The short version
- A colour additive must be listed for its use, and either come from a certified batch or be exempt from certification.
- A cosmetic with an unsafe colour additive is adulterated, and FDA can refuse it at the border.
- A colour may be used around the eyes only if its listing says so.
- The US label names a colour by its US name; a CI number may follow in brackets but can't replace it.
Listed, and certified or exempt
Section 721 of the Act treats a colour additive in a cosmetic as unsafe unless it is listed for that use and either comes from a batch FDA has certified or is exempt from certification (21 U.S.C. 379e(a)). A cosmetic that is not a hair dye and contains an unsafe colour additive is adulterated (21 U.S.C. 361(e)).
- Exempt from certification — mostly mineral, plant and animal colours such as iron oxides, titanium dioxide, mica and carmine: 21 CFR part 73, subpart C.
- Subject to certification — the synthetic FD&C and D&C colours, certified batch by batch: 21 CFR part 74, subpart C.
- Lakes — the FD&C, D&C and Ext. D&C lakes remain provisionally listed (21 CFR 81.1, part 82) and may not be used in the area of the eye. The exceptions are the FD&C Blue No. 1, FD&C Yellow No. 5 and FD&C Red No. 40 Aluminum Lakes, which part 74 lists for the eye area.
Sources: 21 U.S.C. 379e (FD&C Act §721); 21 U.S.C. 361(e) (FD&C Act §601(e)); 21 CFR part 73, subpart C; 21 CFR part 74, subpart C; 21 CFR part 82
The eye area needs its own listing
No listing or certification authorizes a colour in a product for the area of the eye unless it specifically provides for that use (21 CFR 70.5(a)). The area of the eye includes the eyebrow, the skin below the eyebrow, the eyelids and the eyelashes (70.3(s)). FD&C Yellow No. 6 and the D&C reds, for example, are listed only for cosmetics generally or for external use, so they are not permitted in an eyeshadow, eyeliner or mascara.
Sources: 21 CFR 70.5(a); 70.3(s); 21 CFR part 73, subpart C; 21 CFR part 74, subpart C; 21 CFR part 82
CI numbers on a Korean ingredient list
| CI number | US listed name | Certification | Eye area |
|---|---|---|---|
| CI 77491 | Iron oxides | Exempt | Permitted |
| CI 77891 | Titanium dioxide | Exempt | Permitted |
| CI 19140 | FD&C Yellow No. 5 | Certified | Permitted |
| CI 42090 | FD&C Blue No. 1 * | Certified | Permitted |
| CI 15850 | D&C Red No. 6 | Certified | Not permitted |
| CI 15850:1 | D&C Red No. 7 | Certified | Not permitted |
* CI 42090 does not always mean FD&C Blue No. 1: FDA also lists its diammonium salt as D&C Blue No. 4, which is for externally applied cosmetics only. Check which one the supplier's specification names.
On the label, name a colour by its US name, such as "FD&C Yellow No. 5" or "Yellow 5". A CI number may follow in brackets ("Yellow 5 (CI 19140)"), but it can't replace the name. Colours may be listed together at the end of the ingredient declaration, in any order (21 CFR 701.3(f)).
Sources: 21 CFR part 73, subpart C; 21 CFR part 74, subpart C; 21 CFR 701.3, 701.11, 701.12, 701.13; Cosmetic Ingredient Names
Where Senda fits
Senda is building a colour-additive check on the ingredient list: each colour matched to its US listing, with a flag for a colour that needs certification or is not listed for the use. Senda files nothing with FDA.