ANSES proposes that cannabidiol (CBD) be classified as a "presumed human reproductive toxicant"
On the basis of the available studies in animal models showing impaired fertility and development, ANSES has identified the substance CBD as a presumed human reproductive toxicant, and has submitted a proposal for it to be classified in the European CLP Regulation. The scientific dossier is available for public consultation on the website of the European Chemicals Agency (ECHA) until 16 May 2025, for comments or provision of additional information.
Cannabidiol (CBD; CAS No. 13956 29 1) is one of many phytocannabinoids produced by the cannabis or hemp plant (Cannabis sativa L.). Molecules of CBD, as well as delta-9-tetrahydrocannabinol (THC), are mainly found in the plant's flowers and leaves. In France, since 2021, products containing CBD have been exempt from the general ban on narcotics, regardless of their presentation, if they comply with the conditions laid down by the Ministerial Order of 30 December 2021 implementing Article R. 5132-86 of the French Public Health Code.
A booming market for CBD consumer products
The use of CBD has become widespread since 2021. It is marketed in a broad range of everyday consumer products (cosmetics, vaping products, etc.) and is therefore subject to regulations specific to each use.
In France, CBD products are sold by almost 1500 specialist shops and several thousand tobacconists, as well as certain pharmacies and e-commerce websites.
In 2022, 16.4% of adults had consumed CBD at least once in their lives, reflecting the growing prevalence of this substance among the general public.
Adverse effects on fertility and on development of the foetus and breastfed infant
In the spring of 2023, ANSES initiated work on a harmonised classification of CBD. This was carried out at the request of the French competent authority (Directorate General for Labour) in application of European Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP). Harmonised classification at European level ensures that consumers, professionals and companies marketing products have access to clear information on the intrinsic dangers of the substance.
In the course of its work, ANSES noted that CBD was not registered with ECHA in accordance with the REACH Regulation (on registration, evaluation and authorisation of chemicals), despite large production volumes and rapidly growing use. As a result, no assessment of its health risks to humans and the environment is available, even though this is required of manufacturers and importers under REACH. The analysis of the hazards of CBD was therefore based on the scientific literature and the data available for the pre-clinical trials conducted to obtain marketing authorisation in the United States and the European Union for Epidyolex®. This medicine, which contains CBD alone, is indicated as an adjuvant treatment for rare forms of epilepsy in children.
Studies in monkeys, rats and mice have shown adverse effects of CBD on spermatogenesis and fertility, as well as increased perinatal mortality and disrupted neurodevelopment.
On the basis of the weight of evidence accumulated in animals, ANSES is recommending that CBD be classified as follows under the CLP Regulation:
Reproductive toxicity; Category 1B
(H360FD: May damage fertility. May damage the unborn child.
H362: May cause harm to breast-fed children)
A classification proposal submitted for public consultation
On 17 March, the dossier associated with this proposal was submitted for public consultation on ECHA's website, until 16 May 2025. The aim of this consultation is to give all stakeholders the opportunity to comment on this proposal, by providing any additional scientific arguments and information they may have on the substance's hazard properties. Comments can be sent via a dedicated form on the ECHA website.
Following this consultation, the initial proposal, comments received and ANSES's responses to them will be analysed by ECHA’s Committee for Risk Assessment, which will then issue an opinion on the harmonised classification of CBD.
This regulatory process is concerned solely with assessing the hazards of CBD and does not, at this stage, determine the risk management measures applicable to products containing this substance in the various sectors of use. These measures depend on regulations specific to each sector.