a&r’s News Digest – We dedicate this month’s issue to EFSA’s final guidance for health claims regarding muscle function and exercise capacity, and five new novel food approvals. Also, meet Made for_, this month’s startup.


Regulatory News

EFSA guidance for health claims regarding muscle function and exercise capacity

Following the draft guidance on the scientific requirements for health claims related to muscle function and physical performance being subject to public consultation during the summer (from 16 July to 2nd September 2018), EFSA has now published the final version of the document – “Guidance on the scientific requirements for health claims related to muscle function and physical performance”

This guidance is intended to support applicants in preparing their applications for the substantiation of health claims in this area. The document focuses on several key issues:

  • examples of claimed effects which are considered to be beneficial physiological effects,
  • definition of the target population for which the claim is intended;
  • characteristics of the human intervention studies which can provide evidence for the scientific substantiation of specific claims addressed in this guidance (e.g. appropriate outcome variables and methods of measurement, suitable study group(s), suitable controls).

The guidance, however, does not intend to a) provide an exhaustive list of beneficial physiological effects and studies/outcome variables which could be acceptable for claim substantiation, or b) address potential health relationships and related outcome variables/methods of measurement which have not yet been considered by the Panel in the context of a particular application.

New in this update is the definition of terms to describe parameters related to physical exercise (e.g. physical fitness, physical activity, physical exercise, and physical performance), and exercise characteristics (e.g. intensity/load, frequency, duration, and mode/type). Also, a new addition to the guidance is a paragraph on claims based on the essentiality of nutrients, meaning nutrients that are required for normal human body function such as protein for growth or maintenance of muscle mass and magnesium for muscle function. In addition, more detailed information on accepted outcome parameters related to muscle function is provided.

Please refer to the full guidance document for a more comprehensive overview. Are you looking for regulatory and/or clinical support? Our team of experts is more than happy to support you on your claim substantiation journey.

Five new novel food ingredients approval

Last month, the European Commission approved five new novel foods which may be placed on the market within the Union under Regulation (EU) 2015/2283. Out of the five novel food approvals, four are proprietary ingredients, meaning that they will have a period of five years from the date of entry into force of the Regulation during which they can only be placed on the market by the initial applicant. These proprietary novel foods are:

The fifth novel food, xylo-oligosaccharides has no proprietary data and will be included in the Union list of authorized novel foods. Several conditions of use apply, depending on the final product.

Innovation Corner

As we did in our previous issues, we now introduce to you another exciting startup company. We believe that there are products as well as ideas developed by creative and innovative startup companies that can be very inspiring and are worth spreading!

Made for_, a Berlin-based Personalized Nutrition startup

Personalization and customization are big trends in many different industries. Consumers are getting used to this approach and, due to the high demand, it is becoming a reality in many sectors. Companies discover that they can elevate their customers’ loyalty and engagement by providing personalized solutions.
“Personalized Nutrition” is an approach solution that is in high demand with consumers. In most cases, it is related to offerings based on selected micronutrients that are differently dosed for each individual. The level of personalization may begin with simple differentiation at the level of gender (male vs. female) or age group (teens, 50+ etc.) and end at products that provide a personalized micronutrient cocktail based on individual genome or gut microbiome analyses. Between these two extremes, a landscape of products personalized for individual eating habits, activity levels, biomarkers, or single genes is evolving.
Many companies, from start-ups to multi-nationals, invest in research on Personalized Nutrition. Most of the products currently present on the market have been developed by start-up companies that are in some cases fueled by interdisciplinary cooperation in science hubs. An example of a startup company that has recently emerged from an innovation food hub is Made for_. Made For_ is a Berlin-based consumer brand that help users achieve their health goals by guiding them through the complexity of taking the right nutrients. It delivers daily dosages of supplements based on the user’s lifestyle habits and the selected health goals.
If you would like to read more about Personalized nutrition, have a look at one of our previous issues – Personalized Nutrition: A continuous Innovation Trend in the Nutritional Business.

NutraBusiness Intel

Coca-Cola Amatil and The Coca-Cola Company make joint investment in Made Group

4 October 2018

Australian beverages manufacturer Coca-Cola Amatil and The Coca-Cola Company have jointly acquired a 45 per cent minority interest from Australia-based beverage company Made Group.
Made Group makes Cocobella (coconut water) Rokeby Farms (yogurt, milk and smoothies), Impressed (cold pressed juice), Schnobs (cold brewed coffee) and NutrientWater (enhanced water). This announcement follows Coca-Cola’s acquisition of Organic & Raw Trading Co, which makes the Mojo brand of naturally fermented, live culture, organic kombucha drinks.

Capri Sun buys majority stake in European beverage start-up

8 October 2018

The Capri Sun Group (Switzerland) acquired a majority stake of Austrian based drink-startup – All I Need, a producer of canned and bottles organic teas containing ingredients such as aronia, açaí and tumeric. This deal allows the Capri Sun Group to diversify its product portfolio beyond Capri-Sun Juice drink in a pouch and expand its presence in the healthy beverage market particularly in tea-based beverages.

PepsiCo acquires Health Warrior

31 October 2018

Health Warrior, Inc., is a U.S.-based company that makes plant-based products including nutrition bars and vegan protein powder made with superfoods such as chia, quinoa and pumpkin seeds. This acquisition by PepsiCo is the first investment under The PepsiCo HIVE. The transaction will expand PepsiCo’s nutrition portfolio to offer consumers additional options in an exciting growth category.

Dermapharm to acquire herbal supplier Euromed

18 November 2018

Dermapharm is a leading manufacturer of patent-free branded pharmaceuticals for selected markets in Germany. EUROMED S.A. is a Spanish based manufacturer of standardized herbal extracts and natural active ingredients for the pharmaceutical, nutraceutical and cosmetic industries. With the acquisition of EUROMED, Dermapharm will expand its expertise in herbal medicinal products. The deal is expected to be completed at the beginning of 2019.

Lesaffre acquires fermented ingredient developer Gnosis

18 November 2018

Lesaffre (France), a global key player in yeasts and fermentation has fully-acquired Gnosis, an Italian producer specialized in the development, production and sale of fermentation-derived ingredients for the food and nutraceutical industries. This acquisition, for an undisclosed fee, will enhancing Lesaffre presence in the nutritional ingredients sector.

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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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