Good Fragrance NOAEL Data GHS Classified Sensitization Data

Vanillin

INCI: VANILLIN

CAS Number
121-33-5
Function
Fragrance ingredient; nature-identical aromatic aldehyde. Primary aromatic compound of natural vanilla produced synthetically from guaiacol (petrochemical route), lignin (paper industry byproduct), or ferulic acid (biotransformation from rice bran). Molecularly identical to vanilla-derived vanillin. Antioxidant secondary activity. Wide cosmetic use as fragrance, flavoring in oral care, and masking agent.
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. Labelling threshold: 10 ppm (leave-on) / 100 ppm (rinse-off) per EU Regulation 2023/1545. No concentration restriction in cosmetics.
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted without restriction. GRAS for food use (21 CFR). No US cosmetic concentration cap. Guaiacol/petrochemical route ISO 16128 NI=0; partial NI for lignin-derived or ferulic acid biotransformation routes.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
moderate
Sensitization
moderate

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Vanillin. 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 1000 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 437 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 100 mg/kg bw/day oral dog Chronic COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Chronic COSMOS_DB
dose_tested 1000 mg/kg bw/day oral rat Chronic COSMOS_DB
dose_tested 437 mg/kg bw/day oral rat Chronic COSMOS_DB
dose_tested 100 mg/kg bw/day oral dog Chronic COSMOS_DB
dose_tested 500 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 10000 ppm oral rat oral REACH
NOAEL 10000 ppm oral rat oral REACH

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Signal Word
WARNING
Hazard Statements
May be harmful if swallowed Harmful to aquatic life

Sensitization Profile

Contact sensitization data for Vanillin based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
fragrance
EU Allergen Listed
yes
Patch Test Positive Rate
0.3%
Cross-reactivity Group
balsam-of-peru-group
Reaction Type
contact-dermatitis
IFRA Restricted

Source: EU 2023/1545; SCCS/1459/11

Expert Verdict

Vanillin (nature-identical synthetic) is the dominant commercial form of vanilla fragrance. Molecularly identical to natural vanilla-derived vanillin with the same allergen profile. EU Regulation 2023/1545 mandates labelling above 10 ppm (leave-on) or 100 ppm (rinse-off). Lignin-derived and ferulic acid routes offer improved natural origin credentials without molecular difference.

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Concern Level: Low

Regulatory Flags

fragrance nature-identical eu-allergen labelling-required regulation-2023-1545 antioxidant sensitizer-risk epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Vanillin safe in cosmetics?

Vanillin (nature-identical synthetic) is the dominant commercial form of vanilla fragrance. Molecularly identical to natural vanilla-derived vanillin with the same allergen profile. EU Regulation 2023/1545 mandates labelling above 10 ppm (leave-on) or 100 ppm (rinse-off). Lignin-derived and ferulic acid routes offer improved natural origin credentials without molecular difference. The EU classifies Vanillin as "restricted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Vanillin allowed in the EU?

Vanillin EU regulatory status: restricted. Maximum allowed concentration: Labelling threshold: 10 ppm (leave-on) / 100 ppm (rinse-off) per EU Regulation 2023/1545. No concentration restriction in cosmetics.. This is based on EU Regulation 1223/2009 and its amendments.

What does Vanillin do in cosmetics?

Vanillin functions as: Fragrance ingredient; nature-identical aromatic aldehyde. Primary aromatic compound of natural vanilla produced synthetically from guaiacol (petrochemical route), lignin (paper industry byproduct), or ferulic acid (biotransformation from rice bran). Molecularly identical to vanilla-derived vanillin. Antioxidant secondary activity. Wide cosmetic use as fragrance, flavoring in oral care, and masking agent.. It is classified as a Fragrance in our database. CAS number: 121-33-5.

What is the Margin of Safety for Vanillin?

adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for Vanillin?

The NOAEL (No Observed Adverse Effect Level) for Vanillin is 1000 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Is Vanillin classified as hazardous under GHS?

Vanillin carries a GHS signal word of "WARNING". Hazard statements: May be harmful if swallowed Harmful to aquatic life. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance โ€” at cosmetic use concentrations, hazard thresholds may not be met.

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