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Annex III Entry 98 CMR07/12/2023

SALICYLIC ACID

Benzoic acid, 2-hydroxy-

SALICYLIC ACID is listed in Annex III and may only be used under the conditions shown in this record. Maximum concentration in this record: (a) 3.0% (b) 2.0% (c) 0.5%.

Restricted substance— Annex III, EU Regulation 1223/2009
Max conc.: (a) 3.0% (b) 2.0% (c) 0.5%
Entry: 98
CMR

Reading this entry

Salicylic acid has two regulatory lives. As a preservative it belongs to Annex V; this Annex III entry governs every other use, and says so in a line that is easy to read past.

  • Rinse-off hair products: 3.0%. Most other products: 2.0%. Body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant: 0.5%.
  • These conditions apply 'for purposes other than inhibiting the development of micro-organisms' — preservative use is Annex V.
  • Not for children under three, not in oral products, and not where the lungs may be exposed by inhalation.
  • The limits are inclusive of any use of salicylic acid, so preservative and active content count together.

The sentence that decides most questions about this entry is the one that reads least like a rule: for purposes other than inhibiting the development of micro-organisms in the product. Salicylic acid used to preserve a formulation is governed by Annex V. Salicylic acid used as an exfoliant, an anti-dandruff agent or anything else is governed here. The regulation adds that the purpose must be apparent from how the product is presented, so the claim on the pack is part of what determines which entry applies.

The three concentration tiers are not a general limit with exceptions. The 0.5% group — body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant — is named product by product, and a product outside all three named groups has no entry to sit in.

Two further conditions travel with every tier. Nothing for children under three, and nothing that may expose the lungs by inhalation, which rules out powder and spray formats regardless of concentration. And the limits are inclusive of any use of salicylic acid: a product using it both as a preservative and as an active counts the total, not each role separately.

Checked against

Chemical identity and properties

PubChem 2D chemical structure for CAS 69-72-7
CAS 69-72-7PubChem CID 338

Salicylic Acid

Salicylic acid is a monohydroxybenzoic acid that is benzoic acid with a hydroxy group at the ortho position. It is obtained from the bark of the white willow and wintergreen leaves. It has a role as an antiinfective agent, an antifungal agent, a plant hormone, a keratolytic drug, an EC 1.11.1.11 (L-ascorbate peroxidase) inhibitor, a plant metabolite and an algal metabolite. It is a conjugate acid of a salicylate. ChEBI

IUPAC name
2-hydroxybenzoic acid
Molecular formula
C7H6O3
Molecular weight
138.12 g/mol
Exact mass
138.031694049 Da
XLogP3
2.3
Topological polar surface area
57.5 Ų
Hydrogen-bond donors
2
Hydrogen-bond acceptors
3
Covalent units
1
Defined stereocentres
0

Also known as

o-hydroxybenzoic acid2-Carboxyphenolo-CarboxyphenolRetarder WRutranexSalonilKeralytDuoplant
16 more reported names
FreezoneSaligelIonilPsoriacid-S-stiftBenzoic acid, 2-hydroxy-Stri-DexSalicylic acid soapVerrugonSalicylic acid collodionPhenol-2-carboxylic acid2-Hydroxybenzenecarboxylic acidTrans-Ver-SalOrthohydroxybenzoic acidAcidum salicylicumAcido salicilicoIonil-Plus
External database identifiers

Retrieved from NIH PubChem on 2026-08-31 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

Record details

Maximum concentration

(a) 3.0% (b) 2.0% (c) 0.5%

Other restrictions

(a) (b) (c)

Not to be used in preparations for children under 3 years of age. Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Not to be used in oral products. For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.

These levels are inclusive of any use of salicylic acid.

Warnings

(a) (b) (c)

Not to be used for children under 3 years of age*

* Solely for products which might be used for children under 3 years of age.

INCI glossary name

SALICYLIC ACID

Chemical name

Benzoic acid, 2-hydroxy-

Chemical / IUPAC name

2-hydroxy benzoic acid

Regulatory information

Regulation

(EU) 2021/850

See every entry this act set

CMR

CategoryCarcinogenicMutagenicReprotoxic
Cat. 2

Key data

Annex
Entry number
98

Inventory links for SALICYLIC ACID

Inventory Restriction reference
Ref 37595

SALICYLIC ACID

CAS: 69-72-7
EC: 200-712-3

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

Annex III 97
Nearby record in the same annex

MUSK KETONE

CAS: 81-14-1
EC: 201-328-9
Annex III 96
Nearby record in the same annex

MUSK XYLENE

CAS: 81-15-2
EC: 201-329-4
Annex III 100
Nearby record in the same annex

TRICLOCARBAN

CAS: 101-20-2
EC: 202-924-1
Annex III 102
Nearby record in the same annex

METHYL EUGENOL

CAS: 93-15-2
EC: 202-223-0

What Annex III means for SALICYLIC ACID

SALICYLIC ACID 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 5 CosIng inventory ingredients for name and identifier cross-reference. The page also surfaces 12 related annex records with overlapping identifiers, annex logic or naming patterns.

Compliance checklist

  • Ensure formulation concentration does not exceed: (a) 3.0% (b) 2.0% (c) 0.5%
  • Confirm product type compatibility: (a) Rinse-off hair products (b) Other products except body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant (c) Body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant
  • Include required warning statement on product label.
  • Document conditions of use in the Product Information File (PIF).
  • This substance has CMR classification. Review the CMR table above and verify current Annex II/III status before use.

Frequently asked questions

SALICYLIC ACID 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 69-72-7 is the unique numerical identifier assigned to SALICYLIC ACID 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.

SALICYLIC ACID has a CMR (carcinogenic, mutagenic or reprotoxic) classification under EU CLP Regulation. Under Article 15 of EU Cosmetics Regulation 1223/2009, CMR substances of category 1A or 1B are prohibited in cosmetics unless specifically permitted. Category 2 CMR substances may be used only if assessed safe by the SCCS. Always verify current annex status and any applicable derogations before use.

The maximum concentration of (a) 3.0% (b) 2.0% (c) 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.

Source note for Annex III record SALICYLIC ACID

This page summarizes one Annex III record for SALICYLIC ACID 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 SALICYLIC ACID, but confirm any final regulatory decision against the current official annex wording and source files.

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