We dedicate this month’s issue to a&r at Vitafoods Asia, a new THMP product for female libido, news on FSMPs regulation in Germany, and a soon-to-be-ending public consultation by the EU Commission on the Mutual Recognition Regulation.

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News

a&r at Vitafoods Asia – Afterparty

During this two-day event, there were great opportunities for networking and gaining access to the latest ingredients and raw materials showcase in the Asia Pacific nutraceuticals market.

The Tasting Bar is one or the side attractions of the exhibition. There, visitors have the opportunity to have a sensorial experience of the latest functional foods and beverages. This year, winners were Cosmax Bio’s pomegranate concentrate jelly and Chemical Resources (CHERESO) with Grecobe a green coffee bean extract, in the categories best tasting food and best tasting beverage, respectively.

As mentioned in our previous issue, a&r was present with three different talks: Asian market – Opportunities for Growth (Dr. Volker Spitzer); Innovation and Best Practice in Alternative Delivery Options (Dr. Volker Spitzer); Access to the EU Market (Dr. Iris Hardewig). On request, we can share our presentations with you (click here).

a&r comments: Great opportunity to reach out the Asia Pacific market. After 6 consecutive years being hosted in Hong Kong, Vitafood Asia will be moving to Singapore in 2017.

product

New THMP for Women

Remisens®, an herbal product targeted at reviving the failing female libido, was launched in Germany on July 1, 2016.

Turnera diffusa, traditionally used by the Maya against dizziness and imbalance, was first described as an aphrodisiac in 1699 by a Spanish missionary, who also gave it the name Damiana. In the USA, a Damiana tincture was marketed as early as in 1874 and is described in the first edition of the “National Formulary” published in 1888. The first European mention of the plant dates back to a 1934 edition of the British Pharmaceutical Codes.

This long tradition of Damiana as a sexual enhancer is reflected in the fact that Remisens® is registered as a Traditional Herbal Medicinal Product (THMP) in Germany. This category requires 15 years of marketing tradition in the EU territory, or 30 years outside of it, in order to receive marketing authorization.

Schaper & Brümmer claim Remisens® to be the first herbal drug for treatment of failing libido in women.

a&r comments: Products targeting female libido, compared to their “male” counterparts, are few and far between. This is a welcome addition and an effective usage of the THMP category.

regulation

BVL and BfArM position paper on FSMP – Characterization of Food for Special Medical Purpose (balanced diets)

The BVL (Federal Office of Consumer Protection and Food Safety) and the BfArM (Federal Institute for Drugs and Medical Devices) compiled a position paper, which will be the basis for future assessments of FSMP products (Food for Special Medical Purposes). The document outlines the legal basis of this food category with a focus on the demarcation of FSMPs and drugs.

Seven assessment criteria are defined, enabling an objective and comprehensive classification of a product as a FSMP. All these criteria were already documented in the previous regulation, but until now, German authorities have interpreted them with great tolerance. This may change in the future:

As a general term of reference, consumers of FSMP are a specific group of patients with a) a limited, impaired, or disturbed capacity to take, digest, absorb, metabolize, or excrete ordinary food or certain nutrients contained therein, or metabolites or b) patients “with other medically-determined nutrient requirements“. The position paper makes it clear that there must be a causal relationship between “other medically-determined nutrient requirement” and the disease, e.g. an increased salt requirement for patients suffering from cystic fibrosis, because of increased salt excretion. A requirement for omega-3 fatty acids for patients with inflammatory joint disease will no longer be accepted according to the position paper.

Another point that will be handled in a more restrictive way in the future concerns the subsidiarity clause. It requires that the effects of that FSMP cannot be reached by modification of the common nutrition including food supplements. For example, for people suffering from lactose intolerance or from hyperlipidaemia, a modification of the nutrition can be sufficient and FSMPs may not be required.

a&r comments: The position paper of the BVL/BfArM provides more transparency concerning the assessment criteria for FSMPs in Germany. Important to note that BVL/BfArM will evaluate FSMPs based on the above mentioned criteria from now and will not wait until 2019, when the new delegated acts come into force. It remains to be seen how the regional supervisory bodies will deal with already marketed products. If you are interested in more specific information about the new approach taken by BVL/BfArM, please contact us!

Hot topic ending soon!

Public consultation on Mutual Recognition by the European Commission ends in September

A public consultation by the European Commission on the possible revision of the Mutual Recognition Regulation (EC) No 764/2008 is ongoing until the 30th September 2016. Mutual Recognition is a principle established to ensure free movement of goods in the European Union. No harmonized rules exist at the European level, thus when a product is lawfully sold in one EU country, it should be able to be sold in another EU country without having to adapt to national technical rules. However, the right of marketing the product in another EU country can be refused when the EU country of destination has justified diverging product requirements. The Mutual Recognition Regulation (No 764/2008) establishes several procedural frameworks to both businesses and national authorities. This public consultation consists of an online questionnaire that is available in all the official EU languages and seeks the view of all interested parties on three major points: the principle and possible shortcomings of the Mutual Recognition Regulation, its functioning, and possible options for its revision.

a&r comments: The application of the Mutual Recognition Regulation, laid down in (EC) No 764/2008, turned out to be not optimal, resulting in loss of market opportunities and unnecessary costs for businesses, and a lack of choices for consumers on the national markets. This principle may also apply to food supplements where the harmonized EU regulations are complemented by provisions on a national level, leading to unnecessary hurdles in the free trade of goods.

If your business was affected by regulation (EC) No 764/2008, please use your voice to help improve current European legislation and contribute to this public consultation. It will be available until the end of September. For further information, please use the link provided above.

analyze realize news digest july 2016

5th Supplement Claims workshop – 30 September 2016, Brussels

Supplement claims

SupplySide West – 4-8 October 2016, Las Vegas

Supply Side West

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.

Don’t hesitate to contact us: newsletter@a-r.com