EU Cannabinoid Market Entry: Navigating Novel Food Authorization and Cross-Border Trade Compliance

Matter Overview

A US-based hemp extract manufacturer sought to export CBD isolate and full-spectrum hemp extract products to distributors in Germany and the Netherlands. The EU regulatory framework for CBD had undergone significant evolution: the European Commission had classified CBD as a novel food under Regulation (EU) 2015/2283, requiring pre-market authorization before the products could be legally sold for human consumption in EU member states. Separately, Germany's Cannabis Act (CanG), effective April 2024, had created a new regulatory category for cannabis-derived products that intersected with the novel food framework. The client needed to determine which products required novel food authorization, which could enter under existing food supplement frameworks, and what customs documentation was required for each product category.

Work Performed

Hoban's international cannabis practice conducted a product-by-product classification analysis under the EU novel food regulation, using the European Food Safety Authority (EFSA) application guidance and the member state-level guidance published by Germany's BfR (Federal Institute for Risk Assessment) and the Netherlands' NVWA (Netherlands Food and Consumer Product Safety Authority).

The analysis identified a critical distinction: CBD isolate products at 99%+ purity, depending on the extraction solvent and process, had a defensible classification pathway as a "chemically defined substance" under Annex IV of the novel food regulation rather than as a novel food extract — a distinction that would allow them to enter the market under existing food supplement notification procedures in Germany without a full novel food authorization. Full-spectrum extracts did not have the same pathway.

Hoban prepared a legal opinion supporting the chemically defined substance classification for the isolate line, coordinated review of the opinion by German regulatory counsel, and prepared the customs classification documentation (including CN codes and EU Organic Equivalence documentation) for the isolate shipments.

For the full-spectrum line, we advised the client to obtain a co-applicant position in an existing EFSA novel food authorization proceeding rather than filing independently — a strategy that reduces cost and timeline by joining an application already in the EFSA queue.

Outcome

The CBD isolate product line entered Germany and the Netherlands within four months of engagement under the chemically defined substance pathway. The full-spectrum line is pending EFSA authorization under the co-applicant strategy. No customs enforcement actions have been initiated.

Lessons Learned

The EU cannabinoid regulatory landscape is more navigable than US-based companies assume — but it requires jurisdiction-by-jurisdiction analysis because member states implement the novel food framework differently. The chemically defined substance distinction is a genuine pathway for high-purity isolates, not a loophole; it requires technical documentation on the extraction process that most companies have not assembled. Co-applicant positions in existing EFSA proceedings are available and dramatically reduce the novel food authorization timeline and cost.

Engage Hoban Law Group

Hoban Law Group advises cannabis and hemp companies on EU market entry, novel food authorization, and cross-border trade compliance across 30+ countries. [Schedule a consultation](/consultation?source=matter&matter_slug=international-cannabinoid-trade-counsel-eu-2024&matter_type=international-cannabis-policy).