Key steps for EU REACH compliance testing of chemical raw materials
Date：2025-09-23 09:46:33 Classification
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REACH is the European Union's regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH). It is a proposed regulation covering the safety of chemical production, trade, and use, restricting the use and content of toxic and hazardous substances covered by REACH. Key steps and operational points for EU REACH compliance testing for chemical raw materials are summarized based on EU Regulation (EC) No. 1907/2006 and the latest industry practices:
I. Core Compliance Steps (4 Steps)
▶ Step 1: Obligation Determination and Registration Planning
1. Tonnage Screening
- Confirm whether the annual production or import volume of the chemical is ≥1 ton (within the EU). Exceeding the limit requires mandatory registration.
- Special Exemptions:
- Non-isolated intermediates, polymer monomers (requires separate assessment)
- Radioactive materials, and items temporarily stored under customs supervision.
2. Substance Classification and Identification
- Distinguish the substance type (monomer/mixture/article), which directly affects the test items:
- Monomer: Detect hazardous substances (such as lead and cadmium) by purity.
- Mixture: Components must be separated for registration.
▶ Step 2: Data Preparation and Joint Submission
1. Test Data Requirements
| Tonnage Range | Testing Depth
| 1-10 tons/year | Basic Physicochemical and Acute Toxicity
| 10-100 tons/year | Add Genotoxicity and Repeated-Dose Toxicity
| >100 tons/year | Comprehensive Ecotoxicology Data
2. Joint Submission
- Multiple manufacturers of the same substance are required to share data to reduce testing costs (saving 30%-50%).
- Designate a Lead Registrant (LR) to centrally submit the core data dossier.
▶ Step 3: Registration Dossier Submission and Evaluation
1. Dossier Creation Tool
- Organize data using the IUCLID 6 format and submit through the REACH-IT platform.
- Must include:
- Chemical Safety Report (CSR)
- Exposure Scenario (ES) and risk management measures
2. ECHA Evaluation Process
- Dossier Assessment: Review data completeness (feedback within 90 days).
- Substance Assessment: Focus on high-risk substances (e.g., CMR/PBT substances). Retesting may be required.
▶ Step 4: Authorization and Ongoing Compliance
1. SVHC List Management
- If containing Substances of Very High Concern (SVHC) (e.g., phthalates, heavy metals):
- Safety Data Sheets (SDS) must be shared with the supply chain if the concentration is >0.1%.
- Annual export volume >1 ton must be notified to ECHA.
2. Dynamic Update Obligations
- The SVHC list is updated semi-annually (currently contains over 250 items).
- When the process/formulation is changed, registration information must be updated within 72 hours.
II. Key Risk Control Points
1. Supply Chain Traceability
- Suppliers must provide complete SDSs and Declarations of Compliance to avoid the use of unregistered raw materials.
- Verify that intermediates meet the Strict Control Conditions (SCC) and are eligible for simplified registration.
III. Cost Optimization Strategy
- Phased Registration: Prioritize the application for a PPORD exemption (5-year registration exemption for R&D use) for new substances.
- Testing Alternatives: Utilize QSAR models or cross-reference data to reduce animal testing (saving 40% in costs).
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