CBD Regulation UK

CBD Regulation and Laws in the UK

To understand CBD regulation in the UK we need to take a closer look at CBD – or cannabidiol – and its origins. The CBD in CBD oils on the UK market mainly comes from either ‘Industrial hemp’ – also known by its Latin name Cannabis sativa – or other strains of the Cannabis plant.

Historically, Industrial hemp has been cultivated for its fibre for use in clothing, paper and construction. More recently, in part due to a better understanding of its safety and therapeutic properties, industrial hemp is grown to make CBD for use in food, food supplements and vape products.

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CBD is legal in the UK. But the picture is more complicated than that – here, we look at all the UK laws and regulations surrounding this remarkable compound.

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Note: In August 2019 we updated our guidance on the limit of THC from “1 mg per pack” to “No THC (recommended limit of detection: 0.01%). The change in advice was made in order to provide a ‘best practice’ to businesses which takes into account the ‘exempt product’ laws, the corresponding Home Office guidance and the fact that many labs offering CBD testing services may not reliably detect 1 mg of THC. More information is provided below.

CBD as a Novel Food

Authorities in EU member states now regard food, drink and food supplements with CBD as a “novel food”. A key regulation of novel foods is premarket authorisation which means any manufacturer intending to put CBD into food are required to apply to the European Commission via an online application.

Read about the position of the Food Standards Agency (UK authority) in the section ‘Food Standards Agency and CBD’ below.

Examples of CBD foods in scope of novel food regulations:

• CBD oils, capsules & oral sprays
• CBD gummies, mints & other sweets
• CBD infused tea, coffee, beer and soft drinks
• CBD snacks including energy bars

Excluded from novel food regulations are CBD foods where the CBD is derived from cold pressed hemp seed oil or flour.

What is a Novel Food?

As defined by the European Commission:

“Novel Food is defined as food that had not been consumed to a significant degree by humans in the EU before 15 May 1997, when the first Regulation on novel food came into force.”

The Novel Food Regulation

Like with most EU regulations including GDPR the data protection regulation, Novel Food Regulation EU 2015/2283 was developed to harmonise national laws across Europe. Without harmonisation, you have a diverse and complex patchwork of regulation with each Member State having their own laws. This can hinder development of the single market.

The Novel Food Regulation has to be applied directly to all Member States without deviation from its laws. In this way it is unlike a Directive, for example the Tobacco Products Directive, in which States can deviate from the rules to some extent.

The Novel Food Catalogue

The EU keeps a list of all novel foods in a searchable database. Cannabidiol is listed under ‘cannabinoids’ and has been assigned a status:

Status of Cannabidiol and other cannabinoids:

“The hemp plant (Cannabis sativa L.) contains a number of cannabinoids and the most common ones are as follows: delta-9-tetrahydrocannabinol (Δ9-THC), its precursor in hemp, delta-9-tetrahydrocannabinolic acid A (Δ9-THCA-A), delta-9-tetrahydrocannabinolic acid B (Δ9-THCA-B), delta-8-tetrahydrocannabinol (Δ8-THC), cannabidiol (CBD), its precursor in hemp cannabidiolic acid (CBDA), cannabigerol (CBG), cannabinol (CBN), cannabichromene (CBC), and delta-9-tetrahydrocannabivarin (Δ9-THCV). Without prejudice to the information provided in the novel food catalogue for the entry relating to Cannabis sativa L., 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”

What does this mean?

The entry for CBD in the catalogue confirms that CBD foods are by definition a Novel Food and should be subject to Novel food regulation whereby a novel food application is required.

In fact, the status has only recently been updated after a review by the EU authorities (read Update January 2019) below.

The old status which no longer applies is below:

Update 25th January 2019:

The Danish health authority released information about the potential change to the status in a statement:

“There is a process in progress in the EU to determine whether other parts of the hemp plant (eg, leaves or flowers) and extracts of the plant have been legally marketed in the Community before May 15, 1997. Then Novel Food Catalog will be updated and clarified with respect to to which parts of the hemp plant are not considered covered by the novel food rules.”

However, the authorities did not find ‘a history of consumption’ of cannabinoids before May 15, 1997 and so, according to novel food regulation, a novel food application is required.

CBD as a food supplement

With CBD in food now classed as a Novel Food it also means CBD that is intended for a CBD oil food supplement must follow the same regulatory pathway – a Novel Food premarket authorisation.

In fact, one company, Cannabis Pharma S.R.O, pre-empted the update to the status and submitted an application some time ago. It is currently under assessment and, according to one industry source, may get approval in March 2020.

Legality of CBD flower and bud in the UK

CBD flower and CBD bud have become the popular term to mean the flower and bud of hemp. With claims of CBD content, low but ‘legal’ levels of THC, flower and bud are commonly sold as ‘tea’ and under other guises. Despite the increasing availability of CBD flower and CBD bud in UK shops and online, not dissimilar the dispensaries in the US, these products are in fact a controlled substance in the UK. Then why is it sold openly you might ask?

Like with many rules for CBD there is some confusion. Claims of legality of CBD flower and bud made by retailers are commonly based on the fact that they have been sourced from ‘EU approved varieties’ and contain ‘less than 0.2% THC’.

Now, it is true that there are ‘EU approved varieties’ and these must have less than 0.2% THC (unless medicinal). But in the UK these rules relate to the cultivation of hemp for which a license is required; not for the sale of parts of the hemp plant.

To understand further we need to know more about the conditions of the hemp cultivation license. As part of the hemp cultivation license only the fibre and hemp seeds can be processed for commercial purposes (e.g hemp seed, hemp seed oil, hemp fibre for construction purposes etc).

The rest of the plant including the bud and flower must be destroyed. None can leave the site. On this basis, the bud and flower cannot be made for sale in shops. The flower and bud effectively fall under the generic term of ‘cannabis’ and so fall in scope of the Misuse of Drug Act along with other controlled substances.

Enforcement of CBD flower and bud UK laws

Enforcement of the laws surrounding CBD flower and bud has been relatively light considering its controlled status. It reflects the light touch of the government and enforcement authorities in the UK which also probably lends to the confusion.

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UK Cannabis Laws: A Timeline

1928: Dangerous Drugs Act

First laws on the possession of cannabis introduced in Britain

1967: Drugs (Prevention of Misuse) Act

Recommendations made to reduce the penalties for possession of cannabis

1971: The Misuse of Drugs Act

A restriction is placed on the cultivation of all species of cannabis plant

2001: The Misuse of Drugs Regulations

New laws permits cannabis cultivation under a special licence issued by the Home Office and the smoking of cannabis for research purposes.

2015: The Misuse of Drugs (Designation)

The Misuse of Drugs paves the way for the first ‘medical marijuana’: Sativex – the first cannabis-based medicine in the UK –  is allowed on to the UK market under prescription.

2019: Draft new rules for CBD?

We can expect new rules on the sale and manufacture of CBD soon!

Clarification of the legal limit of THC

There is some confusion in the industry regarding the legal limit for THC in CBD oils and other products in the UK.  To clarify, the 0.2% figure refers to the cultivation of hemp (for which a licence is required), hemp products such as hemp seeds and hemp oil derived by cold pressing of hemp seeds. It does not apply to CBD products derived by highly efficient extraction methods such as CO2 supercritical or solvent extraction (methods by which the majority of CBD products on the market is made).

So the 0.2% limit does not relate to the CBD oils, capsules, drinks available bought in shops. In fact, for a CBD product to be fully legal we are advising that your product should contain no THC (or ‘not detected’) as verified by an accredited lab with a limit of detection of 0.01%. We explore this matter in more detail below.

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Guidance on the legal THC limit

The rules for THC limits in CBD products are not explicit which is probably the reason for the confusion in the industry. But we can get some clarity from the cannabis and controlled drug laws including Misuse of Drugs Act 1971, 2001 and 2010. These laws lay down the conditions for which THC is allowed.

Specifically, under the Misuse of Drugs Regulations 2001, ‘exempt product’ status allows for under certain conditions the presence of no more than 1 mg of THC per pack in any given CBD product. The tricky part is to meet this condition reliably and consistently. The CBD testing market is awash with unaccredited, unverified labs so businesses seeking THC testing may unwittingly chose a lab that cannot reliably detect 1 mg THC.

On this basis, we consider it a risky strategy for a business to adopt the ‘no more than 1 mg limit’ while not talking into account a critical factor: the accuracy of the test itself. Not only that, it makes the assumption that the other conditions of the ‘exempt product’ status are met which is not necessarily the case for all product types and in all scenarios.

We advise business to verify that the products they sell contain no THC (or ‘not detected’) using an accredited lab running an accredited THC test with a limit of detection at 0.01% or lower.

Food Standards Agency and CBD

The Food Standards Agency (FSA) provide information on their website about their position on CBD. Essentially, they will align with the EU authority position: that CBD is a novel food and fall within novel food regulations.

Importantly, they have set a deadline for producers to comply with novel food regulation. Read more about what the FSA say in our blog post.

The message from the FSA is clear: producers of CBD oils, snacks, drinks, gummies etc should prepare and submit a novel food application. Without a validated or approved application, after 31st March 2021, you risk your products being removed from shelves. As of 13th February 2020, for products not currently on the market, require a novel food application before marketing.

MHRA and CBD

Over the last few years, the MHRA – the UK health authority – has been releasing sporadic statements on their view of the regulatory status of CBD and cannabinoid-containing products. The latest statement from December 2016 reads as follows:

“Our primary concern is patient safety and we wish to reiterate that individuals using cannabidiol (CBD) products to treat or manage the symptoms of medical conditions should discuss their treatment with their doctor.

MHRA will now work with individual companies and trade bodies in relation to making sure products containing CBD, used for a medical purpose, which can be classified as medicines, satisfy the legal requirements of the Human Medicines Regulations 2012.”

They have also written to some companies that market CBD products on their opinion. We can expect more statements from the MHRA in due course.

Trading Standards and CBD

Trading Standards (TS) is the authority that oversees the CBD retail market. So far, little has been said by the Chartered Institute of Trading Standards on the topic of CBD. This is probably because they are waiting for a UK regulatory framework and instruction from the MHRA and other authorities. But in due course, we are likely to see a surveying of the UK market including lab testing of cannabidiol-containing products sold from shops. TS may investigate labelling such as health claims made and CBD and THC content.

Update (September 2018): This month police confiscated cannabis and CBD products from a shop in Plymouth. Officers supported by Trading Standards seized the products for “testing and police enquiries” as reported by Plymouth Live.

The ‘Cannabis Product Directive’ – or CPD

The ‘Cannabis Products Directive’ or CPD is a proposed regulatory framework for cannabis products in the EU. It has been developed by the Cannabis Trades Association (CTA) and pitched to the health authorities of the EU as a basis for new CBD regulation.

Despite its name, the CPD is not an official EU Directive or regulation. It is a concept by the CTA to presumably help bring about proportionate CBD regulation.

Click here to read more about the Cannabis Product Directive.

Safety Data Sheets:

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Resources

Directive 2002/53/EC – permitted crops

Directive 2002/57/EC – marketing of industrial hemp

The Misuse of Drug Act of 1971

The Misuse of Drugs Regulations of 2001

The Misuse of Drugs (Designation) of 2015

Apply for Home Office licence to cultivate Industrial hemp here.

EU database for permitted varieties of industrial hemp.