Is Subtilisin safe in cosmetics?
Subtilisin has a safety rating of "MODERATE" in our database. EU status: permitted. US status: restricted. 1 toxicological study endpoint(s) are available in our database.
Subtilisin
Also known as: EINECS 232-752-2, Subtilisin bpn', Subtilisin carlsburg, Subtilisin NOVO, Subtilopeptidase A (+5 more)
INCI: SUBTILISIN
Subtilisin (CAS 9014-01-1) is a cosmetic cosmetic ingredient functioning as Skin conditioning agent (serine protease enzyme from *Bacillus* spp.). NOAEL 572 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.
Cross-Vertical Regulatory Divergence
Subtilisin is classified GHS Danger (H302, H315, H318, H334, H335, H400, H411, H320) in the chemicals database but is allowed in EU cosmetics.
Source: Cosmetics: ingredients.eu status; Chemicals: ghs classifications.signal word/hazard statement code
Function
Skin conditioning agent (serine protease enzyme from *Bacillus* spp.)
Editorial assessment
MODERATE
Preliminary editorial note — not a computed safety verdict.
Chemistry & Identifiers
IUPAC Name
3-[(3R,6R,9S,16S,19R,22S,25S)-3,9-bis(2-amino-2-oxoethyl)-16-[(1R)-1-hydroxyethyl]-19-(hydroxymethyl)-6-[(4-hydroxyphenyl)methyl]-13-octyl-2,5,8,11,15,18,21,24-octaoxo-1,4,7,10,14,17,20,23-octazabicyclo[23.3.0]octacosan-22-yl]propanoic acid
InChIKey
VLKSXJAPRDAENT-OWGHDAAGSA-N
Regulatory Status
EU EU Status
permitted
US US Status
restricted
US Notes
Not specifically restricted; permitted under general cosmetic provisions
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Subtilisin.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
1 study endpoint found for Subtilisin. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | =572 mg/kg bw/day | oral | Rat | subchronic | ECHA |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Subtilisin across SCCS product categories, with measured dermal absorption where available.
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Harmful / IrritantCorrosiveHealth Hazard
Hazard Class and Category
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
Hazard Statements
- H335 May cause respiratory irritation
- H315 Causes skin irritation
- H318 Causes serious eye damage
- H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled
Inserted via ATP: CLP00
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (1)
Skin Eye Respiratory Irritation
An eye irritant.
Source: Hazardous Substances Data Bank (HSDB)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Chemical reaction regulator
Cleaning agent
Pharmaceutical
Softener and conditioner
Regulatory List Membership (1)
EPA Safer Chemical Ingredients List (SCIL)
Editorial summary
Preliminary editorial summary for Subtilisin — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
potential-allergen
epa_safer_alternative
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Subtilisin by CAS number or substance name.
Studies
1
Lowest NOAEL
572 mg/kg bw/day
Highest NOAEL
572 mg/kg bw/day
ECHA
Known Synonyms
EINECS 232-752-2
Subtilisin bpn'
Subtilisin carlsburg
Subtilisin NOVO
Subtilopeptidase A
Subtilopeptidase B
Subtilopeptidase C
Subtilopeptidase bpn'
Thermoase PC-10
UNII-0ZP13EBC5Y
Chemical Function
Cleaning agent
Chemical reaction regulator
Regulatory Lists
Canada; consumer_product; Substances in Products - Canada (4/2014)
inert_ingredient; non_food_use; Pesticides
Cleaning products and household care - laundry and fabric treatment - laundry detergent; Europe
Cleaning products and household care - dishwasher and dishes - automatic dishwashing detergent; Europe
SCIL (9/2019)
Australian Status
AICIS status: listed_with_terms
Specific information requirements: Obligations to provide information apply. These obligations are: 1. If the assessment report about the chemical recommends secondary notification of the chemical in particular circumstances and any of the circumstances occur in relation to the introduction (importation or manufacture) of the chemical by a person, then the...
Frequently Asked Questions
Is Subtilisin allowed in the EU?
Subtilisin EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Subtilisin do in cosmetics?
Subtilisin functions as: Skin conditioning agent (serine protease enzyme from *Bacillus* spp.). It is classified as a cosmetic ingredient in our database. CAS number: 9014-01-1.
What is the NOAEL for Subtilisin?
The NOAEL (No Observed Adverse Effect Level) for Subtilisin is =572 mg/kg bw/day based on a subchronic study via oral route in Rat. Source: ECHA.
Is Subtilisin used outside cosmetics?
Subtilisin also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Subtilisin have different safety status in cosmetics vs industrial chemicals?
Subtilisin is classified GHS Danger (H302, H315, H318, H334, H335, H400, H411, H320) in the chemicals database but is allowed in EU cosmetics.
Compliance Tools
Check Subtilisin compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
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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