Internationally accredited certifications from SGS and Intertek. Full compliance for EU REACH, US FDA, and global quality standards.
All certificates issued by internationally accredited third-party laboratories. Click to preview and download.
In vitro cytotoxicity test per ISO 10993-5:2009 Appendix C (MTT assay) on L929 mouse fibroblast cells. Cell viability at 100% extract concentration: 74.58% (pass threshold: 70%). No cytotoxic potential confirmed.
Screening of 247 SVHC substances in the ECHA Candidate List (as of Jan 21, 2025) plus 7 Potential SVHCs (as of Feb 28, 2025). All results below 0.1% (w/w) threshold - fully compliant for EU market supply chain obligations.
Testing of 8 regulated PAHs per REACH Annex XVII Entry 50 (EU 2021/1199), referenced to AfPS GS 2019:01 PAK. All 8 PAHs were not detected (below 0.1 mg/kg MDL). Safe for consumer products including baby items.
Total extractives test per US FDA 21 CFR 175.300 using three food simulant liquids. All results not detected (below 1.0 mg/inch2), well within the 18 mg/inch2 reference limit.
Flammability classification for curtains and drapes per EN 13773:2003+A1:2007. Sample (Leatherette, 652 g/m2) achieved the highest classification - Class 4 (not easily ignitable, no flame spread, no flaming debris).
Vertical burn test per FAA FAR Part 25.853 Appendix F, Part I (b)(4) - 12-second flame exposure. All 6 specimens passed: 0s afterflame, 0s drip flame, burn length 3.8-4.2 inches (limit: <=15s, <=5s, <=8").
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Zero VOC and formaldehyde-free for indoor air quality. REACH and PAHs compliance mandatory for EU market entry.
EN 13773 Class 4 flame retardancy required for automotive safety. Low VOC per VDA 277 for cabin air quality.
FDA compliance for mouthing contact. EN 71 toy safety. Zero phthalates, BPA, and heavy metals required.
FDA and ISO 10993 biocompatibility for patient contact. Disinfectant-compatible for hospital-grade cleaning.
UV and salt spray resistance for marine environments. REACH compliance for EU yacht and boat manufacturing.
RoHS compliance for electronics. REACH and PAHs for EU market. Low VOC for indoor device use.
All tests conducted by internationally accredited laboratories with IAF and ILAC mutual recognition
World's leading inspection, verification, testing and certification company. Headquartered in Geneva, Switzerland.
Total Quality Assurance provider with 1,000+ laboratories in 100+ countries. UK-based FTSE 100 company.
Independent testing service provider with 150+ years of history. German-based Notified Body for EU regulations.
Every certificate carries a unique verification number that can be authenticated on the official website of the issuing testing institution. We maintain full traceability from raw material sourcing to final product testing.
TOPSUN is committed to manufacturing silicone leather products in full compliance with all applicable international regulations. Our products are tested and validated to ISO 10993-5:2009 biocompatibility standards, with all batches undergoing rigorous third-party SGS testing before market release. We continuously monitor regulatory changes in the EU, US, and other target markets to ensure ongoing compliance. Custom formulations can be developed to meet specific regional certification requirements.
Common questions about our certifications and compliance documentation
