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REACH Registration & Compliance Support  QbD Group

REACH Registration & Compliance

Preparing to register substances under REACH?

Whether you're registering a new substance, updating an existing dossier, or expanding your market access in the EU/EEA, REACH compliance demands precision, strategy, and up-to-date data.

At QbD Group, we help you navigate every step, from substance characterization and IUCLID dossier build to SDS authoring and Chemical Safety Reporting. With our expert support, you can register with confidence and stay compliant.

 

What is REACH registration?

Under REACH, all chemical substances manufactured or imported into the EU/EEA in quantities of 1 tonne or more per year must be registered with ECHA.

The obligation usually applies to:

  • EU/EEA manufacturers

  • Importers of substances or mixtures from outside the EU/EEA

  • Only Representatives acting on behalf of non-EU companies

Registration is based on the “one substance, one registration” principle and is submitted digitally via the REACH portal using IUCLID.

Why is it important?

Accurate substance identity and composition data are the foundation of a successful dossier. They help to:

  • Avoid duplicate testing and unnecessary costs

  • Ensure reliable hazard and risk assessments

  • Streamline the evaluation process and reduce post-submission questions

Getting the fundamentals right – such as SIP, analytics, impurities, and use mapping – saves time, money, and effort throughout the registration.

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How can we help?

No matter what your nitrosamine risk assessment (NRA) needs are, we have different services to support you:

Substance Characterization & SIP

Substance Characterization & SIP

We prepare a defensible Substance Identification Profile (SIP) and compile the analytical package required for REACH registration, in line with the “one substance, one registration” principle.
Our support includes:

  • Substance identification and analytical data package

  • Qualitative and quantitative composition profile (constituents and additives)

  • Impurity assessment aligned with the SIP

  • IUCLID data entry and documentation upload

These steps are essential to avoid rework and ensure consistent dossier decisions.

Safety Data Sheets (SDS) & Extended SDS

Safety Data Sheets (SDS) & Extended SDS

We draft and maintain REACH-compliant Safety Data Sheets (SDS) in accordance with Annex II (16 sections), including extended SDS for substances or mixtures that require exposure scenarios (typically ≥ 10 t/y).
Our services cover:

  • Authoring of SDS and extended SDS

  • Updates following changes in classification, uses, or hazard data

  • Biosafety/biosecurity assessments where relevant

Chemical Safety Report (CSR)

Chemical Safety Report (CSR)

For substances requiring a CSR, we provide end-to-end support—from data collection to dossier submission.
Our services include:

  • Hazard assessment (human health, physicochemical, environmental, PBT/vPvB)

  • Exposure assessment and risk characterization

  • CSR preparation and submission in IUCLID

  • CSR updates based on new data, uses, or regulatory changes

Why QbD Group?

With over a decade of experience in regulatory compliance, QbD Group is your trusted partner for REACH registration and dossier management.

  • Our experts have supported successful REACH registrations across a wide range of chemical sectors, from specialty chemicals to pharma ingredients.

  • We combine deep regulatory knowledge with hands-on IUCLID expertise to minimize delays, costs, and post-submission questions.

From substance characterization to Chemical Safety Reports, we cover the full lifecycle of your REACH obligations—with a strategic, quality-driven approach.

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10+ years of experience

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Full lifecycle dossier support

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Successful registrations across EU and globe

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In-depth IUCLID and CSR expertise

 

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Ready to take te next step?

Let QbD Group guide you through the complexities of REACH registration and compliance. Contact us today to discuss how we can support your submission.

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