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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR No. 2011-001

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: Silver (CAS Reg. No. 7440-22-4) and cetyltrimethylammonium bromide (CAS Reg. No. 57-09-0)
Use Limitations*: For use as components of an antimicrobial formulation to be used to preserve composite countertops consisting of a polymeric binder and inorganic filler. The antimicrobial formulation will contain up to 0.5 % by weight of silver and up to 30 % by weight of cetyl trimethylammonium bromide with the remainder consisting of a suitable substance regulated for the intended use. The antimicrobial formulation will be incorporated into the polymeric binder at a level not to exceed 1 % by weight. The final composite countertop will incorporate the polymeric binder at a level not to exceed 10 % by weight with the remainder consisting of inorganic filler of a quality suitable for food-contact use. The final food contact article will be used in contact with all foods at room temperature and below.
Requestor: Nanobiomatters BactiBlock S.L.

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

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