Who is required to register?
You may direct specific questions to FDA by telephone at 1-800-216-7331 or 301-575-0156 or by email at email@example.com
- Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register the facility with the FDA.
- Examples of FDA-regulated foods and food additives for humans or animals include:
FDA general food categories (defined under 21CFR 170.3)
- Baked goods and baking mixes, including all ready-to-eat and ready-to-bake products, flours, and mixes requiring preparation before serving.
- Beverages, alcoholic, including malt beverages, wines, distilled liquors, and cocktail mix.
- Beverages and beverage bases, nonalcoholic, including only special or spiced teas, soft drinks, coffee substitutes, and fruit and vegetable flavored gelatin drinks.
- Breakfast cereals, including ready-to-eat and instant and regular hot cereals.
- Cheeses, including curd and whey cheeses, cream, natural, grating, processed, spread, dip, and miscellaneous cheeses.
- Chewing gum, including all forms.
- Coffee and tea, including regular, decaffeinated, and instant types.
- Condiments and relishes, including plain seasoning sauces and spreads, olives, pickles, and relishes, but not spices or herbs.
- Confections and frostings, including candy and flavored frostings, marshmallows, baking chocolate, and brown, lump, rock, maple, powdered, and raw sugars.
- Dairy product analogs, including nondairy milk, frozen or liquid creamers, coffee whiteners, toppings, and other nondairy products.
- Egg products, including liquid, frozen, or dried eggs, and egg dishes made therefrom, i.e., egg roll, egg foo young, egg salad, and frozen multicourse egg meals, but not fresh eggs.
- Fats and oils, including margarine, dressings for salads, butter, salad oils, shortenings and cooking oils.
- Fish products, including all prepared main dishes, salads, appetizers, frozen multicourse meals, and spreads containing fish, shellfish, and other aquatic animals, but not fresh fish.
- Fresh eggs, including cooked eggs and egg dishes made only from fresh shell eggs.
- Fresh fish, including only fresh and frozen fish, shellfish, and other aquatic animals.
- Fresh fruits and fruit juices, including only raw fruits, citrus, melons, and berries, and home-prepared ''ades'' and punches made therefrom.
- Fresh meats, including only fresh or home-frozen beef or veal, pork, lamb or mutton and home-prepared fresh meat-containing dishes, salads, appetizers, or sandwich spreads made therefrom.
- Fresh poultry, including only fresh or home-frozen poultry and game birds and home-prepared fresh poultry-containing dishes, salads, appetizers, or sandwich spreads made therefrom.
- Fresh vegetables, tomatoes, and potatoes, including only fresh and home-prepared vegetables.
- Frozen dairy desserts and mixes, including ice cream, ice milks, sherbets, and other frozen dairy desserts and specialties.
- Fruit and water ices, including all frozen fruit and water ices.
- Gelatins, puddings, and fillings, including flavored gelatin desserts, puddings, custards, parfaits, pie fillings, and gelatin base salads.
- Grain products and pastas, including macaroni and noodle products, rice dishes, and frozen multicourse meals, without meat or vegetables.
- Gravies and sauces, including all meat sauces and gravies, and tomato, milk, buttery, and specialty sauces.
- Hard candy and cough drops, including all hard type candies.
- Herbs, seeds, spices, seasonings, blends, extracts, and flavorings, including all natural and artificial spices, blends, and flavors.
- Jams and jellies, home-prepared, including only home-prepared jams, jellies, fruit butters, preserves, and sweet spreads.
- Jams and jellies, commercial, including only commercially processed jams, jellies, fruit butters, preserves, and sweet spreads.
- Meat products, including all meats and meat containing dishes, salads, appetizers, frozen multicourse meat meals, and sandwich ingredients prepared by commercial processing or using commercially processed meats with home preparation.
- Milk, whole and skim, including only whole, lowfat, and skim fluid milks.
- Milk products, including flavored milks and milk drinks, dry milks, toppings, snack dips, spreads, weight control milk beverages, and other milk origin products.
- Nuts and nut products, including whole or shelled tree nuts, peanuts, coconut, and nut and peanut spreads.
- Plant protein products, including the National Academy of Sciences/National Research Council "reconstituted vegetable protein" category, and meat, poultry, and fish substitutes, analogs, and extender products made from plant proteins.
- Poultry products, including all poultry and poultry-containing dishes, salads, appetizers, frozen multicourse poultry meals, and sandwich ingredients prepared by commercial processing or using commercially processed poultry with home preparation.
- Processed fruits and fruit juices, including all commercially processed fruits, citrus, berries, and mixtures; salads, juices and juice punches, concentrates, dilutions, "ades", and drink substitutes made therefrom.
- Processed vegetables and vegetable juices, including all commercially processed vegetables, vegetable dishes, frozen multicourse vegetable meals, and vegetable juices and blends.
- Snack foods, including chips, pretzels, and other novelty snacks.
- Soft candy, including candy bars, chocolates, fudge, mints, and other chewy or nougat candies.
- Soups, home-prepared, including meat, fish, poultry, vegetable, and combination home-prepared soups.
- Soups and soup mixes, including commercially prepared meat, fish, poultry, vegetable, and combination soups and soup mixes.
- Sugar, white, granulated, including only white granulated sugar.
- Sugar substitutes, including granulated, liquid, and tablet sugar substitutes.
- Sweet sauces, toppings, and syrups, including chocolate, berry, fruit, corn syrup, and maple sweet sauces and toppings.
Who does not have to register?
- Private residences of individuals, even though food may be manufactured/ processed, packed, or held in them.
- Non-bottled water drinking water collection and distribution establishments and structures, such as municipal water systems.
- Transport vehicles that hold food only in the usual course of their business as carriers.
- Farms -- see below
- Restaurants -- i.e., facilities that prepare and sell food directly to consumers for immediate consumption, including pet shelters, kennels, and veterinary facilities that provide food directly to animals. Facilities that provide food to interstate conveyances, such as commercial aircraft, or central kitchens that do not prepare and serve food directly to consumers, are not restaurants for purposes of 21 CFR Part 1, Subpart H.
- Retail food establishments, such as grocery stores, delis, roadside stands that sell food directly to consumers as their primary function, meaning that annual food sales directly to consumers are of greater dollar value than annual sales to other buyers.
- Nonprofit food facilities,which are charitable entities that meet the terms of § 501(c)(3) of the Internal Revenue Code and that prepare or serve food directly to the consumer or otherwise provide food or meals for consumption by humans or animals in the U.S. This includes central food banks, soup kitchens, and nonprofit food delivery services.
- Fishing vessels that do not process fish. Such fishing vessels may engage in practices other than processing such as harvesting and transporting fish, and heading, eviscerating, or freezing fish solely to prepare the fish for holding on board the vessel.
- Facilities regulated exclusively and throughout the entire facility by the U.S. Department of Agriculture, that is, facilities handling only meat, poultry, or egg products.
Criteria for Exemption from Registration
Farms are exempt if
- the farm is in one general physical location,
- it is devoted to growing, harvesting, washing, trimming of outer leaves, and/or cooling of produce,
- it involves raising animals (including seafood) for human or animal consumption (FDA considers activites such as milking cows and collecting eggs from chickens to be ''harvesting'' when applied to animals, because these activities are similar to harvesting crops) and/or,
- foods that are manufactured or processed are exclusively consumed on that farm or another farm under the same ownership.
- Farm-operated roadside stands that sell food directly to consumers as its primary function are exempt from registration.
- Packers of fruits, vegetables, and mushrooms are considered farms and are exempt if: All food used is grown, raised, or consumed on the owner's farm or another farm under the same ownership
- Packers of fruits, vegetables, and mushrooms are not exempt and must register if: they pack or hold food crops that have been grown on farms owned by someone else
- Warehouses or produce auctions are operations that hold food for resale are not exempt and must register.
- Feed mills and pet food manufacturers, process, pack, or hold feed for animal consumption are not exempt and must register.
Private residences of individuals
- A food manufacturing business that operates from within a private home is exempt and does not have to register even though food may be manufactured/processed, packed, or held there.
- see Guidance and Requirements for Pennsylvania Home Food Processors for more information on home food businesses.
Retail food establishments
- Groceries, delis, and roadside stands, that sell food directly to consumers as their primary function, meaning that annual sales directly to consumers are of greater dollar value than annual sales to other buyers are exempt and not required to register.
- Farm-operated roadside stands that sell food directly to consumers as its primary function are exempt from registration.
- Operations that prepare and sell food directly to consumers for immediate consumption are exempt.
- Central kitchens are not exempt if they do not prepare and serve food directly to consumer and must register.
- Facilities that provide food to interstate conveyances, such as to commercial aircraft are not exempt and must register.
Non-profit establishments that prepare food for, or serve food directly to, consumers
- Charitable entities that meet the terms of of the Internal Revenue Code 501(c)(3) and that prepare or serve food directly to the consumer or otherwise provide food or meals for consumption by humans or animals in the U.S are exempt.
- Examples of nonprofit food establishments include central food banks, soup kitchens, and nonprofit food delivery services.
Transport vehicles that hold food only in the usual course of their business as carriers.
- trucks or other motor carriers are exempt.
- However, truck or marine terminals or freight forwarders are not exempt and must register because they hold food.
- If a vehicle such as a railcar is used as a storage bin for a manufacturing plant, it would be "holding'' food, not transporting it, and would not be exempt and must register.
- The regulation does not exempt facilities based on how long they hold food.
Facilities regulated exclusively throughout the entire facility by the U.S. Department of Agriculture
- Facilities handling only meat, poultry, or egg products are exempt.
Fishing vessels not engaged in processing
- Those that harvest and transport fish and that may engage in practices such as heading, eviscerating, or freezing fish solely to prepare the fish for holding on board the vessel are exempt.
Non-bottled water, drinking water collection and distribution establishments and structures
- i.e. municipal water systems are exempt.
FDA's discussion of exemption criteria can be accessed in the online version of the interim final rule.
Registration is easy, free, and required by law. For help with registration, contact FDA In the U.S call 1-800-216-7331 or 301-575-0156 From elsewhere call 301-575-0156 Fax questions to 301-210-0247 Email questions to firstname.lastname@example.org.
Other Questions about Registration
Is there a fee to register?
- There is no fee to register
- FDA has advised registrants that registration is easy and free and to be cautious when companies offer to assist with registration for a fee.
How do I register?
- Registrations can be submitted electronically via the Internet, through surface mail on a paper form or a CD-ROM, or through fax
What information Is required?
- Physical address
- Phone number of the facility and parent company, if the facility is a subsidiary
- All trade names the facility uses
- Food product categories (21 CFR 170.3)
- A statement certifying that the information submitted is true and accurate and submitter is authorized to register the facility
- Name and contact information of the person submitting the certification statement
- Name of foreign facility's U.S. agent, if applicable, and the agent's contact information
- Emergency contact information
What will happen if I am required to register my facility but fail to do so?
- Registration is easy, free, and required by law.
- Food manufacturers need to register by December 12, 2003.
- FDA will initially take an educational rather than enforcement approach for the first several months of the regulation.
- However, repeated failures to register can bring a civil action in Federal court or the Federal government can bring a criminal action in Federal court to prosecute persons who are responsible for the commission of a prohibited act.
For help with registration, contact FDA In the U.S call 1-800-216-7331 or 301-575-0156 From elsewhere call 301-575-0156 Fax questions to 301-210-0247 Email questions to email@example.com.