Colour Cosmetics

Colour cosmetics, foundations, lipsticks, eyeshadows, mascaras and blushers, are defined regulatorily by two things: the colorants they contain, which come from a positive list, and where on the body they are applied, because a lipstick is partly ingested and an eyeshadow sits beside the eye. Both shape the assessment more than the rest of the formula.

Colorants and the Annex IV positive list

Cosmetic colorants are not open-ended. Only substances on Annex IV may be used to colour a cosmetic, each carried with its field of application, its maximum concentration where one applies, and purity criteria. Crucially, the field of application matters: some colorants are not permitted in products used near the eyes, and some are not allowed in products applied to the lips or mucous membranes. A pigment acceptable in a blusher may be prohibited in an eyeliner or a lipstick, so the colour palette has to be checked entry by entry against where the product is used.

Lip products and ingestion

Lip products are partly ingested in normal use, so the assessment treats oral as well as dermal exposure. Heavy-metal content, lead in particular, is controlled as a technically unavoidable trace under Article 17 rather than by a single permitted limit, and the assessor judges whether the traces present are technically unavoidable and safe at the ingested exposure. That ingestion model is what distinguishes a competent lip-product assessment from a generic one.

Eye-area products and microbiology

Products used around the eye are held to stricter microbiological limits, with lower permitted total viable counts, because contamination near the eye carries a higher risk. Mascaras and liquid liners need a robust preservative system, proven by challenge testing, and a realistic period-after-opening, since they are used with an applicator returned to the pack.

Titanium dioxide and particle size

Titanium dioxide is a permitted colorant and UV filter, but its harmonised classification as a suspected carcinogen by inhalation makes its physical form decisive. Loose powders and sprayable products, where the particles can be inhaled, are a specific concern that the SCCS has addressed by restricting certain powder and aerosol uses, while bound forms in pressed or liquid products are treated differently. The nanoform is a separate case again, requiring Article 16 notification and permitted only under the conditions set in the Annex VI nano entries, not in applications that can be inhaled.

Microplastics, glitter and pigment carriers

The microplastics restriction, Regulation (EU) 2023/2055, reaches deep into colour cosmetics. Loose plastic glitter was banned from 17 October 2023, and make-up, lip and nail products containing intentionally added synthetic polymer microparticles must be reformulated by 17 October 2035, with a “This product contains microplastics” label required from 17 October 2031. Because many effect pigments and finishes are carried on synthetic polymer substrates, this is not only about glitter; it reaches mainstream foundations and eyeshadows, and the long deadline reflects how hard those products are to reformulate.

How we help

We check every colorant against its Annex IV field of application, assess lip products on ingestion exposure and eye products to the stricter microbiological standard, advise on titanium dioxide by physical form, and map a colour range against the microplastics deadlines so reformulation is planned rather than forced. The label and the period-after-opening are set to match the assessed product.