Novel Food Regulations for CBD

Ensuring product quality, safety, and efficacy

The demand for cannabidiol (CBD) products has grown rapidly due to a combination of people moving towards natural health and wellness solutions, coupled with increased awareness of the medicinal benefits of CBD. There are now a huge array of consumer CBD products such as oils, tinctures, and gummies available through both specialist and general retail channels.

 

 

 

 

 

 

Broughton is an independent life sciences contract research organization serving a global roster of clients across a range of active ingredients including cannabis and CBD. With over 15 years of analytical testing experience in UKAS accredited, GMP, and GLP laboratories, we offer a fully integrated service including on-site stability storage facilities and consultancy on formulation, chemistry toxicology, clinical and behavioral studies, as well as regulatory support. Our facilities are inspected by UKAS to ISO 17025 to assess our ability to generate precise and accurate test data.  

In 2019 the novel food regulation was designated a suitable regulatory pathway for the portion of CBD products defined as food in the UK and European Union (EU). The definition of food is any substance or product, whether processed, partially processed, or unprocessed, intended to be, or reasonably expected to be ingested by humans. More specifically, novel foods are foods that have not been widely consumed by people in the UK or EU before May 1997.

 

The novel food application process can be broken down into three parts.

 

Part 1: Administrative Data

Requires administrative data, such as information relating to the applicant.

 

Part 2: Characterization of the novel food, technical and scientific data

Requires information specific to the novel food such as:

  • identity of the novel food
  • production process
  • compositional data
  • specifications
  • the history of use of the novel food and/or of its source
  • proposed uses and use levels and anticipated intake
  • ADME (absorption, distribution, metabolism, and excretion)
  • nutritional information
  • toxicological information and allergenicity

It should also include a list of all references.

 

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Part 3: Annexes to the dossier

Should include:

  • the glossary or abbreviations of terms quoted throughout the dossier
  • certificates on the accreditation of laboratories, certificates of analyses, etc.
  • full copies/reprints of all pertinent scientific data (published and unpublished)
  • full study reports
  • scientific opinions of national/international regulatory bodies

To learn more about Novel Food Regulatory pathway for CBD in the UK and EU

Download our Medicinal Cannabis and CBD Services Brochure
We work across a wide range of CBD matrices.
  • Oils
  • Drops or tinctures
  • Capsules
  • Gummies
  • Sweets and confectionery
  • Baked goods
  • Oral pouches
  • Drinks 
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Toxicology

Toxicological evaluation plays an important role in new product development, product stewardship, and regulatory submission. It is an essential scientific discipline to demonstrate the acceptability, safety, and compliance of a product or formulation. All manufacturers have a duty of care to understand their products and how they affect the people who use them.

At Broughton, we have a team of globally renowned toxicology consultants who are available to help clients design risk assessment and stewardship strategies for specific regulatory pathways, advise on formulations, and help them understand their products better to gain the trust of both regulators and consumers.

Stability Studies

We run real-time, in-use, and accelerated stability studies to evaluate the product performance and quality of cannabis and CBD products and formulations over time. Our on-site stability chambers have approximately 60,000 liters of storage capacity. We can store products at standard ICH and bespoke temperature and humidity conditions. Our storage chambers are controlled to +/- 2°C and +/-5% RH of their target conditions. We create a dedicated cross-functional project team, so clients get insight and advice based on their test results.

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