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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR number 1997-009

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: Acrylic copolymers (consisting of isooctyl acrylate (CAS Reg. No. 29590-42-9), ethoxylated hydroxyethyl methacrylate (CAS Reg. No. 25736-86-1) and monomers regulated in 21 CFR 177.1010 (a)(1), (2) and (3)) and D&C Green No. 5 (CAS Reg. No. 4403-90-1)
Use Limitations*: As adhesive components in pressure-sensitive tape for use in splicing paper that will subsequently be repulped and used in the manufacture of food-contact paper complying with 21 CFR 176.170. The isooctyl acrylate and ethoxylatedhydroxyethyl methacrylate monomers must not make up more than 25% and 30% by weight, respectively, of the acrylic copolymer units and at least 50% by weight of the finished acrylic acid copolymer units must be derived from one or more of the following monomers (isooctyl acrylate, ethoxylated hydroxyethyl methacrylate, and the monomers listed in 21 CFR 177.1010 (a)(1)). The use level of the D&C Green No. 5 must not exceed 500 ppm in the dry adhesive.
Requestor: ACC Consulting Group, Inc., on behalf of Adhesives Research Inc.
Quick links to regulation: 176.170

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

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