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The eye area

What the definition reaches

Updated

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An anatomical boundary in a color additive regulation, and it is wider than the eye.

The definition, in full

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, and conjunctival sac of the eye, the eyeball, and the soft areolar tissue that lies within the perimeter of the infra-orbital ridge.

Two bony landmarks set the boundary

The supra-orbital ridge above the eye and the infra-orbital ridge below it. So the area is the whole orbital region rather than the eye itself, which is why it catches products applied to skin.

The eyebrow is named explicitly

Which puts brow gel, brow powder and brow pencil inside the area of the eye. That is the single most commonly missed consequence of this definition, because a brow product does not feel like an eye product.

And so is the skin below the eyebrow

Which is the eyelid region, and the soft areolar tissue within the infra-orbital ridge, which is the under-eye area. A concealer used under the eye is being applied inside the defined area.

So the question is per product and per use

A highlighter used on a cheekbone is outside; the same highlighter marketed for the inner corner of the eye is inside. The intended use decides, and the intended use is what you publish.

Which makes a multi-use claim expensive

A single powder marketed for eyes, cheeks and lips has to satisfy the listings for all three uses. Narrowing the claim to the areas your colors are listed for is often the cheaper and more honest route.

Mascara is the clearest case

Applied to the eyelashes, which the definition names. There is no reading under which a mascara is outside the area of the eye, and the colors available for it are correspondingly narrow.

References

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 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.