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Overview of ingredients, regulatory highlights of 2018

2018-12-19T17:27:59+01:00

a&r’s News Digest – We dedicate this December issue to our overview of ingredients, regulatory highlights of 2018, and recent nutraceutical market information.

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a&r looks back on 2018

Another year has gone by. We were involved in super interesting projects, had the chance to meet former and new clients, visited trade shows, and attended expert events all around the world.

The a&r MatchMaking Platform, launched in 2017 to bring together companies looking for local and worldwide in/out-licensing opportunities in natural health products, hasexperienced a fast growth this year. In 2018, about thirty new business opportunities featuring premium finished products, branded ingredients, and other technologies were included in our licensing database. Twenty life science companies chose our MatchMaking Platform as an additional channel to expand their business into new markets, thus accelerating business growth and profit. Daily enquiries regarding products offered in the licensing database confirm that the MatchMaking Platform is an excellent strategy for innovation. During the matchmaking process, a&r confidently supported clients by performing technology and product scouting, due diligence, competitive intelligence, market analysis, providing advice on clinical trials, etc. To explore your next business opportunity, please contact Dr. Natalia Wszelaki: matchmaking@a-r.com.

This year, we also launched a&r Innovation insights, a tailor-made innovation scouting service to support your business. You can pick and choose what is important for you and your business and we deliver it straight to your screen. Be inspired!

Meanwhile we have hosted several free a&r webinars on relevant subjects related to the natural health products. We hope you enjoyed our selection. We will definitely continue this activity next year! We also develop tailor-made trainings targeting specific company needs. They are available both web-based or face-to-face. Get in touch if you want to learn more.

In the current nutraceutical market, branded ingredients with clinically proven efficacy and IP are key assets. The clinical investigation of a product’s health benefits is a clear differentiator between similar products. So, when commissioning a CRO with the design of a clinical trial, several aspects should be considered for the successful outcome of the trial. Given our experience and competence, a&r can provide you with the proper support.Please contact us for more details and support.

Thank you for giving us the opportunity to support your business and to share with you our unique combination of regulatory and scientific consulting and clinical research expertise in the field of natural health products.

Ingredients and Regulatory Highlights

Top ingredients / trends

Healthy aging continues to be a hot topic. Also, “beauty from within” is on the rise. Consumers are on the hunt for youth-boosting foods and drinks. The growing aging population, increasingly youth-centric society, and consumer motivation for self-care are drivers for these health solutions.

Continuing the trend seen in previous years are pre- and probiotics. They are high-demand ingredients, whether for digestive health, immune, or mental health. Intensive research opens up additional indication areas for probiotics. Likewise, algae, grasses, and collagen-containing foods are on the rise. Other interesting ingredients are fermented extracts.

Hemp products are gaining more and more interest in the food arena, although the regulatory situation of CBD-containing products is not yet solved. Cannabis extracts that contain cannabidiol (CBD) levels higher than the CBD levels in the source of Cannabis sativa L. are considered novel in food. Hemp oil (without CBD), obtained by cold-pressing the seeds or other plant parts, does not require pre-market authorization as hemp oil was consumed in the EU to a significant degree before 1997.

All innovative ingredients rely on the health benefit they offer to the consumer as a key differentiator. So, brands are investing more in clinical research to support the health benefits of their products.
Brands are also using healthy confectioneries to drive innovation. This was already observed last year but to a lesser extent. Brands are exploring delivery formats such as chocolates, jelly sticks, and gummies to bring innovation to their products. Supplements targeting “beauty from within” are a good example of products exploring these delivery formats.

Continuing an ongoing trend, “natural” and “organic” are words often found in ingredients and products. Thus, vitamins and minerals derived from natural sources are gaining more and more importance as ingredients.

Sustainability is another buzz word. Consumers are demanding more transparency within products, searching for brands that they can trust and that have an environmentally friendly approach and consider animal welfare.

Sports nutrition continues to move mainstream, being less and less a niche. Brands are actively exploring this segment with cutting edge sports nutrition and functional ingredient solutions delivering innovative, on-the-go functional foods and beverages.

With consumer centricity and holistic health and wellness solutions being key market drivers, digital solutions and/or wearables are slowly gaining more and more attention, as they offer increased consumer engagement. They can be interesting solutions to support brands for portfolio extension. Similarly, providing consumers with an experience/discovery rather than “just” a product is gaining more and more relevance for the food and beverage markets.

Regulatory

The regulatory situation around Cannabis has been in the spotlight. While the regulatory situation is clear for industrial hemp for non-food purposes, the same cannot be said for its use as food. While hemp seeds, seed proteins and seed oils became common food ingredients, national regulations may still restrict their use in food. Recently, cannabidiol (CBD), an innocuous structural relative of tetrahydrocannabinol (THC) attracted a lot of interest. Since CBD does not have the psychotropic potential attributed to THC, there are discussions about whether or not CBD concentrates are suitable as food ingredients. In addition, food ingredients with CBD levels that are higher than the CBD levels in the plant – which would include cannabis extracts – fall under the Novel Food Regulation (EU) 2015/2283 and require a pre-market authorization. The situation is far more complicated when it comes to medical cannabis. Until now, there is no harmonized EU law on cultivation or authorized cannabis-based drugs. Nevertheless, the cannabis drug and food market are expected to massively change in the next couple of years. If you are considering to develop, import, or market cannabis containing products as food or drug we can guide you through the legal jungle on cannabis. Get in touch today!

The Novel Food Regulation ((EU) 2015/2283; NFR) went into force at the beginning of this year. The aim of this regulation is to improve the conditions of food business operators bringing new and innovative foods to the EU market while maintaining a high level of food safety for European consumers. With the creation of the Unions list of novel foods, specifications and conditions of use for these foods and food ingredients are centralized. The Union list is updated regularly. All authorization decisions can be found on theCommission website. All authorizations granted under the old regulation are no longer applicant-specific but have become generic following their inclusion in the Union list. Now, a year down the line, we have the first examples for authorizations with or withoutprotection of proprietary data. A number of notifications based on traditional foods from non-EU countries were submitted but not yet included in the Union list. The new NFR also triggered food business operators to consult with National Authorities to determine the status of their novel foods (art. 4(2) of the NFR). A summary table of finalized evaluations under art. 4(2) can be found here. All these examples help understand how the authorization process works and is put into practice under the new conditions. For the firsttime a triple combination of herbal extracts (Cynanchum wilfordii Hemsley, Phlomisumbrosa Turcz. and Angelica gigas Nakai (EstroG -100™)) gained approval as a novel food. However, no health claim has as yet been approved.

There have been plenty of discussions around maximum levels of vitamins and minerals allowed in food supplements in Europe. Due to the lack of action from the EU Commission on defining these maximum levels, as was foreseen in the directive 2002/46/EC, more and more Member States are setting their own maximum levels for vitamins, minerals, and other substances. After Belgium, Norway, Denmark, Italy, and France, the Spanish Council of Ministers has approved this year a decree containing maximum levels for “other substances” allowed in food supplements. Also, The Netherlands published its final text introducing new maximum levels of vitamin B6 in food supplements. Meanwhile, Germany has not yet legally defined maximum levels for vitamins and minerals in food supplements, but the BfR has suggested recommended safe levels. Looking at the maximum levels of the different Member States, the values differ considerably, hindering the free movement of goods in the EU.

Also during this year, EFSA provided an update on two scientific guidances for health claim applications, one being on oxidants, oxidative damage and cardiovascular health and the other related to muscle function and physical performance. These updated guidances support applicants in the preparation of their applications for authorization of health claims. If you would like to read more about the updates introduced on the guidance related to muscle function and physical performance, please go to our November issue.

In terms of ingredients and claims, from the six EFSA opinions on innovative/proprietary health claims (article 13.5) published this year, two received a positive opinion. They were: a) Carbohydrate solutions and contribute to the improvement of physical performance during a high-intensity long-lasting physical exercise and b) Black tea and improvement of attention. One negative EFSA opinion for an article 14 health claim application, was also published (Symbiosal® and lowering of blood pressure and reduced risk of hypertension). In the meantime, one claim was approved by the EU Commission on a combination product referring to the reduction of disease risk (14.1 health claim). This claim was submitted by Laboratoire Lescuyer (France) on Limicol®. In 2013, EFSA had already issued a positive opinion on this health claim. Now, 5 years later, the EC Commission finally agrees.

The use of botanicals in food supplements among Member States is a complex business. To make things even more complex, Italy has recently published a new Decree which includes a new list of botanicals allowed in food supplements. With this decree, Italy becomes a stand-alone market for some food supplements containing botanicals, and there is no longer harmonization on the use of botanicals among the BELFRIT States. The Decree took effect on the 10th December 2018. Likewise, the impasse concerning “on hold” botanical claims used in foods continues. Under the Commission’s Regulatory Fitness and Performance (REFIT) program, botanicals have been under “reflection” concerning the use of health claims to establish a community list of permitted general health claims for foods. However, no news is yet available. It looks like no real solution is expected for botanical claims in the near future.

NutraBusiness Intel

Danone and Mars join Givaudan’s Mista innovation platform

29 November 2018

Givaudan, a global leader in flavors and fragrances, launched MISTA, an innovation platform for the food industry based in San Francisco (USA). MISTA, which will open its doors in early 2019, is an optimizer, enabling start-ups and established corporations to optimize ideas, products, people, and investments.

Joining Givaudan as Founding Members of MISTA are Danone, Mars Inc., and Ingredion Inc. as well as a number of strategic partners with world class capabilities from across the food industry.

Unilever to acquire Horlicks and other consumer healthcare nutrition products from GSK

3 December 2018

Unilever has signed an agreement to acquire the Health Food Drinks portfolio (GSK HFD) of GSK in India, Bangladesh and 20 other predominantly Asian markets. This transaction supports Unilever’s strategy to increase its presence in health-food categories as well as in high-growth emerging markets.

Crown acquires five skincare brands from GSK

3 December 2018

Crown Laboratories, Inc., an integrated skin care company, announced the acquisition of North American distribution rights to five consumer healthcare brands (OTC) from GSK. The selected brands are PanOxyl (daily acne wash), Sarna (anti-itch lotion), Zeasorb (anti-fungal and prevention product), Desenex (anti-fungal powder for athlete’s foot), and Mineral Ice (pain-relieving gel). These products expand Crown Laboratories’ consumer portfolio by adding brands that treat multiple conditions.

a&r wishes you Merry Christmas and Happy New Year!
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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