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July 31, 2020

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What Food Contact Substances are Cleared for Use During Irradiation of Food?


Are polyolefin materials that comply with Title of the 21 Code of Federal Regulations (C.F.R.) Section 177.1520 [polymers] compliant with 21 C.F.R. 179.45 relating to irradiated foods?  


The Threshold of Regulation (TOR) Rule permits FDA to exempt a food contact material from regulation based on exposure and toxicology. In 2010, FDA issued a TOR Exemption (No. 2010-002) for all food contact articles used to irradiate pre-packaged food provided that certain conditions are followed. Specifically, the TOR permits the following materials:

  1. Food additives listed in Title 21 of the Code of Federal Regulations (C.F.R.) Parts 174 through 186;

  2. Substances for which there is an effective food-contact substance notification; and

  3. Substances that are the subject of a TOR exemption,

to be used in food-contact articles during the irradiation of prepackaged food. However, this exemption only applies when:

  1. The radiation processing is done in compliance with 21 C.F.R. Part 179;

  2. The substances are not subjected to radiation doses above 4.5 kGy; and

  3. The packaged food is irradiated either in a verifiably oxygen-free environment or while frozen and contained under vacuum.

TOR letters are of general applicability meaning that any food packager may rely on them.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 42


About this Author is the premier online resource for the global packaging industry. It provides a wide range of information on laws and regulations—both in the U.S. and other countries throughout the world—that affect packages and packaging materials. features news articles on current issues affecting the packaging industry, in-depth features, an Ask an Attorney section, links to packaging industry and government websites, and detailed information on the U.S. Food and Drug Administration (FDA) Food Contact Notification system.