European Chemicals Agency Classifies CBD as Reproductive Toxicant
The European Chemicals Agency (ECHA) has agreed with a determination classifying cannabidiol (CBD) as a ‘human reproductive toxicant’, a decision that could significantly impact the European CBD cosmetic and supplement sectors. This classification, stemming from a 2025 submission by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), suggests CBD ‘may damage fertility, the unborn child’ and ‘may cause harm to breast-fed children’.
According to a report by Business of Cannabis, the European CBD market generates revenues close to $2.5 billion, with the CBD skin care segment alone valued at over $750 million. The ECHA’s Risk Assessment Committee (RAC) reached its toxicity conclusion in March 2026. Following this, in April 2026, the Directorate General for Food (DGAL), a subsidiary of ANSES, announced preparations for a national control plan in France for 2026. This plan targets all food products and food supplements containing CBD, THC, or other cannabinoids.
Industry Response and Regulatory Challenges
Industry stakeholders have expressed concerns regarding the potential ramifications of the CBD reproductive toxicant classification. Francesco Mirizzi, Managing Director of the European Industrial Hemp Association (EIHA), stated that while the process is not yet concluded and the RAC opinion is a scientific hazard assessment, it is not an automatic ban. However, he noted that this development is likely contributing to increased restrictive approaches and enforcement actions in certain Member States, including France.
Key concerns for the industry include:
- Cosmetics Sector Impact: Under Article 15 of the EU Cosmetics Regulation, substances classified as Carcinogenic, Mutagenic, or Reprotoxic (CMR) 1A or 1B are strictly prohibited in cosmetic products without a specific exemption. The current classification places CBD in this category.
- EIHA’s Strategy: The EIHA intends to challenge the proposed Category 1B classification, advocating for a reclassification to Category 2. They also plan to seek a specific exemption as provided by cosmetics legislation.
- Market Certainty: Jacopo Vladimiro Paolini, Vice-Chair of the Copa-Cogeca Working Group on Hemp and Flax, highlighted that the ECHA classification process is creating significant concern across the European hemp and CBD sector, particularly regarding legal certainty, market access, and investment.
The Union of Industrialists for the Vaporization of Hemp Extracts (UIVEC) previously alerted the industry to this threat. UIVEC noted that the data used in the ANSES submission referenced adverse effects observed in rats subjected to high doses (300mg per 1kg weight) during trials of the CBD-based drug Epidiolex. UIVEC has engaged with the French Ministry of Agriculture and Food Sovereignty, expressing concerns over the ‘unilateral change’ and arguing that the new crackdown primarily targets synthetic cannabinoids.
Next Steps in European CBD Regulation
The French CBD market, valued at €200 million in annual turnover, supports approximately 15,000 direct employees and 1,200 agricultural holdings. It is distributed through about 2,500 specialized CBD shops and an estimated 20,000 French pharmacies.
An ECHA spokesperson confirmed that the RAC opinion has been forwarded to the European Commission. The Commission will consider this opinion within its decision-making procedure, which typically takes three to nine months before a draft decision is published and undergoes member state consultation. The Commission’s Scientific Committee on Consumer Safety is also separately evaluating CBD for cosmetics, providing an additional avenue for industry data submission to challenge final decisions.
This development follows a broader European context, including the laborious Novel Food process, which recently determined a safe daily consumption upper-limit of 2mg of CBD per day for an individual weighing 70kg. French authorities have a history of targeting CBD, including the 2020 Kanavape case, where the European Court of Justice ultimately determined CBD is not a ‘narcotic drug’, and an unsuccessful attempt in 2022 to outlaw the sale of CBD flowers.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Hemp Gazette does not provide medical recommendations, diagnoses, or treatment plans. Always consult a qualified healthcare practitioner before making any decisions regarding your health or any medical condition. Statements concerning the therapeutic uses of hemp, cannabis, or cannabinoid-derived products have not been evaluated by Australia’s Therapeutic Goods Administration (TGA). Medicinal cannabis products in Australia are accessed via prescription pathways under TGA regulation.
