CBD Maker Claims First Positive EU Novel Food Opinion

An Irish CBD manufacturer says it has cleared a barrier that has stalled the European market for years — a positive safety opinion from the EU’s food regulator for cannabidiol as a novel food. If the claim holds up once the opinion is published, it would be the first of its kind. But the document is still a draft, the regulator has not released it, and even a favorable opinion would not put CBD supplements on shelves anywhere in the bloc.

Chanelle McCoy Health, which makes the Pureis range of lab-made CBD, said it had received a draft positive opinion from the European Food Safety Authority (EFSA) on its novel food application. The company chose its words carefully, describing the finding as “not a negative opinion” and saying the final version remains under embargo until a publication date is set. EFSA has not confirmed the outcome, and the draft cannot yet be independently verified.

What a positive opinion actually buys

The distinction matters. EFSA’s role is to carry out a scientific safety assessment, not to decide what can be sold. A positive opinion is a safety finding; it does not authorize a product for the market. Once EFSA delivers an opinion, the European Commission and national governments decide whether to add the ingredient to the Union List of authorized novel foods — the step that actually opens the EU market. To date, the only authorized CBD product in the bloc is the prescription epilepsy medicine Epidyolex.

So even on the company’s own account, a favorable opinion would trigger a Commission-led authorization process rather than end one. Ingestible CBD sold as a food supplement remains unauthorized across the EU until that process runs its course.

Why EFSA has been saying no

The skepticism is earned. In 2022, EFSA effectively stopped the clock on the roughly 19 CBD dossiers then in its queue, concluding it could not establish the safety of CBD as a food because of gaps in the toxicology data — including possible effects on the liver and on the endocrine, nervous and reproductive systems. Applicants were told the burden was on them to close those gaps.

The agency has not shifted far since. In an updated safety statement adopted in December 2025, EFSA’s expert panel set only a provisional safe intake level of about 2 mg a day for a 70 kg adult — and even that applies narrowly to highly purified supplement formulations, while excluding anyone under 25, pregnant or breastfeeding women, and people on other medication. Where it has ruled on individual products over the past year — a synthetic CBD, a plant-derived isolate, a hemp extract — the answer each time was that safety could not be established.

That record is what makes a genuinely positive opinion notable. Chanelle McCoy Health’s case rests on the nature of its ingredient: a synthetic CBD made in a laboratory rather than extracted from the plant, with no detectable THC. The company argues that gives it the batch-to-batch purity and consistency EFSA’s reviewers have repeatedly demanded.

What it would mean for the market

Any EFSA opinion would also land in a fragmented enforcement landscape. Because authorization ultimately rests with the Commission and member states, national rules diverge sharply: Germany treats unauthorized CBD foods strictly, and Greece has moved to ban hemp flower outright despite warnings it conflicts with EU law. A single safety opinion would not override that patchwork.

The safety debate is also running on more than one track. In May 2026, EU chemicals regulators backed a French proposal to classify CBD as a reproductive toxicant — a hazard classification under separate chemicals law that is distinct from EFSA’s food-safety review but adds to the pressure on the ingredient. Chanelle McCoy Health notes the two frameworks are separate and that its dossier was judged only on food-safety grounds.

The novel food route is only one path into Europe for cannabis-derived products; others, such as Vertanical’s botanical pain drug, are pursuing approval as medicines instead. Beyond the bloc, the company said its oral CBD supplement has been approved by Saudi Arabia’s food and drug regulator, with applications moving through more than 40 markets, and that it is seeking investment to expand. It is also pursuing a separate UK novel food application, though unresolved UK-EU talks on aligning food-safety rules cloud that route.

For now, the claim rests on a document only the company has seen. The test will be whether EFSA publishes an opinion that matches the company’s description — and, if it does, whether the Commission and member states are willing to act on it.