CBD Edible Market

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CBD Edible Market

CBD Novel Food UK

CBD is not a Narcotic

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UK to take the lead and define the safety standards for the sustainable future of the CBD industry?

The European Commission (EC) has said on record that it is pausing all CBD novel foods applications as it reviews whether CBD should not be classified as a food at all, but instead a narcotic.

The reasoning behind this pause relates to a line on the United Nations Single Convention on Narcotic Drugs from 1961 which states that “extracts and tinctures” of the flowering tops of the hemp plant (cannabis sativa) should be classed as a narcotic. CBD companies have until September to put forward their case to the EC.

It is peculiar that the EC should be reassessing their forward-looking classification of CBD as a novel food based on a 60-year-old convention that resulted in the devastating war on drugs. A battle which has been, in the words of Barack Obama, “an utter failure”.

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You would think they would have learnt the lesson on the damage caused through making popular substances illicit, based on non-scientific evidence.

The World Health Organization (WHO) produced a critical review of CBD in 2018, in which they concluded it “exhibits no effects indicative of any abuse or dependence potential” and “is generally well tolerated with a good safety profile”. They also say in the report that “there is no evidence of recreational use of CBD or any public health-related problems associated with the use of pure CBD.”

These WHO conclusions do not reflect the properties that you would associate with a “narcotic”. WHO have put forward a series of recommendations to the UN to amend the Single Convention on Narcotic Drugs from 1961, one of which is the removal of the phrase “tinctures and extracts”  from Schedule 1 of the 1961 treaty and another to make CBD exempt from international control. The UN will vote on these recommendations in December 2020.

You would think they would have learnt the lesson on the damage caused through making popular substances illicit, based on non-scientific evidence.

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The World Health Organization (WHO) produced a critical review of CBD in 2018, in which they concluded it “exhibits no effects indicative of any abuse or dependence potential” and “is generally well tolerated with a good safety profile”. They also say in the report that “there is no evidence of recreational use of CBD or any public health-related problems associated with the use of pure CBD.”

These WHO conclusions do not reflect the properties that you would associate with a “narcotic”. WHO have put forward a series of recommendations to the UN to amend the Single Convention on Narcotic Drugs from 1961, one of which is the removal of the phrase “tinctures and extracts”  from Schedule 1 of the 1961 treaty and another to make CBD exempt from international control. The UN will vote on these recommendations in December 2020.

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In the US, the FDA has approved Epidiolex, which contains CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age and older. This demonstrates that the FDA has concluded this particular drug product is safe and effective for its intended use.

The FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors they intend to take into account in prioritising enforcement decisions. They intend to balance the goals of protecting the public and providing more clarity to industry regarding their enforcement priorities as they move towards a clear regulatory pathway. This seems a well reasoned and realistic approach.

There exists a trend for consumers towards organic products and many foods are being consumed for their health benefits. The concept of food as a medicine is a powerful and healthy option, and CBD is a prime example of such a product with popularity on the rise, as reflected in sales.

Should the EC deem CBD to be a controlled narcotic it will have a devastating impact on the lives of millions of European CBD consumers who rely upon the therapeutic properties of CBD they consume. For these people, CBD has been a life-changer, if not a life-saver, and has enabled them to avoid or reduce more harmful prescription drugs, reduce smoking, decrease alcohol consumption and keep away from other dangerous drugs. You could argue that CBD would reduce demands on European health services and can make people’s lives healthier, thus making them a more productive workforce.

Beyond the impact on consumers, there will be the impact on the hundreds, if not thousands, of companies that have sprung up around the CBD economy. These companies employ hundreds of thousands of people and serve millions.

The European Commission cannot believe that consumers will simply stop buying CBD. The demand will continue to exist. This demand is increasing month on month as people spread their positive testimonies of the therapeutic benefits they experience from consuming CBD products.

The results of such a decision, should it come to fruition, would be CBD moving into the black market. There are already concerns over the safety and authenticity of CBD products on the market, and outlawing CBD will make the situation infinitely worse.

Despite the resistance from many in the CBD industry as to whether CBD should be a novel food in the first place, it does have great benefits. This is because it forces the industry to generate the data to verify the safety of CBD for humans. However, all that work will be in vain should the EC decide it is in fact a controlled narcotic.

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As for the UK CBD market, this decision would seem to have little impact, and could even be a golden opportunity for our domestic CBD industry, which is estimated to be worth £1 billion by 2025. The UK Foods Standards Agency (FSA) has on record said that they follow the lead of the Home Office who categorically say CBD is not a narcotic.

The FSA had also always been in agreement with the European Food Safety Authority (EFSA) that CBD is a novel food and products need to go through a safety and risk assessment before they can be legally sold as a food supplement. As the UK is about to go its separate way to the rest of the European Union, the FSA has put in place a plan to bring the equivalent of novel foods assessment in-house. This leaves the UK with an excellent opportunity to take the lead and define the safety standards for the sustainable future of the CBD industry.

what does novel food mean

Is the CBD bubble about to burst?

Business guidance on cannabidiol (CBD) as a novel food

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Novel foods or novel food ingredients have no history of “significant” consumption in the European Union prior to 15 May 1997.

Any food or food ingredient that falls within this definition must be authorised according to the Novel Food legislation, Regulation (EC) No 258/97 of the European Parliament and of the Council.

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Novel foods

How to ensure the products you sell comply with the legislation for novel foods.

How to ensure the products you sell comply with the legislation for novel foods.

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  1. Novel food authorisation
  2. Union list and authorised novel foods
  3. Determining novel status
  4. Cannabidiol (CBD) products
  5. Consultation process (Article 4)
  6. Process for authorisation of a novel food
  7. Enforcement

Novel foods are foods which have not been widely consumed by people in the UK or EU before May 1997. This means that the foods don’t have a ‘history of consumption’. Examples of novel foods include:

  • new foods, for example, phytosterols and phytostanols used in cholesterol reducing spreads
  • traditional foods eaten elsewhere in the world, for example, chia seeds, baobab
  • foods produced from new processes, for example, bread treated with ultraviolet light to increase the level of vitamin D present

We are responsible for ensuring that novel foods coming on to the market are safe for consumers. 

Novel food authorisation

Before a novel food can be legally marketed in the UK, it is required to have a pre-market safety assessment and authorisation.

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This applies to any food and food ingredient that hadn’t been used in the UK or EU for human consumption to a significant degree before May 1997.
 
The food must also be either:

  • food ingredients with a new or intentionally modified primary molecular structure
  • micro-organisms, fungi, algae or cell culture
  • plants or animals
  • food produced by new production process that significantly changes the product nutritionally or in relation to the food safety risks
  • minerals or engineered nano-materials

Food additives, flavourings, and extraction solvents used in the production of food are excluded from the definition of novel foods, but also require pre-market safety assessment and authorisation. 

Union list and authorised novel foods

  • safe
  • not misleading for the consumer
  • not replace other foods in a way that would put consumers at a nutritional disadvantage

Unless the data protection measures are triggered, you can sell an authorised novel food in accordance with the conditions set out in the Union list. The Union list shows where data protection is in place.

You have to submit a novel food application if you want to sell a novel food in a way that is not included in the Union list. 

Where data protection is triggered, for a period of five years the authorisation can only be used by the applicant. This would not prevent other applicants seeking their own separate authorisation.

Determining novel status

It is your responsibility to know if the novel foods regulation applies to a product you want to sell. While there is no single list of novel foods, or a list of foods that are not novel, you can check the following resources:

Cannabidiol (CBD) products

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The novel food status of CBD extracts was confirmed in January 2019, and the Novel food catalogue has been updated to reflect this change. 

You can find more information on CBD products in our CBD guidance.

Consultation process

  • are unsure of the status of your product 
  • have evidence that it has a history of consumption in the UK or EU prior to May 1997 

Commission implementing regulation (EU) 2018/456 (Opens in a new window) details the information that is required by authorities to make a decision on whether the product is subject to the Novel Foods Regulation.

This consultation will need to be sent to an EU member state, and as the UK is no longer a member state we are not able to accept any requests at this time. The outcome of the process will be made publicly available on the Commission’s website.

If the consultation process decides your product is novel, then you will need to apply for authorisation to legally market the product in the EU. 

Process for authorisation of a novel food

If you intend to market a novel food which has not been authorised, you will need to apply for authorisation. There are two authorisation routes under the EU Novel Food Regulation no. 2015/2283  (Opens in a new window)and there is no fee payable.

In both cases you must provide a dossier of information and submit it to the European Commission through an electronic portal. (Opens in a new window)

There is further advice available on the procedure for submitting applications to the UK from 1 January 2021.

Traditional foods from countries outside the UK or EU

This is a simplified route to authorise products that have 25 years’ continuous use by a significant number of people in a country outside the UK or EU. 

This route has reduced data requirements reflecting their wide use in other parts of the world. The European Food Safety Authority (EFSA) has published guidance for traditional foods from third countries .

If no objections are received from member states or EFSA within a four-month period, the product is authorised and placed on the Union list.

If objections are raised, there is an additional opportunity to address the areas highlighted through a traditional food application.

Full applications

For all other novel foods, a full set of information is required to be submitted to the Commission which will ask the advice of EFSA where appropriate. EFSA has published guidance on the scientific requirements of an application.

It can take up to nine months for a risk assessment to be completed when further information is not required. If there is a positive EFSA opinion, the Commission has a further seven months to authorise the food and add it to the Union list of novel foods.

Enforcement

Local authorities, including Trading Standards and Environmental Health Officers, are responsible for the enforcement of novel foods legislation.

If you have a concern about products being marketed which may be illegal or dangerous to health contact the relevant local authority.

insights into the £billion pound cbd edibles industry

 CBD edible sales reached more than $1 billion during 2018 alone. This is expected to continue to grow exponentially to $4.1 billion by 2022.

If you’ve been anywhere near a health shop recently, you’ll have no doubt seen CBD – the non-psychoactive cannabis derivative turned lifestyle craze.

Some estimates say that 7 million people in Britain have already used CBD for its purported wellness benefits (which include relaxation and better sleep). Yet for all the hype, the truth is that the CBD industry is facing a bit of a roadblock. At least in the UK anyway.

CBD Infused Edible Industry-Market Size, Share, Demand, Trends, Statistics, Product Sales, Competitive Landscape and Industry Growth.

Though CBD seemingly arrived from nowhere, this wasn’t a case of it being ‘legalised’ by the government. It was actually never illegal: the oils contain such small traces of THC (the chemical that gets you high), they were never covered by our drugs legislation in the first place. But it wasn’t until cannabis went mainstream in America, that CBD got popular enough to be commercially-viable.

The UK CBD Edibles market is growing rapidly with new products becoming available all the time.

Then last year a bombshell report – the largest study of CBD products in Britain to date – revealed serious concerns about quality control. The report found that not only did most products in Britain suffer from inaccurate labelling, over half of those tested exceeded the permitted amount of THC. That made them illegal, and potentially dangerous too.

In response, the Food Standards Agency – the body that looks after food safety in Britain – has said that, as of March 2021, all CBD products sold here will have to be individually registered as a ‘novel food’. In order to get that status, they need to prove exactly what’s in them (and that they’re not dangerous to human health).

That won’t affect businesses making CBD products not intended to be consumed (like bath-bombs and body-oils) but it will throw a huge spanner in the works for anyone selling oils and vapes. Not least because the vast majority of those products are imported from Europe, often without a guarantee of exactly what’s in them.

Is this the end of CBD in Britain? Probably not. This week Crispin Blunt, the Tory MP and long-term drug reform campaigner, spoke at Europe’s biggest cannabis conference, where he called on Downing Street to take the opportunity to ‘onshore’ the industry – that is, to make it easier for British businesses to produce CBD here, rather than shipping oil from Poland, Czechia and Italy (three of the countries that dominate the CBD wholesale industry).

You can see how this might appeal to the government, but it would also require a major change to the licensing laws around growing cannabis.

After all, the UK has historically been one of the strictest countries in Europe even when it comes to industrial hemp – the low-strength ropey cannabis that is sometimes harvested into cheaper CBD products. Many of the oils you can buy perfectly legally in Britain – that is until next March anyway – would actually be illegal (or at least very difficult to make).

None of this has stopped the CBD fad taking off in Britain. Instead it’s led to a cottage industry of white-label CBD oils being shipped wholesale from Europe and then relabelled by UK companies. Many of these wholesalers exhibit at cannabis conferences in the UK, although the brands that re-sell their goods are less keen to shout about it.

Until now, there’s been no rule that CBD products have to show an independent lab report with an exact breakdown of their CBD and THC content (and that they don’t contain harmful toxins like DXM). While many oils do have test reports, they’re not always the ones that reach the high street. Last time I checked, most of the oils in Holland & Barrett didn’t.

But there’s one other factor that might save the CBD industry. So far the big cannabis firms from North America – the ones with the means and expertise to meet FSA standards – have held back on exporting CBD products to Britain. But that probably had something to do with the fact that the legal status of CBD was slightly ambiguous in the UK.

If nothing else, the FSA ruling shows that the authorities aren’t necessarily worried about CBD per se; just the potential for unsafe products to sneak on to the market. Of course, the government might still decide to ban it, but I’d suspect not. And that just might give the big American firms the confidence to export here.

Does this mean that CBD fans should stock up on their favourite product before March? That might be a little overcautious. You’d hope, after all, that the brands who wax lyrical about the brilliance of the stuff might be willing to ensure their CBD is sourced from quality suppliers. But it does raise a shadow of uncertainty over the industry: and one that’s worth keeping an eye on.

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