CBD products are widely available, but their regulatory environment is not yet harmonized. Below you will find an overview of recent news related to CBD worldwide.
In Europe, as of May 2020, four CBD applications have been submitted to the EU Commission. Only recently (31st March), the European Commission gave a mandate to EFSA to perform a risk assessment to the first application (CBDepot Dossier NF 2019/1371).
Regarding current legal disputes, on 14 May 2020, Advocate General Tanchev presented his opinion before the Court of Justice of the European Union (CJEU) regarding the dispute concerning the marketing of an electronic cigarette containing CBD in France (Case C-663/18). The Advocate General Tanchev declared the French ban on hemp-derived CBD to be contrary to EU law. The full opinion of the Advocate General is available here. According to the law firm Allen & Overy, which is representing Antonin Cohen (former manager of Kanavape), the Court’s decision is expected to be rendered from September 2020 onwards, and in the vast majority of cases, the Court follows the opinion of the Advocate General.
In February 2020, the UK Food Standards Agency (FSA) set the deadline of 31 March 2021 for food business operators (FBO) who currently have CBD products on the market to provide technical and safety data on their products. After that date, only FBO that have submitted a valid novel food application for the authorization of their CBD product will be allowed to remain with their product on the market.
On the 20th of May 2020, the UK association for the cannabinoid industry (ACI) received clarification from the FSA on several points concerning the required information novel food applications that have been raised by their members. To have access to the full Q/A, please click here.
Also, and regarding the lack of standardized analytical method for cannabinoid or CBD products, which is a critical step for this industry, ACI is currently in discussions with the Laboratory of Government Chemists (LGC) for the development of a cannabinoid testing methodology with a higher precision control.
Also, the FSA issued a consumer advice communication on CBD extracts. You can read it in full here.
In Australia, the regulatory body for therapeutic goods – Therapeutic Goods Administration (TGA) – has announced recently that it is currently evaluating making CBD available over-the-counter (OTC) in Australia following a public consultation. CBD is currently a Schedule 4 substance and therefore only available with a prescription. The switch would then be from a Schedule 4 to a Schedule 3 substance. TGA was accepting public submissions about the proposed rescheduling of CBD up to 22 May 2020.
If approved, the amended scheduling will mean that cannabis products in which CBD comprises 98% or more of the total cannabinoid content will be available over-the-counter without a prescription in pharmacies across Australia for therapeutic use. It is proposed that CBD products will come with a recommended daily dose of 60 mg or less, in packs containing not more than 30 days’ supply, and be available only to adults over the age of 18. The decision is expected by June 2020. For more information click here.
Until very recently, there was no laboratory, at a global level, with a recognized method for validating cannabinoids in hemp. At the end of April, an expert review panel from AOAC International announced that a liquid chromatography–diode array detection (LC-DAD) method, which was previously approved as Official Method of Analysis 2018.11 for cannabinoids in Cannabis plant materials, concentrates, and oils, is now approved for hemp. With this new approved and validated method, laboratories will be able to evaluate hemp for tetrahydrocannabinol (THC) on a dry-weight basis. The method was developed within a collaborative project between Eurofins Food Integrity & Innovation (USA) and the University of Chemistry and Technology (Czech Republic), led by Dr. Katerina Mastovska.
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