Steps for EU REACH test report on industrial catalysts
Date：2026-06-25 09:48:40 Classification
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REACH Compliance Steps for Industrial Catalysts
Industrial catalysts are typically classified as "substances" (single substance or formulation) under REACH. The compliance path is as follows:
Six-Step Compliance Process
Step 1: Identity Determination and Tonnage Confirmation
Determine Product Identity
Single Substance (e.g., pure chemicals)
Formulation (multi-component mixtures, commonly found in catalysts)
Article (finished products, such as catalytic converters)
Estimated Annual Export Volume: Tonnage determines registration level (1-10 tons, 10-100 tons, 100-1000 tons, >1000 tons)
Step 2: Check Pre-Registration Status
Log in to the ECHA website and check the "REACH Registration Database"
Confirm whether the substance has already been registered by other companies in the same tonnage range.
If already registered: You can use the registration data as a "downstream user," simplifying the process.
If not registered: You need to complete the full registration yourself.
Step 3: Data Collection and Gap Analysis
The following core data needs to be prepared:
| Data Type | Specific Content
| Physicochemical Properties | Melting point, boiling point, density, solubility, particle size, etc.
| (Q)SAR data | Quantitative structure-activity relationship prediction
| Toxicological data | Acute toxicity, skin irritation, sensitization, etc.
| Ecotoxicological data | Aquatic organism toxicity, degradation, bioaccumulation
| Exposure scenarios | Catalyst usage conditions, exposure routes
Some data can be exempted through literature or QSAR models, but critical endpoints (such as high tonnage) must be measured.
Step 4: Outsourced Testing (if required)
Selection of Institution: A laboratory with GLP (Good Laboratory Practice) accreditation
Testing Items:
Physicochemical parameter testing
Acute oral/dermal/inhalation toxicity
Skin and eye irritation, sensitization
Mutagenicity (Ames test, etc.)
Acute toxicity to aquatic organisms
Conduct chronic toxicity and reproductive toxicity studies if necessary
Obtain Report: Obtain a GLP-compliant test report
Step 5: Dossier Preparation (IUCLID)
Prepare the registration dossier using the ECHA official tool, IUCLID software.
The content includes:
Substance identification information
Classification and labeling
Safety Data Sheet (SDS)
Chemical Safety Report (CSR)
Summary of test data
High tonnage (>10 tons) requires a CSR
Step Six: Submit ECHA and Pay Fees
Submit online through the REACH-IT system
Pay registration fees (tiered by tonnage and company size)
Wait for ECHA processing (usually 2-4 weeks)
Once a registration number is obtained, the product can be legally placed on the EU market.
Ongoing obligations after registration
Even after registration, the following obligations still apply:
1. SVHC Screening: Regular (1-2 times per year) comparison with the ECHA candidate list; currently, there are 253+ items (DEZEW Testing CNAS Registration No.: L8083).
2. SDS Update: 16-section SDS provided free of charge upon request from downstream users.
3. Downstream User Notification: If SVHC content in the product is >0.1%, ECHA notification is required.
4. Dossier Update: Update promptly when new data is added or the application changes.
Key Notes:
Sole Representative (OR): Non-EU companies must appoint a "sole representative" within the EU to submit registration.
Time Cost: The complete registration cycle typically takes 6-18 months; advance planning is recommended.
Cost Range: Including data fees, the total registration cost is approximately tens of thousands to hundreds of thousands of euros (depending on tonnage and testing requirements).
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