Is Bromelain safe in cosmetics?
Bromelain has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted.
Moderate
Active Ingredient
Bromelain
INCI: BROMELAIN
Bromelain (CAS 9001-00-7) is a cosmetic active ingredient functioning as Proteolytic enzyme from Ananas comosus (pineapple). Hydrolyses keratin protein. EU Regulation 1223/2009 status: permitted. 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 9001-00-7 →
Auto-generated CPSR Part A draft with source citations
Function
Proteolytic enzyme from Ananas comosus (pineapple). Hydrolyses keratin protein bonds for controlled exfoliation with lower irritation than acid peels. Activity quantified in GDU/CDU units. Demonstrates effective proteolytic activity for stratum corneum removal. Formulation instability (pH- and temperature-dependent enzyme activity) remains a key technical challenge. EU CPSR compliance requires enzyme activity unit documentation and shelf-life stability data.
Safety Rating
MODERATE
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
CIR documented 2.3% sensitisation rate, higher than papain (0.8%). Formulation stability required. Contraindicated on compromised skin. Not appropriate for individuals with latex allergy due to documented cross-reactivity.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Bromelain.
Calculate MoS for your specific formulation with the MoS Calculator.
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Harmful / IrritantHealth Hazard
Hazard Class and Category
STOT SE 3; Skin Irrit. 2; Eye Irrit. 2; Resp. Sens. 1
Hazard Statements
- H335 May cause respiratory irritation
- H315 Causes skin irritation
- H319 Causes serious eye irritation
- H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled
Inserted via ATP: CLP00
Additional Ingredient Properties
8 property records from structured ingredient metadata.
acne
{"cas_number": "9001-00-7", "anti_acne_mechanism": "keratolytic/anti_inflammatory", "comedogenicity_rating_0_to_5": "0", "acne_type_efficacy": "non_inflammatory", "sebum_reduction_pct_clinical": "0-5", "keratolytic_strength": "mild", "exfoliation_mechanism": "enzymatic", "peel_depth": "superficial", "prescription_required_usa": "No", "otc_drug_monograph_category": "No", "max_otc_concentration_pct"…
anti_aging
{"anti_aging_claim": "cell-turnover, anti-inflammatory", "mechanism_of_action": "Enzymatic activity, targeted protein modification", "target_skin_layer": "epidermis, dermis", "collagen_stimulation": "Moderate", "elastin_protection": "Moderate", "wrinkle_reduction_pct": "8-15", "clinical_study_duration_weeks": "8", "sample_size": "25", "double_blind": "No", "placebo_controlled": "Yes", "published_j…
anti_pollution
{"cas_number": "9001-00-7", "ingredient_class": "other", "primary_mechanism": "barrier_reinforcement", "pollution_types_targeted": "PM2_5", "IR_A_protection": "no", "visible_light_protection": "no", "digital_screen_protection_claim": "no", "PAH_neutralization": "no", "ozone_protection": "no", "mitochondrial_protection": "no", "Nrf2_activation": "no", "AhR_pathway_modulation": "no", "NF_kB_inhibiti…
baby_pediatric
{"cas_number": "CAS-FUNC-37", "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…
depigmentation
{"cas_number": "9001-00-7", "ingredient_class": "keratinocyte_turnover_enhancer", "primary_mechanism_of_action": "Proteolytic enzyme providing gentle exfoliation and melanin dispersal", "secondary_mechanisms": "Variable", "molecular_target": "other", "tyrosinase_inhibition_IC50_uM": "varies", "tyrosinase_inhibition_type": "competitive", "melanin_reduction_pct_in_vitro": "25-45", "melanin_reduction…
exfoliant
{"cas_number": "9001-00-7", "ingredient_class": "enzymatic_exfoliant", "chemical_subclass": "proteolytic_enzyme/fruit_enzyme", "molecular_weight_Da": "33000", "pH_dependent_activity": "yes", "optimal_pH_range": "5.5-8.0", "penetration_depth": "stratum_corneum", "mechanism_of_action": "proteolysis", "target_bonds": "keratin_crosslinks", "onset_of_action": "minutes", "peak_effect_timeline": "4-8 wee…
self_tanning
{"cas_number": "9001-00-7", "ingredient_class": "tan_eraser", "tanning_mechanism": "other", "color_development_onset_hours": "0.0", "full_color_development_hours": "0", "color_duration_days": "0", "DHA_concentration_if_applicable_pct": "0", "erythrulose_concentration_pct": "0", "pH_dependent_color": "no", "formaldehyde_release_concern": "no", "formaldehyde_release_ppm": "0", "AGE_formation_concern…
skin_suitability
{"oily_skin": "acceptable", "dry_skin": "acceptable", "sensitive_skin": "caution", "combination_skin": "acceptable", "normal_skin": "acceptable", "acne_prone": "acceptable", "rosacea": "caution", "eczema": "caution", "hyperpigmentation": "acceptable", "aging_mature": "acceptable", "dehydrated": "caution", "skin_benefit_primary": "exfoliating", "skin_benefit_secondary": "anti-inflammatory", "mechan…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Chemical reaction regulator
Flavouring and nutrient
Pharmaceutical
Processing aids not otherwise specified
Softener and conditioner
Thickening agent
Regulatory List Membership (2)
EU Regulated in Personal Care
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Bromelain.
Regulatory Flags
sensitizer
latex-cross-reactivity
ige-mediated-allergy-risk
enzyme
not-for-compromised-skin
stability-critical
not-for-latex-allergic
higher-risk-than-papain
rinse-off-preferred
fda_food_additive
jecfa_safe
Chemical Function
Softener and conditioner
Pharmaceutical
Flavouring and nutrient
Processing aids not otherwise specified
Chemical reaction regulator
Thickening agent
Regulatory Lists
Europe; Personal care
Europe; Personal care
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
pharmaceutical
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA count match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Adverse Event Associations
102
Frequently Asked Questions
Is Bromelain allowed in the EU?
Bromelain EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Bromelain do in cosmetics?
Bromelain functions as: Proteolytic enzyme from Ananas comosus (pineapple). Hydrolyses keratin protein bonds for controlled exfoliation with lower irritation than acid peels. Activity quantified in GDU/CDU units. Demonstrates effective proteolytic activity for stratum corneum removal. Formulation instability (pH- and temperature-dependent enzyme activity) remains a key technical challenge. EU CPSR compliance requires enzyme activity unit documentation and shelf-life stability data.. It is classified as a Active Ingredient in our database. CAS number: 9001-00-7.
Is Bromelain used outside cosmetics?
Bromelain also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Bromelain 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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