a&r’s News Digest – We dedicate this January issue to cannabinoids being classified as novel food, and to the increase of the maximum levels for vitamin A in food supplements in France.


Tax relief for a&r French customers

We are glad to inform you that The French Ministry (Ministère de l’Education Nationale de l’Enseignement Supérieur et de la Recherche) has re-accredited a&r as an R&D company for the years 2019 – 2021.

Therefore, French a&r customers will be able to benefit from a tax relief (up to 30% of R&D expenses) on their project.

Regulatory News

Cannabinoids are considered Novel Food

The market of cannabidiol (CBD)-containing products has been booming in Europe, although the regulatory environment around these products was not well defined. More specifically, it was not clear whether extracts from leaves, flowers, and seeds could be used as or in foods. This led to a lot of uncertainties among manufacturers of cannabis products.

The European Commission has addressed these issues and recently updated the Novel Food Catalogue regarding Cannabis sativa L.Cannabidiol and Cannabinoids. The Novel Food Catalogue lists products of animal or plant origin and other substances and their Novel Food status, based on information provided by the EU Member States. It has to be stressed though, that the Novel Food Catalogue is not legally binding.

In the current version of the Novel Food Catalogue, “some products derived from the Cannabis sativa plant or plant parts such as seeds, seed oil, hemp seed flour, defatted hemp seed have a history of consumption in the EU and therefore, are not novel” but “extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as “novel”.

In other words, and according to the Novel Food Catalogue, more or less all products consisting of or containing hemp extracts from plant parts other than seeds are considered novel foods and require a novel food application. Other plant parts (like leaves) might only be considered as non-novel, if the history of use prior to May 1997 can be established and if not forbidden by national laws. Hemp seeds and hemp seed oil (which is free from CBD) are not considered Novel Food.
The implications of this decision for the CBD business are enormous, as many of the products already on the market might become illegal.

The pending novel food application for trans-cannabidiol only concerns food supplements and does not cover other food applications. No further information is publicly available on the status of this application or the exact composition of the extract. We will keep you posted about further developments.

France updates Vitamin A maximum levels in food supplements

Earlier this year, the French authority DGCCRF published a new update for maximum levels for vitamins and minerals in food supplements as well as warnings to populations at risk. When the quantity of a nutrient present in a daily dose exceeds the maximum level for this nutrient, the food supplement is considered to be detrimental to health within the meaning of Article 14 of Regulation (EC) No 178/2002. Nevertheless, if a FBO wishes to review one or more of the established values by the DGCCRF, he/she can prepare a technical file to demonstrate the safety of the proposed value and submitted for a scientific evaluation to the ANSES (l’Agence Nationale de Sécurité Sanitaire de l’Alimentation, de l’Environnement et du Travail).

New in this update is the increase of the maximum level of vitamin A (retinol) in food supplements in all target populations (general population, children 10 years old or younger, and children over 10 years old). For instance, for food supplements targeting the general population, the maximum level of vitamin A (as Retinol equivalent (RE)) increased from 800 μg RE to 1000 μg RE. In Belgium the maximum level for Vitamin A allowed in food supplements is slightly higher (1200 µg Vitamin A (RE)) while in Germany and according to the latest BfR’ recommendation, the maximum level of vitamin A in food supplements is only 200 μg RE.

Considering warnings to populations at risk, and since an excess of retinol is teratogenic, the intake of food supplements containing vitamin A is not recommended for pregnant women as well as women wishing to become pregnant. Moreover, as epidemiological studies have shown an association between hypervitaminosis A, osteoporosis, and hip fractures, the consumption of food supplements containing vitamin A is also not recommended for menopausal women. Menopausal women have a higher risk of osteoporosis and fracture. However, it remains in the responsibility of the food business operator to mention the risks on the product label.

No changes on maximum levels for minerals were identified. However, although the maximum level has not been changed, the French Authority discourages prolonged consumption of food supplements containing manganese.

To have access to the full document please click here.

Innovation Corner

As 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!

YO – Home Sperm Test

Men’s health and in particular men’s fertility has been on the spotlight in recent years. With couples choosing to have children later in life, fertility is becoming a hot topic. In most western countries, couples are having their first child in their 30s, only after finding the “right” partner and starting their carriers. So, the actual window for having a child is progressively narrowing. By postponing parenthood, couples are likely to experience more problems while trying to get pregnant.

In earlier times, no one would talk openly about infertility but now talking about fertility problems is becoming more widespread, mainly among women. Infertility was very much associated with women but in reality, more than half of all cases of infertility may be related to male factors associated with sperm quality (such as sperm count; sperm motility). Evidence suggests that sperm quality can be influenced by certain nutrients (e.g. selenium, zinc), which can then have a direct impact on sperm quality.

As with women, men have unique health needs and challenges, some of which can be addressed with food supplements. However, the food supplement market is a crowded space, and innovative solutions are in demand.

Digital health, through wearables, sensors and kits is expected to contribute to the growth of supplement sales, as consumers are becoming more invested in maintaining a healthier lifestyle. These digital tools can be used by consumers to monitor and measure personal health data.

The YO Home Sperm Test (Medical Electronic Systems, USA) is an FDA and CE approved, clinically validated, smartphone-based solution for testing motile sperm in a home, private setting. The YO kit and app uses a smartphone video camera to count sperm in real time and compares sperm count and motility to data from a global study conducted by the World Health Organization.

The YO home kit could be used by men to monitor the effects of food supplement on sperm quality parameters and thus men’s fertility. Companies that are able to support couples in their fertility monitoring in combination with fertility-based food supplements will have a stronger-hand on the market.

At the end, food supplement companies can take advantage of these type of innovative digital solutions to help consumers shape their individual health and nutrition plans, and also meeting the demand for personalized nutrition.

NutraBusiness Intel

GSK and Pfizer to combine consumer businesses

19 December 2018

GlaxoSmithKline Plc (GSK) and Pfizer Inc have agreed to combine their consumer healthcare businesses into a “world-leading” joint venture with combined annual sales of around GBP 9.8 billion (USD 12.7 billion), with the majority owned by the British company GSK.
According to GSK, this transaction provides a unique opportunity to accelerate GSK’s strategy and create substantial value for shareholders as well, as it lays foundation for separation of GSK to create two new UK-based global companies focused on Pharmaceuticals/Vaccines and Consumer Healthcare.

Italy’s Recordati acquires France’s Tonipharm

31 December 2018

Recordati announced the full acquisition of Tonipharm S.A.S., a France-based company in the self-medication market with over-the-counter (OTC) products. Tonipharm products under the umbrella brand Ginkor (OTC treatments based on ginkgo biloba) are very well-known products on the French market. This acquisition will allow Recordati to expand its portfolio of over-the-counter products in the French market. The financial terms of the deal were not disclosed.

Chr. Hansen Health & Nutrition shows solid growth driven by probiotics for infant formula

17 January 2019

Based in Denmark, Chr. Hansen A/S is a global bioscience company that develops natural solutions for the food, beverage, nutritional, pharmaceutical, and agricultural industries. The company has just reported a solid growth of 10% in the first three months of the financial year 2018/19, with Health and Nutrition delivering the strongest growth. This growth was driven by global demand for probiotics for infant formula in human health.

Novelties in our MatchMaking Platform

a&r MatchMaking Platform Iron Deficiency

Iron deficiency is the most common nutritional deficiency in the world. But most iron products are poorly absorbed and cause unpleasant, gastrointestinal side-effects. You would like to offer a novel, effective, but gentle iron form? We have just added one to a&r’s licensing database! ID#88 is clinically proven, patented, well absorbed, safe, and gut microbiome friendly. This is the next generation iron product and an upgrade to your portfolio. For more information, visit our MatchMaking Platform and get in touch at matchmaking@a-r.com

a&r MatchMaking Platform Kidney

An innovative synbiotic supporting kidney health just made it to our MatchMaking Platform. ID#77 is a blend of pre- and probiotics clinically proven to support healthy kidney function. With global patent protection, this food supplement is open for new business opportunities. Do you want to learn more about ID#77? Get in touch with us at: matchmaking@a-r.com. For further business opportunities visit the a&r MatchMaking Platform.

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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.

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