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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions
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TOR number 1996-007

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: Polyglycerol esters of fatty acids regulated in 21 CFR 172.854
Use Limitations*: As an adjuvant (e.g., antifogging agent, antistatic agent) in polypropylene films regulated in 21 CFR 177.1520 and having a maximum thickness of 100 um in contact with all types of food under Conditions of Use A through H (Table 2, 21 CFR 176.170).
Requestor: Center for Regulatory Services on behalf of Riken Vitamin Company Ltd., of Japan.
Quick links to regulation: 176.170
177.1520

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