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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. 1225

Metlac S.p.A.

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: 1,6-Hexanediol (CAS Reg. No. 629-11-8).
Notifier: Metlac S.p.A.
Manufacturer: Metlac S.p.A.
Intended Use: The FCS is intended for use as a monomer, alone or in combination with the polyhydric alcohols listed in 21 CFR 175.300(b)(3)(vii)(c), in the production of polyester resins used as coatings for (1) metal substrates used in the manufacture of single-use food-contact articles or components of such articles; and (2) any suitable substrate used in the manufacture of repeated use food-contact articles or components of such articles.
Limitations/Specifications*: The FCS may be used in contact with (a) powdered infant formula (i.e., excluding ready-to-consume infant formula and infant formula concentrate) under room temperature conditions (i.e., Condition of Use E) and below; and (b) all food types, other than infant formula, under Conditions of Use A through H, as described in Table 2 at 21 CFR 175.300(d). The polyester resin produced from the FCS may constitute up to 100% of the final food-contact coating formulation. The FCS may be used at a maximum level not to exceed 30 mol-% of the polyester resin.
Effective Date: Dec 19, 2012
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo