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 employs tens of thousands of people, generates revenues close to $2.5bn, with the CBD skin care market, alone, worth over $750m.
However, Business of Cannabis 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’.
This news has sent shockwaves through the industry with two of its leading trade bodies warning of significant downstream consequences.
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’.
Francesco Mirizzi, Managing Director of the European Industrial Hemp Association (EIHA) which represents scores of European producers, manufacturers and CBD retailers said: “At this stage, it is important to clarify that the process is not yet concluded.
“The opinion adopted by ECHA’s Risk Assessment Committee (RAC) constitutes a scientific hazard assessment and does not automatically translate into any ban of CBD products in the EU.
“That said, this development is clearly not positive for the sector and is likely contributing to the renewed restrictive approaches and enforcement actions currently being observed in certain Member States, including France.”
EIHA is talking to the European Commission on this with particular concerns in relation to the EU Cosmetics sector.
Under Article 15 of the EU Cosmetics Regulation, any substance classified as CMR 1A or 1B is strictly prohibited from use in cosmetic products, without a specific exemption.
Mr Mirizzi added: “At EIHA, we intend to actively engage in the next regulatory steps. In particular, we will challenge the proposed Category 1B classification and advocate for a reclassification to Category 2, which we believe would more appropriately reflect the available scientific evidence and the existing uncertainties.
“In parallel, EIHA also intends to seek a specific exemption as foreseen by the cosmetics legislation.
“We believe it is essential that future regulatory discussions take place transparently, with proper consideration of scientific evidence, realistic exposure scenarios, and the economic consequences for a sector that is already operating under significant regulatory uncertainty.”
Jacopo Vladimiro Paolini, CEO of Italian CBD company Enacta, and Vice-Chair of the Copa-Cogeca Working Group on Hemp and Flax, said: “The current situation around the ECHA classification process is clearly creating significant concern across the European hemp and CBD sector, particularly due to the potential implications for legal certainty, market access and investment across the value chain.”
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.
In 2022 the French authorities tried, unsuccessfully, to outlaw the sale of CBD flowers, and in the last few years it has taken aim at the sale of synthetic cannabinoids.
This is all in the broader, pan-European context of the laborious Novel Food process which has seen a recent determination that a safe daily consumption upper-limit of CBD is 2mg per day , for someone weighing 70kg.
French trade group the Union of Industrialists for the Vaporization of Hemp Extracts (UIVEC) first alerted the wider industry to the threat of the ECHA determination early last year, as reported by Business of Cannabis.
It highlighted how the data being used in the ANSES submission refers to the adverse effects on rats, which had been subjected to doses of 300mg per 1kg weight, during trials of the CBD-based drug Epidiolex.
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 announced, would have immediate and largely irreversible consequences for these operators in the short term.
“This is a scenario we hope to avoid through dialogue, but it cannot be ruled out at this stage,” she added.
The French CBD market is currently valued at €200m in annual turnover, employs between around 15,000 people directly, of which 90% are in SMEs, and is supported by 1,200 agricultural holdings.
It is distributed through approximately 2,500 specialised CBD Shops and an estimated 20,000 French pharmacies – two thirds of the French pharmacy network.
Business of Cannabis has approached ANSES for a comment on these developments as is awaiting a response.
A spokesperson for the the ECHA, said: “The RAC (risk assessment committee) has adopted an opinion recommending a harmonised classification for cannabidiol, and ECHA will forward this opinion to the European Commission.
“The Commission will then consider the RAC opinion within its decision‑making procedure. While RAC opinions are a key scientific input and are generally taken into account, their adoption by the Commission is not automatic. The Commission will decide how to proceed.”
The EC normally takes between three to nine months before publishing its draft decision, which then has to go through member state consultation, before it becomes regulation.
The EC’s Scientific Committee on Consumer Safety is separately evaluating CBD for cosmetics and the industry can still submit data to challenge its final decision.
The post CBD Is A ‘Reproductive Toxicant’ Say The EU In A Major Blow to Industry appeared first on Business of Cannabis.
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European CBD employs tens of thousands of people, generates revenues close to $2.5bn, with the CBD skin care market, alone, worth over $750m.
However, Business of Cannabis 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’.
This news has sent shockwaves through the industry with two of its leading trade bodies warning of significant downstream consequences.
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, Managing Director of the European Industrial Hemp Association (EIHA) which represents scores of European producers, manufacturers and CBD retailers said: “At this stage, it is important to clarify that the process is not yet concluded.
“The opinion adopted by ECHA’s Risk Assessment Committee (RAC) constitutes a scientific hazard assessment and does not automatically translate into any ban of CBD products in the EU.
“That said, this development is clearly not positive for the sector and is likely contributing to the renewed restrictive approaches and enforcement actions currently being observed in certain Member States, including France.”
EIHA is talking to the European Commission on this with particular concerns in relation to the EU Cosmetics sector.
Under Article 15 of the EU Cosmetics Regulation, any substance classified as CMR 1A or 1B is strictly prohibited from use in cosmetic products, without a specific exemption.
Mr Mirizzi added: “At EIHA, we intend to actively engage in the next regulatory steps. In particular, we will challenge the proposed Category 1B classification and advocate for a reclassification to Category 2, which we believe would more appropriately reflect the available scientific evidence and the existing uncertainties.
“In parallel, EIHA also intends to seek a specific exemption as foreseen by the cosmetics legislation.
“We believe it is essential that future regulatory discussions take place transparently, with proper consideration of scientific evidence, realistic exposure scenarios, and the economic consequences for a sector that is already operating under significant regulatory uncertainty.”
Jacopo Vladimiro Paolini, CEO of Italian CBD company Enacta, and Vice-Chair of the Copa-Cogeca Working Group on Hemp and Flax, said: “The current situation around the ECHA classification process is clearly creating significant concern across the European hemp and CBD sector, particularly due to the potential implications for legal certainty, market access and investment across 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.
In 2022 the French authorities tried, unsuccessfully, to outlaw the sale of CBD flowers, and in the last few years it has taken aim at the sale of synthetic cannabinoids.
This is all in the broader, pan-European context of the laborious Novel Food process which has seen a recent determination that a safe daily consumption upper-limit of CBD is 2mg per day , for someone weighing 70kg.
French trade group the Union of Industrialists for the Vaporization of Hemp Extracts (UIVEC) first alerted the wider industry to the threat of the ECHA determination early last year, as reported by Business of Cannabis.
It highlighted how the data being used in the ANSES submission refers to the adverse effects on rats, which had been subjected to doses of 300mg per 1kg weight, during trials of the CBD-based drug Epidiolex.
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 announced, would have immediate and largely irreversible consequences for these operators in the short term.
“This is a scenario we hope to avoid through dialogue, but it cannot be ruled out at this stage,” she added.
What Happens Next?
The French CBD market is currently valued at €200m in annual turnover, employs between around 15,000 people directly, of which 90% are in SMEs, and is supported by 1,200 agricultural holdings.
It is distributed through approximately 2,500 specialised CBD Shops and an estimated 20,000 French pharmacies – two thirds of the French pharmacy network.
Business of Cannabis has approached ANSES for a comment on these developments as is awaiting a response.
A spokesperson for the the ECHA, said: “The RAC (risk assessment committee) has adopted an opinion recommending a harmonised classification for cannabidiol, and ECHA will forward this opinion to the European Commission.
“The Commission will then consider the RAC opinion within its decision‑making procedure. While RAC opinions are a key scientific input and are generally taken into account, their adoption by the Commission is not automatic. The Commission will decide how to proceed.”
The EC normally takes between three to nine months before publishing its draft decision, which then has to go through member state consultation, before it becomes regulation.
The EC’s Scientific Committee on Consumer Safety is separately evaluating CBD for cosmetics and the industry can still submit data to challenge its final decision.
The post CBD Is A ‘Reproductive Toxicant’ Say The EU In A Major Blow to Industry appeared first on Business of Cannabis.
Continue reading...
