CBD (cannabidiol) as a ‘cosmetic’ could soon be banned in the European Union amid efforts from France to classify it as a reprotoxic substance.
On September 11, France issued a proposal to the European Chemicals Agency (ECHA) to classify CBD as a ‘carcinogenic, mutagenic, or reprotoxic (CMR) substance’, based on what it says is its potential ‘reproductive toxicity’.
The proposal, which was first announced in June last year, has seen the ECHA issue a call for data on the safety of pure CBD and extracts that may contain contaminants like THC to establish the safety of the substances when used as a cosmetic ingredient.
While some research, including a 2019 FDA literature review, suggests CBD could potentially cause male reproductive toxicity in animals, the CEO and founder of Paris-based cannabis consultancy Augur Associates, Benjamin-Alexandre Jeanroy, says this proposal may be driven more by politics than science.
What happened?
The ECHA published France’s intention to introduce a ‘harmonised classification labelling (CLH)’ for CBD, a process which is designed to ensure the consistent labelling, and effectively manage any potential risks.
The French proposal focuses on CBD’s potential reproductive toxicity, referring the adverse effects of a substance on any aspect of the reproductive cycle, including the impairment of reproductive function and the induction of adverse effects in the embryo.
It forms part of a wider effort by the Scientific Committee on Consumer Safety (SCCS) to establish harmonised standards across the block and regulate the use novel ingredients in cosmetic products.
Since 2021, CBD has been included in the Cosmetic Ingredient Database (CosIng) the official database of cosmetic ingredients in the EU, under two separate entries covering both synthetically produced CBD and CBD derived from extraction.
Under the listing, it notes that CBD can potentially be used for its antioxidant, anti-sebum, and skin protection properties.
While CBD is permitted for use in cosmetic products, no full regulations have yet been determined, placing the substance in a grey area which will be familiar for any CBD business operating in Europe.
The ultimate decision on the future of CBD in Europe will be made by the CSSC, which could prohibit its use in cosmetics altogether if submitted evidence confirms its toxicity, but a positive opinion from the regulatory body could also solidify its future usage.
Its investigation will involve several steps, including dossier submission, consultation and the development of a final opinion from the Committee for Risk Assessment.
What’s behind France’s proposal?
Over the past few year’s, France has had a turbulent relationship with CBD, and this is not the first time it has attempted to limit its usage or ban it entirely.
Most notable was 2020’s Kanavape case, which saw the European Court of Justice rule that French authorities had acted unlawfully in prosecuting two businessmen who imported CBD flowers from the Czech Republic in 2014 – as CBD is ‘not a narcotic’.
This attempt to crack down on CBD backfired, and set a legal precedent that has come to the rescue of many CBD companies prosecuted in Europe over the last few years.
According to Mr Jeanroy, this case could follow a similar track.
“The way French authorities have handled cannabis and hemp in recent years has often put politics before science, with science sometimes being used to justify specific policies they wanted to push forward,” he told Business of Cannabis.
“The question is, why is France doing this? I think it needs to be placed in the context of France’s involvement over the past decade, especially since Macron’s presidency, which has largely been a force of conservatism on these issues.”
He explained that he had since seen this conservative stance play out ‘first hand’ during a drug policy meeting organised by the Czech Presidency of the Council of the European Union two years ago.
“This was the first time cannabis was at the center of such discussions. What I observed was that France was not a major help, and in fact, acted more as a force to preserve the status quo in this forum. We’ve seen this before, in efforts to restrict the use of cannabis flower, and now with France pushing to limit the legality of CBD in the European Union.”
Furthermore, he points out that these issued are primarily handled by France’s Interministerial Mission on Drugs and Addictions (MILDECA), which is under the authority of the Prime Minister but heavily influenced by the Interior Ministry.
Since Nicolas Prisse’s tenure as president of MILDECA, he says the agency has been a force for maintaining the status quo, especially in keeping cannabis prohibition in place and restricting its legal use to the maximum extent.
Given that this decision will be made by the EU, he added that it is worth considering France’s influence at an international level, which he believes is waning.
“It’s a collective process, so it will depend on how much influence France has… It seems that they haven’t had a lot of success in the past in regards to closing up the markets and the different uses for CBD.
“Taking into account the apparent loss of influence of France in the new configuration after the European elections, including the retractation of France candidates for the President of the Commission, there is a definitive sense that France is losing influence within the European Union in some capacity, and therefore that that does not bode well for it.
“So, while this is an important topic for France, I’m not sure it will have the impact they expect.”