Spice Oleoresins and the US FDA: GRAS Listings, Colour Additives, FEMA Numbers and Solvent Limits

The Main Route: 21 CFR 182.20

21 CFR 182.20 lists essential oils, oleoresins (solvent-free) and natural extractives that are generally recognised as safe (GRAS) for their intended use. It names the source plants. Black pepper, capsicum, cardamom, celery seed, cinnamon and cassia, coriander, cumin, fennel, fenugreek, ginger, mustard, nutmeg, onion, paprika and turmeric oleoresins all rest on this listing. “Solvent-free” does not mean zero residue. It means solvent residues within the part 173 tolerances below.

Affirmed Separately: Clove and Garlic

Clove and garlic have their own GRAS affirmations in part 184. 21 CFR 184.1257 covers clove and its derivatives, and 21 CFR 184.1317 covers garlic and its derivatives. Both name oleoresins. The affirmation states the functions and conditions of use, so the reviewer works from that section rather than from 182.20.

When the Oleoresin Is a Colour

A spice oleoresin used to colour food is a colour additive, and colour additives need their own listing. Three matter here:

• Paprika oleoresin: 21 CFR 73.345, exempt from certification.
• Turmeric oleoresin: 21 CFR 73.615, exempt from certification.
• Marigold (tagetes): 21 CFR 73.295 lists tagetes meal and extract for chicken feed only, to enhance the yellow of skin and eggs. It is not a human-food colour listing. Lutein from marigold for foods and supplements reaches the US market by other routes, which the buyer’s reviewer confirms for the finished product.

The same paprika oleoresin can therefore be a flavour under 182.20 and a colour under 73.345, depending on why it is in the food.

Labelling Follows the Function

21 CFR 101.22 sets the label consequences:

• Paprika, turmeric, saffron and other spices that are also colours must be declared as “spice and coloring” unless they are declared by their common or usual name.
• Under 101.22(a)(3), “natural flavor” expressly includes an oleoresin used for flavour.
• Colour additives exempt from certification may be declared under 101.22(k)(2) by a term such as “Color Added”, or by a name such as “colored with paprika” or “paprika color”.

The function in the finished food decides which wording applies.

Residual Solvent Tolerances: 21 CFR Part 173

Ask for the extraction solvent to be named on the certificate and its residue reported by GC against the relevant limit. A certificate that says only “residual solvents: complies” does not tell the reviewer which tolerance applied.

FEMA GRAS Numbers and CAS Numbers

The Flavor and Extract Manufacturers Association publishes its own GRAS determinations for flavour use. Many US flavour houses ask for the FEMA number alongside the CFR listing.

Cardamom, celery seed, cinnamon, coriander, cumin, mustard and onion oleoresins rest on 182.20 without a separate FEMA oleoresin entry. Ajwain (Trachyspermum ammi) appears in neither 182.10, 182.20 nor part 184, and FEMA lists no ajwain oleoresin. Its US flavour use depends on the buyer’s own GRAS determination or another route.

Where to Find It on Our Pages

Each of our oleoresin pages carries this regulatory identity in the specification table: the US listing, FEMA number, CAS number and, where relevant, EU additive status. Examples are paprika, turmeric and capsicum. These are the published listings. Whether a given use is permitted depends on the finished product, the use level and the market, and the buyer’s regulatory reviewer confirms it.