Tools and directories

The check, before the first shade ships

Updated October 2026

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One: for every colorant, which listing and which uses?Two: is any application inside the area of the eye?Three: which declaration form are you using?Four: is the safety substantiated, per shade?Five: does the format exist?And fill by weight File it per shade Two of the five are per shade, so this is a table References

Five questions, and the first two have to be answered for every shade.

One: for every colorant, which listing and which uses?

Part 73, 74 or 82, recorded by regulation number with the permitted uses beside it. "Cosmetic grade" is not a defined term and will not answer this. Get the citation from the supplier.

Two: is any application inside the area of the eye?

Using the regulation’s definition: the orbital region between the supra-orbital and infra-orbital ridges, including the eyebrow, the skin below it, the lids, the lashes and the soft tissue under the eye. Brow and under-eye products are inside.

Three: which declaration form are you using?

Strict descending order, or the permitted grouping with colors last and unordered. If a shade range shares a declaration, check all four conditions of the "may contain" route, including that no non-common brand designation appears.

Four: is the safety substantiated, per shade?

Each ingredient and each finished product, before marketing. A new shade is a new finished product for this purpose. The alternative is a conspicuous warning that the safety has not been determined.

Five: does the format exist?

Loose powder in a jar, with the single 43 mm sifter disc if the neck matches. An emulsion in one of the 9 airless pumps. A pressed pan, a palette, a mascara or a brow wand is not available from this catalog.

And fill by weight

Because static makes a fine pigment settle unpredictably, so a volumetric fill gives inconsistent declared quantities across a run and across shades of different density.

File it per shade

Colorant listings and uses, the eye-area determination, the declaration form, the substantiation entry and the container. Adding a shade adds a row, and that is the step that catches the range extension failure.

Two of the five are per shade, so this is a table

The colorant listings and the eye-area determination have to be answered for every shade, which makes the compliance record a row per shade rather than a document per product. The row added last is the one nobody fills in.

References

21 CFR parts 73, 74 and 82, the listings of color additives exempt from certification, subject to certification, and provisionally listed. Each listing states the uses for which the color is permitted, and many exclude use in the area of the eye. law.cornell.edu

21 CFR 70.3(s), which defines the area of the eye as the area enclosed within the circumference of the supra-orbital ridge and the infra-orbital ridge, including the eyebrow, the skin below the eyebrow, the eyelids and the eyelashes, the conjunctival sac, the eyeball and the soft areolar tissue within the perimeter of the infra-orbital ridge. law.cornell.edu

21 CFR 701.3(f), the alternative to strict descending order: ingredients other than color additives above 1 percent in descending order, then those at not more than 1 percent without respect to order, then color additives without respect to order of predominance. law.cornell.edu

21 CFR 701.3(g) and (h), which permit a declaration to include an ingredient not in the product where it is identified by the phrase "may contain" and it is a color additive added to some batches for color matching, or where four stated conditions about shaded products sold under a common trade name are met; and which permit an assortment sold in one package to declare its color additives in a single composite list. law.cornell.edu

21 CFR 740.10, which requires each ingredient and each finished cosmetic product to be adequately substantiated for safety before marketing, and makes an unsubstantiated one misbranded unless it bears "Warning - The safety of this product has not been determined" on the principal display panel. law.cornell.edu

Written from federal regulation and from measured catalog data, not from a formulation bench. Whether a given color additive is listed for a given use, including use in the area of the eye, is a question about that listing in 21 CFR parts 73, 74 and 82. Nothing here is a determination about a specific colorant.