EU and UK compliance with the novel food application for CBD isolate

Christian Hendriksen, VP of International Expansion at Mile High Labs, illustrates how they are continuing compliance with the novel food application to ensure safe and effective cannabinoids can be available to all

Mile High Labs, the world’s leading producer of hemp-derived cannabinoids, submitted a novel food application to the European Food Safety Authority (EFSA) and the UK Food Standards Agency (FSA) for its CBD isolate ingredient and CBD isolate-based finished products in April 2020. This application is the culmination of ten months of work to generate the required data and compile adequate information to support the product’s quality, consistency and safety.

CBD novel food application

In February, the FSA stated that all CBD products on the UK market must have a novel food application through the validation phase of the review process before 31 March 2021. Under the requirements, any CBD food products failing to gain regulatory approval before the 31 March 2021 deadline will be taken off the shelves. Mile High Labs is one of the first companies to have filed a CBD novel food application with both the EFSA and FSA.

“This application was more complicated than usual because of the complexities associated with hemp-based products,” said Wendi Young, VP of Regulatory and Compliance, Mile High Labs. “It was necessary for us to address all of the concerns expressed by various regulatory agencies. We collaborated with experienced consultants from the UK to guarantee that our application met the expectations of both the EFSA as well as the FSA.”

The Company’s application includes information on the quality of the product, hemp biomass intake controls, stability data, manufacturing controls, labelling commitments, as well as testing requirements and specifications for both CBD isolate and finished products. Additionally, Mile High Labs is providing an assessment of the target population, a combined intake evaluation and toxicological data that supports the safe consumption of CBD.

Novel Food regulation

Under Novel Food regulation, all food products containing cannabinoids derived from hemp will be affected. This includes CBD tinctures, gummies, soft gels, beverages and any products that are consumed orally.

“Our novel food application is a key step in ensuring continued compliance for our customers, as well as our products, in the European market,” said Christian Hendriksen, VP of International Expansion, Mile High Labs. Hendriksen urges CBD brands to be conscious of whether their supplier is taking the proper steps to ensure compliance.

“The application process has two main parts: the first is to ensure you can consistently manufacture high-quality products. Mile High Labs’ raw material is processed in a GMP and ISO-certified lab by people with a pharmaceutical background, so most of the groundwork was already completed. The second is toxicology, where manufacturers gather extensive data to prove that a CBD product is safe for consumption. This explains why Mile High Labs is starting with isolate as there are fewer complexities.”

Approved isolate

CBD brands using this approved isolate will be able to leverage the Mile High Labs’ novel food application. Customers can purchase the isolated ingredient to manufacture their own finished products, or they can choose from the white-label range with formulations included in the application or select a custom formulation for different strengths and flavours. As long as brands stay within the parameters mentioned in a validated and approved application, their formulations can be compliant with the EU regulations.

“We welcome dialogue with any European CBD company who would like to discuss how they can leverage our novel food application to not only keep their products on the shelves, but to demonstrate their commitment to safety and compliance,” said Hendriksen. “As the industry becomes increasingly regulated, it’s more important than ever to partner with a manufacturer that understands these requirements and how to meet them.”

Please note: This is a commercial profile