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#VFE19, EFSA opinon to probiotic health claim and ANSES warning

2019-05-02T17:45:26+02:00

a&r’s News Digest – We dedicate this April issue to Vitafoods, EFSA negative opinon to probiotic health claim, the recent ANSES warning on food supplement containing glucosamine and/or chondroitin sulfate in France. Also, recent innovations in the nutricosmetic space will be discussed.

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Meet us at Vitafoods Europe!

In just a few days we will be attending Vitafoods Europe in Geneva (7th – 9th of May). Vitafoods Europe is the place where the nutraceutical industry come together to create innovation, connect with business leaders and find effective solutions. We are extremely excited to attend this event and to have the opportunity to share our expertise as well as learn from others. If you are around, come and visit us at booth H130.

Don’t miss our expert’s presentation:

Innovation in Probiotics
May 7th (Tuesday) – 11:00 – 11:40
Probiotics Theatre
Dr. Iris Hardewig

Is it time for CBD supplements in the EU?
May 8th (Wednesday) – 15:20 – 15:50
Education Programme
Dr. Heike Stier

We are also Chairing one of the Educational Programme sessions, this year on Nutricosmetics:

Nutricosmetics: Eating for Beauty
Tuesday 7th May, 14:00 – 17:40
Chairing: Dr Inês Rocha, Scientific Consultant, and Dr. Iris Hardewig, Head of Consulting & Strategic Innovation

For more detailed information about this session and who is joining, please click here.
Meanwhile, if you would like to book a meeting with us beforehand, please get in touch.

Looking forward to meet you there!

Regulatory News

Probiotic health claim rejected by EFSA (negative opinion)

EFSA has again rejected the health claim (under article 14) related to Nutrimune and immune defence against pathogens in the gastrointestinal (GI) tract and upper respiratory tract (URT) from H.J. Heinz Supply Chain Europe B.V..

Nutrimune is a pasteurised cow’s skim milk fermented with Lactobacillus paracasei CBA L74. The claimed effect proposed by the applicant is “supports the immune system in defence against pathogens in the upper respiratory and gastrointestinal tract of young children” (aged 12–48 months old).

Despite the fact that the food/constituents and claim effect was sufficiently characterized, the evidence provided to stablish a cause and effect relationship between the consumption of Nutrimune and immune defence against pathogens in the GI and URT was still considered insufficient by the EFSA panel. The most important limitation of the application seemed to be the quality of one of the human studies, especially with respect to clinical trial methodology and planning.

Novel Food guidance by FSE

Earlier this year, Food Supplements Europe (FSE) released an update of the Novel Food Guideline from 2018 on how to verify the novel food status under the Novel Food Regulation (EU) 2015/2283 (NFR), which considers the developments and experiences after 1 year of application of this regulation. The main goal of this guidance document is to help food business operators understand the scope of the new NFR and the principles to apply when verifying the status of their food products or food ingredients. Examples and practical tools are provided to assess the novel food status, in compliance with Implementing Regulation (EU) 2018/456 on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283.

The updated guidance specifically addresses recent developments and discussions that might affect the status of new foods, such as

  • The outcome of the Court of Justice case relating to the classification of new breeding techniques (Case C-528/16).
  • the concept of QPS (qualified presumption of safety) of microorganisms.
  • The implementation and application of the Union List of authorized novel foods.

This guidance was shared and endorsed by the main Eu novel food experts/players. To have access to this guidance please click here.

French authority agency (ANSES) releases statement that food supplements for joint health should be avoided by certain at-risk populations

A recent warning by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) states that diabetics, pregnant women, children, and those with certain food allergies should stop taking joint health supplements containing glucosamine and/or chondroitin sulfate due to a risk of adverse events.

This statement comes as a result of an expert assessment on the adverse reactions potentially associated with the consumption of dietary supplements containing glucosamine and/or chondroitin sulfate being identified under ANSES nutriavigilance scheme.

ANSES recommends manufacturers to better inform consumers about the risks associated with the consumption of these food supplements by these specific populations as well as to report to the nutrivigilance scheme any adverse reactions likely to be related to the consumption of these food supplements.

Furthermore, ANSES considers it necessary that the maximum authorized daily doses of glucosamine and chondroitin sulfate in food supplements be standardized at European level based on safety data from robust safety studies – currently lacking – for these two compounds.

EU enforces Mutual Recognition to reduce trade barriers within EU

The new regulation on mutual recognition EU 2019/515 will enter into force on 19 April 2020 and will repeal the current EC 764/2008. According to the new regulation, member states will have to accept products that are lawfully marketed in another member state unless they can prove that the product poses a serious risk on the people or the environment of the member state.

Previously, it had been a challenge for food or supplement producer to document that a product is “legally marketed” in a certain member state. The new regulation establishes the “mutual recognition declaration”, a self-voluntary declaration which can be used to demonstrate the lawful marketing of goods in a member state to the authorities of another member state. A template for this document is provided in the Annex of the regulation. This document can be issued by the food producer under his own responsibility. This new tool will considerably facilitate marketing products in different member states.

This will be especially relevant for dietary supplements containing relatively high amounts of vitamins and minerals, herbals or other compounds which are critically viewed in some member states. However, please note that the mutual recognition process may not be employed for FSMPs.

In case competent authorities refuse to accept a product, a SOLVIT centre established by the EU Commission can be contacted to resolve the issue.

If you need support bringing products on the market in other EU member states, please contact us!

Business opportunities and Education

14th International Workshop on Nutrition & Health Claims Europe

We would like to inform all our clients that Health Claims Europeis offering a one-day interactive workshop where they will bring a detailed situation analysis with integrated debate time on the latest developments related to nutrition and health claims in Europe, followed by a look forward, especially as what concerns Nutrition Profiles, botanicals and claims, and probiotic/prebiotic claims. This event with be hosted on the 28th May in Belgium. Our expert, Iris Hardewig will be one of the speakers in the afternoon session.

This workshop was developed specifically for Legal Counsels, Management, Regulatory, Marketing and development staff of European Food Industry and companies interested in importing food products in the European Union.

If you would like to attend this workshop, please contact us. We will be more than glad to offer you a discount code on the applicable registration rate.

Innovation Corner

Recent innovations in the nutricosmetic space

Nutrition has long been associated with healthier skin, hair and nails. Although not a new concept, beauty from within or nutricosmetics is gaining momentum. Nutricosmetics are oral nutritional supplements which purposes to support beauty such as the function and the structure of the skin, with formulations targeting highly specific areas such as UV protection, whitening and pigmentation for the skin, but also retention and growth for the hair and strengthening for nails.

According to Transparency Market Research, the global nutricosmetics market is expected to rise at a 5.0% CAGR from 2017 to 2025, to become worth US$7.93 bn by 2025, from US$5.13 bn in 2016. The global market for nutricosmetics can be segmented based on their primary functions into weight management, skin care, hair and nail care, and multi-functional. Among them, skin care segment accounted for a leading share in the market in 2017.

On the ingredient side, there has been some recent innovations. For example, a new ingredient showcased last September at VitaFoods Asia in Singapore was PhytoflORAL® from Frutarom. PhytoflORAL®is a patented, clinically-studied ingredient for skin lightening and photoprotection. It was developed by IBR, Ltd., (Israel) and it is a proprietary ingredient derived from tomatoes rich in the colourless carotenoids, phytoene and phytofluene. It is available as a powder that can be used in multiple applications, including capsules, chewable tablets, drinks and pre-mix sachets.

Well established players in the cosmetic space are also entering this market. Following 25 years in the cosmetics industry, the Swiss based company Mibelle AG Biochemistry has developed three ingredients targeting hair loss (AnaGain™ Nu), skin collagen formation (DracoBelle™ Nu) and skin stem cell vitalization (PhytoCellTec™ Md Nu) which will be showcased at Vitafoods Europe next month in Geneva. The company is launching these ingredients as food actives suitable for applications such as gummies, functional beverages, dairy products and bars.

In terms of health claims, there are authorized health claims targeting the maintenance of normal skin, hair and nails (e.g. zinc) but only for vitamins and minerals.

Vitamins and many food-derived antioxidants have been used in oral formulations targeting beauty. Beauty brands are now moving beyond supplements to food and drink categories such as juices and snacks. For example, collagen, a well known ingredient in cosmetics, has recently received a boost in its use in food formulations targeting beauty. While collagen’s use in oral formulations is quite recent in the Western world, in Asia collagen is a popular ingredient in food and drink products. In Japan, foodstuffs containing collagen are already well established. Collagen’s growing popularity is linked to its positive effects on skin health. Thus, collagen is being added to a variety of categories such as juices, yogurts and snack bars. The finish based company, Juustoportti Food, just released Juustoportti Collagen Yogurt. This is the first example of yogurt containing collagen in Europe. The yogurt is lactose-free and contains collagen and vitamin C, which is said to promote the normal formation of collagen for the normal function of skin and bones. Another innovative product containing collagen is the so called “beauty balls”. Last month, Health Lab Food (Australian company) released in the UK its Skin Hero Choc Cherry Collagen Beauty Skin Ball. The product is described as a super clever beauty snack featuring marine collagen to nourish skin, hair and nails.

If you want to know more about nutricosmetics and be up to date with the recent developments in this field, then joint us at the Education Programme session on Nutricosmetics on the 7thMay in Geneva. Our experts, Dr Inês Rocha and Dr Iris Hardewig, will be Chairing this session and would be glad to meet you.

NutraBusiness Intel

Martin Bauer Group acquires BI Nutraceuticals

26 March 2019

The Martin Bauer Group has acquired BI Nutraceuticals, a leading full-service manufacturer and supplier of plant-based ingredients in the United States.
This acquisition gives the German company a boost in the USA market with portfolio of botanical ingredients and a versatile manufacturing hub servicing the USA Tea, Beverage, Food and Dietary Supplements industries.

Nestlé Health Science invests in global strategic partnership with Amazentis to develop its new cellular nutrient Urolithin A

2 April 2019

Nestlé Health Science entered into a global strategic partnership with Amazentis, a Swiss-based pioneer in science-driven nutritional health for its nutrient Urolithin A.

Urolithin A is a bioactive dietary metabolite that is naturally produced when eating certain foods, such as the pomegranate, though it is difficult for most people to get enough of this specialized nutrient from food alone. Urolithin A has shown to improve mitochondrial function by activating mitophagy, a process by which aging and damaged mitochondria are cleared from the cell.

This partnership will support Nestlé’s pursuit of growth opportunities both in consumer healthcare and medical nutrition. Nestlé Health Science will take an equity stake in Amazentis and receive global rights to use Amazentis’ patented Urolithin A technology for dietary supplements, select foods and beverages, and medical nutrition products. Meanwhile, Amazentis will retain co-exclusive rights for the online distribution of dietary supplements and select food products as well as global exclusive rights for distribution of certain other defined categories.

Nestlé Health Science and Amazentis will also conduct a joint research program to expand applications of Urolithin A into new consumer health and medical benefit areas.

Lonza and Chr. Hansen enter live biotherapeutic products joint venture DSM and Phynova reach agreement for global distribution of Reducose®

2 April 2019

Chr. Hansen Holding A/S, a global bioscience company, and Lonza AG, a pharma contract manufacturing company, have signed a strategic agreement to establish a 50/50 joint venture to become the partner of choice for developing and manufacturing live biotherapeutics products for pharma and biotech costumers. This joint venture will operate from its headquarters in Basel (Switzerland) and have production facilities in Denmark and Switzerland.
This is a phased investment of approximately EUR 90 million to be shared equally between the partners over three years.

Unilever to acquire OLLY Nutrition

18 April 2019

Unilever has signed an agreement to acquire OLLY Nutrition, a premium U.S.-based wellbeing business in the vitamins, minerals, and supplements category. OLLY is known for its gummy vitamins and supplements, and also sells protein powders and snack bars. The terms of the deal were not disclosed.

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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