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HomeU.S. FDA Food Regulations › U.S. FDA Food Canning Establishment (FCE) Registration and Process Filings (SID)

U.S. FDA Food Canning Establishment (FCE) Registration and Process Filings (SID)

The U.S. FDA requires companies that produce certain shelf-stable, hermetically-sealed low-acid canned or acidified foods to obtain a Food Canning Establishment (FCE) registration. In addition, manufacturers must file documentation with U.S. FDA for each process used in the production of foods subject to these requirements. These submissions are known as a "Process Filing" and each is assigned a unique "Submission Identifier" (SID).

Avoid U.S. FDA refusals and detentions when shipping canned, bottled, jarred, and other shelf-stable foods in the United States by ensuring your food canning establishment is properly registered and your scheduled processes are properly filed. Registrar Corp helps FCE establishments register with FDA and submit process filings to FDA. Process Filing Time Frame.

If you need a U.S. FDA FCE Registration

Registrar Corp's team of FCE-SID Regulatory Specialists provides assistance with the FCE Registration process, guidance accessing U.S. FDA's online LACF system, and unlimited SID submission support for 12 months, including:
  • Expert FCE-SID guidance as to required elements, formats, and particularities of FCE-SID submissions
  • FCE-SID Certificates issued by Registrar Corp documenting your valid SID listings to assure your customers that your products have been properly filed with U.S. FDA
  • Multi-lingual support for communication between U.S. FDA and your company throughout the FCE registration and SID filing process
U.S. FDA FCE-SID Registration Guidance  ››


If you already have a U.S. FDA FCE Registration
Select one of the following options:

Option 1: New U.S. FDA SID Filing Guidance
Registrar Corp's U.S. FDA SID Filing Service includes unlimited SID submission support for 12 months. Registrar Corp helps companies avoid untimely delays and incomplete submissions by providing:
  • Expert SID guidance as to required elements, formats, and particularities of SID submissions
  • SID Certificates issued by Registrar Corp documenting your valid SID listings to assure your customers that your products have been properly filed with U.S. FDA
  • Multi-lingual support for communication between U.S. FDA and your company throughout the entire SID filing process

New U.S. FDA SID Filings  ››

Option 2: Order a Certificate for each of your existing U.S. FDA SID Filings
Certificates of Process Filing (SID) issued by Registrar Corp include verifying the status of your SID(s) with U.S. FDA, faxing and emailing an electronic version of your Certificate, and mailing the original Certificate to you.
  • Certificates issued by Registrar Corp documenting your valid SID listings to assure your customers that your low-acid or acidified food product processes have been properly filed with U.S. FDA
  • With a Certificate of Process Filing, you will periodically receive simplified forms enabling us to quickly update your information on file with the U.S. FDA. Such reminders help ensure your SID remains accurate and prevents the accidental loss of your critical information
  • Sending a copy of your Certificate of Process Filing along with each shipment may help avoid errors and delays

Order Your FCE-SID Certificate  ››


If you believe that your product may be excluded from U.S. FDA FCE-SID requirements

U.S. FDA FCE-SID regulations are complicated and contain numerous "exclusions" (exceptions) for various low-acid or acidified products depending on factors such as processing method, pH changes during processing, etc. U.S. FDA inspectors may not always know merely by looking at the package whether a process filing ("SID") is required. In such circumstances, the inspector could detain the product, send samples for laboratory testing, and request processing information from the manufacturer. Such detentions could last weeks. FCE-SID Exclusion Certificates issued by Registrar Corp address this potential problem by:
  • Helping manufacturers determine whether an exclusion applies and then compiling and organizing adequate evidence that the food is excluded from the SID requirement
  • Assisting the company in preparing documentation of the product's exclusion status in a format that allows a U.S. FDA inspector to easily, quickly, and reliably confirm that a process filing is not required
  • Helping manufacturers communicate with U.S. FDA in the event of a detention

U.S. FDA FCE-SID Exclusion Guidance  ››




 
U.S. FDA Regulations:

U.S. FDA FCE/SID: 21 C.F.R. sections 108, 109, 113, 114


Fees:

FCE-SID Filing Service
First Year: US$ 1995

FCE-SID Filing Service
Annual Renewal: US$ 995

FCE-SID Exclusion Certificate:
US$ 395/product















































Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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