REACH Dossier Preparation and Submission

What is a REACH Dossier?

A REACH dossier is the registration dossier that companies must submit to ECHA under the REACH Regulation in order to legally manufacture or import a substance in the European Union. This dossier includes information on the physical and chemical properties of substances, as well as their effects on human health and the environment.

A properly prepared registration dossier ensures regulatory compliance, market access, and helps prevent commercial disruptions. Chemleg can support you throughout this process.

When is a REACH Dossier Required?

A REACH registration is mandatory for substances manufactured or imported into the EU in quantities of 1 tonne or more per year. To complete this registration, a REACH dossier must be prepared.

Therefore, companies based in the EU that manufacture or import substances are subject to dossier obligations, and non-EU companies exporting to the EU via an Only Representative may choose to be compliant under the REACH regulation in order to cover their clients.

How is a REACH Dossier Prepared?

REACH dossiers can be categorized into Lead Registration Dossiers and Joint Registration Dossiers. Detailed information and preparation steps for each are provided below:

1. REACH Lead Registration Dossier

    

   The lead registration dossier is the main and most comprehensive dossier submitted for a substance. All companies wishing to register the same substance in the EU must appoint a single Lead Registrant. The Lead Registrant is responsible for preparing the lead dossier, which typically includes:

• Substance Identification: Detailed information such as CAS and EC numbers, purity, and impurities.
• Hazard Data: All test results and study summaries on the substance’s physico-chemical, toxicological, and ecotoxicological properties.
• Chemical Safety Report (CSR): Required for substances of 10 tonnes or more per year; includes hazard assessment, exposure scenarios, and risk characterization.
• IUCLID Format: All data must be prepared using ECHA’s IUCLID software in a structured format.
• Submission via REACH-IT: The IUCLID dossier is submitted to ECHA through the REACH-IT portal and the registration fee is paid.

2. REACH Joint registration Dossier

    

   The joint registration dossier complements the lead dossier and includes company-specific information for each registrant. The preparation steps are as follows:

• Referencing the Lead Dossier: The joint registrant refers to the hazard data and CSR provided in the lead dossier.
• Company and Substance Information: Each joint registrant provides their company details and the annual tonnage band of the substance (e.g., 10–100 tonnes/year).
• Uses: Each joint registrant provides their own uses for the substance. If the joint registrant uses the substance differently from what is covered in the lead registrant’s CSR, they may need to include their own exposure scenarios or risk management measures.
• IUCLID Format: This dossier is also prepared using the IUCLID software.
• Submission via REACH-IT: After the lead dossier is submitted, joint registration dossiers are submitted individually via REACH-IT and the relevant fees are paid.

Stay Compliant with Chemleg’s REACH Dossier Services

Chemleg offers expert support for dossier preparation and submission under EU REACH Regulation. With our end-to-end compliance service, you can ensure full legal compliance and protect your company from delays and penalties.

Our dossier preparation & submission service includes:

• Substance Identification & Data Collection
• Data Gap Analysis & Testing Strategy
• IUCLID Dossier Compilation
• Chemical Safety Report (CSR)
• Submission via REACH-IT
• Dossier Submission & Update Management

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