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What are the application procedures and required documents for EU REACH accredit

Date:2026-07-01 10:20:31 Classification :【question】 Visits:
EU REACH Certification Testing Application Process and Required Documents

I. Application Process

1. Preliminary Preparation

Confirm product CAS number, purity, and annual export volume (determine registration tonnage)

Screen for SVHCs (Substances of Very High Concern) (currently 253 items) and Annex 17 restricted substances

Engage an EU Sole Representative (OR) – a legal prerequisite for non-EU companies

2. Selecting a Testing Institution

Priority Verification: GLP certification + CNAS/CMA accreditation + ECHA official operational experience

Recommended one-stop service: "Testing + Registration + OR Agent"

3. Laboratory Testing

| Tonnage Level | Testing Depth

| 1-10 tons | Physicochemical properties + basic toxicity

| 10-100 tons | Add ecotoxicology and mutagenicity

| >100 tons | Complete reproductive toxicity and chronic toxicity data are required.

4. Registration Dossier Submission

Prepare the technical dossier using IUCLID software.

Prepare the CSR (Chemical Safety Report).

Submit it through the REACH-IT system using the OR account.

Pay the registration fee to ECHA.

5. Obtaining a Registration Number + Continuous Maintenance

Once you obtain the registration number, you can legally export to the EU.

Continuously monitor SVHC list updates (January/July annually) and regularly update the dossier.

II. Required Documents List

Basic Company Information

Business License, Production and Operation Permit

EU OR Representative Authorization Letter

Company Information in English (Name, Address, Contact Person)

1. Product Technical Data

CAS Number, Chemical Name, Molecular Formula, Structural Formula

Product Purity (%) and Impurity Analysis Report (COA)

Detailed Production Process Flow Chart

Chinese/English SDS (compliant with GHS and CLP requirements)

2. Testing and Compliance Documents Materials

Physicochemical property test reports (flash point, boiling point, density, etc.)

Toxicological test data (acute, sensitizing, mutagenic, etc.)

Ecotoxicological data (algae, daphnia, fish)

Usage information and description of exposure scenarios

3. Registration-related documents

IUCLID technical dossier

CSR chemical safety report

Tonnage certificate

SIEF data sharing agreement (if any)

III. Special Notes

Special assessment of high-risk substances: NMP, DMF, dichloromethane, etc., are listed as restricted substances in Appendix 17. A special assessment of the usage scenario and exemption conditions is required before application; otherwise, the application may be rejected directly.

Cost optimization suggestions: Joining the SIEF data sharing forum can share testing costs, saving up to 60-70%; first-time exporting companies can prioritize basic tonnage (1-10 tons) registration to reduce initial costs.

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