On 18 September 2026 the EFSA Journal published the NDA Panel opinion on the safety of synthetic cannabidiol (CBD) obtained by chemical synthesis as a novel food. It is the first positive EFSA opinion on this matter. The Panel considered the product of the applicant Chanelle McCoy CBD Ltd. safe at a maximum dose of 2 mg CBD per day for adults over 25 — excluding pregnant women, lactating women and people taking medicines.

Key distinction: an EFSA scientific opinion is not an authorisation. Until an implementing regulation of the European Commission is adopted, placing synthetic CBD on the market as a novel food in the EU remains unlawful.

1. What exactly did EFSA assess?

At the request of the European Commission, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) assessed the safety of CBD obtained by chemical synthesis under Regulation (EU) 2015/2283. The opinion has DOI 10.2903/j.efsa.2026.10154 (first publication 18 September 2026, editorial correction 21 September 2026).

The novel food consists of at least 98% (w/w) CBD and is intended exclusively for use dissolved in medium-chain triglyceride (MCT) oil in food supplements. Maximum proposed daily dose: 2 mg. Target population: the general adult population over 25, excluding pregnant and lactating women. Safety in people taking medicines was not established.

Primary source: the full text of the opinion is available at DOI 10.2903/j.efsa.2026.10154. The abstract confirms a BMDL10 of 10.5 mg/kg bw/day (relative liver weight in female rats) and application of an uncertainty factor of 400 following the 2026 update of the EFSA statement.

2. Key figures from the opinion

Assessment elementNDA Panel conclusion
Purity of the novel foodat least 98% (w/w) CBD
CarrierMCT oil (exclusively)
Maximum daily dose2 mg CBD
BMDL10 (relative liver weight, female rats)10.5 mg/kg bw/day
Uncertainty factor400
Safe intake level0.026 mg/kg bw/day (about 2 mg/day for 70 kg)
Target populationAdults over 25 (excluding pregnancy, lactation and people on medicines)
GenotoxicityNo concerns
Final conclusionSafe under the proposed conditions (except for people taking medicines)

These values come directly from the abstract and the text of the opinion. They must not be confused with doses used in medicinal products (Epidyolex) or with proof of clinical efficacy. The novel-food procedure assesses safety, not health claims.

3. Glossary

Novel food
A food or food ingredient that had not been consumed to a significant degree in the EU before 15 May 1997 and that requires authorisation under Regulation (EU) 2015/2283.
BMDL10
The lower confidence limit of the benchmark dose corresponding to a 10 percent change in a parameter. In this opinion it is the key toxicological reference point.
Uncertainty factor (UF) 400
The value adopted by the NDA Panel in the 2026 update of the statement in order to account for persisting data gaps (including reproductive and developmental toxicity).
EFSA opinion versus Commission authorisation
The scientific opinion closes the risk-assessment stage. The decision to enter a substance on the Union list of novel foods belongs to the European Commission and the Member States.

4. What must happen before lawful placing on the market?

  1. EFSA scientific opinion — stage completed for this specific synthetic CBD (18 September 2026).
  2. Decision of the Commission and the Member States — an implementing regulation amending the Union list of novel foods (Implementing Regulation (EU) 2017/2470).
  3. Conditions of the entry — food category, maximum amount, target population, additional labelling requirements and warnings.
  4. National compliance — in Poland, among other things, GIS notification of placing a food supplement on the market, if the product is classified as a food supplement.

Only point 2 opens a lawful route to market. A message that a positive EFSA opinion means the product is already legal in the EU is misleading.

5. Parallel opinions from the same period

On 18–21 September 2026 EFSA published three opinions on CBD:

  • Synthetic CBD (DOI 10.2903/j.efsa.2026.10154) — positive conclusion at 2 mg/day.
  • CBD isolated from Cannabis sativa L. (DOI 10.2903/j.efsa.2026.10318) — safety cannot be established (the applicant did not reply to requests for additional data).
  • Extract of Cannabis sativa L. (DOI 10.2903/j.efsa.2026.10319) — parallel assessment (details in the full text).

The difference follows, among other things, from the completeness of the file, the production process and the toxicological data available. Not every CBD product automatically benefits from the positive conclusion.

Practical implication: a manufacturer or importer must match the product exactly to the conditions assessed in the specific opinion (purity, carrier, dose, population). An opinion on chemical synthesis does not transfer automatically to plant isolates or extracts.

6. What the opinion does not decide

  • It does not authorise health claims (Regulation (EC) No 1924/2006).
  • It does not approve doses other than 2 mg/day or other forms (for example powder, or capsules without MCT).
  • It does not establish safety in people under 25, in pregnancy, in lactation, or in people taking medicines.
  • It does not replace a status assessment in other jurisdictions (UK FSA, USA and others).

7. What to do in practice now

Monitor draft implementing regulations of the Commission and meetings of the Standing Committee on Plants, Animals, Food and Feed. Do not place production orders that assume immediate placing on the EU market solely on the basis of the opinion. If communications about health benefits are planned, prepare a separate substantiation and claim-authorisation strategy — independent of novel food. For products already present on other markets, check the local legal status separately.

Conclusion

The NDA opinion on synthetic CBD (DOI 10.2903/j.efsa.2026.10154) is a concrete, positive safety outcome at 2 mg per day for adults over 25. The fairest message for the market is: a scientific green light is not yet a regulatory green light. Placing on the EU market as a novel food requires an implementing regulation of the Commission.

Educational material, not legal or medical advice. Before market decisions, check the current Union list of novel foods and obtain advice on the classification of the product.

Primary sources

  1. EFSA NDA Panel. Safety of synthetic cannabidiol as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 2026;24(9):e10154. DOI: 10.2903/j.efsa.2026.10154 — primary opinion; source of the 2 mg/day dose, BMDL10 of 10.5 mg/kg bw/day, UF 400 and the population exclusions.
  2. EFSA NDA Panel. Safety of cannabidiol isolated from Cannabis sativa L. as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 2026. DOI: 10.2903/j.efsa.2026.10318 — parallel opinion (safety cannot be established).
  3. Regulation (EU) 2015/2283 on novel foods — procedural frame: EFSA opinion, then a Commission decision.
  4. Implementing Regulation (EU) 2017/2470 — Union list of novel foods (the place of a possible entry).
  5. EFSA NDA Panel. Update of the statement on safety of cannabidiol as a novel food. EFSA Journal 2026. DOI: 10.2903/j.efsa.2026.9862 — update of the statement (source of UF 400 and the provisional level of 2 mg/day).

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