On November 19, the EU’s Court of Justice gave the long-awaited judgment on the classification of cannabidiol (CBD). The Court judged that CBD cannot be qualified as a “narcotic” in the eyes of the law. As a result, CBD products can be marketed and benefit from the free movement guaranteed by Articles 34 to 36 of the Treaty on the Functioning of the European Union (TFEU). Here, Katia Merten-Lentz and Manon Ombredane explain the details of the judgement in more detail (in French):

 

La Cour de justice européenne se prononce sur le cannabidiol

Cet article a été publié dans Les Marchés, le Média de l’Alimentaire
Le 19 novembre 2020, la CJUE a rendu un arrêt (1) très attendu par l’industrie du cannabidiol (CBD) dans lequel elle affirme que le CBD ne peut être qualifié de « stupéfiant » et que par voie de conséquence, sa commercialisation doit pouvoir bénéficier du principe de libre circulation garantie par le Traité sur le fonctionnement de l’Union européenne.
La Cour de justice de l’Union européenne (CJUE) avait été saisie d’une question préjudicielle par la cour d’appel d’Aix-en-Provence, à la suite de la condamnation en première instance des anciens dirigeants de la société Kanavape. Il leur avait été reproché de commercialiser et de distribuer, en France, une cigarette électronique qui contenait du cannabidiol (CBD issu du Cannabis sativa), produit en République tchèque, à partir de plants de chanvre cultivés légalement et utilisés dans leur intégralité (feuilles et fleurs incluses), puis importés en France. La cour d’appel d’Aix-en-Provence avait préféré interroger la CJUE sur la conformité au droit de l’UE, de la réglementation française qui interdit la commercialisation du CBD légalement produit dans un autre État membre lorsque l’entièreté de la plante est utilisée.

La CJUE commence par écarter la question de savoir si les règlements nos 1307/2013 et 1308/2013 (relatifs à l’organisation commune des produits agricoles) s’appliquent au CBD (2) pour se concentrer davantage sur la question de sa libre circulation qui est étroitement liée à la qualification – ou pas – du CBD de stupéfiant.

Selon la CJUE, le CBD n’est pas un « stupéfiant »

À cet égard, la CJUE fait une lecture très progressiste des deux textes internationaux auxquels se réfère le droit de l’UE. D’une part, en relevant que le CBD n’est pas mentionné dans la Convention des Nations unies de 1971 sur les substances psychotropes et, d’autre part, en jugeant que classer le CBD comme un « stupéfiant » serait contraire à l’esprit de la Convention des Nations unions de 1961 sur les stupéfiants qui « est fondée, notamment, sur un but de protection de la santé physique et morale de l’humanité » ; a contrario, par exemple, des extraits de cannabis contenant du THC, substance psychoactive.

La CJUE conclut que le CBD ne comportant pas de principe psychoactif en l’état actuel des connaissances scientifiques, il ne peut être qualifié de « stupéfiant » et que donc, les articles 34 à 36 du TFUE garantissant le principe de libre circulation lui sont applicables.

La CJUE relève néanmoins que la France pourrait, en vertu de l’article 36 du TFUE, s’opposer à l’importation de CBD légalement fabriqué en République tchèque pour un motif de protection de la santé publique, mais encore faudrait-il que cette restriction au principe de libre circulation, la plus dure qu’il soit, soit justifiée et proportionnée.

Étape positive pour les dossiers Novel food

À cet égard, la CJUE émet des doutes quant à la conformité de la législation française au droit de l’UE, s’appuyant, notamment, sur le fait que la France n’applique pas la même restriction selon que le CBD est d’origine naturelle ou synthétique. La CJUE ajoute que « s’agissant de la nécessité de l’interdiction de commercialiser […], il appartient à la juridiction de renvoi d’apprécier les données scientifiques disponibles et produites devant elle afin de s’assurer […] que le risque réel allégué pour la santé publique n’apparaît pas comme étant fondé sur des considérations purement hypothétiques ». La CJUE laisse ainsi le mot final au juge national.

Cet arrêt constitue une nouvelle étape positive pour la commercialisation du cannabidiol en Europe et notamment pour les dossiers Novel food. En effet, la Commission européenne avait mis, cet été, l’évaluation de plusieurs dossiers « en pause », souhaitant vérifier la compatibilité d’une « possible » autorisation Novel food des produits dérivés du Cannabis sativa, avec la définition de « denrée alimentaire » qui exclut les stupéfiants et les substances psychotropes. Avec la confirmation de la CJUE que le CBD n’est pas un stupéfiant, l’évaluation scientifique devrait ainsi pouvoir reprendre.

 

(1) Arrêt C‑663/18 B S
(2) « Le CBD présent dans la plante de Cannabis sativa dans son intégralité ne saurait être considéré comme un produit agricole et, partant de cela, ne saurait être considéré comme un produit visé par les règlements nos 1307/2013 et 1308/2013 ». Arrêt C‑663/18 § 56

Last month, Katia merten-Lentz was delighted to give her insights on CBD and Novel Foods to FoodNavigator.

CBD is considered a Novel Food by European regulators. While many CBD products remain on the market, they have not been authorised by European authorities. FoodNavigator takes a look at the path to compliance and tries to shed some light on the questions of who needs to submit a Novel Foods dossier, what it needs to include, and when it should be completed.

European food law expert Katia Merten-Lentz, partner at Keller Heckman, elaborated: “To get a green light from the EU Commission the dossier has to be as detailed as possible and as consistent as possible, both on a regulatory perspective and a scientific one in order to demonstrate that, first of all the new ingredient is safe and, secondly, the consumer will not be misled.”

Merten-Lentz echoed the conclusion that most – but not all – CBD brands will be covered by a Novel Foods application submitted by their ingredient supplier. “It depends on the ingredient, but also on the other transformations this ingredient will undergo. If one or another process drastically modifies the main characters of the ingredient already authorised then a new authorisation will be required.”

Read further here: https://www.foodnavigator.com/Article/2020/05/05/CBD-and-Novel-Foods-A-guide-to-who-what-and-when

Cannabidiol (‘CBD’) has burst onto the world stage in recent years, and the EU is no exception, with shops selling CBD products opening up in various countries across Europe. While CBD can be incorporated into cosmetics and used for medical uses, it is quickly gaining traction in the food and drink market, with CBD found in supplements, infused into teas and coffees, cocktails, confectionary and a variety of other edible items.

Increased consumer demand is driving producers desire to enter the market

As more and more consumers become eager to try food and drink containing CBD, producers are keen to meet new demand for edible goods containing the CBD compound. Products that contain CBD, however, must comply with complex legal and regulatory requirements before their food or drink can be purchased, and CBD food producers have been grappling with restrictions set at EU level, as well as ensuring they’re meeting national regulations in each of the markets where they want to sell their goods. As a result, desire remains high to bring CBD food and drink products onto the market, although ensuring these goods are fully compliant with new regulations has created additional complexities that must be overcome before market entry can be achieved.

What are Cannabinoids and Delta-9-tetrahydrocannabinol?

CBD is generally made from the Cannabis sativa L. plant, which is a variety of industrial hemp. The plant itself is made up of nearly 500 different compounds and of these, 100 are cannabinoids which, depending on the compound, have either psychoactive or non-psychoactive effects. CBD is one of these non-psychotic compounds, and is now commonly – but often, not legally – found in food products such as dietary supplements like tinctures Actually certain member States ( but not all, for instance Belgium has zero tolerance) permitproducts which contain  levels of Delta-9-tetrahydrocannabinol (‘THC’) at less than 0,2%.

What’s the difference between CBD and THC, and what does it mean from a regulatory perspective?

All cannabinoids interact with the human body through what’s known as the endocannabinoid system which regulates several of the body’s functions. Both THC and CBD are cannabinoids, but the main difference is the interaction they have with the brain (however ingested).

The low levels of THC in foods and drinks are key because it’s this compound that’s responsible for the principal psychoactive effects of cannabis when ingested – in other words, human consumption of certain amounts of THC will get consumers ‘high.’ To have any such psychoactive effect, a considerably higher rate of THC would have to be consumed.

CBD affects different receptors in the brain and has no such psychoactive effect, but instead is thought to affect different brain processes that influence things like moods or pain, without any of the ‘high’ associated with consumption of THC.

As a result of the divergent effects of THC and CBD, the compounds could be considered very differently in terms of their regulation, given THC has a psychoactive effect which therefore means it can be linked to drug laws.

Food law aside, it is worth noting that the classification of cannabinoids is exceptionally complex, and there are still unanswered questions that relate to if having THC available in food goods is safe. ( see https://www.efsa.europa.eu/fr/efsajournal/pub/4141)

CBD in food and drink: the food law basics

Any food that contains CBD must always comply with food legislation, notably Regulation (EU) 2015/2283 on Novel Foods, in addition to the general safety principles, which state that food cannot be unsafe.

 What did the modifications to the Novel Food regulation change?

In a bid to at least partially clarify the regulatory landscape that surrounds CBD food and drink, in January 2019, the European Commission and the Member States agreed to review the Novel Food regulation and by the way, amend previous entries in the Novel Food catalogue in relation to any food products that contain CBD, as well as references to the Cannabis sativa L. plant.

To give further context, it’s important to note that EU legislation lays out that foods which were not available for human consumption within the Union before 15 May 1997 are considered ‘Novel Foods’ which require further risk assessment and authorization before they can be sold in the EU market.

As a result of the amendments to the Novel Food catalogue (now a compiled EU list), some products that are derived from Cannabis sativa L. are not considered novel when using certain parts of the plant such as seeds, seed oil, hemp seed flour, defatted hemp seed, as well as other products derived from the plant. To be applicable, the varieties of Cannabis sativa L. used must be registered in the EU’s ‘Common Catalogue of Varieties of Agricultural Plant Species.’

The amended entry in the Novel Food catalogue that relates to CBD, now classifies CBD as a novel food type – a decision which was taken because the compound doesn’t have a long-standing history of consumption in the EU. (the European Commission was not convinced by the evidences provided by the Trade associations). The rule applies to both plant extracts or synthetically obtained CBD, and includes the extracts themselves as well as any food products the CBD is added to.

What do the new regulations mean for producers looking to enter products with CBD into the EU market?

As a result of the amended Novel Food catalogue, producers wishing to sell products in the EU that contain food and drink with hemp extract or CBD are required to follow the relevant process as set out in the Novel Food procedure (Regulation (EU) 2015/2283). As part of this process, food or drink producers will be required to present a case that evidences CBD as a safe, albeit novel ingredient in food and beverages if consumed in certain amounts.

What does this mean for the ingestible CBD foods already on the market?

What does this mean for the ingestible CBD foods already on the market?

We already see a lot of food, drinks and other ingestible CBD products in the European market, which can give the impression to potential consumers that these goods are approved at EU level. Many purchasers assume that if the sale of such products is not endorsed by the EU, it wouldn’t be possible to find them for sale. As we see with the abundance of readily-available CBD products for purchase in Europe, this isn’t always the case. But of interest please note the increasingly number of RAASFF notifications.A parallel can be drawn with insects as a food source: we now regularly find insects for sale in stores, but as yet, this food group doesn’t have any ‘Novel Food’ authorization.

Simply put, any food which is not expressly approved by the EU is considered as ‘unsafe’ – given the EU’s last ruling on the topic, CBD food and drinks currently fall into this categorization ( interesting hearing re the 0,2% limit next 23 Octobre: case (C-663/18)  .  As a result,  – except in some Member States where some hemp oils with a THC level less than 0,2% and a very simple process of extraction – any CBD food or drink product on the market in the EU, is not compliant with EU Novel Food laws.

Consequently the implementation of the following transitional measures seem difficult since almost none of the products currently on the market could be considered as lawfully placed.

“Foods not falling within the scope of Regulation (EC) No 258/97, which are lawfully placed on the market by 1 January 2018 and which fall within the scope of this Regulation may continue to be placed on the market until a decision is taken in accordance with Articles 10 to 12 or Articles 14 to 19 of this Regulation following an application for authorisation of a novel food or a notification of a traditional food from a third country submitted by the date specified in the implementing rules adopted in accordance with Article 13 or 20 of this Regulation respectively, but no later than 2 January 2020.”

This article was first published by Food Navigator on September 18, 2019. 

Katia Merten-Lentz reflects on the trends and consumer preferences which could slow down or speed up applications to bring novel foods to market. She explores why cultured meat, ‘immuno-boosting’ foods and a consumer’s general prioritization of health and hygiene could all play a part (article available in French only):

Cet article a été publié sur Les Marchés, le Média de l’alimentaire

 

Les nouveaux aliments, désormais encadrés par le règlement Novel Food, vont-ils se voir freinés ou accélérés par la pandémie de Covid-19 ? Réflexion.

Le désormais – fameux – règlement Novel Food, actualisé en 2018, avait redonné un élan d’innovation aux opérateurs de l’agroalimentaire. La pandémie va-t-elle freiner cette énergie créative ? Difficile à dire à ce stade, bien que beaucoup d’analystes s’accordent à prédire que le consommateur va, très probablement, privilégier sa sécurité sanitaire et la protection de l’environnement, pour se tourner vers des productions locales et sanitairement garanties « zéro risque », ouvrant ainsi la voie à des innovations.

La chaîne de transmission du Covid-19 via la consommation d’animaux « sauvages », pourrait, par exemple, favoriser des solutions innovantes, telles que la viande in vitro, qui présenteront l’avantage d’avoir été « cultivées » dans un environnement aseptisé.

Une autre tentation commerciale risque également d’émerger en cette période difficile : tous les produits relaxants ou « anti-Covid » vont bénéficier d’une cote certaine.

De nouveaux ingrédients boostés

Le contexte de pandémie peut, ainsi, être favorable à de nouveaux ingrédients alimentaires, censés « booster » le système immunitaire ou simplement apaiser l’angoisse du confinement. Mais Bercy le rappelle fermement sur son site Internet : il n’existe pas, à ce jour, d’aliments – et en particulier de compléments alimentaires – permettant de se protéger du Covid-19. Dès lors, toute présentation d’un tel produit relèverait de la pratique commerciale trompeuse * et les agents de la concurrence, de la consommation et de la répression des fraudes (DGCCRF) sont donc particulièrement vigilants sur ce type de produits et d’annonces commerciales.

Ils le resteront également à l’égard de tout nouvel ingrédient qui aurait été placé sur le marché sans l’obtention du sésame européen : l’exemple du cannabis et de ses nombreux dérivés est à ce titre édifiant. Il convient, en effet, de rappeler que malgré une exposition médiatique forte, laissant à penser que tous les dérivés de cannabis, peuvent être commercialisés sans réserve, tel n’est pas le cas. Et pour les extraits de cannabidiol, aucune autorisation n’a encore été formellement octroyée.

Plusieurs dossiers Novel Food pendants ont simplement, à ce stade, fait l’objet de questions de la part de l’Efsa. Mais il est vrai que la situation est loin d’être claire, entre CBD/CBG, naturel, de synthèse… d’autant que des produits qui seraient de simples dérivés de cannabis sativa, et non pas des extraits, peuvent bénéficier d’un historique de consommation avant 1997 et être, à ce titre, autorisés à être placés sur le marché européen.

Tout reste à faire pour la viande in vitro

En ce qui concerne la viande in vitro, tout reste, en revanche, à faire. La mise sur le marché européen d’un nouvel aliment de ce type devra respecter toutes les étapes de la procédure Novel Food afin de démontrer qu’il n’est ni dangereux ni trompeur pour le consommateur sur la base d’un dossier solide et cohérent, tant du point de vue scientifique que réglementaire.

Aucun produit de la sorte n’a encore été commercialisé, car aucune autorisation Novel Food n’a été obtenue à ce jour.

Certes des dossiers sont en cours de préparation et une quinzaine de sociétés à l’échelle mondiale travaillent sur la viande artificielle, en Israël, aux États-Unis, en Espagne, au Royaume-Uni, aux Pays-Bas et en France. Mais encore aujourd’hui, la difficulté reste de passer d’une projection recherche et développement à la production de masse.

Aussi, la première start-up qui recevra ce précieux sésame aura un avantage compétitif considérable sur ses concurrentes. L’industrie agroalimentaire ne doit donc pas baisser les bras : la demande en produits innovants devrait rester forte. L’autre bonne nouvelle est que nos institutions européennes sont confinées mais continuent de travailler !

This article was first published by EU Food Law on March 19, 2019.

Marketing Cannabidiol (CBD) in the EU has become more complex and, in some cases, is subject to national restrictions.

Shops selling products containing Cannabidiol (CBD) are popping-up across Europe drawing more and more attention on the legality, write Katia Merten-Lentz and Manon Ombredane of international law firm Keller & Heckman.

Cannabis sativa L is a well-known plant made up of more than 480 compounds, including over 100 cannabinoids composed of both psychoactive and non-psychoactive compounds[1] including CBD. CBD contained in food products like tinctures is often derived from the industrial hemp variety cannabis sativa L. which contains low level of Delta-9-tetrahydrocannabinol (THC)[2] (<0,2%).

Setting aside the question of the classification of cannabis under International Drug Control Conventions[3] and the possible safety issue related to the presence of THC, food containing CBD must – as any other foodstuff – comply with the food legislation. This includes Regulation (EU) 2015/2283 on novel foods[4] as well as the general principle set out under the General Food Law[5] according to which food must not be unsafe[6].

Novel foods catalogue modified

What recently caught the attention of national authorities across Europe, as evidenced by the multiplication of RASFF notifications, is the European Commission decision to modify the Novel Food catalogue.  In a recent meeting of the European Commission’s Working Group on Novel Food, the European Commission and the Member States agreed to modify the entries related to cannabis sativa L, cannabidiol and cannabinoid in the Novel Food catalogue in a tentative to clarify the regulatory landscape for food products containing CBD.

Accordingly, the new entry for Cannabis Sativa L. is now clearly stating that:

“In the European Union, the cultivation of Cannabis sativa L. varieties is permitted provided they are registered in the EU’s ‘Common Catalogue of Varieties of Agricultural Plant Species’ and the tetrahydrocannabinol (THC) content does not exceed 0.2 % (w/w). Some products derived from the Cannabis sativa plant or plant parts such as seeds, seed oil, hemp seed flour, defatted hemp seed have a history of consumption in the EU and therefore, are not novel. Other specific national legislation may restrict the placing on the market of this product as a food or food ingredient in some Member States. Therefore, it is recommended to check with the national competent authorities”

In parallel, the new entry for “Cannabinoids”[7] provides that:

“The hemp plant (Cannabis sativa L.) contains a number of cannabinoids and the most common ones are as follows: delta-9-tetrahydrocannabinol (Δ9-THC), its precursor in hemp, delta-9-tetrahydrocannabinolic acid A (Δ9-THCA-A), delta-9-tetrahydrocannabinolic acid B (Δ9-THCA-B), delta-8-tetrahydrocannabinol (Δ8-THC), cannabidiol (CBD), its precursor in hemp cannabidiolic acid (CBDA), cannabigerol (CBG), cannabinol (CBN), cannabichromene (CBC), and delta-9-tetrahydrocannabivarin (Δ9-THCV). Without prejudice to the information provided in the novel food catalogue for the entry relating to Cannabis sativa L., extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel

Generally, a food which a has not been used for human consumption to a significant degree within the Union before 15 May 1997 and which falls within the categories set out under Article 3(2)(a) of the Regulation (EU) 2015/2283 on novel foods [8] must be subject to a risk assessment and authorization prior to the placing on the EU market. During a previous meeting of the Working Group on Novel Foods[9], the European Industrial Hemp Association (EIHA) was invited to present arguments supporting the fact that hemp extract containing CBD should not be considered novel,[10] notably based on its history of safe use in the EU. But, following the meeting, it seems that none of the EIHA arguments could convince the European Commission and the Member States to consider hemp extract containing CBD as not novel.

Accordingly, the way forward for business operators decided to sell hemp extract and derived products containing CBD in the EU is to go through the Novel Food procedure set out under Regulation (EU) 2015/2283. To this date, only one dossier has been submitted to the European Commission aiming at supporting the safety of cannabidiol as novel food in food supplements for adults at a daily intake of up to 130mg or 1,86mg/kg[11].

Member state differences

On the other side, for products that may contain CBD such as “seed oil” but which are not novel due to their history of consumption in the EU, the placing on the EU market is not simple as well. As pointed out under the entry for Cannabis sativa L. “other specific national legislation may restrict the placing on the market of this product as a food or food ingredient in some Member States.

This is for instance the case in Belgium that restricts the marketing of food derived from Cannabis Sativa L. The plant is listed in the List 1 “Hazardous plants that cannot be used as or in foodstuffs” of the Royal Decree of 29 August 1997 on the manufacture of and trade in foodstuffs composed of or containing plants or plant-based preparations.

Hence, even though the recent modification of the Novel Food catalogue may have brought some clarity regarding the novel food classification, business operators wishing to market CDB on the EU market must avoid other pitfalls and notably, they must pay attention to possible national restrictions that may apply to food products derived from Cannabis sativa L.


[1] See European Parliament Motion for a resolution on use of cannabis for medicinal purposes (2018/2775(RSP)), 13 February 2019

[2] Main psychoactive constituent of cannabis

[3] In this respect, the World Health Organization recently recommended rescheduling cannabis and its chemical components under international drug treaties.

[4] Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001, OJ L 327, 11.12.2015, p. 1–2

[5] Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, amended

[6] Article 14 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law

[7] The entry for CBD refers to the entry “cannabinoids”

[8] E.g. food consisting of, isolated from or produced from plants or food resulting from a production process not used for food production within the Union before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances.

[9] Held on 16 October 2018

[10] EIHA presentation is available at: http://eiha.org/media/2019/01/18-10-16_NF-WG-EIHA-Presentation-Released-final.pdf

[11] Request for a scientific opinion on trans-Cannabidiol as a novel food (NF 2018/0349) (EFSA-Q-2018-00512)