calculations.48 The percentage must be in parentheses following the name of the ingredient and expressed to the nearest 1 percent. Firms may use percentage declarations for as many or as few ingredients as they choose, as long as the information is not misleading. Manufacturers must still list ingredients in descending order, by weight.
Certified Colors
There are two categories of colorings, those requiring FDA certification and those exempt from certification. Each batch of synthetic colorings must be certified by FDA as meeting the color additive’s requirements for composition and purity. These “certified colors” must be named specifically in the ingredient statement; e.g., “FD&C Blue No. 1”.49 However, the law exempts butter, cheese, and ice cream from having to show the use of color, with the exception of FD&C Yellow No. 5. Yellow No. 5 must always be declared for all foods because it triggers allergic reactions in some people.50
Noncertified Colors
Colors exempt from certification, such as caramel, paprika, and beet juice, do not have to be specifically identified, but can be listed simply as “artificial colors.” Alternatively, noncertified colors may be listed by their common or usual names, such as “caramel coloring” and “colored with beet juice”. Note that the functional purpose of added coloring must always be declared (e.g., “____color” or “colored with____”).51
Spices and Flavors
Spices, flavors, and noncertified colors may be listed generically, without naming the specific source, except that any artificial colors or artificial flavors must be identified as artificial.52
Flavor versus Flavor Enhancers
Although flavorings or flavors may be listed generically, ingredients that are used as flavor enhancers are not exempt from individual declaration in the ingredient statement. For instance, MSG is a flavor enhancer and must be declared individually in the ingredient statement of a food to which it is added.
Protein Hydrolysates
Hydrolyzed proteins are proteins that have been broken down by acid or enzymes into amino acids. Protein hydrolysates are added to foods to serve many functions, such as leavening agents, stabilizers (to improve consistency), thickeners, flavorings, flavor enhancers, or as a protein source. When protein hydrolysates are added to foods as flavorings, they always function as flavor enhancers and, as such, must be declared individually by their common or usual name. The source of protein in hydrolysates used for flavor‐related purposes also must be identified, such as “hydrolyzed corn protein” or “hydrolyzed casein.”53
Caseinate
A declaration of casein and caseinate as a milk derivative must be included with the ingredient listing for foods that claim to be non‐dairy, such as coffee whiteners. Some states require products marketed as dairy substitutes to be labeled as “nondairy.” However, the nondairy label may lead consumers to think that caseinates are not milk derived. When caseinate is added to a food that is labeled nondairy, the caseinate must be identified as a milk derivative in the ingredient statement. This is in addition to the allergen labeling requirements of the Food Allergen Labeling and Consumer Protection Act (FALCPA).
Incidental Additives and Processing Aids
“Incidental additives” are additives that are present in a food at insignificant levels and have no technical or functional effect in that food. Incidental additives are not required to be listed in the ingredient statement.54
“Insignificant amount” is quantitatively defined only for sulfiting agents, which is less than 10 ppm (10 mg/Kg) in the finished food. Sulfites being the single additive with a defined insignificant amount indicates how rarely this category applies. The sulfite 10‐ppm threshold is the only additive where scientific literature has established the quantitative amount for a lack of technical and functional effect. The sulfite threshold is the level where sensitive individuals begin having allergic‐type reactions. Any amount of a substance that would cause an allergic reaction in an individual is no longer insignificant.
To invoke the exemption from listing an incidental additive in the ingredient statement, the manufacturer must document that the incidental additive is nonfunctional in the finished food. If FDA challenged a company on an ingredient being listed in the ingredient statement, the burden falls on the company to prove their ingredient is nonfunctional. A qualified food scientist or food chemist should sign off on the facts and reasoning, and this should be kept in writing in a file in case FDA asks for it. Without such proof, failure to declare these ingredients would result in the food being deemed misbranded.
For the purposes of the incidental‐additive exemption, most are processing aids which:
1 Were added to a food but removed before packaging;
2 Were converted to constituents normally present in the food and do not significantly increase the amount normally found in the food (for example, as salt); or
3 Are substances added for their functional effect in processing but are present in insignificant amounts and have no functional effect in the finished food.55
For example, water may be added during food processing but cooked off and no added water is present in the final food. Beyond processing aids, additives that remain present but that have no technical or functional effects in the final food are rare. Almost everything added to a food has a technical or functional effect.
Another category of incidental additives is substances that migrate to food from packaging or equipment as authorized under the food additive requirements. Like other incidental additives, to be exempt from ingredient labeling, the substance must present in a food at insignificant levels and have no technical or functional effect in that food. In addition, of course the substance migration must be authorized as safe.
NOTES
1 3.10 FALCPA. Before the Food Allergen and Consumer Protection Act (FALCPA), consumers did not always know the source of particular ingredients. A primary reason is that processed ingredient names do not always clearly indicate the name of the source food. For example, “sodium caseinate” is an ingredient that most consumers do not know is made from milk. FALCPA requires that the common name of the source (in this case, “milk”) must be listed as well as the ingredient name. None of the ingredient exemption listed above alleviate the FALCPA requirement. See Section 3.8 infra.
2 3.11 Corn syrup is not “corn sugar”. The Corn Refiners Association (CRA) petitioned the FDA to authorize “corn sugar” as an alternate name for high‐fructose corn syrup (HFCS). CRA argued, among other things, that consumers are confused by the name “high fructose corn syrup” and “incorrectly believe that HFCS is significantly higher in calories,
