The European Union's Novel Food Regulation (EU) 2015/2283 continues to evolve, with significant implications for companies importing botanical extracts into the EU market. If you are sourcing ingredients from China for nutraceutical, food, or cosmetic applications destined for Europe, here is what you need to know in 2026.

What Is the EU Novel Food Regulation?

The Novel Food Regulation (EU) 2015/2283 governs food ingredients that have not been consumed to a significant degree in the EU prior to May 1997. Botanical extracts that do not have a established history of consumption in Europe may be classified as novel foods, requiring pre-market approval before they can be legally sold in the EU.

Key Updates for 2026

The European Commission has tightened requirements around:

• Identity verification: Full botanical characterization including Latin name, plant part, extraction solvent, and processing method must now be submitted with novel food applications.
• Specifications: Quantified active constituents or marker compounds are required — "botanical extract" alone is no longer sufficient as a specification.
• history of use: Evidence of significant consumption in third countries (e.g., China) must now be accompanied by a comparative exposure assessment.
• CBD and cannabinoid extracts: EFSA continues to enforce zero-tolerance for novel food applications lacking complete safety dossiers.

How This Affects Your Sourcing

If you are importing botanical extracts into the EU, work with your supplier to ensure:

• Full specifications including HPLC assay for active constituents are available
• Extraction solvents used comply with EU Directive 2009/32/EC (food extraction solvents)
• Manufacturing process is documented with a complete Technical Dossier
• Prior informed consent from the novel food applicant in the EU is obtained if the ingredient is already under application

What Nourish Ingredients Can Do

We help EU buyers navigate the compliance landscape. Our team works with suppliers to prepare complete technical documentation packages, including specifications, manufacturing process descriptions, and third-party test reports, to support your regulatory submissions.