EU REACH Chemical Testing Compliance Process for Chemical Mixtures
Date：2025-12-19 09:26:26 Classification
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Core processes for EU REACH compliance of chemical mixtures: Exporting chemical mixtures (such as cleaning agents, paints, inks, lubricants, etc.) to the EU requires compliance with REACH regulations (EC No.). (1907/2006) Compliance revolves around three core aspects: substance identification, SVHC control, and Safety Data Sheet (SDS) preparation. The specific process is as follows:
I. Compliance Prerequisites: Clarifying Mixture Types and Obligations
Obligation Triggering Conditions
Registration Obligation: If the annual export volume of a single substance in a mixture exceeds 1 tonne, registration with ECHA must be completed through the EU Sole Representative (OR).
Notification Obligation: If the SVHC content in a mixture is >0.1% (by weight) and the annual export volume exceeds 1 tonne, notification to ECHA is required.
Information Transmission Obligation: Regardless of compliance status, a Safety Data Sheet (SDS) containing SVHC information must be provided to downstream users.
Key Thresholds
SVHC Limits: Single substance content ≤0.1% (Exceeding this must be clearly indicated in Chapter 3 of the SDS).
Registration Threshold: Annual import volume of a single substance ≥1 tonne (A complete registration dossier, including toxicological and ecotoxicological data, must be submitted).
II. Complete Compliance Flow Process (Phase-Based Implementation)
Phase 1: Substance Identification and Risk Assessment (1-2 weeks)
Component Breakdown
List all components (accurate to CAS number), distinguishing between major components (>1%) and trace components (<0.1%).
Example: For cleaning agents, surfactants (e.g., AES), solvents (e.g., ethanol), and preservatives (e.g., MIT) need to be broken down.
SVHC Screening
Check the latest SVHC candidate list (reaching 251 items by 2025), focusing on:
Phthalates (e.g., DEHP, DBP)
Polycyclic aromatic hydrocarbons (PAHs)
Heavy metals (lead, cadmium, hexavalent chromium)
New additions in 2025: Hexamethyldisilazane, Perfluorohexylsulfonic acid (PFHxS)
Supply Chain Information Collection
Require raw material suppliers to provide:
Substance Safety Data Sheets (SDS, must conform to EU format)
Purity certificates (e.g., ≥99.9%)
Previous batch test reports (must be certified by ISO) (Issued by Laboratory 17025)
Phase 2: Laboratory Testing and Data Validation (2-4 weeks)
Testing Items
| Test Type | Core Method
| SVHC Full Screening | GC-MS/LC-MS
| Specific Substance Quantification | ICP-MS (Heavy Metals), HPLC (Flame Retardants)
| Physicochemical Properties | Flash Point, pH Value, Viscosity Determination
Sample Requirements
Provide 3 unopened original packaging samples (each ≥500ml/g)
If nanomaterials are included, a TEM electron microscopy analysis report is required.
Phase 3: Technical Documentation Preparation and Submission (2-3 weeks)
Safety Data Sheet (SDS) Preparation
Must comply with the 12 mandatory requirements of the European Union (EN ISO 11014 standard):
Chapter 3: Complete List of Ingredients (including SVHC and CAS Number)
Chapter 8: Safe Handling and Exposure Control Measures
Chapter 15: REACH Compliance Declaration (e.g., "This mixture complies with EC No....") 1907/2006 Requirements)
Registration/Notification Submission
Registration: Submit through ECHA's REACH-IT platform, including:
Substance intended use (e.g., industrial cleaning, home care)
Risk Assessment Report (RAR)
Exposure scenario description (calculated using the EUSES model)
Notification: Submit an SVHC notification form (must indicate the concentration range of the substance in the mixture)
Phase 4: Market Access and Post-Regulation (Ongoing)
Labeling and Packaging
Affix hazard pictograms according to CLP regulations (e.g., "flame" symbol for flammable liquids)
Affix "Contains SVHC" warnings (if concentration > 0.1%)
Document Retention
Retain SDS, test reports, and registration certificates for at least 10 years
Update SVHC list compliance annually
III. Typical Industry Case Examples: REACH Compliance of Cleaning Agents
Ingredient Screening: Surface Testing Nonylphenol polyoxyethylene ether (NPEO, newly added SVHC in 2025) in active ingredients
Limit control: MIT preservative content must be ≤0.01% (Appendix XVII limit)
SDS special requirements: Must state "Avoid prolonged skin contact" in Chapter 9
IV. Common Misconceptions and Avoidance Guidelines
"Exempt Ingredient" Trap: Natural extracts (such as plant essential oils) containing SVHCs (such as aflatoxin) still require testing.
Testing agency selection: Choose ECHA-accredited laboratories (such as Dezewei Testing CNAS registration number: L8083), avoid using non-EU standard methods.
Cost control: Prioritize the "stratified testing method"—screen high-risk substances first, then quantify suspected excessive items.
Compliance Toolkit
ECHA Official Resources:
SVHC Candidate List Inquiry
REACH-IT Registration System
Testing Standards:
EN 14362-1:2021 (Detection of azo dyes in textiles)
EPA 3550C:2007 (Solid phase extraction pretreatment)
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