EFSA has issued a provisional acceptable daily intake for CBD at 0.0275mg per kilogram of body weight per day. For an average adult weighing 70kg, that equates to approximately 2mg per day. Most commercially available CBD supplements in Europe currently deliver doses of 10mg to 100mg per day. The EFSA provisional ADI does not immediately remove CBD products from the EU market, but it creates a compliance framework that most current formulations cannot satisfy — and it directly affects the outcome of pending Novel Food authorization applications for CBD.

CBD (cannabidiol) is classified as a Novel Food in the EU under Regulation (EU) 2015/2283. EU-market CBD products require Novel Food authorization before commercial sale. A number of Novel Food authorization applications for CBD are currently in progress under the EFSA review pipeline. The 2mg/day provisional ADI changes the calculus on those applications: products dosed above 2mg/day will face a significant compliance challenge in demonstrating safety at their marketed dose levels. Brands with pending applications will need to assess whether their dossiers address EFSA's safety concerns at doses above the provisional ADI, and whether reformulation to a 2mg/day dose is commercially viable for their product range.

The provisional ADI is also separate from the UK FSA position. The UK Food Standards Agency has issued guidance setting 10mg/day as the figure consistent with a tolerable intake, though the UK FSA position has not been finalized as a formal ADI and remains under review. US brands planning both UK and EU entry with CBD formulations should note that the two regulatory systems are on different tracks, with different provisional figures and different timelines to any final determination. A UK-compliant 10mg/day formulation is not automatically EU-compliant at the 2mg/day EFSA provisional figure.

• EFSA provisional CBD acceptable daily intake: 0.0275mg/kg/day — approximately 2mg/day for a 70kg adult
• Most commercial CBD supplements on the EU market are currently dosed at 10mg to 100mg per day — well above the EFSA provisional ADI
• The provisional ADI affects pending Novel Food authorisation applications — products above 2mg/day face a materially harder compliance path under the EFSA safety framework
• The EU EFSA provisional ADI is separate from the UK FSA position, which uses a different figure and has not yet been finalised as a formal ADI
• Brands with EU-market CBD supplement applications or product ranges should seek qualified EU regulatory advice on the implications for their specific dossiers and formulations before making reformulation or withdrawal decisions

The EFSA provisional ADI for CBD is a significant regulatory development for any brand with EU-market CBD products or applications in progress. It is not the final word — provisional ADIs can be revised as safety evidence accumulates — but it defines the compliance benchmark for EU Novel Food applications in the near term. Brands that have been building EU entry plans around CBD as a core formulation ingredient need to factor the 2mg/day figure into those plans now. Expandly's EU compliance program includes Novel Food regulatory strategy for supplement brands, covering both assessment of current EFSA positions and planning for reformulation requirements ahead of EU market entry.