EU Regulation Of CBD In Foods And Cosmetics – Food, Drugs, Healthcare, Life Sciences


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.



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