Mile High Labs has confirmed it has applied for Novel Food status for both its bulk CBD isolate and finished products.
Following the announcement from the Food Standards Agency (FSA) earlier this year that CBD products must have Novel Food approval to remain on the market after March 31, 2021, the company has announced its submission to the European Food Safety Authority (EFSA) and the UK’s FSA for its CBD isolate ingredient and CBD isolate-based finished products. Under the requirements, any CBD food products failing to gain regulatory approval before the deadline will be taken off the shelves.
The application is the culmination of 10 months of work to generate the required data and compile adequate information to support the product’s quality, consistency and safety and Mile High Labs says it is one of the first companies to have filed such an application.
“This application was more complicated than usual because of the complexities associated with hemp-based products,” commented Wendi Young, VP of Regulatory and Compliance at 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 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.
Christian Hendriksen, VP of International Expansion, added: “This is a monumental day for Mile High Labs and the CBD industry as a whole. Our novel food application is a key step in ensuring continued compliance for our customers, as well as our products, in the European market.”