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Bottom line: origin in India or China is not a separate legal category in the European Union. The same plant material can be food, a supplement ingredient, a Novel Food, a medicinal product or an unauthorised substance depending on its form and use. “Ayurvedic” and “traditionally used in Chinese medicine” describe a cultural context, not an EU authorisation.

1. Define the material before assessing the plant name

Start with the complete specification: botanical name and synonyms, plant part, form (raw material, powder, infusion, oil, extract, fraction or isolate), drug-extract ratio, solvent, carrier, chemical markers, standardisation, proposed daily serving and route of use. Ashwagandha root, a 10:1 root extract and an isolated withanolide are not the same regulatory input.

Also establish whether the product is food. A capsule with a physiological effect may be a food supplement, but presentation, dose and therapeutic promises can move the product towards medicinal-product classification. A supplement notification cannot cure a medicinal presentation or a claim to treat disease.

2. Four EU legality gates

  1. Novel Food: was this form and use consumed to a significant degree in the EU before 15 May 1997?
  2. Regulation 1925/2006: is the substance or its relevant constituent in Annex III as prohibited, restricted or under scrutiny?
  3. Food-supplement and national-list rules: does the destination Member State accept the plant, part, preparation and dose, and does it require notification?
  4. Safety, classification and communication: are quality and toxicology documented, and are the product and its advertising kept outside medicinal and unauthorised health-claim territory?
flowchart TD
 A[Plant material from India or China] --> B[Identity: species, part, extract, dose]
 B --> C{Novel Food?}
 C -->|Yes or uncertain| D[Catalogue + Article 4 consultation / authorisation or third-country notification]
 C -->|No| E[Check 1925/2006 and national law]
 D --> F{Annex III to 1925/2006?}
 E --> F
 F -->|Prohibited/restricted/scrutiny| G[Do not market until conditions are met or remove material]
 F -->|No entry| H[Safety review and national-list check]
 H --> I{Health claim?}
 I -->|Yes| J[EU Register, authorisation and conditions of use]
 I -->|No| K[Label, advertising, notification and quality review]
 J --> K
 style G fill:#7f1d1d,stroke:#f87171,color:#fecaca
 style K fill:#064e3b,stroke:#10b981,color:#d1fae5
Diagram 1. The regulatory sequence: origin does not replace any of the tests.

3. Novel Food and the 15 May 1997 cut-off

Regulation (EU) 2015/2283 covers food not consumed to a significant degree in the Union before 15 May 1997, including new plant preparations and ingredients made by new processes. The comparison concerns not only the species but also the plant part, extract, chemical profile and proposed food. A history of use in India or China does not prove a history of EU food consumption.

Use the Novel Food Status Catalogue as a starting point, remembering that it is non-binding. If status remains uncertain, the operator may consult the competent authority of the first intended Member State under Article 4. If the material is novel, check the Union List of authorised novel foods, including specifications, conditions of use and additional labelling.

Traditional food from a third country

The Regulation offers a simplified route for traditional foods from third countries. “Traditional” still requires evidence of a safe history of food use for at least 25 years by a substantial part of the population in at least one third country. The notification is sent to the Commission; Member States and EFSA may raise reasoned safety objections. Absence of objections and an updated Union List are necessary before lawful placing on the market. Ayurvedic literature or a Chinese materia medica alone is not a substitute for the procedure.

4. What Regulation (EC) No 1925/2006 does

Regulation 1925/2006 governs the addition of vitamins, minerals and certain other substances to foods. Article 8 allows an EU procedure where a substance may pose a risk to health. Annex III has three parts: Part A means prohibition, Part B restriction and Part C substances under Community scrutiny, commonly while further data or risk-management measures are considered.

This is not a blanket ban on Asian herbs. Check the exact substance, plant or preparation and product category. Examples illustrating the mechanism include Ephedra species and yohimbe, hydroxyanthracene derivatives and green-tea extracts containing EGCG. Traditional use in China or India does not disapply Annex III.

No Annex III entry is not a safety certificate. General food law, the prohibition on unsafe food, contaminant rules and national requirements still apply.

5. National lists: important, but not one EU list

Directive 2002/46/EC harmonises the supplement concept and lists of vitamins and minerals, but it does not create a complete EU positive list for botanicals and other physiological substances. Member States therefore use positive, negative or restricted lists and administrative guidance. The Commission’s study on substances other than vitamins and minerals documents this diversity.

  • Belgium, France and Italy (BELFRIT): a shared reference project for part of the botanical field, not a single EU harmonising Regulation. Always check the binding national act and current conditions.
  • Germany: the BVL Stofflisten assist classification of plants, plant parts and borderline food/medicine products. They do not replace a product-specific assessment.
  • France: the 24 June 2014 order lists plants and conditions or warnings; a listing does not allow every extract or dose.
  • Italy: the Ministry of Health publishes guidance and lists for plant substances and preparations; safety, quality and product status remain separate questions.
  • Poland: first placing on the market may require a notification to GIS under the Food Safety and Nutrition Act. A submitted notification is not approval of composition or advertising.

Mutual recognition can support movement of a lawfully marketed product, but it does not erase justified safety, classification and consumer-protection requirements. “Sold in Italy” is therefore not a stand-alone proof that an identical extract can be marketed in Poland, Germany or France.

6. EFSA, PAFF and the “food-supplement team”

EFSA performs scientific risk assessments and publishes supporting tools. Its Compendium of Botanicals helps identify potential hazards. It has no legal force: inclusion is not a ban and absence is not proof of safety or legality.

The European Commission runs Novel Food procedures, prepares implementing acts and maintains Union Lists. The PAFF Committee is a Member State forum for committee procedures on food and feed safety. It is not a body granting an individual operator a general licence for a herb.

If “food-supplement team” refers to a national group, guidance or resolution, identify its precise legal basis and remit. An expert paper, authority position, industry list or team opinion may inform an assessment but cannot replace an EU Regulation, national statute, Novel Food authorisation or binding national act. The operator remains responsible for the product file and notification.

7. Food supplements: notification, safety and import controls

A supplement is food in a dose form, not a mini-medicine. The file should cover botanical identity, supplier and origin, specification, extraction process, markers, contaminants (including heavy metals, pesticides and microbiology), stability, serving and label. For Indian and Chinese materials, authenticity, substitution, residual solvents and batch controls deserve particular attention.

In Poland, the Food Safety and Nutrition Act provides for notification of first placing on the market. The Commission explains that Member States may require monitoring notifications under Article 10 of Directive 2002/46/EC. This is an information duty, not prior authorisation.

flowchart LR
 A[Supplier documents] --> B[Botanical identity and plant part]
 B --> C[Process: extraction, solvent, DER, markers]
 C --> D[Safety: toxicology, metals, pesticides, microbiology]
 D --> E[Status: Novel Food, 1925/2006, national list]
 E --> F[Supplement composition and warnings]
 F --> G[Separate health-claim and advertising review]
 G --> H[Notification / destination-country monitoring]
 style D fill:#1e3a5f,stroke:#38bdf8,color:#dbeafe
 style E fill:#312e81,stroke:#a78bfa,color:#ede9fe
 style H fill:#064e3b,stroke:#10b981,color:#d1fae5
Diagram 2. The compliance file goes beyond an extract supplier’s certificate.

8. Health claims are a separate compliance test

Regulation (EC) No 1924/2006 applies to claims in food labelling, presentation and advertising. Lawful food use or a long history of traditional use does not authorise “supports immunity”, “anti-inflammatory”, “improves sleep” or “protects the liver”. Each expression must be qualified as a potential health claim.

Start with the EU Register of Nutrition and Health Claims and the act authorising the entry. Then match substance, preparation, dose, population, conditions and wording. An EFSA opinion is scientific evidence in the procedure, not marketing authorisation.

Botanical claims “on hold” after C-386/23

Many botanical-claim assessments remain suspended. That does not create a free zone. The CJEU judgment in C-386/23 confirms the relevance of Article 10(1) and (3) of Regulation 1924/2006 to advertising a supplement with botanical claims. Treat “on hold” as a high-risk area, not a positive authorisation. Product names, graphics, influencer posts, websites, social media and B2B material can form one commercial communication.

9. Examples: avoid quick conclusions

  • Ashwagandha: Ayurvedic use does not decide the status of every extract. Check form, consumption history, country, safety and communications.
  • Berberis or berberine: plant, pure substance and extract can produce different assessments. An Article 8 process under Regulation 1925/2006 may change the risk picture; a draft EFSA opinion is not itself a prohibition.
  • Turmeric: root, oils, oleoresins and concentrated extracts are not automatically equivalent. Check Novel Food, national lists, contaminants and claims.
  • Ginseng, schisandra, tulsi, gotu kola and other Indian or Chinese botanicals: a traditional name is the starting point for identity, not the legal conclusion.

10. Importer and brand-owner checklist

  1. Obtain Latin name, plant part, preparation, DER, solvent, markers and daily dose.
  2. Check Novel Food status and the Union List; consider Article 4 consultation if uncertain.
  3. Search Annex III to Regulation 1925/2006 and amending acts.
  4. Compare national lists, conditions and warnings in each target Member State.
  5. Build a safety and authenticity file with batch controls.
  6. Confirm Polish notification or other destination-country monitoring duties.
  7. Review claims, product name, graphics, website, social media and advertising separately.
  8. Never present an EFSA opinion, Compendium entry or notification receipt as a legalisation certificate.
Scope note: this is a regulatory map, not individual legal advice. The result can change with extraction, dose, destination country, new EU acts or updates to a national list.

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