21 CFR 172 and the FDA rules for direct food additive uses
21 CFR 172 permits specific direct food additive uses under set conditions. Find how it differs from GRAS, secondary additives and food-contact rules.
21 CFR 172 covers food additives permitted for direct addition to food for human consumption. Its permissions apply to specified uses, subject to each entry's conditions and the general requirements in §172.5.
Part 172 is not a complete list of lawful food ingredients. Secondary direct additives, food-contact substances and GRAS uses have separate provisions. A matching substance name alone does not establish permission for your formulation.
What a 21 CFR Part 172 listing permits
Check the substance's identity and specifications, food category, intended function, quantity and any other conditions in its provision. Section 172.5 also requires good manufacturing practice. Use no more than reasonably required for the intended physical, nutritive or other technical effect. The additive must be of appropriate food grade and prepared and handled as a food ingredient. A listing does not relieve that use from any other provision of the Act.
For example, §172.140(a) permits ethoxyquin as an antioxidant for color preservation in chili powder, paprika and ground chili. The limit is 100 ppm. But that does not permit ethoxyquin in every food, and the ceiling does not override the reasonably-required-quantity rule.
Which related FDA part should you check?
The official Title 21 subchapter index identifies these subjects. This table points to the relevant text. It does not establish permission for a substance. Adjacent part numbers are easy to mix up. Part 171 is a petition route, not another permitted-substance list.
| Part | Subject |
|---|---|
| 170 | General food-additive framework, including §170.3 definitions |
| 171 | Food additive petitions |
| 172 | Direct food additives |
| 173 | Secondary direct food additives |
| 174-178 | Indirect additives: general rules, adhesives and coatings, paper and paperboard, polymers, adjuvants, production aids and sanitizers |
| 179 | Food irradiation |
| 180 | Interim permissions pending additional study |
| 181 | Prior-sanctioned food ingredients |
| 182 | Substances generally recognized as safe |
| 184 | Direct food substances affirmed as GRAS |
| 186 | Indirect food substances affirmed as GRAS |
| 189 | Substances prohibited from use in human food |
21 CFR 173.315 and produce-washing chemicals
Part 173 covers secondary direct additives. For example, §173.315 conditionally permits chemicals for washing or assisting in peeling fruits and vegetables. Quantities must not exceed the minimum required for their effect.
The potable-water rinse requirement applies to uses under paragraphs (a)(1), (a)(2) and (a)(4), not every use in the section. The additive container's label and labeling must bear the name of the additive or a statement of its composition, and the label or labeling must give adequate directions for compliant use.
GRAS is a separate route
Absence from Part 172 does not, by itself, mean an ingredient is prohibited. Section 170.30 sets conditions for generally recognized as safe uses. Parts 182, 184 and 186 do not contain every GRAS substance.
GRAS requires general recognition of safety among qualified experts. Under §170.30, scientific-procedure GRAS requires the same quantity and quality of scientific evidence as food-additive approval. That recognition must rest on generally available and accepted evidence. A notice in FDA's GRAS inventory is not automatically FDA approval. The inventory includes notices regardless of FDA's response, including insufficient-basis and ceased-evaluation outcomes.
Food-contact permission does not cover direct addition
Section 174.5(c) does not treat a food-contact clearance as permission for safe direct addition to food. Paragraph (a) still bars an intended technical effect in the food itself, except as otherwise permitted.
21 CFR 170.3(e)(1) covers intended uses reasonably expected to make a substance a food component or affect food characteristics, subject to statutory exemptions. A packaging component with no migration is not a food additive on that basis. Paragraph (e)(3) defines a food-contact substance as one used to manufacture, pack, package, transport or hold food, with no intended technical effect in the food.
An effective FCN covers the food-contact substance manufactured or prepared by the manufacturer or supplier identified in the submission. Another manufacturer or supplier marketing the same substance for the same use must also submit an FCN. Do not treat every distributor as that second manufacturer. Purchasers may rely on the notification covering the identified manufacturer or supplier, for the notified use and within its limitations.
RegAffairs AI's answer on direct additives, food contact and GRAS links the relevant regulatory text.