a&r’s News Digest – We dedicate this month’s issue to regulatory news about the UK reclassification of glucosamine products and new maximum levels of vitamin B6 in Food Supplements in The Netherlands. A special space for Innovation will now have a dedicated section on our newsletter. In this issue, meet Mitte®, a smart home water system startup.


Invitation to our a&r Webinar series

We are happy to invite you to our next free webinar!

Building Scientific Evidence to Support Nutrition & Health Claims
by our expert Dr. Heike Stier

Date: 27st of September 2018 (Thursday)
Time: 15:00 – 15:45 (30 min talk and 15 min Q&A)

In our next webinar we provide an overview of the current situation of the Nutrition and Health Claims according to the EU claim regulation (EC 1924/2006). We will present and examine the updated EFSA scientific and technical guidance for the preparation and presentation of a health claim application, which was published in 2017. We will finally focus on what can be learned from indication specific EFSA guidance documents and from previous EFSA claim evaluations, so that the necessary scientific evidence can be collected for a successful health claim application.

Dr. Heike Stier is a senior consultant in the consulting & strategic innovation team at analyze & realize. She has been supporting clients in the development of natural health products for more than 10 years.


What is in a&r’s webinar pipeline?

The next free webinar in our pipeline will focus on the next generation of probiotics.

Innovation in probiotics
by our expert Dr. Iris Hardewig

Probiotics do no longer only target the immune system and/or gut health. Recent research shows that probiotics and also prebiotics have a much broader application range. The webinar will focus on innovations in the probiotics space, what are the latest products and what comes next? This webinar may help you identify opportunities to extend your product portfolio.

More information on how to register to this free webinar will follow soon!

Regulatory News

UK reclassifies certain glucosamine products as medicines

Earlier this month, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) reclassified certain glucosamine products as medicines. According to the MHRA statement, products containing doses equal to or greater than 1178 mg per day of base glucosamine (equivalent to 1500 mg glucosamine sulphate) can no longer be classified as food supplements and are now medicines. This reclassification was based on the evidence of pharmacological effects as well as the intended use of consumers. Glucosamine-containing products are currently being used to alleviate joint problems – a medicinal purpose.

This MHRA decision will affect most of the current food supplements on the market. All food supplements containing doses of glucosamine of at least 1178 mg per day will now need a marketing authorization. Alternatively, reformulation of the product is necessary. If you need support with your glucosamine-containing product, please get in touch.

The Netherlands sets new national maximum levels for vitamin B6 in Food Supplements (FS)

There has been plenty of discussions around maximum levels of vitamins and minerals allowed in food supplements in Europe. The Directive 2002/46/EC on food supplements envisages the setting of maximum and minimum amounts of vitamins and minerals in supplements however the Commission has not yet taken any action. Hence, national bodies have taken matters into their own hands and now several EU countries have set their own maximum levels for vitamins and minerals allowed in food supplements. This time was The Netherlands.

At the end of August, The Netherlands published its final text introducing new maximum levels of vitamin B6 in food supplements. The maximum daily dose of vitamin B6 in food supplements in The Netherlands is 21 mg for adults. For children, different maximum daily doses were set-up depending on the age group. As an example, a maximum daily dose of 3 mg of vitamin B6 is allowed in food supplements for children aged 1 to 3 years of age, while products containing more than 7 mg of vitamin B6 per daily dose are only suitable for children under 17 years of age. This new regulation will enter into force on October 1st, 2018. For existing products, it is foreseen that they can remain on the market until the stocks are sold out.

The maximum daily doses of vitamins A (1200 μg; in the form of retinol) and D (75 μg) for food supplements were maintained.

Earlier this year was Germany who came with new recommendations on maximum levels of vitamins and minerals. If you would like to read more about it click here.

Innovation Corner

From now on, we will introduce to you interesting new startup companies or innovative products in every a&r newsletter. We believe that there are products as well as ideas developed by some creative and innovative startup companies that can be very inspiring and are worth spreading!

Mitte®, a smart home water system targeting consumer personal demands and environment

The demand for bottled water has been growing during the last decade due to associated health and wellness, but environmental concerns are shadowing the sector. Considering the increased consumer awareness of plastic bottle use and its damaging impact on the environment, both on land/soil and the oceans, products and technologies that address this problem will be well received by consumers. The Guardian reported last year that a million plastic bottles are bought around the world every minute, and by 2021, this number will have increased by another 20%. Alongside these concerns, consumers have been showing preference for vitamin and mineral rich drinking water products that do not imply losing portability. Thus, bottled water companies are looking to gain market space with solutions that are more environmentally friendly and also appealing to health-conscious consumers. An example of a manufacturer that targets these key drivers is Mitte®. This company aims to offer consumers clean and healthy water while promoting sustainability.

Mitte®, a Berlin-based startup company founded in 2015, is a provider of a smart water system that unites water purification with enhancement (by adding minerals and trace elements via different cartridge options), giving consumers a personalized and healthy water in their own home. They have just raised $10.6 million in a financing round led by Danone Manifesto Ventures along with Singapore-based VisVires New Protein Fund and venture capital Alfred Karcher SE & Co. This countertop device, which is expected to be available by mid 2019, purifies tap water and after adds minerals via cartridges. The product was pitched at a retail price of 429 euros, according to the 2017 kickstarter campaign. To know more about this product, please visit the company website.

a&r on the news

We are proud to share with you our latest article on the AgroFood Industry Hi Tech journal about the regulatory situation of food supplements in Europe by our expert Irene Wohlfahrt.

Food supplements are regulated in Europe by the Food Supplements Directive. Since this only clearly regulates vitamins and minerals, Member States have begun to devise their own legislation for the so-called “other substances” such as botanicals, which leads to increasing dis-harmonization of the European marketplace. If you would like to read the full article please click here.

NutraBusiness Intel

Mundipharma closes asset purchase agreement with Vital Food Processors

7 September 2018

New Zealand-based company Vital Food Processors closed a purchase agreement with Mundipharma providing the global rights (excluding NZ) to commercialize the digestive health supplement Zyactinase™. Zyactinase™ is a freeze-dried extract of Kiwifruit (Actinidia deliciosa) with clinically-proven gastrointestinal health benefits.

Endexx announces investment in EcoHealth Neuropathy 

13 September 2018

Endexx Corporation, a provider of innovative medical marijuana management and technology solutions for entrepreneurs, has announced its investment in full-service healthcare provider for the treatment of diabetic neuropathy EcoHealth Neuropathy Inc.. The aim is to launch its platform for clinical and technology-driven management of neuropathies.

APN agrees to sell Nutritionals to Lactalis 

13 September 2018

South African company Aspen Pharmacare Holdings (APN) has agreed to divest its Nutritionals business and sell its global baby milk business to French dairy company Lactalis Group for 12.9 billion rand ($865 million; €740m). This deal supports Lactalis’s strategy to rebuild its infant nutritional business after a global product recall.

Coca-cola acquires organic kombucha brand from Organic & Raw Trading 

19 September 2018

The Coca-Cola Company, one of the largest drinks company in the world, has acquired Organic & Raw Trading Co., an Australia based company and maker of the kombucha brand MOJO. The MOJO Kombucha is a fermented beverage packed with active enzymes, organic acids and probiotics. Kombucha is the fastest-growing beverage category in Australia. This is the first time Coca-Cola has acquired full ownership of a brand in this category. The deal terms were not disclosed.

Nestlé likely to divest from Skin Health business 

20 September 2018

Nestlé aims to sell its skin health unit and focus on food, drinks and nutrition health. The Swiss-based company stated that the “future growth opportunities of Nestlé Skin Health lie increasingly outside the group’s strategic scope”. Its skin health business markets a range of medical and consumer healthcare products ranging from acne treatments to injectable skin fillers.

Additions to our MatchMaking Platform

Joint pain is a major health issue for a significant part of the adult population worldwide. People who suffer from knee pain, require chronic analgesic treatment, often associated with side effects. A truly meaningful alternative has been included in the MatchMaking platform: Natural and effective food supplement able to reduce knee pain in only 48 hours, clinically proven drug-free solution with no sides effects typical for conventional analgesics.

Credits: Pexels

ar MatchMaking Platform

This OTC is a herbal medicinal product preventing and treating cold and flu that will be a great addition to your product portfolio. Innovative multi-ingredient combination with clinically proven efficacy and tolerability in more than 1000 subjects.
Time to embrace innovation and keep a healthy pipeline!

Credits: Pexels

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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.

Don’t hesitate to contact us: newsletter@a-r.com