EU Regulators and the CBD Reclassification Process
The European Chemicals Agency (ECHA) has issued an opinion classifying cannabidiol (CBD) as a reproductive toxicant, a determination that has initiated a significant regulatory challenge for the European industrial hemp sector. This decision, if fully implemented, could have substantial implications for the EU’s cosmetics industry, which utilises CBD in various products. Francesco Mirizzi, Managing Director of the European Industrial Hemp Association (EIHA), has clarified that the process is not yet concluded, stating, “The opinion adopted by ECHA’s Risk Assessment Committee constitutes a scientific hazard assessment and does not automatically translate into any ban of CBD products in the EU.”
The European Commission typically requires three to nine months to publish a draft decision following an ECHA opinion. This draft then undergoes consultation with member states before becoming a regulation. Consequently, any prohibition on CBD products would not take effect before mid-2027 at the earliest, as reported by GN: industrial hemp. As previously reported by Hemp Gazette, the ECHA’s initial determination had already put the sector on notice regarding potential market impacts.
Industry’s Dual Strategy Against CBD Reclassification
The EIHA has outlined two parallel lines of action to counter the proposed CBD reclassification:
- Challenging the Classification: EIHA intends to advocate for a reclassification of CBD from Category 1B to Category 2. Category 1B indicates confirmed reproductive toxicity, while Category 2 suggests probable toxicity. A positive opinion from the Scientific Committee on Consumer Safety (SCCS) for a Category 2 substance can allow its continued use in cosmetics, and the SCCS currently holds a positive opinion on CBD for cosmetic applications.
- Seeking Specific Exemptions: In parallel, EIHA plans to apply for an exemption under Article 15 of the EU Cosmetics Regulation. This article generally prohibits substances classified as Carcinogenic, Mutagenic, or Reproductive Toxicant (CMR) 1A or 1B from cosmetic use but includes provisions for specific exemptions under certain conditions.
Francesco Mirizzi stated, “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.”
Scientific Basis and Economic Impact
The adverse effects cited in the submission by ANSES, a French public institution and the primary opponent in this matter, are derived from trials involving the pharmaceutical product Epidiolex. These trials administered CBD to rats at doses of 300mg per kilogram of bodyweight. EIHA argues that these exposure levels bear no meaningful relationship to the concentrations typically found in commercial cosmetic products. The association is collaborating with a regulatory affairs consultancy specialising in European cosmetics to develop a formal document presenting this argument, with funding pooled collectively through EIHA membership.
The economic stakes are considerable. The EU CBD skin care market alone is valued at over $750 million. A prohibition without exemption would eliminate a core revenue stream for numerous operators, particularly impacting companies that have focused primarily on the cosmetics segment.
Broader Regulatory Context and Industry Conduct
Beyond the CBD reclassification, the regulatory environment in the EU is tightening. From May 15, France has mandated the withdrawal of all food supplement products containing CBD that have not received novel food authorisation. Mirizzi noted that this decision is connected to the ANSES findings later confirmed by ECHA, contributing to France’s enhanced market compliance enforcement. While the European Food Safety Authority (EFSA) has issued a positive safety assessment for novel food applications, removing scientific urgency for action, some member states are proceeding with stricter regulatory measures.
Mirizzi acknowledged that while public policies and scientific institutions have been stringent, part of the reaction stems from unethical practices within the sector, such as unsubstantiated health claims on food products or the use of synthetic substances. He emphasised the need for proportionate scrutiny, applied to actual sources of concern, and conducted with transparency to allow legitimate operators to plan effectively. “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,” Mirizzi concluded.
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.
