- Commission Regulation (EU) 2024/996 restricts Vitamin A in cosmetics — it does not ban it. Retinol, Retinyl Acetate and Retinyl Palmitate are now Annex III restricted substances: permitted, but capped.
- The limits, as Retinol Equivalent (RE): 0.05% RE in body lotion and 0.3% RE in other leave-on and rinse-off products, plus a mandatory warning.
- Two deadlines: 1 November 2025 (no new placing on the market) and 1 May 2027 (full withdrawal). The same regulation also restricts Alpha-Arbutin, Arbutin, Kojic Acid, Genistein and Daidzein.
1. What Regulation (EU) 2024/996 changed
For years, retinol and its esters were used in cosmetics without a harmonised concentration limit. That changed with Commission Regulation (EU) 2024/996 of 3 April 2024, published in the Official Journal on 4 April 2024. It amends Annexes II, III, V and VI of Regulation (EC) 1223/2009 and, among other measures, sets the first EU-wide limits on Vitamin A in cosmetic products.
The single most important point to get right: this is a restriction, not a prohibition. Retinol remains a legal, usable cosmetic ingredient. What the regulation does is cap how much of it a product may contain and require a consumer warning.
2. The legal nature: an Annex III restriction
Vitamin A was added as entry 376 of Annex III — the list of substances cosmetics may contain only subject to restrictions. That placement is the whole story.
Under Art. 14(1)(b), a restricted substance that is not used in accordance with the conditions of Annex III is prohibited. So retinol is now governed by a conditional permission: legal within the limits and with the warning, non-compliant outside them. This is the opposite situation to an Annex II prohibition, where the substance cannot be used at all.
Entry 376 groups three substances together:
- Retinol (CAS 68-26-8 / 11103-57-4)
- Retinyl Acetate (CAS 127-47-9)
- Retinyl Palmitate (CAS 79-81-2)
3. The exact limits: 0.05% and 0.3%, as Retinol Equivalent
The maximum concentrations in entry 376 are:
| Product category | Maximum concentration |
|---|---|
| Body lotion | 0.05% Retinol Equivalent (RE) |
| Other leave-on and rinse-off products | 0.3% RE |
Two details matter for correct application.
The limit is expressed as Retinol Equivalent (RE). The three forms — Retinol, Retinyl Acetate and Retinyl Palmitate — are not capped independently. They are converted to a common retinol-equivalent basis and counted together against the limit. A formula combining retinol and retinyl palmitate must sum both, expressed as RE, and stay within the cap.
Body lotion is singled out. Body lotion has the lowest cap (0.05% RE) because it is applied over a large skin surface, increasing total exposure. Other leave-on products (face creams, serums) and rinse-off products share the higher 0.3% RE cap.
4. The two deadlines: 1 November 2025 and 1 May 2027
EU cosmetic transition periods always come in two stages, and entry 376 follows that pattern:
"From 1 November 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market."
"From 1 May 2027 cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market."
The distinction between the two is operational and important:
- Placing on the market is the first making-available of a product in the EU — broadly, the manufacturer or importer putting a batch into the supply chain. From 1 November 2025, no non-compliant retinol product may enter the market.
- Making available covers every subsequent supply, down to the shelf. From 1 May 2027, non-compliant product must be gone entirely — including stock already sitting in distribution.
The roughly 18-month gap between the two dates exists to let existing stock sell through. Vitamin A received one of the longest transition windows in the regulation, because the SCCS found no immediate health concern at current market concentrations.
5. The mandatory warning
Beyond the concentration cap, entry 376 requires a specific label warning on every product containing Vitamin A:
"Contains Vitamin A. Consider your daily intake before use."
The rationale is in the regulation's recitals: consumers are already exposed to vitamin A through food and food supplements, so the warning is about cumulative intake, not the cosmetic concentration in isolation. The wording does not require disclosing the specific concentration used — only that the product contains vitamin A and that the consumer should consider total daily intake.
For a Responsible Person, the practical consequence is that compliance has two halves: reformulate to the cap and update the label with the mandatory warning. Meeting the limit without adding the warning is still non-compliant.
6. Why the EU restricted retinol
The restriction rests on two SCCS opinions:
- SCCS/1576/16 (2016) first established that 0.05% RE in body lotion and 0.3% RE in other products were safe at the formulation level, and quantified the cumulative-exposure concern.
- SCCS/1639/21 (2022 revision) confirmed those limits and refined the population-level finding: the contribution of vitamin A from cosmetics, although low, may be of concern for the 5% of consumers with the highest exposure to vitamin A from food and supplements.
The logic is cumulative-intake risk management, not acute toxicity. Vitamin A is an essential nutrient, but excess intake over time carries known risks — so the EU capped the cosmetic contribution and asked consumers to consider their total daily intake. The same risk-based, evidence-led approach drives most modern amendments tracked through the regulatory watch.
7. The rest of Regulation 2024/996
Retinol is the headline, but 2024/996 is a multi-substance regulation. Its full title references "Vitamin A, Alpha-Arbutin and Arbutin and certain substances with potential endocrine disrupting properties." The other measures:
| Substance | Annex III entry | Limit | Product type |
|---|---|---|---|
| Genistein | 373 | 0.007% | All products |
| Daidzein | 374 | 0.02% | All products |
| Kojic Acid | 375 | 1% | Face and hand products |
| Alpha-Arbutin | 377 | 2% / 0.5% | Face cream / body lotion |
| Arbutin | 378 | 7% | Face cream |
Genistein and Daidzein are phytoestrogens restricted on endocrine-disruption grounds. Alpha-Arbutin and Arbutin carry an additional condition: hydroquinone in the formulation must remain at the lowest possible, unavoidable trace level. For these substances the deadlines are earlier than retinol's — 1 February 2025 (placing on the market) and 1 November 2025 (making available).
The same regulation also moved 4-Methylbenzylidene Camphor (4-MBC) to Annex II (prohibited) and removed it from the Annex VI UV-filter list — a reminder that a single omnibus regulation can restrict some substances and ban others in the same act.
8. What it means for formulators
Translating the rules into practice:
- A face serum or cream may contain up to 0.3% RE of Vitamin A. Professional-grade products above that — retinol serums at 0.5% or 1% — must be reformulated down to the cap or they cannot remain on the EU market.
- A body lotion must not exceed 0.05% RE, six times stricter than other leave-on products, because of the larger application area.
- Every Vitamin A product, at any compliant concentration, must carry the "Contains Vitamin A. Consider your daily intake before use" warning.
- The Product Information File and safety assessment must reflect the RE calculation across all three forms, summed.
The clock is the binding constraint: products placed on the market must comply from 1 November 2025, and the market must be fully clear of non-compliant stock by 1 May 2027.
9. How to verify and track the restriction
CosIng database — /en/cosing-database: look up Retinol, Retinyl Acetate and Retinyl Palmitate to see the Annex III entry, the RE limits per product category, and the mandatory warning, kept current with the latest amendments.
Regulatory monitoring — limits like these change with each omnibus regulation. The guide on monitoring EU cosmetic regulation changes explains how to track new SCCS opinions and amending regulations so a deadline like 1 November 2025 is never a surprise.
Related reading on recent restrictions: Regulation 2023/1545 on fragrance allergens, CMR substances in cosmetics and the Annex III restricted-substances guide.
10. Frequently asked questions
Is retinol banned in the EU? No. Regulation (EU) 2024/996 restricts it. Retinol, Retinyl Acetate and Retinyl Palmitate are Annex III substances — permitted but capped, with a mandatory warning.
What are the new retinol limits? 0.05% RE in body lotion and 0.3% RE in other leave-on and rinse-off products, with the three forms counted together as Retinol Equivalent.
When do the rules apply? No new placing on the market from 1 November 2025; full withdrawal from 1 May 2027.
What warning is required? "Contains Vitamin A. Consider your daily intake before use."
Why did the EU restrict retinol? Two SCCS opinions found that cosmetic vitamin A adds to dietary and supplement intake, which can be a concern for the highest-exposed consumers — so the EU capped the concentration and required a warning.
We respond within 24 business hours. Tell us which Vitamin A forms you use, in which products, and at what concentration.