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U.S. Department of Health and Human Services

Inventory of Food Contact Substances Listed in 21 CFR
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FCN No. 1615

NYCO

Consult the regulation(s) cited below to see if your substance is authorized for your intended use.
Food Contact Substance: Hexanoic acid, 3,5,5-trimethyl-, 1,1-[oxybis[2,2-bis[[(3,5,5-trimethyl-1-oxohexyl)oxy]methyl]-3,1-propanediyl]] ester (CAS Reg. No. 65870-97-5).
Notifier: NYCO
Manufacturer/Supplier: NYCO
Intended Use: As a lubricant with incidental food contact as in the context of 21 CFR 178.3570, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The maximum use level in the finished lubricant is 100%, at a maximum temperature of 250°C. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Feb 3, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

* Definitions

  • CAS Reg. No. (or other ID): Chemical Abstract Service (CAS) Registry Number® for the substance or a numerical code (other ID) assigned by HFP to those substances that do not have a CAS Registry Number (977nnn-nn-n series).
  • Substance: The name of the additive as recognized by HFP.
  • 21 CFR: The Code of Federal Regulations, Title 21 is the preferred reference to determine the regulatory status of Indirect Food Additives. Substances whose names appear in 21 CFR, parts 175-178 are authorized for specified intended users and conditions of use as stated in the regulation. Note that substances may appear in more than one regulation, or several times in the same regulation.

Note that if a substance is mentioned in 21 CFR parts 175-178 and thus, is listed above, any other citations for the same substance in other sections of 21 CFR dealing with food additives (parts 1-199 inclusive) may also be cited.
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