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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 262

EMS Chemie AG

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.
Food Contact Substance: Nylon 6/69 (CAS Reg. No. 51995-62-1), manufactured by the condensation of 49.5+ 0.5 weight percent epsilon-caprolactam, 19.4+0.2 weight percent hexamethylenediamine, and 31.2+0.3 weight percent azelaic acid.
Notifier: EMS Chemie AG
Manufacturer/Supplier: EMS Chemie AG
Intended Use: As a non-food-contact layer of a co-extruded multilayer film in accordance with the uses permitted for nylon 6/69 resins as set forth in 21 CFR 177.1395.
Limitations/Specifications: 1) The FCS may be used in contact with all food types indentified in Table 1, except alcoholic foods, under Conditions of Use B through H as described in Table 2. 2) The resin shall meet the specifications set forth in 21 CFR 177.1500(b), item 14, except that the maximum extractable fraction in water may be up to 6 percent by weight of the resin. Laminate structures employing the resin shall meet the extractive limitations for nylon 6/69 resins in accordance with 21 CFR 177.1395.
Effective Date: Oct 11, 2002
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 179 kB)
FDA Decision: Finding of No Significant Impact (FONSI)