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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR number 2017-004

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-propanone, 2-hydroxy-1-(4-(2-hydroxyethoxy)phenyl)-2-methyl- (CAS Reg. No. 106797-53-9) and 2-propenamide, N,N-methylenebis- (CAS Reg. No. 110-26-9)
Use Limitations: 1-propanone, 2-hydroxy-1-(4-(2-hydroxyethoxy)phenyl)-2-methyl- (CAS Reg. No. 106797-53-9) may be used as a photoinitiator in the manufacture of polyether sulfone (PES) filter membranes. 2-propenamide, N,N-methylenebis- (CAS Reg. No. 110-26-9) may be used as a hydrophilic crosslinker in the manufacture of PES filter membranes. The PES filter membranes may be used for filtration of aqueous, acidic, and alcoholic (50% alcohol or less) foods, except for infant formula and human milk, at room temperature or below. The PES filter membranes are for repeat use and can be sterilized between uses at temperatures up to 130°C for two hours. PES filter membranes containing the subject food contact substances are not for use in contact with infant formula or human milk. Such uses were not included as part of the intended use of these substances in the TOR exemption.
Requestor: Gradient on behalf of Parker Hannifin Corporation

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

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