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In the European Union, cannabidiol (CBD) is not automatically considered a traditional foodstuff. Instead, it falls squarely under the Novel Food Regulation (EU) 2015/2283, which mandates that any food product not consumed to a significant degree within the EU before May 1997 must undergo a rigorous pre-market safety authorization process. This classification emerged from a landmark 2019 ruling by the European Court of Justice, which clarified that CBD extracted from the Cannabis sativa plant is not a narcotic drug, provided the THC content remains below 0.2%, but simultaneously confirmed that it qualifies as a novel food. Consequently, any company wishing to legally sell CBD-infused edibles, beverages, or dietary supplements across the bloc must submit a comprehensive dossier to the European Food Safety Authority (EFSA) for scientific evaluation. This dossier must include detailed data on the product’s chemical composition, proposed manufacturing processes, stability over its shelf life, and—most critically—toxicological safety, including genotoxicity and reproductive toxicity studies. The EFSA then has a period to assess the application, during which it may request additional data, before delivering its opinion to the European Commission, which ultimately grants or denies authorization. This framework is designed not to ban CBD but to ensure a high level of consumer protection, requiring that the burden of proof for safety rests squarely on the producers. However, the stringent data requirements have proven exceptionally challenging for the industry, as complete toxicological studies are expensive and time-consuming, effectively creating a high regulatory barrier to market entry that very few applicants have successfully navigated to completion.