• analyze & realize news digest of October 2017

Regulatory news on botanicals and Novel Foods, SSW


a&r’s News Digest – We dedicate this month’s issue to regulatory news on botanicals and Novel Foods, a brief overview on SupplySide West and relevant information about clinical trial registration.



Health claims for food supplements containing botanicals – Light at the end of the tunnel?

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 will be presented to EU member states and stakeholders and discussed at workshops at the end of this month (in OTC bulletin – 20 October 2017).

a&r comment: It seems that very soon there will be a decision concerning health claims and botanicals. We look forward to receiving more detailed information on this matter!

Draft Union List for Novel Foods published

On 5th of October 2017, the European Commission published the draft implementing a decision establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 and a first draft for the actual Union list. The Union list contains specifications and conditions of use for foods and food ingredients that are authorized in the European Union.
The two documents will be open for comments until November 2, 2017. Please have a look at the list and provide your comments!


European Food Supplements Conference – 8-9 March 2018 in Berlin – Save the date

After 15 years of the Food Supplements Directive being in effect, we would like to raise awareness for the next European Food Supplements Conference that will happen in Berlin early next year. This event will be organized by the German Federation of Food Law and Food Science (BLL; www.bll.de) in co-operation with Food Supplements Europe, the association representing the sector at European level.

The aim of the event is to analyze current developments, to discuss future challenges, and to exchange ideas and solutions – to give fresh impetus to the discussion surrounding pending issues in the field of food supplements within Europe, and how to address them. It will focus on the most significant topics currently discussed across Europe such as botanicals in food supplements, harmonized maximum levels of vitamins and minerals, and the role of food supplements for health and wellbeing. For this discussion, key players from regulatory authorities, science, industry, and society will come together.

Registration for the event will open soon. Please feel free to email: berlin-conference@bll.de for more information.

Clinical News

Stevia leaves approved in the EU

After failing to receive novel food status due to insufficient safety data, stevia leaves can now be sold in European countries, as it was established that they were to a significant extent sold and consumed in the EU prior to 1997. Hence stevia leaves are no longer considered Novel food and therefore do not need Novel Food approval. This applies to infusions made from stevia leaves such as tea, herbals and fruit infusions. Thus, stevia leaves are not considered additives and therefore do not require an E number.

In parallel, there are stevia extracts (steviol glycosides), which are approved as additives in a vast majority of food categories. The approval of stevia leaves is a very significant step because stevia extracts are currently not allowed to be used in organic products. This opens innovation opportunities targeting consumers searching for natural alternatives to sugar and artificial sweeteners.

Ingredients and Claims – authorized/refused Health Claims by the European Commission (EC)

In 2017, two health claims were authorized by the EU Commission. In the same period of time, the Commission rejected nine claims.

Authorized claims:

  • Creatine (EU) 2017/672 (claim Art.13(5)): Daily creatine consumption can enhance the effect of resistance training on muscle strength in adults over the age of 55
  • Lactitol (EU) 2017/676 (claim Art.13(5)): Lactitol contributes to normal bowel function by increasing stool frequency

In terms EFSA opinions and of health claims and during 2017:

Claim that received a positive EFSA opinion:
Article 14 health claims for infants (from birth) and young children up to 3 years of age

Claim that received a negative EFSA opinion:
Article 13.5 health claims that received a negative opinion by EFSA:

Article 14 health claims for infants (from birth) and young children up to 3 years of age

In summary, no EFSA positive opinions were published on innovative/proprietary claims; only one positive opinion for generic ingredients targeting children development was published.

SupplySide West (SSW)

a&r take home message

Once again, a&r attended SupplySide West in Las Vegas. SSW is a platform selected as a catapult by ingredient suppliers and service companies to introduce their new ingredients, products, technologies and solutions.

Our main take-aways after this event on ingredients, health and market trends:


  • Branded ingredients with clinically proven efficacy and IP assets are the future of the nutraceutical industries.
  • Ketogenic diet, a high-fat, adequate-protein, low-carbohydrate diet, is gaining popularity and can be supported with ketone-based food supplements.
  • Concerns about authenticity of herbal ingredients are rising.
  • As already seen last year, there is a continued interest in new sources of protein; as developing countries’ economies grow, so does their demand for protein.
  • An increased interest in ingredients sourced from marine plants was spotted as research showing their benefits is growing.
  • Probiotics are still on high demand; whether for digestive health, immune, or mood as acceptance by healthcare providers and consumers continues to grow.
  • There is increased demand for cognitive health ingredients, not only for brain health but also in sports nutrition. The growth in sport nutrition is attributed to the boom in the connection between the brain’s mental activity and performance.


The health areas with the most focus this year were support of healthy aging with increased focus on maintenance of muscle mass (dietary essential amino acids) and joint health.

The growing aging population, increasingly youth-centric society, and consumer motivation for self-care are driving the demand for healthy aging solutions. Moreover, the Baby Boomers also focus on healthy aging.


A strong driver for this market is personalized nutrition, as healthcare providers and consumers are becoming more aware that “one size fits all” is not a viable option in health.
There is a shift towards a “Fitness Move” as consumers are searching for preventive rather than reactive measures to avoid future health problems. The rising costs of healthcare worldwide also promote this preventive trend. Furthermore, there is also an increased interest by Millennials in food supplements for energy.

When it comes to business strategies for the nutraceutical industry and for innovators to expand their business, commercial transactions (licensing and matchmaking) are a strategy for innovation. Companies are buying products or companies to have access to new products, technologies, and desirable geographic markets. This is why a&r just launched its MatchMaking Platform, so we could better support our former and new clients with their business. For more details about our platform visit us at: https://www.a-r.com/matchmaking/

a&r MatchMaking Platform

We are proud to announce the launch of our new 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. The platform is now live: https://www.a-r.com/matchmaking-database/

a&r brings its unique combination of passion and expertise into this field. For more than 20 years, we have been developing a strong network in the natural product industry with more than 1000 clients. This allows us to efficiently select the most attractive business partnering opportunities to increase revenue in your future business.

In addition, 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.

Dr. Naira Quintana recently joined a&r to lead the MatchMaking Platform. She brings a strong blend of academic expertise in natural products research and industry experience in the OTC business.

Contact Dr. Naira Quintana in order to explore your next business opportunity: matchmaking@a-r.com

Mintel GNPD (Database)

We have access to Mintel’s Global New Product Database (GNPD). The database reflects new product launches worldwide, giving a host of information about the products, from label and ingredients to launch date to manufacturing and distributing company, and many more.

With this tool, we are able to provide you with:

  • competitor analysis in your target markets, including pricing, packaging images, claims,
  • product examples for certain ingredients, e.g. all products containing beta glucan, and
  • landscaping of certain market segments
  • and other topics

Please contact us so we can discuss which information is relevant for you and how we can adapt the search criteria to get the most valuable output for you!

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