• a&r News Digest

NEWS DIGEST by a&r | September 2020


We dedicate this September issue to Vitafoods virtual Expo, recent news around botanicals, and maximum levels for food supplements. Also, join us for our next webinar about food enzymes.


Our next webinar: “Food enzymes – A regulatory survival kit”

by our expert Dr. Johannes Klinger

Using food enzymes is well established in food production processes, such as baking or starch processing. During the last decades, with progress in protein engineering and biotechnology, they developed into key drivers of innovation in the food market.

Whether established or new, these biocatalysts have to be authorized by the European Commission according to Regulation (EC) 1331/2008. The requirements for the food enzymes are quite complex and call for strategic planning right from the start of the enzyme development, especially for enzymes derived from genetically modified microorganisms.

This webinar will give you a sound background on these topics and prepare you for your food enzyme application.

Date: 19th of November
Time: 3 pm CET

Register now for free

Regulatory News

a&r at Vitafoods Virtual Expo

Earlier this month, we participated in Vitafoods Virtual Expo, one of the main and most awaited virtual events connecting the nutraceutical, supplement, and functional food industries. During the show, we had the opportunity to showcase some of our top services:

Weight managementNovel foods & new food improvement agentsMedical devicesInnovation in infant nutritionTargeting immunity
Claims on natural health productsStrategic ConsultingClinical researchClinical trials in COVID-19 timesBotanicals

Visitors had the opportunity to learn more about our service portfolio and to contact our experts in a variety of regulatory and clinical topics. We were delighted to connect with you and to learn more about your interest in research services – be it in regulatory affairs or clinical research.

Apart from connecting with clients, we also had the opportunity to learn more and participate with the different micro-communities available at the show from probiotics to botanicals. Our Director of Business Development and Strategic Innovation, Dr. Inês Rocha, hosted one of the show’s innovations tours about immune health. If you did not have the chance to listen to the podcast, we give you a sneak peek of what was discussed below.

What are the three biggest considerations for brands in the nutraceutical space looking to focus on the immune health segment?

With the COVID-19 pandemic dominating the news, consumers’ focus on health and well-being is even stronger. According to the Nutrition Business Journal, immunity-specific supplement sales are expected to increase by over 50% this year, surpassing $5 billion in sales. Also, consumers’ perspective is changing not only towards convenience but also towards protection and support. So, the increasing demand for products offering immune health benefits is one of the biggest considerations for brands to focus on in this segment.

Other considerations are nutrition and holistic approaches to support the immune system as well as the increasing evidence around the microbiome and its role in immune health. Thus, consumers are seeing the value of prevention and the importance of having an optimal micronutrient intake in current times. As well as the link between digestive and immune health via microbiome, probiotics have been seen to have a positive effect on digestive health, but their benefits for supporting a healthy immune system are becoming more widely recognized.

What are some of the more unique ingredients and formulations addressing immune health that you’ve seen? 

Due to the current spread of COVID-19, consumers are searching for ways to support their immune health. So even well-known ingredients such as vitamin C and D, zinc, probiotics and botanicals (e.g. Echinacea) are gaining traction.

Is immune health relevant to you? Are you looking for regulatory, product development or claims strategy support? Or do want to know more about interesting innovative ingredients, new products, or trendy delivery formats, then get in touch. We would be happy to support you.

Quality requirements, botanicals, and upper limits for vitamins and minerals in food supplements – an update

During Vitafoods Virtual Expo we had the opportunity to hear Dr Patrick Coppens from Food Supplements Europe talk about several aspects of interest for the food supplement industry.

Food supplements have to comply with specific hygiene rules under the EU food legislation, but the hygiene legislation does not contain much specific information for food supplements. Therefore, Food Supplement Europe has developed several quality guidance documents to support companies with applying GMP rules for food supplements. The developed guidance covers general quality requirements for food supplements but also includes guidance specific for botanical preparations. To have access to these guidelines please click here.

Quality is also linked to a large extent to contaminants, thus the EU regulation 1881/2006 on contaminants applies also to food supplements. In this respect, some compounds have set maximum levels for food supplements such as for citrinin, lead, and polycyclic aromatic hydrocarbons. Currently under discussion is the set of maximum levels for pyrrolidine alkaloids in plants. This will be a very challenging aspect as it will affect current practices. This change will impact the supply chain from growers to collectors of plants. To help companies prepare for that legislation, new guidance – Guidelines and recommendations to reduce the presence of pyrrolizidine alkaloids in food supplements – was set up to support companies with what they have to do throughout the supply chain to ensure that they can meet the low pyrrolizidine alkaloids limits that will come in 2 years.

When it comes to botanicals, the Commission is showing engagement to the harmonization of plants including the safety aspects as concluded by the REFIT program (for more information read our June issue. In parallel, safety discussions at the Commission level regarding the plants allowed to be used in food supplements continue under article 8 of EU 1924/2006 regulation (Part A: Prohibition, Part B: Allowed under specific conditions and Part C: Scrutiny), where the Commission assesses the safety of plants. For example, we have the case of Ephedra where a decision was taken to forbid/ban its use in food supplements in the EU. Ephedra is now included in List A. Current safety discussions involve hydroxyanthracene derivatives (compounds present in e.g. Allo, Rhubarb, Senna), catechins from green tea, and monacolin K (from Red yeast rice), where a decision is pending. Also, alpha-lipoid acid is under assessment.

Concerning maximum levels, there is no harmonization between the Member States for vitamins and minerals in food supplements. This leads to a barrier in trade which in most cases leads also to mutual recognition for products being refused. Thus, Member States and industry have requested the Commission to start work on the harmonization of maximum levels. This would allow consumers to access the same products in all Members States. This task is now on the agenda for the Commission.

Our team of experts is following these topics very closely, as this will greatly impact the food supplement industry in years to come. If you need support, please get in touch with us.

NutraBusiness Intel

DuPont and P&G enter research collaboration in next generation probiotics

The DuPont Human Microbiome Venture announced a research partnership with the Procter & Gamble Company (P&G), focusing on the discovery and development of innovative next generation probiotics for human health. This partnership aims to accelerate the development and commercialization of innovative next generation probiotics, initially to be used in dietary supplements. Both companies have been conducting extensive research on human commensals to help address metabolic health issues in humans.

21.09.2020 · Source

Chr. Hansen acquires Jennewein Biotechnologie GmbH

Chr. Hansen has entered into an agreement to acquire all of the shares of Jennewein Biotechnologie GmbH, a leading company in Human Milk Oligosaccharides (HMO) market. The acquisition will extend and strengthen Chr. Hansen’s microbial and fermentation technology platforms.

22.09.2020 · Source

Daring Foods raised $8,000,000 in Series A funding

Daring Foods, a startup company based in Los Angeles and offering alternatives in the form of plant-based chicken made from five non-genetically modified ingredients has announced the completion of a Series A funding round of $ 8 million. This was led by Maveron LLC, a venture capital firm that invests in early-stage consumer brands. Other investors include GoodFriends, Stray Dog Capital, Palm Tree Crew Investments, and private investors like Mike Smith (CFO of Stitch Fix) and Brian Swette (former chairman of Burger King).

22.09.20202 · Source & Source

Your experts

Irene Wohlfahrt
Irene WohlfahrtSenior Consultant
Dr. Inês Rocha
Dr. Inês RochaDirector of Business Development and Strategic Innovation

Since a&r was founded, our purpose has been to act as your innovation experts for natural health products.

Within the consumer health care space, a&r is one of the leading consultancies and clinical research organizations with a strong focus on natural health products. For more than two decades we have been supporting our clients with scientific, regulatory, and clinical expertise.

With experience, enthusiasm and strong result orientation we apply our core competences: the compilation of dossiers for market compliance in Europe and the performance of clinical studies according to local and international requirements.

We help our customers in the design and implementation of future-oriented innovation strategies in their target markets.

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