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Exporting ayurveda and herbal products (HS 1211) — novel food and heavy metals

Last reviewed 2026-10 · 4 sections

Ayurvedic and herbal products face a regulatory question before any commercial one: what is this product, in this destination? The same herb can be a food, a supplement, a cosmetic or a medicine — and each path has a different gate.

Classification follows the regulatory category

  • 1211 covers plants and parts of plants used in pharmacy, perfumery or similar purposes — the raw botanical. Extracts and essences generally move to a different heading, and a formulated product in measured doses is a medicament.
  • 3004 applies to preparations put up in measured doses or for retail sale as medicaments. The distinction is presentation and purpose, not the ingredient list.
  • This matters twice: for duty, and because the destination regulator reads the classification as a signal about what the product is.

What the destination will decide

  • European Union. A botanical food not consumed to a significant degree in the EU before 1997 can fall under the novel food regime and require authorisation before it may be sold. Some traditional Indian botanicals are affected, and the assessment is product-specific.
  • United States. Dietary supplements are regulated as a category, with notification requirements for new dietary ingredients, and permitted structure/function claims but not disease claims. A claim that a product treats or prevents a disease converts it into a drug, with the consequences that follows.
  • Elsewhere. Many markets have their own traditional-medicine category. Do not assume a product that is a 'traditional medicine' in India is one in the destination.

Heavy metals: the recurring cause of rejection

Ayurvedic products have repeatedly been the subject of detentions and recalls for heavy metals — lead, mercury and arsenic in particular — as well as pesticide residues and, in some cases, undeclared pharmaceutical ingredients. Destination limits are strict and testing is routine. The implication is practical: establish contaminant testing of the finished product and traceability of every botanical input, because a single positive result can trigger an import alert across your whole product range.

Documents and market reading

  • Commercial invoice, packing list, transport document, certificate of origin.
  • Product dossiers and manufacturing licences as the destination requires; heavy-metal and residue test reports; claim substantiation; GMP evidence for the manufacturing site.
  • Trade data for 1211, 1302 and 3004 measure very different things — raw botanicals, extracts, and retail preparations. Comparing unit values across them is meaningless.

Use the tools

Sources & further reading

Ministry of AYUSH U.S. FDA — dietary supplements EU — novel food

These guides summarise public material from the bodies named above. They are general information, not advice on a specific shipment, and they are not a substitute for a ruling from your customs authority or a qualified customs broker / consultant.

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