Noval Foods

 

Novel Foods: A pivotal milestone for
the UK’s ACI

The steady rise of the legal cannabinoid market in the U.K., estimated to be worth $1 billion in 2021, made it necessary for businesses that are committed to naturing safe, legal, and flourishing commercial cannabis extract market in Europe and the U.K. to form a membership organization, The Association of Cannabinoid Industry (ACI).
 

The rise also caught the attention of the food regulatory body, The Food Standards Agency (FSA), which classified CBD as ‘Novel foods.’ 
 

The FSA defines Novel foods as foods that have had limited consumption in the U.K. prior to May 1997. 
 

This classification made it necessary for cannabinoids to be evaluated on several safety standards set out by the Food Safety Agency (FSA), more importantly on toxicological, chemical, microbiological, and stability parameters of not only the food but also the packaging materials. 
 

This evaluation aimed to create a safety profile for CBD prior to its approval and sale to the general public.  

Application for consideration

The classification of Cannabinoid as “Novel Food” in February 2019 and a consequent issue of compliance deadline by FSA a year later, in February 2020, made it mandatory for companies and businesses to have their applications validated before the deadline. 
 

As a requirement by the FSA and EFSA, after evaluation of the “novel food” on the four main parameters, a dossier and an application (collectively 'Application') must be submitted to them for validation and/or authorization before it can be offered to the market for the general public. 
 

Businesses that would not have complied by the deadline would face dire consequences; their products would be phased out of the market. 
 

As a result, the ACI took the lead in representing its members, forming a consortium by partnering with Advanced Development and Safety Laboratory (ADSL)  in carrying out safety studies on CBD then submitting an application to the FSA, consequently ensuring its members are compliant before the deadline. 
 

ACI’s application included administrative, scientific, and safety data that demonstrably outlines the toxicological, microbiological, and chemical parameters of the food and packaging materials. 
 

The FSA has two models of application but demands full application when it comes to CBD, a feat which the consortium completed by submitting several applications to the FSA for consideration on behalf of its members.

Core Areas of Toxicological Requirements for CBD Products

The FSA raised concerns on the potential effects of CBD on the liver and specific groups such as breastfeeding mothers. 

To that effect, FSA made it a requirement to carry out toxicological testing on CBD. It set up four toxicological testing areas for CBD to be ‘Generally Regarded as Safe ‘(GRAS). Here is a look at the four core areas.
 

  • Kinetics: It simply focuses on how CBD is absorbed, distributed, and excreted out of the body. The main focus point is the plasma proteins where CBD binds before being absorbed into the bloodstream. The process where CBD is absorbed into the blood in a specific portion is referred to as bioavailability. The bioavailability of CBD stands anywhere between 13% - 19%. For instance, if you ingest 40mg of CBD, only 5.8 mg or less shall be absorbed into your bloodstream.

  • Genotoxicity: Genotoxicology focuses on the effects CBD has on the genetic makeup. The main focus is to validate that CBD does not cause harmful changes to the DNA structure. Toxic substances that may alter the DNA may lead to mutations and even cancer. As laid down by the FSA, CBD should not compromise the integrity of the DNA.

  • Repeated Dose Toxicity Testing (sub-chronic, chronic toxicity, and carcinogenicity): The purpose of this parameter is to confirm safe consumption levels and to determine the effect of repeated exposure of CBD to the user. The time frame in which repeated exposure experiments are done vary from 14 days, 3 months up to 2 years. 

  • Reproductive and Developmental Toxicity:  Reproductive toxicity focuses on the effects towards sex and fertility of not only the adults that partake of CBD but also their offspring, while developmental toxicity focuses on a developing embryo.
     

The ACI-ADSL consortium carried out toxicological tests and made applications to FSA to ensure CBD is safe for human consumption whilst their members stay in business. Such studies place ACI on the lead in the CBD industry. 

Leading the CBD Industry in Novel Foods

As a result, on February 15, 2021, the ACI submitted its novel food application on behalf of the CBD study consortium. 

The toxicology research was a success due to a formidable and reliable partnership between ACI and Advanced Developmental and Safety Laboratory ( ADSL ).

The move was to make ACI members legally compliant before the set-out deadline and support the legal cannabinoid industry by carrying out research and consolidating resources. ACI emerged as a frontrunner in ensuring a sustainable cannabinoid industry. 

“I am delighted to submit these dossiers on behalf of the ACI-ADSL XBD safety consortium and support an industry on the cusp of...a fully legally compliant market,” said Dr. Parveen Bhatarah. 

Dr. Bhatarah is the Regulatory and Compliance lead and was in charge of this consortium. “Well done to our consortium members who have delivered on the substantial data requirements that were asked of them. We’re very pleased to lead the way to a sustainable cannabinoid industry.” She added. 

Safety Information to Support the Industry Globally

While carrying out the study, ACI and ADSL-CBD consortium collected massive data and processed it into meaningful safety information as mandated by the FSA’s novel food application process. 

“The FSA has always had an ethical responsibility to gain evidence to prove that CBD is safe for human consumption. While the submission of the ACI and ADSL CBD consortium safety study ACI is well on the way to providing FSA this evidence.” Said Dr. Paul Duffy, Toxicology Associate at the ACI. 

This submission is the accumulation of months of work from numerous members, like our Farm. 

The UK, having a clear regulatory framework for compliance means the data provided is very reliable. This data shall not only be dependable in meeting demands from the U.S. and E.U. regulatory authorities but also support the industry globally.