Acidified Foods – What is a “small amount” of low acid ingredients?

I’m often asked by clients if their product is an acidified food or is it an acid food according to the regulations. It may seem like semantics, but correctly classifying the product could be the difference between a having regulatory-required thermal process or not. In many cases, sauces and condiment products may only have a small amount of low-acid ingredients in the formula. Many ketchup products, tomato-based sauces, marinades, rubs, and pastes often fall in this grey area.

To answer this question, let’s first take a look at the definitions from 21 CFR114.3(a)(b), emphasis mine:

“Acid foods means 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.”

I highlighted the relevant provision that certain sauce and condiment products may or may not fall under.  This 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), than it is excluded from the production and process controls (such as heat requirement) listed in 21 CFR subpart E 114.80.  From experience, I surmise that FDA and many 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 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:

1. no more than 10% of the formula by weight can be low-acid food(s), and

2. the addition of the predominant acid should not cause a “significant difference in pH.”

Sauces, pastes, and dressings often fall on the cusp of this definition.  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.  In order for us to assess these products we need specific formulas (levels of each ingredient used) and processing information, and some basic laboratory analyses, like pH for each individual ingredient.  If pH cannot feasibly be determined for every ingredient, we can find reference pH values for most ingredients. 

Peter Taormina