ANSES proposes that cannabidiol (CBD) be classified as a presumed human reproductive toxicant
On the basis of the available animal studies showing impaired fertility and development, ANSES has identified the substance CBD as a presumed human reproductive toxicant. It has therefore submitted a proposal for this substance to be classified in the European CLP Regulation. From 17 March 2025, the scientific dossier has been available for public consultation on the website of the European Chemicals Agency (ECHA), for comments or provision of additional information on the substance.
Cannabidiol (CBD; CAS No. 13956 29 1) is one of many phytocannabinoids produced by the cannabis or hemp plant (Cannabis sativa). Unlike delta-9-tetrahydrocannabinol (THC), it is not considered a narcotic, since a 2020 ruling by the Court of Justice of the European Union.
A rapidly growing market for CBD consumer products
The use of CBD has become widespread since 2021, after a specific regulatory framework was established and trials for therapeutic uses were conducted in France. It is marketed on a massive scale in a broad range of consumer products (cosmetics, foods and food supplements, vaping products, etc.) and is therefore subject to specific regulations for each of its uses.
Products containing CBD are distributed by almost 1700 specialist shops (as of 2021), as well as some pharmacies, and are also sold on the Internet. In France in 2022, 16.4% of adults had consumed CBD at least once in their lives, demonstrating the rapid spread of this substance despite it only recently becoming available to the general public.
Therapeutic use of CBD
CBD, alone or in combination with THC, has a number of therapeutic indications, including anti-epileptic and anti-spastic effects.
Only Epidyolex® currently has marketing authorisation in France. This medicine, which contains CBD alone, is indicated for the treatment of epileptic seizures associated with specific disorders in patients who do not respond to the usual treatments.
Presumed adverse effects on fertility and on development of the foetus and breastfed infant
In the spring of 2023, ANSES initiated the procedures to obtain a possible harmonised classification of CBD at European level, to ensure that both consumers and companies marketing products have access to clear information on the possible dangers of this substance. This work was carried out at the request of the French competent authorities (DGT/DGS/DGPR) under European Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP).
CBD is not registered under the REACh Regulation, despite large production volumes and rapidly growing uses. This means that no regulatory assessment (as would be required by REACh) of its health risks to humans and the environment is available. To analyse the hazards of CBD, ANSES examined the scientific literature and the data produced for trials conducted for the authorisation of Epidyolex® in the United States and the European Union.
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 these results obtained in animals, ANSES is recommending that CBD be classified and labelled 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)
Classification proposal submitted for public consultation
The dossier associated with this proposal has been submitted for public consultation on ECHA's website until 16 May 2025. This consultation aims to give all stakeholders the opportunity to comment on these proposals, by providing any additional scientific arguments and information they may have. Comments can be sent via a dedicated form on the ECHA website.
Following this consultation stage, the initial proposal, comments and ANSES's responses to them will be analysed by ECHA’s Committee for Risk Assessment, which will then issue its opinion on updating the classification of CBD.
This scientific process does not prejudge any possible consequences in terms of risk management in accordance with the sector-specific regulatory provisions in force.