Cannabis products between European Pharmacopoeia and the hidden

barriers in EU regulation

Author bio: Dr. ADANELA MUSARAJ

SCHOOL OF RANSNATIONAL GOVERNANCE

EUROPEAN UNIVERSITY INSTITUTE

adanela.musaraj@eui.eu

(Quality and regulatory umbrella for HTC and food market)

The EDQM supplies chemical reference substances (CRS), herbal reference standards (HRS)
and biological reference preparations (BRP) for cannabis products, among billions and billions
of other substances. But cannabis products are becoming more and more various, and differ
significantly in concentrations of ∆9 -tetrahydrocannabinol (THC) and cannabidiol (CBD).
Higher doses of THC can intensify the risk of harm from cannabis, while CBD may partially
counterbalance some of these effects. Existing proposals for standard cannabis units have been
based on specific methods of administration (e.g. joints) and there are too many other methods
on the market, like pipes, bongs, blunts, dabbing, vaporizers, vape pens, edibles and liquids
that still needs standardisation. Other proposals (e.g. grams of cannabis) cannot account for
heterogeneity in THC concentrations among different cannabis products.

CBD in Europe – Legislation on the EU and National Levels

CBD is considered a novel food by European Regulators. While many CBD products remain
on the market, they have not been authorized by the European authorities. CBD was placed in
Novel food catalogue January 2019, meaning the ingredients required a pre-market
authorisation. The difficulties with this situation was that the novel food classification was
applied to an emergent, but already existing industry. Novel Food is defined as food that had
not been used for human consumption to a significant degree in the European Union before
15th May 1997. Previously to this decision, only enriched CBD was considered novel food.
Now a new entry Cannabinoids was created, and it states all hemp extracts to be novel. Also,
the entry of Cannabis sativa L. was changed and now only seed-derived products are considered
food. The leaves and flowers are left in a ‘grey zone’. At the level of the European Union, CBD
is now considered to be the unauthorized new food.

 How HTC pipes, bongs, blunts, dabbing, vaporizers, vape pens, edibles and liquids
market is regulated

1. CBD/THC Regulation in Italy for other using methods of HTC

Some of the measures European states are now taking can be illustrated by a recently adopted
resolution proposed by the Agricultural Commission in the Italian Senate. It proposes a raise
in the THC level in the industrial hemp that comes from EU varieties from 0.2 to 0.3 %. By
now, only Stabilimento chimico Farmaceutico Militare di Firenze can produce and sell legally
standardize medical hemp

The resolution proposed by the Italian Agriculture commission would level it up with the rest
of the global market since permitted levels of THC in CBD products in North America and
Australia are 0.3 %. It also asks for the regulation on the sales of dried, chopped or pelleted
biomass from the entire plant or its parts, with THC content not exceeding 0.2 %. There are no
current guidelines on CBD or THC limits considering food in Italy, and this resolution calls
for defining them.

In practice, to avoid leaves and flowers being left in the ‘grey area’ and to escape further
regulatory confusion, some Italian companies started registering CBD hemp flower products
as animal feed. However, registering pure cannabinoids such as CBD extracts as animal feed
is not permitted. CBD for pet food is also forbidden.

Italians are not alone in this novel practice. Following the novel food change, many European
companies approached the issue by relabelling their products. Austrian bio-tech company
CannHelp recalled all of its CBD-based oils, foods, and cosmetics. The company has relabelled
the oils so they are now categorized as “aromatic products” and, as such, placed back on the
shelves.

2. CBD/THC Regulation in Germany

The German Office for Consumer Protection and Food Safety (BVL) outlawed CBD in food
and food supplements in March 2019. The products containing cannabidiol are prohibited
unless they were authorized as a medicinal product or novel food. As of April, Nordic Oil and
other German companies were subjected to a serious of raids, with their products containing
CBD confiscated. The simultaneous searches targeted a number of shops selling CBD products.
Bavaria is considered to be the toughest German federal state when it comes to cannabinoids,
but the shops in other parts of the country, e.g. Hamburg, were reportedly searched on suspicion
of narcotics trafficking, too.

3. CBD Oil Novel Food regulation in Spain

In April 2019, the Spanish Agency for Consumer Affairs, Food Safety and Nutrition
(AECOSAN) issued guidance that stated CBD oils, regardless of whether its origin is natural
or synthetic, as well as extracts and other parts of the plant Cannabis sativa L. (flowers, leaves,
and stems) are considered novel food.

4. THC classified under pharmaceutical regulation in Sweden

In June, the Swedish Supreme Court ruled CBD oil containing low levels of THC to be
classified as a narcotic. Also, the court disagreed with the Swedish Medical Products Agency’s
proposal to put the products for oral consumption or inhalation containing cannabidiol under
pharmaceutical legislation. Industrial hemp is an exemption from Swedish anti-drug
legislation, and it only applies to plants, not products. Since 2017, eight companies selling CBD
oil as a dietary supplement have been banned from distributing their products by the Swedish
Medical Products Agency. Sweden also leads the European Union’s member states in the
number of CBD notifications submitted through the EU’s Rapid Alert System for Food and
Feed (RASFF) portal. Out of 35 notifications, 14 are from Sweden.
 5. Polish Tax Classification on CBD oils

In Poland, tax classification places CBD oils in the same group as cooking oils and margarine,
and therefore subjects to a 5% value-added tax (VAT) rate, comparing to a 23% rate to medical
cannabis. Local reports say the Chief Sanitary Inspectorate and the police have intensified their
enforcement activities on retail stores that sell CBD products. More than 20 Polish CBD stores
were subjected to confiscation of their goods by law enforcement bodies.

6. Cannabis as “Other Smoking Tobacco” in Belgium

Another news in European legislation came from Belgium in May, when Public Finance
Service (FPS Finance) issued an announcement clarifying that “plant-based smoking products
containing CBD and some THC content” were legal and belonged to the category of “other
smoking tobaccos”. It defined the products as dried hemp flowers that are tobacco-free, can be
consumed through combustion and did not contain more than 0.2% THC. The Health, Food
Chain Safety and the Environment (HFCSE) called the manufacturers to contact the authorities
before placing any herbal product for smoking on the market. This move brings a tax of roughly
30% and an additional 21% for VAT on hemp flowers.

7. Ukraine and Slovakia – Virtually Illegal

Ukraine has kept its THC level at 0.08% (for seed and fiber production), and Slovakia is the
only country in the European Union where CBD and THC are still illegal. Only the cultivation
of industrial hemp varieties approved by the EU and with less than 0.2% THC is legal in
Slovakia, and it cannot be cultivated to extract CBD. The local pharmaceutical business is also
seeking approval for the development and manufacture of cannabinoid-based drugs in both
states.

8. Bulgaria to Set CBD Regulation

Not all EU member states have announced the enforcement of novel food catalog guidelines
on CBD, and there are unconfirmed reports that Bulgaria recently issued a license that would
permit the sale of CBD food products.

9. CBD “Soft Drug” in the Netherlands

The Netherlands, as the biggest European hemp producer, has a legislative framework derived
from the Opium Act introduced in 1912, and amended in 1976, when the distinction between
‘hard’ and ‘soft’ drugs was introduced. By this Act, CBD is not legal but tolerated as a soft
drug. The Opium Act was amended in 1999 when hemp that is produced exclusively for the
fiber hemp market with a THC content of less than 0.2% was legalized. It’s still illegal to
produce CBD oils because it’s illegal to produce plant extracts, so the hemp is being produced
in the Netherlands and then processed abroad. Furthermore, under Dutch law, the maximum
level of THC in CBD products is 0.05%. CBD isolates and THC extracts are prohibited for sale
to the public but allowed for export.

10. Switzerland 1% THC

In Switzerland, the legal level of THC is at 1% since 2017 and the HTC pipes, bongs, blunts,
dabbing, vaporizers, vape pens are approved by the Federal Office of Public Health
(FOPH) and certified by Swiss Laboratory Examinations < with strong review and indication
of the CBD and THC values of our CBD hemp / cannabis products (CBD grass flowers, CBD
oils, etc.)

11. Great Britain – CBD Legal as Novel Food

In Great Britain, the biggest CBD market in Europe, THC is listed as a controlled substance
under the Misuse of Drugs Act 1971. CBN (Cannabinol) and CBDV (Cannabidivarin) are also
class B controlled substances. Only CBD isolated in its pure form is not listed as a controlled
substance. Growing your own cannabis and hemp is allowed with a license from the UK Home
Office for licensed medical distributors or companies that sell nutritional supplements. CBD
products sold as nutritional supplements must be labeled in accordance with The Food
Supplements Regulations from 2003. The sale of hemp flowers and buds is prohibited. CBD
extracts and other derived products are considered novel foods and need to gain authorization.
As we are informed by the Food Standards Agency (FSA), currently there are no CBD extract
products authorized as novel foods in the UK and the products on the market are in
contravention of the novel food regulations. The ‘grey zone’ of the European legislative
becomes even greyer knowing CBD was never listed as a food supplement in the EU. The
reference EU legislation in the area of food supplements is Directive 2002/46/EC, but the use
of substances other than vitamins or minerals in the manufacture of food supplements may be
governed by national rules or may be subject to other specific EU legislation.