EU PAHS Regulation

I. Definition and Hazards of PAHs

• Carcinogenicity: For example, Benzo(a)pyrene is classified as a Group 1 carcinogen by the International Agency for Research on Cancer (IARC);

• Bioaccumulation: Difficult to degrade and can accumulate through the food chain;

• Environmental toxicity: Contaminates soil and water sources, affecting ecological balance.

II. Scope of Application and Product Categories

1. Tyres and extender oils: Item 50 of REACH Annex XVII explicitly restricts 8 PAHs in tyres and extender oils, with Benzo(a)pyrene (BaP) ≤1mg/kg and the sum ≤10mg/kg;

2. Products in contact with the human body: Such as rubber or plastic components in toys, electronic and electrical appliances, sports equipment, and clothing, which must comply with stricter limit values (e.g., German GS certification requirements);

3. Clay targets for shooting: New item 50a added in 2025 restricts 18 PAHs, with the sum ≤50mg/kg (effective April 22, 2026);

4. Other materials: Such as lubricating oils, rust inhibitors, coatings, and other industrial products that may contain PAHs.

III. Core Control Requirements and Limit Values

1. Mandatory Requirements of REACH Annex XVII

• Tyres and extender oils:

• Sum of 8 PAHs (including BaP, BeP, etc.) ≤10mg/kg;

• Benzo(a)pyrene (BaP) ≤1mg/kg.

• Rubber/plastic components in contact with the human body:

• For products in prolonged skin contact (e.g., handles, watch straps), sum of PAHs ≤10mg/kg, BaP ≤1mg/kg;

• Toys and children's products must comply with the stricter German GS certification standard.

2. German GS Certification (AfPS GS 2019:01 PAK)

• Categorized control:

• Category 1 (oral contact or toys for children under 36 months): Sum of 15 PAHs ≤0.5mg/kg, BaP ≤0.2mg/kg;

• Category 2 (products with prolonged skin contact): Sum of 15 PAHs ≤10mg/kg, BaP ≤1mg/kg;

• Category 3 (products with short-term contact): Sum of 15 PAHs ≤200mg/kg, BaP ≤20mg/kg.

3. New Regulation for Clay Targets (Effective 2026)

• Sum of 18 PAHs ≤50mg/kg (by dry weight), covering production, sale, and use stages.

IV. Test Items and Methods

1. Substance list for testing:

• REACH Annex XVII: 8 PAHs (such as BaP, BeP, Benzo(b)fluoranthene, etc.);

• German GS Certification: 15 PAHs (excluding Acenaphthylene, Acenaphthene, Fluorene);

• New Clay Target Regulation: 18 PAHs (including Benzo(j)fluoranthene, Indeno(1,2,3-cd)pyrene, etc.).

2. Test methods:

• GC-MS (Gas Chromatography-Mass Spectrometry): A commonly used method capable of detecting trace PAHs as low as 0.25μg/kg;

• HPLC-FLD (High-Performance Liquid Chromatography with Fluorescence Detection): Suitable for PAHs with strong fluorescence characteristics (e.g., BaP).

• ISO 21461: Determines the bay region hydrogen content of oils in rubber compounds using nuclear magnetic resonance (NMR) spectroscopy (indirect assessment of PAHs content);

• IP 346: Determines the polycyclic aromatics (PCA) content in extender oils using the refractive index method.

• Tyres and extender oils:

• Other products:

V. Certification Process and Compliance Essentials

1. Certification process:

• Sample testing: Commission an EU-accredited laboratory (e.g., SGS, TUV) to conduct PAHs content testing;

• Report review: The laboratory issues a compliance report; the enterprise must retain the report for at least 10 years for spot checks;

• Market access: No official registration is required, but all supply chain links (e.g., raw materials, additives) must comply with PAHs requirements.

2. Compliance essentials:

• Material selection: Prioritize raw materials with low PAHs content, such as non-petroleum-based lubricants and eco-friendly rubber;

• Supply chain management: Require suppliers to provide PAHs declarations to ensure components (e.g., screws, adhesives) are compliant;

• Labeling and documentation: Indicate "REACH PAHs compliant" on the product manual or packaging and archive test reports.

VI. Latest Developments and Key Considerations

1. Regulatory updates:

• April 22, 2026: The new PAHs regulation for clay targets takes effect; enterprises need to adjust production processes in advance and avoid using PAHs-containing binders;

• REACH SVHC List: Certain PAHs (e.g., BaP) may be included in the SVHC (Substances of Very High Concern) list, requiring supply chain notification obligations.

2. Risk alerts:

• Material changes: If product formulations, suppliers, or production processes change, PAHs content must be retested;

• Market surveillance: EU customs and regulatory authorities may conduct PAHs spot checks on imported products; non-compliant products will be detained or recalled;

• Alternative solutions: Developing PAHs-free eco-friendly materials (e.g., bio-based plastics) represents the long-term compliance trend.

VII. Synergies with Other Regulations

1. EU Toy Safety Directive (EN 71):

• Toys must comply with both PAHs limit values (REACH Annex XVII) and the chemical testing requirements of EN 71-10.

2. German LFGB Regulation:

• PAHs migration limits in food contact materials must comply with the stringent requirements of LFGB (e.g., BaP ≤0.01mg/kg).

3. Other Global Regulations:

• US California Proposition 65: Requires warning labels for products containing PAHs;

• China GB Standards: For example, GB 31604.38-2021 specifies the determination method for PAHs in food contact materials.

VIII. Summary