Is Gemfibrozil safe in cosmetics?
Gemfibrozil has a safety rating of "POOR" in our database. EU status: prohibited. US status: prohibited.
Poor
Cosmetic Ingredient
Gemfibrozil
Also known as: 2,2-Dimethyl-5-(2,5-dimethylphenoxy)pentanoic acid, 5-[(2,5-Dimethylphenyl)oxy]-2,2-dimethylpentanoic acid, Genlip, Lipur, Lopid (+14 more)
INCI: GEMFIBROZIL
Gemfibrozil (CAS 25812-30-0) is a cosmetic cosmetic ingredient functioning as Pharmaceutical lipid-lowering agent (fibrate); not a conventional cosmetic. EU Regulation 1223/2009 status: prohibited. 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 25812-30-0 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Gemfibrozil is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H351, H361, H411, H301, H317, H318, H360D).
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Pharmaceutical lipid-lowering agent (fibrate); not a conventional cosmetic functional ingredient
Safety Rating
POOR
Chemistry & Identifiers
IUPAC Name
5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid
InChIKey
HEMJJKBWTPKOJG-UHFFFAOYSA-N
Regulatory Status
EU EU Status
prohibited
US US Status
prohibited
US Notes
Prohibited in cosmetics — FDA classifies it as a drug (NDA-approved); inclusion in a cosmetic renders the product a drug under FD&C Act §201(g)
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Gemfibrozil.
Calculate MoS for your specific formulation with the MoS Calculator.
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
3
Volume
66
Evaluation Year
1996
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Intermediate
Tonnage Band
Intermediate use only
Substance Type
SUBSTANCE
SVHC Candidate
No
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (2)
Carcinogen Classification
3, not classifiable as to its carcinogenicity to humans. (L135)
Source: Toxin and Toxin Target Database (T3DB)
Carcinogen Classification
Gemfibrozil | Group 3: Not classifiable as to its carcinogenicity to humans | Volume 66: (1996) Some Pharmaceutical Drugs
Source: International Agency for Research on Cancer (IARC)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
No specific technical function
Pharmaceutical
Regulatory List Membership (1)
California Proposition 65 (OEHHA)
Expert Verdict
Expert safety assessment and concern-level summary for Gemfibrozil.
Regulatory Flags
prop65
Known Synonyms
2,2-Dimethyl-5-(2,5-dimethylphenoxy)pentanoic acid
5-[(2,5-Dimethylphenyl)oxy]-2,2-dimethylpentanoic acid
Genlip
Lipur
Lopid
BRN 1881200
EINECS 247-280-2
Apo-Gemfibrozil
Bolutol
Cholespid
Clearol
Elmogan
Fetinor
Fibratol
Fibrocit
Gemfibril
Gemfibromax
Gemlipid
Gemnpid
Chemical Function
Pharmaceutical
No specific technical function
Regulatory Lists
detected; MN Chemical Screening; surface_water
pharmaceutical
OEHHA Proposition 65 (3/2019)
detected; drinking_water
detected; drinking_water
detected; pharmaceutical; wastewater
detected; pharmaceutical; soil
detected; pharmaceutical; wastewater
detected; drinking_water; pharmaceutical
detected; MN Chemical Screening; pharmaceutical; surface_water
detected; MN Chemical Screening; surface_water
detected; MN Chemical Screening; pharmaceutical; surface_water
detected; MN Chemical Screening; surface_water
detected; MN Chemical Screening; surface_water
detected; MN Chemical Screening; surface_water
detected; drinking_water; MN Chemical Screening
Canada; pharmaceutical
OEHHA Proposition 65 (1/2023)
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
GEMFIBROZIL
ChEMBL ID
CHEMBL457
Max Phase
4
Adverse Event Associations
442
Frequently Asked Questions
Is Gemfibrozil allowed in the EU?
Gemfibrozil EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does Gemfibrozil do in cosmetics?
Gemfibrozil functions as: Pharmaceutical lipid-lowering agent (fibrate); not a conventional cosmetic functional ingredient. It is classified as a cosmetic ingredient in our database. CAS number: 25812-30-0.
Is Gemfibrozil used outside cosmetics?
Gemfibrozil 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.
Does Gemfibrozil have different safety status in cosmetics vs industrial chemicals?
Gemfibrozil is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H351, H361, H411, H301, H317, H318, H360D).
Compliance Tools
Check Gemfibrozil 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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GERMINATED CARTHAMUS TINCTORIUS SEED/PLANTAGO ASIATICA SEED/NELUMBO NUCIFERA SEED/PSORALEA CORYLIFOLIA SEED/ALLIUM TUBEROSUM SEED/BRASSICA CAMPESTRIS SEED/ZIZYPHUS JUJUBA FRUIT/ASTRAGALUS MEMBRANACEUS ROOT/PLATYCODON GRANDIFLORUM ROOT/POLYGONUM MULTIFLORUM/ANGELICA GIGAS/VELVET/PORIA COCOS/LYCIUM CHINENSE FRUIT/PANAX GINSENG ROOT/EUCOMMIA ULMOIDES BARK/TRIBULUS TERRESTRIS FRUIT/POLYGALA TENUIFOLIA ROOT/DENDROBIUM NOBILE/ACHYRANTHES JAPONICA/EPIMEDIUM KOREANUM/REHMANNIA GLUTINOSA ROOT/CORNUS OFFICINALIS FRUIT/RUBUS COREANUS FRUIT/MORINDA CITRIFOLIA/ALPINIA OXYPHYLLA SEED EXTRACT
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