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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR No. 1999-022

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 copolymer consisting of linear low density polyethylene complying with 21 CFR 177.1520(c), item 3.2, which has been subsequently grafted with 0.8% or less by weight of maleic anhydride.
Use Limitations*: The intended use would involve the blending of the subject additive at levels up to 15 weight percent with other polyolefins complying with 21 CFR 177.1520 to form a polymeric film with a maximum thickness of 1 mil. The blended polymeric film would function either as the adhesive non food-contact inner-layer or as the heat seal food-contact layer in multilayered packaging that will be approximately 4 mils thick and used to hold processed meat during and after cooking.
Requestor: Keller and Heckman on behalf of Mitsui Chemicals Inc.
Quick Links to regulations in 21 CFR (referenced above): 177.1520

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