DEFINITIONS
Acid Foods - are foods that have a natural pH of 4.6 or below.
"Natural pH" means the pH prior to processing. However, if a processor receives an acid food (including fermented foods with a pH of 4.6 or below) and during processing allows the pH to rise above 4.6 (through washing, lye peeling, etc.) and then adds an acid or acid food to reduce the pH to 4.6 or below, that product would be considered an acidified food.
Acidified foods - are low-acid foods to which acid(s) or acid food(s) are added and which have a water activity (aw) greater than 0.85 and 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 non-standardized food dressings and condiment sauces) that contain small amounts of low-acid food(s) and have a resultant finished quilibrium 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 regulation.
Low-acid foods - 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.
Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not classed as low-acid foods.
Acid foods - Those foods such as most tomatoes and many fruits, which have a natural pH of 4.6 or less even if acid is added during processing.
Repacked Acidified or Fermented Foods -
Previously acidified or fermented foods, which are usually received in bulk, and which are then repacked into retail size containers, generally with the addition of a fresh acid brine, are not acidified foods as long as the repacker does nothing, such as washing, to raise the pH above 4.6 prior to packing. If there is a washing step to remove the old brine, or any other similar processing step, determine the pH of the product prior to the addition of the fresh acid brine.
IS IT AN ACIDIFIED FOOD?
Acid foods with small amounts of low-acid foods-
This exclusion applies to acid foods (finished equilibrium pH of 4.6 or below) where the addition of small amounts of low-acid food(s) results in a finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food. These products are referred to as "formulated acid foods."
This category of foods covers a multitude of products including sauces, dressings, fillings, toppings, etc. [Note: that in the definition of acidified foods, this category of excluded foods contains the terms "small amount", "significantly differ" and "predominant acid or acid food."] These terms are not definitive and are therefore subject to interpretation. It is therefore difficult to address this issue in a manner, which applies to all products because of the diversity of products. Basically, it must be determined whether the acid(s) or acid food(s) are acidifying the low-acid ingredients(s) or whether the addition of the low- acid ingredients(s) significantly raises the pH of the acid(s) or acid food(s). When does the finished equilibrium pH significantly differ from the pH of the acid or acid food? This will depend on the closeness of the finished equilibrium pH to 4.6 and possibly other factors. For example:
This might be a significant difference:
Finished product pH = 4.5
Acid ingredients pH = 4.4
This might not be a significant difference:
Finished product pH = 3.8
Acid ingredients pH = 3.4
Predominant acid or acid food- may be an ingredient, which either by quantity, amount of acidity contributed or its characterizing attributes is providing certain characteristics to the product. For example, in a product like salsa, tomatoes characterize the food by odor, and taste, and may be predominant by weight. Jalapeno Peppers (which are received acidified) characterize the product by taste even though the quantity may be small. The vinegar or other acids will be predominant by the amount of acidity provided. As noted below, all acid ingredients are considered to be predominate for the purpose of determining if a product is an acidified food.
It is the processor's responsibility to determine the status of his or her products under these regulations. A processor should first request the assistance of an expert on acidified foods. Such assistance may be available at a university that has a food science extension service. In some cases, the processor may desire an opinion in writing from the FDA as to the status of their products.
The following list delineates the information needed about each product to determine whether they are acidified or acid foods:
1. Quantitative formula.
t Express ingredients in same units of measure (e.g. oz., lbs., fluid oz., liter, kilograms, etc.) or use percent of total formula.
2. Designate which ingredients are acid and low acid.
t By pH preferably or describe, e.g., fresh, dried, previously frozen or canned.
[Note: some canned products can be acidified or LACF (thermally processed
at temperatures, which will destroy spores, so the pH of the canned product may
be needed]
t pH of each ingredient will be most helpful - range of pH values where appropriate
t Describe ingredients - particle size, dry
3. Describe processing steps including times (e.g., how long in the acid brine) and temperatures (i.e., time of heat treatment, hot-fill temperature and hold time), acidification method (i.e., batch, direct) and type of finished product container.
4. pH of the acid ingredients combined in the proportion in which they appear in the formula.
5. pH of the finished product (after addition of the low-acid ingredients to the acid ingredients and all processing and packing has been completed).
t At least 6 units of a code lot or batch and relate to ingredient pH values.
t Should have several batches or days production to get a feel for normal variation.
If a processor or his adviser/consultant determines that a product is not covered by the regulations as an acidified food, he should have this kind of information available as evidence to document that the product is not an acidified food.
If a processor states that a product(s) is not acidified, but the investigator believes it is, ask them to provide the information as stated above to document their conclusion. If they do not provide this information, the investigator must obtain as much of this information as possible and submit it to CFSAN (HFS-607) for review and evaluation. Only after a determination has been made that a product is an acidified food should the firm be cited for violations of the Acidified Food regulations.
Any questions about the status of a food under the regulations should be directed to the Center for Food Safety and Applied Nutrition, Division of
Enforcement, HFS-607,
Processors of formulated acid foods (those multi-ingredient products determined to have been excluded from Part 114, i.e., not acidified foods) are responsible for assuring that the food products that they manufacture are safe. This means that they should employ manufacturing procedures, which will insure that their products are at a pH of 4.6 or lower.