Registration Dossier for UK REACH

A Registration Dossier under UK REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) is a comprehensive submission containing all necessary data for a chemical substance to be legally manufactured, imported, or used in Great Britain (England, Scotland, and Wales).

1. Purpose of the Registration Dossier

  • Provides scientific data on a chemical’s properties, classification, and safe use.
  • Ensures compliance with UK REACH regulations for substances ≥1 tonne per year.
  • Supports risk assessment and management of chemicals in the supply chain.

2. Key Components of a UK REACH Registration Dossier

A. Substance Identification

  • Chemical name, molecular formula, and structure.
  • CAS number, EC number, and other identifiers.
  • Composition details, including purity and impurities.

B. Manufacturing and Use Information

  • Production methods and intended applications.
  • Supply chain details (e.g., industrial, professional, or consumer use).

C. Hazard Classification and Labelling

  • Compliance with UK CLP (Classification, Labelling, and Packaging) regulations.
  • Hazard statements, precautionary measures, and safety labels.

D. Physical and Chemical Properties

  • Data on solubility, stability, reactivity, boiling/melting points, and flammability.

E. Toxicological and Ecotoxicological Studies

  • Human health impact (e.g., acute toxicity, skin irritation, reproductive toxicity).
  • Environmental hazards (e.g., aquatic toxicity, persistence, and bioaccumulation).

F. Exposure Assessment and Risk Management

  • Worker and consumer exposure scenarios.
  • Recommended protective measures.

G. Chemical Safety Report (CSR) (Required for ≥10 tpa Substances)

  • Comprehensive risk assessment of the substance.
  • Safe handling recommendations for all identified uses.

3. Who Needs to Submit a Registration Dossier?

  • Manufacturers producing chemicals in Great Britain.
  • Importers bringing substances from the EU or other countries.
  • Only Representatives (ORs) acting on behalf of non-UK suppliers.

4. Submission Process

  • Registrations must be submitted via the UK REACH-IT system (managed by HSE).
  • Companies may use existing EU REACH data, but data-sharing agreements may be required.
  • Fees apply based on company size and substance tonnage.

5. Deadlines for UK REACH Registration

  • High-tonnage & hazardous substances (≥1,000 tpa, CMRs, aquatic toxicity) – Deadline: October 27, 2023.
  • Medium-tonnage substances (≥100 tpa) – Deadline: October 27, 2025.
  • Low-tonnage substances (≥1 tpa) – Deadline: October 27, 2027.

6. Importance of Compliance

  • Non-compliance results in legal penalties and market restrictions.
  • Ensures chemical safety for workers, consumers, and the environment.
  • Facilitates continued business operations in the UK chemical market.