By Joerg Gruenwald, analyze & realize ag01.19.21
When industrial hemp first appeared on the radar in Europe, it was exempt from the scope of the UN’s Single Convention of 1961, meaning that, other than its relative marijuana, it was not per se considered a drug. Neither was its constituent cannabidiol (CBD) considered a narcotic, in contrast to the other famous hemp compound, tetrahydrocannabinol (THC), which is contained in industrial hemp in very small amounts only (below 0.3%). Varieties that contain 0.2% THC or less are legal to be cultivated in the EU. Any hemp product that contains more than that is considered a narcotic, and can therefore not be sold as a food or a food/dietary supplement.
CBD, both the extract from hemp and the synthetic form, was initially considered novel food though, which led to a number of novel food applications for marketing authorization. This was nipped in the bud by the preliminary decision by the EU Commission to consider CBD derived from the plant a narcotic, a decision that effectively removed CBD from the purview of food and into the drug space. Synthetic CBD was not affected by this rule, and novel food applications for it could proceed as planned.
The rationale behind this decision by the EU Commission was that it could not be ruled out that trace amounts of THC remained in CBD extracts, and depending on the respective extract, this trace amount might reach critical levels. The burgeoning CBD market was thus excluded from all food categories and reduced to cosmetics and, of course, vaporizers.
Reopening the Door
But a recent decision by the Court of Justice of the European Union (CJEU) has finally restored CBD’s status, and with it, the prospects of the entire industry. Interestingly enough, the decision was reached in the context of a Mutual Recognition case when a CBD oil lawfully made from the whole hemp plant in the Czech Republic was not allowed market access in France. French law, being on the stricter end of the national legislation scale in the EU, prohibits the sale of CBD unless it is extracted from hemp fiber and seeds only.
The CJEU ruled that a Member State may not prohibit the marketing of CBD lawfully produced in another Member State, as the provisions on the free movement of goods within the EU are of course also applicable to CBD. In this context, the court also ruled that CBD cannot be regarded as a “narcotic drug” as it “does not appear to have any psychotropic effect or any harmful effect on human health.”
Much Needed Harmonization
This crucial decision for the CBD industry will not only lead to all the stopped novel food applications for hemp extracts being revived. It will also bring much needed harmonization to the EU market, which was sorely lacking before, as the French situation described demonstrates. With its decision, the CJEU has stated that EU Member States may not prohibit the marketing of lawfully supplied CBD products from anywhere in the EU unless there are valid safety concerns.
Of course, the EU Commission’s decision on the CBD status will have to formally be overturned first, but industry insiders consider it likely this will happen now that the EU’s highest court has ruled on the matter. The Commission has already stated that it will “carefully assess the judgement.” A harmonization of cannabinoid regulations throughout the EU is expected to follow. Safety assessments and standards developed by the hemp industry, combined with successful novel food applications, will eventually lead to legally marketable CBD products all over Europe in three years at the latest.
The only remaining stumbling blocks are the CBD rulings in the individual EU states. Some countries such as Italy consider all CBD products medicines, although Italy’s Ministry of Health only recently revoked this decree. It is important to note in this context that the CJEU’s decision supersedes national legislation, so at least with regards to CBD not being a narcotic, Member States can now no longer ban the sale of these products within the food space.
Joerg Gruenwald
analyze & realize ag
Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: jgruenwald@a-r.com; Website: www.analyze-realize.com.
CBD, both the extract from hemp and the synthetic form, was initially considered novel food though, which led to a number of novel food applications for marketing authorization. This was nipped in the bud by the preliminary decision by the EU Commission to consider CBD derived from the plant a narcotic, a decision that effectively removed CBD from the purview of food and into the drug space. Synthetic CBD was not affected by this rule, and novel food applications for it could proceed as planned.
The rationale behind this decision by the EU Commission was that it could not be ruled out that trace amounts of THC remained in CBD extracts, and depending on the respective extract, this trace amount might reach critical levels. The burgeoning CBD market was thus excluded from all food categories and reduced to cosmetics and, of course, vaporizers.
Reopening the Door
But a recent decision by the Court of Justice of the European Union (CJEU) has finally restored CBD’s status, and with it, the prospects of the entire industry. Interestingly enough, the decision was reached in the context of a Mutual Recognition case when a CBD oil lawfully made from the whole hemp plant in the Czech Republic was not allowed market access in France. French law, being on the stricter end of the national legislation scale in the EU, prohibits the sale of CBD unless it is extracted from hemp fiber and seeds only.
The CJEU ruled that a Member State may not prohibit the marketing of CBD lawfully produced in another Member State, as the provisions on the free movement of goods within the EU are of course also applicable to CBD. In this context, the court also ruled that CBD cannot be regarded as a “narcotic drug” as it “does not appear to have any psychotropic effect or any harmful effect on human health.”
Much Needed Harmonization
This crucial decision for the CBD industry will not only lead to all the stopped novel food applications for hemp extracts being revived. It will also bring much needed harmonization to the EU market, which was sorely lacking before, as the French situation described demonstrates. With its decision, the CJEU has stated that EU Member States may not prohibit the marketing of lawfully supplied CBD products from anywhere in the EU unless there are valid safety concerns.
Of course, the EU Commission’s decision on the CBD status will have to formally be overturned first, but industry insiders consider it likely this will happen now that the EU’s highest court has ruled on the matter. The Commission has already stated that it will “carefully assess the judgement.” A harmonization of cannabinoid regulations throughout the EU is expected to follow. Safety assessments and standards developed by the hemp industry, combined with successful novel food applications, will eventually lead to legally marketable CBD products all over Europe in three years at the latest.
The only remaining stumbling blocks are the CBD rulings in the individual EU states. Some countries such as Italy consider all CBD products medicines, although Italy’s Ministry of Health only recently revoked this decree. It is important to note in this context that the CJEU’s decision supersedes national legislation, so at least with regards to CBD not being a narcotic, Member States can now no longer ban the sale of these products within the food space.
Joerg Gruenwald
analyze & realize ag
Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: jgruenwald@a-r.com; Website: www.analyze-realize.com.
