FDA canned and acidified foods: FCE registration and SID process filing

Which foods are covered

Low-acid foods are foods, other than alcoholic beverages, with a finished equilibrium pH above 4.6 and a water activity above 0.85; tomatoes and tomato products with a pH below 4.7 are not classed as low-acid. When such foods are thermally processed and packed in hermetically sealed containers, they fall under the low-acid canned food rules. Acidified foods are low-acid foods to which acids or acid foods are added, with a water activity above 0.85 and a finished equilibrium pH of 4.6 or below.

Carbonated beverages, jams, jellies, preserves, acid foods and foods that are stored, distributed and retailed under refrigeration are not acidified foods. If you are unsure whether a sauce, drink or pickled product is covered, measure its pH and water activity and get expert advice before shipping.

Forms used for registration and process filing

• Form FDA 2541: food canning establishment registration, giving the FCE number
• Form FDA 2541d: low-acid retorted method
• Form FDA 2541e: acidified method
• Form FDA 2541f: water activity or formulation control method
• Form FDA 2541g: low-acid aseptic systems
• Electronic submission through the AF/LACF system in FDA Industry Systems is recommended

Deadlines, records and foreign processors

A commercial processor must register with FDA no later than 10 days after it starts making, processing or packing these foods, and file its scheduled processes no later than 60 days after registration and before packing any new product. Each food must then be processed at least to the filed scheduled process. Spoilage, process deviations or microbial contamination must be reported, and processing records, including pH records for acidified foods, are kept for 3 years from the date of manufacture.

The rules apply to foreign processors that offer low-acid foods for import into the US. Instead of an emergency permit, FDA can ask for the refusal of admission of foods that may be injurious, and refused foods are not admitted until FDA finds the processor complies; FDA may also inspect the foreign plant. The electronic system is limited to facilities that are also registered as food facilities, so keep both registrations current.