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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR No. 2006-002

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:
  1. Glycerol monooleate complying with 21 CFR 184.1323, as long as it is used at GMP levels (i.e., the minimum amount necessary to achieve the intended effect);
  2. Polyamide 6/66 complying with 177.1500(b) 4.2 and 177.1395; and,
  3. Polyamide 6/12 complying with 177.1500(b) 13.1 and 177.1395.
Use Limitations*: Use as a lidding film to cover a polystyrene foam tray intended to be used in contact with ground beef during electron beam irradiation of the ground beef in a nitrogen atmosphere, at doses of 1.5 to 3.0 kGy. This exemption applies when these components are irradiated, incidental to the irradiation processing of prepackaged food, in a vacuum or in an oxygen-free environment at doses not exceeding 3.0 kGy
Requestor: Cryovac Sealed Air Corp.
Quick Links to regulations in 21 CFR (referenced above):
177.1395
177.1500
184.1323

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

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