What are FDA requirements regarding Canned Foods and Low Acid Canned Foods?

Special regulations apply to the manufacture of heat processed low-acid canned foods and acidified foods (21 CFR 108, 113, and 114).

The purpose of these regulations is to ensure safety from harmful bacteria or their toxins, especially the deadly Clostridium botulinum. This can only be accomplished by adequate processing controls, and appropriate processing methods, such as cooking the food at the proper temperatures for sufficient times, adequately acidifying the food, or controlling water activity. The regulations, first adopted in 1973 and revised in 1979, are based on proposals made by the canning industry following FDA investigations of deaths and illnesses from botulism associated with lax practices in low-acid canned food and acidified food processing.

Low-acid canned foods are heat processed foods, other than alcoholic beverages, that have an acidity greater than pH 4.6 and a water activity (aw) greater than 0.85 and which are packaged in hermetically sealed containers." Water activity" is a measure of the water available for microbial growth. A hermetically sealed container is any package, regardless of its composition (i.e., metal, glass, plastic, polyethylene-lined cardboard, etc.), that is capable of maintaining the commercial sterility of its contents without refrigeration after processing.

Acidified foods are low-acid foods to which acid(s) or acid food(s) are added to reduce the pH to 4.6 or below (increase the acidity), and with a water activity greater than 0.85. Pimentos, artichokes, some puddings, and some sauces are examples of acidified foods. Questions about product status can be referred to FDA at the address given below.

All commercial processors of low-acid canned foods and acidified foods are required to register their establishments and file processing information for all products with the Food and Drug Administration, using appropriate forms. Registration and process filing are required for both U.S. establishments and those in other countries that export such foods to the United States (21 CFR 108.25 and 108.35).

Registration and process filing forms are obtainable on request (please include a self-addressed address sticker) from the Food and Drug Administration, LACF Registration Coordinator (HFS-618), 200 C Street, S.W., Washington, D.C. 20204.

In addition to registering and filing the processing information, processors must comply with other mandatory provisions of 21 CFR 108, 113 and 114. In the regulations, the mandatory provisions are always preceded by the word "shall." The regulations for low-acid canned foods and acidified foods (21 CFR 108, 113 and 114) are obtainable from the Food and Drug Administration, Industry Activities Staff (HFS-565), 200 C Street, S.W., Washington, D.C. 20204 (please include a self-addressed address sticker).