a&r’s News Digest – We dedicate this month’s issue to Cannabis and short regulatory news.



Cannabis – an EU market soon to expand?

Cannabis sativa L. is a plant with multiple faces. Industrial hemp was bred to contain very little tetrahydrocannabinol (THC). Under the premise that the THC content does not exceed 0.2 % of the plant and without prejudice to other national regulations, the plant and their parts are accepted food sources in the EU (Novel Food Catalogue, 2018). Nowadays, hemp is used as a source of fiber mainly for non-food purposes. Hemps seeds, seed proteins and seed oils became common food ingredients. However, it must be noted that national regulations may restrict the use of industrial hemp in food.

The situation is far more complicated when it comes to medical cannabis. The medical cannabis plant or its plant parts, including its secreted resin (”hashish”) and its main constituent tetrahydrocannabinol (THCs), are classified as Narcotic Drugs and thus are not legally marketed unless a specific permission is granted. Consequently, the cultivation, production, trade, import, export, sale, purchase and possession of all plant parts of cannabis is illegal (when without permission).
Until now, there is no harmonized EU law on cultivation or authorized cannabis-based drugs. Cannabis-based medicines like Sativex and Marinol are only available in some EU member states but not throughout the entire EU. Since 2016, medicinal products containing CBD are allowed in the German market but only as prescription drugs. Across the Atlantic, the FDA just approved the first cannabis derived drug, Epidiolex from GW Research Ltd, which contains CBD to treat serious forms of childhood epilepsy.

Whereas some EU countries have decriminalized the cultivation of cannabis for personal medicinal purposes, like The Netherlands and the Czech Republic (up to 5 plants), the cultivation of cannabis for recreational purposes remains illegal all over Europe.

Very recently, cannabidiol (CBD), an innocuous structural relative of THC attracted a lot of interest. Since CBD does not have the psychotropic potential attributed to THC, there are discussions about whether or not CBD concentrates are suitable as food ingredients. In addition, food products with CBD levels that are higher than the CBD levels in the plant – which would include cannabis extracts – fall under the Novel Food Regulation (EU) 2015/2283 and require a pre-market authorization. A respective application for trans-cannabidiol is currently being evaluated by EFSA. Once the authorization is granted, all CBD extracts that meet the specifications of the authorized product can be generically used in food supplements for adults with a daily intake of up to 130 mg or 1.86 mg/kg body weight. The outcome of this evaluation and the further decision process in the European Commission is impatiently awaited but it is impossible to predict whether or not CBD will be authorized as a food ingredient.
The cannabis drug and food market is expected to massively change in the next couple of years. A recent report states that, as Europe has a population size of over 742 million people (more than double of USA and Canada together), an annual GDP of over €15 trillions in 2017 and a total annual healthcare expenditure of €2.3 trillions, Europe could be the largest cannabis market in the world.

Are you considering to develop, import, market cannabis containing products as food or drug? We can guide you through the legal jungle on cannabis. Get in touch today!

Other important determinants mentioned for the NHR claim effect towards consumer preferences and purchase behavior were linked with the product itself but the results were inconclusive. However, the authors concluded that the effect of a product with claims was dependent of the product perceived healthiness and this was also strongly dependent on the interaction between the product and the nutrients in the NHR claim (e.g. NHR claim about omega-3 lead to higher preference for a fish product than for bread which would be better advertised with a claim about fiber). Moreover, the effect of NHR claims on nutritional unfavorable products could potentially mislead the consumer by making the product appear healthy (e.g. vitamins and minerals added to sugary breakfast cereals).

It is important to build trust with consumers and not provide misleading information. Food business operators should make sure that they provide consumers with meaningful nutritional or health claims on their products. We can support you and develop a tailor-made claim strategy and roadmap for your product. Get in touch today!

Short Regulatory News

Haskap berries soon to be granted NF authorization based on traditional use in a third country 

After a request under Article 14 of the Novel Food Regulation (EU) 2015/2283, EFSA considered that the available data on composition and history of use of berries from three varieties of L. caerulea (Lonicera caerulea var. emphyllocalix, L. caerulea var. kamtschatica, L. caerulea var. edulis) do not raise safety concerns.

Hence, Haskap berries will soon be granted Novel Food approval based on traditional food use in a third country and can be placed on the market within the European Union.

New update of the Union list 

On the 23 July 2018 an update to the Commission Implementing Regulation (EU) 2018/1023, correcting the Union list of Novel Food was published. Please click here for more detailed information!

Open consultation for genotoxicity of chemical mixtures

EFSA has invited to an open public consultation on a draft statement on “Genotoxicity Assessment Chemical Mixtures”. EFSA considers that this point was not fully clarified in the guidance document on harmonized risk assessment methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals.

Interested parties have now the possibility to provide their views and are invited to participate and send their comments until the 9th September 2018.

NutraBusiness Intel

By-Health buys Penta-vite from Bayer

6 June 2018

Chinese food supplements By-Health has acquired Bayer Consumer Health’s Penta-vite Australian vitamins brand for €13.2 million. Pentav-vite is one of the leading child nutrition brands in Australia and this deal represents the latest step in line with their internationalization strategy. Earlier this year By-Health purchased the Australian probiotic company Life-Space.

OptiBiotix signs an exclusive agreement with Alfasigma in Italy

21 June 2018

UK-based OptiBiotix Health has signed a license agreement that grants Alfasigma exclusivity to commercialize food supplements containing its LPLDL® probiotic strain in Italy. LPLDL® strain has shown to improve blood lipid profiles in clinical trials. The ten-year agreement includes an upfront payment and royalties that have not been disclosed.

Uriach has acquired two Italian companies

21 June 2018

Uriach has completed the acquisition of Progine Farmaceutici and AR Fitofarma specialized in innovative food supplements, for an undisclosed sum.

Progine is a leading pharmaceutical company who develops and markets specialist medical aids and devices for the Italian gynecology market. AR Fitofarma is a leading food supplement companies in Italy who focus on pediatrics. The revenue of the two companies is €5 million and €7 million, respectively.

Ascendis will sell its non-core assets

25 June 2018

Ascendis Health, the South African-based international healthcare company, plans to offload smaller local non-core business as part of a strategic business review. These are: Sports Nutrition in South Africa excluding their biggest brand Scitec, Ascendis direct (the company’s selling and network marketing business in southern Africa and Nigeria) and Ascendis production plant in Isando (Johannesburg).

Vision Healthcare acquires Cute nutrition

26 June 2018

Vision Healthcare– OTC company present in several EU countries- has recently acquired food supplements e-commerce specialist Cute Nutrition for an undisclosed sum. Cute is strongly focused on beauty and weight loss products specially made for women. The firms’ portfolio possesses more than 30 products that are currently sold through its own e-commerce platform and Amazon in EU and US.

J&J acquires food supplements company Zarbee’s Naturals

30 July 2018

Johnson & Johnson’s consumer-health care reached a deal to buy children’s cough-syrup producer Zarbee’s Naturals for an undisclosed sum. This acquisition will support J&J to better reach health-conscious millennial parents and increase sales from its consumer-health unit.

Zarbee’s was founded in 2008 as a drug-free cough syrup brand for children. Currently, their portfolio covers sleep, immune support and vitamins. Zarbee’s markets its health-care products as healthier alternatives to traditional OTC medicines since they don’t contain alcohol, gluten or dyes.

This is not the first move of J&J towards preventive healthcare. In February 2017 the company invested in DayTwo, an Israeli startup focused on personalized microbiome analysis for diabetes nutrition.

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Your experts

Irene Wohlfahrt
Irene WohlfahrtSenior Consultant
Dr. Inês Rocha
Dr. Inês RochaScientific Consultant

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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