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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR No. 2007-001

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:
  1. 1,2-Benzisothiazolin-3-one (BIT); (CAS Reg. No. 2634-33-5),
  2. 1,1,3-tris(5-tert-butyl-4-hydroxy-2-methylphenyl)butane; (CAS Reg. No.1843-03-4), and
  3. naphthalene sulfonic acid-formaldehyde condensate, sodium salt; CAS Reg. No. 9084-06-4).
Use Limitations*: As components of an adhesive formulation when used as specified below: Substance A, a biocide preservative will be used according to its FIFRA registration as a product preservative in water based adhesive products. Substances B and C will be used as antioxidants in adhesives and will be used at levels not to exceed 1 percent of the adhesive. The adhesive shall be used at GMP levels (i.e., the minimum amount needed to accomplish the intended technical effect). Also, these substances are limited to use in formulations with modified butadiene /styrene copolymers.
Requestor: Kraska Consultants, Inc.

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

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