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NEWS DIGEST by a&r | March 2020


We dedicate this March issue to the possibility to postpone the date of the MDR implementation, our services during COVID 19, recent EFSA health claim opinions, and the proposed ban of hydroxyanthracene derivatives in food. Also, join us for our next free webinar about the protein revolution and get a sneak peek of a&r virtual trade show event scheduled in May.


Invitation to a&r’s Webinar series

We are happy to invite you to our next free webinar of 2020!

by our expert Dr. Steffi Dudek

The food industry is currently experiencing a true revolution – the development of new protein sources. The key driver of this revolutions are ecological and economical necessities, the increasing consumer demand for sustainability and the rise of veganism and vegetarism. Also, consumer’s acceptance of unconventional, untraditional protein sources has evolved.

Proteins from seeds, leaves, insects, fungi and algae are used to replace ’classical’ food protein sources or are textured in ways to generate completely new culinary experiences. Microorganism are taught to synthesise animal proteins, yeasts transform waste streams of food production into new food proteins, yeast protein make plant burgers look like beef, and sooner or later, cell-based meat will be mainstream.

The ambitions and expectations towards these innovations are high. But although the nutrient ‘protein’ seems to be such a commonplace, not all novel proteins or protein sources automatically qualify as food.

If this question could affect your business, we invite you to join our next webinar, where we will explain when newly developed food proteins might fall under the Novel Food Regulation, and how to best integrate a necessary novel food application into your development process.

Dr. Steffi Dudek coordinates novel food applications in the Consulting & Strategic Innovation team at analyze & realize.

Date: 30th of April 2020
Time: 15:00 – 15:45 (30 min talk and 15 min Q&A)


Regulatory News

European Commission to propose postponement of MDR implementation

On 25 March 2020, the EU Commission announced that it is working on a proposal to postpone the date of application of the Medical Device Regulation (MDR) for one year. The proposal is expected to be submitted in early April. The Commission is asking the Parliament and Council to adopt it quickly as the deadline for entry into force is the end of May.

This decision will relieve pressure from national authorities, notified bodies, manufacturers, and other actors and will allow them to fully focus on urgent priorities related to the coronavirus crisis.

However, please bear in mind that this is still a plan of the Commission and not yet an adopted amendment. Be prepared for all scenarios.
What should you do? Independent of the outcome of this proposal, we advise our clients to keep working on their product dossiers. Time will still be short!

If you need regulatory and/or clinical support for your substance-base medical device(s), then get in touch. We can support you in this journey.

COVID-19 and a&r’s services

The COVID-19 pandemic is causing global challenges not only to us as individuals but also to the global economy.

Following WHO and German authorities’ recommendations and a&r´s business contingency policy, a&r has implemented a well structured home office work regulation for most its colleagues.

Our teams are working remotely, and we reassure you that we are here for you. As always in the last 20 years you can rely on the experts of a&r as if these challenging times would just be „business as usual“.

Please drop us a line, if you need regulatory and or clinical support or have a burning question.

Make your contribution. Stay at home! Stay safe!

Three negative opinions on 13.5 health claims by EFSA

In the first trimester for 2020, EFSA has published three opinions for the scientific substantiation of article 13.5 health claims. They were for:

If you need support with your claim application and you are planning a clinical trial, our experts can support you with collecting the required scientific evidence for an EFSA conform health claim application.

EU Commission publishes draft regulation banning the use of hydroxyanthracene derivatives (such as aloe extracts) in foods

On March 4, the EU Commission published a draft implementing regulation to restrict the use of hydroxyanthracene derivatives in food. With this amendment, the following substances would be considered as prohibited substances in food:

  • Aloe-Emodin
  • Emodin
  • Danthron
  • Hydroxyanthracene derivative (containing aloe extracts)

At the same time, Rheum and Cassia and Rhamnus extracts in food would be placed under Community scrutiny. This means that food business operators, or any other interested parties, may at any time submit for evaluation scientific data demonstrating the safety of the substance.

The draft implementing regulation is open for feedback until 22 of April 2020 (midnight Brussels time). Stakeholders are invited to contribute with their comments. If you want to contribute, please click here.

The reason for this decision from the Commission is the result from EFSA’s scientific opinion on the possible harmful effects associated with the consumption of foods containing hydroxyanthracene derivatives and preparations thereof, for example, in food supplements. In 2017, the EFSA Panel noted proof of genotoxicity of the hydroxyanthracene-derivates aloe-emodin and emodin and danthron and that no safe intake level could be established. Based on this, the Commission plans to prohibit these substances in food.

Spanish food authority AESAN opens public database for food supplements, foods for specific population groups and natural mineral waters marketed in Spain

At the beginning of the month, the Spanish Agency for Food Safety and Nutrition (AESAN) made available an online database that lists the food supplements and foods for specific population groups which have been notified in Spain, and in accordance with their specific legal framework.

To access this database, click here (in Spanish).

This information was previously only accessible by the Spanish competent authorities. This action aims to increase transparency in this sector. Nevertheless, responsibility for the regulatory compliance of the products listed in this database rests with the food business operator. You can read more about it here.

a&r virtual trade show event

In light of the ongoing COVID-19 health situation, several conferences and trade shows had to be cancelled or postponed. Nonetheless, these events are of great relevance to us as they provide a singular physical space for our experts to engage in fruitful discussions with our existing and/or new clients.

Despite the current situation, a&r would like to engage with stakeholders from health and nutrition industries and thus is planning to host a two-day free virtual nutraceutical event in mid-May.
The event will include among other things:

  • free webinars given by our experts on regulatory and clinical research topics
  • run 15-minutes virtual consultation slots with our experts (pre-booking required)

Our goal is to share our experience and passion to maximize the value of your products and serving your consumers’ needs.

Be prepared to join us in May! More detailed information about this event will follow soon.

NutraBusiness Intel

Stratum Nutrition® announces distribution agreement with 3i Solutions

Stratum Nutrition®, a global natural supplement and food ingredients company, just signed a distribution agreement with 3i Solutions (a dispersion technology specialist) for eggshell and eggshell membrane wellness ingredients. This alliance adds strategic value for both companies within the dietary supplement marketplace.

2 March 2020 • Source

AFT sees increase demand of Vitamin C product as a result of COVID-19

New Zealand based company, AFT Pharmaceuticals, is experiencing strong demand for a number of its products following the Covid-19 outbreak including Vitamin C Lipo-sachets®.

23 March 2020 • Source

Probi and Viva5 joint venture to target niche probiotic markets

Probi, a Swedish based probiotic company, enters a strategic joint venture with health and wellness company Viva5 Group (USA) to co-develop consumer friendly probiotic products (novel probiotic ingredients and technologies) in areas such as functional food, beverages and pet health. Viva5 Group and Probi will own 51 % and 49 % share, respectively, and will have equal representation on the Board of Directors. Probi will have an option to acquire the share majority of the company at a later stage.

24 March 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