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NEWS DIGEST by a&r | June 2020

2020-07-27T18:35:44+02:00

We dedicate this June issue to the on-going regulatory hurdles around CBD and the Commission evaluation regarding health claims on botanicals.

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Regulatory News

CBD and its continued regulatory hurdles

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.

Botanicals and health claims – European Commission suggests ‘traditional use’ approach

Plants and their preparations are widely available on the EU market as foods or as herbal medicines, and their classification as “food” or medicine is of the responsibility of Member States. Thus, a plant substance classified as a “food” in one Member State, can be classified as “medicine” in another Member State.

The European Regulation (EC) No 1924/2006, regulates the nutrition and health claims made on foods. Since 2012, the Commission established an “on-hold” list of more than 2000 health claims relating to plant substances. These “on-hold” claims may still be used on the EU market under the responsibility of food business operators and under certain conditions. Hence, health claims on botanicals are currently “on-hold” and waiting for a decision about their evaluation process.

After a long wait, on the 20 May 2020, the Commission completed the evaluation of the regulation on nutrition and health claims made on foods with regard to nutrient profiles and health claims made on plants and their preparations and of the general regulatory framework for their use in foods, as part of the Regulatory Fitness and Performance programme (REFIT).

Concerning health claims on plants and their preparations and their regulatory framework, the evaluation findings showed:

  • Consumers continue to be exposed to unsubstantiated health claims from the “on-hold” list (claims that have not yet been assessed by EFSA).
  • Food business operators have benefited from the current situation, contrary to the pharmaceutical industry, as they have been able to continue using health claims on plant substances without having to undertake clinical trials to support the application for health claims.
  • The Claims Regulation is coherent with other EU legislation applicable to plants used in foods, but there is a discrepancy in the recognition of “traditional use” data for claims made on foods and Traditional Herbal Medicinal Products.
  • The safety of foods containing plants is adequately addressed by EU general rules on food safety. Potential risks to consumers might arise due to increased numbers of national rules that assess the safety of certain plant substances in foods.
  • It is not coherent to have harmonized rules on health claims while the use of plants in foods is governed by national rules.
  • A EU harmonization on plants used in foods through a positive or a negative list of plants would improve the situation with regard to safety and the smooth functioning of the internal market.

The full outcome of the evaluation was:

“Overall, the evaluation findings show that, in the current situation, the objectives of the Claims Regulation are not fully attained. It could be appropriate to explore the notion of ‘traditional use’ in the efficacy assessment of health claims on plants used in foods together with the effects of the coexistence, on the EU market, of Traditional Herbal Medicinal Products on the same plant substances. In the light of the shortcomings highlighted above about the smooth functioning of the internal market and the possible openness to the notion of ‘traditional use’ to substantiate health claims on plants, there are merits for further studying the potential EU harmonisation of the field of plants, including the safety aspect. “

Despite the urgent need for a harmonized decision concerning health claims on botanicals (currently “on-hold” claims), no final decision is to be expected soon.

NutraBusiness Intel

Chr. Hansen acquires UAS Laboratories LLC to extend the microbial platform and strengthen probiotic production flexibility

Chr. Hansen Holding A/S entered into an agreement with the owners of UAS Laboratories LLC (“UAS Labs”) to acquire 100% of the Wisconsin-based B2B company specializing in clinically documented probiotics. The acquisition of UAS Labs will further strengthen and expand Chr. Hansen’s global microbial platform and Human Health business, and is aligned with the strategy of pursuing bolt-on acquisitions that fit into the microbial platform.

9 June 2020 • Source

Nestlé Health Science agrees to acquire majority stake in Vital Proteins

Nestlé Health Science is acquiring a majority stake in Vital Proteins, a US-based company specialized in dietary supplements, foods and beverages based on collagen. The acquisition is subject to regulatory approval.

10 June 2020 • Source

Debiopharm‘s novel microbiome remodeling program licensed to Takeda for the treatment of GI disorders

Debiopharm, a Swiss biopharmaceutical company, signed an exclusive license agreement and research collaboration with Takeda to develop novel microbiome therapeutics for the treatment of gastrointestinal (GI) disorders. The preclinical program is focused on novel, narrow spectrum, microbiome remodeling agents targeting a combination of intestinal pathobiont bacterial species while sparing healthy commensal bacteria.

10 June 2020 • Source

Perrigo partners with Kazmira LLC to enter CBD market through a two-phased, science-based approach

Perrigo entered the cannabidiol (“CBD”) market through a strategic investment in and long-term supply agreement with Kazmira LLC. Kazmira is a US supplier of hemp-based CBD products free of tetrahydrocannabinol (“THC-free”).
In the first phase of the partnership, the two companies will collaborate to scale-up Kazmira’s facilities and laboratories, in accordance with current Good Manufacturing Practices (“cGMP”), to produce THC-free CBD from industrial hemp. In the second phase of the partnership, Perrigo will work to launch THC-free hemp-based CBD products in a number of global markets, while leveraging its supply agreement with Kazmira, which is exclusive for the U.S. store brand market.

18 June 2020 • Source

Probi and Örebro University to collaborate on research into exploration of novel, needle free vaccines

Örebro University, in collaboration with Probi AB, and nine other Swedish companies have been granted funding for research into novel, needle free vaccines through delivery via mucous membranes instead of using traditional injections.
The delivery technology project will include the use of probiotic bacteria as carriers for the vaccine antigens, with the aim of inducing immunity against pathogens. The capability of probiotic bacteria to persist in close proximity to the mucosal surfaces will be utilized for presenting the vaccine antigens to the immune system and exerting immune-stimulating effects.

2 July 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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