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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. 1858

COIM S.p.A, Italy

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: Polyester-polyurethane adhesive formulated from the following: Benzene, 1,1'-methylenebis[isocyanato (CAS Reg. No. 26447-40-5); hydrocinnamic acid 3,5-di-t-butyl-4-hydroxyoctadecyl ester(CAS Reg. No. 2082-79-3); 1,6-Hexanediol (CAS Reg. No. 629-11-8); 2,2-Dimethyl-1,3-propanediol (CAS Reg. No. 126-30-7); Hexanedioic acid (CAS Reg. No.124-04-9); diethylene glycol (CAS Reg. No. 111-46-6); α-Hydro-ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)] (CAS Reg. No. 25322-69-4); 1,3-Benzenedicarboxylic acid (CAS Reg. No. 121-91-5); 1,3-Isobenzofurandione (CAS Reg. No. 85-44-9); Dipropylene glycol (CAS Reg. No. 25265-71-8); Trimethylolpropane (CAS Reg. No. 77-99-6); Oxirane, 2-methyl-, polymer with α-hydro-ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)] and 1,1'-methylenebis[isocyanatobenzene] (CAS Reg. No. 167883-19-4); 1,3-Propanediol, 2-methyl- (CAS Reg. No.2163-42-0).
Notifier: COIM USA Inc.
Manufacturer/Supplier: COIM USA Inc.
COIM S.p.A, Italy
Intended Use: For use as an adhesive in laminate structures that are intended for use in contact with all types of food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The adhesive may be applied as a non-food contact layer at a maximum rate of 2.4 grams per square meter (2.4 g/m2) of laminate surface area. The food-contact layer separating the FCS from food will be a minimum of 1 mil thick and will be comprised of low density polyethylene (LDPE) or another polymer with equal or greater barrier properties. Laminate structures using the FCS may be used in contact with all food types under Conditions of Use A through H, as described in Table 2. The finished food contact articles containing the FCS are not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Mar 16, 2018
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo