REACH Registration & Dossier Strategy

Introduction

From substance to submission. From compliance to confidence

To market a chemical substance in Europe, you need more than safety data. You need a registration dossier that meets strict REACH requirements and holds up under scrutiny. Triskelion helps you define your registration strategy, build a robust dossier and navigate the entire submission process. Whether you are a lead registrant or part of a joint submission, we ensure that your product reaches the market safely, legally and responsibly.

What is REACH registration, and why does it matter?

REACH (Registration, Evaluation, authorization and Restriction of Chemicals) is the main regulatory framework for chemical substances in the EU. Any company placing a substance on the European market above one tonne per year must register that substance with ECHA, including detailed information on identity, composition, toxicology, environmental fate and exposure.

Registration is not just a legal checkbox. It is the foundation of your compliance and a signal to your clients and regulators that your product has been assessed thoroughly. A weak or incomplete dossier can lead to rejection, increased costs or enforcement action. A strong dossier protects your market access and builds trust.

What does the legislation require?

Depending on your role (importer, manufacturer or representative) and your tonnage band, the REACH regulation requires you to submit a registration dossier that includes:

Substance identity and composition information
• Data on physico-chemical, toxicological and ecotoxicological properties
• Chemical safety assessment (CSA) and chemical safety report (CSR)
• Exposure scenarios and use descriptions
• Evidence of data sharing or data waivers

The registration must be submitted via IUCLID and is subject to ECHA’s completeness check and possible compliance evaluation. Dossiers must be regularly updated when new information becomes available or when the scope of use changes.

What does this mean in practice?

REACH dossier preparation becomes a challenge when
• your substance has unclear composition or borderline identity
• you need to rely on data waivers, read-across or non-testing strategies
• you are part of a joint submission but need substance-specific elements
• you lack the time or expertise to complete IUCLID or CSR sections

Without a clear strategy, registration becomes time-consuming, expensive and error-prone. It is essential to know what is required, what can be waived, and how to justify your approach scientifically and legally. That is where Triskelion comes in.

How we support your REACH registration

Triskelion provides full support for REACH registration and dossier development.

Strategic advice: we help define your registration scope, tonnage band obligations and testing requirements
• Data generation and interpretation: we conduct required studies and help you build scientifically justified waivers or read-across
• IUCLID and CSR preparation: we compile and structure your dossier in line with ECHA standards
• Submission and follow-up: we support you during completeness checks, compliance evaluation or ECHA communication

Our multidisciplinary team combines regulatory insight with scientific depth, helping you navigate REACH with clarity and confidence.

Frequently asked questions

Do I always need to test?
Not necessarily. We help you identify where waivers or existing data can be used — saving time and avoiding unnecessary animal testing.

Can I register without being the lead registrant?
Yes. In joint submissions, Triskelion helps ensure that your specific obligations are still met.

What if ECHA finds an issue?
We help you respond to completeness or compliance checks and manage dossier updates or corrections.

Need help with REACH registration?

We help you translate data into a compliant dossier — and a clear market position. Contact us for an intake, dossier review or tailored proposal.