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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR number 1998-011

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: Industrial starch-modified (i.e., starch manufactured with up to 5% 2,3-epoxypropyltrimethylammonium chloride in accordance with 21 CFR 178.3520 and further modified with up to 4.5% glycidoxypropyl- trimethoxysilane.
Use Limitations*: For use in the manufacture of : (1) Paper towels and napkins destined for single service food-contact applications at temperatures not to exceed 212°F; and (2) Paper/paperboard containers destined to hold food at room temperature (120°F) or below, provided the level of the modified starch in the paper products does not exceed 1% by weight and the finished paper products meet applicable extractive limitations in 21 CFR 176.170.
Requestor: National Starch and Chemical Co.
Quick links to regulation: 176.170
178.3520

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

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