CBD & Novel food
UK CBD Novel Food Regulation Clarified
If you have been following the news in the CBD industry, then there is a good chance you have heard about the Novel Food Regulation. Relevant to all cannabis business owners, the regulation attempts to standardise and control the vastly underregulated CBD industry.
The change was a long time coming. Over the past few years, the industry in Europe chose a wild-west approach towards the business. As governments showed low interest in the issue, the industry has been taken under scrutiny by independent organisations and journalists.
The current setup puts all the pressure on the customer, not the producer. CBD is a great cannabinoid, and people should be able to take full advantage of all its properties. But they should not have to do the research themselves to find out whether or not the product they purchase is safe to consume.
The Novel Food regulation wants to solve this issue. But will it?
What is Novel Food?
The term “Novel Food” refers to any food that has not been widely consumed by citizens of the European Union or the United Kingdom prior to the 15th of May of 1997.
The push for a precise cut-off date was a result of the sudden growth in popularity of genetically modified and artificially enhanced foods. Within this category, one can find a multitude of products. They range from traditional food grown using new techniques, such as artificially fortified eggs, to bread that contains vitamin D added through ultraviolet light exposure.
Most Novel Foods enter the market accompanied by a health claim that has not yet been proven to be true, and as a result, the producer has limited marketing opportunities. The consumer should always be the priority. The responsibility to communicate clearly which claims have been scientifically proven by EFSA should lie on the producer.
The purpose of the discussed regulation was to ensure that any kind of new food entering the market is safe before being made available to consumers in Europe.
As a result, any company aiming at revolutionising the food industry with a new ingredient or an “updated” version of a classic food needs to understand the concept of Novel Food and the responsibilities that come with it.
It is crucial to understand that it is not the responsibility of the EU or of local government bodies to test new foods before they enter the market. It is the producer who needs to conduct the necessary tests and research.
What Does CBD Have to Do with It?
A Brief History of Cannabis
CBD, a non-psychoactive cannabinoid found in the cannabis plant, is believed to have a multitude of health benefits. It is a close cousin of THC, a cannabinoid responsible for the psychoactive effects of marijuana.
According to historians, humans have been cultivating cannabis plants since the end of the Ice Age. The oldest evidence of cannabis was found in Japan and is around 10 200 years old. Cannabis kept spreading through the continent and eventually reached Europe around 5000 years ago.
Our ancestors have since used cannabis for medical purposes and as a trade commodity, while hemp became a go-to material for various industrial purposes, such as rope making.
The history of cannabis is relevant because we have enough historical evidence to say that cannabis has been consumed for thousands of years.
If Hemp Has Been Consumed for Thousands of Years, Why Is CBD Considered Novel Food?
Many people within the industry questioned the reasoning behind classifying CBD as a novel due to the amount of reliable information and strong evidence of cannabis consumption prior to May 1997.
Producers and experts working in the industry have voiced their objections loud and clear. They have pointed out that even though Europeans might not have consumed cannabis in 1997, it was consumed hundreds and thousands of years ago and should not be classified as novel.
Since there is no limit on how far back we can go to prove previous consumption, lawmakers listened and agreed that hemp and hemp-related products, such as cold-pressed hemp seed oil, should not be considered novel.
Unfortunately for many producers, the rule does not apply to CBD-infused products, as well as extracts and isolates. This is because producing extracts and isolates requires significant modification of the hemp plant consumed before 1997.
What Is Happening in the UK Right Now?
The Backstory
The idea of applying the Novel Food Regulation to the CBD industry came from the European Union.
Following the results of a referendum that took place on 23rd of June 2016, the UK left the European Union in January 2020, with a 12 month transition period. The transition period allowed close cooperation between ex-partners before the complete detachment of the UK from the EU.
Since the EU has not managed to complete the details of the Novel Food application process in regards to CBD, Brexit provided the UK with an opportunity to approach it in their own way. UK lawmakers had to make a choice. They could either abandon the process entirely or build one of their own.
Option two was the winner.
On the 13th of February 2020, the UK announced they would move forward with regulating the market even though they are no longer a part of the EU. They requested all CBD products that fall under the Novel Food definition be authorised before being sold to the public.
In order to apply for authorisation, anybody wishing to produce or sell CBD products in the UK would have to fill in an elaborate and detailed application by the 31st of March 2021.
This meant that British business owners were only given slightly over one year’s notice.
The UK government made it clear that this rule should also be applied to products that were already on the market on the day of the announcement, the 13th of February 2020. This meant that products that were already on the shelves or sold online to UK customers were allowed to remain on the market, as long as producers ensured their products got validated by the 31st of March.
If, on the other hand, you decided to start a CBD company anytime from the 13th of February onwards, you were forbidden from selling your products until authorisation from the government was granted.
What Happened on the 31st of March 2021?
The communication regarding the UK government’s expectations toward existing companies has been very clear from the beginning. If you have a CBD product on the UK market and want to keep on selling it, your products need to be validated by the 31st of March 2021.
The idea seemed easy and straightforward. All producers have to conduct research and a set of tests to confirm the safety of their products. They then have to present the results to the relevant governing body and keep on doing what they do best – sell.
But what sounded like a pretty straightforward plan ended up turning out to be a logistical nightmare.
Two main obstacles appeared on the road for CBD producers who wanted to comply with this new regulation.
First of all, the process of conducting all of the required research and tests turned out to be very time-consuming and very expensive. Because the industry is still in its early stages, a limited number of companies and specialists can provide the services required to run highly detailed research and tests needed for the application.
Second of all, the application and the necessary documentation are both highly technical and challenging for people without any legal or regulatory experience.
As a result, the one-year notice period the UK government provided to the business owners turned out to be too short.
Fortunately, the decision-makers decided to re-adjust their approach based on the feedback they received from companies working on their application.
To support business owners who already had CBD products on the shelves, the FSA (Food Standards Agency), responsible for the Novel Food applications, decided to make changes to their requirements.
Instead of requiring validation before the 31st of March, the FSA decided to accept submission of incomplete applications instead. All as long as the intention to complete the required testing was there, and as long as the product was safe, legal and labelled correctly, it was allowed to stay in the shops and on the market.
This change was due mainly to a lack of FSA resource meaning that they couldn’t validate all applications by the 31st March. Instead, they have given themselves an indefinite amount of time to validate the applications. The creation of the on-hold list is only for companies who can provide evidence that they are working to provide the missing information. The company still has to provide evidence that they are working to provide the missing information. The application can be rejected if this missing information is not provided in an acceptable timeframe or to a suitable quality.
What If Your Product Was Not on the market before the 13th of February 2020?
A CBD isolates or extract that entered the market after the deadline of 13th of February 2020 and was not validated needs to be taken off the shelves and can not return to the UK market until such authorisation is obtained.
After the 31st of March 2021, products entering the market will need to file and get the authorisation beforebeing on the shelves.
The FSA made it very clear on multiple occasions that there will be no exceptions, which means that from now on, impartial and professional product testing is a must.
How Do I Know If My CBD Product Qualifies as Novel Food?
It might be challenging to clearly say whether a particular product intended for sale is or is not novel.
If the product is an isolate or an extract, the answer is clear – it needs to be authorised before entering the UK market. But if there are certain exceptional circumstances the producer believes might influence the product’s classification, it might make sense to get in touch with the FSA. They provide a service (free of charge) where one can request a consultation on the product and its novel status.
While getting an answer back might take some time, it will most likely save some companies a lot of work, time and money in the long run. That is because if a product is not considered novel, then there is no need to worry about the application.
On the other hand, if the authorities decide that the discussed product is novel, the producer will be forced to apply and meet the necessary requirements for authorisation. The process of consultation with FSA will have no impact on the application, nor its approval.
How Much Will It Cost to Get Your CBD Product Approved?
The process of getting your CBD extract or isolate approved by the FSA is time-consuming and very expensive.
While the application itself is free of charge, compiling the necessary information, understanding what research and testing needs to be done, as well as conducting the research will cost a lot of money and require a substantial amount of work hours.
The total price will depend on many conditions, especially on the product type, but in theory, it can cost anywhere between £20.000 and £350.000.
What Does the Authorisation Process Look Like?
A lot has to happen before a novel food product can be approved by the FSA and be sold legally on the UK market.
The official application, which is the first step of a long-lasting process, is expected to contain a multitude of information. The more detailed and specific the application is, the bigger the chances are for a successful and speedy processing.
The Novel Food application will need to include both basic administrative information, as well as additional, detailed information, some of which will require consultation with professionals and specialists.
An applicant is required to answer questions such as:
● What is the product you intend to sell?
● How is it produced?
● What is it composed of?
● What are its specifications?
● What is the history of how the novel food and the raw ingredients included in the product?
● What is your proposal of how it should be used?
● What are the details on absorption, distribution, metabolism and excretion?
● What are the nutritional values?
● What are the test results on toxicological information and allergenicity?
Note that this information has to be based on reliable sources, for example, lab testing needs to be done by professionals working in accredited laboratories.
To assure the authenticity of the provided information, the application should also include multiple certificates and analyses of test results from the accredited laboratories (including proof of the lab’s accreditation).
Copies and reprints of all relevant scientific data, the opinions of national and international regulatory bodies, as well as a complete study report are also required.
You can read about the application requirements in more details here.
The Criticism
Multiple organisations and business owners have criticised the Novel Food regulation and its potential negative impact on small business owners.
While big corporations can easily absorb the costs of full authorisation, small and medium-sized businesses have been struggling.
Securing the necessary funds to complete lab testing and get the professional legal support needed can be impossible for the smaller players. As a result, many small companies try and attempt to lead the process in-house. But with very little to no previous experience in regulatory affairs, and limited access to legal guidance, attempting the process in-house might result in a poor application.
Therefore, big corporations and foreign companies who can afford this added expense will dominate the market. This will also inadvertently create a barrier to entry that is almost impossible to overcome by small enterprises.
Without any government support, small and medium-sized businesses that have been providing high-quality products (before the 31st of March) may not survive.
The Potential Long Term Benefits of Regulating the UK CBD Market
While the EU initiated the idea of regulating the CBD industry, the process of validation and authorisation of cannabis products within the EU has been put on pause.
While the deadline for application in the UK has passed, the EU has yet to set one up as novel foods must have an authorisation prior to being sold.
Each EU country has its own country-specific rules on CBD. These specific rules can vary anywhere from which parts of the hemp plant can be extracted from (the whole plant, only the stem, only the leaves, etc.), and how much THC is allowed both in the hemp plant and in the final product.
While these rules might have been enough for when the industry was just starting up, the expectations are much higher now.
European customers are becoming more competent and knowledgeable. More and more users are becoming aware of the fact that the CBD market is overflowing with low-quality and unreliable products. But there is only so much consumers can do.
One thing CBD users can do is limit their purchases to products that have been tested by independent laboratories. While this information is usually easy to find, it is not always easy to interpret it.
Consumers are not used to making such assessments, as they tend to rely on local regulatory bodies. These regulatory bodies are trusted to keep control over the quality and safety of products available on the shelves, identifying reliable laboratories and analysing necessary information so that the consumer doesn’t have to.
Since this is something that is lacking in the industry here in Europe, customers often put their trust in specialised stores and boutiques. The stores’ employees can often provide support through answering any pressing question, but most importantly, by wanting the best quality products. This is something European governments are not currently doing.
The UK’s decision to regulate the CBD market will slow it down at first. There is no doubt about that. But after the initial phase, the process will likely get streamlined and simplified.
A potential negative impact is that the UK market might be less diverse, especially at the beginning. However, the suppliers that will remain active will now have a government-issued proof of quality.
Assuming the government manages to overcome the first post-Brexit export hurdles, the UK might be on its path to becoming the most trustworthy market in the entire continent and be an example the rest of Europe can look up to.
Conclusion
The implementation of the CBD Novel Food regulation in the UK means that from now on, every single product that includes cannabinoid extracts will need to be officially authorised before it can enter the UK market.
While the FSA has underestimated how big of a mountain applicants need to climb to complete the application process, they are trying to have a “pragmatic and appropriate” approach to the entire issue. To support existing businesses, the deadline requirements have been changed. As a result, most firms with products on the shelves before the 13th of February 2020 can keep selling their products while completing all the necessary tests and research.
The process aims to ensure the safety of UK customers, but it might have some negative consequences for small and medium enterprises.
Entering the industry with new CBD products will be limited to companies with substantial funding or corporations worldwide that have the resources necessary to complete lengthy and highly technical application processes.
While it is too early to tell if this step will benefit or harm the UK CBD industry in the long run, this is most definitely a development worth keeping a close eye on. What impact will it have on the European CBD industry? Only time will tell.