Foundations, lipsticks, eyeshadows and mascaras go on the most sensitive parts of the face and stay there for hours. That is why makeup safety testing is more than a formality: colour, texture and wear mean nothing if a product irritates an eye or grows bacteria in the tube. This checklist explains what the EU expects from colour cosmetics, which tests matter for each type, and the risks that are specific to eye-area products such as mascara.
Contents
- The short answer
- Why makeup is different from skin care
- Step 1: Colourants, pigments and ingredient rules
- Step 2: Stability and compatibility
- Step 3: Microbiological quality and eye-area limits
- Step 4: Preservation and the mascara problem
- Step 5: Skin and eye tolerance
- Testing by makeup type
- Makeup claims that need evidence
- A makeup testing checklist
- Frequently asked questions
- Key takeaways
The short answer
Makeup sold in the EU needs a signed safety assessment (CPSR) built on real data: an ingredient and colourant review, stability and compatibility testing, microbiological quality testing and, for water-based products, a preservation efficacy (challenge) test. A patch test supports skin tolerance claims. Mascara and other eye-area products call for the strictest microbiological limits and the most careful attention to preservation, packaging and claims. The right test list depends on the formula, the pack and the intended use.
Why makeup is different from skin care
Makeup combines several risk factors. It contains pigments and powders that must meet purity and colourant rules. It is applied close to or on the eyes and lips, where products can be swallowed or reach mucous membranes. Many items are used with brushes, sponges and fingers, which carry bacteria back into the pack. Products are often kept for months in handbags and bathrooms. And long wear creates a long contact time with the skin. A safety assessor therefore looks at the pigments, the preservation system, the packaging and the way people really use the product.
Read also Baby Cosmetics Safety Testing: What the File Must Show
Step 1: Colourants, pigments and ingredient rules
In the EU, colourants are controlled by a positive list: only the listed colourants may be used, and each entry states where on the body it may be used and any limits. Some are not allowed in products for the eye area, or are restricted to rinse-off use. Other points worth checking:
- Impurities in pigments such as heavy metals. Technically unavoidable traces of prohibited substances are tolerated only if the product is safe under normal use.
- Nanomaterials, which require notification to the Commission before launch and are marked “(nano)” in the ingredients list.
- Fragrance allergens, which must be declared above set thresholds, including in lip products.
- Glitter and microplastics: loose glitter has been banned in the EU since October 2023, and other synthetic polymer microparticles are being phased out.
- Powders such as talc, which must be pure and free of harmful contaminants.
The assessor records each of these checks in the CPSR.
Step 2: Stability and compatibility
Makeup must look and behave the same in month twelve as on the first day. A stability and compatibility test checks colour drift, separation, sweating in lipsticks, caking in powders and changes in smell or texture under accelerated conditions. It also checks the pack. Metal tubes, brush wands, applicators, magnetic palettes and pumps can interact with pigments, oils and solvents. For mascara, drying and clumping in the tube, brush performance and leakage are part of the story. Test the formula in the final pack, because a formula that is stable in a glass jar may fail in a lightweight plastic tube.
Step 3: Microbiological quality and eye-area limits
A microbiological specifications test checks that the finished product has low levels of aerobic bacteria, yeasts and moulds, and no specified harmful organisms such as Pseudomonas aeruginosa, Staphylococcus aureus or Candida albicans. SCCS guidance generally applies a stricter acceptance limit to eye-area products, products on mucous membranes and products for children under three than to other cosmetics. Mascara, eyeliner and eye shadow fall in the strict group. Test each new batch type and repeat after formula or supplier changes.
Read also Lip Balm Safety Testing: What Lip Products Need Before Sale
Step 4: Preservation and the mascara problem
Mascara is one of the toughest products to preserve. Every time the wand goes back into the tube, it carries bacteria from the lashes and the eye area into a warm, moist formula. Liquid foundations, concealers and liquid eyeliners share this risk. A challenge test shows whether the preservative system kills or controls reference microorganisms over 28 days, and it is expected for water-based colour cosmetics. Anhydrous products such as many lipsticks, pressed powders and balms may be assessed differently, because there is little free water. Preservation also supports the period after opening on the label: a shorter period is common for eye-area products and should match the data.
Step 5: Skin and eye tolerance
A patch test on human volunteers supports claims such as “dermatologically tested” or “for sensitive skin” for foundations, concealers and lip products. For mascara and eye shadow, claims such as “ophthalmologist tested” or “suitable for contact lens wearers” need their own evidence, usually from a separate eye tolerance study. The assessor reviews all irritation data, including the ingredient profile, to decide whether the product is safe for its intended use. The EU banned animal testing of cosmetics, so safety relies on existing data, alternative methods and human studies.
Testing by makeup type
- Mascara and liquid eyeliner: strict microbiological limits, strong preservation, brush and pack tests, eye tolerance evidence.
- Foundation and concealer: preservation for water-based types, colour stability, skin tolerance, and separate rules if an SPF claim is made.
- Lipstick and lip gloss: colourants allowed for lip use, accidental ingestion, fragrance allergens, oxidation of oils.
- Powders, blush and eyeshadow: pigment purity, talc quality, binder stability, microbiological quality, eye-area limits for eye shadow.
- Nail products and eyebrow products: their own ingredient restrictions and warnings, so check with your assessor.
Read also Perfume Safety Testing: What Fragrances Need Before Launch
Makeup claims that need evidence
“Long-wearing”, “24-hour”, “smudge-proof”, “hypoallergenic”, “for sensitive eyes” and “lash-growing” all need to be truthful and supported. A lash-growth claim can move a product into medicine territory, and some active substances that stimulate lash growth are not allowed in cosmetics. A foundation with an SPF claim becomes a sun protection product with its own filter limits and testing rules. If you cannot support a claim, remove it from packaging, website and advertising. The EU common criteria require claims to be legal, truthful, evidenced, honest, fair and to support informed choice.
A makeup testing checklist
- Check pigments, colourants and other ingredients against the positive lists and annexes.
- Choose the final packaging, including brush or applicator.
- Run a stability and compatibility test in the final pack.
- Run a microbiological specifications test, with eye-area limits where relevant.
- Run a challenge test for water-based formulas such as mascara and liquid foundation.
- Run a patch test, and eye tolerance work if you want eye-related claims.
- Obtain the signed CPSR, build the product information file and notify the product.
- Re-assess after every change of pigment batch, supplier, formula or packaging.
If you buy pigments or bases in bulk, a safety data sheet for the raw material helps your team handle it safely.
Frequently asked questions
Does a mascara need a challenge test?
Almost always, because it is water-based, opened repeatedly and applied near the eye. The assessor decides, but you should plan for it.
Can I reuse the data for several shades?
Sometimes. Shades that differ only in pigment may share stability and preservation data if the assessor agrees, but each colourant must be checked and some pigments interact with the base.
Is a lipstick tested like a mascara?
No. Lipsticks are usually anhydrous, so microbiological risk is lower, but the safety focus moves to colourants, accidental ingestion and stability of oils and waxes.
Key takeaways
- Makeup needs a signed CPSR backed by colourant review, stability, microbiology and, for water-based types, challenge testing.
- Eye-area products, especially mascara, have the strictest microbiological limits and the highest preservation demands.
- Test each formula in its final pack, brush and applicator included.
- Back every makeup claim with evidence, and review safety when pigments or suppliers change.