Final conclusion of the European Commission (November 19, 2020)
In July 2020, the European Commission informed all parties who had submitted a novel application for the approval of foods for a product containing CBD, which was obtained by extracting the upper parts of the flowers and fruits of the hemp plant (Cannabis sativa L.)
These can be classified as cannabis extracts, which are covered by the United Nations Convention on Narcotic Drugs of 1961, and therefore cannot be considered food.
Legal position of hemp products (Cannabis sativa L., Hanf (DE), hemp (EN))
March 2017: Germany legalizes cannabis flowers and extracts for medical purposes.
January 2018: The World Anti-Doping Agency (Wada) removes cannabidiol (CBD) from the list of prohibited substances.
October 2018: Canada legalizes recreational cannabis.
December 2018: Michigan is the tenth US state to legalize recreational cannabis, and 23 others allow medicinal use.
In the case of the industrial hemp plant (Cannabis sativa L. from an approved hemp variety with a delta-9-tetrahydrocannabinol (THC) content of less than 0.3%) a distinction must be made between the different parts of the plant used.
In fact, industrial hemp seeds and derived products like hemp seed oil are known as food.
The hemp leaves, and to a lesser extent the flowers *, appear to be known for their use as an infusion.
(*: Although herbal teas made from hemp flowers are available on the European market, it is currently being discussed at the level of the Commission’s expert group whether the new varieties should not be classified even though they are compliant in THC and have increasingly high concentrations of other cannabinoids, especially cannabidiol (CBD ), as a food without a history of consumption before May 15, 1997 in the European Union, therefore as a new food “Novel Food” “.)
The new foods “Novel foods” are regulated at European level by REGULATION (EU) 2015/2283 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 November 2015 on novel foods. They need a permit to market them as food.
Therefore, marketing of these products (as food or dietary supplements) that contain synthetic CBD is not permitted in Austria or Europe without authorization for placing on the market in accordance with the above-mentioned Regulation (EU) 2015/2283.
Finally, cannabis-, CBD- and / or THC-based products can also fall within the scope of other regulations applicable in Austria (drugs, cosmetics, e-liquids, tobacco, etc.).
CBD is obtained from the cannabis plant, but according to the ECJ it is not an addictive substance.
So far, three applications for approval as a novel food for CBD for use in dietary supplements have been submitted for evaluation by EFSA and the European Commission: Trans-Cannabidiol (submitted in June 2018), Synthetic Trans-Cannabidiol (submitted in November 2019), Cannabidiol from the chemical synthesis (submitted in January 2020). However, these applications have not yet been assessed by EFSA. In fact, these files seem to be locked for the time being, as there is currently a discussion at European level as to whether or not CBD and other cannabinoids can be classified as narcotic drugs.
According to the Novel Food catalog, some products made from the cannabis sativa plant or parts of plants, such as seeds, seed oil, hemp seed meal and defatted hemp seeds, have been consumed in the EU in the past and are not new. Other actual national legislation may also relate to the marketing of this trust as a food or food ingredient in a particular membership.
The Cannabis sativa L. plant is made up of a number of cannabinoids, tetrahydrocannabinol (THC) and cannabidiol (CBD).
According to the Novel Food catalog, extracts of Cannabis sativa L. and cannabinoid-containing secondary products are considered novel foods, as a previous history of consumption has not been proven. This applies both to the extracts themselves and to any products to which they are added as an ingredient (such as hemp seed oil), as well as extracts from other plants that contain cannabinoids. Synthetically obtained cannabinoids are also considered new.
Según datos científicos, solo la flor o la hoja de Cannabis sativa L. es probable que contenga CBD de forma natural.
Even if the novel food catalog has no legal value, it is updated on the basis of the information provided by the member states of the European Union and serves as a guide to determine if a product requires approval according to Regulation (EU) 2015 / 2283 for new products. it food.
So far, the global authorities are of the opinion that the CBD safety regulation of the EU 2015/2283 and it is forbidden to market food or nutritional supplements containing cannabidiol (CBD) in the whole of the Union as long as it does not belong to the regulation of this regulation is.
Between January 2019 and March 2020, purchases were made in the RASFF (rapid alert system for food and feed) and in Switzerland, but also in Belgium, Finland, Italy, Greece, Lithuania and Poland. These messages relate to food supplements and oils, but also to other foods such as chocolate, chewing gum, coffee with hemp flowers, honey or beverages.
Many national authorities in Europe also have personal texts or information (guides, questions and answers, news). Austria, Belgium, Denmark, Spain), Lithuania, Luxembourg).
With regard to France, the DGCCRF applies the interpretation of the novel food catalog. CBD and CBD oil are considered novel foods (not allowed) either in foods or in dietary supplements. Only hemp seeds or hemp seed oil (i.e. obtained by cold pressing) without THC and without CBD are considered food in France and can be used in dietary supplements. In addition, there is a national restriction in France that goes beyond European regulations: the law of August 22, 1990 only allows the cultivation, import, export and industrial and commercial use of fibers and seeds of Cannabis sativa L varieties that are approved at European level. The use of flowers or leaves is therefore strictly prohibited. In October 2018 the Court of Justice of the European Union received a request for a preliminary ruling on the compatibility of the French hemp regulations with European law, namely whether the provisions of the law of August 22, 1990 the cultivation, industrialization and marketing of hemp exclusively on fiber and seeds to impose a restriction that does not comply with European law. The Court’s opinion has not yet been delivered. Even if the Court of Justice of the European Union concluded that the text laying down restrictions on the parts of hemp that could be used did not have to do so, it would not change the novel foods status of CBD. impose a restriction that does not comply with European law. The Court’s opinion has not yet been delivered. Even if the Court of Justice of the European Union concluded that the text laying down restrictions on the parts of hemp that could be used did not have to do so, it would not change the novel foods status of CBD. impose a restriction that does not comply with European law. The Court’s opinion has not yet been delivered. Even if the Court of Justice of the European Union concluded that the text laying down restrictions on the parts of hemp that could be used did not have to do so, it would not change the novel foods status of CBD.
In Belgium, the Cannabis sativa L. plant is listed on List 1 of the Royal Decree of 29 August 1997 (Dangerous plants that must not be used as or in food). A specific deviation from this prohibition can be requested by the authorities, in particular for hemp seeds or other seed products (oil that is produced by simply pressing seeds) with all the details of the product (with batch number and corresponding analysis certificate). The assessment is made on a case-by-case basis, taking into account the THC content of each batch and the other characteristics of the product. However, Cannabis sativa leaves or flowers in the form of an infusion or herbal tea cannot be exempted, even if the THC content is very low. CBD and CBD extracts are considered novel foods and are therefore not allowed.
For the United Kingdom, where some CBD products are on the market due to a hitherto unclear legal context, the English authorities (Food Standard Agency) confirmed in a manual in February 2020 that they also consider CBD extracts and isolates as novel foods . However, they accept a tolerance for existing CBD products in the UK market: companies must submit novel food authorization applications by March 31, 2021 and have them fully validated. After this date, only products for which the FSA has a valid application will be allowed to remain on the market. The FSA advised local authorities that companies can continue to sell their existing CBD products during this time, as long as they are not mislabelled, are not unsafe, and do not contain substances covered by drug legislation. However, no new CBD extracts or isolates should be sold until they have the required approval. With a deadline of February 13, 2020, the FSA also advises healthy adults not to consume more than 70 mg of CBD per day and those who are pregnant, breastfeeding or taking medication not to consume CBD products.
In this context, some companies have already followed the novel food regulation procedures in an attempt to get their ingredients approved.
At the end of 2019, a consultation process led to the conclusion that a CBD isolate (purity> 98%) dissolved in MCT oil (medium-chain triglyceride) is a novel food (“New for use as or in food”).