Standards and Regulations

These questions are designed to help you determine whether a product is subject to [restrictions/conditions].21 CFRPart 113(Low-acid canned food)）、21 CFR Part 114(Acidified foods) or neither of these jurisdictions apply. Please note that subject to21 CFR Part 113 or 114 The products under its jurisdiction must also comply with21 CFRPart 108The relevant requirements. Please note that these issues may not cover all products and all situations.21 CFRPart 108、113 and114 It stipulatesFDARelevant parameters for the regulation of low-acid canned foods and acidified foods. If you are unsure about the regulatory status of a specific product, please consult [the relevant authority/relevant authority].FDA。

Prerequisites

Is the product stored, distributed, and retailed under refrigerated or frozen conditions? If yes, proceed to 1(a). If no, proceed to 2.

a. This product is not governed by Part 113 or Part 114 of 21 CFR.

2. Has the product been continuously inspected by the USDA Food Safety and Inspection Service (FSIS) under the Meat and Poultry Inspection Program of the Federal Meat Inspection Act or the Poultry Products Inspection Act? (Such food labels contain a statement indicating USDA inspection.) If yes, proceed to 2(a). If no, proceed to 3.

a. This product is not governed by Part 113 or Part 114 of 21 CFR.

3. Is the water activity of the finished product less than or equal to 0.85? If yes, proceed to 3(a). If no, proceed to 4.

a. This product is not governed by Part 113 or Part 114 of 21 CFR.

4. Is the final equilibrium pH of the product 4.6 or lower? If yes, proceed to 5. If no, proceed to 4(a).

a. Is the product an alcoholic beverage? If so, the product is not governed by Part 113 or Part 114 of 21 CFR.

b. Is the product a tomato or tomato product and has a final equilibrium pH less than 4.7? If so, the product is not governed by Part 113 or Part 114 of 21 CFR.

c. If you answer “No” to question 4, and also “No” to 4(a) and 4(b), then your product is a low-acid food governed by Part 113 of 21 CFR.

5. Is the natural pH of the product 4.6 or lower without the addition of any acid? If yes, proceed to 5(a). If no, the product is an acidified food governed by Part 114 of 21 CFR.

a. Does the product contain low-acid ingredients? If yes, proceed to 5(b). If no, the product is an acidic food but is not governed by Part 113 or Part 114 of 21 CFR.

b. Is the product primarily an acidic or acidic food, and (1) contains only a small amount of low-acid food ingredients, and (2) has a final equilibrium pH that is not significantly different from the pH of the primary acidic or acidic food? Consult the FDA for assistance with this assessment. If yes, proceed to 5(b)-(i). If no, proceed to 5(b)-(ii).

i. This product is not governed by Part 113 or Part 114 of 21 CFR. However, you may voluntarily submit the process filing shown in Figure 1.

ii. This product is an acidified food governed by Part 114 of 21 CFR.

If the product is a fermented food and its final equilibrium pH is 4.6 or lower, it is not governed by Part 113 or Part 114 of 21 CFR. However, you may voluntarily submit a process filing as shown in Figure 1.

If the product is a fermented food and the final equilibrium pH is greater than 4.6 and the water activity is greater than 0.85, then the product is a low-acid food governed by Part 113 of 21 CFR.