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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR No. 2013-001

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 mixture of 3-(trihydroxysilyl)propyldimethyloctadecyl ammonium chlorides (CAS Reg. No. 199111-50-7)
Use Limitations*: For use as an antimicrobial to preserve finished food contact articles. The food contact substance (FCS) will be used as an additive without food type or temperature limitation in:
  1. food preparation surfaces (where the FCS is either incorporated into the resin, a food contact laminate layer, or applied to the surface as part of a coating). The FCS may be used at a maximum use level of 1 weight percent of the resin, laminate, or coating.
  2. polymeric tubing for the transfer of beverages. The FCS may be used at a maximum use level of 1 weight percent of the finished tubing.
  3. repeat use activated carbon water filters. The FCS may be used at a maximum use level of 0.25 weight percent of the carbon block.
Requestor: BIOSAFE, Inc.

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

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