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
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 (firstname.lastname@example.org). Our team can support you.
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 (email@example.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.
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