• Banner Newsletter

NEWS DIGEST by a&r | December 2019

2020-01-29T13:41:05+01:00

We dedicate this December issue to our overview of ingredients, regulatory highlights of 2019, and recent nutraceutical market information.

SUBSCRIBE

Invitation to a&r’s Webinar series

We are happy to invite you to our next free webinar, the first one of 2020!

Substance-based medical devices under MDR – Steps you need to take!
by our experts Dr. Marlen Landschreiber and Dr. Solveigh Krusekopf
.

Major changes will come to pass under Regulation (EU) 2017/745 for the majority of currently self-certified CE class I devices, which will be assigned higher risk classes. This applies also for substance-based devices such as nasal sprays, throat lozenges, topical products and many others. The European Parliament has just approved the 2nd corrigendum of the MDR, resulting in a prolongation of the re-certification period until 26 May 2024. Despite this gain in time manufacturers need to fulfill new requirements already by 26 May 2020.

The webinar will focus on practical approaches for realization of selected legal requirements which are new and most challenging for manufacturers of MDD class I devices. Thus, you will learn how you can acquire relevant clinical data to prove the performance and safety of your device. You will further learn how you can meet the fundamental needs regarding implementation and running of your Post-Market Surveillance and vigilance system. As a result of this webinar, you will have gained deeper insights into the scope and feasibility of the MDR clinical and post-market legal requirements.

Date: 29th of January 2020 (Wednesday)
Time: 15:00 – 15:45 (30 min talk and 15 min Q&A)

REGISTER HERE!

Ingredients and Regulatory Highlights of 2019

Top ingredient/trends of 2019

The most prominent ingredient during this year was certainly cannabis/cannabidiol (CBD). The market of CBD-containing products as food/food supplements is thriving, but the classification of CBD products as novel food has serious repercussions for the industry.

Plant-based proteins are another hot trend that is here to stay, as part of the so-called plant-based revolution. The market for plant proteins is expanding rapidly in response to a fast-growing segment of consumers who are concerned about their health, animal welfare, and/or the fate of the planet. Developing new sources of protein that have not been consumed by humans in the EU prior to May 15, 1997 will raise the question whether these proteins might fall under the Novel Food Regulation. Even protein isolates from established food sources could be considered novel and might require a pre-market authorization. Of course, this is also true for any up-cycled side streams of food production for human consumption. We have addressed this topic in more detail in our News Digest October issue.

Nutricosmetics was other buzzwords of this year. Although not a new concept, nutricosmetics are on the rise. However, new and deeper concepts are entering the market, which not only focus on the appearance of skin, hair, or nails per se, but also promote a more holistic approach e.g. to healthy aging. Today, consumers are taking more preventative, holistic, and eco-conscious approaches to their health, personal care, and lifestyles. Thus, the line between wellness and beauty is blurring.

The trend seen in previous years for pre- and probiotics is continuing, not only in the food supplement space but also in topical formulations. Likewise, algae, grasses, and collagen-containing foods are on the rise.

Essential oils are also gaining some spotlight, both in food applications and in medicinal products. We have seen them added to chewable softgels targeting sore throat and blocked nose, in combination with active ingredients in a smart capsule to be used in water bottles targeting detoxification, as well as in antispasmodic preparations.

Sustainability and traceability are key aspect for consumers. According to Innova Market Insights, in 2018, 65% of consumers expected companies to invest in sustainability. That rose to 87% in 2019 (Average of US, UK, China). Clean label is no longer a trend but a must have. A recent innovative example is the just launched KitKat by Nestlé in Japan, that uses the sweet juice of fresh cocoa fruits as substitute for traditional sugar (cocoa pulp received novel food authorization as traditional food this year).

Sugar alternatives are also on the rise with consumers being more aware of the need to reduce sugar intake. An example of this is allulose which is currently under evaluation under EFSA as novel food.

With consumer centricity and holistic health and wellness solutions being important market drivers, nutrition that supports physical and emotional well-being is key. It is therefore not surprising that products containing nootropic substance (substances that enhance cognition and memory and facilitate learning) are attracting a lot of attention. Similarly, brands are entering the age of personalized nutrition, where science and technology dictate how food impacts our overall health and wellness.

Regulatory News

Cannabidiol (CBD)

The market of cannabidiol (CBD)-containing products has been booming in Europe, Canada and the USA while regulations were clearly lagging behind. In January, the European Commission updated the Novel Food Catalogue regarding Cannabis sativa L., Cannabidiol and Cannabinoids. 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. The confusion in the industry around CBD persisted even after the update to the Novel Food Catalogue by the European Commission.

In order to bring some light and guidance to food business operators, a&r team of experts hosted two seminars on the CBD topic to help clarify the regulatory challenges that food business operators currently face, and explain the requirements for the submission of Novel Food applications for CBD in foods/supplements.

Despite the resistance of some players in the CBD industry, there seems to be consensus among National Authorities about the status of CBD products. The German “Bundesamt für Verbraucherschutz und Lebensmittelsicherheit” (BVL) published a clarification note and Q&A on CBD, THC and hemp extract, where it states that before placing products containing CBD on the market, either an application for authorization of a medicinal product or a request for authorization of a novel food must be submitted. In both procedures, the safety of the respective product must be demonstrated by the applicant.

Recently, the UK Food Safety Agency (FSA) evaluated an isolated CBD dissolved in MCT (medium-chain triglyceride) oil in the context of an Article 4-enquiry and classified the product as novel food .

Courts increasingly follow the view of the European commission and the National authorities. Very recently, one German court decision concluded that CBD is to be classified as novel food based on the absence of evidence of its consumption before 15 May 1997.

There is still a pending novel food application for trans-cannabidiol but this application 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. Just a few days ago, a second novel food application on has been submitted to EFSA.

On the other side of the Atlantic, the regulatory grey zone of CBD is also under scrutiny. Last month, the U.S. Food and Drug Administration (FDA) has informed the public that due to the lack of scientific information supporting the safety of CBD in food, CBD cannot be recognized as safe (GRAS) for its use in human or animal food. Meanwhile, the FDA has issued several warning letters to companies selling CBD-containing products for illegally selling various products containing CBD.

If you are considering to develop, import, or market cannabis-containing products as foods or medicinal products, we can guide you through the legal jungle on cannabis. Get in touch today!

Substance-based Medical devices

In May 2017, the Medical Device Regulation (EU) 2017/745 (MDR) entered into force, replacing the old Medical Decide Directive (MDD; 93/42/EEC medical devices). So theoretically, for a time period of 3 years following the entry into force of the MDR, manufacturers could decide to certify their products either under the new MDR or under the old MDD. However, after 26th May 2020, this will no longer be possible. Existing products (certified under MDD) may stay on the market until their certification expires, at the latest May 2024. Substance-based medical devices class I that are not reclassified can be produced until 25th May 2020 and then stay on the market until already distributed stock runs out. Despite the gain in time due to prolongation of the re-certification period until 26 May 2024, manufacturers already need to fulfill certain new requirements by 26 May 2020.

During this year, certified Notified Bodies (NB) were considered the bottleneck for the industry under MDR. By July 2019, only 2 NB had been designated to certify medical devices. Now, 7 MDR Notified Bodies are available in Europe (excluding BSI Assurance UK Ltd due to Brexit). The list of NBs available at any given time can be found via the NANDO website.

In order to keep products on the market, manufacturers of substance-based medical devices need to be prepared to upgrade their product technical documentation according to MDR and, when necessary, invest in clinical data. If you need support with updating your technical documentation, or in case you lack clinical equivalence information, we can support you with performing your own clinical study. If you want to know more about the challenges you are facing, please read our August News Digest issue. Alternatively, please register for our webinar on “Substance-based medical devices under MDR – Steps you need to take!” which will take place on the 29th of January 2020 (see invitation above). We can guide and support you through the process of the MDD-to-MDR transition timely and efficiently. We can provide you with independent and dedicated expert support.

Novel food authorizations

Two years after the Novel Food Regulation ((EU) 2015/2283) entered into force, 13 new novel food authorizations were granted this year, e.g. for extending the specifications or the conditions of use concerned, such as:

  • Lipid extract from Antarctic Krill (Euphausia superba). Extension was granted to address the gap in phospholipid content between ‘Antarctic Krill oil from Euphausia superba’ and ‘Antarctic Krill oil rich in phospholipids from Euphausia superba’. The specifications are now combined to ‘phospholipids content ≥ 35 % to < 60 %’.
  • Schizochytrium (microalgae) Oil. Extension of the conditions of use to fruit and vegetable purees is now granted with a maximum level of DHA of 100 mg/100 g.

Or as new traditional foods from non-EU countries (according to Article 14 of (EU) 2015/2283):

Or as new novel food ingredient:

For a more in-depth overview of all novel food authorizations granted this year, please click here.

Health claims, scientific opinions, and EFSA’s Dietary Reference Values

Also during this year, EFSA published two negative opinions for the scientific substantiation of article 13.5 health claims, one regarding an aqueous extract from white kidney bean (Phaseolus vulgaris L.) to ‘help to reduce body weight’, and the other related to a combination of beta‐sitosterol and beta‐sitosterol glucoside and normal function of the immune system. EFSA has also published a negative opinion for the scientific substantiation of an article 14 health claim related to Nutrimune and immune defence against pathogens in the gastrointestinal (GI) tract and upper respiratory tract (URT). Nutrimune is a pasteurized cow’s skim milk fermented with Lactobacillus paracasei CBA L74. The claimed effect proposed by the applicant is “supports the immune system in defense 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 establish a cause and effect relationship between the consumption of Nutrimune and the defense 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. If you need assistance with clinical research, please get in touch. Our team of experts can support you!

During the past 10 years, EFSA has been evaluating/updating the values for macronutrients such as proteins and carbohydrates, as well as 14 vitamins and 13 minerals. In September, EFSA’s last scientific opinion was published setting the Dietary Reference Values (DRVs) for sodium and chloride. During this year, an interactive tool that provides a quick and easy search of DRVs by population group or nutrient, was also released by EFSA; it is called DRV Finder. This tool allows nutritionists and other health professionals to make quick and easy calculations using EFSA’s dietary reference values.

EU Mutual recognition

The EU has enforced Mutual Recognition to reduce trade barriers within EU with a new regulation on Mutual Recognition (EU 2019/515). The regulation will enter into force on 19 April 2020 and will repeal the current Regulation (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. If you would like to read more about it please refer to our News Digest from April 2019.

Botanicals

This year, the Herbal Medicinal Products Committee (HMPC) has updated 26 herbal medicinal products, from publishing final updates to herbal monographs such as with Cynara cardunculus L. (syn. Cynara scolymus L.), folium (artichoke leaf) to conduct several public consultations for the periodic review of several herbal monographs. For more detail information visit EMA website. If you are planning to develop a new herbal drug or need assistance with your CTD, we are here for you. Get in touch!

NutraBusiness Intel

Givaudan to acquire Indena’s cosmetics business

Italian based company Indena has reached an agreement to sells its cosmetic business to Givaudan to focus on pharmaceuticals and health food.
This acquisition will support Givandan 2020 strategy to expand the capabilities of its Active Beauty business.

26 November 2019 • Source

IFF merges with DuPont’s Nutrition & Biosciences (N&B) business

International Flavors and Fragrances (IFF), which makes flavors and fragrances for food, personal-care and household products, and who bought Frutarom in 2018, agreed to merge with US DuPont’s Nutrition & Biosciences (N&B) business for $26.2bn. Under the terms of the agreement, DuPont shareholders will own 55.4% of the shares of the new company and existing IFF shareholders will own 44.6%.

16 December 2019 • Source

MatchMaking banner newsletter

Your experts

Irene Wohlfahrt
Irene WohlfahrtSenior Consultant
Dr. Inês Rocha
Dr. Inês RochaDirector of Business Development and Strategic 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.

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