Regulatory Seminar: CBD-based products in the EU
a&r experts are hosting a seminar on the current regulatory situation for cannabidiol-containing food products in the EU at the beginning of April in Berlin.
This will be an interactive seminar and we will provide you with an overview of the current regulatory challenges companies face regarding CBD-containing products in EU. We will explain the requirements for the submission of Novel Food applications for CBD in food/supplements and discuss under which conditions shared applications might be useful.
Participants will have the opportunity to discuss specific questions with our regulatory experts. A limited number of one-on-one meeting time slots are available before and after the workshop.
German evaluation of borderline products between Food – Drug and Food – Novel Food
Earlier this month (7th February 2019), the German “Joint expert commission BVL and BfArM for classification of substances” published several position papers on definitions of the terms: “nutrient”, “uptake”, “pharmacological action”, and “significance threshold”.
Interestingly, for the definition of nutrients, the German commission sticks to the classical definition covering only fat, protein, carbohydrates including fiber, as well as vitamins and minerals. This is highly relevant, as it may influence the acceptance of products in the category of Food for Special Medical Purposes (FSMPs). This product group is defined as intended for the dietary management of patients with a limited, impaired, or disturbed capacity to take, digest, absorb, metabolize or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements. The narrow definition of nutrients proposed by the German commission may suggest that only fat, protein, carbohydrates including fiber, as well as vitamins and minerals may be used in FSMPs, but no herbal extracts, probiotics, or other compounds with health benefits. If this is indeed the intention of the German Commission needs to be discussed.
Furthermore, the commission published three statements on the classification of curcumin extracts, synephrine, and ayurvedic products. According to the commission, there is no scientific evidence for a pharmacological action of curcumin, so that a classification as medicinal product is not required. However, for curcumin-based ingredients with an improved bioavailability, the available toxicological data is insufficient. The commission concluded that it has to be decided case-by-case whether these products require a safety assessment according to the Novel Food Regulation (EU) 2015/2283. A way forward for food manufacturers could be to show that the improved bioavailability of curcumin supplements is comparable to that in a natural food matrix (containing fats, pepper, and being micellized during gastro-intestinal passage), which has a long history of use before 1997.
The statements are open for public discussion until 7th March 2019. The deadline may be extended upon request.
News on EMA Monographs
The Herbal Medicinal Products Committee (HMPC) has finally published the monograph on Cynara cardunculus L. (syn. Cynara scolymus L.), folium (artichoke leaf). Updates to the posology (daily dose and single dose) for some artichoke leaf extracts were made.
The Committee (HMPC) also opened a public consultation (15th February 2019) on the draft revision of Rhamnus frangula L., cortex (Frangula bark) monograph, which was adopted in 2006 as a well-established herbal medicine for short-term use in cases of occasional constipation. The deadline for comments on this revision will end on 15th May 2019.
Additionally, the HMPC was now opened for public consultations for the periodic review of several herbal monographs (submission period: 15th February 2019 – 15th May 2019) and is now inviting all interested parties to submit any scientific data that the HMPC should consider for their evaluation:
Before submitting new data, the HMPC kindly asks the interested parties to carefully check the published ‘List of references supporting the assessment’ and ‘Overview of comments received during the public consultation’. This is to avoid the submission of data that was already evaluated on the initial assessment work. Please contribute!
Six new novel food ingredients approved (December 2018 to February 2019)
Since December last year, the European Commission approved six new novel foods which may be placed on the market within the Union under Regulation (EU) 2015/2283. Out of these six novel food approvals, three were notified according to Article 14 of (EU) 2015/2283 as traditional foods from non-EU countries, and the other three were applications according to Article 10 of (EU) 2015/2283 requesting the extension of the specification or the conditions of use.
The new traditional foods are:
The applications for the extension of the specifications or the conditions of use concerned are:
- Lipid extract from Antarctic Krill (Euphausia superba) by Aker BioMarine A/S (Norway). Extension was granted to address the gap in phospholipid content between ‘Antarctic Krill oil from Euphausia superba’ and ‘Antarctic Krill oil rich in phospholipids from Euphausia superba’. The specifications are now combined to ‘phospholipids content ≥ 35 % to < 60 %’.
- Schizochytrium sp. (microalgae) Oil by DSM Nutritional Products Europe. Extension of the conditions of use to fruit and vegetable purees is now granted with a maximum level of DHA of 100 mg/100 g.
- Allanblackia seed oil by Unilever NV/Unilever PLC. Extension of the conditions of use was granted to uses in mixtures of vegetable oils and milk and in yellow fat and cream-based spreads up to 30 % (w/w).
EFSA positive opinion on the safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283
The EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) has assessed the safety of the yeast biomass of Yarrowia lipolytica yeast biomass as a novel food pursuant to the Novel Food Regulation (EU) 2015/2283. In its assessment, the Panel concluded that the dried and heat-treated yeast biomass pose no health risks as a result of the its manufacturing process. Thus, no further toxicological data are needed and the yeast biomass of Yarrowia lipolytica is considered safe. You can have access to the full EFSA opinion here.
Success Story at a&r
Enzymatica AB announces positive outcome of ColdZyme® mouthspray clinical trial
A multicenter clinical trial with 400 participants conducted during the common cold season of 2018 has been successfully completed for the Swedish company Enzymatica AB to evaluate the use of ColdZyme® Mouth Spray in various assessments of common cold symptoms for proof of efficacy.
For more detailed information, please click here.
Common cold studies are one of a&r’s core competencies – please contact us if you are interested in a clinical trial e.g. to investigate the immune enhancing effect or symptom relief characteristics of your product in the upcoming common cold season 2019/2020. This is the right time to initiate such a project with us.
Like we did in previous issues, we now introduce to you another exciting company. We believe that there are products as well as ideas developed by creative and innovative companies that can be very inspiring and are worth spreading!
Ava, an ovulation tracking Bracelet
Previously overlooked, women’s health segment has been in the spotlight in recent years, with companies wanting to find innovative solutions to target this segment of the population.
The term Female technology or in short “Femtech” refers to software, diagnostics, products, or services that use technology (apps, wearables, and other technologies) to improve women’s health. It involves the use of digital devices as a way to motivate users to track and manage their health.
Femtech is becoming a big business. According to Frost & Sullivan, women will correspond to 50% of the global population as target consumers, and to a market potential of $50 billion by 2025. Moreover, women are increasingly playing an instrumental role across the healthcare sector not only as consumers, but also as decision makers, healthcare professionals, and caregivers (more information). Thus, companies (e.g. clinical diagnostics, bio-pharmaceuticals, and medical device) need to embrace this market opportunity.
Digitalization of this segment can go from finding solutions targeting reproductive health (e.g. fertility solutions), to pregnancy & nursing care (e.g. prenatal screening), pelvic & uterine healthcare (e.g. urogenital health) or general health and wellness (e.g. diagnostic tests).
An example of a startup company targeting women’s health is Ava. The company’s initial product consists of a sensor bracelet and an app that uses technology to detect a woman’s fertile window. Ava’s technology has been validated in several clinical trials.
Digital women’s health solutions such as Ava can be seen as stand-alone products, but they can also be an interesting solution to extend certain companies’ portfolios within the women’s health segment.
Sanofi joins digital health innovation hub
31 January 2019
The consumer healthcare business unit of Sanofi has made a partnership with Startup Creasphere. Creasphere is the first digital health innovation hub in Europe, where forward-thinking corporations and disruptive startups can meet and create meaningful engagements.
Dermapharm Expands International Herbals and Supplements Capacity with two Acquisitions
15 February 2019
Dermapharm AG, a German generics and OTC company has acquired Euromed alongside German company CFP Packaging GmbH. Euromed is a Spanish-based producer of standardized herbal extracts and natural active substances for the pharmaceutical, nutraceutical, food, and cosmetic industries. With these two acquisitions, Dermapharm boosts its international herbal medicines and food supplement presence and production capacity.
Teva out-licenses OTC and cosmetics portfolio to Trimb for Scandinavia
21 February 2019
Teva Pharmaceutical Industries Ltd., an Israeli based company, has out-licensed a portfolio of consumer health and cosmetic brands to Trimb Healthcare AB, to market across Scandinavia (Denmark, Norway, and Sweden).
Under this exclusive licensing agreement, Stockholm-based Trimb, gains access to a portfolio of established OTC brands such as Flux (oral-care line), Decubal and Apobase (skincare brand for dry and sensitive skin), Fludent (lozenges for caries), DailyCare (vitamin B12 dietary supplement range) and Lactocare (probiotic for digestive health). As part of the agreement, the Teva sales and marketing team overseeing these brands will join the Trimb organization.
Novelties in our MatchMaking Platform
Check out the newest addition to our licensing database! ID#76 is a Traditional Herbal Medicinal Product (THMP) for the symptomatic relief of cough associated with cold. It is a ready-to-market combination of well-known expectorants available as easy-to-swallow tablets.
To learn more about this business opportunity, contact our MatchMaking expert at firstname.lastname@example.org
Expand your portfolio with ID#78, a food supplement enabling Vitamin D to be delivered buccally/sublingually! Buccal/sublingual delivery not only allows fast absorption but also bypass the first-pass metabolism. Bioavailability is clinically confirmed.
If you‘re interested in this licensing/distribution opportunity, contact our MatchMaking expert at email@example.com