FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE
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U.S. FDA Registration
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Food Canning Establishment Registration FCE & Submission Identifier SID
Click the button below to see the service steps in an easy-to-follow graphic format.
Aside from FDA Food Facility Registration FFR, the US FDA requires most companies to produce shelf-stable food (canned, bottled, jarred, vacuum packed, etc.). Low-Acid Canned Food -LACF, pH above 4.6- or Acidified Foods -AF, pH below 4.6- to obtain a Food Canning Establishment (FCE) registration number before import and distribution in the US market. Upon registration, the FDA issues a unique 5-digit FCE number, identifying each processing plant.
The US FDA also requires that all LACF/ AF manufacturers file their scheduled processes, known as Process Filing, for each product and each style, container size, type, and processing method. The FDA assigns each process filing a specific Submission Identifier (SID) unique to every product category and packing size. The SID number is 11 digits long and specific to each product type and packing size, so it is not to be mistaken for the food facility registration number, which also consists of 11 digits. To import AF or LACF to the US, all manufacturers must have both FCE and SID for the imported products.
The FCE-SID submission involves the following four steps:
1- Creation of an FCE account for the manufacturer
2- Obtaining the low-acid/ acidified food process information
3- Submission of low-acid/ acidified product data by FDA Agent
4- Review of the SID submissions and approval notice by the FDA
Important points to consider before starting FCE-SID registration
The FDA only allows the AF, LACF manufacturer, or their official FDA agent to create an FCE account and submit SIDs. Remember, wholesalers, US distributors or other players are not allowed to create an FCE account or apply for one on behalf of the manufacturer
Before any company starts the SID submission process, it is essential to provide the necessary food safety documents generated in-house or through a third-party laboratory. This will help the SID submission and FDA review process move forward smoothly without interruption.
Heat penetration (HP) and temperature distribution (TD) studies, specific to sterilizer systems (retort), are examples of documents often required during SID submission for low-acid foods. Furthermore, the process authority must demonstrate that critical factors are satisfactorily examined, that food safety is scientifically substantiated, and that the study results are reported in process summary documentation for acidified and low-acid foods.
Unless exempt, foods that fall under Food Canning Establishment (FCE) requirements must also comply with the FDA Preventive Controls Rule, necessitating the designation of a Preventive Controls Qualified Individual (PCQI) for Food Safety plan development.
Creating FCE and submitting the SID fillings usually takes 10-15 days. Generally, within 1-2 weeks after the fillings are completed, the FDA will review the SIDs and either approve them or provide their comments and ask for more product information. Registration of acidified food AF typically takes a shorter time. Low-acid canned food LACF SID usually takes longer to submit and get approved.
How do FCE-SID Exceptions Work?
It’s not always easy to determine if your food and beverage products need an FCE-SID submission or if the FDA excludes them. However, to stay away from costly FDA import detentions, it is essential to speak to FDA consultants who are experts in this area. If you want to determine if your product is LACF or AF or excluded from submission, you may ask us for our FCE-SID free initial assessment expert service. Obtaining your food product’s pH and water activity level will help make a better assessment of whether FCE-SID is required or not.
If you are an Acidified or Low-Acid Canned Food manufacturer. In that case, FDA Listing Inc. will help your company to ensure that your Food Canning Establishment is correctly registered with the FDA and that your scheduled process for each product is appropriately declared and filed. Our FCE SID service gives you one year of free expert consultations for your new products.
Service Details & Fees
First SID Submission
Each Additional SID
Time Required (Filing)
FCE Registration
30-Min Expert Consultation
FDA Communications
795 USD
195 USD
2-3 Days
_______ Related Services _______
Frequently Asked Questions (FAQ)
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
Frequently Asked Questions (FAQ)
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
Service Details & Fees
First SID Submission
795 USD
Each Additional SID
195 USD
Time Required (Filing)
2-3 Days
FCE Registration
30-Min Expert Consultation
FDA Communications
_______ Related Services _______