The information submitted appears to indicate that the product may be excluded from FDA Low-Acid Canned Foods (21 CFR 108.35 and 113) and Acidified Foods regulations (21 CFR 108.25 and 114) for the following reason:

• The product requires refrigeration at or below 45°F (7.2°C) during transport, storage, and through retail sale before opening.

Registrar Corp may assist your facility by issuing Exclusion Certificates for your excluded products.

FCE-SID Exclusion Certificates provide access to the supporting documentation for the exclusion of the product from FCE-SID filing requirements to the FDA inspectors at the port of entry, who may exercise discretion concerning the entry. FDA does not issue FCE-SID Exclusion Certificates.

Based on this exclusion, we will need the following information in order to issue an Exclusion Certificate for this product:

• Copies of the product labeling
• Container description (packaging type, container dimensions, or volume/net weight)

Based on the information you provided, you've finished assessing FCE-SID requirements for product.

The information submitted appears to indicate that the product may be excluded from FDA Low-Acid Canned Foods (21 CFR 108.35 and 113) and Acidified Foods regulations (21 CFR 108.25 and 114) for the following reason:

• The product may be a naturally fermented food.

FDA defines a naturally fermented food a product that:

1. has been salted or held in a brine solution; and
2. has been allowed to ferment for 1 or more weeks in covered containers; and
3. the product has reached a pH of 4.6 or below at the end of fermentation period without the use of any added acid, and
4. the growth of microorganisms and their enzymes in the product are responsible for the biochemical changes that occur during food fermentation, including the lowering of the pH to 4.6 or below [FDA CPG - Ch. 3 - 7303.803A].

For naturally fermented products, please note that we request a detailed process flow diagram of the fermentation processes that includes the pH at each step.

If you are a foreign firm exporting to the U.S., you may need to provide certain entry port documentation to avoid shipping complications.  A Regulatory Specialist is currently reviewing the information you have provided, and we will contact you shortly with comments.

Based on the information you provided, you've finished assessing FCE-SID requirements for asas.

The information submitted appears to indicate that this product is subject to FDA Low-Acid Canned Foods regulations (21 CFR 108.35 and 113).

FDA defines low-acid canned food as any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (aw) greater than 0.85 [21 CFR 113.3(n)].

You may be required to obtain a Food Canning Establishment (FCE) registration and file documentation with U.S. FDA for each process used in the production of foods subject to these requirements.

Registrar Corp can help you comply with FDA Low-Acid Canned Food regulations.

Based on this determination, we will need the following information in order to assist you with FDA Low-Acid Canned Food requirements:

• Temperature Distribution Studies
• Heat Penetration Studies

Typically, separate studies should be provided for each product as well as each container size and container type of each product. If a process authority determines that the study covers more than one product, container type, or container size, the report should clearly indicate what products, sizes, or containers are covered as well as an explanation as to why the study applies to those products, sizes, or containers.

For assistance with U.S. FDA FCE-SID regulations or other U.S. FDA regulations, contact Registrar Corp at +1-757-224-0177 or chat 24/7 at Live Help.

Based on the information you provided, you've finished assessing FCE-SID requirements for asas.

Your product may be excluded from Low-Acid Canned Foods (21 CFR 108.35 and 113) and Acidified Foods regulations (21 CFR 108.25 and 114) due to low water activity.

FDA defines low-acid canned food as means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (AW) greater than 0.85 [21 CFR 113.3(n)].

Accordingly, products with a low water activity are excluded from Low-Acid Canned Foods and Acidified Foods regulations.

Registrar Corp may assist your facility by issuing Exclusion Certificates for your excluded products; however, if the water activity of the finished product ever exceeds 0.85, we may recommend that a process filing be submitted for the product.

FCE-SID Exclusion Certificates provide access to the supporting documentation for the exclusion of the product from FCE-SID filing requirements to the FDA inspectors at the port of entry, who may exercise discretion concerning the entry. FDA does not issue FCE-SID Exclusion Certificates.

Based on this exclusion, we will need the following information in order to issue an Exclusion Certificate for this product:

• Five formal lab reports on the Water Activity for each product. If you wish, you can provide one report for each product that includes at least 5 Water Activity values from different batches/lots of the product. The batch/lot numbers should be clearly indicated on the report. The report should look professional and indicate the following:
• The name of the sample (which should be the name as it appears on the label)
• The temperature at which the analysis is performed
• The test method
• The signature of the individual responsible for the analysis
• Container description (packaging type, container dimensions, or volume/net weight)
• Copies of the product labeling

For assistance with U.S. FDA FCE-SID regulations or other U.S. FDA regulations, contact Registrar Corp at +1-757-224-0177 or chat 24/7 at Live Help.

Based on the information you provided, you've finished assessing FCE-SID requirements for asas.

The information submitted appears to indicate that the product may be excluded from FDA Low-Acid Canned Foods (21 CFR 108.35 and 113) and Acidified Foods regulations (21 CFR 108.25 and 114) for the following reason:

• The product is carbonated.

In order to qualify for this exclusion, the product label should include an appropriate statement to indicate that the product is carbonated.

Registrar Corp may assist your facility by issuing Exclusion Certificates for your excluded products.

FCE-SID Exclusion Certificates provide access to the supporting documentation for the exclusion of the product from FCE-SID filing requirements to the FDA inspectors at the port of entry, who may exercise discretion concerning the entry. FDA does not issue FCE-SID Exclusion Certificates.

Based on this exclusion, we will need the following information in order to issue an Exclusion Certificate for this product:

• Detailed process flow diagram of the carbonation process
• Copies of the product labeling
• Container description (packaging type, container dimensions, or volume/net weight)

Based on the information you provided, you've finished assessing FCE-SID requirements for asas.