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NEWS DIGEST by a&r | February 2020


We dedicate this February issue to the recent updates regarding EFSA’s Food Consumption Database and the German Stoffliste, and to BfR’s opinion on red yeast rice in food supplements. Also, read the latest news on CBD space and join us for our next free webinar on new protein sources.


Invitation to a&r’s Webinar series

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

The protein revolution – Regulatory considerations
by our expert Dr. Steffi Dudek 

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

Save the date! More information will follow soon

Regulatory News

New surveys boost EFSA’s Food Consumption Database

This month, EFSA announced that it has expanded its food consumption database with a new batch of data collected under the EU Menu project. The new release includes nine additional dietary surveys carried out in six countries – Austria, Belgium, Cyprus, Greece, the Netherlands, and Slovenia. The food consumption surveys provide new information in all age groups covered by the EU Menu – infants, toddlers, children, adolescents, adults, the elderly, and special groups. Also, the statistics are broken down by gender.

The food consumption database plays a key role in the evaluation of the risks related to possible hazards in food, allowing estimates of consumers’ exposure to such hazards; a fundamental step in the risk assessment process.

BVL opens calls for its revised version of the “Stoffliste” (German list of botanicals)

This month, the German BVL (Federal Office of Consumer Protection and Food Safety) has published a draft version of the 2ndedition of its botanical Stoffliste. The Stoffliste is the German equivalent to other EU country specific Plant Lists.

The substance lists are intended to make it easier for food business operators (and surveillance authorities) to classify plant substances with regard to their use as food or food ingredients, and thus represent a recommendation regarding the marketability of substances as food. The lists have been elaborated with support from the Austrian and Swiss authorities and are currently open for public consultation.

These lists can be downloaded in three Excel Annexes (2 updated lists of “plants and plant parts” (A-K and L-Z) and 1 list of mushrooms (A-Z).

Interested parties now have the opportunity to comment on the lists before they are published in their final version.

The BfR’s “no go” to Red Yeast Rice as food supplement

Food supplements containing red yeast rice (in various quantities) are marketed in the EU. In 2018, the EU Commission commissioned a safety assessment of monacolin K in food supplements from the European Food Safety Authority (EFSA). This EFSA report was unable to identify a dietary intake of monacolins that does not give rise to concerns about harmful effects to health.

In a recent opinion from the German Federal Institute for Risk Assessment (BfR), the BfR does not recommend the consumption of food supplements based on red yeast rice due to serious questions about their safety. The Institute advises that such products should only be taken after medical consultation or under medical supervision. This is in line with BfR’s previous assessment from 2010 where the institute assessed the health implications of a red yeast rice product in tablet form that provided a daily dose of 3 mg of monacolin K, among other ingredients. BfR concluded that this product should not be placed on the market in Germany on health protection grounds and because of serious health risks.

At European level, the Commission is still reflecting how to regulate products containing red yeast rice.

Cannabidiol (CBD) regulatory environment in Europe and UK

CBD products are widely available on the European market but are not properly authorized as CBD is considered a novel food. Any novel food requires an authorization by the European Commission, which is preceded by a thorough safety evaluation by EFSA. Currently, three CBD applications have been submitted to the EU Commission. Apparently, EFSA did not yet initiate the formal evaluation procedure (status February 2020).

In February, the Irish food safety authority (FSA) has issued a recall for various CBD foods and food supplements which contained unsafe levels of delta‐9‐tetrahydrocannabinol (THC) based on EFSA’s acute reference dose. For the full list of the recall batches, please click here.
Food businesses, including online retailers, currently selling the implicated batches of these CBD products must immediately remove them from the market. Moreover, consumers should not purchase or consume any of the implicated batches.

In Germany, a higher court ruled that CBD is considered novel food following an appeal against the decision of the Düsseldorf Administrative Court of September 27, 2019.
This decision is now final and confirms the decision made by the previous court.

Meanwhile in the UK, the Food Standards Agency (FSA) has set the deadline of 31 March 2021 for CBD food business operators to provide more information about their products (safety and content). After that date, only products that have submitted valid novel food authorization applications will be allowed to remain on the market.
In addition, the agency advises vulnerable groups (pregnant, breastfeeding or people taking any medication) not to consume CBD products. For healthy adults, FSA recommends no more than 70 mg a day (about 28 drops of 5 % CBD) unless under medical direction.
As a response, the Cannabis Trades Association (CTA) states that although they do not agree in full with all that is being proposed, CTA believe it is a positive step towards ensuring consumer safety and that CBD will be on the shelves for many years to come.

If you would like to speak to our Novel Food experts get in touch (business@a-r.com). Our team can support you.

Stricter infant formula marketing rules in the EU from 22 February 2020

Infant formulas and follow-up formulas are strictly regulated in Europe. From 22 February 2020, all infant formulas, follow-on formulas (EU Delegated Regulation 2016/127) as well as infant food for special medical purposes (EU Delegated Regulation 2016/128) must comply with regulation changes. The only exception is for infant formula manufactured from protein hydrolysates, which must be compliant by 22 February 2021.

The changes refer to updated information on product composition (new minimum and maximum nutrient levels), new labelling requirements which will affect the presentation of the nutritional table and ingredients list (e.g. unit changes for some nutrients; re-labelling of some nutrients, e.g. folic acid will be listed as folate), and the communication to consumers will adhere to claim restriction, meaning no nutrition and health claims are permitted on infant formula, follow-on formula, or infant food for special medical purposes formulations. The only nutrition claims permitted on infant formula are ‘Contains DHA’ and ‘Lactose only’/‘Lactose-free’ where applicable.

If you want to read more about this topic, in please click here.

Meet us at 2nd Gut Health Summit

The 2nd Gut Health Summit will focus on the market perspectives for probiotics and prebiotics with three main discussion sessions reviewing science, claims, regulatory topics, access to market, and consumer communication.

Our Head of Consulting & Strategic Innovation, Dr. Heike Stier, will be attending the event on 17th March in Brussels, Belgium, and will be giving a presentation on “Which Science is Needed to Obtain Pre- or Probiotics Claims in the EU?”

If you would like to meet her and discuss your next project please get in touch (business@a-r.com).

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.

NutraBusiness Intel

Nestlé Health Science is to form a partnership with Valbiotis

Nestlé Health Science has signed a strategic partnership with Valbiotis, a research and development company committed to scientific innovation for preventing and combating metabolic diseases, for the development and commercialization of an innovative and patented product to reduce the risk of developing Type 2 Diabetes. TOTUM-63 is a combination of 5 plant extracts specifically designed to reduce the risk of developing Type 2 Diabetes in prediabetic subjects.

5 February 2020 • Source

DuPont Nutrition & Biosciences Enters into Collaboration with Microbiome Specialist MRM Health

DuPont Nutrition & Biosciences (DuPont) announced a new collaboration with the MRM Health NV (MRM Health), a biopharmaceutical company focused on the discovery and development of innovative therapeutics based on the human microbiome. DuPont and MRM Health will join forces to tackle a range of metabolic diseases, in which the proprietary MRM Health technology platform and some selected DuPont strains will be combined to develop novel therapeutics based on live bacterial strain combinations.

19 February 2020 • Source

SkinBioTherapeutics signs agreement with Winclove Probiotics to develop a psoriasis food supplement

SkinBioTherapeutics plc, a life science company focused on skin health, has signed a development agreement with “Winclove Probiotics B.V.” to design and developm a probiotic blend that addresses the symptoms associated with psoriasis (a skin condition). This blend will be developed into a probiotic food supplement which will be called AxisBiotix™.

19 February 2020 • Source

DSM to acquire Glycom to accelerate growth in infant nutrition

Royal DSM, a global science-based company in the field of nutrition, health, and sustainable living, has reached an agreement to acquire Danish-based Human Milk Oligosaccharide (HMO) supplier Glycom in a €765 million deal. HMOs are a complex group of oligosaccharides exclusively found in human breast milk. They act as prebiotics in infants, helping to develop the desired microbial flora by serving as feed for the good bacteria in the intestine.

21 February 2020 • Source

Stada acquires 15 consumer brands from GSK

German based company, Stada AG, is strengthening its consumer healthcare presence in Europe by acquiring fifteen well-established consumer healthcare brands from GlaxoSmithKline’s (GSK). The portfolio includes cold & flu, pain and skincare brands such as Venoruton, Coldrex and Cetebe.

24 February 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