Are you trying to avoid an unnecessary or non-consumer-friendly ingredient declaration? Are you looking to build a clean label? Or do you ever wonder if a specific ingredient falls under the definition for “incidental additives” and may be exempt from an ingredient listing?  

The FDA does not provide a definition for “insignificant level.” As a general rule of thumb, it is understood as an amount which is undetectable using the most sensitive testing method available, and/or residue levels present at a level that is too low to have any technical effect in the finished food product.  

In short, “incidental additives” are ingredients, added to food directly or indirectly, present in final food at insignificant levels. The ingredients do not have any technical or functional effect in that food. 

Here are 3 major categories of incidental additives:

1. Substance(s) added to recipes as a functional ingredient of a component

Even after the component has been incorporated into the final food, the specific ingredient is present at an insignificant level and has no technical effect in the finished product.

For example, silicon dioxide is used in a seasoning mix at less than 2% as anticaking agent. The same seasoning mix is then used in a soup product at 1%. Silicon dioxide will be present at 0.02% in the soup. Since silicon dioxide will not be present at a significant level or have a functional effect on the soup, it will be exempt from declaration. Conversely, if the same seasoning mix is added to a dry soup mix, even though the amount of silicon dioxide is low, it will still have a technical effect in the finished soup mix product and silicon dioxide will have to be declared in the ingredient list.

2. Processing aid

  • Substances that are added to food during processing but are removed in some manner before being packaged in its finished form. An example would be water added to cake mix along with other ingredients like eggs and milk; then the added water is completely baked off in the finished cake product. Since added water is no longer present in the product, therefore, water is not required to be declared.
  • Substances that are added to food during processing are converted into constituents normally present in food and do not significantly increase the amount of the constituents naturally found in the food. For example, added pH adjustment agents, that were converted to salt, but do not significantly increase the salt level in food.
  • Substances that are added to food for their technical effect during processing, but are present in insignificant levels in the finished product with no functional effect. An example includes adding adsorbent to drinking water, which is then filtered out to remove heavy metals.

3. Substances migrating to food from equipment or packaging.

Example: Sunflower lecithin added to a cake baking pan as a releasing agent. To achieve its function, only a small amount of the ingredient is needed. Since this will be present in the final product in a negligible amount and has no function in the cake, it is not required to be declared in the ingredient list.

Generally, nutritive material, added vitamins, added minerals, added amino acids, spices, seasoning, and flavoring would not be considered as incidental additives, as they always affect the characteristics of food. 

Other examples of ingredients that would always be included in ingredient listing:

  • Ingredient added to a component with no function in end product but has significantly contributed a nutrient
    • E.g., potassium hydroxide may be used as a processing aid but will be significantly increasing the potassium value, so it should be included in the ingredient declaration.
  • Ingredient added to food indirectly and has no effect in a final food product
    • However, if the component is used at a very high amount in the recipe, then the ingredient does not meet the “insignificant amount” definition and is therefore required to be included in the ingredient declaration. E.g., 5% cornstarch is used as anticaking agent in a cake mix. With the cake mix contributing to 95% of the recipe, cornstarch will be present in the finished product at 4.75%. This is a significant amount and therefore must be listed in the ingredient list. 
  • Ingredient with multiple functionalities
    • E.g., Mannitol may be used as humectant, sweetener, and a texturizer. In case a product uses a sugar content claim on the label, even if mannitol is used only as an incidental additive, because of the sugar claim, mannitol, as a sugar alcohol, will still need to be added to the ingredient declaration. Sugar Alcohol value in gram will need to be added to Nutrition Facts Label.
  • Ingredient used as processing aid but contains a major allergen
    • E.g., soy lecithin used as a releasing agent. Since it contains soy protein, a major allergen, it will always be required to be declared.

What can Mérieux NutriSciences do for you?

Is your product’s food label in compliance with all applicable federal regulations? Mérieux NutriSciences’ Labeling Compliance & Nutrition Services team can help by customizing your claims to mitigate mislabeling risk. After review, our experts can integrate directly with your team to provide you with compliant labels for sale in the United States or Canada. Ready to get started on your label review? Contact us today!

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