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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR number 2005-007

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: Polystyrene foam tray with a multi-layer food-contact coating. The coating may contain:
  1. The following substances as long as they meet the applicable use level limitations in §178.2010 or an effective notification:
    1. Tetrakis[methylene(3,5-di-tert-butyl-4-hydroxyhydrocinnamate)methane] (CAS Reg. No. 6683-19-8).
    2. Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3).
    3. Di-tert-butylphenyl phosphonite condensation product with biphenyl (CAS Reg. No. 119345-01-6).
    4. Tri(mixed mono- and di-nonylphenyl) phosphate (CAS Reg. No. 26523-78-4)
    5. Tris(2,4-di-tert-butyphenyl)phosphite (CAS Reg. No. 31570-04-4)
    6. Cyclic neopentanetetrayl bis(octadecyl phosphite) (CAS Reg. No. 3806-34-6)
  2. The following substances as long as they are used at GMP levels (i.e. the minimum amount necessary to achieve the intended technical effect).
    1. Butylated hydroxytoluene (BHT)
    2. Diatomaceous silica
  3. A blend of a styrene-butadiene thermoplastic elastomer and a styrene-butadiene copolymer, both complying with §177.1640, as components of the non-food contact layers of the laminate.
  4. An ethylene vinyl alcohol copolymer, complying with §177.1360, as a component of the non-food contact layers of the laminate.
Use Limitations*: For use in contact with ground beef during electron beam irradiation of the ground beef in a nitrogen atmosphere, at doses not to exceed 3.0 kilograys (kGy).
Requestor: Mitec Advanced Technology
Quick links to regulation: 177.1360

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