Kratom and Novel Food: What the EU Regulation Means for Buyers and Sellers - Kratoein

Kratom and Novel Food: What the EU Regulation Means for Buyers and Sellers

Anyone looking into the legal situation around kratom in Germany and the EU runs into one term: Novel Food. It explains why products made from Mitragyna speciosa may not be sold as food or as food supplements – and why reputable vendors use the notice “not intended for consumption” instead.

This article explains the regulation in plain language, without the legalese.

What is Novel Food, exactly?

“Novel Food” is the legal term for novel foods. EU Regulation (EU) 2015/2283 defines a novel food as a food that was not consumed to a significant degree within the EU before 15 May 1997.

The principle behind it: anyone who wants to place a food on the EU market that was not common in Europe before 1997 must first go through a safety assessment by EFSA (the European Food Safety Authority) and then obtain an authorization from the European Commission.

That sounds bureaucratic, but the reason is comprehensible: foods unknown in Europe could bring allergies, interactions or unexpected health risks with them. The regulation is meant to ensure such products are examined for safety before they are marketed widely.

Why does kratom fall under Novel Food?

Mitragyna speciosa and its leaves were not consumed as food in the EU before 1997 – at least not to any significant extent. The traditional chewing of kratom leaves in Southeast Asia does not count as an “EU history of consumption” within the meaning of the regulation.

In legal terms, kratom is therefore a novel food for which no Novel Food authorization exists. Without that authorization, kratom may not be placed on the EU market as a food, as a food supplement or as a food ingredient.

That is the reason why kratom products in Germany and in almost every EU country carry the notice “not intended for human consumption”. It is not a protective formula – it is the correct legal positioning of the product.

Kratom is legal nonetheless – how do those two fit together?

This is the point at which confusion usually arises. The answer lies in one important distinction.

Novel Food regulates the sale as a food. It says nothing about whether a plant or an extract is generally prohibited or dangerous.

In Germany, kratom is not listed in the Narcotics Act (BtMG) – possession, acquisition and sale are legal. The Novel Food Regulation restricts only the manner of marketing: kratom may not be advertised and sold as a food or as a supplement for human consumption.

Sold as a botanical product, not intended for consumption – for scientific, decorative or other purposes – kratom is permissible in Germany.

What does this mean in practice for buyers?

For buyers in Germany, the following points are relevant:

  1. The purchase is legal. Acquiring kratom products as botanical goods is not a criminal offense in Germany, provided the product is correctly declared.
  2. Health claims are not permitted. Sellers may not make statements about health effects, neither on the packaging nor in advertising. This is not only a Novel Food question but also a matter for the German Medicinal Products Advertising Act (Heilmittelwerbegesetz, HWG).
  3. Responsibility lies with the buyer. Because kratom is not authorized as a food, responsibility for personal handling rests entirely with the buyer. There are no officially reviewed dosage recommendations and no authorization as a food supplement.
  4. Quality is not regulated by the state. Because there is no official food status, there is also no obligation to meet particular quality standards – apart from the general product safety requirements. Individual vendors offset this with voluntary laboratory analyses and by publishing certificates of analysis.

What would be required for a Novel Food authorization?

A Novel Food authorization requires:

  1. A complete application to EFSA, including scientific data on safety
  2. A risk assessment by EFSA experts (typically 1.5 to 2 years)
  3. A decision by the European Commission
  4. An entry in the EU Novel Food Catalogue

This process is laborious and cost-intensive – and to date no company has completed it successfully for kratom. For comparison: CBD started down the same path and is likewise still wrestling with open authorization questions.

Kratom and Novel Food in other EU countries

The Novel Food Regulation applies EU-wide, but enforcement varies. Several member states have additional national rules on top of it:

Country Status
Denmark, Latvia, Lithuania, Poland Listed in national narcotics legislation → kratom is prohibited there
Germany, Austria, Netherlands, Belgium, Czech Republic and most other EU countries Kratom is legal, but subject to the Novel Food restriction
Sweden Classified as a health risk and de facto excluded from the market

One thing applies across every EU country: buyers are responsible themselves for checking whether import and possession are permitted at their own place of residence.

Note: This article does not constitute legal advice. The legal situation can change. For specific legal questions we recommend consulting a lawyer specializing in food law. Products made from Mitragyna speciosa are placed on the market in Germany as botanical goods and not intended for human consumption.

Conclusion

Novel Food Regulation (EU) 2015/2283 is the central regulatory framework determining how kratom may be sold in the EU. Kratom is not a food in the European legal sense, and without a Novel Food authorization it may not be marketed as one. That explains the notice “not intended for consumption” on every reputable kratom product. Purchase and possession are legal in Germany – but responsibility for personal handling rests entirely with the buyer.

Further reading

Legal notice

This article is for informational purposes only and does not constitute legal advice. Its content is not intended to encourage consumption. Laws may change; the applicable regulations and information from official bodies are authoritative. Image source: https://www.kratoein.com/

Back to blog