Did you know that some shelf-stable foods, which are sealed airtight and have specific pH and water activity levels, are required to adhere to FDA regulations for Food Canning Establishments (FCE)? Determining whether your products meet these FCE standards can be quite challenging. Both FCE and SID as well as facility registration, US Agent, and FSVP Agent details be presented to your customs broker before exportation to the USA.
Here at Quality Smart Solutions, our team of regulatory experts is here to ensure you are compliant with these new requirements. We can assist you with product designation, your FCE-SID filing (including compliance with LACF regulations), and verifying Submission Identifiers (SIDs which is a 5-digit identifier) for your FCE products before shipping to help you avoid any potential delays. i.e. manufacturers of LACF and AF products must be registered with the FDA and obtain product registration.
LACF = low-acid canned foods
AF = acidified foods
*LACFs are foods with a pH higher than 4.6 and a water activity greater than 0.85.
*Afs are foods that have a pH of 4.6 or lower and water activity greater than 0.85.
Recently, the FDA changed its LACF electronic filing system worth noting. One significant change is the introduction of a “Not Filed-Incomplete” status for SIDs. When an SID submission is marked as incomplete, you cannot use that SID for shipping products to the United States until the issue causing the incompleteness is resolved. This status also prohibits you from using the incomplete scheduled process for packaging. However, you have a 30-day window to address the “Incomplete” standing before the filing is deleted. These regulations necessitate unique process filings for each manufacturing process in these food categories, and each filing is associated with a Submission Identifier (SID) number.
Completing the FDA FCE SID submission process can be complex and time-consuming, particularly for non-U.S. manufacturers. To avoid potential issues like detentions, entry errors, or low filer evaluations, verifying that your FCE products’ SID numbers are on file with the FDA is essential. Utilizing FCE Compliance tools such as SID Verifiers can simplify this process and confirm the presence of your SIDs in the FDA database.
If the SID submission is deemed incomplete, the Manufacturer is unable to utilize the SID for shipments to the United States until the underlying issue is addressed. Additionally, it prohibits the Manufacturer from packaging the product using the incomplete scheduled process. Our regulatory experts will also ensure compliance with all other requirements like FDA Registration and act as your US Agent & FSVP Import Agent.
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