Color Cosmetics: MoCRA Plus the Color Additive Rules

Makeup makers tend to hit a specific confusion point that skincare and fragrance folks mostly avoid: color additives are their own separate regulatory system in the US, sitting alongside MoCRA rather than inside it. You can do everything right on the MoCRA side, register your facility, list your product, name a responsible person, and still have a problem if the actual pigments in your eyeshadow were never approved as color additives for that use in the first place.

Two systems, one product

MoCRA, the Modernization of Cosmetics Regulation Act passed in 2022, is the newer, broader framework covering facility registration, product listing, safety substantiation, and adverse event recordkeeping for cosmetics generally. It applies to your lipstick or eyeshadow the same way it applies to a body lotion or shampoo. Some small businesses are exempt from the registration and listing pieces specifically, though the safety substantiation expectation still runs underneath the whole framework.

Color additives are governed separately, under their own long-standing FDA approval system, which predates MoCRA by decades. Every color additive used in a cosmetic in the US needs to be approved for that specific use, and a lot of colorants are approved for some uses but not others. A pigment cleared for use around the eyes is not automatically cleared for lip products, and vice versa, because ingestion risk and eye-area sensitivity are evaluated differently.

Why this trips up color cosmetics specifically

A shampoo or moisturizer formula might use one or two colorants, if any, mostly for aesthetic tinting that customers barely notice. A color cosmetics line lives and dies by its pigments, often stacking multiple colorants in a single eyeshadow pan or lipstick bullet, sometimes six or eight different color additives in one SKU. Every one of those needs its own approval check for the specific product category you're putting it in.

This means the ingredient review for a color cosmetics brand genuinely has more surface area than for most other cosmetic categories, not because MoCRA treats color cosmetics differently, but because color additive approval is inherently ingredient-by-ingredient and category-by-category.

What this looks like in practice

A few scenarios that come up constantly with makeup formulators:

• A mica-based shimmer approved broadly across cosmetic categories is generally lower-risk to work with across your whole line.
• A specific lake pigment approved for external use but restricted from lip or eye-area products needs to be checked against exactly where you're putting it, not just whether it's approved somewhere.
• Glitter and other decorative particulates used in cosmetics have their own scrutiny around particle size and material safety, separate again from standard color additive approval.
• A colorant approved in another market, say the EU, is not automatically approved in the US. Color additive approval is jurisdiction-specific, the same way ingredient restrictions generally are, and a green light elsewhere tells you nothing about US status.

Building your compliance checklist for a color line

If you're running a color cosmetics brand, your checklist realistically has two parallel tracks rather than one:

1. MoCRA track: facility registration (unless exempt), product listing, a named responsible person, safety substantiation on file, and an adverse event recordkeeping process in place.
2. Color additive track: every colorant in every product checked against current FDA approval status for that specific product category, not just approval in general.

Missing either track leaves a gap. A perfectly registered and listed product line with an unapproved colorant in one SKU is still a problem, and a beautifully sourced, fully approved pigment set does not satisfy your MoCRA obligations on its own.

Requirement	Where it comes from	What it covers
Facility registration	MoCRA	Where the product is made
Product listing	MoCRA	What products exist and their ingredients
Responsible person	MoCRA	Who FDA contacts, who stands behind safety
Safety substantiation	MoCRA	Evidence the finished product is safe
Color additive approval	Separate FDA color additive rules	Whether each specific pigment is cleared for this specific use

Cosmetic Comply's ingredient mapping and screening work is currently built around Canada's CNF and Hotlist system, with the US, EU, and Australia on the way. For color cosmetics brands working across markets, keeping a clean, well-documented ingredient list with accurate INCI names and CAS numbers now is exactly the groundwork that makes any market's ingredient review, including the US color additive check, faster and less error-prone whenever you're ready to formally verify each colorant's approval status.