Food and medical grade rubber products are critical for safety-critical applications, requiring strict compliance with global standards to ensure non-toxicity, biocompatibility and regulatory adherence. For international buyers, verifying FDA, CE and REACH compliance is essential for market access and risk mitigation.
FDA (U.S. Food and Drug Administration) Governed by 21 CFR 177.2600 for repeated-use rubber in food contact. It mandates a positive list of approved polymers (EPDM, NBR, Silicone, FKM) and additives, with strict extraction and migration tests to prevent harmful substance leaching. Medical-grade rubber must meet USP Class VI for biocompatibility (no cytotoxicity, sensitization or systemic toxicity).
CE Marking (EU Compliance) For food contact, it aligns with Regulation (EC) 1935/2004 and EU 10/2011, requiring GMP production and migration testing (e.g., 4% acetic acid/ethanol immersion). Medical devices need ISO 13485 quality management and ISO 10993 biocompatibility tests before CE marking.
REACH (EU Registration, Evaluation, Authorization and Restriction of Chemicals) Restricts SVHC (Substances of Very High Concern) like heavy metals, phthalates and PAHs. Manufacturers must register substances, provide SDS and ensure no prohibited materials are used in production.
· Raw Material Control: Use only FDA/CE-approved polymers and additives; avoid heavy metals, aromatic amines and non-approved vulcanizing agents.
· GMP Production: Cleanroom environment, strict process traceability and batch-wise testing to prevent contamination.
· Testing Protocols: Food-grade tests include migration and heavy metal analysis; medical-grade requires sterilization resistance (121°C autoclave) and biocompatibility verification.
We provide FDA, CE and REACH-compliant rubber products with full documentation, batch traceability and third-party test reports. Our strict quality system ensures safe, reliable solutions for food processing, medical devices and pharmaceutical applications worldwide.
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