Two important regulatory developments published this month indicate meaningful progress for CBD as a Novel Food in Europe.
On the EU side, EFSA has published its first favourable scientific opinion for a CBD Novel Food application. In its assessment of a synthetic CBD ingredient, EFSA concluded that the novel food is safe under the proposed conditions of use, while noting that safety could not be established for individuals taking medication.
This marks an important step forward following the position adopted by EFSA in 2022, when the authority concluded that the safety of CBD as a Novel Food could not be established due to significant scientific uncertainties and data gaps, including questions relating to liver effects, reproductive toxicity and long-term exposure. As a result, the assessment of numerous CBD Novel Food dossiers progressed only slowly while additional evidence was generated.
At the same time, the UK has reached a significant milestone of its own.
Food Standards Agency (FSA) and Food Standards Scotland (FSS) have completed the assessment of the first three high-purity CBD Novel Food applications, previously issued positive safety assessments, conducted a public consultation, and have now published recommendations to Ministers supporting their authorisation. The FSA describes this as a major milestone in the regulation of the CBD food sector and a potential regulatory first for Great Britain.
While EFSA and the FSA have applied different assessment approaches and arrived at different acceptable intake levels, both authorities are now moving beyond the initial question of whether CBD can be assessed as a Novel Food and toward defining the conditions under which authorisation may be granted. EFSA's assessment supports a safe intake level of approximately 2 mg/day for a 70 kg adult for the specific synthetic CBD product and conditions assessed; while the FSA maintains a provisional acceptable daily intake of 10 mg/day for the high-purity CBD applications it has evaluated.
Taken together, these publications may represent one of the clearest signals in recent years that the regulatory framework for CBD Novel Foods is beginning to mature. Although differences remain in the scientific assessments and intake levels considered acceptable by regulators, both the EU and the UK are now progressing toward regulatory decisions based on defined conditions of use. For applicants, regulators and the broader food supplement sector, greater regulatory certainty has long been one of the key expectations. These recent developments suggest that the conversation is gradually shifting from scientific standstill to regulatory decision-making.
While many assessments and decisions still lie ahead, September 2026 may be remembered as an important milestone month for the future of CBD Novel Foods in Europe.
