3. Compositional Aspects

General Foods
USA

This section provides the compositional requirements for the food category and/or food products in scope and information on permitted nutrients, ingredients, and additives. 

3.1 Composition Requirements

Please refer to Section 3.1 of category/product-specific guidebooks.

3.2 Raw Material Requirements

All food and beverage products produced for human consumption are required to conform with the requirements of the Food Safety Modernization Act [1]. There is no exhaustive list of approved ingredients that can be used in food. Each ingredient needs to be assessed individually for its intended level and purpose.

3.3 Fortification

The FDA has a food fortification policy that outlines the foods that can be fortified [2]. It specifies that the fortification policy does not apply to food subject to any other Federal regulation for a food or class of food that requires, permits, or prohibits nutrient additions.

3.4 Other Permitted Ingredients

None. Please refer to Section 3.4 of category/product-specific guidebooks.

3.5 Permitted Additives

In the US, "food additive" is defined in Section 201(s) of the FD&C Act as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use); if such substance is not GRAS or sanctioned prior to 1958 or otherwise excluded from the definition of food additives [3].

There is an extensive list of substances that are permitted for use in food and beverages, some of them have restrictions on the types of food and/or limits on the amount that may be added. Substances added to food are either permitted food additives found at 21 CFR 173 or GRAS substances found at 21 CFR 184 or are listed on the GRAS notice website. The best means to investigate the use of a substance in food is via the Food Additives Listing website [4].

3.6 Permitted Flavors and Colors 

Permitted coloring additives are identified at 21 CFR 73 [5]. Some flavoring materials are identified at 21 CFR 172.510 [6] and 172.515 [7]. Most flavoring materials are Generally Recognized As Safe (GRAS) and the GRAS list is maintained by the Flavor and Extract Manufacturers Association which is accessible at https://www.femaflavor.org/fema-gras.

3.7 Permitted Processing Aids 

The USA does not have a list of processing aids suitable for use in food and beverage production. 

A processing aid is an approved food additive or GRAS substance that is added to a food during processing but is not present in the consumer food product or is at a concentration that is so low it has no effect on the consumer food product. [8]

3.8 Additional Notes 

None. 

3.9 References

1. Food Safety Modernization Act (FSMA) 

https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma

2. 21 CFR Part 104 Subpart B 

https://www.ecfr.gov/current/title-21/part-104/subpart-B

3. Food Ingredient & Packaging Terms

https://www.fda.gov/food/food-ingredients-packaging/food-ingredient-packaging-terms#:~:text=Food%20Additive%20%2D%20A%20food%20additive,substance%20intended%20for%20use%20in

4. Food Additive Listings

https://www.fda.gov/food/food-ingredients-packaging/food-additive-listings

5. 21 CFR Part 73 - LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION 

https://www.ecfr.gov/current/title-21/part-73

6. 21 CFR 172.510 - Natural flavoring substances and natural substances used in conjunction with flavors 

https://www.ecfr.gov/current/title-21/section-172.510

7. 21 CFR 172.515 - Synthetic flavoring substances and adjuvants 

https://www.ecfr.gov/current/title-21/section-172.515

8. 21 CFR 101.100(a)(3)(ii) 

https://www.ecfr.gov/current/title-21/part-101/section-101.100#p-101.100(a)(3)(ii)