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Regulations on Food Contact and Medical Applications

TERATHANE® PTMEG, taken as alpha-hydro-omega-hydroxypoly (oxytetramethylene), is FDA-cleared under the following paragraphs:

21 CFR 175.105 As component of P.U. adhesives intended for use in packaging, transporting, or holding food...
21 CFR 177.1680 In polyurethane resins for dry food contact...
21 CFR 177.2600 Rubber articles and/or synthetic polymers intended for repeated use may be safely used in producing, manufacturing, packaging, transporting, or holding food,...
21 CFR 177.1590 As component in polyester elastomers
Please note that various medical devices based on 1,4-butanediol, TERATHANE® or both have been approved by the FDA, including those used within the body. Formulators are cautioned, however, that FDA approval is not given generically for these devices; it must be applied for separately by each manufacturer of each device.
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