In mid-April this year, the European Commission published a statement confirming that cannabidiol (CBD) and other cannabinoids derived from the plant Cannabis sativa L. (hemp) are considered novel foods under Regulation (EU) 2015/2283 of the European Parliament and of the Council of the European Union on 25 November 2015 on novel foods[1] (the “Novel Food Regulation“), which cannot be placed on the European Union market.
Following the declaration of the European Commission, the State Agricultural and Food Inspection Authority (hereinafter the “SAFI”) is currently preparing measures that will reflect it in the legal regulation of the production and marketing of food and food supplements containing these ingredients.
In this article, we would like to introduce You to the issue of the use of the Cannabis sativa L. (hemp) plant in general, including the possibility of using this plant and its cannabinoids in food and food supplements, and outline further expected legislative developments in this area.
Technical cannabis
According to Section 2 (1) (g) of Act No. 167/1998 Coll., on Addictive Substances (hereinafter the “Addictive Substances Act”), technical cannabis is defined as cannabis from a plant from which cannabis containing no more than 1 % of THC substances can be obtained or which comes from seed of varieties listed in the Common Catalogue of Varieties of Agricultural Plant Species, which is valid in all Member States of the European Union.
According to Section 2 (1) (a) of the Act on Addictive Substances, addictive substances are narcotic substances and psychotropic substances of natural or synthetic origin that have psychoactive effects and are also listed in one of the Annexes 1 to 7 of Government Regulation No. 463/2013 Coll., on the lists of addictive substances, as amended, with the exception of cannabis extract and tincture, which contains no more than 1 % of substances from the THC group and meets the safety condition.
At the same time, however, it is necessary to keep in mind Article 1 (b) of the 1961 United Nations Single Convention (UN) on Narcotic Drugs, as amended by the 1972 Protocol, promulgated in the Collection of Acts of the Czech Republic under No. 47/1965 Coll. (hereinafter the “Convention on Narcotic Drugs”), according to which the flowering or fruiting tops of the cannabis plant (excluding grains and leaves which do not have tops) from which the resin has not been excluded, irrespective of its use, are considered to be a narcotic substance.
The above definition implies that the tops or parts of plants with tops are always considered an intoxicant, regardless of THC content.
In the context of the relevant statutory definitions, technical cannabis is therefore not considered an intoxicant (addictive substance) if it is:
- technical cannabis containing not more than 1 % THC, which at the same time
- meets the safety condition, and at the same time
- comes from a part other than the flowering or fruiting top of the plant.
Technical cannabis that cumulatively fulfils the above conditions can be legally cultivated and processed, including for food production, cosmetics, etc.
Legal restrictions
The legislative restrictions under the Addictive Substances Act, which generally apply to the handling of cannabis, again reflect the 1 % THC threshold, above which strict conditions are imposed for any handling of cannabis, including the need to obtain a handling permit from the Ministry of Health. In this context, Article 5 (5) of the Act on Addictive Substances expressly provides that no permit is required for the handling of technical cannabis plants or technical cannabis, in particular for industrial, food, cosmetic, technical, or horticultural purposes.
Potential use of cannabis in food and food supplements
a) Czech Republic
According to Section 10 (1) (f) of Act No. 110/1997 Coll., on Food and Tobacco Products, as amended (hereinafter the “Food Act”), it is prohibited to place food (i.e. also food supplements) on the market containing substances in violation of the requirements for the composition of food supplements or substances prohibited in the production of food pursuant to Ordinance No. 58/2018 Coll., on Food Supplements and Food Composition, as amended (hereinafter the “Ordinance on Food Supplements and Food Composition”).
Ordinance on Food Supplements and Food Composition provides in its Section 5 for general requirements for the composition of food, whereby, among other things, narcotic drugs or psychotropic substances may not be added to food, either singly or in a mixture within the meaning of the Act on Addictive Substances, precursors of category 1 of Annex I to Regulation (EC) No. 273/2004 of the European Parliament and the Council on 11 February 2004 on drug precursors and other substances which have been proven to have a toxic, genotoxic, teratogenic, hallucinogenic, narcotic or other adverse effect on the human body may not be added to food individually or I mixture.
In view of the above legal definition of addictive substances, it can be concluded that only leaves, seeds or parts of plants without tops from authorised varieties of technical cannabis with a THC content of up to 1 % may be used in the food industry.
However, in this context, it should be kept in mind that the legislation does not define the permitted amount of THC in food, and this conclusion does not imply that food supplements or food in general can contain a certain amount of THC. It is only limit which the plant Cannabis sativa L. as such must meet in order to be used for the purpose of producing food, including food supplements.
The SAFI and the Ministry of Agriculture, as part of the supervisory practice, explicitly appeal that the flower of the cannabis plant cannot be used for food purposes. In the context of the application of the relevant provisions of the Ordinance on Food Supplements and Food Composition, it has been repeatedly and explicitly confirmed that the cannabis plant without the flower (top) is not considered to be a narcotic or psychotropic substance and its use in food is not contrary to Section 5 of the Ordinance on Food Supplements and Food Composition, and therefore also to the Food Act.
A food containing THC in excess of the limit is considered by the SAFI to be unsafe and therefore unfit for human consumption within the meaning of Article 14 (1) of Regulation (EC) No. 178/2002 of the European Parliament and of the Council of European Union on 28 January 2002 laying down the general principles and requirements of food law.
If a food manufacturer fails to comply with food safety requirements under a directly applicable EU regulation governing food requirements, it commits an offence under Section 17 of the Food Act, which is punishable by a fine of up to CZK 50,000,000 and sanctions in the form of a ban on placing the food on the market and withdrawal from the market.
b) European Union- NOVEL FOOD
The legal regulation of so-called novel foods applies to foods for which there is no documented history of consumption before 15 May 1997, the date on which Regulation (EC) No. 258/97 of the European Parliament and of the Council of European Union on 27 January 1997 on novel foods and novel food ingredients, which was replaced by the Novel Food Regulation, came into force, and there is insufficient scientific evidence of their effect on human health.
According to the Novel Food Regulation, only novel foods authorised and listed by the European Union may be placed on the market as such in the European Union or used in or on foods in accordance with the conditions of use and labelling requirements set out therein.
Cannabis sativa L.
Hemp (Cannabis sativa L.) is on the market in the European Union as a food or food ingredient and was already largely consumed before 15 May 1997 therefore its access to the market is not covered by the Novel Food Regulation.
However, it must also be a variety registered in the Common Catalogue of Varieties of Agricultural Plant Species.
Specific legislation may govern the marketing of this product as a food or food ingredient in individual member states. Therefore, the conditions for the use of cannabis in food may vary from one member state to another.
Cannabinoids
Within the topic of novel foods, cannabinoids have been under consideration in the European Union for a long time.
Hemp (Cannabis sativa L.) contains a number of cannabinoids, the most common of which are: delta-9-tetrahydrocannabinol (Δ9-THC), its precursor in cannabis, delta-9-tetrahydrocannabinoil acid A (Δ9-THCA-A), delta-9-tetrahydrocannabinoil acid B (Δ9-THCA-B), delta-8-tetrahydrocannabinol (Δ8-THC), cannabidiol (CBD), its precursor in cannabidiol cannabidiol acid (CBDA), cannabigerol (CBG), cannabinol (CBN), cannabichromene (CBC) and delta-9-tetrahydrocannabivarin (Δ9-THCV).
Due to data gaps and uncertainty about the potential risks associated with the consumption of cannabidiols, no decision has yet been taken on their inclusion in the list of authorised novel foods and conditions of use, and a safety assessment under the Novel Food Regulation is required before they can be placed on the market as a food or food ingredient.
In this context, the European Food Safety Authority (hereinafter referred to as “EFSA”) is currently dealing with dozens of applications. More information on the current status of EFSA’s assessment of cannabidiol (CBD) can be found HERE.
Circumvention of this legal regulation can again be qualified as non-compliance with food safety requirements under directly applicable EU legislation, which carries the risk of sanctions as described above.
Opinion of the European Commission and further developments
As announced at the beginning of this article, the European Commission published a statement in mid-April this year confirming that cannabidiol (CBD) and other cannabinoids derived from the Cannabis sativa L. (hemp) plant are considered novel foods and cannot be placed on the market.
The reason for proceeding with this solution is the lack of sufficient scientific evidence on the effects of cannabinoids on human health.
Until EFSA makes a formal decision on the safety of cannabinoids for human health in the ongoing procedures reported above, food or food supplements containing these substances cannot be placed on the European Union market.
Following the European Commission’s announcement, the SAFI embarked on the preparation of a measure of a general nature, which would introduce a ban on the marketing of food and food supplements with CBD and other cannabinoids derived from hemp, while the products in question would not be allowed to be resold after the ban has been issued.
According to the latest publicly available information, however, Prime Minister Petr Fiala, Minister for Regional Development Ivan Bartoš and Minister of Agriculture Zdeněk Nekula have jointly taken a position to prevent the adoption of the general measure in question and to find a way to ensure that food and food supplements containing CBD do not fall under this ban and that their marketing is governed by clear and predictable rules.[2]
Conclusion
The question of the placing on the market of foods and food supplements containing cannabidiol (CBD) and other cannabinoids derived from the Cannabis sativa L. (hemp) plant has long been subject to EFSA’s assessment, as it has not yet been possible to gather sufficient verified evidence of their harmfulness or adverse effects on human health.
SAFI’s initial effort to immediately adapt to the current EU stance ran into a government initiative to exempt food and food supplements with CBD from the marketing ban.
We will continue to monitor whether, from when and to what extent the ban will apply, as well as other related legislative and other processes, and will keep You informed of further developments and news in due course.
If You have any questions related to food law, please do not hesitate to contact us.
[1] EU, Regulation (EU) 2015/2283 of the European Parliament and the Council of the European Union on 25 November 2015 on novel foods. In: eurlex.europa.eu. [online]. Available from: EUR-Lex – 32015R2283 – EN – EUR-Lex (europa.eu)
[2] Hospodářské noviny, Fiala opposes total ban on CBD products. V: Hospodářské noviny. [online]. 10. 5. 2023. [cit.2023-30-05]. Dostupné z: Fiala je proti úplnému zákazu produktů s CBD | Hospodářské noviny (HN.cz)
Mgr. Tereza Dvořáková, attorney – dvorakova@plegal.cz
Mgr. Jakub Málek, managing partner – malek@plegal.cz
31. 5. 2023