Update on the regulatory status of CBD in food in Europe

Nutraveris

Last update 7 December 2020.

In January 2019, the Cannabis sativa L. and Cannabidiol / Cannabinoids entries were clarified in the Novel Food catalogue available on the European Commission website.

With regard to the plant for any use, it is recalled 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).

According to the Novel Food catalogue, 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. However, other specific national legislation may restrict the placing on the market of this product as a food or food ingredient in some Member States.

The plant Cannabis sativa L. contains a number of cannabinoids, including tetrahydrocannabinol (THC) and cannabidiol (CBD).

According to the Novel Food catalogue, 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), as well as to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are also considered as novel.

According to scientific data, only the flower or leaf of Cannabis sativa L. are likely to contain CBD naturally.

Even if the Novel Food catalogue has no legal value, it is updated on the basis of information provided by the Member States of the European Union and serves as orientation on whether a product will need an authorisation under Regulation(EU) 2015/2283 on novel foods.

To date, the European Authorities consider that CBD, whatever its source, is a novel food according to Regulation (EU) 2015/2283 and therefore that it is forbidden to market foods or food supplements containing cannabidiol (CBD) throughout the European Union, as long as it is not specifically authorized according to the provisions of this Regulation.

Between January 2019 and November 2020, 79 notifications concerning foods containing cannabidiol (CBD) classified as an unauthorized novel food ingredient were published in the RASFF (Rapid Alert System for Food and Feed) particularly by Sweden, Germany, Spain, Denmark, Austria, Switzerland, but also Belgium, Finland, Italy, Greece, Lithuania, and Poland. These notifications mainly concern food supplements and oils, but also other foods such as chocolate, chewing gums, coffee with hemp flowers, honey, or drinks.

Many national authorities in Europe have also published official texts or information (guides, questions and answers, news) intended for operators confirming that CBD and hemp extracts containing CBD are considered as novel food (for example: Germany, Austria, Belgium, Denmark, Spain, Lithuania, Luxembourg).

With regard to France, the DGCCRF applies the interpretation of the Novel Food catalogue. CBD and CBD oil are considered novel food (not allowed) either in food or in food supplement. Only hemp seed or hemp seed oil (i.e. obtained by cold pressing) without THC and without CBD are considered as food in France and can be used in food supplements. In addition, in France, there is a national restriction which goes further than European regulations: the Law of 22 August 1990 only authorizes the cultivation, import, export and industrial and commercial use of fibers and seeds of Cannabis sativa L varieties authorized at European level. The use of flowers or leaves is therefore strictly forbidden.

In Belgium, the Cannabis sativa L. plant is present on list 1 of the Royal Decree of 29 August 1997 (Dangerous plants which cannot be used as or in food). A specific derogation from this prohibition may be requested from the authorities, in particular for hemp seed or other seed products (oil produced by simple pressing of seeds) with all the information on the product (with batch number and corresponding certificate of analysis); 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, no derogation may be granted for leaves or flowers of Cannabis sativa in the form of an infusion or herbal tea, even when 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 present on the market due to an unclear legal context so far, the English Authorities (Food Standard Agency) confirmed in February 2020 in a guidance that they consider also CBD extracts and isolates as novel foods. However, they accept a tolerance for existing CBD products on the United Kingdom market: Businesses need to submit, and have fully validated, novel food authorisation applications by 31 March 2021. 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 businesses can continue to sell their existing CBD products during this time, provided they are not incorrectly labelled, are not unsafe and do not contain substances that fall under drugs legislation. However, no new CBD extracts or isolates should be sold until they have the necessary authorisation. With an enews of 13 February 2020, the FSA also advises healthy adults to take no more than 70mg CBD a day, and those who are pregnant, breastfeeding or taking any medication not to consume CBD products.

Given this context, some companies have already followed the procedures of the regulation on novel foods in an attempt to have their ingredients authorized.

At the end of 2019, a consultation procedure led to the conclusion that a CBD isolate (purity > 98%) dissolved in MCT oil (medium-chain triglyceride) is a novel food (“Novel when used as or in foods”).

Three applications for authorisation as a novel food for CBD for use in food supplements have been transmitted to date by the European Commission for assessment by EFSA: Synthetic trans-Cannabidiol, Cannabidiol derived from chemical synthesis, Synthetic cannabidiol. Those applications concern only synthetic cannabidiol. Several applications for authorisation as a novel food for CBD from Cannabis sativa  have been also submitted to the European Commission. However, the applications concerning CBD extracted from Cannabis sativa are blocked since July 2020 because of a Commission’s preliminary view that CBD extracted from the flowering and fruiting tops of the hemp plant is covered by Schedule I of the Narcotics Convention (i.e. ‘extracts and tinctures of cannabis’).

The Court of Justice of the European Union has recently concluded that CBD (cannabidiol) extracted from Cannabis sativa cannot be regarded as a ‘narcotic drug’ because it does not appear to have any psychotropic effect or any harmful effect on human health on the basis of available scientific data. This judgement of 19 November 2020 (Case C‑663/18) follows a request of preliminary ruling concerning the French legislation limiting the industrialisation and marketing of hemp solely to fibre and seeds. This judgement is not specific for foods, and it would not change the fact that CBD (from Cannabis sativa or synthetic) is considered as a Novel food according to Regulation (EU) 2015/2283,and that CBD could be used in food only with a specific authorisation granted according Regulation (EU) 2015/2283. However, this opinion from the Court of Justice of the European Union should be a good argument for the European Commission to review its preliminary view and to accept to send the applications concerning CBD extracted from Cannabis sativa to EFSA for scientific assessment.

Our experts are at your disposal to guide you through the regulations. With more than 10 years of experience in the industry and success, we offer a complete and tailor-made service in Novel Food dossiers.

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