Recent regulatory news related to CBD worldwide.

EU

On June 8, 2020, two CBD novel food applications for synthetic Cannabidiol passed EFSA’s validity check. We look forward to more news.

However, according to Vitafoods Insights and CBD-Intel, the progress on novel food authorizations for CBD-extracts (non-synthetic cannabinoids) will be paused until EU regulators decide whether extracts from hemp flowers constitute a drug under narcotics laws. A decision on this could be made as early as September. Until this decision is made all novel food applications for non-synthetic cannabinoids/CBD have been frozen and will not be reviewed by EFSA.

The European Industrial Hemp Association (EIH) received the green light from its members to move forward with an “unprecedented” study on the toxicology of CBD and THC, as part of a joint novel food authorization application. The anticipated cost of the joint application project is projected to be around €3.5 million ($3.9 million).

In order to ensure that its members will be covered across the whole European market, EIHA will submit two novel food applications: one to the UK Food Safety Authority (FSA) for the British market, and the other to EFSA for the EU market. For now, it remains unclear which hemp-derived products or CBD formulations will be included in the EIHA novel food applications (both in EU and UK).

UK

Also, The Association for the Cannabinoid Industry (ACI) announced on the 19th June that they will lead a CBD safety study consortium to generate data to assess the safety of CBD and to discern exactly what the recommended daily dose should be.

This consortium will grant companies the opportunity to provide the evidence, which several organizations are asking for, such as the FSA, the Committee of Toxicology, and the MHRA, EFSA and FDA, whilst sharing the burden of costs of such studies.

The CBD safety study consortium will identify data gaps and generate analytics based accordingly. The goal is to generate data to be used across a broad range of secondary (finished) products.

USA

The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, filed a citizen petition calling on FDA to regulate cannabidiol (CBD) as a legal dietary supplement.

The industry association asks the FDA to act and establish a “regulatory pathway to legally market dietary supplements containing hemp-derived CBD”.

Do you want to bring to the market a CDB containing a product? Do you need support on your novel food application? Our novel food experts can support you. Get in touch with us for more detailed information.

– 08.07.2020

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