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NEWS DIGEST by a&r | January 2020

2020-02-06T14:06:39+01:00

In this January issue, we wish to share with you our achievements during 2019. We will also provide you with the current approach by EU and UK authorities regarding CBD products on the market, and we will discuss innovation and infant nutrition clinical research. Also, meet us next month at Probiota in Dublin!

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a&r looks back on 2019 – success stories

Another year has gone by and, as usual, a&r has been involved in amazing projects. We also had the chance to meet former and new clients; we visited trade shows and attended expert events all around the world.

Regulatory services

Substance-based medical device

In the last one and a half years, we have supported several clients with the compilation of their technical documentation for substance-based medical devices under the new MDR regulation, including all necessary test and studies.

Novel Food

When it comes to novel food regulatory support, the novel food expert team has been involved in over 40 novel food projects under the previous novel food regulation (EC) 258/97 as well under the current NFR (EU) 2015/2283. Only in the last two months, we have submitted two novel food applications.

Herbals

Our expert team has also been constantly supporting clients in herbal drug applications. If you are planning a THMP registration in any EU countries or need assistance with any part of your CTD, we are here for you. Get in touch!

CBD

With overwhelming interest and the very positive feedback received from participants, we hosted two regulatory seminars on the current regulatory situation for cannabidiol-containing food products in the EU. The seminars provided an overview of the regulatory challenges that food business operators currently face and explained the requirements for the submission of Novel Food applications for CBD in foods/supplements.

Regulatory webinars

Currently, we are also resuming our activities regarding our interactive free webinars. We hope you enjoy our selection. This month, we hosted the first of this year on substance-based medical devices under MDR – steps you need to take! by our medical device experts Dr. Marlen Landschreiber and Dr. Solveigh Krusekopf. If you are interested in a tailor-made training on any regulatory topic, get in touch.

Clinical services

Our clinical research department has accompanied more than 25 human clinical studies investigating very innovative nutrition and medical device products, conducted either for marketing or regulatory purposes. a&r offers a newly developed quality management approach, which provides exactly those services that are required to deliver high-quality data by reflecting the specific needs and requirements (budgets!) of clients and products.

In one health claim application process, the EFSA panel confirmed that the clinical studies conducted by a&r have shown the claimed effect. Thus, we know how to run studies accepted by EFSA.

Thanks to very precise planning and perfect execution by our clinical operations team, a&r was able to include more than 700 subjects in a cold-and-cough study within 4 months, and this only in the Berlin area. By the way – completely within the previously agreed budget!

In 2019, we were able to expand our expertise in weight management, prediabetics, and infant nutrition. Another growth & tolerance study aiming for more than 300 newborns investigating a new infant formula will be closed in recruitment soon due to a unique collaboration with only 12 (!) efficiently operating clinical trial centers and partners in 3 European countries.

When requested by our clients, we also publish the results of clinical studies conducted by our CRO. Recently, we published the results of 2 clinical studies, one being on effects of aged garlic extract on arterial elasticity using EndoPATTM technology and the other one on the safety and tolerability of cellobiose in healthy subjects. For full information on these publications, click here. Furthermore, we have recently successfully completed one FDA regulatory study, and another one is ongoing.

Licensing and Matchmaking

The a&r MatchMaking Platform, which was launched in 2017 to bring together companies looking for local and worldwide in/out-licensing opportunities in natural health products, has successfully included about thirty new business opportunities in our licensing database featuring premium finished products, branded ingredients, and other technologies. Daily enquiries regarding products offered in the licensing database confirm that the MatchMaking Platform is an excellent strategy for innovation. During the matchmaking process, a&r confidently supported clients by performing technology and product scouting, due diligence, competitive intelligence, market analysis, providing advice on clinical trials, etc. To explore your next business opportunity, please contact Dr. Inês Rocha: matchmaking@a-r.com.

Thank you for giving us the opportunity to support your business and to share with you our unique combination of regulatory and scientific consulting and clinical research expertise in the field of natural health products.

Regulatory News

Cannabidiol (CBD) – EU (mainland) versus UK approach

In the last years, numerous CBD containing food products appeared on the European market. In contrast to tetrahydrocannabinol (THC), CBD is not classified as a narcotic, and its possession and consumption for consumers is in principle legal. This does not automatically mean that CBD can be legally sold as a food ingredient, however.

So, one year ago, the European Commission updated the Novel Food Catalogue regarding Cannabis sativa L., Cannabidiol, and Cannabinoids. With this update, and according to the Novel Food Catalogue, more or less all products consisting of or containing hemp extracts from plant parts other than seeds are considered novel foods and require a novel food application.

Despite resistance from industry, three CBD novel food applications have been submitted to the EU Commission (for more information check EFSA Registry of Questions mainly for synthetic CBD isolate. It seems that EFSA did not yet initiate the formal evaluation procedure (as of January 2020). The result of the safety evaluation by EFSA/EU Commission will determine whether CBD (and hemp extracts) will have a future in the food sector, or whether drug status and defined use in cosmetic will remain the only legal category for these ingredients.

The UK is the EU market (until Brexit) where more CBD-containing products can be found. In a recent application for consultation to determine the status of a novel food, pursuant to Article 4(2), the UK Food Standards Agency (FSA) considered CBD as novel food stating that “a history of consumption had not been demonstrated for the CBD isolate” and “that the final product was different from the starting material and that there may be differences in exposure because of the concentration of the CBD component”. Despite this, and based on FSA Board meeting from 22 January 2020, the UK Agency is currently applying a proportional approach to regulation with CBD. Meaning that the Agency’s approach is to work with the industry in a compliance approach towards novel food. But for now, no CBD-containing product will be removed from the market. If there is any evidence that CBD poses a significant risk to health, then the Agency will take actions under the Food Safety Law. However, the Agency finds it important to mentioned that consumers need to understand that there are no authorized CBD products on the market and that these products are currently unregulated, and they need to make their decisions in that light.

Similarly, the Cannabis Trade Organization (CTA), in a press release from 22 January also mentioned that FSA has no current plans to immediately withdraw CBD products from the shelves (until further notice). CTA is planning to launch a systematic campaign of political and media engagement to keep pressure on the FSA) not to attempt to enforce any move against the CBD industry based on the ‘Novel Foods’ issue.

While there is a consensus among National Authorities on the status of CBD in Europe, different approaches toward CBD-containing products on the market are being taken, mainly between EU mainland countries and the UK (de jure not a part of the EU as of January 31st). To see which EU countries have been more active in enforcing the novel food regulation, –  “unauthorized novel food ingredient cannabidiol (CBD) in food supplement” –  please have a look at the Food and Feed Safety Alerts (RASFF) portal.

If you are considering to develop, import, or market cannabis-containing products as foods or medicinal products, we can support you. Get in touch!

Medical Device Regulation and Notified Bodies – a quick follow-up

The number of certified Notified Bodies (NB) under the Medical Device Regulation (MDR; (EU) 2017/745) is still one of the bottlenecks for the industry. Four months before the regulation enters into force, only 8 MDR Notified Bodies are available in Europe (excluding BSI Assurance UK Ltd due to Brexit). The list of NBs available at any given time can be found via the NANDO website.

For Medical Devices, as for all other EU regulations, there will be a transition period under Brexit till the 31st Dec. 2020 where all the EU rules still apply.

Meet us at Probiota!

Probiota is a leading event for those in the probiotic, prebiotic, and microbiome space. Our novel food expert Dr. Steffi Dudek will be attending the event (10 – 12 February, 2020) in Dublin, Ireland.

If you would like to meet her and discuss your next project, please get in touch.

Our regulatory and clinical teams are passionate about the power of natural health products, and we want to bring our expertise, enthusiasm, and creativity to help you to deliver tailor-made innovation solutions that differentiate your product in this market space.

Clinical Research

Innovation in infant nutrition

No doubt that breastmilk is the best nutrition for infants. Therefore, health authorities worldwide recommend exclusive breastfeeding for 4-6 months. But especially in industrialised countries, only 25 % of infants are exclusively breastfed at the age of 6 months.

Manufacturers of infant nutrition are committed to improving their formulas and to mimic the composition of breastmilk as much as technically possible.

Because infant formulas may be the only nutrition for this vulnerable population group, infant nutrition is highly regulated. Nutrient profiles are defined, and only authorized ingredients can be used. Strict requirements for the demonstration of safety and tolerability make innovation in infant nutrition ingredients time-consuming and expensive. In addition, nutrition and health claims are not allowed, and restrictions to labelling and advertising apply.

Despite these challenges, the market has recently seen disruptive innovations, like the introduction of the first human milk oligosaccharides (HMOs), which are manufactured either by chemical synthesis or by fermentation with metabolically modified microorganisms. It is thought that these oligosaccharides act as prebiotics in the intestinal tract of the neonate mammal, helping the intestinal flora to develop. All milk types contain oligosaccharides, but in human breastmilk, the complexity and concentration of this fraction is much higher than in animal milk, e.g. cow or goat milk. Meanwhile, 2’-fucosyllactose alone or in combination with Lacto-N-neotetraose or Difucosyllactose is authorized as an ingredient in infant nutrition, and several applications for other HMOs are currently being evaluated by EFSA.

Another example is whey basic protein, a protein fraction from whey that is rich in bovine lactoferrin, lactoperoxidase, and TGF-β2, which can be used in infant nutrition. Bovine lactoferrin is very similar to human lactoferrin. This iron-binding protein is one the most abundant proteins in early breast milk and exhibits multiple biological activities.

However, in order to obtain a market authorization for novel foods as ingredients in infant formulas, or for nutrients or additives that are not yet authorized for this target group, clinical studies with infants might be required. At a&r, we have executed several growth and tolerance studies with more than 300 newborn (0 to 14 days after birth old) per study from different EU countries, including complex microbiota (sub)-studies. Due to our carefully selected and experienced investigator network, we mastered timely recruitment. Also, our regulatory team has developed a deep understanding of infant nutrition regulations and can support a smooth market access.

If you would like to know more about e.g. our clinical research services in infant nutrition, get in touch.

NutraBusiness Intel

Nestlé Health Science to further scale the future of personalized nutrition with the acquisition of LivingMatrix™

Atrium Innovations, a company of nutritional health products recently acquired by Nestlé Health Science, expands its role in personalization within the medical professional and consumer spaces with the acquisition of San Francisco-based LivingMatrix™. LivingMatrix is a technology-based, data and algorithm-driven personalized functional medicine platform, which was designed by clinicians to help practitioners effectively evaluate and engage patients, create personalized, actionable care plans and track patient health outcomes.

3 January 2020 • Source

Bayer and Azitra partner to harness the human skin microbiome as a source for new natural skin care products for sensitive and eczema-prone skin

Bayer and Azitra Inc., a clinical-stage medical dermatology biotech company, announced a joint development agreement to collaborate in the identification and characterization of skin microbiome bacteria mainly with Staphylococcus epidermidis strains to identify potential candidates for the treatment of adverse skin conditions and diseases. Prospective areas of application include medicated skin care products for sensitive, eczema-prone skin as well as therapeutic products for skin diseases such as atopic dermatitis.

10 January 2020 • Source

Beyond Meat® and Roquette announce multi-year pea protein supply agreement

Beyond Meat, a leader in plant-based meat, announced a multi-year pea protein supply agreement with Roquette, global leader in plant-based ingredients and a pioneer of plant proteins. With this supply agreement Roquette increases the amount of pea protein to be supplied to Beyond Meat over the next three years.

15 January 2020 • Source

Gardein launches new version of Ultimate Plant-Based Burger

Gardein, a brand of Conagra Brands, Inc., is launching a new version of their Ultimate Plant-Based Burger. The new Ultimate Plant-Based Burger is made out from pea protein and replaces the firm’s Ultimate Beefless Burger made from soy protein. The Gardein Ultimate Plant-Based burger will be sold in the freezer sections of grocery stores and mass retailers nationwide (USA).

21 January 2020 • Source

Nestlé announced collaboration with Burcon and Merit for plant-based ingredients

Nestlé established a joint development agreement with Merit Functional Foods and its technology partner Burcon NutraScience, two key players in the development and production of high-quality plant proteins. This partnership will enable Nestlé to strengthen internal capabilities and accelerate innovation in novel plant protein ingredients for use in Nestlé’s plant-based foods and beverages.

24 January 2020 • Source

Nestlé acquires Zenpep, expanding its medical nutrition

Nestlé announced that it has entered into an asset purchase agreement with Allergan to acquire the gastrointestinal medication Zenpep. Zenpep (a mix of digestive enzymes (lipases, proteases, and amylases) from pig pancreas) is a prescription medicine (USA) for people who cannot digest food normally by helping the body use fats, proteins, and sugars from food. This acquisition will expand Nestle’s medical nutrition business and complement its portfolio of therapeutic products.

The deal is expected to be finalized concurrent with the merger of Allergan and AbbVie. Financial details of this acquisition are not being disclosed.

27 January 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.

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