• a&r News Digest of December 2017

What a great year we had! Ingredients and regulatory highlights of 2017

a&r’s News Digest – We dedicate this month’s issue to our overview of ingredients and regulatory highlights of 2017 and recent nutraceutical market information.

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News

2017 – How was this year?

winner nutra ingredients awards vitafoods europe 2017 service provider of the year regulatory clinical trials study center berlinWhat a great year we had! a&r was awarded Service Provider of the Year by NutraIngredients awards. This means that we were recognized for our obsession with natural health products. For more than 20 years, we have been making use of our unique combination of regulatory and scientific consulting and clinical research expertise to cover the full spectrum of all that matters in the field of natural health products. We use our profound expertise and creativity and translate it into tailor-made innovation solutions to maximize the value for our clients’ products and serving consumer needs.

Thank you again, we would not have made it without you!

When it comes to business strategies for the nutraceutical industry and for innovators to expand their business, commercial transactions (licensing and acquisition) are a strategy for innovation to have access to new products, technologies, and desirable geographic markets. With our clients in mind and willing to expand their business opportunities in the current challenging nutraceutical market we launched a&r MatchMaking Platform. This platform aims to accelerate local and global transactions for in/out-licensing or sale/acquisition of natural health products. Unlike other platforms, it is focused on the area of natural health products. a&r can confidently assist clients in the different stages of the matchmaking process, including technology and product scouting, due diligence, competitive intelligence, market analysis etc. Please contact Dr. Naira Quintana in order to explore your next business opportunity: matchmaking@a-r.com

Branded ingredients with clinically proven efficacy and IP assets are the future of the nutraceutical industries. Clinical investigation of a product’s health benefits is based on careful design and accurate conduct of a human clinical trial. When commissioning a CRO with the design of a clinical trial, several aspects should be considered, e.g. registration of a clinical trial. Given our experience and competence, a&r can provide you with the proper support. Please contact us at business@a-r.com for more details and support.

2017 also brought a series of free a&r webinars on relevant subjects related to the natural health products. We will continue this activity next year! Keep in touch for more a&r free webinars.

Ingredients and Regulatory Highlights

Top Ingredient and Trends

As already seen in 2016, probiotics continue to have a strong presence, gaining more and more awareness worldwide and becoming a high-demand ingredient, whether for digestive health, immune, or mood. They can be found in many delivery forms including chocolate, jelly sticks, and gummies. Likewise, new sources of protein continue to be trendy, following developing countries’ economic growth.

Present in every trade show were berries and their proprietary extracts with clinically proven health benefits. Ingredients sourced from marine plants were also spotted as research showing their benefits is growing. Astaxanthin was also showcased at several trade shows in response to a growing demand for natural ingredients, also with proprietary extracts.

An “old comer” was hemp, either as a protein source or as cannabidiol (CBD) oil, getting stronger and stronger with several food products including healthy snacks ideal for athletes. Another hot trend was food supplements targeting hangover. Ketogenic diet, a high-fat, adequate-protein, low-carbohydrate diet, is gaining popularity and can be supported with ketone-based food supplements.

Capsules and tablets are still the main delivery formats used by producers to present their products. However, alternative formats also showed an increase in interest for product differentiation such as soft gums. Jellies as well are an alternative and interesting way to deliver food supplements, e.g. honey moisture jelly and melatonin jelly. Chocolate is another extremely successful carrier for nutraceuticals. This is in line with current consumer trends striving for the combination of different benefits such as pleasure and health.

Medical devices (MD) were a big trend category during this year. Nevertheless, in the long run, producers with substance based MD might have to update their class status if they want to keep their products on the market. It is important to mention that cranberry-based products are no longer allowed to be marketed as MD (more detailed information here). Likewise, probiotics (live bacteria) are also no longer acceptable as ingredients for MD under the new MD regulation. If you need any regulatory support, get in touch! We will be glad to support you. We will also run a webinar on this topic early next year. More information will follow soon. Stay tuned!

Personalized Nutrition is a continuous innovation trend in the nutritional business (for more details, read our April issue. Healthcare providers and consumers are becoming more aware that “one size fits all” is not a viable option in health. Additionally, there is a shift towards a “Fitness Move” as consumers are searching for preventive rather than reactive measures to avoid future health problems.

This year’s health area trend focused on healthy aging. The growing aging population, increasingly youth-centric society, and consumer motivation for self-care are driving the demand for healthy aging solutions.

Regulatory

For the first time since 2011, EFSA refreshed the scientific and technical guidance for the preparation and presentation of a health claim application, providing a better-structured format with a more coherent and more logical layout. There were no substantial changes in contents, but on structure e.g. the new part 3 now outlines requirements for the characterization of the claimed effect in more detail.

In terms of ingredients and claims, no EFSA positive opinions were published on innovative/proprietary claims; only positive opinions for generic ingredients targeting children development were published.
It is important to mention that several EU countries, e.g. Belgium, Italy, and Germany, have set maximum levels for some vitamins and minerals.

Concerning Novel Foods, the new Novel Food Regulation (EU)2015/2283 will enter into force at the beginning of next year (January 2018). Two types of applications – for “typical” novel foods (article 10) and for traditional foods from third countries (article 14) are possible. Under the new Novel Food Regulation, there are new market opportunities for traditional foods as they can now be brought to the market following a relatively simple notification procedure, provided sufficient evidence for the history of safe use outside of the EU is available.

This year and as already mentioned, a new regulation on MD was adopted – (EU) 2017/745. This new regulation will handle borderline products more strictly. Thus, substance-based MD can no longer be classified as class I, but will be at least class II-a or II-b. Many of the currently marketed oral MD will have to either be re-classified or transferred to a new product category. It is important to keep in mind that, for a time period of 3 years following entry into force of the Regulation on MD, manufacturers may decide to certify their products either under the new Medical Device Regulation (MDR) or under the old Medical Device Directive (MDD). However, after 2020, this will no longer be possible.

Finally, the impasse concerning “on hold” botanical claims used in foods will need a solution very soon, as the European Court of Justice (ECJ) made a statement that the current situation is unacceptable. This increases the pressure at the European Commission level to come up with a solution. Under the Commission’s Regulatory Fitness and Performance (REFIT) programme, botanicals have been under “reflection” concerning the use of health claims to establish a community list of permitted general health claims for foods. The draft conclusions from a report by the European Commission on whether the health claims regulation 1924/2006 is “fit for purpose” with regard to botanicals was presented to EU member states and stakeholders (according to OTC bulletin – 20 October 2017). Now, more than ever, there is a need for a clear decision concerning health claims and botanicals, as it was suggested by the ECJ that a rejected claim is better than one on hold, since a rejected claim provides a legal certainty which is the point of the regulation.

NutraBusiness Intel

Atrium Innovations will be acquired by Nestlé for $2.3 billion

Earlier this month, Nestlé announced that it agreed to acquire Atrium Innovations (transaction to be completed Q1 2018). Atrium is globally recognized for the development, production, and commercialization of innovative and scientifically-proven natural health products. Its strategy is complementary with Nestlé science-based natural solutions for consumers and health care professionals. With this acquisition, Nestlé will extend its consumer healthcare nutrition portfolio, and Atrium will compete more effectively in the global market place.

A clear evidence that silos between industries will be breaking down in the future.

AB-BIOTICS sells AB-FORTIS patent to Frutarom

Earlier this month, Nestlé announced that it agreed to acquire Atrium Innovations (transaction to be completed Q1 2018). Atrium is globally recognized for the development, production, and commercialization of innovative and scientifically-proven natural health products. Its strategy is complementary with Nestlé science-based natural solutions for consumers and health care professionals. With this acquisition, Nestlé will extend its consumer healthcare nutrition portfolio, and Atrium will compete more effectively in the global market place.

A clear evidence that silos between industries will be breaking down in the future.

Walgreens will invest in Chinese pharmacy chain

Walgreens has announced that it will invest $416 million to acquire 40% stake in Sinopharm Holding GuoDa Drug Store Co., Ltd (GuoDa).  Walgreens is the second-largest pharmacy store chain in the US behind CVS Health. GuoDa retails pharmaceutical and healthcare products across China.

Walgreens was already present in China through Alliance Boots. This new investment highlights the interest of Walgreens in the Chinese fast-paced retail pharmacy business.

Walgreens investment took place in the same week that CVS announced to spend $69 billion to buy Aetna, the third largest health insurer in the U.S. CVS also has international operations but has not revealed interest in China yet.

Merry Christmas and Happy New Year!

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

2018-01-08T17:47:39+00:00