Is Betaine safe in cosmetics?
Betaine has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Betaine
Also known as: 4-04-00-02369, BRN 3537113, (Carboxymethyl)trimethylammonium hydroxide, inner salt, EINECS 203-490-6, Jortaine (+15 more)
INCI: BETAINE
Betaine (CAS 107-43-7) is a cosmetic humectant functioning as Humectant, osmolyte, osmoprotectant; zwitterionic; stabilizes cellular protein. NOAEL 812 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted, max 8.7% (rinse-off). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 107-43-7 →
Auto-generated CPSR Part A draft with source citations
Function
Humectant, osmolyte, osmoprotectant; zwitterionic; stabilizes cellular protein structure under osmotic stress; non-tacky sensory profile; derived from sugar beet (Beta vulgaris) processing
Safety Rating
EXCELLENT
Regulatory Status
EU EU Status
permitted
EU Max Conc.
8.7% (rinse-off)
US US Status
permitted
US Notes
FDA GRAS as flavoring agent (FEMA 4223). No concentration limits for cosmetic use. FDA VCRP reports 459 product uses, primarily leave-on skin care. FDA-approved drug form (betaine hydrochloride) for homocystinuria treatment.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Betaine.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Betaine. 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 | =20 mg/kg/d | oral | rat | developmental toxicity | CIR_vision_codex |
| NOAEL | =20 mg/kg/d | oral | rat | developmental toxicity | CIR_vision_codex |
| NOAEL | =20 mg/kg/d | oral | rat | developmental toxicity | CIR_vision_codex |
| NOAEL | =20 mg/kg/d | oral | rat | developmental toxicity | CIR_vision_codex |
| NOAEL | =40 mg/kg/d | oral | rat | developmental toxicity | CIR_vision_codex |
| NOAEL | =40 mg/kg/d | oral | rat | developmental toxicity | CIR_vision_codex |
| NOAEL | =40 mg/kg/d | oral | rat | developmental toxicity | CIR_vision_codex |
| NOAEL | =40 mg/kg/d | oral | rat | developmental toxicity | CIR_vision_codex |
| NOAEL | =50 mg/kg bw/d | oral | rat | repeated dose toxicity | CIR_vision_codex |
| NOAEL | =50 mg/kg bw/d | oral | rat | repeated dose toxicity | CIR_vision_codex |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Betaine across SCCS product categories, with measured dermal absorption where available.
Dermal Penetration Profile
Skin absorption and penetration characteristics of Betaine, relevant to systemic exposure and MoS calculations.
Absorption %
3-6%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
117.1 Da
Log P
-2.5
Systemic Absorption
minimal
Topical Bioavailability
2-4%
Safety Margin Factor
low
Source: Cosmetic Science
EPA ToxValDB — Toxicity Values
6 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LEL | =4000 mg/day | Human | oral | chronic | EFSA |
| LEL | =4000 mg/day | Human | oral | subchronic | EFSA |
| LEL | =10000 mg/kg-day | Pig | oral | subchronic | EFSA |
| LEL | =10000 mg/kg-day | Pig | oral | subchronic | EFSA |
| LEL | =10000 mg/kg-day | Pig | oral | subchronic | EFSA |
| NOEL | <1 % | Rat | oral | - | HESS |
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
Additional Ingredient Properties
10 property records from structured ingredient metadata.
acne
{"cas_number": "107-43-7", "anti_acne_mechanism": "anti_inflammatory", "comedogenicity_rating_0_to_5": "0-1", "acne_type_efficacy": "inflammatory", "sebum_reduction_pct_clinical": "0-5", "prescription_required_usa": "No", "otc_drug_monograph_category": "No", "max_otc_concentration_pct": "No limit", "japan_quasi_drug_anti_acne": "No", "korea_functional_cosmetic_acne": "No", "eu_cosmetic_restriction…
amino_acid
{"cas_number": "107-43-7", "ingredient_class": "amino_acid", "source_origin": "plant", "molecular_weight_range_Da": "117", "amino_acid_composition_key": "trimethylglycine", "charge_at_pH_5_5": "zwitterionic", "water_solubility": "soluble", "oil_solubility": "insoluble", "film_forming_ability": "moderate", "moisture_binding_capacity": "excellent", "NMF_component": "yes", "skin_penetration_depth": "…
anti_aging
{"anti_aging_claim": "hydration-plumping, barrier-repair", "mechanism_of_action": "Building block for proteins, NMF component", "target_skin_layer": "epidermis", "collagen_stimulation": "Mild", "elastin_protection": "Mild", "wrinkle_reduction_pct": "8-15", "clinical_study_duration_weeks": "8", "sample_size": "25", "double_blind": "Yes", "placebo_controlled": "Yes", "published_journal": "Int J Cosm…
anti_pollution
{"cas_number": "107-43-7", "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_inhibitio…
baby_pediatric
{"cas_number": "107-43-7", "ingredient_class": "moisturizer_baby", "pediatric_safety_rating": "excellent", "minimum_age_months": "0", "neonatal_safe": "yes", "premature_infant_safe": "yes", "skin_barrier_maturity_consideration": "Trimethylglycine, osmolyte", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_weight_concern": "Humectan…
comedogenicity_detail
{"comedogenicity_rating": "0", "irritancy_rating": "0", "skin_type_suitability": "all,oily,dry,sensitive,combination,normal,acne-prone,rosacea", "acne_safe": "yes", "source": "Osmolyte humectant"}
concentration
{"min_concentration_pct": "1.0", "max_concentration_pct": "5.0", "typical_concentration_pct": "2.0", "product_type": "Cleanser", "function_at_concentration": "Hydration, mild", "source": "Supplier TDS"}
cost_pricing
{"cost_tier": "mid-range", "estimated_cost_per_kg_usd_low": "10", "estimated_cost_per_kg_usd_high": "20", "natural_premium_markup_pct": "0", "organic_certified_premium_pct": "0", "supply_chain_volatility": "low", "primary_source_region": "Europe/China", "bulk_discount_threshold_kg": "500", "seasonal_price_variation": "low", "commodity_or_specialty": "commodity", "substitute_ingredients": "Sodium P…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-static agent
Dispersing agent
Flavouring and nutrient
Humectant
Processing aids not otherwise specified
Softener and conditioner
Viscosity modifier
Wetting agent (non-aqueous)
Regulatory List Membership (4)
EU Regulated in Personal Care
EU Restricted for Children (Cosmetics)
EPA Safer Chemical Ingredients List (SCIL)
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Betaine.
Regulatory Flags
gras-fda
cosmos-approved
humectant
anti-irritant
eu-unrestricted
cir-approved
natural-origin
eu_children_restricted
epa_safer_alternative
fda_food_additive
jecfa_safe
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Betaine by CAS number or substance name.
Studies
28
Lowest NOAEL
20
Highest NOAEL
300
Units vary across source rows: mg/kg/d, mg/kg, mg/kg bw/d
CIR_vision_codex
Known Synonyms
4-04-00-02369
BRN 3537113
(Carboxymethyl)trimethylammonium hydroxide, inner salt
EINECS 203-490-6
Jortaine
NSC 166511
Glykokollbetain
UNII-3SCV180C9W
Acidin-Pepsin
Novobetaine
Hepastyl
(trimethylammoniumyl)acetate
1-Carboxy-N,N,N-trimethyl-Methanaminium
1-Carboxy-N,N,N-trimethyl-Methanaminium hydroxide
1-carboxy-N,N,N-trimethylmethanaminium inner salt
2-(trimethylazaniumyl)acetate
2-N,N,N-trimethylammonio acetate
2-trimethylammonioacetate
2-trimethylammonioethanoate
Bet
Chemical Function
Humectant
Anti-static agent
Softener and conditioner
Viscosity modifier
Regulatory Lists
pharmaceutical
active_ingredient; animal_products; Europe; pharmaceutical; residue
Europe; pharmaceutical
children; Europe; Personal care
children; Europe; Personal care - body hygiene - body wash
children; Europe; Personal care - hair styling and care - shampoo
Europe; Personal care
Europe; Personal care
Europe; Personal care
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
SCIL (9/2019)
Canada; pharmaceutical
Canada; pharmaceutical
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
GLYCINEBETAINE
ChEMBL ID
CHEMBL1182
Frequently Asked Questions
Is Betaine allowed in the EU?
Betaine EU regulatory status: permitted. Maximum allowed concentration: 8.7% (rinse-off). This is based on EU Regulation 1223/2009 and its amendments.
What does Betaine do in cosmetics?
Betaine functions as: Humectant, osmolyte, osmoprotectant; zwitterionic; stabilizes cellular protein structure under osmotic stress; non-tacky sensory profile; derived from sugar beet (Beta vulgaris) processing. It is classified as a Humectant in our database. CAS number: 107-43-7.
What is the NOAEL for Betaine?
The NOAEL (No Observed Adverse Effect Level) for Betaine is =20 mg/kg/d based on a developmental toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: CIR_vision_codex.
Is Betaine used outside cosmetics?
Betaine also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Betaine 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
Related Ingredients
Alanine
Excellent
Same category
skin conditioning, hair conditioning,...
Aspartic Acid
Excellent
Same category
antistatic, hair conditioning, skin c...
Erythritol
Excellent
Same category
Humectant; water activity reduction a...
Glycerin
Excellent
Same category
Humectant that attracts water from de...
L-Glutamic Acid
Excellent
Same category
Enzymatically converts to pyrrolidone...
Mannitol
Excellent
Same category
Anti-caking agent; Binder; Deodorizer...
1-Methylhydantoin-2-imide (Creatinine)
Excellent
Similar safety
Skin conditioning (skin brightening/l...
2,6-Dimethyl-7-octen-2-ol (Dihydromyrcenol)
Excellent
Similar safety
Fragrance (perfuming), masking
2-Ethoxy-2,6,6-Trimethyl-9-Methylenebicyclo[3.3.1]Nonane (Boisiris™)
Excellent
Similar safety
Fragrance (rich woody, orris/iris roo...
2-Hydroxypropylcarbamato Amodimethicone
Excellent
Similar safety
Hair conditioning; modified aminosili...
2-O-Ethyl Ascorbic Acid
Excellent
Similar safety
Softener and conditioner
3 O Ethyl Ascorbic Acid
Excellent
Similar safety
Antioxidant; tyrosinase inhibitor; me...
Acrolein
Poor
Chemical family
No approved cosmetic function — it is...
Beta-Alanine
Moderate
Chemical family
Skin conditioning, hair conditioning,...
Betaine
Excellent
Chemical family
Humectant, skin conditioning, anti-st...
Is Betaine in Your Products?
Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.
Try Piro Free →Analyze Your Full Ingredient List
Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Betaine in your formulation.