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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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The database lists effective premarket notifications for food contact substances that have been demonstrated to be safe for their intended use. The list includes the food contact substance (FCS), the notifier, the manufacturer of the FCS, the intended use, the limitations on the conditions of use for the FCS and its specifications, the effective date, and its environmental decision. Under section 409(h)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348 (h)(2)(C)) a food contact substance notification (FCN) is only effective for the manufacturer or supplier identified in the notification. Persons who market a FCS based on an effective notification must be able to demonstrate that the notification is effective for their food contact substance. All persons who purchase a food contact substance manufactured or supplied by a manufacturer or supplier identified in an effective notification may rely on that notification to legally market or use the food contact substance for the use that is the subject of the notification, consistent with any limitations in that notification. Additional information about Food Contact Substances and the definitions of Food Types and Conditions of Use are available on the FCS Program page.

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  • Select the FCN number below to view the record details, including its intended use, limitations, specifications, and the Final Environmental Impact Decisions.
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  • The search results will return hits of records containing words that include the search term. For example, a search for the color red will return results that include terms such as reduce, ingredient, and manufactured. To limit results to only the searched term, place a space before and after the word in the basic search or in the advanced search “this exact phrase” field.
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Records Found: 7 Page 1 of 1
(sorted Z-A)
Food Contact Substance Manufacturer/Supplier Effective Date
1718 Polyurethane adhesive formulated from:
  1. Polyester resins prepared by the reaction of a mixture of acids and alcohols listed in 21 CFR 175.300 (b)(3)(vii);
  2. Isocyanate hardeners consisting of one or more of the following
    1. m-xylylene diisocyanate (CAS Reg. No. 3634-83-1),
    2. m-xylylene diisocyanate-trimethylol propane prepolymer (CAS Reg. No. 51852-81-4),
    3. 2-ethyl-1-hexanol reaction products with 1,6-diisocyanatohexane,
    4. 1,6-diisocyanatohexane (CAS Reg. No. 822-06-0), and
    5. prepolymers of them.
  3. Optional use, in either the urethane hardener or polyester resin portions of the resin, of trimethoxysilane coupling agents containing amino, epoxy, ether, or mercapto groups comprising not more than 3 percent by weight of the cured adhesive and/or the triethoxysilane coupling agent described in the notification.
  4. An inorganic filler must be included in the adhesive as described in the notification.
DIC Corporation Feb 22, 2017
1018 A mixture of equal proportions of lytic-type phages, ECML-4 (157,308 bp), ECML-117 (66,854 bp), and ECML-134 (166,783 bp), isolated from fresh and salt water environments in phosphate-buffered saline. Intralytix, Inc. Feb 5, 2011
518 2-propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No 464178-90-3). Solenis LLC Oct 20, 2005
202 Aluminum, hydroxybis(2,4,8,10-tetrakis(1,1-dimethylethyl)-6-hydroxy-12H-dibenzol(d,g)(1,3,2)dioxaphosphocin 6-oxidato)-, (CAS Reg. No. 151841-65-5). The FCS will be manufactured and characterized as described in the notification. Asahi Denka Kogyo K.K. May 4, 2002
186 Cis-endo-bicyclo(2.2.1)heptane-2,3-dicarboxylic acid, disodium salt (CAS Reg. No. 351870-33-2). Milliken Chemical, Division of Milliken & Co. Jan 30, 2002
31 Fluorescein, disodium salt or dipotassium salt (CAS Reg. No. 518-47-8) and (CAS Reg. No. 6417-85-2) Nalco Chemical Co. May 11, 2000

(sorted Z-A)
Food Contact Substance Manufacturer/Supplier Effective Date