🇫🇷 France Needs to Revise its Hemp Regulations If It Wants to Comply with EU Law

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ACTIVEurope

9 min readFeb 19, 2019

Are French hemp regulations compliant with EU law?

On 23 October 2018, the Court of Appeal of Aix-en-Provence (France) referred a preliminary question to the Court of Justice of the European Union (CJEU), asking it to confirm whether the French regulations surrounding the cultivation and marketing of hemp (the cannabis plant) are compliant with EU law or not. The specificity of the French regulations is that they restrict the cultivation and marketing of hemp-based products to products derived from specific parts of the plant (seeds and fiber) only.

What is hemp?

Cannabis and its derivatives (e.g. the cannabis resin, THC, etc.) are often simply referred to as the third largest family of natural drugs, and by far the most consumed drugs in the world, and therefore strictly regulated at the international and national level. However, there are different species of the cannabis plant (e.g. Cannabis sativa, Cannabis indica, Cannabis ruderalis) and considerable differences between cannabis varieties in terms of concentration of active substances (cannabinoids).
The industrial hemp plant, Cannabis sativa L., is one of the cannabis plant species. It differs from other cannabis plants in genetic make-up, and in particular, the genes for cannabinoid production (the hemp plant does not contain major genes allowing for the production of the psychoactive substance tetrahydrocannabinol (THC), and also tends to contain higher levels of other — non-psychoactive — cannabinoids). In the European Union, Cannabis sativa plants with a concentration of 0.2% or less THC are generally referred to as “hemp”[1], the cultivation of which is allowed for industrial purposes.

Dissecting the Hemp plant and French regulations: a difficult task

The case dates back to 2014 when two entrepreneurs launched Kanavape, a CBD-based electronic cigarette (without nicotine). The CBD used in Kanavape was extracted from hemp plants legitimately cultivated in the Czech Republic in accordance with EU law.

The legislation regarding the extraction of CBD from the hemp plant is different from one EU country to another. The CBD used in Kanavape was extracted from the whole hemp plant in accordance with the applicable Czech legislation. Using the whole plant is much more interesting because the quantity of CBD is higher in some parts of the plant than in others (the flowers for instance). In France however, it is illegal to exploit the whole hemp plant. Both entrepreneurs were thus accused of having used the whole hemp plant to gather the necessary quantity of CBD for their products.

Indeed, France has a specific derogation which is rendered possible by paragraph II of Article R. 5132–86 PHC. It was inserted in French law by means of the 22nd of August 1990 Implementing Order on cannabis which specifically authorizes:

"the cultivation, importation, exportation and industrial and commercial use (fibers and seeds) of varieties of Cannabis sativa L. satisfying the following criteria: (i) the delta-9-tetrahydrocannabinol content of these varieties is not greater than 0.20% (ii) the determination of the delta-9-THC content and the taking of samples for that determination shall be carried out in accordance with the European Community method provided for in the Annex […]”

These provisions excel in ambiguity.
What constitutes an “industrial and commercial use”? How restrictive is the reference to “fibers and seeds”? Is the mention “fibers and seeds” a mere expression to differentiate “hemp for fiber” (meaning for commercial and industrial use) from “cannabis for drugs”? And to what extent does it limit the use of these parts of the hemp plant?

What is the difference between CBD and THC?
· Tetrahydrocannabinol (THC), and more specifically delta-9-tetrahydrocannabinol, is the principal psychotropic constituent of the cannabis/hemp plant, responsible for its psychotropic effect, and listed as a psychotropic substance under international and French law.
· Cannabidiol (CBD) is another cannabinoid naturally found in cannabis/hemp plants, which — in contrast with THC — is not deemed a psychotropic constituent and not listed as a narcotic or psychotropic substance under international or French law.
Source : European Industrial Hemp Association

Where does CBD come from in the Hemp plant and why is it important?

First, it is important to highlight, that the products commercialized by Kanavape did not contain THC

Most importantly, the most prominent international reference body, the World Health Organisation’s (WHO) Expert Committee on Drug Dependence (ECDD) holds the opinion that “CBD does not appear to have abuse potential or cause harm”, that “there is no evidence of any public health-related problems associated with the use of pure CBD” and therefore advised against the scheduling of the substance (in June 2018).

Moreover, French farmers are allowed to grow industrial hemp. In fact, France is one of the most important EU producers with the Netherlands. Yet, the regulation surrounding the exploitation and commercialization of industrial hemp only allows the exploitation and commercialization of the plant’s fibers and seeds. CBD can in principle be extracted from all parts of the plant, including the flowering or fruiting tops, as well as the leaves, fibers, seeds, and stalks. However, extraction from fibers and seeds is not economically viable and technically reliable given the very low content of CBD therein.

More about CBD from the World Health Organisation (WHO) :
In its November 2017 Meeting, the WHO Expert Committee on Drug Dependence (ECDD) considered that CBD is generally well tolerated with a good safety profile and concluded that “in its pure state, CBD does not appear to have abuse potential or cause harm” and “current information […] does not justify scheduling of the substance.”
1. This position has been confirmed by the ECDD in its comprehensive Critical Review Report of CBD of June 2018, which summarizes that “there is no evidence of recreational use of CBD or any public health-related problems associated with the use of pure CBD.”
2. The ECDD therefore recommended that “preparations considered to be pure CBD not be placed under international drug control as the substance was not found to have psychoactive properties, and presents no potential for abuse or dependence.
The ECDD’s Critical Review Report on CBD, 4–8 June 2018 is available here.
For more information, check out the WHO ECDD Q&A Review of cannabis, August 2018, available here.
See also WHO ECDD, Fortieth Report, 23 July 2018, available here.

France vs EU laws — The specter haunting regulators and professionals

The issue at stake in the Kanavape case is the compliance of French law, which imposes a total ban on all hemp flowers with EU law and more specifically with the EU framework regulating the cultivation of hemp, which ensures that only non-psychotropic (‘non-drug’) varieties are cultivated and traded in the EU.

By ensuring that only non-psychotropic varieties are cultivated and traded in the EU, it appears that EU law sufficiently addresses public health risks constituted by the use of drugs. France thus cannot justify the ban on the basis of public health reasons. Moreover, by preventing the commercialization of a product lawfully produced and marketed in another EU member state, France violates the fundamental EU principle of free movement of goods.

What does the principle of free movement of goods in the EU involve?
· Any product lawfully produced and marketed in another EU member state must, in principle, be admitted to the market of any other member state.
· In the absence of EU harmonization measures, member states cannot prohibit products that are legally produced and marketed in other member states to be marketed in their territories.
· When these are justified by general, non-economic considerations such as public health, public security, public policy or public morality.
· Member states cannot use national measures as a means of arbitrary discrimination or disguised restriction on intra-EU trade, and must not go beyond the necessary level.
Source: French Gouvernement

Because justice is slower than innovation, we shouldn’t wait to regulate

France should anticipate and launch a public discussion on the creation and professionalization of a national wellbeing hemp industry

For the French Courts to assess whether France is applying EU law correctly is a very serious matter. For this reason, the EU Court of Justice will have to help French courts interpret if the French regulatory framework complies with EU law or not. By referring a preliminary question to the CJEU, the Aix-en-Provence Court of Appeal has expressly put the compatibility of French law with EU law into question. This aligns with the position paper that ACTIVE , the 1st pan-European CBD Trade Association provided to the French Interministerial Mission for Combating Drugs and Addictive Behaviours (MILDECA) back in September 2018.

What is a preliminary question and how does the CJEU deal with it?
The CJEU rules on cases brought before it. One of the most common types of cases is:
Interpreting the law through preliminary rulings under Article 267 of the Treaty on the Functioning of the EU (TFEU) — national courts of EU member states are required to ensure that EU law is properly applied at the national level. However, courts in different countries might interpret it differently. Every national court can request a preliminary ruling regarding the interpretation and application of EU law vis-à-vis national measures, if it considers it necessary for delivering its judgement. The same mechanism can be used to determine whether a national law or practice is compatible with EU law.
Source: European Union

On February 8th, 2019, Jean-Baptiste Moreau, a French MP tweeted the following forward-looking statement:

“The ECJ’s decision will be crucial in determining the way the legislation surrounding the commercialization of CBD evolves. It could lead to the condemnation of France which has an extremely rigid legal framework for cannabis-based products. It is thus essential that we anticipate and launch a discussion on the subject.”

Smart Regulation— the way forward

At ACTIVE, we believe that in the interest of everyone: users, professionals and regulators, the French authorities should by no means wait for the CJEU’s ruling to adopt an adjusted regulatory framework in order to secure the safe use of CBD based products.

The demand for CBD products (e-liquids, food, cosmetics) is increasing at a very rapid rate. The exponential demand for CBD is meeting with a total lack of regulation. It is without a doubt that many people will be affected by this legal loophole if it is not dealt with. In the digital age, it is not unusual that people affected by neurological disorders such as epilepsy decide, most of the time out of despair, to buy non-compliant and even dangerous CBD products online. In order to avoid potentially dangerous products being bought, France needs to provide an immediate regulatory response.

For instance, France could put in place a three-tier regulatory framework depending on the level of CBD to be administered or used, as suggested by the European Industrial Hemp Association (EIHA) :

In high dosages, CBD can be considered as medicine and needs to be regulated accordingly. This is what the National Drug Agency (ANSM) is currently working on.
In physiological doses, CBD needs to be sold without a prescription or as a dietary supplement. This approach has already been adopted for a wide variety of substances such as valerian, glucosamine, chondroitin (sulfate), Ginkgo biloba, as well as some vitamins and iron-based products.
In smaller dosages, CBD needs to be authorized without any restrictions in food products or e-liquids for electronic cigarettes.

If you share the opinion that it is essential to empower European companies to join together to develop the legal framework for CBD products; we want to hear from you.

Why Join ACTIVE ?

Write to our Executive Director, Laurène Tran laurene@tradeactive.org

About Us

ACTIVE (Association for Cannabinoids, Terpenes, and Innovative Ventures in Europe) is the first pan-European trade association for cannabinoids and terpenes uniting companies, scientists, thought leaders, and investors in key European markets. We protect, educate, and connect stakeholders with a stake in medical cannabis and wellness hemp to coordinate a unified voice.