Cannabidiol (CBD) is an ingredient of the hemp plant.
CBD is not psychoactive, so it does not induce intoxication. Many of the effects attributed to CBD have not yet been substantiated by scientific evidence. In its recently published statement, the EU Food Safety Authority (EFSA) outlined the significant data gaps regarding the safety of CBD. It has not been sufficiently clarified what effect CBD has on the liver, the gastrointestinal tract, the endocrine system, the nervous system and on people's psychological well-being, among others. Studies in animals show significant adverse effects especially in relation to reproduction. It is important to determine if these effects are also seen in humans. Due to these data gaps, the safety of CBD in food cannot be proven at this time.
Situation in Austria
Cannabinoid-containing oils/extracts marketed as such or in foods are considered novel foods and must be approved in the EU. At present, no such approval has been granted. Thus, placing on the market is not permitted.
Tobacco products and nicotine-containing e-cigarettes or liquids with CBD (e.g. cigarettes with tobacco and hemp, e-cigarettes with nicotine-containing CBD liquid, etc.) are not permitted.
The use of cannabinoids and especially CBD in the form of the extract for feeding purposes in animals is not allowed without exception.
Since September 2019, CBD has been approved by the EU Commission as an active ingredient in the orphan drug "Epidyolex".
A relatively new trend are cannabinoid-containing oils/extracts, which are mostly marketed as food supplements, but are increasingly used in food products such as confectionery or cakes. Cannabinoid-containing extracts marketed as such or in food products are generally considered as novel foods according to the Novel Food Regulation (EU) 2015/2283.
Novel foods are foods that have not been used for human consumption to any significant degree in the European Union prior to May 15, 1997 ("history of safe consumption") and fall into at least one of the categories listed in Article 3(2)(a) of the above-mentioned Regulation. Only approved novel foods included in the Union list may be placed on the market as such or used in foods in accordance with the conditions and labeling requirements laid down in the list. At present, there is no such authorization. Thus, placing on the market is not permitted.
Tobacco and related products
Currently, tobacco and related products, including herbal smoking products such as CBD hemp in the form of hemp flowers for smoking or e-cigarettes with CBD liquids, etc., are increasingly marketed in Austria. Often a positive effect for the health is suggested to it. CBD is thereby attributed an anxiety-relieving, nerve cell-protecting (neuroprotective), antipsychotic, anti-inflammatory, nausea-inhibiting and muscle-slackening (antispasmodic) effect, etc., which is why CBD at least gives the appearance of having a health benefit for humans.
The marketing of tobacco products and e-cigarettes containing nicotine or liquids with vitamins or other additives that give the impression that these products have a health benefit or pose lower health risks is expressly prohibited under the Tobacco and Non-Smokers Protection Act. Accordingly, tobacco products and nicotine-containing e-cigarettes or liquids with CBD (e.g. cigarettes with tobacco and hemp, e-cigarettes with nicotine-containing CBD liquid, etc.) are not permitted.
According to current knowledge and the ongoing discussion between the EU member states, it is largely undisputed that hemp flowers and buds may not be used as feed. Hemp leaves are viewed differently due to their CBD content, but here too there are signs of exclusion from the feed chain due to negative findings from feeding trials with dairy cows that were given hemp silage.
Cannabinoids and especially CBD in the form of the extract are classified as a feed additive, which is currently not yet approved. Accordingly, the use for feeding purposes is not allowed without exception. This also applies to products described in a "creative" way as flavoring agents or mouth care products, if it can be assumed from the general perception of the market and the presentation of the products that they are intended for oral ingestion by the animal. Also affected by the feed ban are hemp oils or other plant oils to which CBD or other cannabinoids have been added in defined quantities or concentrations. As a potential feed additive, CBD, for example, is to be classified in the category of zootechnical additives and here under the functional group of "agents for stabilizing the physiological state". Individual approval procedures are currently underway or being prepared, but due to the fundamental concerns of individual EU countries, procedural delays are to be expected, making it difficult to predict when the approval process will be completed.
Since September 2019, CBD has been approved by the EU Commission as an active ingredient in the orphan medicinal product"Epidyolex" (approval number EU/1/19/1389) under Regulation 2000/141/EC. It is used, together with clobazam, in patients 2 years of age and older for the adjuvant treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS).
From a pharmaceutical law perspective with regard to CBD products, both the German Medicines Act (AMG) and Directive 2001/83/EC, on which the AMG is based, make a fundamental distinction between functional medicinal products and presentation medicinal products when defining whether a product can be a medicinal product.
Based on relevant ECJ jurisprudence, a product is a functional medicinal product if it has a significant influence on human physiological functions through a pharmacological effect in connection with the prevention or cure of a disease or a medical-therapeutic benefit, whereby the therapeutic efficacy must be scientifically proven.
A classification of CBD products as presentation medicinal products based on disease-related statements of the product is to be evaluated independently of a classification of the product as a functional medicinal product. As in the past, the Federal Office for Safety in Health Care (BASG) considers CBD products that are appropriately promoted as having properties to cure or alleviate or prevent human or animal diseases or pathological conditions to be presentation medicinal products. If the BASG becomes aware of such a promotion, it will take action and start an investigation.
Last updated: 28.09.2022