EU Regulators in the CBD Reclassification process
ECHA (European Chemicals Agency) issued an opinion classifying CBD (cannabidiol) as a reproduction toxicant. The decision has created a regulatory challenge in the European industrial hemp market. If fully implemented, this decision could have significant implications for EU cosmetics, who use CBD in a variety of products. Francesco Mirizzi (Managing Director, European Industrial Hemp Association, EIHA) clarified the fact that the process has not been completed. He stated, “The opinions adopted by ECHA’s Risk Assessment Committee are scientific hazards assessments and do not automatically translate to any bans of CBD products within the EU.”
It usually takes the European Commission between three and nine months to release a draft of a decision in response to an ECHA’s opinion. After consultation, the draft goes through a regulatory process. According to, CBD products will not be banned before the middle of 2027. GN: industrial hemp. Hemp Gazette has reported previously that ECHA’s initial decision had put the sector in the know about potential market effects.
Dual Strategy of Industry Against CBD Classification
EIHA has developed two lines of parallel action in response to the proposed CBD reclassification.
- Challenge the classification: EIHA will advocate for the reclassification CBD from category 1B into Category 2. While Category 2 is indicative of probable toxicity to reproductive systems, Category 1B signifies confirmed reproductive toxicology. The Scientific Committee on Consumer Safety can give a positive recommendation for the continued use of a substance in Category 2. CBD is currently rated as safe for cosmetic application by the SCCS.
- Looking for specific Exemptions EIHA intends to request an exemption from Article 15 EU Cosmetics Regulation. Article 15 of the EU Cosmetics Regulation prohibits cosmetics from using substances that are classified as Carcinogenic (CMR), Mutagenic or Reproductively Toxicant (1A or 1B). However, it also contains provisions for exemptions.
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.”
Science and economic impact
The adverse effects cited by ANSES (a French institution that is the main opponent to this case) are derived in part from studies involving Epidiolex, a pharmaceutical product. In these trials, CBD was administered to rats in doses as high as 300mg/kg of body weight. EIHA asserts that these levels do not correspond to concentrations commonly found in cosmetic products. This association, in collaboration with a European Cosmetics regulatory affairs consultant, is developing a document that presents this argument. The funding for the project will be pooled by EIHA members.
It is a matter of considerable economic importance. EU CBD skin-care market is worth over $750m. It would remove a major revenue source for many companies, especially those that are primarily focused on cosmetics.
Broader regulatory context, industry behavior and
In addition to the CBD reclassification in the EU, regulatory environments are tightening. France mandates the removal of CBD-containing food supplements that do not have novel food authorization. This will take effect on May 15. Mirizzi pointed out that this decision was based on the ANSES conclusions, which were later confirmed by ECHA. This has contributed to France’s improved market compliance enforcement. While the European Food Safety Authority, (EFSA), has published a positive evaluation of safety for novel applications in food, removing any scientific urgency, some members states continue to implement stricter regulations.
Mirizzi admitted that, while the public policy and scientific institutions were strict, part of this reaction was due to unethical practice within the industry, like unsubstantiated claims of health on food or the use synthetic substances. He stressed the importance of a proportionate level of scrutiny that is applied only to real sources for concern and carried out in a transparent manner to enable legitimate operators to make effective plans. “We think it’s important that regulatory discussions in the future are transparent and take into consideration scientific evidence, realistic risk scenarios, as well as economic effects for a industry that already operates under considerable regulatory uncertainty,” concluded Mirizzi.
Disclaimer: The information contained in this article does not constitute medical advice. Hemp Gazette is not a medical provider and does not offer diagnoses or treatment plans. Before making decisions about your health, or any other medical conditions, always consult with a qualified healthcare provider. The Therapeutic Goods Administration in Australia (TGA) has not evaluated any statements regarding the therapeutic use of cannabis or hemp-derived products. TGA regulates the access to medical cannabis in Australia.