EU Regulation of CBD in Foods and Cosmetics
There has been tremendous growth in the number of foods and cosmetics on the market that contain cannabidiol (CBD). According to recent market research studies, Europe's cannabis and CBD markets are set to continue growing exponentially over the next few years. Regulators in Europe are now taking a closer look at the market for foods and cosmetics which contain CBD.
In this Advisory, we summarise the current regulatory environment in Europe for foods and cosmetics containing CBD. We also comment on the fast-changing environment in the US.
Cannabinoids and CBD
Cannabinoids are chemical compounds, found in certain plants or manufactured synthetically, that act on cannabinoid receptors to produce a range of physiological effects. Two of the most important cannabinoids are tetrahydrocannabinol (THC), the principal psychoactive compound in cannabis and cannabidiol (CBD) which, in contrast to THC, does not cause a "high" and, according to a report from the World Health Organisation (WHO)1, does not exhibit effects indicative of abuse or dependence potential.
THC and CBD are two of some 113 cannabinoids found in cannabis plants, a genus of flowering plants in the family Cannabaceae. The classification of cannabis species is controversial; Hillig (2005)2 proposed three species of cannabis: C sativa, C indica, and C ruderalis, whereas other researchers suggest that cannabis plants comprise a single species, C sativa, with a number of subspecies.3 Cannabis has been cultivated for thousands of years. Certain varieties are grown for their fibre or edible seeds (hemp and hemp seeds), which contain low levels of THC (0.3% or less), whereas other varieties serve as sources of marijuana and hashish, and are high in THC (15 - 40%).
The WHO Expert Committee on Drug Dependence recommended on 24 January 2019 to the United Nations that preparations considered to be pure CBD should not be scheduled within the International Drug Control Conventions. The Committee proposed adding a footnote to the entry for "cannabis and cannabis resin" in Schedule I of the Single Convention on Narcotics Drugs of 1961 to specify that CBD preparations are not under international control.4
This recommendation was due to be considered by the UN Commission on Narcotic Drugs in March 2019 but the vote was postponed to allow member states more time to discuss the consequences of potential changes in scheduling of cannabis for national and international control measures. A new date for the vote has not been set yet.
Foods containing CBD
Under European Union law, food that has not been consumed to a significant degree by humans in the EU before 15 May 1997, when the first Regulation on novel foods came into force, is considered as "Novel Food" and controlled in a stricter manner than regular foods under Regulation (EU) 2015/2283 ("the Novel Food Regulation").5
Novel Food can be newly developed, innovative food, food produced using new technologies and production processes, as well as food which is or has been traditionally eaten outside of the EU. Examples of Novel Food include new sources of vitamin K (menaquinone) or extracts from existing food (Antarctic Krill oil rich in phospholipids) or agricultural products from third countries (chia seeds, noni fruit juice).
Food producers can place a Novel Food on the EU market only after the European Commission has processed an application for the authorisation of the novel food, has adopted an implementing act authorising its placing on the market and updated the EU list of novel foods. A food or ingredient will be authorised only if it meets the criteria laid out in Article 7, namely it is shown to be safe, not nutritionally disadvantageous and does not mislead the consumer. There are three routes by which an apparently novel food may be approved or authorised under the Novel Food Regulation:
- by showing the food's significant history of use in the EU prior to 1997, through the official consultation procedure provided for in Article 4 (i.e. that the food or ingredient is not, in fact, a Novel Food); or
- as a traditional food from a third country in accordance with Article 15, where a history of safe food use for at least 25 years can be demonstrated; or
- a full application based on submission of a dossier for registration of a Novel Food in accordance with Articles 10-13.
The EU Novel Food Catalogue lists foods and ingredients viewed as novel foods, for which an authorisation should be obtained. The Catalogue itself, has no legal status, but is frequently used by EU Member States to assist in enforcement of the Novel Food Regulation.
The cultivation of Cannabis sativa L. varieties is permitted in the EU provided they are registered in the EU's 'Common Catalogue of Varieties of Agricultural Plant Species' and the tetrahydrocannabinol (THC) content in the plant does not exceed a concentration of 0.2 %, which in practice means that cultivation of only the hemp variety of Cannabis sativa is permitted.
The European Commission's Working Group of Novel Foods has recently reclassified CBD as a Novel Food for the purposes of the EU Novel Food Catalogue.6 This currently states in relation to Cannabis sativa L:
"[…] 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 entry for cannabinoids now states:
"[...] 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".
As a result of this change, the European Commission now regards all extracts of hemp and derived products containing cannabinoids (including CBD) as novel. Hemp seeds, flour and seed oil remain excluded from the categorisation of Novel Foods in the Catalogue, as long as cannabinoids have not been added as ingredients. While, as stated above, the Catalogue has no legal status, in practice it will be given substantial weight by national authorities, who may therefore conclude that foods containing CBD may be placed on the EU market only once an authorisation under the Novel Foods Regulation has been obtained. Nevertheless, the current approach to CBD, at Member State level, following the amendment to the Novel Foods Catalogue, is variable:
- the Irish Food Safety Authority considers CBD products based on the manufacturing process applied. CBD oil prepared through cold-pressing of hemp seeds, may be sold on the basis that this oil contains low levels of CBD. In contrast, CBD obtained through methods such as supercritical CO2 extraction, would be viewed as Novel Foods for which an authorisation is required.
- other authorities (e.g. those in Belgium and Austria) do not permit CBD products to be marketed.
A novel food application for CBD is currently under consideration with the European Food Safety Authority (EFSA) to authorise the use of CBD in food supplements for adults with a daily intake of up to 130 mg. This application was made by Cannabis Pharma s.r.o., a company from the Czech Republic and is based on publicly available safety and toxicological information and toxicity reviews. The opinion of the EFSA is reportedly expected soon. This decision will be closely monitored by the industry as it may have wider significance for the CBD food products market.
CBD food products lawfully on the market prior to 1 January 2018 may rely on the transitional provisions of the Novel Foods Regulation. As long as an application for an authorisation is filed before 2 January 2020, the product can continue to be marketed until an authorisation decision has been taken by the Commission.
The status of foods containing CBD also determines the claims that may be made when they are marketed. If such products qualify as foods or food supplements, only specific health or nutrition claims authorised in the EU Register in accordance with Regulation (EC) No 1924/2006 may be made. Any CBD product taken for a medical purpose and associated with medical claims must be authorised as medicinal products.
Following the change in the EU Novel Foods Catalogue, the UK Food Standards Agency (FSA) revised its guidance on CBD:
"The FSA accepts the clarification from the EU that CBD extracts are considered novel foods. We are committed to finding a proportionate way forward by working with local authorities, businesses and consumers to clarify how to achieve compliance in the marketplace in a proportionate manner".
In the meantime, the CBD industry groups have criticised the handling of the situation by the FSA. On 26 March 2019, CannaPro, a UK trade association, wrote to the FSA asserting its members' rights for compensation for associated losses due to the "misclassification" of their products as novel foods.
CBD in cosmetics
Regulation (EU) No 1223/2009 (the Cosmetics Regulation) defines a cosmetic product as any substance or mixture intended to be placed in contact with external parts of the human body for the purposes of cleaning, perfuming, changing its appearance, protecting, keeping in good condition or correcting body odours.7
Article 3 of the Cosmetics Regulation states that any cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use. Annex I contains the requirement for a cosmetic product safety report.
Annex II8, lists the substances that are prohibited from use in cosmetics. This list includes any substance referred to in Tables I and II of the Single Convention on Narcotic Drugs of 1961 (the Single Convention) 9, which includes cannabis.10 However, the Single Convention uses a narrow definition of Cannabis limited to "the flowering or fruiting tops of the cannabis plant" and excludes the seeds and leaves of the plant when not accompanied by the tops.11
It follows that from an EU law perspective, CBD may be used in cosmetics placed on the EU market when obtained from cannabis, cannabis resin, cannabis extracts and cannabis tinctures originating from the seeds and leaves that are not accompanied with the fruiting tops of the cannabis plant. In any case, the general legal requirements for cosmetic products, including those relating to safety are applicable.
The is directly applicable in the UK and therefore, CBD may be used in cosmetics placed on the UK market provided they are obtained from cannabis, cannabis resin, cannabis extracts and cannabis tinctures originating from the seeds and leaves that are not accompanied with the fruiting tops of the cannabis plant.
In 2013, the UK Government introduced the Cosmetic Products Enforcement Regulations 2013 to create new enforcement powers, offences and penalties for breaches of the Cosmetics Regulation.
The US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have recently taken action in relation to companies selling CBD products in the US.
On 28 March 2019, the agencies sent warnings letters to three companies they believe advertised products in a way that may be in violation of the Federal Food, Drug and Cosmetic Act as well as the Federal Trade Commission Act. We recently reported on the US Agencies, states and local governments responses to the congressional legalisation of CBD or Hemp (see our Advisory here).
While FDA maintains its position that CBD is not appropriate for use in conventional food or dietary supplements, the FDA's departing commissioner Scott Gottlieb M.D. recently stated that the FDA was using its enforcement discretion with respects to certain products containing CBD. The FDA has said it will take enforcement action against CBD products that are on the market if manufacturers are making "over-the-line" claims about products. Some examples that the FDA have given of these types of claims include:
"CBD successfully stopped cancer cells in multiple different cervical cancer varieties."
"CBD also decreased human glioma cell growth and invasion, thus suggesting a possible role of CBD as an antitumor agent."
"For Alzheimer's patients, CBD is one treatment option that is slowing the progression of that disease."
On 2 April 2019, the FDA announced that in light of the growing interest in the development of therapies and other FDA regulated consumer products derived from cannabis and its components including CBD, it would be taking "new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis derived products". These steps include:
- A public hearing on 31 May 2019, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety. Requests to make oral presentation and comments at the hearing should be submitted by 10 May 2019. Electronic or written comments can be submitted prior to 2 July 2019.
- the formation of a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health. This group will be co-chaired by Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. and Principal Associate Commissioner for Policy Lowell Schiller. The working group plans to begin sharing information and/or findings with the public as early as Summer 2019.
- updates to the FDA webpage with answers to frequently asked questions on this topic to help the public understand how the FDA's requirements apply to these products.
- the issuance of multiple warning letters to companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations (see examples listed above).
Regulators and competent authorities in Europe and the US are taking a closer look at the market for food and cosmetic products which contain CBD and are gearing up to bring enforcement action against companies selling CBD products that make "over the line" claims. European regulators are a few steps behind the US and have yet to take the same proactive steps, but the recent reclassification of CBD as a Novel Food suggests they might be gearing up to follow suit.
© Arnold & Porter Kaye Scholer LLP 2019 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.
"Preparations containing predominantly cannabidiol and not more than 0.2 percent of delta-9-tetrahydrocannabinol are not under international control" footnote to the entry for cannabis and cannabis resin in Schedule I of the Single Convention on Narcotic Drugs (1961) recommended by WHO ECDD on 24 January 2019.
As of 1 January 2018, the new Regulation (EU) 2015/2283 on novel foods (the Novel Food Regulation) is applicable. It repeals and replaces Regulation (EC) No 258/97 and Regulation (EC) No 1852/2001 which were in force until 31 December 2017.
Regulation (EU) No 1223/2009, Article 2(1)(a) defines cosmetics as "any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours"
"Cannabis" means the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin has not been extracted, by whatever name they may be designated.