We dedicate this October issue to the protein paradigm shift and to a potential MDR Corrigendum. Also, meet us next week at CPhI in Frankfurt!


Regulatory News

Plant-based protein – the protein paradigm shift

In the food sector, plant proteins are widely used both in conventional and in organic markets. Although animal protein consumption is increasing at global level, the EU is seeing the emergence of low animal protein diets. Recent changes across some EU countries suggest the beginning of a shift back towards plants and to less meat protein consumption, stemming from health concerns, economics, and consumer choice. For a deeper insight into the main food market segments for Protein-Rich Plants or crops (PRPs,) please refer to the EU report on “Market developments and policy evaluation aspects of the plant protein sector in the EU”.

This month, we have attended the third edition of the Food Valley Summit in Wageningen where experts discussed solutions for the protein transition. According to the Wageningen University & Research, there are four key drivers for the protein shift:

  • The environmental impact reduction (agriculture systems need to shift towards sustainable nutritional sources as the current food production chain, among others, is responsible for more than 25% of global greenhouse gasses)
  • Zero hunger for the growing population (the global protein demand will increase by 30-50% by 2050, so more equitable food systems are required to prevent increasing hunger and malnutrition)
  • Resilient production systems (with increased impact on climate change, food scarcity will put more pressure on already fragile areas, thus resilient protein systems are urgently needed to support these fragile areas)
  • Public health (the animal protein content in western diets has dramatically increased in the last decades, leading to an increase of chronic-disease mortality)

There is consensus that, to achieve a true change on the current protein paradigm, several aspects have to come together:

  • technology (e.g. improve crop production by optimizing their protein yield or by using innovative aquatic productions systems)
  • production (e.g. by reducing food loss and waste, transformation of side streams into microbial or insect protein, or use of nitrogen-fixing crops like chickpeas)
  • consumption development (e.g. introduction of new protein sources, e.g. from protein-rich plants, aquatic plants, algae, or fungi, and last but not least insects)

Developing new sources of protein that have not been consumed by humans in the EU prior to May 15, 1997, will raise the question whether these proteins might fall under the Novel Food Regulation. Even protein isolates from established food sources might be considered novel and require a pre-market authorization. Of course, this is also true for any up-cycled side streams of food production for human consumption.

a&r has been very active in the field of alternative food sources such as plant proteins. Our food experts would be happy to support you bringing your new plant protein sources to the market. Get in touch with us if you have any questions!

MDR – A new Corrigendum on the way?

The EU Medical Devices Regulation (MDR, 2017/745), which came into force in May 2017, must be implemented by 26th May 2020. So far, only five Notified Bodies are able to certify products under the new regulation. As far as we know, only two products have been CE certified under MDR, one being BSI for a class IIa inhaler and the other was TÜV SÜD for class III software, both issued in earlier this September.

Now, with just a few months to go, the drama around the new MDR continues. There are rumors that a second Corrigendum is on the way. EUDAMED will be delayed by 2 years and launch together with IVDR in May 2022 (official information) and self-care medical devices (meaning class I) may be granted a four-year “grace period” before they have to comply with new regulation standards (rumor). Apparently, this Corrigendum is sitting at Council level, waiting for Parliament approval.

Manufacturers of class I medical devices might soon get some breathing room to comply with the MDR, but this is not yet official.

We are following this situation closely and will keep you posted. Get in touch if you would like our support!

Upcoming events

Meet us at CPhI

Our team is passionate about the power of natural health products and wants to bring our expertise, enthusiasm, and creativity to help you deliver tailor-made innovation solutions that stand out from the market.

Attending the shows? Then do no miss the opportunity to meet our Director of Business Development & Strategic Innovation Dr. Inês Rocha. She will be happy to discuss your next project.

Book an appointment with us!

NutraBusiness Intel

Givaudan Active Beauty unveils first instant microbiome analysis and profiling system

2 October 2019

Givaudan, a Swiss manufacturer of flavors, fragrances, and active cosmetic ingredients, just launched an instant microbiome analysis and profiling system (i-MAPS), which will allow the personalization of nutricosmetic products based on consumers’ unique microbiomes. The individualized mapping of the skin microbiome will be done in approximately seven hours rather than in seven days for a standard analysis. Moreover, each profile will provide exclusive information about the bacteria present in the microbiome and will be correlated to a skin type such as oily, dry, sensitive, or ageing.


Carbiotix signs collaboration agreement with consumer digestive health tracking company Food Marble

8 October 2019

Carbiotix AB, a biotechnology company based in Lund (Sweden) that develops Microbiome Modulator Therapeutics (MMT) that amplify the production of key metabolites for the treatment of different metabolic and chronic diseases, signed a collaboration agreement with Food Marble Digestive Health Ltd. (“Food Marble”) to conduct a study to examine the correlation between digestive health and gut health.
The eight-week study managed by Food Marble, an Irish provider of consumer digestive health tracking devices, will be supported by Carbiotix’ gut health analysis and include a group of 20 individuals who ingest two different prebiotic fibers.


Nestlé partners with several Swiss organizations and will launch innovation ecosystem on food and nutrition in 2020

11 October 2019

Nestlé has joint forces with The Swiss Canton of Vaud, the Swiss Federal Institute of Technology in Lausanne (EPFL), and the Swiss Hospitality Management School in Lausanne (EHL Group) to develop and promote a global innovation ecosystem on food and nutrition. This initiative will be launched in 2020 as the “Swiss Food & Nutrition Valley”. The main aim is to attract talent, start-ups, and investment to the region.


In a&r MatchMaking Platform

a&r MatchMaking Platform

With consumers prioritizing their emotional and mental well-being, we at a&r embrace adaptogens! An innovative, natural OTC adaptogen made it to a&r’s MatchMaking Platform. The product consists of a multi-plant combination, boosting physical and mental performance, with clinically proven efficacy and tolerability in extreme environmental conditions.


Winter is near! The MatchMaking team wants to help you strengthen your Cough and Cold pipeline to tackle the low temperatures. This unique blend of herbal oils is an effective natural solution to fight sore throat during cold. Accelerate innovation and keep a healthy pipeline.

To our MatchMaking Platform
MatchMaking banner newsletter

Your experts

Irene Wohlfahrt
Irene WohlfahrtSenior Consultant
Dr. Inês Rocha
Dr. Inês RochaDirector of Business Development & Srategic 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