Specific requirements for REACH chemical test reports for solvents.
Date：2025-12-15 09:52:31 Classification
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Solvents, as typical "chemical substances/mixtures," are subject to stricter REACH requirements than ordinary articles. They must not only be monitored for SVHCs (Substances of Very High Concern), but also meet compliance requirements throughout the entire process, including registration, notification, and Safety Data Sheets (SDS). There are indeed many details involved.
I. Core Regulatory Basis for REACH Testing of Solvents
Basic Framework
REACH Regulation (EC 1907/2006): Applicable to all chemical substances, mixtures, and articles containing chemical substances.
Key Provisions:
Registration: Pure solvents or solvent-based mixtures with an annual production/import volume ≥ 1 tonne must submit a registration file (including a Chemical Safety Report, CSR) to ECHA.
Notification: If the solvent contains substances on the SVHC candidate list (updated to 251 items as of 2025), and the concentration is >0.1% (by weight), and the annual import volume... ≥1 ton, ECHA notification required
Restriction: Solvent components explicitly restricted in Annex XVII (e.g., trichloroethylene, formaldehyde) must be strictly controlled in content.
Additional requirements specific to solvents
Classification and Labelling (CLP Regulation): GHS classification must be based on the solvent's physicochemical properties (e.g., flammability, toxicity). Labels must include official EU languages such as French/German.
Safety Data Sheet (SDS): A complete set of 16 items (including ingredient information, hazard statement, and protective measures) must be provided and signed by the responsible party (OR) within the EU.
II. Testing Items and Threshold Requirements (by Scenario)
Pure Solvents (e.g., ethanol, acetone)
| Testing Type | Core Items
| SVHC Screening | 251 Substances of Very High Concern (e.g., benzene, asbestos, PAHs)
| Restricted Substances (Annex XVII) | Trichloroethylene (≤0.1%), Formaldehyde (≤0.1%), Vinyl Chloride Monomer (Not Detectable)
| Physicochemical Properties | Flash point, boiling point, and explosion limits (for CLP classification)
Solvent-based mixtures (e.g., paint thinners, cleaning agents)
Mandatory testing items:
Component separation test: CAS numbers and contents of all components (≥0.1%) are required. A full scan is required if separation is not possible.
Total SVHC content: A notification is required if the cumulative concentration of all SVHCs in the mixture is >0.1%.
Carcinogenic/mutagenic/reproductive toxic substances (CMR): such as benzene compounds (benzene ≤0.1%, ethylbenzene ≤0.5%)
Example: If a solvent-based cleaning agent contains diethyl phthalate (DEHP) (an SVHC substance) at a concentration of 0.3% and exports 5 tons to the EU annually, then: ① Test the precise DEHP content ② Submit a notification to ECHA ③ Clearly indicate the following in the SDS:
III. Report Content and Technical Documentation Requirements
Eight Core Information Items the Test Report Must Include:
Product Identification: Solvent name, CAS number, batch number, manufacturer information
Testing Method: Standard must be specified (e.g., GC-MS for VOCs, ICP-MS for heavy metals)
SVHC Test Results: Specific content of each substance (expressed in "mg/kg" or "%")
Declaration of Conformity: Clearly state whether it complies with REACH registration/notification/restriction requirements
Laboratory Accreditation: Must be ISO certified 17025 certification, and listed in the ECHA accredited laboratory list.
Testing Date and Report Validity: The report has no fixed validity period, but re-verification is required after the SVHC list is updated.
Sample Information: Sampling location and quantity (≥500mL representative sample required).
EU Responsible Person (OR) Information: Name, address, and contact information (importer or authorized representative).
Required Technical Documents:
Supply Chain Declaration: REACH compliance report provided by upstream raw material supplier (covering all components).
Exposure Scenario Analysis: Assess exposure risks for solvent usage scenarios (e.g., industrial cleaning, paint dilution).
Risk Management Measures: Recommendations such as using explosion-proof containers and wearing respiratory protective equipment.
IV. Application Process and Common Misconceptions
Key Steps (Taking an annual import volume of 5 tons of solvent as an example):
Pre-registration: Submit the substance name and tonnage range in the ECHA system (must be completed 6 months before the first import).
Testing Commission: Send samples to an accredited laboratory, clearly requesting testing "according to Annex XVII of the REACH Regulation + SVHC 251".
Data Compliance Check: Ensure the testing method complies with EN regulations. ISO standards (e.g., EN 14362-1 for azo dye testing)
Registration/Notification: Submit registration documents (administrative fees apply, approximately €10,000-€50,000) or notification forms through the REACH-IT system.
SDS Compilation and Distribution: Ensure downstream users (e.g., EU distributors) have access to the latest SDS.
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