safrole
safrole

Safrole

Common names: Allylcatechol methylene ether, Shikimol, Sassafras, Safrol.
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KIDSADVISORY SAFETY RATING
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Risky
Published by Jordana Tobelem, RD, LDN — Last Updated on Apr 16, 2025
Medically reviewed by Dr. William Lin, MD
Safrole is a naturally occurring compound found in various plants, notably in the sassafras tree (Sassafras albidum), where it constitutes about 80% of the essential oil. Historically, safrole was utilized as a flavoring agent in foods and beverages, such as root beer and sassafras tea, due to its distinct aroma and taste.[1] Safrole has been discontinued in the food industry due to health concerns, particularly its potential carcinogenic effects.[2]
Research has indicated that safrole can induce liver tumors in animal studies, leading to its classification as a potential carcinogen.[2] Consequently, regulatory agencies like the U.S. Food and Drug Administration have prohibited the use of safrole as a food additive to mitigate potential health risks.[1] Despite its ban in food products, safrole is still utilized in other industries, including the manufacture of certain fragrances and insecticides.[2]

Safety Overview

Regulatory Bodies

FDA (US)
The FDA has prohibited the use of safrole as a food additive, citing its carcinogenic potential in animal studies. Consequently, safrole and sassafras oil containing safrole are banned from use in human food products in the United States.[1]
Health Canada
Health Canada has identified safrole as a prohibited substance in food, aligning with international assessments of its carcinogenic potential. The use of safrole-containing substances in food products is not allowed in Canada.[3]
EFSA (Europe)
EFSA considers safrole to be genotoxic and carcinogenic. Its use as a flavoring agent in food products is not permitted within the European Union.[4]
WHO (World Health Organization)
The WHO’s International Agency for Research on Cancer (IARC) has classified safrole as possibly carcinogenic to humans (Group 2B), based on sufficient evidence of its carcinogenicity in experimental animals.[5] Regulatory agencies worldwide have banned safrole due to its carcinogenic potential, particularly after animal studies showed its link to liver cancer.

FDA GRAS

U.S. Food and Drug Administration – Generally Recognized as Safe (GRAS)
Current Status
Not Classified

EWG Rating

Environmental Working Group
EWG Rating: None
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More about Safrole

  • Beverages: Root beer, sassafras tea, certain herbal teas.
  • Confectionery: Candies flavored with sassafras, traditional chewing gums, old-fashioned lozenges.
  • Baked Goods: Sassafras-flavored cookies, spiced cakes, herbal breads.

Historical Use
Safrole, a major component of sassafras oil, was historically utilized as a flavoring agent in products like root beer and sassafras tea.[2] Its pleasant aroma and taste made it a popular additive in various foods and beverages.[6] However, in 1960, the U.S. Food and Drug Administration banned its use as a food additive due to evidence of its carcinogenicity in animal studies.[7]
Current Exposure
Today, consumer exposure to safrole is significantly reduced due to regulatory bans on its use in food products.[7] However, trace amounts of safrole can still be found naturally in certain spices, such as nutmeg, cinnamon, and black pepper, as well as in some essential oils.[5] Caution is advised when using spices or products containing safrole or related compounds.

Carcinogenicity
Safrole has been shown to cause liver tumors in rodents, leading to its classification as "reasonably anticipated to be a human carcinogen" by the National Toxicology Program.[2]
Genotoxicity
Studies have indicated that safrole can form DNA adducts, which may contribute to mutations and cancer development.[8]
Hepatotoxicity
Exposure to safrole has been associated with liver damage, including hepatocellular carcinoma, in animal studies.[9]
Neurotoxicity
Research suggests that safrole and its metabolites may induce neuronal apoptosis, potentially affecting the central nervous system.[10]

Toxicological Studies
In a 13-week study, F344 gpt delta rats were administered diets containing 0.1% and 0.5% safrole, with the higher dose equating to approximately 500 mg/kg body weight per day.[11] Results indicated significant hepatotoxicity, including increased liver weights and elevated liver enzymes, as well as renal toxicity in male rats.[11]
Long-Term Safety
Chronic exposure to safrole has been linked to hepatocarcinogenic effects in rodents, with studies showing liver tumor formation at doses as low as 1,000 mg/kg body weight per day over extended periods.[12] These findings have raised concerns regarding the long-term safety of safrole consumption in humans.[12]

High-Risk Groups
Individuals who chew betel nut or areca quid, practices common in Southern and Southeastern Asia, are at increased risk of exposure to safrole, as these substances can contain high concentrations of safrole. This exposure has been linked to a higher incidence of oral, esophageal, and liver cancers in these populations.[13] Individuals with pre-existing liver conditions may be more susceptible to safrole-induced hepatotoxicity, as safrole has been shown to cause liver damage in animal studies.[14]
Health Impacts
Epidemiological studies have indicated that individuals engaging in betel nut or areca quid chewing, which involves significant safrole exposure, exhibit an increased incidence of oral, esophageal, and hepatocellular cancers. This is attributed to the carcinogenic properties of safrole and its metabolites.[15] Safrole exposure also poses increased cancer risks, particularly for vulnerable populations such as pregnant women, where it has been shown to cross the placenta in animal studies.[14]

Recommended Intake
Due to its carcinogenic potential, safrole has been banned as a food additive in the United States since 1960. Consequently, there is no established acceptable daily intake (ADI) for safrole, and its consumption is not recommended.[2]

General Safety Level
Safrole, a natural component found in certain essential oils, has been identified as genotoxic and carcinogenic, leading to its ban as a food additive in many countries. Consequently, its use in consumer products has significantly declined.[2]
Sensitive Individuals
While safrole is primarily recognized for its carcinogenic properties, there is limited evidence regarding its potential to cause allergic reactions. However, individuals with existing sensitivities to fragrance compounds may exhibit allergic responses upon exposure to safrole-containing products.[16]

FAQ

What is safrole?

Safrole is a naturally occurring organic compound found in sassafras and certain spices, historically used for flavoring but now restricted due to health concerns.

How much safrole is in sassafras?

Sassafras root bark contains about 6-9% safrole by weight, though exact amounts vary depending on the plant.

Why is safrole banned?

Safrole is banned in food products due to its potential carcinogenic properties and its use in illicit drug synthesis.

References

  1. US Food and Drug Administration FDA n.d. Code of Federal Regulations Title 21: Safrole Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=189.180 ↩︎
  2. National Toxicology Program NTP 2021 Safrole - 15th Report on Carcinogens National Institutes of Health Available at: https://www.ncbi.nlm.nih.gov/books/NBK590823/ ↩︎
  3. Health Canada 2012 List of Contaminants and Other Adulterating Substances in Foods Health Canada Available at: https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/chemical-contaminants/contaminants-adulterating-substances-foods.html ↩︎
  4. European Commission 2002 Opinion of the Scientific Committee on Food on the safety of the presence of safrole in flavourings and other food ingredients with flavouring properties EC Health & Consumer Protection Directorate-General Available at: https://ec.europa.eu/food/system/files/2020-12/sci-com_scf_out140_en.pdf ↩︎
  5. International Agency for Research on Cancer IARC 1976 IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans Some Naturally Occurring Substances World Health Organization 10 231-244 Available at: https://publications.iarc.fr/_publications/media/download/2931/d7a4e802483b1374482768a36a7c78e1b33aa1c8.pdf ↩︎
  6. Opdyke DLJ 1974 Monographs on fragrance raw materials Safrole Food and Cosmetics Toxicology 12(1) 107-110 Available at: https://api.pageplace.de/preview/DT0400.9781483147970_A23873426/preview-9781483147970_A23873426.pdf ↩︎
  7. Benedetti M Malnoe A Broillet A 1977 Absorption metabolism and excretion of safrole in the rat and man Toxicology 7(1) 69-83 Available at: https://www.sciencedirect.com/science/article/abs/pii/0300483X77900397 ↩︎
  8. Chen CL Reddy MV Randerath K 1999 Safrole-DNA adducts in oral tissue from oral cancer patients with a habit of betel quid chewing Carcinogenesis 20(12) 2331-2334 Available at: https://academic.oup.com/carcin/article/20/12/2331/2529859 ↩︎
  9. Liu TY Chen CC Chen CL Chi CW 1999 Safrole-induced oxidative damage in the liver of Sprague-Dawley rats Food and Chemical Toxicology 37(7) 697-702 Available at: https://pubmed.ncbi.nlm.nih.gov/10496370/ ↩︎
  10. Su L Zhao B Lu X Wang N Zhao J 2007 Safrole oxide induces neuronal apoptosis through inhibition of integrin u03b24/SOD activity and elevation of ROS/NADPH oxidase activity Life Sciences 80(11) 999-1006 Available at: https://pubmed.ncbi.nlm.nih.gov/17188719/ ↩︎
  11. Jin M Kijima A Suzuki Y Hibi D Inoue T Ishii Y Nohmi T Nishikawa A Ogawa K Umemura T 2011 Comprehensive toxicity study of safrole using a medium-term animal model with gpt delta rats Toxicology 290(2-3) 312-321 Available at: https://pubmed.ncbi.nlm.nih.gov/22024337/ ↩︎
  12. US Environmental Protection Agency EPA 1980 Safrole Estragole and Related Compounds Carcinogenicity and Genetic Toxicology EPA 600/1-80-003 Available at: https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=91014TUN.TXT ↩︎
  13. Chang MC Ho YS Lee PH Chan CP Lee JJ Hahn LJ Jeng JH 2002 Areca nut extract and arecoline induced the cell cycle arrest but not apoptosis of cultured oral KB epithelial cells association of glutathione reactive oxygen species and mitochondrial membrane potential Carcinogenesis 22(9) 1527-1535 Available at: https://academic.oup.com/carcin/article-abstract/22/9/1527/2608158 ↩︎
  14. New Jersey Department of Health 2011 Safrole - Hazardous Substance Fact Sheet NJ.gov Available at: https://nj.gov/health/eoh/rtkweb/documents/fs/1642.pdf ↩︎
  15. Bode AM Dong Z 2014 Toxic phytochemicals and their potential risks for human cancer Cancer Prevention Research 8(1) 1-8 Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4289646/ ↩︎
  16. Scientific Committee on Consumer Safety 2012 Opinion on Fragrance Allergens in Cosmetic Products European Commission Available at: https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_102.pdf ↩︎

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