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Pyrrolizidine Alkaloids in Herbal Teas: Why the EU Set Some of the World's Strictest Limits

Written by SGS Digicomply Editorial Team | Nov 30, 2025 1:59:59 PM

Herbal teas market themselves as natural, wellness-focused alternatives to traditional beverages. Yet brewing a cup of chamomile or peppermint might expose you to pyrrolizidine alkaloids—a class of naturally occurring toxins that can damage the liver, alter DNA, and potentially cause cancer. Since July 2022, the European Union has enforced maximum limits on these compounds in teas, herbs, and supplements. For manufacturers, distributors, and quality teams, understanding these limits isn't optional—it's a compliance obligation with serious enforcement behind it.

A complete and filterable database with global regulations on pyrrolizidine alkaloids—including maximum levels, analytical requirements, and product-specific rules—is available to SGS Digicomply users. Feel free to explore the Global Ingredient Monitor demo and try this tool in action.

What Are Pyrrolizidine Alkaloids?

Pyrrolizidine alkaloids (PAs) are toxic compounds produced by over 6,000 plant species as defense mechanisms against herbivores. Species like Senecio, Heliotropium, Symphytum (comfrey), and Borago (borage) are the primary culprits. These plants grow as weeds in agricultural fields and contaminate crops during harvest. Just three to four toxic plants per hectare can contaminate up to 1,000 kg of product.

How PAs Enter Food

PAs don't belong in food—they enter through accidental cross-contamination during cultivation and harvesting. Herbal teas are particularly vulnerable because herbs are often grown in open fields where PA-producing weeds thrive. During mechanical harvesting, these weeds get collected alongside the intended crop.

Beyond teas, PAs appear in honey (via contaminated pollen), leafy greens, spices like cumin, food supplements, and even pseudocereals. Products marketed as health foods are frequently the highest risk.

The Health Risk

Pyrrolizidine alkaloids are hepatotoxic, genotoxic, and carcinogenic. Once ingested, they're metabolized in the liver into reactive compounds that bind to DNA and proteins, causing cellular damage. Acute poisoning can trigger veno-occlusive disease—blocked blood flow from the liver, potentially causing liver failure. Chronic low-level exposure raises cancer risk.

In 2017, EFSA concluded that PA exposure through tea, herbal infusions, and supplements poses a long-term health concern, especially for frequent consumers. EFSA identified no safe threshold. For infants, children, and pregnant women, the risk is amplified.

EU Maximum Levels: The Framework

Commission Regulation (EU) 2020/2040, now part of Regulation (EU) 2023/915, set maximum PA levels effective July 1, 2022. The EU regulates the sum of 21 specific pyrrolizidine alkaloids plus 14 additional isomers that co-elute during analysis.

Key limits:

  • Herbal infusions (dried) for infants and young children: 75 µg/kg (dried), 1.0 µg/kg (liquid ready-to-drink). This is one of the strictest food contaminant limits globally.
  • Herbal infusions (dried) for general consumption: 200 µg/kg.
  • Tea (Camellia sinensis, dried): 150 µg/kg. For powdered tea extracts, a concentration factor of four applies.
  • Food supplements (botanical preparations): 400 µg/kg.
  • Dried herbs and cumin: 400 µg/kg.
  • Borage leaves (fresh/frozen): 750 µg/kg. Dried borage and related herb mixtures: 1,000 µg/kg—the highest threshold, reflecting naturally elevated PA content.
  • Pollen and pollen-based products: 500 µg/kg.

Member States can impose stricter national rules. Even if a product meets EU limits, countries like Germany or France may ban certain PA-containing botanicals outright.

Enforcement Reality

EU authorities treat PA limits seriously. In 2025, regulatory agencies conducted targeted sampling on herbal teas, spices, and supplements. Products exceeding limits face withdrawal, recalls, and financial penalties. Retailers are equally liable.

Germany's Federal Institute for Risk Assessment (BfR) continues publishing PA occurrence data and emphasizes that while contamination has decreased in some categories, herbs, spices, and supplements remain high-risk.

Why This Matters

If you produce, import, or distribute herbal products in the EU, PA compliance is mandatory. The 75 µg/kg threshold for infant products is particularly challenging. Meeting it requires rigorous supplier qualification, incoming material testing, and traceability systems.

Reformulation isn't always viable—PAs are intrinsic to certain plants. Some companies have discontinued products rather than attempt compliance. Others shifted to PA-free alternatives, though this requires consumer re-education.

Good agricultural and manufacturing practices reduce contamination—field management, hand-sorting, visual inspection—but low-level contamination remains difficult to eliminate entirely. Testing becomes the final verification, and frequent batch testing is now standard for high-risk ingredients.

Global Regulatory Tracking

The EU's PA framework is one of the most comprehensive globally, but other markets are following. Canada evaluates PA risks through Health Canada, Australia is considering limits, and the US FDA has issued warning letters on PA-containing botanicals.

Tracking these evolving standards across markets is resource-intensive. SGS Digicomply's Global Ingredient Monitor consolidates regulations, maximum levels, analytical requirements, and enforcement updates in real time. Filter by substance, product, and jurisdiction for immediate compliance visibility.

Explore demo: Global Ingredient Monitor

In a landscape where "natural" doesn't mean "safe" and trace contaminants carry enforcement risk, having a global view isn't optional—it's essential.