a&r’s News Digest – We dedicate this month’s issue to FSMP and innovation in infant nutrition. New innovation scouting service available from a&r – see below!


a&r dedicated services

Innovation Newsletter NEW

Would you like to be on top of Innovation concerning natural health products? We deliver a tailor-made Innovation Newsletter to support your business. Every newsletter is designed according to client needs, covering different topics such as ingredients/extracts, final products, delivery systems, and packaging, spanning several health categories. You can pick and choose what is important for your business and we will deliver it to your screen!

Scouting for natural health products for more than 20 years! Get in touch today (business@a-r.com) for a free sample. Be inspired! Our experts can help!

MatchMaking Platform

We have recently launched our a&r MatchMaking Platform. This platform aims to accelerate local and global transactions for in/out-licensing or sale 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 to 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

Regulatory News

Food for Special Medical Purposes (FSMP) – new rules for an old product category?

 With the aim to improve the enforcement of the regulatory framework and finally to protect the consumer, the Food for Specific Groups regulation (EU) No 609/2013 abolished the previous PARNUT concept in 2016. Later, the Commission Delegated Regulation (EU) 2016/128 was published with updates for the specific requirements for the labelling and composition of Food for Special Medical Purposes (FSMP) including a list of substances allowed for this product category. Basically, the definition of FSMP has not changed significantly, with some exceptions such as the fact that the use of nutrition and health claims in FSMPs is explicitly not allowed. Also new: Article 3 of the FSG Regulation empowers the EU Commission – in case of uncertainty – whether a product falls under the FSMP regulation or not. The Commission may address scientific questions regarding the classification of FSMPs to EFSA. EFSA, in turn, published a technical and scientific guidance document guiding applicants when providing relevant information to help EFSA in the scientific assessment of FSMPs. What is important, the Commission’s power under Article 3 is not intended to replace the presently applicable regime. This means that, in the future, national authorities will also have the general responsibility of enforcing the FSG regulation and verifying whether a product placed on the market as FSMP really falls within the scope of the applicable legislation. With the publication of the EU “Commission Notice on the Classification of FSMP” at the end of last year, the Commission provided another piece to the puzzle of how to implement the FSG regulation, this time intended to support food business operators in providing the relevant data to prove the compliance with the provisions applicable to FSMPs.

As the regulation is not definitive in all points and leaves some room for interpretation, it may be possible that some Member States’ competent authorities will continue to have divergent approaches to the classification of the same product as FSMP.

As the EU Court of Justice is the final authority when interpreting EU law and making binding decisions, it remains to be seen what the practical implementation of the FSG/FSMP regulation will actually look like.

Innovation in Infant nutrition

Infant nutrition is regulated under the same ruling as FSMPs ((EU) No 609/2013). Due to the strict regulations, innovation in infant nutrition formulations is a complex and lengthy process. The requirements for safety and tolerability of the ingredients and final products are in a tough regulatory environment, as we are dealing in most cases with food for neonates.

New formulations and products represent a challenge as they usually require clinical trials with infants in order to obtain a new market authorization (for both novel ingredients and novel formulas). To learn more about infant nutrition and recent regulatory and clinical challenges please read our Newsletter issue from June 2017: click here.

In the last few years, there has been an incremental growth of innovation in infant nutrition formulations with new launches including long-chain unsaturated fatty acids, reduced lactose content, alternative milk sources, or and new packaging or dosing formats.

However, during 2016/17, there was a disruptive innovation in infant nutrition with the approval of the novel foods human milk oligosaccharides (HMOs) such as 2′-fucosyllactose (2’FL) and lacto-N-neotetraose. The assumption is that the oligosaccharides present in milk act as pre-biotics in the intestinal tract of the neonate, helping the intestinal flora to develop and protect infants from e.g. infections.

These oligosaccharides will enable manufacturers to overcome one of the detriments of artificial infant formulas and to develop formulas that are a step closer to breast milk.

For an extra reading on this subject click here.

Invitation to our a&r webinar series

We are happy to invite you to our next free webinar!

Food for Special Medical Purposes (FSMP) – new rules for an old product category?

Foods for Special Medical Purposes (FSMPs) are intended for the exclusive or partial feeding of people whose nutritional requirements cannot be met by normal foods. They can only be used under medical supervision. They are regulated under (EU) No 609/2013 as of 20 July 2016. This regulation sets general composition and labeling rules. The European Commission Delegated Regulation (EU) 2016/128 supplements this regulation as regards the specific compositional and information requirements for FSMPs, which will be applicable from 22 February 2019 (replacing Directive 1999/21/EC).

The webinar will provide an overview on recent developments regarding the implementation of the Food for Specific Groups (FSG) legislation with a specific focus on FMSPs and give practical information on the requirements for products to be marketed as FSMPs.

Dr. Annegret Nielsen is a Senior consultant in the Consulting & Strategic Innovation team at analyze & realize.

Date: 21st of March 2018 (Wednesday)
Time: 3:00pm (CET) (30 min talk and 15 min Q&A)


NutraBusiness Intel

Nutraceutix amplifies Probi’s sales

16 Feb 2018

Probi, the Swedish probiotics specialist, reported sales up by 42 % (approximately € 16 mill) thanks to an entire year of sales from Nutraceutix. US-based Nutraceutix is a CMO acquired by Probi in 2016 for $105 million.

BioGaia’s probiotic to be launched in China

18 Jan 2018

BioGaia has signed an exclusive agreement with Abbott for the rights to commercialize BioGaia Protectis chewable tablets in China. BioGaia Protectis is a food supplement containing the patented acid lactic bacterium Lactobacillus reuteri that helps microorganisms restore a natural balance in the gut. Launch of the product is planned for this year. BioGaia has already successfully collaborated with Abbot in Latin America and Thailand.

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