a&r’s News Digest – We dedicate this month’s issue to borderline cases for substance-based medical devices, novel food authorization for triple root extract, corrections to the Union List of Novel Foods and proof of tradition after UK’s withdrawal from the Union.


Regulatory News

Borderline cases of substance based medical devices

Borderline cases in medical devices are considered to be those where it is not clear from the outset whether a given product is or is not a medical device. The European Commission released recently an update of the manual on borderline cases. Despite the fact that this is not legally binding, there is a high risk of similar product being challenged once they have been classified as non-medical device in the manual. However, only the European Court of Justice (ECJ) can provide an authoritative interpretation of Community law.

An example of these borderline cases is D-mannose. D-mannose was introduced in the EU market in 2015 as a medical device Class IIa for the prevention of urinary tract infections (UTIs). However, based on the scientific data available, the interaction between D-mannose and FimH (a cellular constituent of the fimbria of Escherichia coli present within the user’s body) is due to a pharmacological mode of action and not by a mechanical or physical action. Escherichia coli is the main cause of UTIs. Thus, medical devices containing D-mannose do not meet the definition of a medical device and should, therefore, not be marketed in this category.

Another interesting example included in this manual is mineral salt (zeolite), which is used in suspension formulation of medical device products intended to reduce the effect of alcohol. This product is to be taken before the consumption of alcohol with the purpose of reducing the blood ethanol content. According to the manufacturer, the product is a medical device because it prevents and reduces the risk of developing diseases such as hepatic cirrhosis, arterial hypertension, or ischemic/ haemorrhagic ictus by physically binding ethanol. However, reducing the absorption of ethylic alcohol in the blood is not considered a medical purpose. Thus, this product does not fit the definition of medical device, according to Article 1.2 of Directive 93/42/EEC, and thus should not be marketed as such.

Do you need a gap analysis to align with the New Medical Device Regulation (MDR) for your product? a&r has experience to assist medical device companies to update their Technical Documentation.

We will assist you with a fast and creative solution to bring or keep your product successfully on the market. Meet our experts at Vitafoods. Get in touch today!

Triple combination herbal extract gains novel food status

An extract of three herbal roots, Cynanchum wilfordii, Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai (EstroG -100™) just received a novel food authorization under Regulation (EU) 2015/2283 (21st March 2018). This novel food ingredient can be used in food supplements intended for post-menopausal women.

Prior to the authorization, there was a safety assessment by EFSA that concluded that the extract was considered safe when added to food supplements at a maximum daily dose of 175 mg, which corresponds to the safe level of intake for an adult person with a default body weight of 70 kg.

This is the first time that a triple combination herbal extract gained approval as a novel food. Important to mention is that no health claim was yet approved.

Union List corrections

The Union List of Novel Foods, laid down in Commission Implementing Regulation (EU) 2017/2470, was updated (inclusion of last notifications). Some discrepancies between the Union List and the original authorizations as well typographical errors were corrected.

For more information, please check the following documents:

Proof of Tradition for THMP after UK’s withdrawal from the Union

Early this year, the European Medicines Agency provided some clarification related to the United Kingdom’s withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralized Procedure.

For the registration of traditional herbal medicinal products, a period of traditional use within the EU of at least 15 years has to be documented. Data on traditional use in the UK during the period of UK membership in the EU will be accepted also after UK withdrawal (Brexit).

NutraBusiness Intel

Probi signs agreement with Cilag on probiotc OTC product

23 March 2018

Probi, a Sweden-based probiotic company, signed a long-term agreement with pharma company Cilag GmbH International, a member of the Johnson & Johnson Family of Companies, for the development of a probiotic product.

Givaudan to acquire Naturex for approximately US$1.6 Billion

26 March 2018

Givaudan, a Swiss manufacturer of flavors and fragrances for the food, beverage and fragrance industries announced that it will acquire Naturex, a French manufacturer and marketer of plant-based specialty ingredients for the food, health and cosmetic industries, in a two-part deal. This acquisition will strengthen Givaudan’s portfolio of natural extracts and ingredients.

Nutrino raised $10 million investment to uncover trends based on personalized nutrition

10 April 2018

Nutrino, an Israelian nutrition data startup, announced the completion of Series A round of $8 million, bringing the total raised to $10 million. This investment will expand Nutrino’s services across the digital health sector, including food analytics and nutrition insights for people living with diabetes and further development of Nutrino’s comprehensive Food database. This platform allows manufacturers to track trends, test product ideas, and understand the competitive landscape.

Tespo raises $3.5M in Series A Funding Led by DSM Venturing

16 April 2018

Tespo, a health and wellness technology company which provides consumers with all-liquid dietary supplements through a countertop dispenser, just closed a deal with DSM Venturing in $3.5M as an investment in personalized, pill-free supplement innovation.

P&G acquires Merck’s Consumer Health Business for US$4.2 Billion (3.4 billion Euros)

19 April 2018

The German Merck’s unit includes vitamin brands such as Femibion, Neurobion, and Nasivin. This acquisition allows P&G to expand its portfolio of consumer healthcare products.

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Your experts

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.

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