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Canned Food
FCE REGISTRATION

Before you export any acidified food (AF) or low-acid canned food (LACF) product to the United States, register your company with the U.S. Food and Drug Administration, to avoid the detention of your shipment.

Consumers are looking for exciting, healthy food, and canned foods often provide needed nutrients at a lower cost than fresh, frozen and dried forms, when price, waste and time to prepare are considered.

FOOD CANNING ESTABLISHMENT REGISTRATION

The global canned food industry is expected to reach $108 billion by 2022. Innovative product offerings with a focus on convenience, quality and eco-friendliness are expected to drive the market growth.

Low acid, pasteurized, sterilized or acidified products are sold in

  • metal tins & cans
  • canisters, drums, pails,
  • buckets, jars, bottles,
  • flexible pouches or tetra packs.

ITB HOLDINGS LLC provides the following services to domestic and foreign companies that are manufacturers, exporters, warehouses, importers, or distributors:

■ Food Facility Registration

■ Food Canning Establishment (FCE) Registration

■ Process Filing (SID)

■ U.S. Agent Service

■ Prior Notice

■ Label Review

■ Label Design

FDA 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
  • and file scheduled processes for each product, product style, container size and type and processing method.

Submission Identifier – SID numbers (SIDs) must be submitted as Affirmation of Compliance (AofC) codes when importing acidified foods and low-acid canned foods into the United States.

Importers
wholesalers
distributors
brokers
should verify that their suppliers FCE registration is current.

Better Process Control School (BPCS)

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.

Examples of foods that may be acidified foods
  • 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.

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.