a&r’s News Digest – We dedicate this month’s issue to regulatory news: cranberry not allowed as medical device; food suitable for vegans/vegetarians – joint position, new EFSA draft guidance open consultation and introduction to EndoPAT technology at a&r.


Cranberry based products no longer allowed as medical device

Cranberry products as MD are no longer a borderline issue. Late in May and more than one year later, the EU Regulatory Committee on Medical Devices voted in favor of the European Commission’s draft decision on the classification of cranberry products (the so called “Cranberry Decision”) which states that cranberry products which are intended to prevent or treat cystitis and that have a principal intended action based on proanthocyanidins (“PACs”) present in cranberry extract do not fall within the definition of medical devices (according to the “Medical Devices Directive” – Article 13(1)(d) of Directive 93/42/EEC). As a consequence, cranberry based product can no longer been marketed as a medical device.

The formal adoption and publication of the Cranberry Decision are expected sometime in the summer.

Food suitable for vegetarian and vegans – joint position to a legally binding definition

The FoodDrinkEurope, which represents the European food and drink industry, and the European vegan and vegetarian movement, as represented by its umbrella organisation European Vegetarian Union (EVU) have joint forces to propose a legally binding definition for the terms “food suitable for vegans” and “food suitable for vegetarians” for food labelling purposes in accordance with Regulation (EU) No. 1169/2011. Up until now there is no legal binding definition for these terms neither at EU nor at Member States level. Both organizations urge the European Commission to fulfill its obligation in this matter due to the increase interest and demand of this segment.

The proposed wording has the goal to meet the requirements of consumers interested in vegan and vegetarian products as well as those of manufacturers of such foods.

Italy set to put BelFrIt list of botanicals into law

After Belgium, Italy follows and notified to the European Commission with their new draft decree (2017/276/I) with the consolidated list of botanicals that will be allowed for use in food supplements – Decree regulating the use of vegetable substances and preparations in food supplements, replacing the Decree of the Minister for Health of 9 July 2012.
This decree still needs to be approved by the European commission and Members States (by 29 September). Following its approval Italy will join Belgium and officially publish the BELFRIT list. With this decree one single list of plants and one for mushrooms will apply.

During the transition period, food supplements that are placed in the market and comply with the previous decree will be allowed in the market until the end of the stock.

a&r comments: France will come next, the last country of the “BELFRIT” project. If you want to know more about the Belgium situation please read our article from March:https://www.a-r.com/new-regulations-for-novel-food-and-medical-devices/

Draft guidance for the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health

The European Food Safety Authority (EFSA) has asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to revise the guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health which was originally published in 2011. Now and after gathering information in relation to claimed effects, outcome variables and methods of measurement in the context of the scientific substantiation of health claims, a new updated guidance was drafted. Its aim is to help applicants in preparing and submitting their health claims for scientific evaluation. The updated opinion contains some more details on parameters related to cardiovascular health such as post-prandial lipid metabolism or aspects to be considered when measuring blood pressure or endothelial function.

EFSA is now inviting all the interested parties to provide their comments through a public consultation on the draft guidance.

a&r comments: Please contribute and submit your comments. To do so please use the link: http://www.efsa.europa.eu/en/consultations/call/170712.

You can submit your comments until the 3 September 2017.

Assessment of endothelial function by EndoPAT technology

By regulating homeostatic mechanisms, the vascular endothelium is the key modulator of blood vessel function. Impaired responses of the endothelial cells to vasodilatory stimuli are commonly termed “endothelial dysfunction”. This pathological state of the endothelium is associated with an early stage in the development of atherosclerosis and has been recognized as a link to cardiovascular disease risk factors and as a prognostic marker of future cardiovascular events.
A noninvasive method for evaluation of endothelial function is the assessment of peripheral artery tonometry (PAT). Established in recent years and patented as EndoPAT (Itamar Medical Ltd.), this technology is based on detection of the digital arterial pulse wave amplitude with the help of a plethysmographic device. EndoPAT evaluates the peripheral flow induced arterial dilation after provocation of reactive hyperemia in an operator-independent manner. The reactive hyperemia index can be calculated as the ratio of the mean pulse wave amplitude post deflation to the baseline pulse wave amplitude.

FDA approved EndoPAT for use as a diagnostic aid in patients with signs and symptoms of ischemic heart disease. The medical device further received CE certification in Europe as well as Shonin-approval by Japan’s Pharmaceutical and Medical devices Agency and CFDA-approval in China.

It has been successfully applied in diverse clinical trials with natural health products, e.g. for evaluation of the effects on endothelial function by supplementation with lycopenes1, or consumption of high-polyphenol dark chocolate2 and plant stanol esters3.

a&r has recently established EndoPAT in its own study site in Berlin.

a&r comment: This noninvasive and automated technology is a valuable tool for clinical evaluation of endothelial function that may provide supporting evidence for beneficial effects of (nutritional) heart health products.

1 Kim et al. Effects of lycopene supplementation on oxidative stress and markers of endothelial function in healthy men. Atherosclerosis (2011)
2 Nogueria et al. Consumption of high-polyphenol dark chocolate improves endothelial function in individuals with stage 1 hypertension and excess body weight. International Journal of Hypertension (2012)
3 Gylling et al. The effects of plant stanol ester consumption on arterial stiffness and endothelial function in adults: a randomised controlled clinical trial. BMC Cardiovascular Disorders 2013, 13:50

a&r has the pleasure to invite you to the second webinar of 2017.

Topic: Traditional herbal products: Is innovation possible?

Our expert Dr Iris Hardewig will present opportunities of innovation for herbal products. The main focus will be on traditional herbal products (THMPs), but also other product categories will be considered.

Date: 21th of September 2017 (Thursday)
Time: 15:00 – 15:45 (UTC/GMT +2) (30 min talk and 15 min Q&A)

Irene Wohlfahrt
Irene WohlfahrtSenior Consultant
Dr. Inês Rocha
Dr. Inês RochaScientific Consultant

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