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Annex III Entry 377 04/04/2024

Alpha-Arbutin

4-Hydroxyphenyl-alpha-D-glucopyranoside

Alpha-Arbutin is listed in Annex III and may only be used under the conditions shown in this record. Maximum concentration in this record: (a) 2 % (b) 0,5 %.

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Restricted substance— Annex III, EU Regulation 1223/2009
Max conc.: (a) 2 % (b) 0,5 %
Entry: 377

Reading this entry

Alpha-arbutin was restricted in 2024 to 2% in face cream and 0.5% in body lotion, and carries a condition about a different substance: hydroquinone must stay at unavoidable trace level.

  • Face cream: 2%. Body lotion: 0.5%.
  • Hydroquinone in the formulation must be no higher than the unavoidable trace level.
  • 1 February 2025 stops non-compliant products being placed on the market; 1 November 2025 stops them being made available.
  • Beta-arbutin is a separate entry with its own limit — the two are not interchangeable.

The hydroquinone condition is the substantive part of this entry. Arbutin is a glycoside of hydroquinone and can release it, and hydroquinone is prohibited for skin use in the EU. The SCCS assessment that led to Regulation (EU) 2024/996 set the arbutin limits at concentrations where that release stays within what Article 17 tolerates, and the entry states the requirement directly: hydroquinone levels shall remain as low as possible and no higher than the unavoidable trace level.

For a formulator this is a specification and stability question rather than a dosing one. Free hydroquinone content depends on the raw material's purity and on what happens to the product over its life — pH, temperature and time all matter — so meeting the arbutin percentage is necessary and not sufficient.

The product types are named narrowly: face cream at 2%, body lotion at 0.5%. A serum or an essence is not a face cream, and a product outside both named types has no entry to rely on. The two 2025 dates close the transition from either end of the supply chain in the usual way.

Checked against

Chemical identity and properties

PubChem 2D chemical structure for CAS 84380-01-8
CAS 84380-01-8PubChem CID 158637

Alpha-Arbutin

Alpha-Arbutin is a glycoside. — ChEBI

IUPAC name
(2R,3S,4S,5R,6R)-2-(hydroxymethyl)-6-(4-hydroxyphenoxy)oxane-3,4,5-triol
Molecular formula
C12H16O7
Molecular weight
272.25 g/mol
Exact mass
272.08960285 Da
XLogP3
-0.7
Topological polar surface area
120.0 Ų
Hydrogen-bond donors
5
Hydrogen-bond acceptors
7
Covalent units
1
Defined stereocentres
5

Also known as

alpha arbutinUNII-72VUP07IT572VUP07IT5ORISTAR AATP-HYDROXYPHENYL-alpha-D-GLUCOPYRANOSIDERefChem:58967Derma Pella Intimate Brightening4-Hydroxyphenyl a-D-glucopyranoside
16 more reported names
a-Arbutin4-hydroxyphenyl alpha-D-glucopyranosideAC1L4KBIa-D-Glucopyranoside, 4-hydroxyphenylalpha-D-Glucopyranoside, 4-hydroxyphenylf inverted question mark-Arbutin(2R,3S,4S,5R,6R)-2-(hydroxymethyl)-6-(4-hydroxyphenoxy)tetrahydro-2H-pyran-3,4,5-triol(2R,3S,4S,5R,6R)-2-(hydroxymethyl)-6-(4-hydroxyphenoxy)tetrahydropyran-3,4,5-triolP-HYDROXYPHENYL-.ALPHA.-D-GLUCOPYRANOSIDE4-Hydroquinone-alpha-d-glucopyranosideAlpha ArbutineAlfa Arbutinaalpha-Arbutosides5112| cent-ArbutinI+/--Arbutin
Open full PubChem recordPubChem annotations3D structure image
External database identifiers

Retrieved from NIH PubChem on 2026-09-02 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

Record details

Maximum concentration

(a) 2 % (b) 0,5 %

Product type

Face cream Body lotion

Other restrictions

Hydroquinone levels shall remain as low as possible in formulations containing alpha-Arbutin and shall not be higher than the unavoidable trace level.

From 1 February 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market. From 1 November 2025 cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market.

INCI glossary name

Alpha-Arbutin

Chemical name

4-Hydroxyphenyl-alpha-D-glucopyranoside

Regulatory information

Regulation

(EU) 2024/996

See every entry this act set

SCCS opinions

Identified ingredients

Key data

CAS
84380-01-8
EC
617-561-8
Annex
III
Entry number
377

Inventory links for Alpha-Arbutin

Inventory Identified ingredient
Ref 54359

ALPHA-ARBUTIN

CAS: 84380-01-8
EC: 283-934-3

Direct matches are limited for this record, so nearby entries from Annex III are shown as well.

Annex III 378
Shared product type

Arbutin

CAS: 497-76-7
EC: 207-850-3
Annex III 375
Nearby record in the same annex

Kojic Acid

CAS: 501-30-4
EC: 207-922-4
Annex III 379
Nearby record in the same annex

Silver

CAS: 7440-22-4
EC: 231-131-3
Annex III 374
Nearby record in the same annex

Daidzein

CAS: 486-66-8
EC: 207-635-4
Annex III 380
Nearby record in the same annex

Hexyl Salicylate

CAS: 6259-76-3
EC: 228-408-6
Annex III 373
Nearby record in the same annex

Genistein

CAS: 446-72-0
EC: 207-174-9
Annex III 371
Nearby record in the same annex

Pinene

CAS: 80-56-8/ 7785-70-8/ 127-91-3/ 18172-67-3
EC: 201-291-9/ 232-087-8/ 204-872-5/ 242-060-2

What Annex III means for Alpha-Arbutin

Alpha-Arbutin is a restricted substance under Annex III of EU Cosmetics Regulation 1223/2009. Its use in cosmetics is only permitted under the specific conditions set out in the entry above, including applicable concentration limits, product type restrictions and required warning statements.

When including this substance in a formulation, all conditions — maximum concentration, product scope and warning labels — must be met simultaneously. Compliance with one condition does not override the others.

This record is linked to 1 CosIng inventory ingredient for name and identifier cross-reference. The page also surfaces 10 related annex records with overlapping identifiers, annex logic or naming patterns.

Compliance checklist

  • Ensure formulation concentration does not exceed: (a) 2 % (b) 0,5 %
  • Confirm product type compatibility: (a) Face cream (b) Body lotion
  • Document conditions of use in the Product Information File (PIF).

Frequently asked questions

Alpha-Arbutin is listed in Annex III of EU Regulation 1223/2009 as a restricted substance. It may only be used under the conditions specified in the entry, including any maximum concentration, product type limitation and required warning statements shown above.

CAS 84380-01-8 is the unique numerical identifier assigned to Alpha-Arbutin by the Chemical Abstracts Service. In cosmetic compliance work, the CAS number is used to cross-reference the substance across regulatory databases, raw material specifications and safety assessment reports. Multiple EU annex entries may share the same CAS number if the same substance appears under different conditions or in different annexes.

The maximum concentration of (a) 2 % (b) 0,5 % applies to the concentration of the substance in the ready-to-use cosmetic product. When the substance is supplied as part of a blend or mixture, the calculation must account for the contribution of all sources in the formulation. The combined concentration must not exceed the stated limit.

Use the INCI Checker tool on this site to paste your full ingredient list (INCI) and scan it against all Annex II–VI entries. The tool highlights any ingredients that match restricted, prohibited or allergen-flagged records. This is useful for rapid compliance screening of finished product formulas or raw material declarations.
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Source note for Annex III record Alpha-Arbutin

This page summarizes one Annex III record for Alpha-Arbutin from public European Commission cosmetic materials and adds linked inventory or identifier matches when available.

Use this record page to review Annex III conditions for Alpha-Arbutin, but confirm any final regulatory decision against the current official annex wording and source files.

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