Chanelle McCoy Health Claims First Positive EFSA Opinion on CBD Novel Food Application

 

Cannabis Health has not been able to independently verify the contents of the draft opinion as it has not yet been made public by EFSA. Chanelle McCoy Health told us the final opinion remains under embargo and is awaiting further updates on the publication date. 

 

“What we can say is that this is not a negative opinion, and EFSA has assessed our dossier on its merits,” the company said.

 

Restarting the clock on Novel Food assessments 

 

In 2022, EFSA effectively ‘stopped the clock’ on 19 CBD Novel Food applications, concluding that it could not establish the safety of CBD as a Novel Food due to a lack of safety and toxicology data.

 

Chanelle McCoy Health has remained in ‘active scientific dialogue’ with the regulator and says its application progressed because it was assessed on the ‘specific data package submitted’ for the ingredient and its proposed use.

 

It noted that EFSA’s 2022 position was not that CBD was ‘inherently unsafe’ but that it could not establish safety at that time because of ‘data gaps’, and that ‘applicants were responsible for filling those gaps’.

 

The company believes the draft opinion demonstrates that its CBD ingredient “meets the safety requirements for use as a food supplement under the EU Novel Food framework”.

 

Under this framework, EFSA is responsible for carrying out an independent scientific safety assessment of novel food applications. 

 

A positive EFSA opinion does not in itself authorise a product for sale across the European Union.

 

Following publication, the European Commission and EU member states must decide whether to authorise the ingredient and add it to the Union List of authorised Novel Foods.

 

CBD safety under scrutiny

 

The announcement comes against a backdrop of continuing regulatory scrutiny of CBD in Europe.

 

In May, the European Chemicals Agency (ECHA) agreed with a proposal submitted by the French Agency for Food, Environmental and Occupational Health & Safety to classify CBD as a reproductive toxicant under the EU’s Classification, Labelling and Packaging (CLP) Regulation, concluding that it “may damage fertility or the unborn child” and “may cause harm to breast-fed children”.

 

The ECHA classification and EFSA’s Novel Food assessment are distinct regulatory frameworks. ECHA classification is a hazard-classification process for substances under chemicals legislation, while EFSA’s role is a food safety risk assessment, which considers a specific ingredient, manufacturing process, purity profile, proposed conditions of use, exposure level and target population.

 

Chanelle McCoy Health’s proprietary safety dossier has been assessed solely within the Novel Food framework and related specifically to its synthetic CBD ingredient, which is produced in a laboratory and contains no detectable THC.

 

UK and other market updates

 

The company has also confirmed that it continues to pursue a UK Novel Food application with the Food Standards Agency (FSA), as uncertainty remains about how proposed UK-EU sanitary and phytosanitary (SPS) alignment could affect this. 

 

It said it would be ‘premature to speculate’ on any effect the SPS might have as the terms had not been published.

 

“Our position is straightforward: we have pursued both UK and EU regulatory pathways, and we will continue to work with the relevant authorities as the UK-EU position becomes clearer,” the company said. 

 

Separately, its oral CBD supplement has secured approval from the Saudi Food and Drug Authority, with regulatory applications progressing across more than 40 international markets.

 

Building a new category in healthcare

 

Co-Founder Channelle McCoy previously spent almost two decades helping drive international growth for Chanelle Pharma, Ireland’s largest indigenous pharma company, overseeing expansion into 96 global markets and more than 2,500 product registrations.

 

“Building a new category in healthcare is a rare opportunity – one that brings the chance to shape something that has never existed before,” she commented on the announcement.

“CBD has become the most talked-about ingredient globally because many people use CBD similar to other supplements to support their wellbeing, sleep, stress and balance. Our belief in the product, our perseverance, and our commitment to giving people access to safe, high-quality CBD has led to this world-first approval of its kind for Chanelle McCoy Health. We have shown that with the right science, the right standards and the right determination, a small Irish company can lead globally.”

 

The company is now seeking strategic investment to support international expansion and further research and development across wellness, cosmetics, food, beverages, medical devices and veterinary products.

 

Caroline Coen, Co-Founder and Chief Scientific Officer, added: “We made a conscious decision to develop our products to meet some of the toughest regulatory requirements in the world. That meant investing heavily in science, safety and quality from day one.  Approval by Saudi Arabia and confirmation from Europe that our CBD product is safety-approved demonstrates that our rigorous science approach works.”