Colour cosmetics manufacturing: the requirements skincare does not have
A factory that quotes skincare competently is not automatically able to make makeup competently. Two things change the moment colour enters the formula: the colour additives, and the coupling between the product and its packaging.
Colour additives are a different regulatory class
Everything else in a cosmetic is the brand's responsibility to make safe. Colour additives are the exception: in the US they must be approved for the specific use before the product can be sold. They fall into three practical groups.
| Group | Status | What it demands of you |
|---|---|---|
| Certified colours | Approved, and subject to batch certification | Each batch must be certified and carry a lot number. An uncertified batch makes the product adulterated, including at import |
| Exempt from certification | Approved, but still restricted | Still must comply with the conditions in the relevant part of the US code of federal regulations, including permitted uses and limits |
| Everything else | Not approved for that use | Cannot be used. A CI number or an E number is not proof of US approval |
The authoritative lists are published in the US electronic code of federal regulations: 21 CFR part 73 (exempt from certification), part 74 (subject to certification) and part 82 (provisionally listed). The FDA's own overview for use in cosmetics is here.
How to check the colour story on a quote
- Ask for the colour additive by its US name, not its CI number.
- Ask which group it falls in — certified, exempt-from-certification, or neither.
- For certified colours, ask to see the lot number on the batch certificate.
- Check the intended use area. Eye-area products have the narrowest permitted list, and lip products have their own.
The packaging is part of the product
Colour cosmetics couple tightly to their packaging. A lipstick bullet, a pressed powder pan and a gloss applicator are not neutral containers — they interact with the formula. Change the pack and you can invalidate the compatibility and stability testing that supported the original. That is why a colour-cosmetics project often pays for tooling and stability work that skincare would not.
See cosmetic packaging sourcing for who sets the tooling and minimum-order terms, and EU cosmetic regulation for the EU colour-additive position list, where the permitted colourants are set out in an annex to the regulation.
Related reading
- How to Vet a Cosmetic Contract ManufacturerThe eight documents worth asking a cosmetic contract manufacturer for, what each one proves and what it does not — plus three checks you can run yourself before you place an order.
- Cosmetic Packaging Sourcing — The Supplier Most Brands ForgetTubes, bottles, jars, pumps and closures come from a separate supply chain with its own minimum order quantities, tooling costs and colour risk. How to plan packaging without stalling the launch.
- EU Cosmetic Regulation — Who Is Responsible and What Gets FiledThe EU cosmetic regulation explained as a chain of responsibility: the responsible person in the EU, the safety assessment, the product information file and CPNP notification — none of which is a marketing authorisation.
Frequently asked questions
Are colour additives the only cosmetic ingredient needing pre-market approval in the US?
Yes. Colour additives are the one cosmetic ingredient class that requires pre-market approval, and some are subject to batch certification as well. Every other ingredient is the brand's responsibility to make safe.
What happens if a colour additive is not certified when it should be?
The product is considered adulterated and cannot be legally sold, and the same applies at import. This is why the batch certificate and lot number matter for certified colours.
Is a CI number proof that a colour is approved for cosmetics?
No. A CI number identifies the colour; it does not establish that it is approved for a particular cosmetic use. The permitted uses and limits come from the regulations, not from the CI number.
Why does changing the packaging matter for colour cosmetics?
The pack interacts with the formula. Changing the container can invalidate the compatibility and stability testing that supported the original product, so a pack change can force new testing.
Can a skincare factory make makeup just as well?
Not automatically. Colour cosmetics add colour-additive compliance and pack-coupling requirements. A competent skincare quote says nothing about whether the site can handle colour.
Where are the US colour additive rules published?
In the electronic code of federal regulations: 21 CFR part 73 for colours exempt from certification, part 74 for colours subject to certification, and part 82 for provisionally listed colours.