The cannabidiol, CBD, an active substance most often of natural origin, is one of the phyto-cannabinoids. CBD, as the tétrahydrocannabinol (THC), is present in the cannabis flowers and leaves. It is a non-addictive psychotropic drug, unlike THC. It is also a component in the form of an extract, medicine, or everyday consumer products, only some of which are authorised in France under specific conditions of THC content. In addition, CBD is considered at European level as a novel food whose safety is currently being assessed by EFSA.
Regulatory context of CBD and products containing CBD in France
In France, the regulation around the CBD was governed by the law n° 70-1320 of December 31, 1970 relating to health measures to fight against drug addiction, and to the repression of the traffic and the illicit use of poisonous substances. According to this law, any product that contains THC at a rate greater than 0.2% is considered a narcotic and is therefore illegal.
The decree of December 30, 2021 clarifies the rules applicable to the agricultural and economic sectors and supplements the regulations applicable to the different types of products placed on the market. In particular, it provides that the THC content of products obtained from Cannabis sativa should not exceed 0.30%. Thus, all products containing more than 0.30% THC are considered narcotics and therefore prohibited.
The Juge des Référés of the Council of State temporarily suspended, pending the decision on the merits, the measure prohibiting the marketing and consumption of raw flowers and leaves of cannabis varieties without narcotic properties (THC content below 0.3%) by order on Monday 24 January 2022. On 29 December 2022, the Council of State ruled on the merits and annulled the provision of the order of 30 December 2021 prohibiting the sale of cannabis flowers and leaves with a THC (tetrahydrocannabinol) content below 0.3%. The government has taken note of this decision and interministerial work has been initiated to complete, in the light of the Council of State’s considerations, the provisions of the order of 30 December 2021 which remain in force.
At the European level, CBD is a novel food
Furthermore, at the European level, the European Commission, following the decision of the European Court of Justice of 19 November 2019 (cp200141en) has determined that cannabidiol can be considered a novel food and as such its safety for consumption by the general population needs to be assessed by EFSA. The European Food Safety Authority (EFSA) has currently received 19 dossiers. In June 2022, EFSA suspended the evaluation of CBD pending further data. Professor Dominique Turck, Chair of the NDA panel, said: “We have identified several potential hazards associated with the consumption of CBD and have determined that the many gaps in the available data regarding these health effects should be filled before these assessments can continue. It is important to emphasize at this stage that we have not concluded that CBD is harmful as a food.”
Opinion of health experts in France
The National Academy of Medicine has spoken out on CBD products. The National Academy of Medicine has drawn attention to the risks of using CBD and has suggested that:
- “information on the packaging of non-pharmaceutical products containing CBD be improved: risk of drug interactions; procedure for reporting adverse effect; risks associated with driving; risk of testing positive for THC in the context of road safety or sport;
- users are informed of the dose in milligrams of CBD consumed per intake, and that, if it exceeds 50 mg/day, this intake is preceded, in the event of ongoing drug treatment, by prior research, with a health professional ( doctor, pharmacist), possible drug interactions, and does not lead to discontinuation of drug treatment;
- given the diversity of products containing CBD, the regulations and conditions of access to these products are harmonised, so that users have information, or even appropriate support, in the event of use of these products;
- finally, that research explores the hypothesis that the consumption of smoked CBD may constitute a behavioral incentive to use cigarettes (tobacco or cannabis).”
In addition, the National Order of Pharmacists on May 2022 has also prepared an overview on CBD containing products on the basis of the information sheet on CBD published by the Mission interministérielle de lutte contre les drogues et les conduites addictives (MILDECA). On this document, the MILDECA has referenced products with CBD, or CBD extract, or Cannabis sativa parts ,authorized or not authorized, in the cosmetic domains, and the smoking liquids.
To find out more, you can consult:
- the press release of the Academy of Medicine,
- the MILDECA information sheet,
- the decision of the Council of State.
Orchidali can assist you in monitoring and drafting regulatory files.
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CBD in France
The cannabidiol, CBD, an active substance most often of natural origin, is one of the phyto-cannabinoids. CBD, as the tétrahydrocannabinol (THC), is present in the cannabis flowers and leaves. It is a non-addictive psychotropic drug, unlike THC. It is also a component in the form of an extract, medicine, or everyday consumer products, only some of which are authorised in France under specific conditions of THC content. In addition, CBD is considered at European level as a novel food whose safety is currently being assessed by EFSA.
Regulatory context of CBD and products containing CBD in France
In France, the regulation around the CBD was governed by the law n° 70-1320 of December 31, 1970 relating to health measures to fight against drug addiction, and to the repression of the traffic and the illicit use of poisonous substances. According to this law, any product that contains THC at a rate greater than 0.2% is considered a narcotic and is therefore illegal.
The decree of December 30, 2021 clarifies the rules applicable to the agricultural and economic sectors and supplements the regulations applicable to the different types of products placed on the market. In particular, it provides that the THC content of products obtained from Cannabis sativa should not exceed 0.30%. Thus, all products containing more than 0.30% THC are considered narcotics and therefore prohibited.
The Juge des Référés of the Council of State temporarily suspended, pending the decision on the merits, the measure prohibiting the marketing and consumption of raw flowers and leaves of cannabis varieties without narcotic properties (THC content below 0.3%) by order on Monday 24 January 2022. On 29 December 2022, the Council of State ruled on the merits and annulled the provision of the order of 30 December 2021 prohibiting the sale of cannabis flowers and leaves with a THC (tetrahydrocannabinol) content below 0.3%. The government has taken note of this decision and interministerial work has been initiated to complete, in the light of the Council of State’s considerations, the provisions of the order of 30 December 2021 which remain in force.
At the European level, CBD is a novel food
Furthermore, at the European level, the European Commission, following the decision of the European Court of Justice of 19 November 2019 (cp200141en) has determined that cannabidiol can be considered a novel food and as such its safety for consumption by the general population needs to be assessed by EFSA. The European Food Safety Authority (EFSA) has currently received 19 dossiers. In June 2022, EFSA suspended the evaluation of CBD pending further data. Professor Dominique Turck, Chair of the NDA panel, said: “We have identified several potential hazards associated with the consumption of CBD and have determined that the many gaps in the available data regarding these health effects should be filled before these assessments can continue. It is important to emphasize at this stage that we have not concluded that CBD is harmful as a food.”
Opinion of health experts in France
The National Academy of Medicine has spoken out on CBD products. The National Academy of Medicine has drawn attention to the risks of using CBD and has suggested that:
In addition, the National Order of Pharmacists on May 2022 has also prepared an overview on CBD containing products on the basis of the information sheet on CBD published by the Mission interministérielle de lutte contre les drogues et les conduites addictives (MILDECA). On this document, the MILDECA has referenced products with CBD, or CBD extract, or Cannabis sativa parts ,authorized or not authorized, in the cosmetic domains, and the smoking liquids.
To find out more, you can consult:
Orchidali can assist you in monitoring and drafting regulatory files.
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