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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR number 2005-008

Threshold of Regulation Exemptions are generally applicable and are effective for the food contact substance (FCS) for the listed intended use regardless of manufacturer or supplier.
Food Contact Substance: A multilayer packaging film containing:
  1. The following substances as long as they meet the applicable use level limitations in §178.2010 or §178.3860 or an effective notification:
    1. 1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl)benzene (CAS Reg. No. 1709-70-2).
    2. Erucamide (CAS Reg. No. 112-84-5)
  2. Zinc oxide as long as it is used at GMP levels (i.e. the minimum amount necessary to achieve the intended technical effect):
  3. An ionomeric resin, complying with §177.1330, as a component of the food contact layer of the laminate.
  4. Polybutylene, complying with §177.1570, as a component of the food contact layer of the laminate.
  5. An urethane adhesive, provided it complies with §175.105, as a component of the adhesive, non-food contact layer of the laminate.
Use Limitations: The packaging materials are to be used in contact with ground beef during irradiation of the vacuum packed and frozen ground beef at doses not to exceed 3.0 kiloGrays (kGy)
Requestor: Omaha Steaks Co.
Quick links to regulation: 175.105

*For references to food types and conditions of use, see Food Types & Conditions of Use for Food Contact Substances.