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FDA registration
FDA registration is a regulatory requirement that requires companies producing and selling products in the United States or exporting them globally to the United States to register on the FDA website. Because FDA registration is only for information registration on the official website, strictly speaking, FDA registration is only a self declaration behavior, that is, enterprises are responsible for their products meeting relevant standards and safety requirements. If a product has a safety accident, enterprises need to bear corresponding responsibilities.
Note that the result of FDA registration is a registration number, and there is no official certification. The FDA registration certificates circulating on the market are all declarative documents made by agency agencies to meet customer promotional needs, and do not have any special effect.
Since the 9/11 incident, the US FDA has introduced a bill targeting bioterrorism, requiring global food companies exporting to the United States (including human and animal food) to register at the FDA factory. This means that for food entering the US market, the production company or company information must be registered at the FDA official website to obtain the relevant FDA registration number. Therefore, FDA food facility registration is also known as FDA anti-terrorism registration.
FDA food registration is divided into:
1. Food Facility Registration (FFR) - mandatory, mandatory for all food companies exporting to or within the United States
Registration scope: see the human food category table and animal food category table
Required materials: FDA Food Registration Application Form+Business License+Enterprise Authorization Letter (see template)
2. Acidification registration (FCE for enterprise registration, SID for product registration) - mandatory. Low acid canned and acidified food factories exporting to the United States or the United States must do so
Registration scope: Low acid and acidified foods (low acid foods: pH>4.6, water activity>0.85; acidified foods: pH ≤ 4.6, water activity>0.85)
Note: SID is registered according to the variety and specifications of the product, that is, if a product has different specifications, each specification needs to be registered.
Validity period: Any changes in product specifications or sterilization process flow require a new submission for SID registration; If the factory address has changed, all previously submitted SID registrations need to be resubmitted at the new address. (i.e. there is no fixed validity period)
Required materials: test report (heat distribution, heat penetration)+process technical documents+preparation process documents+application form
Low acid products: such as most canned foods such as vegetables, mushrooms, tuna, coconut juice, etc. (pH value and water activity must meet the requirements).
Common acidified foods: Domestic pickled foods, pickles, and other foods are mostly of this category (pH and water activity must meet the requirements).
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