REGISTRATION FDA
Any company that wants to export its products, or simply send samples to the United States, must first register its factory and / or warehouse (Facility) with the American Food and Drug Administration (FDA). Once the registration procedure (Food Facility Registration) has been completed, the FDA will assign the registered company a unique 11-digit number (FFR Number) obtained which will allow you to start exporting your products to the USA. The registration has a two-year value and will expire, regardless of when it will be made, on December 31, 2020.
FDA Registration € 150,00 Register now
US AGENT and TEMPORARY US AGENT
In order to obtain its FDA Number, the Food and Drugs Administration requires that each foreign (non-USA) establishment appoint, and therefore must be represented locally, a US Agent who resides or has an office in the United States, and that however it is physically present there. The agent's function is to liaise between the FDA and the foreign establishment, both for what concerns normal communications and for those relating to possible emergencies. Our annual US Agent service runs for 12 months and includes “free” renewal of the FDA registration. Pangea Export is the only one to make a Temporary US Agent service lasting 2 months available to its customers at the first sending of samples.
Annual US Agent € 450,00 / Temporary US Agent: € 150,00 Register now
FCE - SID
FCE (Food Canning Establishment) registration is mandatory for all manufacturers of vacuum and long-life foods such as peeled tomatoes, canned products, products in oil, canned tuna, etc. Once the production plant has been registered, the preventive certification of the production processes is required for each type of product, to be requested through the SID (Submission Identifier) procedure. This procedure is required due to the possible risk of botulinum proliferation in all low acid (LACF) and acidified (AF) products.
FCE Registration: € 150,00 / SID Process Filling: € 300,00 each
NUTRITION FACTS and LABELING
Food products intended for sale on the American market must reflect the new labeling directives imposed by the FDA starting from 26 July 2018. Nutrition Facts with values expressed for the recommended portion, allergens, location, font and size of the information to be reported in the packaging, must follow with absolute precision the guidelines issued by the American government regarding Labeling. Failure to comply with these rules can lead to more than probable possession of the goods at the US customs.
Creation Nutrition Facts: € 190,00 each / Label Review: € 290.00 each
FCS - FOOD CONTACT SUBSTANCE
FDA considers all substances and their components that, directly or indirectly, come into contact with food, as indirect food additives. Machinery for food processing, packaging products, tableware, containers, household appliances coatings, etc. they must comply with the “Food Contact Substance Act” to be exported to the United States. The safety of each substance will be assessed on the basis of its chemical composition and the relative classification of each individual component in relation to the FCS. For new substances or new uses of components already approved by the FDA it will be necessary to proceed with the 510k Premarket Notification.
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RENEWAL OF FDA REGISTRATION
The US Food Safety Modernization Act (FSMA) of 2010 requires companies already registered with the FDA to renew their registration for food establishments every two years while maintaining the same registration number. The next renewal will have to be carried out starting from 01 October 2020 and no later than 31 December 2020 under penalty of definitive cancellation of your FDA registration. The two-year registration renewal is free for customers who use our US Agent service.
Renewal FDA Registration: € 100,00 / Free with the US Agent service