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Is CBD legal in EU? Services and products that we buy and use nowadays are, or at least should be, well regulated. This includes everything from booking a hotel for your vacation or business trip EFSA’s scientists cannot currently establish the safety of cannabidiol (CBD) as a novel food due to data gaps and uncertainties about potential hazards related to CBD intake.

Is CBD legal in EU?

Services and products that we buy and use nowadays are, or at least should be, well regulated. This includes everything from booking a hotel for your vacation or business trip to buying foodstuffs like milk, personal care products and cosmetics at your local store or online.
The legal status of the items that we buy, use and/or consume depends on several factors, such as:

  1. the classification of the product,
  2. the type and legal status of the ingredients,
  3. the country where the product is sold.

Sounds confusing? We will explain these factors below using concrete examples for CBD and other consumer products.

So, what is the legal status of popular CBD products?

The question of the legal status of CBD products is, besides questions about quality, certainly one of the most important and common from CBD users.

Unfortunately, the answer is not simple or straightforward. The reason for the complexity is that all three of the above-mentioned factors must be considered when we want to define the legality of a certain CBD product, as you will see in the continuation.

1. The classification of CBD products

Did you know that CBD products fall into many different categories of final products? Currently, the most popular and known are:

  • Food supplements, where CBD oil is the most common
  • Foodstuffs like drinks infused with CBD and other active ingredients
  • Cosmetic products containing CBD, such as anti-aging topical creams and serums
  • Personal care products that contain CBD are scarce, but oral hygiene products, for example, are gaining in popularity
  • Medicines with an active pharmaceutical ingredient (CBD in an isolated form or as cannabis extracts)
  • E-liquids with CBD for vaping
  • Smoking a type of cannabis flowers with CBD (so called “tobacco” substitutes)

The legislation and legal status of these diverse forms of CBD products differ, regardless of the fact that they all contain CBD. This is quite reasonable if we consider that some are used on the skin, while others are ingested or even inhaled. Not to mention the purpose – medicines are used to cure and treat diseases, which is not the case for cosmetics and food supplements.

Below is a simple legal classification of the various CBD-related products and the applicable general EU legislation. It is important to note that besides the general legislation, additional EU and national regulations apply as well. Currently, the most “popular” and specific to the world of CBD is EU Regulation 2015/2283 on novel foods. This regulation was discussed in one of our previous blogs.

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*certain forms of cannabis are used for vaporizing (flowering parts) and are classified as a medicinal product.

Are you questioning whether all these CBD products are legal? Well, this depends on other factors, i.e., the type of CBD used as an ingredient in such final products and, interestingly, where the product is sold, as you will see in continuation.

If a producer or seller of a particular product complies with the applicable EU and national legislation, then the answer is “yes” in all cases. Hence, CBD products are legal as long as they are registered and compliant with the legislation that needs to be followed.

2. The type of CBD as an ingredient

While some ingredients like caffeine can be incorporated into cosmetics, food supplements and foodstuffs as well as pharmaceuticals, there are some ingredients that are regulated and can only be used in certain types of products.
One such ingredient is vitamin D, which is a very popular ingredient in food supplements, especially these days, as it boosts the immune system and keeps viral infections away. Some studies also relate vitamin-D intake with potent antiviral properties in the case of Covid-19.

Vitamin D is also an active pharmaceutical ingredient (API) in medicinal products, where daily doses are typically higher than food supplements with vitamin D.

In stark contrast, vitamin D is on the list of prohibited substances in cosmetic products in the European Union. Both forms of vitamin D (ergocalciferol and cholecalciferol) are listed in Annex 2 of EU 1223/2009 – the list of substances prohibited in cosmetic products.

CBD as an ingredient in cosmetic products can occur as an isolated CBD or as hemp/cannabis extract, which typically also contains other phytocannabinoids that can be found in hemp.

Cosing, a comprehensive EU database on cosmetic ingredients, provides the following information for the keyword “cannabidiol”:

As you can see, there are no restrictions on CBD, regardless of its origin – whether it is naturally derived from hemp/cannabis or synthetically produced. The restrictions in the last column refer to the above-mentioned list of prohibited substances given in EU 1223/2009.

We see something similar if we type in Cosing the following keywords “cannabis sativa leaf extract”:

The source of the extract in the case of hemp/cannabis matters in terms of the legality of cosmetic products. For example, only extracts of certain parts, such as stems, seeds and leaves, are allowed. This relates to a rather obsolete, yet still applicable, classification of drugs from the UN Single Convention on Narcotic Drugs, signed in New York on 30 March 1961.

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On the other hand, medical preparations from cannabis can be produced from any part of the plant and can contain either CBD on its own or a combination with other phytocannabinoids, including the psychoactive tetrahdydrocannabinol or THC. THC is classified as a drug according to the UN Convention from 1961, but can be legally used as a medicine under certain circumstances.

3. The legal status of CBD by countries

The legal status of CBD in Europe is defined by EU and national regulations. The legislation and people’s opinions are changing fast and continuously, so the “rules” that apply today might not be effective tomorrow.

For example, last year the European Commission’s preliminary opinion on CBD being a narcotic was withdrawn after a few months. The Commission changed their minds in November 2020, when the European Court of Justice published a judgement stating that CBD that is extracted from cannabis should not be considered as a drug under the 1961 United Nations Single Convention on Narcotic Drugs.

A similar case at the national level happened last October in Italy, which suspended a decree, only a few days old, where CBD preparations were added to “Section B” of the Italian narcotics law’s table of medicines. Just for clarification: medicines in “Section B” require a special prescription that cannot be used multiple times in Italy.

It is clear from the above, that whether a certain CBD product can be legally sold in a certain country depends on its classification.

For example, in all the EU Member States and the UK, cosmetic products with CBD are legal if they comply with the applicable cosmetic regulations.

On the other hand, food supplements with CBD are a little more complex. In the EU, such products need to be approved by the European Commission prior to being sold legally on the market. This is not the case in the UK now, where the authorities decided that CBD products that are currently on the UK market can be sold freely if the producers/sellers have authorization for the approval of such Novel foods in process. For more details on this topic, check our previous blogs on Novel Foods in the EU and in UK.

So, you can see that the legal status of CBD products depends on many factors, such as the form of the final product, the source of the CBD and last, but not least, on country-specific regulations.

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The latter are changing fast. Therefore, our advice to you is to constantly follow the news as it relates to the CBD market. At Pharmahemp, we are closely monitoring the situation in the EU and the UK and any major changes and updates to the legislation will be shared with you instantly.

For any further advice and guidance on specific legislation you can also contact us at [email protected]

Cannabidiol novel food evaluations on hold pending new data

Cannabidiol is a substance that can be obtained from Cannabis sativa L. plants and be synthesised chemically as well. The European Commission considers that CBD qualifies as a novel food provided it meets the conditions of EU legislation on novel foods. Following the submission of numerous applications for CBD under the novel food regulation, the Commission asked EFSA to give its opinion on whether CBD consumption is safe for humans.

Data gaps and uncertainties

EFSA’s expert Panel on , Novel Foods and Food Allergens (NDA) has received 19 applications for CBD as a novel food, with more in the pipeline.

Chair of the NDA Panel, Prof. Dominique Turck said: “We have identified several hazards related to CBD intake and determined that the many data gaps on these health effects need filling before these evaluations can go ahead. It is important to stress at this point that we have not concluded that CBD is unsafe as food.”

There is insufficient data on the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system and on people’s psychological well-being.

Studies in animals show significant adverse effects especially in relation to reproduction. It is important to determine if these effects are also seen in humans.

Support to applicants

Ana Afonso, Head of Nutrition and Food Innovation at EFSA, stated: “Stopping the clock on a novel food assessment is not unusual when information is missing. It’s the responsibility of applicants to fill data gaps. We are engaging with them to explain how the additional information can be provided to help address the uncertainties.”

As part of the follow-up, EFSA is holding an info-session, open to applicants and other groups or individuals with an interest in this issue and novel food more generally. The online event takes place on 28 June – register to attend!

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