Retinol: New EU Restrictions Effective November 2025

The New Limits

As of November 1, 2025, the EU has implemented new concentration limits for vitamin A (retinol and its derivatives) in cosmetic products:

EU Retinol Limits (Effective Nov 2025)

Product Type	Maximum Concentration
Body lotions	0.05% RE
Face creams	0.3% RE
Hand creams	0.3% RE
Other leave-on products	0.3% RE
Rinse-off products	0.3% RE

RE = Retinol Equivalent. Retinyl palmitate and retinyl acetate are converted to RE based on their vitamin A activity.

Products already on the market have until May 1, 2027 to comply (grace period for existing inventory).

Why the Restrictions?

The limits are based on the SCCS revised opinion (SCCS/1639/21, published 2022), which conducted a comprehensive safety assessment of vitamin A in cosmetics. The key concerns:

1. Aggregate Exposure

Vitamin A comes from multiple sources: diet, supplements, and cosmetics. The EU's Tolerable Upper Intake Level (UL) for adults is 1,500 μg RE/day. The SCCS found that:

Cosmetics alone don't exceed this limit
However, when combined with diet (especially for the top 5% of consumers with high dietary vitamin A), aggregate exposure approaches safety limits
Cosmetics contribute approximately 15-20% of total vitamin A intake

2. Dermal Absorption Data

The foundational study by Yourick et al. (2008) established the dermal absorption profile that regulators use:

Key Dermal Absorption Findings

In vitro human skin (split-thickness, 200-320 μm) exposed to 0.3% retinol formulations for 24 hours
Total skin penetration: 5.7-8.9%
Bioavailable portion (viable skin + receptor fluid): 2.4-4.3%
Primary accumulation in stratum corneum: 3.5-5.9%
Minimal systemic absorption: 0.3-1.3% in receptor fluid
Conservative estimate used by SCCS: 7.7% dermal absorption (mean + 2SD)

That 7.7% figure is critical - it's what the SCCS uses for Margin of Safety calculations. The actual absorption may be lower, but regulators use conservative estimates.

3. Teratogenicity Concerns

Vitamin A is a known teratogen at high doses. While cosmetic concentrations are far below problematic levels, the precautionary approach factors in:

Pregnant women may not know they're pregnant in early stages
First trimester is the critical window for vitamin A-related birth defects
Cumulative exposure from multiple product use

This is why retinol products carry pregnancy warnings - not because typical cosmetic use is dangerous, but because the precautionary principle applies.

Retinol vs. Its Derivatives

Not all vitamin A forms are equal. A 2004 study by Antille et al. revealed important differences:

Form	Metabolism in Skin	Notes
Retinol	Loads skin with storage vitamin A	Not converted directly to retinoic acid
Retinal (Retinaldehyde)	Highest metabolic activity	Converts to retinoic acid in skin
Retinyl Palmitate	Increases storage, minimal conversion	Gentlest, least irritating
Retinoic Acid (Tretinoin)	Direct activity	Prescription only - not allowed in EU cosmetics

The key finding: topical retinol acts primarily as a "prodrug" - it loads the skin with vitamin A but doesn't generate significant retinoic acid directly. This is why it's less potent (but also less irritating) than prescription tretinoin.

Formulation Matters

A 2024 study in Scientific Reports found that retinol penetration depth in pig skin was only 14-16 μm - primarily in the stratum corneum, not reaching systemic circulation. But here's the interesting part:

Formulation vehicle significantly affects delivery
Lecithin organogel showed higher penetration than conventional cream despite lower concentration
Penetration enhancers like oleic acid can significantly increase delivery

This means two products with the same retinol percentage can have very different efficacy and absorption profiles based on their formulation.

What This Means For You

Practical Takeaways

If you're in the EU: Products will be reformulated or relabeled by Nov 2025. Check percentages on your current products - if they exceed new limits, they'll change.
Body lotions are more restricted than face products (0.05% vs 0.3%) because of larger application area = higher total exposure.
Pregnancy caution still applies: Even at lower concentrations, avoid retinol during pregnancy and while trying to conceive.
The science supports safety at regulated levels: Cosmetics alone don't pose systemic toxicity risk. The limits address aggregate exposure scenarios.
Percentage isn't everything: A well-formulated 0.3% product may outperform a poorly formulated 1% product.

The Bottom Line

The EU's new retinol limits are based on solid toxicological data and the precautionary principle. At 7.7% dermal absorption and typical use patterns, retinol in cosmetics contributes to overall vitamin A intake but doesn't independently exceed safety thresholds.

The restrictions primarily affect body lotions (large surface area application) and acknowledge that we get vitamin A from multiple sources. For most users, these changes mean slightly reformulated products - not a fundamental change in retinol's role in skincare.

Check your products with our Product Decoder to see if they contain retinoids and understand the new regulatory context.

References

SCCS (2022). Revision of the scientific Opinion (SCCS/1576/16) on vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate). SCCS/1639/21. European Commission.
Yourick JJ, Koenig ML, Bronaugh RL (2008). In vitro and in vivo percutaneous absorption of retinol from cosmetic formulations. Toxicology and Applied Pharmacology. DOI: 10.1016/j.taap.2008.04.024
Antille C, Tran C, Sorg O, Saurat JH (2004). Penetration and metabolism of topical retinoids in ex vivo organ-cultured full-thickness human skin explants. Skin Pharmacology and Physiology. DOI: 10.1159/000077238
Wang Y, et al. (2024). Retinol semisolid preparations in cosmetics: transcutaneous permeation mechanism and behaviour. Scientific Reports. DOI: 10.1038/s41598-024-73240-y
Mélot M, et al. (2009). Studying the effectiveness of penetration enhancers to deliver retinol. Journal of Controlled Release. DOI: 10.1016/j.jconrel.2009.04.023