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Annex III Entry 324 CMR11/09/2023

METHYL SALICYLATE

Methyl 2-hydroxybenzoate

METHYL SALICYLATE is listed in Annex III and may only be used under the conditions shown in this record. Maximum concentration in this record: (a) 0,06 % (b) 0,05 % (c) 0,002 % (d) 0,009 % (e) 0,003 % (f) 0,04 % (g) 0,06 % (h) 0,6 % (i) 0,6 % (j) 0,03 % (k) 2,52 % (l) 0,1 % (m) 0,6 % (n) 0,65 %.

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Restricted substance— Annex III, EU Regulation 1223/2009
Entry: 324
CMR

Chemical identity and properties

PubChem 2D chemical structure for CAS 119-36-8
CAS 119-36-8PubChem CID 4133

Methyl Salicylate

Methyl salicylate (oil of wintergreen or wintergreen oil) is an organic ester naturally produced by many species of plants, particularly wintergreens. The compound was first extracted and isolated from plant species Gaultheria procumbens in 1843. It can be manufactured synthetically and it used as a fragrance, in foods, beverages, and liniments. It forms a colorless to yellow or reddish liquid and exhibits a characteristic odor and taste of wintergreen. For acute joint and muscular pain, methyl salicylate is used as a rubefacient and analgesic in deep heating liniments. It is used as a flavoring agent in chewing gums and mints in small concentrations and added as antiseptic in mouthwash solutions. — DrugBank

IUPAC name
methyl 2-hydroxybenzoate
Molecular formula
C8H8O3
Molecular weight
152.15 g/mol
Exact mass
152.047344113 Da
XLogP3
2.3
Topological polar surface area
46.5 Ų
Hydrogen-bond donors
1
Hydrogen-bond acceptors
3
Covalent units
1
Defined stereocentres
0

Also known as

AnalgitFlucarmitExagienBetula2-Hydroxybenzoic acid methyl esterGaultheriaoelWintergruenoel2-Carbomethoxyphenol
16 more reported names
Methyl o-hydroxybenzoatemethylsalicylate2-(Methoxycarbonyl)phenolSalicylic acid, methyl esterAnthrapole NDBenzoic acid, 2-hydroxy-, methyl esterFEMA No. 2745o-Hydroxybenzoic acid, methyl esterFEMA Number 2745Flavor,wintergreenMetylester kyseliny salicyloveFEMA No. 2154FEMA No. 3113NSC-8204Methylester kyseliny salicyloveLAV5U5022Y
Open full PubChem recordPubChem annotations3D structure image
External database identifiers

Evidence from additional scientific databases

NIH PubChem PUG-View
Exact identifier match4133

Attributed physical-property, hazard, environmental and use annotations.

  • First Aid: EYES: First check the victim for contact lenses and remove if present. Flush victim's eyes with water or normal saline solution for 20 to 30 minutes while simultaneously calling a hospital or poison control center. Do not put any ointments, oils, or medication in the victim's eyes without specific instructions from a physician. IMMEDIATELY transport the victim after flushing eyes to a hospital even if no symptoms (such as redness or irritation) develop.; SKIN: IMMEDIATELY flood affected skin with water while removing and isolating all contaminated clothing. Gently wash all affected skin areas thoroughly with soap and water. If symptoms such as redness or irritation develop, IMMEDIATELY call a physician and be prepared to transport the victim to a hospital for treatment.; INHALATION: IMMEDIATELY leave the contaminated area; take deep breaths of fresh air. If symptoms (such as wheezing, coughing, shortness of breath, or burning in the mouth, throat, or chest) develop, call a physician and be prepared to transport the victim to a hospital. Provide proper respiratory protection to rescuers entering an unknown atmosphere. Whenever possible, Self-Contained Breathing Apparatus (SCBA) shou Source: CAMEO Chemicals
  • Signal: Warning Source: Regulation (EC) No 1272/2008 of the European Parliament and of the Council
  • GHS Hazard Statements: H302: Harmful if swallowed [Warning Acute toxicity, oral]; H317: May cause an allergic skin reaction [Warning Sensitization, Skin]; H361d: Suspected of damaging the unborn child [Warning Reproductive toxicity]; H412: Harmful to aquatic life with long lasting effects [Hazardous to the aquatic environment, long-term hazard] Source: Regulation (EC) No 1272/2008 of the European Parliament and of the Council
  • Precautionary Statement Codes: P203, P261, P264, P270, P272, P273, P280, P301+P317, P302+P352, P318, P321, P330, P333+P317, P362+P364, P405, and P501 (click each P-code to see the statement) Source: Regulation (EC) No 1272/2008 of the European Parliament and of the Council
  • Note: This chemical does not meet GHS hazard criteria for 0.3% (6 of 2210) of reports. Source: European Chemicals Agency (ECHA)
  • Signal: Warning Source: European Chemicals Agency (ECHA)
  • GHS Hazard Statements: H302 (96.9%): Harmful if swallowed [Warning Acute toxicity, oral] Source: European Chemicals Agency (ECHA)
  • Precautionary Statement Codes: P264, P270, P301+P317, P330, and P501 (click each P-code to see the statement) Source: European Chemicals Agency (ECHA)
  • ECHA C&L Notifications Summary: Aggregated GHS information provided per 2210 reports by companies from 32 notifications to the ECHA C&L Inventory.; Reported as not meeting GHS hazard criteria per 6 of 2210 reports by companies.; There are 31 notifications provided by 2204 of 2210 reports by companies with hazard statement code(s).; Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown. For more detailed information, please visit ECHA C&L website. Source: European Chemicals Agency (ECHA)
  • Note: This chemical does not meet GHS hazard criteria for 2.4% (37 of 1530) of reports. Source: European Chemicals Agency (ECHA)
  • GHS Hazard Statements: H302 (97.5%): Harmful if swallowed [Warning Acute toxicity, oral]; H319 (91.1%): Causes serious eye irritation [Warning Serious eye damage/eye irritation] Source: European Chemicals Agency (ECHA)
  • Precautionary Statement Codes: P264, P264+P265, P270, P280, P301+P317, P305+P351+P338, P330, P337+P317, and P501 (click each P-code to see the statement) Source: European Chemicals Agency (ECHA)
  • ECHA C&L Notifications Summary: Aggregated GHS information provided per 1530 reports by companies from 10 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.; Reported as not meeting GHS hazard criteria per 37 of 1530 reports by companies.; There are 9 notifications provided by 1493 of 1530 reports by companies with hazard statement code(s).; Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown. For more detailed information, please visit ECHA C&L website. Source: European Chemicals Agency (ECHA)
  • Cosmetic Ingredient Review Conclusion: The Panel concluded that the following ingredients are safe in cosmetics in the present practices of use and concentration described in the safety assessment, when formulated to be non-irritating and non-sensitizing, which may be based on a quantitative risk assessment (QRA)...Methyl Salicylate... Source: Cosmetic Ingredient Review (CIR)
  • Cosmetic Ingredient Review Finding(s): Safe for use in cosmetics, with qualifications Source: Cosmetic Ingredient Review (CIR)
  • Environmental Bioconcentration: The log octanol/water partition coefficient for methyl salicylate is 2.55(1). The BCF estimated from this log Kow using a regression equation is 4 which indicates that the ester will not bioconcentrate in fish(SRC). Source: Hazardous Substances Data Bank (HSDB)
  • Environmental Fate: TERRESTRIAL FATE: If released on soil, methyl salicylate would readily leach. It would also be expected to partially volatilize from dry soil and photolyze on the soil surface. Based on the results of sceening tests, it would be expected to readily biodregrade. Chemical hydrolysis may be important in alkaline soil. (SRC) Source: Hazardous Substances Data Bank (HSDB)
  • Environmental Fate: AQUATIC FATE: Methyl salicylate is readily biodegradable in screening tests and may be expected to biodegrade in surface waters. Methyl salicylate is expected to hydrolyze in water, the hydrolysis rate increasing with pH. At pH 7.5, its hydrolysis half-life is estimated to be 14.1 days(1,2,SRC). Methyl salicylate will react with singlet oxygen in natural surface waters resulting in a half-life of about 52 hr(3). Methyl salicylate absorbs UV radiation >290 nm and therefore may undergo direct photolysis under environmental conditions. Based on an estimated Henry's Law constant of 9.3X10-7 atm-cu-m/mol(4,5,SRC), a volatilization half-life of 49 days would be expected in a model river(SRC). Source: Hazardous Substances Data Bank (HSDB)
  • Environmental Fate: ATMOSPHERIC FATE: Methyl salicylate reacts with photochemically-produced hydroxyl radicals in the atmosphere resulting in an estimated half-life of 1.4 days(1,SRC). It is fairly soluble in water, 7400 mg/L(2) and may be washed out by rain. Source: Hazardous Substances Data Bank (HSDB)

Mapped by: Existing checksum-valid CAS to unique PubChem CID match. Retrieved: 2026-08-31. Open source record

Scientific classifications and hazard annotations provide context and do not replace the market-specific regulatory decision shown above.

Additional source coverage and match status
SourceResultChecked
NIH PubChem PUG-ViewExact match2026-08-31

A recorded no-match is useful evidence that the source was checked; it is not a claim that the substance does not exist elsewhere.

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) 0,06 % (b) 0,05 % (c) 0,002 % (d) 0,009 % (e) 0,003 % (f) 0,04 % (g) 0,06 % (h) 0,6 % (i) 0,6 % (j) 0,03 % (k) 2,52 % (l) 0,1 % (m) 0,6 % (n) 0,65 %

Product type

Leave-on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant and hydroalcoholic-based fragrances) and leave on hair products (except spray/aerosol products) Face makeup (except lip products, eye makeup and makeup remover) Eye makeup and makeup remover Leave-on hair products (spray/aerosol) Deodorant spray/aerosol Body lotion spray/aerosol Rinse-off skin products (except hand wash) and rinse-off hair products Hand wash Hydroalcoholic-based fragrances Lip products Toothpaste Mouthwash intended for children aged 6–10 years Mouthwash intended for children above 10 years of age and adults Mouth spray

Other restrictions

Not to be used in preparations for children under 6 years of age, with the exception of (k) “Toothpaste”. The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products.

INCI glossary name

METHYL SALICYLATE

Chemical name

Methyl 2-hydroxybenzoate

Chemical / IUPAC name

Methyl 2-hydroxybenzoate

Regulatory information

Regulation

(EU) 2023/1545

See every entry this act set

Identified ingredients

CMR

CategoryCarcinogenicMutagenicReprotoxic
Cat. 2——✓

Key data

CAS
119-36-8
EC
204-317-7
Annex
III
Entry number
324

Inventory links for METHYL SALICYLATE

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

Annex III 379
Shared product type

Silver

CAS: 7440-22-4
EC: 231-131-3
Annex IV 142
Shared product type

CI 77820

CAS: 7440-22-4
EC: 231-131-3
Annex III 326
Nearby record in the same annex

Acid Yellow 3

CAS: 8004-92-0
EC: 305-897-5
Annex III 321
Nearby record in the same annex

TITANIUM DIOXIDE

CAS: 13463-67-7/ 1317-70-0/ 1317-80-2
EC: 236-675-5/ 215-280-1/ 215-282-2
Annex III 327
Nearby record in the same annex

Acetyl Cedrene

CAS: 32388-55-9
EC: 251-020-3

What Annex III means for METHYL SALICYLATE

METHYL SALICYLATE 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 11 related annex records with overlapping identifiers, annex logic or naming patterns.

Compliance checklist

  • Ensure formulation concentration does not exceed: (a) 0,06 % (b) 0,05 % (c) 0,002 % (d) 0,009 % (e) 0,003 % (f) 0,04 % (g) 0,06 % (h) 0,6 % (i) 0,6 % (j) 0,03 % (k) 2,52 % (l) 0,1 % (m) 0,6 % (n) 0,65 %
  • Confirm product type compatibility: (a) Leave-on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant and hydroalcoholic-based fragrances) and leave on hair products (except spray/aerosol products) (b) Face makeup (except lip products, eye makeup and makeup remover) (c) Eye makeup and makeup remover (d) Leave-on hair products (spray/aerosol) (e) Deodorant spray/aerosol (f) Body lotion spray/aerosol (g) Rinse-off skin products (except hand wash) and rinse-off hair products (h) Hand wash (i) Hydroalcoholic-based fragrances (j) Lip products (k) Toothpaste (l) Mouthwash intended for children aged 6–10 years (m) Mouthwash intended for children above 10 years of age and adults (n) Mouth spray
  • 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

METHYL SALICYLATE 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 119-36-8 is the unique numerical identifier assigned to METHYL SALICYLATE 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.

METHYL SALICYLATE 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) 0,06 % (b) 0,05 % (c) 0,002 % (d) 0,009 % (e) 0,003 % (f) 0,04 % (g) 0,06 % (h) 0,6 % (i) 0,6 % (j) 0,03 % (k) 2,52 % (l) 0,1 % (m) 0,6 % (n) 0,65 % 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 METHYL SALICYLATE

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

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