Is Amylase safe in cosmetics?
Amylase has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Amylase
Also known as: EINECS 232-565-6, Pancreatic amylase, alpha Amylase, Amylase, alpha-, Amilosubtilin (+3 more)
INCI: AMYLASE
Amylase (CAS 9000-90-2) is a cosmetic cosmetic ingredient functioning as Skin conditioning (enzyme-based hydrolysis of starches). Reported NOAEL =240 mg/kg bw/day in Human; Rat (INCHEM_WHO_jecfa_jecmono_v1042je01); 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.
View industrial chemical safety profile for CAS 9000-90-2 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Amylase is classified GHS Danger (H334) 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 (enzyme-based hydrolysis of starches)
Safety Rating
GOOD
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Not restricted by FDA; widely used in personal care and industrial applications
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Amylase.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Amylase. 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 | =240 mg/kg bw/day | oral | Human; Rat | Subchronic toxicity | INCHEM_WHO_jecfa_jecmono_v1042je01 |
| NOAEL | =240 mg/kg bw/day | oral | Human; Rat | Subchronic toxicity | INCHEM_WHO_jecfa_jecmono_v1042je01 |
| NOAEL | =150 mg/kg bw/day | - | - | Toxicology study | INCHEM_WHO_jecfa_jecmono_v86je01 |
| NOAEL | =150 mg/kg bw/day | - | - | Toxicology study | INCHEM_WHO_jecfa_jecmono_v86je01 |
| NOAEL | =226 mg/kg bw/day | oral | - | Toxicology study | INCHEM_WHO_jecfa_jecmono_v86je01 |
| NOAEL | =226 mg/kg bw/day | oral | - | Toxicology study | INCHEM_WHO_jecfa_jecmono_v86je01 |
| NOAEL | =240 mg/kg bw/day | oral | Rat | Subchronic toxicity | INCHEM_WHO_jecfa_jecmono_v86je01 |
| NOAEL | =240 mg/kg bw/day | oral | Rat | Subchronic toxicity | INCHEM_WHO_jecfa_jecmono_v86je01 |
| NOAEL | =300 mg/kg bw/day | oral | - | Developmental toxicity | INCHEM_WHO_jecfa_jecmono_v86je01 |
| NOAEL | =300 mg/kg bw/day | oral | - | Developmental toxicity | INCHEM_WHO_jecfa_jecmono_v86je01 |
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Health Hazard
Hazard Class and Category
Resp. Sens. 1
Hazard Statements
- 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)
Additional Ingredient Properties
1 property record from structured ingredient metadata.
baby_pediatric
{"cas_number": "CAS-FUNC-40", "ingredient_class": "other", "pediatric_safety_rating": "good", "minimum_age_months": "3", "neonatal_safe": "no", "premature_infant_safe": "insufficient_data", "skin_barrier_maturity_consideration": "Functional ingredient - generally safe", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_weight_concern…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Chemical reaction regulator
Cleaning agent
Stabilizing agent
Regulatory List Membership (1)
EPA Safer Chemical Ingredients List (SCIL)
Expert Verdict
Expert safety assessment and concern-level summary for Amylase.
Regulatory Flags
potential-allergen
epa_safer_alternative
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Amylase by CAS number or substance name.
Studies
19
Lowest NOAEL
150 mg/kg bw/day
Highest NOAEL
1500 mg/kg bw/day
ToxValDB_ECHA_IUCLID
INCHEM_WHO_jecfa_jecmono_v1042je01
INCHEM_WHO_jecfa_jecmono_v86je01
Known Synonyms
EINECS 232-565-6
Pancreatic amylase
alpha Amylase
Amylase, alpha-
Amilosubtilin
1,4-alpha-D-Glucanase
1,4-alpha-D-Glucan glucanohydrolase
Attenuzyme Flex
Chemical Function
Cleaning agent
Chemical reaction regulator
Regulatory Lists
SCIL (9/2019)
Cleaning products and household care - dishwasher and dishes - automatic dishwashing detergent; Europe
inert_ingredient; non_food_use; Pesticides
Australian Status
AICIS status: listed
Frequently Asked Questions
Is Amylase allowed in the EU?
Amylase EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Amylase do in cosmetics?
Amylase functions as: Skin conditioning (enzyme-based hydrolysis of starches). It is classified as a cosmetic ingredient in our database. CAS number: 9000-90-2.
What is the NOAEL for Amylase?
The NOAEL (No Observed Adverse Effect Level) for Amylase is =240 mg/kg bw/day based on a Subchronic toxicity study via oral route in Human; Rat. A total of 10 study endpoints are available. Source: INCHEM_WHO_jecfa_jecmono_v1042je01.
Is Amylase used outside cosmetics?
Amylase also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Amylase have different safety status in cosmetics vs industrial chemicals?
Amylase is classified GHS Danger (H334) in the chemicals database but is allowed in EU cosmetics.
Compliance Tools
Check Amylase 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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