Is Sodium Hydroxymethylglycinate safe in cosmetics?
Sodium Hydroxymethylglycinate has a safety rating of "MODERATE" in our database. EU status: restricted. US status: restricted.
Sodium Hydroxymethylglycinate
Also known as: Glycine, N-(hydroxymethyl)-, sodium salt (1:1), Sodium (hydroxymethyl)glycinate, N-(Hydroxymethyl)glycine, monosodium salt, Glycine, N-(hydroxymethyl)-, monosodium salt, EINECS 274-357-8 (+3 more)
INCI: SODIUM HYDROXYMETHYLGLYCINATE
Sodium Hydroxymethylglycinate (CAS 70161-44-3) is a cosmetic preservative functioning as Preservative. NOAEL 160 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 0.5%. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.
View industrial chemical safety profile for CAS 70161-44-3 →
Function
Preservative
Editorial assessment
MODERATE
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
restricted
EU Max Conc.
0.5%
US US Status
restricted
US Notes
Washington State: banned effective January 1, 2027 (Aug 2025 rule, WAC 246-930). Often marketed as a natural or gentle preservative, but mechanism of action is formaldehyde release. CIR: safe at current use concentrations. No federal limit.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Sodium Hydroxymethylglycinate.
Calculate MoS for your specific formulation with the MoS Calculator.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Sodium Hydroxymethylglycinate across SCCS product categories, with measured dermal absorption where available.
Sensitization Profile
Contact sensitization data for Sodium Hydroxymethylglycinate based on clinical patch test studies and IFRA standards.
Sensitization Rate
moderate
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
1.0%
Cross-reactivity Group
formaldehyde-releaser-group
Reaction Type
contact-dermatitis
Source: FDA
Dermal Penetration Profile
Skin absorption and penetration characteristics of Sodium Hydroxymethylglycinate, relevant to systemic exposure and MoS calculations.
Absorption %
2-5%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
127.1 Da
Log P
-2.5
Systemic Absorption
minimal
Topical Bioavailability
1-3%
Safety Margin Factor
low
Vehicle Dependent
Yes — absorption varies by formulation
Source: SCCS Opinion
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Health HazardHarmful / Irritant
Hazard Class and Category
Carc. 1B; Muta. 2; Acute Tox. 4; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
Hazard Statements
- H350 May cause cancer
- H341 Suspected of causing genetic defects
- H332 Harmful if inhaled
- H302 Harmful if swallowed
- H335 May cause respiratory irritation
- H315 Causes skin irritation
- H319 Causes serious eye irritation
- H317 May cause an allergic skin reaction
Specific Concentration Limits / M-factors
inhalation: ATE = 3.0 mg/L dusts or mists; oral: ATE = 1100.0 mg/kg bw
Inserted via ATP: ATP15
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 1669
(EU) 2021/1902
Annex V — Permitted Preservatives
Max: 0.5%
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.
KR Korea MFDS Annex 2 (Restricted)
Category: Preservative. Max: 0.5%. —
SA Saudi SFDA (II - Prohibited)
BRIN Brazil/India Cosmetics
Brazil: Permitted Preservative · max 0,5%
India: Prohibited (GNRAS)
India: Permitted Preservative · max 0.005
Additional Jurisdictional Restrictions (5)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | permitted_preservative | 0.5 | Rinse-off products |
| IN | permitted_preservative | 0.5 | all cosmetics |
| BR | permitted_preservative | 0.5 | - |
| UK | banned | - | - |
| ASEAN | permitted_preservative | 0.5% | All products |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Preservative
Softener and conditioner
Regulatory List Membership (2)
EU Regulated in Personal Care
EU CosIng Cosmetics Ingredient Database
Editorial summary
Preliminary editorial summary for Sodium Hydroxymethylglycinate — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
formaldehyde-releaser
iarc-group-1-related
contact-allergen
preservative
washington-state-ban-2027
eu-restricted
annex-v
federal-ban-pending
misleading-natural-label
eu_cosing_listed
Known Synonyms
Glycine, N-(hydroxymethyl)-, sodium salt (1:1)
Sodium (hydroxymethyl)glycinate
N-(Hydroxymethyl)glycine, monosodium salt
Glycine, N-(hydroxymethyl)-, monosodium salt
EINECS 274-357-8
Sodium hydroxymethylamino acetate
Hydroxymethylglycine, sodium salt
UNII-DIG6BWZ9XT
Chemical Function
Preservative
Softener and conditioner
Biocide
Regulatory Lists
inert_ingredient; non_food_use; Pesticides
Europe; Personal care
Europe; Personal care
Canada; Personal care; Substances in PCP - Canada (4/2014)
Europe; Personal care
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
Europe; Personal care - body hygiene - hand soap
Europe; Personal care
active_ingredient; Europe; Pesticides
Australian Status
AICIS status: listed
Frequently Asked Questions
Is Sodium Hydroxymethylglycinate allowed in the EU?
Sodium Hydroxymethylglycinate EU regulatory status: restricted. Maximum allowed concentration: 0.5%. This is based on EU Regulation 1223/2009 and its amendments.
What does Sodium Hydroxymethylglycinate do in cosmetics?
Sodium Hydroxymethylglycinate functions as: Preservative. It is classified as a Preservative in our database. CAS number: 70161-44-3.
Is Sodium Hydroxymethylglycinate used outside cosmetics?
Sodium Hydroxymethylglycinate also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Sodium Hydroxymethylglycinate compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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