What Is A CBD Certificate Of Analysis And How To Read One

If you’re wondering what a certificate of analysis is and how it relates to CBD, here’s an in-depth guide about why it matters and how to read one.

A CBD certificate of analysis is a document produced by a third-party laboratory to analyse the contents of a cannabidiol product.

The most important purpose of the document is to detect how much THC – if any – the product contains. We’ll explain why shortly.

For the certificate of analysis to be authentic, it should be from an ISO-accredited lab, ideally with a 0.01% detection limit.

From top to bottom, this is how to read a certificate of analysis for a CBD product.

The header

At the top of the certificate of analysis, you should find information about the third-party testing lab used to examine the product.

At first glance, that may not seem like something worth reading, but it’s very important. 

It should provide the proof you need that the testing certification was not completed in-house, but by an independent lab without any conflicts of interest.

The header should include the lab’s name and address, plus their licence and accreditation details. In short, it provides enough information so that you can research or contact them.

Some will have a QR code – if you scan this with your smartphone, you may find further information that will help you verify the CBD certificate of analysis’ authenticity.

If you can’t see everything you’re looking for, then try the footer on the certificate.

Cannabinoid types

This is a list of the different cannabinoids present in the CBD product. 

If you were only expecting to see CBD itself here, that may be the case when testing CBD isolate as it’s at least 99% pure CBD. Otherwise, there will be other cannabinoids present.

There are many active cannabinoids found in the Cannabis sativa plant. CBD is one of them and THC is another – this is the one responsible for psychotropic effects. 

When CBD is extracted from industrial hemp, other cannabinoids come with it. By refining it carefully, the CBD can be separated from everything else to varying degrees.

The UK law on CBD oil makes it clear that a CBD product can only contain up to 1 mg of THC per pack. Whereas CBD isolate won’t contain any, other legal CBD products may have very slight trace amounts of THC – but not enough to produce a ‘high’.

Many CBD products will also contain small amounts of other cannabinoids – such as CBDA, CBG or CBC – for example, if it’s a broad-spectrum distillate. We’ve recently written about CBD distillate and how it differs from CBD isolate

Many CBD consumers are happy to see other cannabinoids present in their products. It has been claimed that there could be a ‘full entourage effect’ – with different cannabinoids working together to potentially produce stronger overall effects. 

So, throughout this section on a certificate of analysis, expect to see several cannabinoids mentioned.

Example of a certificate of analysis

Weight percentage

To the right of each cannabinoid, you’ll usually see a percentage. 

These figures reveal the percentage by weight of each cannabinoid from the lab tests, out of the overall weight of the product.

If you don’t see a percentage, you may see the letters ND instead. It means ‘not detected’ – there may be some of this cannabinoid in the product, but so little that there isn’t enough to analyse.

Concentration

This is measured in milligrams per gram or mg/g – it is the concentration of each cannabinoid as part of the entire product.

Again, the letters ND next to a cannabinoid means that it wasn’t detected. If it says ND in the weight percentage column, there should be one in the concentration column too.

Heavy metal analysis

This is the first part of the safety testing results section – just note that not every CBD certificate of analysis has this.

It should reveal the concentration, and there is also an ‘ingestion’ statistic. The latter is the maximum amount of heavy metals – such as mercury – that is safe to consume, presented in micrograms (0.000001 gram, or one-millionth of a gram). 

If there are any traces of heavy metals, then the tested concentration should be far below the number in the ingestion column.

Pesticide analysis

Again, not every certificate of analysis will have this part of the safety testing section. 

An upper limit of potential acceptable consumption is shown by parts per billion (ppb) – but of course what you really want to see next to each pesticide tested for, are the letters ND.

Limit of detection or quantification

These may appear on the certificate of analysis as abbreviations – LOD or LOQ.

It’s a statistic used to confirm the accuracy limit or reliability of the weight and concentration measurements.

As mentioned, we recommend that CBD manufacturers use third-party labs with a detection limit of 0.01% so that there’s no margin for error.

Footer

On some versions of a certificate of analysis, a few of the details we mentioned from the header may be down here – for example, contact information or a QR code.

There should be a signature – this will be from one of the most senior members of staff at the lab.

There may also be a key, explaining any abbreviations used in full.

Final thoughts: What Is A CBD Certificate Of Analysis And How Do You Read One?

We hope this run-through has answered all your questions. Now you know how to read a CBD certificate of analysis.

Remember, if you want to see a certificate of analysis from a CBD provider, any reputable company should make it accessible to consumers. If you can’t find one, just ask for it.

It’s worth taking care and researching any new CBD product you buy in advance. In the Centre of Medicinal Cannabis report CBD in the UK, several products available in shops were tested – some had too much THC and some had high amounts of heavy metals.

One product had no CBD at all – some providers are, wittingly or unwittingly, mislabelling their products. It just shows the importance of only buying high-quality CBD products from reputable providers. For any further information about reading a certificate of analysis, or to ask about specific products, then please contact us.

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European Commission Now Allows Natural CBD in Cosmetics

Back in February 2021, the European Commission (EC) permitted the use of natural CBD in formulating cosmetic products. The decision followed a November 2020 court ruling that the substance was not a narcotic

The EC’s move has started to bring clarity to a matter that has been confusing many for a long time. 

cbd cosmetics

What’s changed?

Essentially, EC’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs added two new substances to the EU CosIng database. This is their database containing information about cosmetic substances and ingredients, and their uses.

They include the naturally-derived cannabidiol that comes from the leaf and other parts of the Cannabis Sativa L. plant. 

The first entry is CBD derived from extract, resin, or tincture of hemp. Its functions include anti-sebum, anti-oxidant, and skin conditioning and protection. 

The second entrant is cannabis sativa leaf extract. Similarly, its functions include skin conditioning and it’s also used as a skin softener.

In late 2020, the European Court of Justice ruled that the entire cannabis plant shouldn’t be classified as a narcotic. 

Consequently, the European Industrial Hemp Association (EIHA) moved to request the EC to update the CosIng database. 

The Commission granted the plea and added the two CosIng entries for CBD derived from the roots and flowers of cannabis. 

Why have these changes been made? 

Several professionals and experts in the cosmetics industry have previously said that the regulation concerning CBD products was unclear. 

This situation had created a disparity in the compliance of EU member states. However, things are beginning to shift, thanks to the new entries. 

Until February 2021, the CosIng database had only permitted synthetic CBD. 

However, the EU Cosmetics Regulation (EC No. 1223/2009) allowed the use of CBD derived from leaves, stems, and some other parts of the cannabis plant. 

Further confusion arose concerning the hemp flower extracts. While most member states disallowed CBD derived from flowers, some permitted it. 

Presently, the CosIng database lists natural CBD derived from cannabis resin or extract and leaves as distinct cosmetic ingredients. 

Of course, the catalogue is only informative and doesn’t serve a legal purpose. 

However, the CosIng guides the member states and helps to synchronise cosmetic product marketing on the continent. 

What’s the difference between synthetic and natural CBD?

So, what exactly is the difference between synthetic and natural CBD? Well, most of the over-the-counter supplements you buy are not organic substances. 

While they are made in a laboratory, these compounds are pretty much identical to their natural counterparts. 

Similarly, synthetic CBD is manufactured in the lab using chemicals and biomolecules. However, it is bioidentical to the hemp plant-derived cannabidiol. Moreover, it affects the body in the same way its natural counterpart does. 

Why, then, has the EU placed strict regulations around the naturally-derived ingredient in the past?

If you manufactured cosmetics from the natural compound, the products would probably contain low CBD concentration. 

Worse still, they could have trace tetrahydrocannabinol. Many jurisdictions regard CBD that contains over 0.2% of THC as a narcotic, including the UK. 

That’s why several countries in the EU place stringent measures on the sale of CBD-containing products. 

On the contrary, EU regulations do not label any synthetic CBD product as a narcotic. They only place restrictions on natural compounds that come from flowers or fruits of the hemp plant. 

However, this regulatory framework was complex, even for experts in the cosmetic field. 

What does the new development mean?

The addition of the two fresh natural CBD ingredients to the catalogue presents a new era in the cosmetic industry. 

First, it clarifies the regulation around the use of these compounds in manufacturing cosmetics. Also, more manufacturers are certainly going to use CBD in production and on a larger scale. 

Moreover, the update in the regulation may spark a heavier investment in research, innovation, and development of CBD products. 

Bigger cosmetics players are likely going to invest more in developing fresh and independent brands. Also, they could extend their current lines of products. 

Consequently, this situation may increase consumer interest and product demand.  

Before the change in the EU regulation, manufacturers and marketers had a hard time dealing with the sourcing of CBD and its products. 

They had to engage in lengthy and complex talks with several entities before making or marketing these substances. These included investors, regulators, wholesalers, retailers, and payment transactors.

The new regulatory landscape removes barriers from the road of manufacturing and marketing CBD cosmetics. Soon, you are going to see more of these products on the market. 

Better still, more consumers are set to benefit from what’s going to be on the counter.  

Also, the new regulation could lead to claims validation. In the past, companies have only been able to make general claims. 

However, the time has come for them to produce solid evidence about the efficacy of their specific CBD products.

What’s next for CBD cosmetics companies?

This good news for the CBD industry does not mean the game is over. 

EIHA managing director Lorenza Romanese said the CosIng updates revealed the rewarding work her organisation did. However, she was quick to add that there was more to do in that area. 

While the EC updated the CosIng database, it’s important to note that the catalogue is not legally valuable. 

This means it is up to each EU Member State to regulate the manufacture and marketing of natural CBD cosmetics. 

For instance, the UK recently recognised the CosIng database as an important guide in the country’s regulations. 

However, Austria still restricts the marketing of cosmetics containing this natural ingredient. 

Also, to sell cosmetic products, you need to conduct safety assessments in line with the Regulation and the CosIng. 

Therefore, brands that would use CBD in their cosmetics should consider the amount of time, research, and cost to put in. 

These companies must prove beyond any reasonable doubt that these products are safe for humans. 

The EC Now Allows Natural CBD In Cosmetics: Conclusion

The inclusion of the two new ingredients in the CosIng database marks a revolution in the CBD cosmetics industry. 

Since the catalogue’s function is to coordinate cosmetic product marketing in all EU states, several members are likely to oblige. 

As a result, more companies will look to manufacture cosmetics that contain natural CBD – widening the potential of the market.

To find out more about the specific CBD regulations in the UK, check out our guide to CBD oil and UK law. Or, if you’d like to know more about getting into the CBD business, contact us today to find out how we can help you!

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Brexit CBD Restrictions: Everything You Need to Know

Brexit has dominated the headlines for the last five years. Now that the UK is no longer in the EU, industries and the economy are starting to feel the effects. Here, we discuss all there is to know about the new Brexit CBD restrictions.

brexit cbd restrictions

CBD law in the UK

First of all, let’s look at the legality of CBD in the UK.

CBD, or cannabidiol, is a compound found in the cannabis plant. CBD products are legal in the UK as long as they don’t contain tetrahydrocannabinol (THC) – the cannabinoid that gets you ‘high’.

THC, along with most other cannabinoids, is a controlled substance under the Misuse of Drugs Act 1971 (MDA). This means it’s illegal to possess, produce or distribute a product that contains THC.

To be legal, a CBD product must contain less than 1mg of THC per pack. Any more than this and it would be considered a controlled substance under the MDA.

Novel food regulations and Brexit

In January 2019, CBD was added to the EU Novel Food Catalogue, meaning it would be subject to the EU’s novel food regulations.

Under these regulations, foods or food ingredients that don’t have a history of consumption prior to May 1997 must be assessed and authorised before they can be marketed.

In February 2020, the Food Standards Agency (FSA) gave UK companies a deadline of 31 March 2021. By then, companies must have a validated novel food application in place for each of their products. Only products linked to such an application would be allowed to remain on the shelves from 1 April 2021.

The FSA recently updated this rule to include products linked to a novel food application that has been submitted (rather than validated) by 31 March 2021. Products can stay on the shelves during the process of validation.

After submitting a novel food application, validation usually takes around 2-3 months. Validation means the applicant has submitted all the necessary information, and the application can move onto the authorisation stage. Full authorisation can take over a year.

Products that weren’t on sale before the FSA’s initial announcement (13 February 2020) must have full novel food authorisation before coming to market.

However, Brexit has complicated novel food regulations for CBD, with Scotland’s pro-EU politics and the Northern Ireland-Republic of Ireland (ROI) border issue complicating the situation.

This has resulted in three different regulatory regimes across the UK. The FSA’s deadline applies to companies in England and Wales, but there are different rules for Scotland and Northern Ireland.

What are the rules in Scotland?

Food safety in Scotland is governed by Food Standards Scotland (FSS), rather than the FSA. FSS has rejected the FSA’s 31 March deadline system and instead opted to follow the EU’s authorisation-only policy.

This means that in Scotland, CBD products must have full novel food authorisation before they can be sold. Currently, there are no CBD products with novel food authorisation.

In December 2020, FSS clarified its position. They acknowledged that there are CBD products already on the market, many of which are still seeking novel food authorisation.

Because of this, FSS is encouraging a proportionate approach to enforcement, taking into account a company’s commitment to gaining legal compliance.

Despite not aligning with the FSA’s approach of allowing products without full novel food authorisation to stay on the shelves, FSS is working closely with the FSA on the validation and authorisation of novel food applications. Companies only need to submit their applications to the FSA, with no need to submit to FSS separately.

What are the rules in Northern Ireland?

Novel food regulations for Northern Ireland have been complicated by the issue of the post-Brexit border between the UK and EU.

The Northern Ireland Protocol was negotiated by the UK and EU to avoid a hard border between Northern Ireland and the ROI. It enables goods to cross between the two countries with no new checks.

Due to the protocol, Northern Ireland has effectively remained in the EU’s single market for goods. This allows goods to move between Northern Ireland and the EU, via the ROI, as they did pre-Brexit, without new checks, tariffs, or paperwork.

This means that companies seeking novel food authorisation for products on the Northern Ireland market need to continue to follow EU rules and the EU’s authorisation procedures.

As a result, the FSA’s 31 March deadline doesn’t apply to products in Northern Ireland. Like Scotland, products need full novel food authorisation before they can be legally marketed for sale.

How is Brexit affecting trade in the CBD market?

The UK’s Brexit trade agreement allows for free trade with the EU, with no tariffs or quotas introduced.

However, Brexit has ended the free movement of goods between the UK and the EU. This is a blow to UK CBD companies. Most companies rely on CBD imported from EU countries that allow hemp growers to use the plant’s flowers. In the UK, hemp flowers are a controlled substance.


As the UK is no longer required to follow EU regulations on product standards, companies are facing new customs checks and more paperwork. This can make shipping goods – including CBD products – much more complicated.

These new difficulties can create extra costs and shipping delays, putting a strain on supply chain relationships. Many CBD companies are already experiencing issues; some shipments being held up at customs or turned away at the border because they don’t have the correct documents.

The danger is that these new challenges may force UK companies to drop their European CBD suppliers and look elsewhere.

Could Brexit bring benefits for the CBD industry?

No longer bound by EU regulations, some believe that Brexit may unlock new opportunities for the UK CBD industry. For example, it may make it possible to develop a CBD sector similar to Switzerland’s, which is thriving.

This is a result of an amendment to the Swiss Narcotics Act in 2011 allowing cannabis with an average THC content <1% to be legally grown and sold. This was followed by a boom in low-THC cannabis retailers and interest in CBD products.

However, the UK currently has stricter rules on the cultivation and processing of hemp than many EU countries, so it remains to be seen whether it will follow suit.

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‘CBD is Not a Narcotic’ says EU Court in CBD Breakthrough

In an exciting development in CBD oil news, the EU’s highest court has ruled that CBD is not a narcotic.

This landmark decision has provided a welcome boost for the European CBD industry, creating a clearer path to full legal compliance for CBD companies.

cbd is not a narcotic says eu court in cbd breakthrough

The latest CBD oil news: CBD is not a narcotic

The ruling by the Court of Justice of the European Union (CJEU) was announced on 19 November 2020. It states that cannabidiol (CBD) is not a narcotic drug because it ‘does not appear to have any psychotropic effect or any harmful effect on human health’.

The ruling came as part of a case known as the ‘KanaVape Case’, which involved the prosecution of French CBD company KanaVape.

KanaVape sold e-cigarettes containing CBD oil derived from whole hemp plants. In French law, only the seeds and fibre of hemp may be used commercially – it’s illegal to use the buds or flowers. CBD oil and UK law are similar in this aspect.

However, the CBD that KanaVape used was produced lawfully in the Czech Republic. Over there, it is legal to use the whole hemp plant to produce CBD oil, and then imported into France.

What does the ruling mean?

The CJEU ruled that the criminal proceedings against KanaVape weren’t consistent with EU law on the free movement of goods. They stated that: ‘A Member State may not prohibit the marketing of cannabidiol (CBD) lawfully produced in another Member State when it is extracted from the Cannabis sativa plant in its entirety and not solely from its fibre and seeds.’

In other words, the EU decision said that France’s ban on marketing hemp-derived CBD products contradicted EU law, as the products in question had been produced legally in another EU member state.

cbd-is-not-a-narcotic-says-eu-court-in-cbd-breakthrough

EU laws on the free movement of goods do not apply to narcotic drugs, as the marketing of narcotic drugs is banned in all EU member states. The court, therefore, had to establish whether CBD should be regarded as a narcotic in order to determine whether the French authorities had contradicted EU law.

The court concluded that ‘the provisions on the free movement of goods within the European Union (Articles 34 and 36 TFEU) are applicable. This is because the CBD at issue in the main proceedings cannot be regarded as a ‘narcotic drug’.’

In describing its reasoning in deciding whether CBD could be considered a narcotic, the court cited two UN conventions: 

  • The Convention on Psychotropic Substances: The court noted that CBD is not mentioned in this convention.
  • The Single Convention on Narcotic Drugs: Although this convention makes reference to cannabis extracts, the court observed that interpreting CBD as a drug on this basis would be ‘contrary to the general spirit of that convention and to its objective of protecting ‘the health and welfare of mankind’.’

The court concluded that on this basis, and ‘according to the current state of scientific knowledge’, CBD is not a narcotic drug.

What else did the ruling say?

The ruling stated that a ban by a member state on the marketing of hemp-derived CBD products may be justified ‘by the objective of protecting public health’ but that it ‘must not go beyond what is necessary in order to attain it’.

The court declared that it was for the French national court to assess whether the prohibition in question was justified on those grounds. However, it noted that France hadn’t banned the marketing of synthetic CBD, which has the same properties as CBD and could be used as a substitute for it. The court also stated:

“The national court must assess available scientific data in order to make sure that the real risk to public health alleged does not appear to be based on purely hypothetical considerations. A decision to prohibit the marketing of CBD, which indeed constitutes the most restrictive obstacle to trade in products lawfully manufactured and marketed in other Member States, can be adopted only if that risk appears sufficiently established.”

More about the KanaVape case

The KanaVape case began in 2014. The French authorities deemed KanaVape to be contravening French law by selling products containing CBD extracted from whole hemp plants.

In 2018, the Court of Appeal of Aix-en-Provence overturned the initial ruling. This was on the grounds that it contradicted the EU principle of free movement of goods. The case was then referred to the CJEU. 

The CJEU sought the guidance of Advocate General Evgeni Tanchev. And, in May 2020, Tanchev was of the opinion that CBD should not be considered a narcotic. This view was not legally binding, but the courts do tend to follow the advice of the Advocate General. Therefore, this was seen as a positive development for the CBD sector.

Unfortunately, this optimism was somewhat dampened in July 2020. The European Commission paused all CBD novel food applications while it considered whether CBD should be regarded as a narcotic. Its preliminary stance was that it should, based on a strict reading of the Single Convention on Narcotic Drugs.

However, the November court ruling definitively contradicted this stance and set a precedent for all EU institutions and member states. 

What does the ruling mean for the CBD industry?

The CJEU ruling marked a huge step forward in CBD oil news and is likely to have major ramifications for the CBD industry in Europe. 

The European Commission has since abandoned its stance that CBD should be classed as a narcotic. Novel food applications for CBD products have resumed, which clears the way for CBD companies to achieve full legal compliance for their products.

Adela Williams, Partner at Arnold & Porter, legal counsel to the Association for the Cannabinoid Industry, said:

“This is clearly an important decision for the European CBD industry. The EU’s highest court has decided that EU member states may not prohibit the marketing of CBD products lawfully supplied in other member states unless a real risk to public health has been demonstrated. Furthermore, the European Court has confirmed that CBD should not be classified as a narcotic under the 1961 UN Convention on narcotics, removing an obstacle to the continued assessment of novel food applications relating to CBD products.”

What is CBD?

CBD is one of a group of chemical compounds called cannabinoids found in the Cannabis sativa plant species.

Unlike tetrahydrocannabinol (THC), another well-known cannabinoid, CBD does not cause psychotropic effects – it doesn’t get you ‘high’. CBD is typically extracted from hemp, a variety of Cannabis sativa that contains little or no THC. 

CBD has seen a surge in popularity recently, as interest has developed in its potential therapeutic benefits. The World Health Organisation has said that CBD is ‘generally well tolerated with a good safety profile’. They’ve also outlined that there is no evidence ‘of any public health-related problems associated with the use of pure CBD’.

We’ll be back soon with more CBD oil news, so watch this space for all the latest developments.

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CBD Oil and UK Law: Everything You Need to Know

UK law on CBD is often met with confusion. CBD oil and other CBD products have seen a surge in popularity in the last few years. However, many people are still unsure whether these products are entirely legal – and there’s also confusion about the regulations they must meet to be sold on the UK market. 

In this article, we’ll tell you everything you need to know about CBD oil and UK law.

cbd oil and uk law

What is CBD oil?

The Cannabis sativa plant species contains chemical compounds called cannabinoids. Of over 100 different cannabinoids, cannabidiol (or CBD) is just one.

Tetrahydrocannabinol (THC) is the cannabinoid that causes psychoactive effects – the one that gets you ‘high’. CBD doesn’t have this effect.

CBD oil is usually extracted from hemp, a strain of Cannabis sativa containing little or no THC. For thousands of years, hemp has been cultivated and used to make products including:

  • textiles and clothing
  • paper
  • rope
  • food
  • insulation
  • biofuel and bioplastics

In recent years, interest has grown in the potential therapeutic and medicinal properties of CBD oil. It is touted as a treatment for a variety of health issues, including anxiety, insomnia and chronic pain. Despite this, we still need more research to fully understand its effects. 

In 2019, a huge step was made in CBD laws. A medication containing CBD – Epidyolex – was approved for use in the UK to treat severe epilepsy. 

Now, foods, food supplements, cosmetics and vape products containing CBD are widely available to buy. Meanwhile, the UK CBD market continues to grow.

However, because of its association with cannabis, there is often a lack of clarity over CBD oil and UK law.

What is the UK law on CBD oil?

So, is CBD oil legal in the UK? The short answer is yes – but it’s a little more complicated than that.

CBD oil is legal as long as it doesn’t contain THC. This, along with most other cannabinoids, is a controlled substance under the Misuse of Drugs Act 1971 (MDA). This means that possessing, producing or distributing a product that contains THC is illegal.

CBD is not a controlled substance. However, a CBD product containing traces of THC is a controlled substance under the MDA, unless it meets the ‘exempt product’ criteria in the Misuse of Drugs Regulations 2001 (MDR).

To meet the criteria, a CBD product must not contain more than 1mg of THC per pack. We’ll explain this in more detail below.

A timeline of CBD oil and UK law

  • 1928: The UK first made cannabis illegal, adding it as an addendum to the Dangerous Drugs Act 1920.
  • 1968: The Wootton Report, a Home Office investigation into cannabis, concluded that cannabis was ‘less dangerous than opiates, amphetamines and barbiturates’. They recommended that imprisonment was ‘no longer an appropriate punishment for those who are unlawfully in possession of a small amount’.
  • 1971: The Misuse of Drugs Act came into force. This listed cannabis as a Class B drug and restricted  the cultivation of all varieties of the cannabis plant.
  • 2001: The Misuse of Drugs Regulations were introduced. This new legislation permitted cannabis to be cultivated under a licence issued by the Home Office and to be smoked for research purposes.
  • 2010: The Medicines & Healthcare products Regulatory Agency (MHRA) issued a marketing authorisation for Sativex. This cannabis-based medicine is the first to be recognised in the UK as having medicinal properties. Sativex is now available as a prescription-only treatment for multiple sclerosis symptoms. 
  • 2018: It became legal for specialist doctors to prescribe cannabis-based medicines for patients with an ‘unmet special clinical need’. The law changed following pressure from parents of children with severe epilepsy, who had benefited from medicinal cannabis. 
  • 2019: CBD was classified as a ‘novel food’. This means any food or food ingredient containing CBD needs pre-market safety assessment and authorisation.

How can I make sure my CBD product meets UK laws on THC limits?

As mentioned previously, CBD products must contain less than the legal limit of THC to be classed as an ‘exempt product’ under the MDR.

The MDR allows for no more than 1mg of THC per container in any given CBD product or preparation. This limit applies regardless of the size of the container. 

For example, a product that comes in a 10ml pack must contain less than 1mg of THC. However, the same product in a larger pack could still only have up to 1mg of THC.

There’s some confusion around CBD oil, UK law and the THC limit, with some sources quoting the limit as 0.2%. However, this figure actually applies to the cultivation of hemp.

Hemp can only be cultivated legally if it has a THC content below 0.2%. This is called ‘industrial hemp’, and you’ll need a licence from the Home Office to grow it.

The 0.2% limit does not apply to CBD products derived through modern extraction methods. This includes the CBD capsules, oils, drinks and other products available in shops.

It can be difficult to consistently meet the 1mg limit, as some unaccredited CBD testing labs are unable to reliably detect 1mg of THC. 

To avoid the risk of unwittingly exceeding the limit, it’s advisable to ensure products contain no THC. Have this verified by an accredited lab, with a limit of detection of 0.01%.

CBD and the UK Novel Food Regulation Law

In January 2019 CBD was added to the Novel Food Catalogue, which is a list of foods that are subject to the EU Novel Food Regulation.

According to this regulation, foods are considered novel if they were not consumed to a significant degree in the UK or EU before May 1997, when the regulation came into force.

All novel foods must have a pre-market safety assessment and authorisation before they can be legally marketed or used in food for human consumption in the UK.

Examples of CBD products that are subject to the Novel Food Regulation include:

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

Hemp products like flour and cold-pressed oils aren’t considered novel. There’s evidence showing these products were consumed before May 1997.

What does the Novel Food Regulation mean for CBD companies?

CBD companies must ensure their products are covered by a novel food application.

On 13 February 2020, the Food Standards Agency (FSA) announced a new deadline of 31 March 2021. By this date, companies needed a validated novel food application in place for all of their products.

After 31 March 2021, only products with novel food validation can remain on the shelves.

Applying for novel food authorisation involves preparing a dossier of manufacturing and product information. This information will demonstrate that your product is safe for human consumption. 

The dossier must then be submitted to the European Commission, or the FSA if submitting after 31 December 2020.

You can read our complete guide to the Novel Foods Application process in our article here.

The flower and bud of the hemp plant are widely available in shops, often sold as ‘tea’ and other products. These products claim to have a high CBD content and ‘legal’ levels of THC.

However, hemp flowers and buds are a controlled substance. The fact they’re openly sold in shops and online is, again, the result of widespread confusion around the law. There’s also a fairly soft stance on enforcement from the UK authorities.

Retailers usually claim their CBD flower and bud products are legal. They often quote the fact that they contain less than 0.2% THC and come from ‘EU approved varieties’ of hemp.

For further information on this topic, we’ve written an extensive blog answering the question ‘Is CBD flower legal in the UK?‘.

What is the UK law on travelling with CBD oil?

If you’re planning a trip, you might be wondering what UK law says about taking your CBD oil with you. 

Since CBD oil is legal in the whole country, you should be able to take it on domestic flights within the UK. Just watch out for the 100ml liquid limit in hand luggage, which includes oils. 

Read our in-depth blog explaining can you take CBD oil on a plane in the UK?

Can you sell CBD as medicine under UK law?

In 2016, the MHRA issued a statement saying: “We have come to the opinion that products containing cannabidiol (CBD) used for medical purposes are a medicine.”

However, they stressed that ‘medicinal products must have a product licence (marketing authorisation) before they can be legally sold, supplied or advertised in the UK’.

Although medical cannabis has been legalised, CBD companies are not allowed to make claims about the medicinal benefits of their products unless they have been granted a medicinal product licence. 

Sativex, Epidyolex and nabilone (a synthetic cannabinoid used for treating chemotherapy-induced nausea and vomiting) are currently the only licensed CBD or cannabis-based medicines available in the UK. 

Businesses can still sell unlicensed CBD products– and some people may use them medicinally. However, these products are not allowed to be labelled or sold as medicine. MHRA advises anyone using CBD to treat or manage medical conditions to discuss their treatment with their doctor.

CBD Oil and UK Law: Conclusion

CBD oil is not only legal to sell – it’s a thriving business opportunity. With markets growing, there’s never been a better time to get involved.

But as we’ve seen, the laws around CBD are often complex – so it’s helpful to have some expert advice on your side.

Our consultancy service can give you the industry expertise you need, whether it’s help with Novel Foods Regulations or tips on expanding your client base. Get in contact with our team today to find out how we can help you.

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CBD Novel Foods Applications: A Complete Guide

Note: this blog was updated with new information from the Food Standards Agency (FSA), released on 22/02/2022

CBD novel foods applications: a complete guide

Products containing CBD now need a validated novel food application to remain on the shelves.

The Food Standards Agency (FSA) has released a list of UK CBD products linked to novel food applications. These applications were submitted before 31 March 2021 to meet new regulatory requirements.

In this article we explain the novel food authorisation process, what this means for CBD companies and what you need to do to comply.

What are novel foods?

Novel foods are foods that do not have a ‘history of consumption’ in the UK or EU.

This means the public did not consume them to a notable degree in the UK or EU before May 1997. This was when the EU Novel Food Regulation came into force.

Some examples of novel foods are:

  • Foods consumed elsewhere in the world, like baobab fruit pulp and chia seeds.
  • Foods made using new processes, like bread treated with UV light to increase vitamin D levels.
  • New foods, like phytostanols and phytosterols in cholesterol-reducing spreads.

Products that are subject to the Novel Food Regulation are placed on the Novel Food Catalogue based on information provided by EU member states.

The Novel Food Catalogue added CBD to the list in January 2019.

What is novel food authorisation?

Novel foods must undergo a safety assessment and authorisation before they are legally marketed or consumed in the UK.

The food must also fall into one of the following categories:

  • Animals or plants
  • Fungi, algae, micro-organisms or cell culture
  • Minerals or engineered nano-materials
  • Ingredients that have a new or intentionally modified primary molecular structure
  • Food produced using a new process that significantly alters the product either nutritionally or in terms of food safety risks

In order to get novel foods authorisation, foods must be safe and must not be misleading to consumers. In addition, they must not replace other foods in a way that would nutritionally disadvantage consumers.

How do I know if a novel food is authorised?

The Union list of novel foods comprises all authorised novel foods.

Want to sell an authorised novel food in a way that is not included in the Union list? You must obtain novel foods authorisation for this new use.

If you intend to sell a product, it’s your responsibility to know whether the Novel Foods Regulation applies to it.

What does the novel food classification mean for the CBD industry?

The CBD market in the UK has grown rapidly over the last few years. According to the Association for the Cannabinoid Industry (ACI), around 1.6 million people now consider themselves to be regular consumers.

However, the growth has happened with little regulation on the quality or safety of products available. This has resulted in confusion for businesses and lowered consumer confidence.

The new regulatory novel food regulations will pave the way for a safe, sustainable and legally compliant CBD market. This means in future, consumers can feel confident the products they’re buying are of high quality.

What does it mean for CBD companies?

You must have a validated novel food application for any product containing CBD.

On 13 February 2020, the FSA set a new deadline for all CBD companies to submit retrospective applications. By 31 March 2021, all products already on sale had to have a validated application for novel food authorisation in place.

After this, only products with a validated novel food application were legally allowed to stay on the market.

This deadline applied to products that were already on the market on the date of the announcement. 

New CBD products that come to the UK market must have full novel food authorisation before their sale. To do this, you must apply for a regulated product authorisation for a novel food.

What does a novel food application involve?

Applying for novel foods authorisation involves preparing a dossier of manufacturing and product information.

You must submit this dossier to the European Commission (or FSA if submitting in the UK from 1 January 2021) through an electronic portal. The dossier must demonstrate that your product is safe for human consumption.

After submission, your application will be evaluated. If you’ve provided sufficient information, it will be validated – this usually takes 2-3 months. This is the stage your application needs to reach before the 31 March 2021 deadline.

Update 12/03/21: After struggling to cope with the volume of applications, the FSA have altered their approach to Novel Food compliance. CBD businesses can now submit applications up until the 31 March 2021 deadline – it is no longer necessary to have the application validated beforehand. Products can remain on sale throughout the validation period. Find out more here.

Following validation, your application will move onto the authorisation process. The European Food Safety Authority (EFSA) will then review the application, carrying out a risk assessment over 9 months.

Once the EFSA approves the application, they will pass it on to the European Commission. They will then have 7 months to authorise the product and add it to the Union list of novel foods.

How do I prepare a CBD novel food application?

Preparing your dossier involves a variety of product testing and data gathering exercises. Some of these may take as little as 2 weeks, while others can take up to 9 months.

Below is the list of required assessments for CBD products, along with estimates on how long each stage takes:

  • Full toxicology assessment: 8-9 months, comprising 7-8 months for the assessment followed by one month to produce the data report
  • Stability assessment: At least 6 months. This should assess a minimum of 6 months’ accelerated stability to support the product’s shelf life. This would be in addition to continued real-time stability testing
  • Product manufacturing data for a minimum of 5 batches: 5 months. You must independently manufacture and test each batch. Total ADME assessment: 2-3 months
  • Genotoxicology studies: 6-7 weeks, comprising initial Ames testing
  • Detailed information on typical CBD exposure and usage: 2-3 weeks
  • Risk assessment and risk mitigation plan: 2-3 weeks
  • Submission of additional supporting data: 2-3 weeks

These activities can happen simultaneously, so in total this process should take around 9 months. However, timescales can vary depending on the complexity of your product.

CBD novel foods applications: a complete guide

Recent developments in toxicology data requirements

The UK government’s Committee on Toxicity (COT)’s ongoing review of CBD safety highlights the need for that new toxicology data.

To meet this need, the ACI announced in September 2020 that it was launching a landmark safety study with a consortium of CBD companies.

The study will address the missing information identified by the COT. This will include whether CBD can cause liver toxicity or drowsiness, or if it interacts with other drugs. Providing this data will be a key requirement for a successful novel foods dossier.

In line with the EFSA’s guidance on preparing a novel food application, the ACI-led study will include a 90-day rodent study according to OECD 408 parameters.

To minimise animal usage, the study will use a single 90-day rodent study. The resulting data will be available to all participating companies. Companies interested in joining the study can contact the ACI.

Meeting the deadline

All CBD products that were on the market in the UK prior to 13 February 2020 needed to have a validated novel food application by 31 March 2021 to remain on the shelves.

From the submission date, it takes 2-3 months to validate a novel food application. Therefore, to meet the deadline, you should have submitted your dossiers by October 2020 and by December 2020 at the very latest.

Given the timeline above, your data gathering activities should have begun by the end of January 2020 to allow 9 months before submission.

If you’re yet to begin the novel food application process, you should follow the novel food application guidance and CBD guidance from the FSA. You should also make sure the novel food application covers the formulation and usage of your product.

If they aren’t doing this or are unlikely to meet the deadline, you could source a supplier that has already done so to avoid supply chain disruption.

Latest guidance post-Novel Foods deadline

As of 26 April 2021, the FSA has a published list of all the CBD products which are not authorised, but can stay on sale. This list was recently updated on 22 February 2022.

The list can help local authorities enforce regulations on the sale of unregulated foods. It’s also useful for retailers to know the status of suppliers.

The list includes applications which:

  • Are validated and in the initial stage of the process before going on to the safety assessment
  • Are ‘on hold’, meaning applicants have started the risk assessment process but haven’t supplied all the information needed

The FSA are regularly reviewing applications made before 31 March to update the list, so it’s worth keeping an eye on.

How will Brexit affect the Novel Food Regulation?

The Novel Food Regulation is an EU regulation. However, the FSA will still require novel foods in the UK to be authorised after the end of the Brexit transition period on 31 December 2020.

Currently, the European Commission and EFSA are responsible for evaluating and authorising novel food applications for the UK.

From 1 January 2021, the FSA and Food Standards Scotland took over responsibility for assessing UK applications. They provide advice to ministers, who then decide if they will authorise novel foods.

For existing authorisations, if your product has been authorised by the European Commission and the appropriate legislation is in place before the end of the transition period, then your authorisation will remain valid in the UK.

However, if you want to make changes to an existing authorisation after 31 December 2020, you’ll need to use the FSA’s authorisation procedure.

For ongoing applications, the FSA states:

“We are finalising procedures for the applications submitted to the EU before the end of the transition period for which the assessment process has not been completed. We will provide guidance in due course.”

How much does a novel food application cost?

There is no fee payable for the application itself, but the cost of testing and reports can be significant.

It could cost just £20,000 if your product uses raw materials that already have a validated novel food application. However, it could cost as much as £350,000 for a complex product that needs a full application.

Novel foods authorisation for CBD products

Worried about novel food regulations or applying for a novel foods authorisation? Leaf Sciences can help. We offer a range of both CBD raw materials and white label products, all covered by a novel food application.

Putting together a full CBD novel food application could involve lots of hassle – and a steep cost. Use our raw materials and white label products to save yourself this difficulty while staying true to your brand.

We also offer consultancy and market intelligence services – something few other wholesale distributors provide. This means we’re a one-stop-shop for new and pre-existing companies looking to expand.

We’re members of the ACI, so we can offer their services for those wanting to submit their own application in full. Contact Leaf Sciences today to find out how we can help your business.

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