The fee for a Certificate of Exclusion issued by Registrar Corp is US$ 395. Exclusion Certificates were developed by Registrar Corp to address a recurring problem faced by companies shipping sealed foods to the United States. FCE-SID rules are complicated and contain numerous "exclusions" (exceptions) for various products depending on factors such as processing method, pH changes during processing, etc. An FDA inspector at the U.S. Port of Entry 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. 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 an FDA inspector to confirm easily, quickly and reliably that a process filing is not required.
Helping manufacturers communicate with FDA in the event of a detention.
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.
