The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires commercial processors of shelf stable acidified foods and low-acid canned foods in a hermetically sealed container to be sold in the United States to:
- register each establishment
- file scheduled processes for each product, product style, container size and type and processing method.
Importers, wholesalers, distributors, brokers should verify that their suppliers’ Food Canning Establishment (FCE) registrations are current.
Keep in mind that Submission Identifier – SID numbers (SIDs) are provided to U.S. Customs (CBP) as Affirmation of Compliance (AofC) codes, when importing acidified foods and low-acid canned foods into the United States.
Low acid, pasteurized, sterilized or acidified products are sold in
- metal tins & cans
- canisters, drums, pails,
- buckets, jars, bottles,
- flexible pouches or tetra packs
Examples of foods that may be Acidified Foods (AF) or Low-acid Canned Foods (LACF):
- Pickled beets, cocktail onions, and cherry peppers (normally pickled by the addition of acid).
- Red bell peppers treated in an acid brine.
- Some pears and tropical fruits that have a natural pH greater than 4.6 and are acidified to a pH of 4.6 or below.
- Fermented green olives subjected to processes (such as lye treatment or washing with low-acid foods) that raise the pH above 4.6, with subsequent addition of acid or acid foods to reduce the pH to 4.6 or below.
- Tomato salsa made from tomatoes with a pH of 4.6 or below and low-acid ingredients, when the amount of low-acid ingredients is not a small amount and/or the resultant finished equilibrium pH differs significantly from that of the predominant acid or acid food.
- Cold-pack pickles that are subjected to the action of acid-producing microorganisms but require the addition of acid or an acid food to achieve a pH of 4.6 or below.
- Low-acid canned foods (LACF): bamboo shoots, bean sprouts, black olives, mushrooms, mussels, sardines, snails, tuna.
- Water activity (aw) and salt controlled LACF bean paste, caviar, canned cake or bread, chutney, guava paste, lupini beans, salted fish, salted vegetables, some oriental cooking sauces, some soy sauces.
- Acidified Foods (AF): artichokes, hearts of palm, non-fermented pickles and pickled products, peppers, pimentos, papaya and other low acid tropical fruits.
- LACF where pH control at levels greater than 4.6 is a critical factor in the scheduled process: clam sauces, gazpacho, okra and tomatoes, limas and corn, some potato salads, some spaghetti and other pasta in tomato sauces, shrimp in tomato sauce, turtle soup.
Carbonated beverages and foods that are stored, distributed, and retailed under refrigeration are excluded.
Jams, jellies, and preserves are excluded.
A food containing both acid food(s) and low-acid food(s) may or may not be covered as an acidified food.
You must file the scheduled processes with the FDA for each low-acid food in each container size as required by 21 CFR 108.35(c)(2). This filing must occur not later than 60 days after registration and prior to the packing of a new product and include the processing method, type of retort or other thermal processing equipment employed, minimum initial temperatures, times and temperatures of processing, sterilizing value, or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process, for each product in each container size.
Scheduled processes for the low-acid and acidified food products are expected to be established by a qualified person, who has expert knowledge acquired through appropriate training and experience in thermal processing requirements for low-acid foods in hermetically sealed containers.
The owner, operator, or agent in charge of a facility, or an individual authorized by one of them, may register that facility.
Foreign facilities must designate a U.S. Agent such as ITB HOLDINGS LLC, for purposes of communication between the facility and FDA. The U.S. Agent is authorized to register any facility.
FDA will not confirm a registration, provide a registration number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.
FDA will conduct this verification step by sending an email to ITB HOLDINGS LLC. If the FDA does not receive a response to its verification request within 30 calendar days, the registration, registration renewal, update, or cancellation submission will be removed from its database and a new submission will be required.
Manufacturers of low-acid foods must use certified equipment, have received proper training at a Better Process Control School and keep extensive records as specified by federal regulations.
Approved courses are offered online in the United States as well as several countries, in 2 day workshop (acidified only) or a 3 1/2 day workshop for the entire course.
The canning process must be reviewed and certified by a Recognized Process Authority.
A Recognized Process Authority is any person recognized to have the training, experience and equipment needed to determine or verify the sufficiency of a thermal process.
This person serves as an independent information resource for both the processor and regulatory agencies. Recognized Process Authorities may be affiliated with private companies, universities or trade organizations.
Here is a list of online courses:
ITB HOLDINGS LLC provides the following services to domestic and foreign companies that are manufacturers, exporters, warehouses, importers, or distributors:
▪ Food Canning Establishment (FCE) Registration.
▪ Process Filing (SID).
▪ U.S. Agent Service.
▪ Prior Notice.
▪ Label Review.
▪ Label Design.
- Company Registration
- Process Filing (SID)
- U.S. Agent Service