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ANSWERS · 4 OCT 2026

What are the EU rules for retinol and retinyl esters in cosmetics after Commission Regulation (EU) 2024/996: Annex entry, maximum concentrations by product type, warnings, transition dates, and what the SCCS concluded?

Commission Regulation (EU) 2024/996 added a new Annex III entry, reference number 376, to Regulation (EC) No 1223/2009. It covers Retinol, Retinyl Acetate and Retinyl Palmitate. The limits are 0.05% Retinol Equivalent (RE) in body lotion and 0.3% RE in other leave-on and rinse-off products. Every product containing any of the three must carry the warning "Contains Vitamin A. Consider your daily intake before use" [1]. Since 1 November 2025, non-compliant products may not be placed on the EU market. From 1 May 2027 they may not be made available at all [2].

Approach: I read the amending act and the current consolidated text of the EU Cosmetics Regulation (version of 1 May 2026). For the SCCS opinion itself I used the Commission's SCCS pages and EUR-Lex, because the SCCS opinion is not in the datasets I can search.

Annex III entry 376 (as in force today)

ColumnContent
Substances (INCI)Retinol; Retinyl Acetate; Retinyl Palmitate
CAS / ECRetinol 11103-57-4/68-26-8 (EC 234-328-2/200-683-7); Retinyl Acetate 127-47-9 (EC 204-844-2); Retinyl Palmitate 79-81-2 (EC 201-228-5)
Product type(a) Body lotion; (b) other leave-on and rinse-off products
Maximum in ready-for-use preparation(a) 0.05% RE; (b) 0.3% RE
Required label wording"Contains Vitamin A. Consider your daily intake before use"

[1][3]

Points to note:

  • The limit is in Retinol Equivalent. It is not a percentage of the ester as weighed into the formula.
  • The warning has no threshold. It applies to "any cosmetic product containing" any of the three substances, whatever the concentration [3].
  • No later changes. I found no amending act after 2024/996 that changes entry 376. The consolidated text of 1 May 2026 matches the 2024 entry.

Transition dates (footnote 45 of the consolidated Annex III)

  • 1 November 2025: non-compliant products may no longer be placed on the Union market.
  • 1 May 2027: non-compliant products may no longer be made available on the Union market, which ends sell-through. [2]

Today (October 2026) you are between the two dates. Non-compliant stock already on the market can be sold until 30 April 2027, but no new non-compliant products can be placed. "Complying with the conditions" covers the label warning as well as the concentration limits.

Recital 20 explains why the transition is longer than usual:

  • There is no immediate health concern.
  • Use levels in products already on the market do not exceed the levels the SCCS considers safe.
  • Shorter deadlines would have meant disproportionate withdrawal and destruction costs.

[4]

By comparison, the same act gave Alpha-Arbutin and Arbutin a much shorter timeline: 1 February 2025 for placing on the market and 1 November 2025 for making available [3].

Legal status before and after

  • Before: Recital 1 states that the three vitamin A substances were not regulated under Regulation 1223/2009. They were used as skin conditioning agents [5].
  • Adoption: The Regulation was adopted on 3 April 2024 and published in OJ L on 4 April 2024 (EUR-Lex, from a search snippet).
  • Entry into force: The twentieth day after publication [6].
  • Same act, other substances: 2024/996 also restricts Alpha-Arbutin, Arbutin, Genistein, Daidzein and Kojic Acid, tightens the rules on Triclosan and Triclocarban, and bans 4-Methylbenzylidene Camphor [3].

What the SCCS concluded

  • Opinion of 6 October 2016 (SCCS/1576/16): The use of vitamin A was found safe. However, the SCCS recognised that the population's overall vitamin A exposure could exceed EFSA's upper intake level [7].

  • Revised opinion of 24-25 October 2022 (SCCS/1639/21):

    • Vitamin A is safe in cosmetics up to 0.05% RE in body lotion and 0.3% RE in other leave-on and rinse-off products.
    • The contribution from cosmetics to overall exposure is low. Even so, it "may be of concern" for the 5% of the population with the highest vitamin A intake from food and food supplements.

    [7]

  • How the Commission used it: Based on that opinion, the Commission found a potential risk above those levels. It set the opinion's figures as the legal limits and added the daily-intake warning for consumers who already get vitamin A from their diet [8].

Sources:

SOURCES · 8

  1. [1](2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraen-1-ol (45); [(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenyl] acetate (45); [(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenyl] hexadecanoate (45) (Annex ref 376) [Cosmetics 02009R1223-20260501] · p.1EU
  2. [2]Annex III: LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN [Cosmetics 02009R1223-20260501] · p.9EU
  3. [3]Annex 1: Annexes II, III, V and VI to Regulation (EC) No 1223/2009 are amended as follows: [Cosmetics 32024R0996] · p.1EU
  4. [4]Recital 20 [Cosmetics 32024R0996] · p.1EU
  5. [5]Recital 1 [Cosmetics 32024R0996] · p.1EU
  6. [6]Article 2 [Cosmetics 32024R0996] · p.1EU
  7. [7]Recital 2 [Cosmetics 32024R0996] · p.1EU
  8. [8]Recital 3 [Cosmetics 32024R0996] · p.1EU
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