Understanding Food Irradiation: What Industry Needs to Know
What is food irradiation?
Food irradiation (using radiation to treat food) is a process that can increase the safety and extend the shelf-life of foods by reducing microorganisms that may be present in the untreated food product. Irradiation has been approved for other food uses such as controlling insects, inspecting foods, and etching the skin of citrus fruits as an alternative to using adhesive stickers for labeling.
What is FDA’s role in ensuring that irradiation of food is safe?
FDA regulates sources of radiation used for treating foods as “food additives.” This means that using sources of radiation to treat food requires approval by FDA before the process can be employed commercially. To seek approval for a source of radiation, an interested party may submit a food additive petition to FDA that contains data demonstrating the safety of the proposed use. FDA grants approval only after agency scientists have thoroughly reviewed the petition and determined that the proposed use is safe. Only uses that undergo this rigorous safety assessment and are found to be safe by FDA experts are permitted.
What types of radiation has FDA approved for use on foods?
FDA regulates sources of radiation used to treat food, which includes both ionizing and non-ionizing radiation sources. The term “radiation” refers to energy that is emitted from a source.
There are two categories of radiation – ionizing and non-ionizing – with the difference being the amount of energy emitted. Ionizing radiation emits enough energy to remove tightly bound electrons from an atom thus creating ions (i.e., atoms with a charge). Non-ionizing radiation does not have sufficient energy to cause ionization. Examples of ionizing radiation include gamma rays, x-rays, and electron beam radiation. Examples of non-ionizing uses of radiation include sound waves, visible light, and microwaves.
FDA has issued regulations allowing for the use of ionizing radiation and non-ionizing radiation to treat specific foods under specific conditions.
The regulations authorizing all of the specific approved uses of radiation for treating foods are listed in Part 179 of Title 21 of the U.S. Code of Federal Regulations (21 CFR).
These regulations list the food products permitted to be irradiated, as well as other conditions of use such as the purpose of irradiation, the maximum absorbed dose, and any labeling requirements.
How do I obtain approval for a new use of food irradiation?
To seek approval for a new use of irradiation, an interested party must submit a food additive petition. FDA has issued guidance for the industry on how to submit and what to include in a food additive petition. Agency experts also are available to consult with potential petitioners in advance of formal submission of a new petition. Those interested in submitting a petition to FDA for a new use of food irradiation should carefully review the agency’s Guidance for Industry: Questions and Answers About the Petition Process and Guidance for Industry: Pre-Petition Consultations for Food Additives and Color Additives.
Typically, FDA experts evaluate three key areas during review of a food additive petition for food irradiation:
- The safety of any chemical products that are formed through the irradiation process, including changes to chemical composition of the food product and any potential toxicity that might result;
- The impact of radiation on the nutritional content of the food; and
- The impact of radiation on the microbiological profile of the food (when applicable).
Can irradiation be a substitute for good manufacturing practices (GMPs)?
No. It is very important to be aware that food irradiation used to reduce microorganisms or insects is not a substitute for good manufacturing practices (GMPs) in a food processing facility, which include proper sanitation practices and temperature controls to ensure the safety of food products. Food irradiation can offer an additional measure of protection against microbial pathogens and insect infestation, but it is not a substitute for GMPs.
Does FDA approve radiation of animal feed?
Yes, uses of radiation for treating animal food or feed are subject to regulation by FDA. Those uses are evaluated by the Center of Veterinary Medicine (CVM) and current approvals are listed in 21 CFR 579.
Do foods have to be labeled indicating they have been treated with irradiation?
Labeling is required when the food product has been treated with ionizing radiation in accordance with 21 CFR 179.26. As a condition of use for ionizing radiation (i.e., gamma rays, x-rays, or e-beam sources), the treated food product must be labeled with the radura symbol and with the statement “treated with radiation” or “treated by irradiation.” This labeling requirement does not apply to the treatment of foods with non-ionizing radiation. (See applicable provision in 21 CFR 179.26)
If food is treated while packaged, does the packaging also require premarket approval?
Yes. Packaging materials, such as plastic wrapping, that are in place and in contact with the food itself when it is irradiated must also undergo premarket approval before use. The regulatory status of a packaging component can be determined as noted in the next question.
How do I know if my packaging material can be used with irradiation while in contact with food?
All components, such as polymer(s) or adjuvant(s), present in the packaging material in place on a food when irradiated must be covered by an existing authorization that specifies the safe conditions of use. To determine whether your component is authorized, please consult the following resources:
- a regulation listed in section 21 CFR 179.45
- an effective food contact notification (FCN);
- a threshold of regulation (TOR) exemption request
Who can I contact for further information?
Contact:
Office of Food Additive Safety (HFS-200)
Phone: (240) 402-1200
FAX: (301) 436-2973
premarkt@fda.hhs.gov
