Food Standards Agency announces deadline for submission of ‘valid’ novel food applications for cannabidiol-rich foods and supplements
The UK’s Food Standards Agency (FSA) has today issued a statement that means companies selling products containing high concentrations of CBD (cannabidiol) that have not submitted “valid applications” for novel food status by 31 March 2021 will be forced from the UK market after that deadline.
This is the first suggestion that, in the wake of Brexit, the UK food regulator hasn’t got plans to relax its regulatory approach after the European Commission’s Novel Food Working Group, comprised of representatives from the then 28 Member States, classified CBD as a novel food in January 2019.
It’s also confirmation that companies that want to sell products in the UK and the European Union (EU) that are classified as novel foods will need to successfully navigate two regulatory obstacles: one in the UK, the other in the EU.
Compiling successful novel applications in the EU has never been easy, rapid or inexpensive, the process generally taking around three years after comprehensive data files are submitted as part of the application process. Typically, the biggest challenges arise in providing sufficient data on human safety, according to the requirements of Article 10 of the EU Novel Food Regulation and the guidance of the European Food Safety Authority (EFSA) released most recently in 2018. The FSA has indicated it will aim to halve the time frame typical in the EU, to just 18 months, with considerable amounts of data being able to be shared between the two applications.
Commenting on the news, ANH founder, executive and scientific director Rob Verkerk PhD said, “The FSA's announcement is predictable given the agency has not been prepared to reconsider, in the wake of Brexit, the novel food classification of CBD made at EU level in January 2019.”
The FSA announcement will inevitably benefit the bigger companies with greater resources, risking a disproportionate impact on smaller companies that have traditionally been the pioneers in the natural products sector.
It will also likely encourage collaboration in compiling dossiers for novel food applications, as well as reformulation by some companies which might move to using CBD ingredients from companies which have already, or are committed to, submitting comprehensive applications.
The costs of such applications are likely to be out of reach of many current players leaving these firmly in the FSA’s crosshairs come 1 April 2021.
At ANH, we are presently seeking legal views on whether the FSA's approach is potentially challengeable if it turns out to have a disproportionate impact on small businesses which are selling high quality, correctly labelled and safe products containing CBD.