Skincare & Face Care

Skincare and face care is the largest cosmetic category and, in safety terms, among the most demanding. A facial moisturiser or serum is typically a leave-on product applied to thin, sensitive skin close to the eyes, every day, over years. That exposure profile drives the assessment, and it is why the same active can be acceptable in a rinse-off body product and restricted on the face.

Exposure and the margin of safety

The safety assessment models realistic exposure: the amount applied, the frequency, the area covered, the proportion retained and the dermal absorption of each ingredient. A daily leave-on facial product produces a high systemic exposure dose, so the margin of safety, the ratio of the no-observed-adverse-effect level to that exposure, is calculated against a demanding scenario. Where an ingredient is also taken in through diet or other products, the assessment has to consider aggregate exposure rather than the cosmetic in isolation.

Restricted actives

The actives that make facial skincare effective are increasingly the ones under restriction, and the assessment turns on getting their concentrations and conditions right. Retinol and its esters, retinyl acetate and retinyl palmitate, are now capped by Commission Regulation (EU) 2024/996 at 0.05% retinol equivalent in body lotion and 0.3% retinol equivalent in other leave-on and rinse-off products, expressed as retinol equivalent so that the derivatives are summed; products must carry the warning that they contain vitamin A and that the consumer should consider their daily intake. The limits applied to products placed on the market from 1 November 2025, with a final sell-through to 1 May 2027, and reflect the SCCS concern about cumulative vitamin A exposure.

Skin-lightening agents are tightly controlled. Hydroquinone is prohibited in cosmetics (it remains only in artificial nail systems), and because alpha-arbutin and arbutin can release hydroquinone, the same 2024/996 act limited alpha-arbutin to 2% in face creams and 0.5% in body lotions and arbutin to 7% in face creams, with kojic acid limited to 1% in face and hand products. Alpha-hydroxy acids such as glycolic and lactic acid are assessed on free-acid concentration and pH, not just the headline percentage, and carry sun-sensitivity considerations.

Preservation and microbiology

A water-containing leave-on emulsion has to be preserved against microbial growth across its in-use life, and the preservative system is assessed against the Annex V list and proven by preservative-efficacy (challenge) testing to ISO 11930. Several common preservatives are constrained: methylisothiazolinone is prohibited in leave-on products, and phenoxyethanol is capped at 1%. Products used around the eye are held to stricter microbiological purity.

Claims and the medicinal borderline

Facial skincare lives closest to the cosmetic-medicine line, because anti-ageing and anti-blemish claims can tip a product into medicinal territory. Claims about the appearance of the skin are acceptable; claims that a product restores, corrects or modifies a physiological function risk reclassification as a medicine. Every performance claim, from reducing the look of wrinkles to improving radiance, has to be substantiated under Article 20 and the Common Criteria, with evidence proportionate to the claim.

How we help

We assess facial skincare to the exposure scenario it actually faces, get the restricted actives to the right concentrations and conditions for each market, design and verify the preservative system, and set the claims so a product stays a cosmetic and stands behind what it says. As the EU and GB annexes continue to diverge on actives, we track both so a facial range stays compliant in each market it sells in.