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NEWS DIGEST by a&r | May 2020

2020-06-03T09:19:14+02:00

We dedicate this May issue to thank you for joining us online during a&r virtual event and to provide an overview of recent CBD regulatory news worldwide.

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The a&r VIRTUAL EVENT – is now over!

a&r virtual event

During the last 3 weeks, we have hosted a virtual event, including a wide range of free webinars in trending industry topics and free 1:1 consultation slots with our experts. The event has been a great success. Thank you to all of you who joined us online.

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Free webinars

  • Substance-based medical devices – Steps you need to take!
  • Scientifically-based claims on food – From FSMP to health claims
  • The protein revolution – Regulatory considerations
  • Main challenges of clinical food trials
  • Digestive health – Fishing in the dark

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Novel food/Additives/Enzymes

Botanicals

Health Claims

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Substance based medical devices

If you have any questions about our event or if you would like to connect with our experts, please reach us via business@a-r.com.

Regulatory News

A global update regarding cannabidiol (CBD) regulatory environment

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.

  • EU

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.

  • UK

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.

  • Australia

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.

  • USA

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.

Are you developing 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.

NutraBusiness Intel

DSM Venturing cornerstones €10m funding round

DSM Venturing, part of Royal DSM, is the cornerstone investor in Phynova’s €10 million funding round. Phynova is working towards fulfilling significant commercial orders for its patented ingredient Reducose® in Europe, China, and North America. This investment builds upon the existing global distribution partnership agreement between the two companies since March 2019. DSM Venturing investment director will be joining Phynova’s board as a result of this investment.

11 May 2020 • Source

ADM supports clinical trial into effects of probiotic supplements for COVID-19 patients in hospital care

ADM and Valencian Hospital de Sagunto have announced their partnership for a clinical trial to determine the effects of using a food supplement containing live microbial strains to promote gut microbiome balance and help improve health functions related to outcomes for COVID-19 patients in high-risk groups.

19 May 2020 • Source

Mammoth Biosciences partners with GSK to develop COVID-19 test

Mammoth Biosciences (USA) entered into a collaboration agreement with GSK consumer healthcare to develop an accurate, easy-to-use, fully disposable, rapid, and handheld test that consumers and healthcare providers in clinics can use to detect active SARS-CoV-2. Mammoth Biosciences will be using its DETECTR platform to develop the test. The partnership will potentially scale Mammoth Biosciences’ development and distribution to widespread commercial and consumer availability.

20 May 2020 • Source

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Your experts

Irene Wohlfahrt
Irene WohlfahrtSenior Consultant
Dr. Inês Rocha
Dr. Inês RochaDirector of Business Development and Strategic Innovation

At analyze & realize, we are experts in the field of natural health products, having provided our services for more than 20 years. We offer a unique combination of expertise in natural health products through our scientific, regulatory, and strategic innovation consulting and our clinical research organization with its own clinical trial center in Berlin, Germany. Thanks to our close interaction with the natural product market as well as our extensive network, we are always at the forefront of the latest information and innovation trends. With its international team of 35 employees, a&r is a leading European one-stop-shop ready to guide and support your needs in natural health product innovation.

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