The EU is not a single rulebook for botanical supplements. The Food Supplements Directive provides a framework, but botanical ingredients are often governed by national rules, and the Novel Food Regulation, contaminant limits, pesticide MRLs, and health-claims rules sit on top. Market entry usually starts with the member state where the product will be sold.

The framework in brief

Food Supplements Directive 2002/46/EC

The directive harmonizes certain aspects of food supplements, including a positive list for vitamins and minerals and labeling requirements. It does not create a harmonized positive list for botanical ingredients. Member states may maintain their own lists, notifications, or restrictions, so the destination country matters.

Novel Food Regulation (EU) 2015/2283

A food or food ingredient that was not used for human consumption to a significant degree within the EU before 15 May 1997 is a novel food and needs authorization before it is placed on the market. The EU Novel Food Catalogue is a starting point, not a final legal determination. The status of a specific extract can depend on the plant, the part, the process, and the historical use.

Contaminants — Regulation (EU) 2023/915

The contaminants regulation sets maximum levels for lead, cadmium, mercury, arsenic, and other contaminants in defined food categories, including food supplements. The applicable limit depends on the product category and, in some cases, the ingredient. Testing should report individual elements, not a total.

Pesticide residues — Regulation (EC) No 396/2005

MRLs are set by pesticide and commodity. A processed extract can concentrate residues, and the relevant commodity and processing factor should be confirmed. The EU pesticides database is the practical reference for current MRLs. Ethylene oxide is a separate concern and is not covered by a standard field-pesticide panel.

Health claims — Regulation (EC) No 1924/2006

Health claims must be authorized and included in the EU register. Many botanical claims remain unresolved or are not authorized. The supplier's ingredient file supports identity and quality, not claim authorization; the brand and its regulatory advisor own that review.

Hygiene and labeling

General food hygiene rules and labeling rules apply in addition to supplement-specific requirements. Allergen declaration and the ingredient list must reflect the actual carrier and extract composition.

Documents we can supply

The exact pack depends on the grade, the application, and your customer's requirements. These are the documents that typically travel with a botanical extract lot.

  • Batch COA with identity, assay, and contaminant results
  • Specification with methods and limits matched to the destination
  • Pesticide multi-residue report with reporting limits
  • Heavy-metal results by element
  • Residual solvent results matched to the process
  • Allergen, GMO, and origin statements
  • Organic transaction certificate where an organic claim is made
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What your team still needs to confirm

01

Confirm the member state where the product will be notified or sold.

02

Check novel food status for the plant, part, and process — not only the species.

03

Confirm the contaminant and MRL limits that apply to your product category.

04

Review health claims against the EU register before designing the label.

05

Check whether the destination requires a supplement notification.

Official sources

Important

Not legal advice

This page is a business-to-business orientation, not a legal opinion. Ingredient status, permitted claims, limits, and notification duties depend on the specific extract, dose, finished product, and current rules. Confirm with a qualified regulatory advisor in the destination market before launch.

Cite this page

Rainwood Botanical. "Botanical extracts for the European Union market." Regulatory notes, October 2026. https://ingredients.rainwoodbio.com/resources/regulatory/european-union/