THE European Union looks set to determine that cannabidiol is a ‘human reproductive toxicant’ in a move which could wipe out the continent’s CBD cosmetic sector and seriously damage the supplements one.
European CBD is a multi-billion dollar industry that employs over tens thousand people and has revenues of close to $2.5 billion. CBD products for skin are alone worth $750m.
However, MEDCAN24 has learnt that following a 2025 submission by ANSES – the French Agency for Food, Environmental and Occupational Health & Safety – the European Chemicals Agency (ECHA) has agreed with its determination that CBD ‘may damage fertility, the unborn child’ and ‘may cause harm to breast-fed children’.
Two of the leading industry trade groups have warned of serious downstream effects.
And, in France, we may be already witnessing the consequences of this ECHA determination – even though it still has to be ratified by the European Commission.
Following a year-long review the ECHA reached its toxicity conclusion in March, and in the following month, during a meeting with French CBD industry trade groups, ANSES subsidiary, the Directorate General for Food (DGAL) announced it was ‘preparing a national control plan for 2026 targeting all food products and food supplements containing CBD, THC, or any other cannabinoid’.
Industry Reaction
Francesco Mirizzi is the Managing Director of EIHA, the European Industrial Hemp Association, which represents a number of European CBD producers, manufacturers, and retailers. He said, “At this point, it’s important to make clear that the process has not been concluded.”
The ECHA Risk Assessment Committee’s (RAC) opinion is a scientific hazard analysis and doesn’t automatically translate to a ban on CBD in the EU.
The French government has recently taken a number of restrictive actions and increased enforcement measures in response to this new development.
EIHA has raised concerns with the European Commission about the EU Cosmetics industry.
Article 15 (EU Cosmetics Regulation) prohibits any substance that is classified CMR 1A, 1B, from being used in cosmetics.
Mr. Mirizzi said: “We intend at EIHA to engage actively in the next regulatory step. In particular, the EIHA will contest the proposed classification of Category 1B. It is our belief that a change to Category 2 would be more appropriate and reflect scientific data and uncertainties.
EIHA intends, in parallel to this effort, to also seek an exemption that is specifically outlined by cosmetic legislation.
We believe that it is important that regulatory discussions in the future are transparent, taking into account scientific evidence, realistic scenarios of exposure, as well as economic implications for a industry that already operates under a significant amount of regulatory uncertainty.
Jacopo Paulini, the CEO and vice-chairman of Copa-Cogeca Working Group Hemp and Flax and the Italian CBD Company Enacta said, “The situation surrounding the ECHA’s classification process has clearly created significant concerns across the European Hemp and CBD Sector, especially due to potential implications on legal certainty and market access, as well as investment throughout the value-chain.”
French CBD Antipathy
It was back in 2020 that the French authorities first took aim at CBD in the now infamous Kanavape case in which the European Court of Justice determined that it is not a ‘narcotic drug’, thus permitting its sale across member states.
French authorities attempted to prohibit the sale CBD flower in 2022 but were unsuccessful. They have now focused their efforts on synthetic cannabinoids.
The Novel Food Process, which is a laborious, pan-European process, has recently determined that the safe upper limit of CBD consumption per day is 2mg. For someone who weighs 70 kg.
MEDCAN24 reported that the French industrialists’ group, the Union of Industrialists for the Vaporization of Hemp Extracts(UIVEC), first alerted the entire industry of the ECHA decision threat in early 2011.
The ANSES report referred to adverse effects in rats that were exposed to 300mg of CBD per kg of weight during Epidiolex trials.
Earlier this week UIVEC had meetings with the Ministry of Agriculture and Food Sovereignty, during which it highlighted concerns over April’s ‘unilateral change’ which it said ‘constitutes a sharp departure from the framework that had been jointly built’ in recent years.
It contends that the new crackdown is primarily targeted at the sale of ‘synthetic cannabinoids’ which ANSES raised concerns about in June last year.
Its General Manager Zoé Demange, said: “Our optimistic scenario is that the Ministry adjusts the plan to focus on the actual public health risks identified by the French health authorities in their joint communication of 19 June 2025.”
And she went on to say that ‘growing number of operators are starting to consider legal action to preserve the legal certainty of their activities’.
The plan as it was announced would have an immediate, and in many cases irreversible, impact on these operators.
This is something we would like to avoid, but at this time it can’t be completely ruled out.
What happens next?
The French CBD market is currently valued at €200m in annual turnover, It employs around 15,000 direct workers, 90% of whom are in small and medium-sized enterprises, with 1,200 farms as a support.
It is distributed through approximately 2,500 specialised CBD Shops and an estimated 20,000 French pharmacies – two thirds of the French pharmacy network.
MEDCAN24 approached ANSES to get a reaction on this development.
According to a spokesperson from the ECHA: “The RAC has recommended a harmonised classifying of cannabidiol. ECHA will then forward this opinion on to the European Commission.”
“The Commission will then consider the RAC opinion within its decision‑making procedure. RAC opinions, while a valuable scientific input are taken into account by the Commission in general, they are not automatically adopted. It is up to the Commission how things will proceed.
The EC usually takes three to nine months to publish its draft decisions, and then it has to be reviewed by the member states before becoming a regulation.
The EC Scientific Committee on Consumer Safety has a separate evaluation of CBD cosmetics. However, the industry may still challenge this decision by submitting data.