In September 2026, the European Food Safety Authority (EFSA) published its first positive Scientific Opinion on the safety of synthetic cannabidiol (CBD) as a Novel Food. The opinion defines specific conditions of use and a provisional safe intake level of 2 mg of CBD per day. It follows the provisional safe intake level established by EFSA in February 2026 to support the assessment of individual applications on the basis of the data submitted by each applicant.

Synthetic CBD: what did EFSA conclude?

EFSA concluded that synthetic CBD can be considered safe under the proposed conditions of use. The Novel Food consists of ≥ 98% (w/w) CBD dissolved in medium-chain triglyceride (MCT) oil and is intended to be marketed exclusively for use in food supplements. Applying the provisional safe intake level previously established for CBD, EFSA concluded that this specific Novel Food is safe at a maximum intake of 2 mg per day for adults aged 25 years and over, excluding pregnant and lactating women. The safety of CBD in people taking medication could not be established.

EFSA also identified important areas of uncertainty. Because of remaining data gaps, including those related to reproductive and developmental toxicity, the Panel applied an uncertainty factor of 400 to derive a provisional safe intake level of 0.026 mg/kg bw per day (equivalent to 2 mg/day for a 70-kg adult).

EFSA’s positive safety assessment does not constitute an authorization. The Novel Food may be placed on the EU market only after the European Commission has authorized it by updating the Union list, under the specified conditions of use.

Analytical testing: supporting quality and regulatory assessment

For ingredients and finished products, analytical testing can provide important evidence on composition, quality and consistency. Depending on the product and regulatory requirements, this may include:

• Purity testing and assay, nutritional substances profile analysis and verification of declared specifications for raw materials and finished products.
• Investigation of impurities, contaminants and process-related residues

These considerations are also reflected in the scientific dossier assessed by EFSA on synthetic CBD. The application included analytical data from multiple batches covering CBD content, related impurities, residual solvents, elements, microbiological parameters and stability.

Taken together, testing and regulatory assessment provide complementary evidence: analytical data help establish the actual characteristics of an ingredient and the finished product, while regulatory expertise determines how those data support the applicable EU Novel Food requirements.

>>> Complife supports operators with Testing & Validation and strategic Regulatory Consulting, combining analytical expertise and regulatory know-how to support the development and compliance of nutraceuticals, including those related to Novel Food application.

Source: EFSA, Safety of synthetic cannabidiol as a novel food pursuant to Regulation (EU) 2015/2283