Is Methylene Glycol safe in cosmetics?
Methylene Glycol has a safety rating of "MODERATE" in our database. EU status: restricted. US status: restricted.
Methylene Glycol
Also known as: EINECS 207-339-5, UNII-6Z20YM9257, Methandiol, dihydroxymethane, formaldehyde hydrate (+1 more)
INCI: METHYLENE GLYCOL
Methylene Glycol (CAS 463-57-0) is a cosmetic cosmetic ingredient functioning as Antimicrobial, nail care agent, nail sculpting agent. EU Regulation 1223/2009 status: restricted, max 0.2%. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.
View industrial chemical safety profile for CAS 463-57-0 →
Auto-generated CPSR Part A draft with source citations
Function
Antimicrobial, nail care agent, nail sculpting agent
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
methanediol
InChIKey
CKFGINPQOCXMAZ-UHFFFAOYSA-N
Regulatory Status
EU EU Status
restricted
EU Max Conc.
0.2%
US US Status
restricted
US Notes
Restricted - the CIR Expert Panel concluded formaldehyde/methylene glycol are safe when formaldehyde equivalents do not exceed 0.074% (w/w); California Assembly Bill No. 496 bans methylene glycol in cosmetics sold or manufactured in California; a new federal regulation will prohibit intentional addition effective January 1, 2027
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Methylene Glycol.
Calculate MoS for your specific formulation with the MoS Calculator.
Sensitization Profile
Contact sensitization data for Methylene Glycol based on clinical patch test studies and IFRA standards.
Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.4%
Cross-reactivity Group
formaldehyde-releaser-group
Reaction Type
contact-dermatitis
Source: ESSCA 2019/20; IVDK; FDA
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 1579
(EU) 2019/831
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
SA Saudi SFDA (II - Prohibited)
ASEAN Cosmetic Directive (II)
Ref: 1579
BRIN Brazil/India Cosmetics
India: Prohibited (GNRAS)
Additional Jurisdictional Restrictions (2)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| GCC | banned | - | All cosmetics |
| KR | prohibited | - | - |
Additional Ingredient Properties
2 property records from structured ingredient metadata.
allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "preservative", "cross_reactivity_group": "formaldehyde-releaser-group", "patch_test_frequency_pct": "0.4", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "ESSCA 2019/20; IVDK; FDA"}
regulatory
{"eu_status": "restricted", "us_status": "restricted", "eu_max_concentration": "0.002", "restricted_in": "nail hardeners max 2.2%", "regulation_reference": "Annex III/13"}
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Softener and conditioner
Regulatory List Membership (2)
EU Banned in Cosmetics
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Methylene Glycol.
Regulatory Flags
eu_banned_cosmetics
eu_cosing_listed
Known Synonyms
EINECS 207-339-5
UNII-6Z20YM9257
Methandiol
dihydroxymethane
formaldehyde hydrate
methanediol
Chemical Function
Biocide
Softener and conditioner
Regulatory Lists
banned; Europe; Personal care
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
ChEMBL ID
CHEMBL4285219
Frequently Asked Questions
Is Methylene Glycol allowed in the EU?
Methylene Glycol EU regulatory status: restricted. Maximum allowed concentration: 0.2%. This is based on EU Regulation 1223/2009 and its amendments.
What does Methylene Glycol do in cosmetics?
Methylene Glycol functions as: Antimicrobial, nail care agent, nail sculpting agent. It is classified as a cosmetic ingredient in our database. CAS number: 463-57-0.
Is Methylene Glycol used outside cosmetics?
Methylene Glycol also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Methylene Glycol compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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