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FDA Review of New Retort Technology



January 28, 2015 by David Lennarz

Did you know that newer Food Canning Establishment (FCE) processing technologies, specifically retort systems, may require a special review by the U.S. Food and Drug Administration (FDA) before they may be used?  FDA regulations state that certain retort systems may be used in the processing of low-acid and acidified canned foods, but many firms are moving away from those listed in the regulations as newer technologies are released.

FDA will not accept scheduled process filing submissions if the foods were processed with unknown retort technology.  So, when a facility wishes to use a new retort system that is not listed in FDA’s regulations, it must obtain permission from FDA to use the system through a petition.

Retort system petitions may take months to complete.  A firm should be prepared to coordinate with their retort’s manufacturer to prepare the information necessary for the review.   FDA will review specific details about how the new technology functions.

Upon receiving a petition, FDA reviews the technology to determine if the equipment falls under the regulations, specifically 21 CFR 113.40(j). Once FDA reviews the new technology, the agency will either accept the retort system or suggest changes.  When FDA accepts the system, the petitioning firm can begin to submit process filings.

Registrar Corp can assist clients with preparing the documentation required for FDA, as well as facilitate communication between FDA and the firm.  Registrar Corp’s FCE-SID service also helps firms complete an FCE registration and submit SID process filings to FDA.

For assistance with FCE registration and SID process filing or for more information about FDA’s requirements for low-acid canned food and acidified food, contact Registrar Corp.

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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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