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What goes wrong

No substantiation file

Updated

On this page9
The alternative to the work is a sentence no business would print.

The requirement

Each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately substantiated for safety prior to marketing. Both levels, and before marketing rather than in response to a complaint.

And the consequence

An unsubstantiated ingredient or product is misbranded unless it bears the conspicuous statement "Warning - The safety of this product has not been determined" on the principal display panel. Nobody chooses the warning.

Color cosmetics have a specific wrinkle

A shade range is many formulations sharing a base, and the substantiation has to cover each of them. A new shade is a new finished product for this purpose even when the base is unchanged.

And eye-area products raise the exposure

Applied beside the eye, often daily, sometimes removed with a solvent. Any safety reasoning has to be built around that rather than around a rinse-off product at the same pigment level.

Supplier data is the input, not the file

A colorant safety sheet addresses handling and sometimes a listing. The finished product assessment is yours, and it is the half that does not arrive with the raw material.

Build it as the range grows

One entry per shade, dated, referencing the colorant listings you already recorded. Assembled alongside the formulation it is proportionate; reconstructed across thirty shades it is a project.

Keep it with the label version

So that adding a shade visibly reopens it. A file describing a range you have since extended is not a current file.

A shade is a finished product

Which is the specific thing that makes this heavier for color cosmetics than for a single-formula product. Thirty shades is thirty finished products to substantiate, and the base being shared does not reduce that to one.

References

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
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
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.