Worldwide: 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

EU Position

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:

  1. 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
  2. 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
  3. 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.

Claims

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.

UK position

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

EU position

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 II 8, 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.

UK position

The Cosmetics Regulation 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.

Cosmetics operators may contact one of the safety assessors available from the UK industry body Cosmetic, Toiletry and Perfumery Association (CTPA) to comply with the safety assessment requirements imposed under Annex I of the Cosmetics Regulations. The Regulation also requires manufacturers to notify the European Commission directly of every cosmetic product placed on the market, using the Cosmetic Product Notification Portal (CPNP).

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.

US position

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).

Summary

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.

Footnotes

1 Cannabidiol (CBD) Pre-review Report. World Health Organisation Expert Committee on Drug Dependence. Thirty Ninth Meeting, Geneva 6-10 November 2017.

2 Hillig KW. Genetic Evidence for Speciation in Cannabis (Cannabaceae). Genetic Resources and Crop Evolution 2005; 52(2): 161-180

3 de Meijer EPM. The Chemical Phenotypes (Chemotypes) of Cannabis. In: Pertwee RG, Ed. Handbook of Cannabis. Handbooks in Psychopharmacology: Oxford University Press; 2014: 89–110.

4 "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.

5 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.

6   http://ec.europa.eu/food/safety/novel_food/catalogue/search/public/index.cfm

7  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"

8 Regulation (EU) No 1223/2009

9 "Narcotics, natural and synthetic: All substances listed in Tables I and II of the Single Convention on narcotic drugs signed in New York on 30 March 1961."

10 Single Convention on Narcotic Drugs, Schedule 1 "Cannabis, cannabis resin, cannabis extracts and cannabis tinctures"

11 "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

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions