We dedicate this September issue to the end of EFSA’s evaluation of Dietary Reference Values (DRVs) for macronutrients and two safety objections by EFSA for traditional foods from a third country.

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Regulatory News

End of a decade – EFSA ends update for DRVs of 34 nutrients

For the last 10 years, EFSA has been evaluating/updating the values for macronutrients such as proteins and carbohydrates, as well as 14 vitamins and 13 minerals. EFSA’s latest scientific opinion about dietary reference values (DRVs) was published this month, setting the DRVs for sodium and chloride. DRVs is an umbrella term for science-based nutrient reference values for the daily intake of healthy populations which include population reference intakes (PRIs), the average requirements (ARs), adequate intakes (AIs), and reference intake (RIs) ranges for macronutrients. These values indicate the amount of a nutrient which must be consumed on a regular basis to maintain health in an otherwise healthy individual (or population).

Based on this scientific opinion, EFSA experts concluded that 2.0 g of sodium per day is both safe and adequate for the adult population. The same value applies to pregnant and lactating women. When it comes to children, the safe sodium intake was adjusted for their respective energy requirements and growth factors. To read more about the dietary reference values for sodium, please click here.

Meanwhile, the dietary reference value for chloride for adults (as well as for children from 11 years of age) was set to be 3.1 g per day. This value is also safe for pregnant and lactating women. The EFSA panel considered that sodium chloride is the main source of chloride in European diets. For the full overview of the EFSA opinion on chloride, please click here.

Apart from EFSA’s DRV opinions published in the EFSA Journal, EFSA has also launched an easy tool – the DRV Finder – last year. The DRV Finder is an interactive tool that provides a quick and easy search of EFSA’s DRVs by population group or nutrient. It contains DRVs for water, fats, carbohydrates, dietary fiber, protein, and energy, as well as for vitamins and minerals. This tool allows nutritionists and other health professionals to make quick and easy calculations using EFSA’s dietary reference values. To have access to DRV Finder, click here.

Negative feedback from EFSA on the safety of leaf powder of Moringa stenopetala and of powder or juice concentrate of berries of Aristotelia chilensis

Following a notification of leaf powder of Moringa stenopetala as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283 (Novel Food Regulation), EFSA was asked by the European Commission whether there are safety objections to the notification. EFSA found, due to the lack of information regarding the quality and quantity of undesirable substances potentially present in the traditional food, that it cannot conclude whether or not the food may pose a risk for human consumption. Thus, EFSA raises safety objections to the placing on the market within the EU of leaf powder of Moringa stenopetala as a traditional food.

Similarly, and following a notification for powder of juice concentrate of Aristotelia chilensis as a traditional food from a third country, also pursuant to the Novel Food Regulation, EFSA pointed out the absence of quantitative information on the presence of alkaloids in the food, which might lead to exposure levels of concern for human health, should the presence of such alkaloids be confirmed. This again resulted in safety objections raised by EFSA to the placing on the EU markets of either powder or juice concentrate of berries of Aristotelia chilensis as a traditional food.

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NutraBusiness Intel

Columbia Care partners with Moeller on CBD-infused products

30 August 2019

Columbia Care Inc., a company with headquarters in Canada and with fully integrated operators in the global medical cannabis industry, has entered into an exclusive agreement with Moeller Pharma GmbH to develop a portfolio of proprietary, plant-based cannabinoid combination functional health and wellness products.

Source

DMK Group fully takes over joint venture DV Nutrition V.O.F.

5 September 2019

The DOC Kaas (part of DMK Group) and Volac have announced that they will bring their joint venture participation in DV Nutrition to an end as a result of their productive collaboration. Both parties have been producing whey protein and lactose-based ingredients since 2004. From now on, the DV Nutrition’s assets will become wholly owned by the DMK Group based in Hoogeveen (Netherlands). With this decision, both partners will be allowed to develop their businesses in different directions.

Source

Futura Signs Joint Venture Collaboration with CBDerma

10 September 2019

Futura Medical, a UK company focused in transdermal delivery with a proprietary transdermal technology (DermaSys®), has entered a joint venture collaboration with CBDerma™ to explore transdermal delivery of cannabidiol (CBD). All Intellectual Property will be jointly owned by both companies.

Source

Strides builds European presence with Fairmed

11 September 2019

With headquarters in India, Strides Pharma Science Limited (Formerly Strides Shasun Limited) acquired the majority stake in Swiss generics and OTC company Fairmed Healthcare for CHF2.2 million (USD2.2 million). With this acquisition, Stides strengthens its presence in Europe

Source

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Your experts

Irene Wohlfahrt
Irene WohlfahrtSenior Consultant
Dr. Inês Rocha
Dr. Inês RochaDirector of Business Development & Srategic Innovation

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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