Cannabis Sativa L.
Kaņepe (sējas) (LV), Hampa (SE), Hemp (EN), hamp (DK), Hanf (DE), hennep (NL), chanvre (FR), cânhamo (PT), konopie siewne (PL), harilik kanep (ET), konopí seté (CZ), Cáñamo (ES), indiai kender (HU), ινδική κάνναβις (EL), navadna ali industrijska konoplja (SL), hamppu (FI)
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.
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
Should Hemp Extracts Be Considered Novel Food?
Read the presentation from EIHA where they share evidence to challenge this position: Should hemp extracts be considered novel food.
European Industrial Hemp Association asked by European Commission to advise on traditional or novel food status of hemp extracts.
“EIHA would like to reiterate its position on hemp extracts: Until EIHA’s presentation the borderline of the naturally occurring CBD level had not been defined in terms of a percentage of CBD. EIHA can confirm that the natural concentration of Cannabidiol in hemp biomass commercially cultivated in the EU is between 1-5% on a dry weight basis.
We should note that hemp strains cultivated outside the EU can contain much higher levels of CBD naturally present. Whilst we accept that the Novel Food Catalogue is not legally binding and only serves as a guidance document for Food Business Operators (FBO’s) and regulatory agencies, this should be seen as the default position for all member states.
FBOs may assume placing products on the market with a natural concentration of Cannabidiol are hence compliant with the European guidance. European guidelines on “Consumption to a significant degree” which also play an important role in the distinction between traditional and novel food, were already published in 2012, and each food placed on the market should comply with them.
EIHA states that the use of aerial parts of hemp is traditional in the human diet and applying traditional processing technologies, does not change a “traditional” status of hemp food and extracts to “novel”. As to the history of traditional food use we emphasize that Industrial hemp comprises different varieties of the Cannabis species from those used in medicinal cannabis or indeed recreational applications. As such, industrial hemp has been used as a traditional food source for several thousands of years. Whereas medicinal and drug cannabis is high in the psychoactive THC, the EU limit for industrial hemp is 0.2% of THC in the upper third of the plant, 0.3% in Canada, USA, China, Czechia and Austria, and 1.0% in Switzerland and several states of Australia.
With such an extensive and documented use of hemp across Europe since the middle-ages, it would be disingenuous to argue that most parts of the hemp plant have not been used as food or in food. Hemp extracts and tinctures were indeed made and sold in products, which would nowadays be “supplements” up to 80 years ago. Other evidence shows the use of hemp green parts (flowers, leaves) in applications such as “hemp-beer” brewing and herbal infusions/tea making. Hemp flowers used for the production of beer-like beverages have been recognised as food ingredients by the European commission since 1998. Secondly, the safety profile of CBD is well documented and widely accepted. Cannabidiol has been proven safe by WHO experts on drug dependence in their final Critical review in 2018 acknowledging “The Committee recommended that preparations considered to be pure CBD should not be scheduled within the international drug control conventions”. “There are no case reports of abuse or dependence relating to the use of pure CBD. No public health problems have been associated with CBD use.” “CBD has been found to be generally well tolerated with a good safety profile.”
This recent change means that now individual food agencies will now interpret these new guidelines as they see fit. We will wait to see how this change affects the CBD industry across Europe.
Country by country applications of the new Novel Food Guidelines on Cannabidiol and other cannabinoid.
As we become aware of each EU member countries stance we will link to the relevant agency and documentation.
PREVIOUS ARTICLE BELOW: Since these changes are very recent we have kept our previous article intact so you can see how the new rules may apply. We advise you to take independent legal advice if you decide to sell CBD products in your country as food supplements to ensure you are compliant with any relevant legislation.
Cannabidiol and the EU novel food guidelines
According to the European Commission: ‘Extracts of Canabis sativa L in which cannabidiol (CBD) levels are higher than the CBD levels in the source Canabis sativa L are novel in food’. This means that if you purify a cbd extract or add CBD isolate and the final product has more CBD cannabidiol than the actual hemp or cannabis plant it originated from then it becomes a novel food and before it may be placed on the market in the EU as a food or food ingredient a safety assessment under the Novel Food Regulation is required.
A literal interpretation of the statement seems to classify CBD isolate as a novel food in and of itself. For this reason we do not use CBD isolate in the production of any products that are intended for ingestion.
Is Cannabidiol classified as a Novel Food?
You can verify this from the EU catalogue of novel foods. Just search for “Cannabidiol”
Novel Food Guidelines – Cannabidiol
Extracts of Canabis sativa L in which cannabidiol (CBD) levels are higher than the CBD levels in the source Canabis sativa L are novel in food. Cannabidiol (CBD) is one of the cannabinoids in Cannabis sativa plant. In the European Union, the cultivation of Cannabis sativa L. varieties is granted 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 % of the plant.
Novel Food Regulation (EU) 2015/2283
The new Novel Food Regulation (EU) 2015/2283 is applicable from 1 January 2018. It aims to improve the conditions, so that businesses can bring new and innovative food to the EU market more easily, while still maintaining a high level of food safety for European consumers. The regulation offers European consumers the benefit of a broader choice of food and a more favourable environment for Europe’s agri-food industry – the second largest employment sector in Europe – to benefit from innovation, which is good for growth and jobs.
What is novel food?
Novel food is defined as food that has not been consumed to any significant degree in the EU before 15 May 1997 (when the first novel food legislation entered into force). This can be newly developed, innovative food or food produced using new technologies and production processes, as well as food traditionally eaten outside of the EU. This definition has not changed with the new Novel Food Regulation.
Authorisation under the Novel Food Regulation.
According to the information available to Member States’ competent authorities, cannabidiol was not used as a food or food ingredient before 15 May 1997. Therefore, before it may be placed on the market in the EU as a food or food ingredient a safety assessment under the Novel Food Regulation is required.
Is this law being enforced?
Right now as far as we can tell very few companies are even aware of this regulation, but it is being enforced in certain jurisdictions. It has been briefly and overzealously enforced in Austria 2 years ago, and is currently being enforced (again overzealously) in Spain. You can find many websites offering high strength CBD products over 10% CBD concentration. These are most probably violating the EU novel food guidelines and are classifying their products as cosmetics, for topical use only even though consumers are obviously buying them for internal use.
We recommend keeping CBD levels below 5%
To stay safe we recommend to keep all CBD food products intended for internal use below 5% CBD concentration. to comply with the new novel food guidelines.
CBD OIL EUROPE HAS NO AFFILIATION OR RELATIONSHIP WITH THE EFSA. ALL INFORMATION ON THIS PAGE IS FOR INFORMATION PURPOSES ONLY AND SHOULD NOT BE CONSIDERED LEGAL ADVICE.