Skin brightening cosmetics are one of the fastest growing categories in Europe and one of the most heavily policed. Two of the most effective actives in the global market, hydroquinone and mercury compounds, are prohibited outright in EU cosmetics, and the legal alternatives now carry concentration limits that were introduced only recently.
If you are formulating a tone-evening serum, importing a brightening range from outside the EU, or reviewing a supplier formula, the ingredient list is only half the problem. The other half is the claim, because language about treating pigmentation disorders moves a product from cosmetic into medicinal territory. This guide sets out what is banned, what is capped, what is still open, and how to keep the marketing on the right side of the line.
Key takeaways
- Hydroquinone is prohibited in cosmetic products under Annex II, with a narrow exception for professional artificial nail systems. Mercury and its compounds are also prohibited.
- Regulation (EU) 2024/996 set limits for alpha-arbutin (2% in face creams, 0.5% in body lotions) and arbutin (7% in face creams).
- Kojic acid is limited to 1% in face and hand products following the same amendment.
- The reasoning behind the arbutin limits is release of hydroquinone, so combining several arbutin sources in one routine is exactly what the limits are designed to prevent.
- Vitamin C derivatives, niacinamide, azelaic acid derivatives and tranexamic acid are not restricted by name, so the safety assessment carries the whole burden.
- Imported brightening creams are a recurring Safety Gate category, usually for undeclared hydroquinone or corticosteroids.
- Claims about melasma, hyperpigmentation disorders or bleaching risk reclassification as a medicinal product.
The prohibited actives
Two substance groups define the boundary of this category.
Hydroquinone
Hydroquinone is a highly effective tyrosinase inhibitor and is prohibited in EU cosmetic products. The only surviving entry permits it in professional artificial nail systems, which is a completely different use. In several markets outside the EU it remains available at 2% over the counter or higher on prescription, which is why imported products and travel purchases keep appearing in enforcement notifications.
Mercury and corticosteroids
Mercury and its compounds are prohibited, with a narrow historic exception for certain eye area preservatives that is now of no practical relevance. Topical corticosteroids such as clobetasol propionate are medicinal substances and cannot be used in cosmetics at all. Both appear regularly in Safety Gate alerts for skin lightening creams, usually undeclared, which is why a certificate of analysis from an unfamiliar contract manufacturer is worth more than a formula sheet.
If you buy finished brightening product from outside the EU and relabel it, you inherit full Responsible Person liability for what is inside. Undeclared hydroquinone will not appear on the INCI list you were given. For this category, ask for batch analysis covering hydroquinone, mercury and common corticosteroids before you place anything on the market.
The actives that now have limits
Regulation (EU) 2024/996 restricted several brightening ingredients that had been used without a numerical cap for years. The limits follow SCCS opinions and are built around exposure rather than around efficacy.
| Substance | Limit | Product type |
|---|---|---|
| Hydroquinone | Prohibited | All cosmetic products (Annex II) |
| Alpha-arbutin | 2% | Face creams |
| Alpha-arbutin | 0.5% | Body lotions |
| Arbutin | 7% | Face creams |
| Kojic acid | 1% | Face and hand products |
| Mercury and compounds | Prohibited | All cosmetic products (Annex II) |
Two details in that table are easy to miss. First, the arbutin entries are written for face creams, so a serum, a mask or a toner using arbutin sits outside the wording of the entry and has to be justified by the assessor against the same exposure reasoning. Second, the alpha-arbutin body limit is a quarter of the face limit, for the same reason retinol is stricter in body lotion: a body product is applied over a much larger area.
The concern with arbutin is that it can release hydroquinone, a prohibited substance. That is why an assessor will ask about purity, the stability of the arbutin in your base and the pH of the finished product. An arbutin formula sitting at a low pH is a different exposure question from the same percentage in a neutral cream.
The actives with no numerical limit
Most modern brightening formulas are built on ingredients that appear nowhere in the annexes: ascorbic acid and its derivatives, niacinamide, tranexamic acid, alpha-arbutin alternatives, licorice root extract and its glabridin fraction, azelaic acid derivatives such as potassium azeloyl diglycinate, and various peptides.
The absence of a limit is not permission for any level. It means the safety assessor sets the ceiling, using the toxicological dossier and the exposure from your specific product. Two practical consequences follow:
- High percentage marketing pushes into thin data. A 20% vitamin C serum needs a defensible dossier at 20%, and the pH needed to make ascorbic acid work also drives skin irritation questions.
- Novel botanicals stall assessments. A brightening extract with no repeated dose toxicity data anywhere cannot produce a margin of safety, which is the single most common reason a CPSR gets stuck. Our explanation of the margin of safety covers why.
Screening the formula against the annexes first, then checking data availability for the unlisted actives, is far cheaper than discovering the problem after packaging is printed. That is the purpose of a formula screening against the annexes.
Where the claims go wrong
This is the category where the medicinal borderline bites hardest. A cosmetic acts on the appearance of the skin. A medicine treats a disease. Melasma, post-inflammatory hyperpigmentation and solar lentigines are recognised conditions, so naming them as targets invites a Member State authority to look at the product as an unlicensed medicine.
Language that causes problems
- Naming a condition: melasma, chloasma, hyperpigmentation disorder, age spots described as a disorder.
- Bleaching or whitening the skin as such, rather than evening its appearance. Several Member States treat skin bleaching claims as outside the cosmetic definition entirely.
- Comparisons with prescription actives, for example describing a formula as an alternative to a dermatologist prescribed cream.
- Before and after imagery presented as clinical results without substantiation on file.
Language that works
Appearance based wording is defensible when you hold the evidence: reduces the look of dark spots, evens skin tone, improves radiance. Under Regulation (EU) 655/2013 every claim needs evidential support in the PIF, and the support has to match the strength of the wording. Our guide to allowed cosmetic claims sets out the common criteria, and the cosmetic versus medicinal borderline explains how presentation alone can move a product.
Building a compliant brightening product
A workable sequence looks like this.
- Screen the formula against Annexes II to VI, paying attention to arbutin, kojic acid and any extract that might carry a restricted constituent.
- Fix the concentrations against the product type wording in the annex entries, not against the general category. If your product is a face serum using arbutin, expect the assessor to reason by analogy with the face cream entry.
- Collect toxicological data for every unlisted active before finalising the formula, especially for botanicals and peptides.
- Write the claims at the same time as the formula, so that the substantiation you need is generated once rather than retrofitted.
- Commission the safety assessment and get the label reviewed against the finished formula. Our CPSR guidance for face creams covers what the assessor works through.
Bringing it all together
Brightening is a category where the compliance risk is concentrated in two places: what is really in the product, and what the pack says it does. The formulation rules themselves are manageable once you know the arbutin and kojic acid limits, and most modern actives are not restricted by name at all. The trouble comes from imported product with undeclared actives, from arbutin used in product types the annex wording did not anticipate, and from marketing copy that names a medical condition.
Get the formula screened, get the data for your unlisted actives, and write claims that describe appearance rather than treatment. That combination keeps a brightening range sellable across all 27 Member States rather than in the ones that have not looked yet.
Lexora screens brightening formulas, calculates the exposure and reviews the claim set before launch. Start with a safety assessment for face cream, add a cosmetic claims compliance check, or screen the formula first with cosmetic formula screening.
Frequently asked questions
Is hydroquinone banned in EU cosmetics?
Yes. Hydroquinone is listed in Annex II of Regulation (EC) 1223/2009 and cannot be used in cosmetic products placed on the EU market. The only remaining permitted use is in professional artificial nail systems under a separate Annex III entry, which is unrelated to skin care.
How much alpha-arbutin can I use in a face cream?
Up to 2% in face creams and up to 0.5% in body lotions, following Regulation (EU) 2024/996. Beta-arbutin is permitted up to 7% in face creams. Where your product is not a cream, the safety assessor has to justify the level against the same exposure reasoning the limits are based on.
Is kojic acid legal in the EU?
Yes, up to 1% in face and hand products. The limit was introduced by Regulation (EU) 2024/996 after an SCCS opinion. Higher levels seen in products from other markets are not acceptable in the EU, and neither is spreading the same total across several products in one routine if your marketing directs consumers to layer them.
Can I say my product treats melasma?
No. Melasma is a medical condition, and claiming to treat it presents the product as a medicine, which puts it outside the cosmetic definition and outside your notification. Describe the effect on appearance instead, for example reducing the look of dark spots, and hold substantiation for whatever you say.
Are vitamin C serums restricted in the EU?
Ascorbic acid and its common derivatives are not listed in the annexes, so there is no fixed maximum. The safety assessor sets the acceptable level for your specific product based on the toxicological data and the exposure, and a low pH formula will attract questions about skin irritation that a neutral one will not.
What should I check before importing a brightening range?
Ask for batch analysis covering hydroquinone, mercury and topical corticosteroids, plus the full quantitative formula including compound raw materials. Undeclared actives are the main reason skin lightening products appear in EU Safety Gate alerts, and as Responsible Person you carry the liability regardless of what the supplier declared.
