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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. 1015

W.R. Grace & Company

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. 629-1 1-8). REPLACES FCN 968.
Notifier: W.R. Grace & Company
Manufacturer: W.R. Grace & Company
Intended Use: 1) 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 coatings for metal substrates used in the manufacture of articles or components of articles for contact with food; 2) 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 coatings for any suitable substrate used in the manufacture of articles or components of articles for repeated contact with food.
Limitations/Specifications*: Polyester coatings containing the FCS may contact (1) all food types, except infant formula, under Conditions of Use A through H, as described in Table 2 at 21 CFR 175.300(d), and (2) powdered infant formula (i.e., excluding ready-to-consume infant formula and infant formula concentrate) under room temperature conditions and below. The FCS may constitute no more than 54 weight percent of the polyhydric alcohols used as starting monomers of the finished polyester coating.
Effective Date: Nov 23, 2010
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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