FDA Guidelines on Packaging for Foods Treated with Ionizing Radiation

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Irradiation of Food and Packaging, Irradiation of Food, FDA Guidelines on Packaging for Foods, packaging materials for irradiated foods, general provisions for food irradiation

Part – 1

Ionizing radiation is a nonthermal process utilized to achieve the preservation of food. At a maximum commercial irradiation dose of 10 kGy, irradiation does not impart heat to the food, and the nutritional quality of the food is generally unaffected.
The irradiation process can reduce microbial contamination on food, resulting in improved microbial safety as well as the extended shelf life of the food. Many studies have been conducted in the last decades on irradiation of various foods, especially foods susceptible to foodborne outbreaks, such as meat and meat products. Nonetheless, from a commercial standpoint, foods are generally prepackaged in the final form (aka case ready) before irradiation to avoid recontamination.
Title 21 of the Code of Federal Regulations (CFR), Part 179.25 (General provisions for food irradiation), subparagraph (c), states that packaging materials subjected to irradiation incidental to the radiation treatment and processing of prepackaged foods shall comply with 21 CFR 179.45 (Packaging materials for use during the irradiation of prepackaged foods).
This list in 21 CFR 179.45 does not include many modern packaging materials presently desired by the food industry in light of the commercialization of food irradiation. This, in turn, has presented new challenges to the FDA and regulated industry. 
Briefly describes:
1) The food additive regulations about food and packaging materials in contact with food during irradiation. 
2) Emerging research aimed at determining the radiolysis products (RPs) formed from new packaging materials, including polymers and additives, after exposure to irradiation.
3) Approaches to evaluating the premarket safety assessment of new packaging materials in contact with food during irradiation. 

US Regulations for Irradiation of Food and Packaging in Contact with Food
Under Section 201(s) of the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (the Act) of 1958, the definition of a food additive includes “…any source of radiation intended for such use”. In connection with Section 409 of the Act, this means that a food is deemed adulterated and cannot be legally marketed if it has been intentionally irradiated unless the irradiation is carried out in compliance with an applicable regulation under the prescribed conditions of use specified in the regulation. The use of packaging materials for irradiated food is considered a new use and is subject to premarket safety evaluation. Components of packaging materials that have been irradiated may migrate to food at different levels in comparison to unirradiated materials. It also holds for the RPs produced as a result of irradiation of the packaging materials. This safety concern can be considered in two scenarios, either a packaging material is irradiated before food contact, or it is irradiated while in direct contact with food (FDA 1986). In either case, the packaging material used should comply with the applicable regulations, as specified in part 179.45. Thus, as dictated by Chapter 21 of the Code of Federal Regulations, Part 179.25 (denoted as 21 CFR 179.25), the irradiation of both food and packaging materials in contact with food are subject to premarket approval before the introduction of the food into interstate commerce.

FDA Guidelines on Packaging for Foods 
21 CFR 179 is the primary regulation that covers irradiation in the production, processing, and handling of food, and it is divided into subparts and sections, as shown in Table 6.1. Subpart B describes radiation and radiation sources, which include gamma-ray, e-beam, and X-ray, as well as the general provisions for food irradiation. Subpart B also lists other radiation processes, including radiofrequency radiation, ultraviolet, and pulsed light. These radiation processes are covered elsewhere and will not be included in this chapter. Subpart C describes packaging materials for irradiated foods. The listing regulations in Part 179 are the result of approvals through the food additive petition process codified in 21 CFR 171. 

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