Is PEG-100 Stearate safe in cosmetics?
PEG-100 Stearate has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted.
PEG-100 Stearate
Also known as: Poly(oxy-1,2-ethanediyl), .alpha.-(1-oxooctadecyl)-.omega.-hydroxy-, Cremophor A, Crill 20,21,22,23, Emcol H 35-A, Empilan CP-100 (+15 more)
INCI: PEG-100 STEARATE
PEG-100 Stearate (CAS 9004-99-3) is a cosmetic emulsifier functioning as emulsifier. EU Regulation 1223/2009 status: permitted, max 25%. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in food safety data.
Function
emulsifier
Editorial assessment
GOOD
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
permitted
EU Max Conc.
25%
US US Status
permitted
US Notes
cosmetic ingredient
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for PEG-100 Stearate.
Calculate MoS for your specific formulation with the MoS Calculator.
Dermal Penetration Profile
Skin absorption and penetration characteristics of PEG-100 Stearate, relevant to systemic exposure and MoS calculations.
Absorption %
1-3%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
4670 Da
Log P
5.2
Systemic Absorption
minimal
Topical Bioavailability
0.5-2%
Safety Margin Factor
low
Vehicle Dependent
Yes — absorption varies by formulation
Source: CIR Expert Panel
EPA ToxValDB — Toxicity Values
5 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | >10680 mg/kg | Rabbit | oral | - | ChemIDplus |
| LD50 | >13350 mg/kg | Rabbit | oral | - | ChemIDplus |
| LD50 | =47170 mg/kg | Rat | oral | - | ChemIDplus |
| LD50 | =57850 mg/kg | Rat | oral | - | ChemIDplus |
| LD50 | >20000 mg/kg | Rat | oral | - | ChemIDplus |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Face Cream | 1–3 | 10 | CIR Safety Assessment |
| Body Lotion | 1–3 | 10 | CIR Safety Assessment |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-static agent
Cleaning agent
Defoamer
Dispersing agent
Emulsifier
Fragrance
Humectant
Lubricating agent
Solvent
Surfactant (surface active agent)
Regulatory List Membership (6)
EU Regulated in Personal Care
EU Restricted for Children (Cosmetics)
IFRA Fragrance Transparency List
EPA Safer Chemical Ingredients List (SCIL)
FDA Substances Added to Food (EAFUS)
FDA Indirect Food Contact Additives
Editorial summary
Preliminary editorial summary for PEG-100 Stearate — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
peg-derived
not-cosmos-eligible
potential-14-dioxane-trace
eu_children_restricted
epa_safer_alternative
ifra_fragrance
fda_food_additive
Known Synonyms
Poly(oxy-1,2-ethanediyl), .alpha.-(1-oxooctadecyl)-.omega.-hydroxy-
Cremophor A
Crill 20,21,22,23
Emcol H 35-A
Empilan CP-100
Empilan CQ-100
Emulphor VT-650
Emunon 3115
Glycol polyethylene monostearate #200
Glycol, polyethylene monostearate #6000
Ionet MS-1000
Kessco X-211
Lipal 400-S
Lipo-Peg 4-S
Nikkol MYS-25
Nissan Nonion S-2
NSC 31811
alpha-(1-Oxooctadecyl)-omega-hydroxypoly(oxy-1,2-ethanediyl)
PEG-150 stearate
PEG-40 stearate
Chemical Function
Solvent
Surfactant (surface active agent)
Cleaning agent
Regulatory Lists
children; Europe; Personal care
children; Europe; Personal care - general moisturizing - hand/body lotion
Europe; Personal care
Europe; Personal care
Europe; Personal care
Canada; pharmaceutical
CEDI
Indirect additives food contact (10/2018)
children; Europe; Personal care
children; Europe; Personal care - general moisturizing - hand/body lotion
IFRA Transparency
active_ingredient; Pesticides
SCIL (9/2019)
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
inert_ingredient; Pesticides
inert_ingredient; non_food_use; Pesticides
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in food safety data.
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Polyoxyethylene (40) stearate
E Number
E431
ADI
0-25 mg/kg bw mg/kg bw
Food Category
emulsifier
Frequently Asked Questions
Is PEG-100 Stearate allowed in the EU?
PEG-100 Stearate EU regulatory status: permitted. Maximum allowed concentration: 25%. This is based on EU Regulation 1223/2009 and its amendments.
What does PEG-100 Stearate do in cosmetics?
PEG-100 Stearate functions as: emulsifier. It is classified as a Emulsifier in our database. CAS number: 9004-99-3.
Is PEG-100 Stearate used outside cosmetics?
PEG-100 Stearate also appears in food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check PEG-100 Stearate 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
Compare limits across jurisdictions
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