A CPSR for makeup is not a skincare safety report with a different name on the cover. Foundations, concealers, powders, blushes, eyeshadows, mascaras and eyeliners each raise questions a safety assessor works through differently from a moisturiser, because colour cosmetics combine heavy pigment loads, application near the eye and mucous membranes, and use patterns a body lotion never faces. Under Regulation (EC) No 1223/2009 every cosmetic on the EU market still needs a Cosmetic Product Safety Report in Parts A and B, but the evidence that fills those parts shifts with the category.
This guide covers what matters most for face and eye-area make-up: how colorants are checked against the Annex IV positive list, why eye products carry tighter microbiological expectations, how nanomaterials and heavy-metal traces are handled, and how shade ranges are grouped or split. A lip-specific companion article covers oral exposure separately, so here the focus stays on the face, the eye area and the documentation your assessor will ask for.
Key takeaways
- Every pigment is checked against the Annex IV positive list and its field-of-application column — some colorants are barred from the eye area or from products contacting mucous membranes.
- Eye-area and young-children products fall into the stricter microbiological limit category, so micro acceptance criteria are tighter than for general skincare.
- Wet products such as mascara depend on preservative efficacy: wand contamination makes a passing challenge test and a short period-after-opening essential.
- Nano titanium dioxide and nano zinc oxide need the [nano] suffix and carry notification implications distinct from pigment grades.
- Heavy metals in mineral pigments are treated as technically unavoidable traces, kept as low as achievable and evidenced through supplier certificates of analysis.
- Loose powders add an inhalation dimension, and a shade range often sits under one assessment with “MAY CONTAIN” labelling — until a variant forces reassessment.
Why make-up is assessed differently from skincare
Skincare is built around water, emollients and a modest active load; make-up is built around pigment — a foundation carries a large fraction of colorants and fillers, a pressed powder more still. That shifts the assessor’s focus from actives and preservatives to the identity, purity and permitted use of every colouring agent, the product’s physical form, and where on the face it is applied. The CPSR structure, exposure calculations and Product Information File are the same as for any cosmetic — our CPSR explained article sets out Parts A and B — but colour cosmetics load extra demands onto each.
Colorants and the Annex IV positive list
Annex IV of the Cosmetics Regulation is a positive list: a colouring agent may be used only if it appears there, and only under the conditions the annex sets. For make-up this is the most consequential check, because a palette or foundation range can contain a dozen or more pigments, each verified individually against its entry.
Annex IV entries also carry a field-of-application column. Some colorants are cleared for general use; others are restricted to rinse-off products, or explicitly not allowed in products applied to the eye area or to mucous membranes. So an eyeshadow and a cheek blush containing the same pigment can land differently — fine on the cheek, disallowed near the eye — and a colour compliant in one format can quietly become non-compliant when the same base is reused for an eye product.
Note: The CI (Colour Index) number on your INCI list is what ties a pigment to its Annex IV entry. Make sure supplier documentation states the CI number and purity criteria, not just a trade name — the assessor cannot verify a colorant they cannot identify.
Eye-area products: microbiology and preservation
Products used around the eye are held to a higher microbiological standard. Acceptance criteria split into categories: products for the eye area, mucous membranes and children under three sit in the tighter category, while general-use products sit in the more permissive one. In the terms of ISO 17516, an eyeliner or mascara is judged against lower microbial counts than a hand cream, so commission microbiological testing against the right category. The same stricter logic applies to infant products, as our note on the CPSR for baby cosmetics explains.
Preservation is the other half, and it matters most for wet products. A mascara is repeatedly reopened and the wand pushed back into the tube after touching lashes, so in-use contamination is recurring, not a one-off. That is why a preservative efficacy (challenge) test, run in line with ISO 11930 thinking, is central here: it shows the system can knock down organisms introduced during use. Because that protection degrades, wet eye products typically carry a short period-after-opening — often six months or less.
Warning: A preservative that performs well in a foundation can fail in a mascara because the wand reintroduces organisms with every use. Do not assume a shared system carries across formats — commission a preservative efficacy challenge test on the actual eye-area formula, not a proxy.
Nanomaterials, mineral pigments and heavy-metal traces
Two ingredient issues recur in colour cosmetics. The first is nanomaterials: titanium dioxide and zinc oxide appear widely in foundations and powders as opacifiers and, in UV-filter foundations, for sun protection. In nano form they must carry the [nano] suffix in the INCI list and bring their own notification implications at registration; pigment-grade behaves differently from the nano grade, so your assessor needs a supplier statement of which is used. If a foundation doubles as an SPF product, those UV-filter and nano checks layer on top of the colour work, as our guide to a CPSR for sunscreen and SPF day creams covers.
The second is heavy-metal traces. Mineral pigments, especially natural ones, can carry trace lead, arsenic, cadmium, mercury, nickel and antimony. The regulation bars these as intentional ingredients but accepts technically unavoidable traces kept as low as reasonably achievable, evidenced by supplier certificates of analysis measuring trace levels against tight internal limits.
| Make-up category | Key risk the assessor focuses on | Typical supporting data |
|---|---|---|
| Liquid/cream foundation | Leave-on dermal exposure across a large facial area; colorant compliance; nano status if TiO2/ZnO present | Full formula with concentrations, pigment CI numbers and specs, nano declaration, stability, micro test |
| Loose powder / setting powder | Inhalable fraction alongside dermal exposure; filler and pigment purity | Particle-size information, pigment CoAs with heavy-metal traces, formula, micro test |
| Mascara | In-use contamination via the wand; preservative efficacy; eye-area micro limits | Challenge test (ISO 11930), micro test to the stricter category, short PAO justification |
| Eyeliner | Colorant field-of-application (eye-area permitted); micro limits for the eye area | Annex IV verification per pigment, micro test, stability |
| Eyeshadow / blush | Colorant compliance across many pigments; pigment purity and traces | Per-pigment CI numbers and Annex IV check, heavy-metal CoAs, formula breakdown |
Exposure, powders and shade ranges
Because make-up covers a large facial area and, for foundation and powder, stays on all day, the dermal exposure calculation uses leave-on assumptions and applied amounts from the SCCS Notes of Guidance; the assessor turns each ingredient’s concentration into a systemic dose and a margin of safety. Higher pigment loads and daily leave-on use reduce those margins, so accurate concentrations matter. Powders add a route creams do not — inhalation — so for a loose powder the assessor weighs the inhalable fraction alongside dermal contact.
Ranges bring their own question. The regulation lets colouring agents that vary across a range be listed after “MAY CONTAIN” (or the ± symbol), so one declaration covers many shades, and shades sharing a base formula and an already-assessed pool of Annex IV-compliant pigments can often sit under one CPSR at the worst-case loading. A shade that introduces a new pigment, changes the base, or exceeds an evaluated concentration generally needs its own review — worth reading our explainer on when a separate CPSR is required for cosmetic variants before you finalise a range.
Note: Keep a shade matrix mapping each SKU to its pigment set and concentrations. It is the fastest way for an assessor to confirm which shades the worst-case assessment covers and which need their own review.
Bringing it all together
Make-up sits at the demanding end of cosmetic safety assessment: pigments to verify against Annex IV, tighter microbiological expectations for the eye area, preservation that must survive real in-use contamination, nano and heavy-metal documentation, and exposure modelling for leave-on facial use and, for loose powders, inhalation. None of it is insurmountable, but it rewards preparation — accurate concentrations, clean supplier certificates and a clear shade matrix ready before you start.
If you are bringing a foundation, powder or eye product to the EU market, our Cosmetic Product Safety Report (CPSR) service handles Parts A and B end to end, including the colorant, nano and micro checks above. To see how it runs from your side, read how to get a CPSR for your cosmetic product, and for budgeting a multi-shade range, our guide to how much a CPSR costs sets out the main cost drivers.
Frequently asked questions
Do I need a separate CPSR for every shade in my foundation range?
Not usually — shades that share one base formula and draw from a common pool of already-assessed, Annex IV-compliant pigments can often be grouped under a single CPSR covering the worst-case loading. A shade needs its own reassessment only when it introduces a new pigment, changes the base formula, or exceeds a colorant concentration already evaluated.
Why are eye-area products held to stricter microbiological limits?
Because the eye is sensitive and readily infected, products for the eye area fall into the tighter microbiological limit category, alongside those for mucous membranes and for children under three. In practice this means lower permitted microbial counts than general skincare, plus close attention to preservative efficacy for wet products like mascara.
What does the [nano] label mean on my foundation ingredients?
It signals an ingredient present in nano form, and it is a mandatory INCI-list label for nanomaterials such as nano titanium dioxide or nano zinc oxide. Nanomaterials also carry notification implications at registration, which is why your assessor needs a supplier statement confirming whether the pigment or UV filter is pigment-grade or nano-grade.
Are heavy metals in mineral make-up allowed?
They are not permitted as intentional ingredients, but the regulation accepts technically unavoidable traces kept as low as reasonably achievable. For mineral pigments you evidence this with supplier certificates of analysis showing measured levels of substances such as lead, arsenic, cadmium and nickel against tight limits.
Do loose powders need anything a pressed powder does not?
Yes — loose powders raise an inhalation consideration pressed products largely avoid. Because fine particles can be inhaled during application, the assessor considers the inhalable fraction alongside dermal contact, so particle-size information for a loose powder is useful supporting data.
Why does mascara need a challenge test when my foundation passed micro testing?
Because mascara faces repeated in-use contamination — the wand reintroduces organisms every time it is dipped back into the tube. A challenge test demonstrates the system can control that recurring contamination, and it must be run on the actual mascara formula rather than assumed from a foundation facing only occasional exposure.
