

If you’d like to explore whether your dossiers are fit for today’s ECHA scrutiny, and advice on a cost-effective dossier quality programme, please contact us for further information. We are here to help.