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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR number 2020-005

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 cross-linked polyamide (complying with 21 CFR 177.2550) modified with proteopolymersomes assembled with Aquaporin Z (AqpZ), aminopropyl-terminated polydimethylsiloxane, and polydimethylsiloxane-polymethyloxazoline copolymers
Use Limitations*: As a component of osmosis membranes and reverse osmosis membranes otherwise complying with 21 CFR 177.2550. The FCS may be used in repeat-use filtration membranes in contact with all food types at temperatures up to 40°C (104 °F). The FCS is not intended for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the TOR exemption.
Requestor: DHI A/S on behalf of Aquaporin A/S
Quick links to regulation: 177.2550

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