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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR No. 1999-012

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: Potassium 2-ethylhexanoate (CAS Reg. No. 3164-85-0) and dodecyltrimethyl ammonium chloride (CAS Reg. No. 112-00-5)
Use Limitations*: Potassium 2-ethylhexanoate and dodecyltrimethyl ammonium chloride, at maximum use levels of 0.075% and 0.03% by weight, respectively, in the manufacture of thermosetting styrenated polyester resins complying with 21 CFR 177.2420 and intended for use as articles or components of articles for repeated use in contact with food , provided the finished resins meet the extractive limitations in 21 CFR 177.2420(c) and the finished articles are thoroughly cleansed prior to their first use in contact with food in accordance with 21 CFR 177.2420(d).
Requestor: Interplastic Corporation; Silmar Resins Division
Quick Links to regulations in 21 CFR (referenced above): 177.2420

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

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