What is the Small Amount Provision in regards to Acidified Foods, and Why Should I Care?
If your product is an acidified food (as defined by 21 CFR 114), or if you cannot demonstrate that it is not an acidified food, then you will have no choice of whether or not to schedule your process, and you will be required by FDA to follow the various quality assurance and good manufacturing practices and record keeping procedures outlined in the document. For example, you would have to follow the production and process controls (such as heat requirement). Sometimes, formulations that result in low pH (acidic) food products won’t necessarily fall under the definition of acidified foods because they are instead actually “acid foods.” If you make an acid food, you are not required to follow the acidified foods regulation.
Acid foods are foods that have a natural pH of 4.6 or below. Acidified foods means low-acid foods to which acid(s) or acid food(s) are added; these foods include, but are not limited to, beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits, and fish, singly or in any combination. They have a water activity (aw) greater than 0.85 and have a finished equilibrium pH of 4.6 or below. These foods may be called, or may purport to be, “pickles” or “pickled —.” Carbonated beverages, jams, jellies, preserves, acid foods (including such foods as standardized and nonstandardized food dressings and condiment sauces) that contain small amounts of low- acid food(s) and have a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food, and foods that are stored, distributed, and retailed under refrigeration are excluded from the coverage of this part.”
The highlighted portion above is known as the “small amount provision.” If a product is determined to be an acid food containing small amounts of low acid food(s), then it is excluded from the production and process controls (such as heat requirement) listed in 21 CFR subpart E 114.80. I can tell you that FDA or state inspection agencies will likely assume an ambient-stored sauce/paste/slather product is an “acidified food” unless you can prove otherwise.
The first step is to find out if the finished product is marketed and sold as shelf-stable and whether it has water activity less than or equal to 0.85 AND has pH less than or equal to 4.6. Such products are excluded from the acidified foods reg. This can easily be done by sending samples of each product in for chemistry (pH and aw). For any other ambient-stored products not meeting such criteria more work is required based on the FDA Guidance for Industry. In order to determine if a product is an acid food containing small amounts of low-acid food it needs to follow two basic criteria:
- No more than 10% of the formula by weight can be low-acid food(s), and
- The addition of the predominant acid should not cause a “significant difference in pH.”
Sauces, pastes, dressings, slathers, and similar products often fall on the cusp of this definition. Keep in mind, water is considered a low-acid ingredient by FDA. Therefore, we recommend that clients perform due diligence and utilize our expertise as a process authority to make these determinations. For us to assess these products, we need the evaluation form filled out for each product. If the client prefers, they can simply send samples of ingredients and Etna Consulting Group and we can do the pH. If pH cannot be determined for every ingredient, we can consult pH tables and see if we can find pH for the ingredients.