The French Agency for Food, Environmental and Occupational Health & Safety (ANSES) has proposed a strict classification of cannabidiol under European chemicals regulations that would remove the ingredient from the region’s wellness and cosmetics markets.
“Studies in monkeys, rats, and mice have shown adverse effects of CBD on spermatogenesis and fertility, as well as increased perinatal mortality and alterations in neurodevelopment,” ANSES notes in the announcement.
“Based on the weight of evidence accumulated in animals, ANSES proposes that CBD be classified as follows under the European Union classification, labelling and packaging of substances and mixtures (CLP Regulation): Reproductive toxicity; category 1B (H360FD: May damage fertility. May harm the unborn child. H362: May be harmful to breast-fed babies).”
Reproductive toxicity category 1B would mean an effective ban on CBD in cosmetics and foods. The European CBD skincare market alone was worth just under $750m in 2024 and is expected to grow by 20% by 2030, according to Grand View Research.
The proposal is out for public consultation on the European Chemicals Agency’s (ECHA’s) website until 16 May 2025.
‘Ridiculous’ Move
French hemp industry association UIVEC called the move “ridiculous.”
UIVEC criticized ANSES for using only data from prescription drug Epidyolex, which uses doses far higher than would be found in cosmetics or foods.
After beginning work on a harmonized classification of CBD in April 2023, ANSES found that CBD was not registered with ECHA in accordance with the Registration, Evaluation, and Authorization of Chemicals (REACH) regulation, despite its significant production and rapidly growing use.
“Consequently, no health and environmental risk assessment was available, even though this is required of manufacturers and importers under REACH.”
ANSES therefore carried out its own hazard analysis using scientific literature and data available for preclinical trials conducted as part of the marketing authorization for Epidyolex in the US and the European Union.
Ban Unlikely
UIVEC said a category 1B classification would be the “worst case scenario,” but expected a lower classification, if any, which would perhaps mean a reproductive toxicity hazard warning label on pure CBD supplied to the manufacturers who make CBD cosmetic and food products.
UIVEC hopes that new evidence coming out of a European Commission Scientific Committee on Consumer Safety (SCCS) review will put the issue to bed before any classification is mooted by the CLP.
Due to what it said was “very limited available information regarding the safety of CBD in cosmetic products”, the EC issued a call for data to collect relevant scientific information that ended in September 2024.
Based on this data, the EC has asked the SCCS to assess the maximum concentration of CBD that is considered safe when used in cosmetic products and to identify the maximum safe level of Delta-9-tetrahydrocannabinol (THC) present as a contaminant in CBD preparations.
The EC also wants to know if the SCCS has “any further scientific concerns with regard to the use of CBD and the possible non-intended presence at trace levels of other cannabinoids, including THC, in cosmetic products.”
“There’s a lot of data that’s available to give an answer to what ANSES has been claiming,” UIVEC commented. “So, hopefully this process will die down somewhat.”
UIVEC Response
The association is working on its own submission to the ECHA consultation and welcomes contributions from HBW Insight readers. UIVEC can be reached at: contact@uivec.org
