Processing of REACH testing report for chemical raw materials in the European Un
Date：2026-03-02 09:27:19 Classification
：【question】 Visits：
Regarding the export of chemical raw materials to the European Union, REACH compliance is not just about issuing a simple "test report", but a systematic compliance process. According to the EU REACH regulation (EC 1907/2006), the compliance obligation of chemical raw materials (substances) mainly depends on the export volume.
The following are detailed guidelines for handling EU REACH compliance (including testing reports) for chemical raw materials:
1、 Core judgment: Do you need "registration" or "testing report"?
For chemical raw materials, two situations must be distinguished:
1. Annual export volume>1 ton: REACH registration is required.
This is a mandatory obligation. A simple test report cannot replace registration.
Test requirement: Registration requires submission of a complete set of data files. According to different tonnages (1-10 tons, 10-100 tons, etc.), physical and chemical tests, toxicology tests (such as acute toxicity, repeated dose toxicity), and ecological toxicology tests need to be conducted. These tests must be conducted in laboratories that comply with GLP (Good Laboratory Practice) standards.
2. Annual export volume<1 ton: No registration required, but REACH testing report or compliance declaration must be provided.
Usually, it is to meet downstream customer requirements and prove that the product does not contain harmful substances.
Testing requirements: Mainly for screening SVHC (Substances of Very High Concern) lists, or for testing restricted substances in REACH Annex 17.
2、 REACH application process for chemical raw materials
Scenario A: REACH registration (export volume>1 ton/year)
This is the mainstream compliance pathway for exporting chemical raw materials to the European Union.
1. Designate a unique representative:
Non EU companies cannot apply directly and must designate a "sole representative" within the EU for registration.
2. Query and Data Purchase:
Check if the substance has been registered. If it is an existing substance, it is usually necessary to join the joint submission and purchase a data authorization letter from the lead registrant to avoid repeated expensive animal experiments.
3. Conduct testing (if there are gaps):
If the existing data does not meet the registration requirements, GLP laboratory needs to be commissioned to conduct supplementary tests (such as physical and chemical properties, degradability, etc.).
4. File production and submission:
Produce a Chemical Safety Report (CSR) and registration file for substances with a capacity of 10 tons/year or more, and submit them to the European Chemicals Agency (ECHA).
5. Obtain registration number:
After passing the review and obtaining the REACH registration number, the product can legally enter the EU market.
Scenario B: Processing REACH testing report (export volume<1 ton/year or customer requirement)
If only the safety of the product needs to be proven, the process is as follows:
1. Fill out the application form:
Provide detailed information about the raw materials (chemical name, CAS number, molecular formula, etc.).
2. Confirm the testing items:
SVHC testing: Screening is conducted based on the SVHC list published by ECHA (updated to over 253 items as of 2026).
Restricted substance testing: Confirm whether the raw materials are subject to the restrictive provisions of REACH Annex 17 (such as heavy metals, specific solvents, etc.).
Note: For pure substances with known components, laboratories usually recommend evaluating them based on the ingredient list rather than blindly conducting comprehensive testing to save costs. *
3. Sample submission for inspection:
Send sufficient samples (usually solid 50g/liquid 50ml or more) to the laboratory.
4. Laboratory testing:
Use GC-MS, ICP-OES and other instruments to analyze the content of harmful substances.
5. Issue a report:
After passing the test, the laboratory issues a REACH testing report.
3、 Key precautions
1. Testing standards and GLP requirements:
If it is for REACH registration, the test data must comply with GLP standards.
If it is for customer inspection, third-party laboratory reports with CMA/CNAS qualifications are generally accepted (Dezewei Testing CNAS registration number: L8083).
2. SDS Safety Data Sheet:
Chemical raw materials must provide safety data sheets (SDS) that comply with REACH regulations. The content of SDS must be consistent with the test report or registration data, which is a key document for downstream users to transmit security information.
3. SVHC reporting obligation:
If the raw material itself contains substances on the SVHC list and the concentration is>0.1%, information must be conveyed to downstream users (reflected in SDS); If the content is>0.1% and the export volume is>1 ton/year, it is also necessary to report to ECHA.
4. Validity period of the report:
The REACH testing report itself does not have a fixed validity period, but it needs to be updated in the following situations:
SVHC list updates (usually twice a year).
Changes in product formula or production process.
Regulatory restrictions have changed.
4、 Cost and cycle reference
REACH testing report:
Cost: depends on the number of testing projects. Single item testing costs several hundred yuan; The cost of comprehensive screening for SVHC is relatively high. If it is a chemical with known composition, the laboratory may issue a conformity statement through evaluation at a lower cost.
Cycle: Usually 5-7 working days.
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