Guidelines for Applying for EU REACH Test Reports for Azo Dyes
Date:2026-07-16 10:04:54 Classification
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Guidelines for Applying for EU REACH Testing Reports for Azo Dyes
Azo dyes (AZO dyes) are among the hazardous substances primarily controlled under the REACH Regulation, widely found in textiles, leather, and plastics. The following details the regulatory background, testing requirements, and application process.
I. Regulatory Background
Article 43 of Annex XVII of the EU REACH Regulation explicitly states:
The sale and use of azo dyes (azo dyes that release 22 restricted aromatic amines upon reduction and pyrolysis) at concentrations exceeding 30 mg/kg are prohibited.
This regulation applies to textiles and leather products that come into prolonged direct contact with the skin or mouth, aiming to prevent these harmful substances from being absorbed through the skin or ingested, thus protecting human health.
II. List of 22 Restricted Aromatic Amines
Aromatic amines explicitly prohibited by the REACH Regulation include:
| Category | Examples of Substances
| Group 1 (Defined Carcinogens) | Benzidine, β-naphthylamine, 4-aminobiphenyl, 4-chloro-o-toluidine, etc.
| Group 2 (Probable Carcinogens) | o-aminoazotoluene, 4-methoxy-m-phenylenediamine, 2,4-diaminotoluene, etc.
Special Note: Not all azo dyes are restricted. REACH only applies to azo dyes that release 22 specific aromatic amines upon reductive decomposition.
III. Testing Standards and Methods
Core Testing Standards
EN ISO 14362-1:2017: Method for the determination of azo dyes in textiles
EN ISO 14362-3:2017: A specific method for the determination of azo dyes in polyester fibers
EN ISO 17234-1/2: Method for the determination of azo dyes in leather
Detection Principle
1. Reduce the sample with sodium dithionite in citrate buffer solution.
2. Extract any aromatic amines that may be released.
3. Quantitative analysis by HPLC (High Performance Liquid Chromatography) or GC-MS (Gas Chromatography-Mass Spectrometry).
4. The limit of detection is usually 30 mg/kg.
IV. Applicable Product Scope
| Product Category | Specific Product | Necessity of Testing
| Textiles | Clothing, scarves, hats, bedding, curtains
| Leather Products | Leather shoes, bags, belts, sofa leather
| Toys/Children's Products | Plush toys, dolls, children's clothing
| Plastic Products | Colored Plastic Accessories and Decorations
| Food Contact Materials | Colored Tableware and Baking Molds
Note: If a product claims to be "eco-friendly" or "azo-free," this must be proven through testing.
V. Report Application Process
1. Preliminary Preparation
Confirm product material, color, and intended use with the testing agency.
Provide product composition information (especially dye type).
2. Sample Submission
Sample Quantity: Typically 5-7 complete products per batch.
Sample Requirements: Brand new, unused, original packaging retained.
Multi-color Products: It is recommended that each color be submitted for testing separately.
3. Laboratory Testing
Cycle: Typically 5-7 working days (Dezewei Testing CNAS Registration No.: L8083)
Expedited Service: Can be shortened to 3-5 working days.
4. Report Issuance
Includes test results, limit standards, and individual judgments.
Report Language: Chinese/English/German/French versions available.
Validity Period: Typically... 1-3 Years
VI. Required Contents of the Test Report
A compliant REACH azo dye test report should include:
Basic Information: Client, Manufacturer, Product Name and Model
Testing Basis: Referenced EU regulations and testing method standards
Testing Items: Full or partial testing of 22 aromatic amines
Result Data: Comparison of measured values and standard limits for each substance
Pass/Fail Judgment: Clear conclusion of "Pass" or "Fail"
Qualification Seals: CMA, CNAS, and official seals of the testing institution
Sample Photos: Clearly showing the submitted sample
VII. Fees and Timeframe Reference
| Item | Scope
| Single Material Testing Fee | 1000-3000 RMB
| Additional Fee for Multi-Color Products | Approximately 500-1000 RMB per color
| Testing Timeframe | 5-7 working days
| Rush Request Fee | Increase by 30%-50%