About
What it is and where it shows up.
Fennel seeds are the dried ripe fruits of Foeniculum vulgare Mill., widely used as an aromatic spice, flavouring agent, and herbal remedy across global cuisines and traditional medicine. They impart a characteristic anise-like flavour due to active constituents principally trans-anethole, fenchone, and estragole.
Safety summary
The regulatory and scientific consensus.
Fennel seeds are generally recognized as safe (GRAS) for ordinary culinary use by healthy adults and are approved as a standardized spice in all major jurisdictions. However, they naturally contain estragole, a compound identified by EFSA as genotoxic and carcinogenic, for which a safe level of dietary exposure could not be established in EFSA's 2025 draft assessment. Concentrated preparations such as herbal infusions and supplements pose particular concern for infants, young children, pregnant women, and breastfeeding women.
Regulatory landscape
What food-safety regulators have decided.
| Jurisdiction | Status | Note |
|---|---|---|
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Fennel (Saunf) whole and powder are standardized under FSSAI Food Safety and Standards Regulations 2010, Chapter 2.9 (Regulation 2.9.9). Product must be the dried ripe fruit of Foeniculum vulgare P. Miller Var. Vulgare, free from colouring matter and harmful substances. Also listed as a permitted nutraceutical ingredient (Foeniculum vulgare – fruit, leaf, oil/extract) under FSSAI Health Supplements Regulations 2016.source |
| FDA (Food and Drug Administration) (United States) | Approved | Fennel seed is listed as GRAS under 21 CFR 182.10 as a spice, natural seasoning, and flavouring. FDA CPG Sec 525.350 separately establishes adulteration thresholds (e.g., ≥3 mg mammalian excreta per pound) for regulatory seizure of contaminated fennel seed lots.source |
| EFSA (European Food Safety Authority) (European Union) | Under_review | EFSA's 2025 draft opinion (public consultation open until 17 September 2025) could not establish a safe level of estragole exposure from fennel seed preparations. EU Regulation (EC) No 1334/2008 prohibits the deliberate addition of estragole to foods and caps naturally present estragole from flavourings at 50 mg/kg in dairy, processed fruits/vegetables, nuts/seeds, and fish products, and 10 mg/kg in non-alcoholic beverages. Fennel seed used as a whole culinary spice remains permitted; concentrated preparations (infusions, supplements) are under active scrutiny. The European Commission requested this assessment following concerns raised by German authorities regarding fennel seed products intended for infants.source |
Who should approach with care
Whose guidance would steer them away.
Infants — EFSA's 2025 draft opinion specifically identified babies and breastfed infants as high-risk groups for estragole-related genotoxic and carcinogenic harm from fennel seed preparations; EMA similarly does not recommend fennel fruit infusions for children up to 4 years of age.
Children — EMA and EFSA both identify young children (up to age 4) as a vulnerable population for estragole toxicity from fennel seed infusions and concentrated preparations, with insufficient data to establish safe exposure thresholds.
Pregnancy — EFSA's draft 2025 opinion concluded that estragole exposure from fennel seed preparations poses a risk to fetuses when consumed by pregnant women, and EMA does not recommend fennel fruit preparations during pregnancy due to limited safety data.
Lactation — EFSA's 2025 draft opinion concluded that consumption of fennel seed preparations by lactating women may transfer estragole to breastfed infants, and EMA explicitly advises against fennel fruit preparations in breastfeeding women.
Research citations
The sources behind this verdict.
- 1FDA. CPG Sec 525.350 Fennel Seed – Adulteration by Mammalian Excreta; Insects. fda.gov
- 2EFSA. Have your say – estragole in fennel seed preparations (Draft Opinion public consultation), 2025. efsa.europa.eu
- 3EFSA. Preparatory work for the evaluation of the safety of preparations from the fruits of sweet and bitter fennel (Foeniculum vulgare Mill. and Foeniculum piperitum (Ucria) C.Presl), 2025. efsa.europa.eu
- 4PubMed. Can Estragole in Fennel Seed Decoctions Really Be Considered a Danger for Human Health? A Fennel Safety Update, 2012. pmc.ncbi.nlm.nih.gov
- 5FSSAI. Food Safety and Standards Regulations 2010 – Chapter 2.9: Salt, Spices, Condiments and Related Products (Regulation 2.9.9 – Fennel/Saunf), 2010. fssai.gov.in
Independently researched5 citations