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:
- REACH Lead Registration Dossier
- 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.
- REACH Joint registration Dossier
- 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
Fill out the form to schedule a consultation with our experts.
Frequently Asked Questions
What documents are required for preparing a REACH dossier?
Key documents include:
- Substance identity information
- Physico-chemical, toxicological, and ecotoxicological data
- Chemical Safety Report (CSR)
- Use scenarios and exposure assessments
- SIEF communication and data-sharing information
Is it mandatory to submit a Chemical Safety Report (CSR) with the REACH dossier?
Yes. A CSR is mandatory for substances produced or imported at 10 tonnes or more per year.
Who can prepare a REACH dossier?
The REACH dossier can be prepared by the EU-based manufacturer/importer, a consultancy firm, or the Only Representative of a non-EU manufacturer.
What happens if a REACH dossier is rejected?
Incomplete or incorrect dossiers will be rejected by ECHA. In such cases, the deficiencies must be corrected, and the dossier resubmitted. Non-compliance may result in the product being withdrawn from the market.
Can a product be placed on the market without a REACH dossier?
No. Manufacturing, importing, or selling substances in the EU without completing registration is prohibited.