An Overlooked Compliance Consideration for Growing Hemp Brands
As hemp companies increasingly explore international market opportunities, understanding novel food regulations, particularly in markets like the European Union, becomes relevant for a growing segment of the industry, even though most current hemp business remains domestically focused.
What Novel Food Regulation Means
Novel food regulations, most prominently in the European Union, require specific safety authorization before a food ingredient not consumed to a significant degree before a defined historical cutoff date can be legally sold. Several hemp-derived cannabinoids, including CBD, have been classified as novel foods in the EU, requiring specific regulatory authorization before legal sale in food and beverage applications.
Why This Differs Significantly From the US Framework
The US framework discussed throughout this publication centers on the Farm Bill's hemp definition and FDA's general food and supplement safety authority. The EU's novel food framework is a fundamentally different regulatory mechanism, requiring proactive safety authorization applications rather than operating under a framework similar to the US dietary supplement structure.
This means a hemp-derived ingredient's legal status in the US Farm Bill framework has no direct bearing on its status under EU novel food regulations, these are entirely separate regulatory questions requiring separate compliance approaches.
The Novel Food Authorization Process
Companies seeking to market novel food ingredients in the EU must submit detailed safety dossiers to the European Food Safety Authority, including toxicological data, proposed use levels, and other safety documentation. This process is significantly more resource-intensive than typical US compliance documentation, often requiring dedicated regulatory affairs expertise and substantial safety study investment.
Current Status of Hemp-Derived Cannabinoids Under EU Novel Food Rules
CBD and several other hemp-derived cannabinoids have pending or completed novel food authorization applications, with the regulatory landscape continuing to evolve as applications are reviewed and decisions issued. Companies interested in EU market access should track the current status of relevant authorization applications rather than assuming a general hemp is legal framework applies.
What This Means for US Operators Considering International Expansion
If international expansion, particularly into EU markets, is part of your growth strategy, novel food compliance represents a genuinely separate regulatory workstream from your US compliance program, requiring dedicated expertise and significant lead time given the authorization process timelines.
Operators should not assume that US compliance credentials, COAs, GMP certification, and other documentation discussed throughout this publication, directly satisfy novel food authorization requirements, though the underlying quality and safety data may inform a novel food application.
Low Gravity Hemp focuses primarily on the US market and the domestic compliance framework discussed throughout this publication. Contact us to talk through your compliance needs for your specific target markets.
