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CBD FSA Novel Food Status Update and What It Means for New Entrepreneurs

CBD FSA Novel Food Status Update and What It Means for New Entrepreneurs

According to the Centre for Medical Cannabis (CMC), the cannabidiol (CBD) market in the UK was estimated to be worth £300 million in June 2019. With the market growing at a rate faster than ever before, it’s expected to be worth approximately £1 billion in 2025. In fact, the CBD market in the UK is the second-largest in the world, only behind the U.S.

Essentially, the CBD market is one of the fastest-growing markets in the United Kingdom and has been flourishing for years. The pandemic has only served to intensify this. However, recent updates to rules and regulations surrounding CBD and CBD-infused products threaten to halt progress, with many wondering how the Food Standards Agency (FSA)’s update on CBD as a novel food will affect the industry and new players entering it. We have broken down this complex topic, explaining everything from the novel food designation itself to testing requirements and procedures for authorisation. Read on to find out how this food update will affect the industry, the entrepreneurs planning to enter it, and those seeking pre-market authorisation for their CBD raw materials and products.

CBD as a Novel Food

Cannabinoid, commonly known as CBD, is a chemical found in the cannabis plant. While it comes from the same plant that produces THC, CBD does not have any psychoactive effects. Instead, it is known for being calming and therapeutic properties.

CBD is considered a novel food by both the European Food Standards Agency (EFSA) and the UK’s Food Standards Agency (FSA). According to both parties, a novel food is one that has not been used to a significant degree by people within the EU or UK prior to 15th May 1997. Because of this, novel foods cannot be sold without going through an approval process called a safety assessment. Since the CBD industry was unable to prove that CBD extract had been significantly used before 15th May 1997, it was branded a novel food and thus, requires authorisation for sale.

What This Means for New Entrepreneurs

While existing products were able to submit applications for authorisation by 31st March 2021, this isn’t as simple for new entrepreneurs. Only products already being sold on or before 13th February 2020 could take advantage of this opportunity. Those just entering the industry require pre-market authorisation, which is a notoriously time-consuming and costly process, no matter the applicant. The application itself is free, but it is gathering and submitting evidence that makes the process lengthy and expensive.

Ingredient manufacturers are likely to be the applicants, but this isn’t where the process ends. Finished brands also need to verify that the formulation and end product are safe and covered by an application submitted by a supplier. Stability, bioavailability, and overall formulation are all taken into account when evaluating an application for authorisation because different production and formulation can affect various factors in the end product. For example, using a heat-treated or cold process can impact bioavailability, absorption, and even purity profile of the CBD.

Entrepreneurs should also note that using authorised ingredients from a raw material supplier can make this process easier. When this is already taken care of, all that remains is risk assessment and stability testing of the final product.

The Importance of Comprehensive Testing and Research

Applications require comprehensive research and evidence determining safety and lack of implications on health. The dossier of information submitted must contain details of the entire production process, nutritional information, research studies, composition of the food, and details of absorption. If everything isn’t included, the application may be rejected for being incomplete.

Additionally, all the information included must be specific to the product itself. Publicly available information will not be enough to make the case for authorisation. Independent scientific testing will be required, which can become costly. This isn’t feasible for smaller businesses and new entrepreneurs who do not have the same financial and technical means as bigger companies.

Since safety and health considerations are the primary reason behind the need for pre-market authorisation, applications will also need to include detailed toxicological testing results, studies on these tests, and reasons for the particular tests submitted. In this regard, it’s especially important to stay away from public information since only directly relevant studies will be accepted. In fact, the FSA has stated that if directly relevant safety information is not included, the application will not progress or be authorised.

Choosing a Reliable and Trusted Laboratory

Unfortunately, the application process can be both expensive and time-consuming. In some cases, hundreds of thousands of pounds worth of research and testing may be required, and the process itself may take years before approval. In fact, even when validated, authorisation is not guaranteed – there’s still a chance that your application may be rejected.

Because of this, it is essential to conduct independent testing with a laboratory that can be trusted. IFS Laboratories is the right partner for the job. Our UKAS-accredited analytical testing services are among the best in the UK and can analyse everything ranging from food supplements and oils to vapes and e-liquids. Our state-of-the-art equipment can help with cannabinoid profiling, terpene analysis, shelf life and stability testing, mycotoxin analysis, and more.

Timeliness is also an important factor. With the authorisation process for novel foods taking more than a year in some cases (up to 18 months), businesses and entrepreneurs acting quickly will benefit from earlier approval. IFS Laboratories can guarantee a thorough job while also keeping deadlines in mind. This way, your product can make its way onto the market faster. Our lab can work to ensure high standards of product quality and can aid you in matters of regulatory compliance. We do so by answering your questions and helping you determine which testing requirements are necessary for your product.

If you are interested in a trusted partner that can help make the authorisation process easier for you, contact us here. We look forward to hearing from you and helping your product reach the market as quickly as possible.