a&r’s News Digest – We dedicate this month’s issue to an overview on the Novel Foods Regulation and the new recommendations on maximum levels of vitamins and minerals in Germany.


Regulatory News

Novel foods regulation overview

The new Novel Foods Regulation ((EU) 2015/2283) went live on January 1, 2018. Its aim 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.

The new Regulation replaces the former system of national authorizations for a simple, faster, centralized EU-procedure. On December 20, 2017, the long-awaited core element of the new regulation, the Union List of Novel Foods, was agreed upon and laid down in Implementing Regulation (EU) 2017/2470. From now on, all authorizations under the previous regulation (EC) 258/97 are generic. The Union list provides the specifications and conditions of use for these foods and food ingredients. Food business operators can directly market their products, provided that they meet the specifications in the Union List, and that the authorized conditions of use are observed. For the most recent version of the Union list (20 December 2017) click here. The list will be updated regularly. Whether and how these updates also include corrections of mistakes and inconsistencies needs to be seen.

The transition from product- and business-operator specific to generic authorizations is a big relief for many in the food business, but some manufacturers of very innovative products are probably deeply disappointed. One issue is that data protection for proprietary data under article 26 and 27 of (EU) 2015/2283 does not apply to those applications that only recently got their Novel Foods authorization under the former regulation. Applications that have not been finalized under the old regulation will be further processed pursuant to (EU) 2015/2283, but may now have the opportunity to request data protection under these articles.

In order to get an overview on the nutrition industry verdict about the new Novel Foods regulation, please read the following press release. As our expert Dr Steffi Dudek points out: “The new regulations certainly represent progress for traditional foods from third countries or for relatively simple products – exotic berries for example. But manufacturers of innovative synthetic or fermented ingredients who got authorisation under the old regulation after investing heavily in research will be disappointed that their proprietary data is not respected in the way they had hoped. I’m also concerned that some products that should be subject to their own authorisation might enter the EU market under a generic authorisation. It remains to be seen how companies will take the responsibility to assess the status of their products.”

On January 5th, the Commission launched an electronic submission form that has to be used for all types of future novel food applications. Applicants have to register on EU login website prior to first use. The e-submission allows applicants to follow-up their applications from the submission until the outcome, improving transparency. To support applicants in this application procedure, there is a user guide available. Make sure you have a look at it before you start!

If you have any question or would like our support, please get in touch with our expert in Novel Foods – Dr. Steffi Dudek: sdudek@a-r.com.

New recommendations for maximum levels of vitamins and minerals in Germany

The excessive intake of vitamins and minerals may result in adverse effects and therefore official bodies deem it necessary to set maximum safe levels for them in food supplements. The Directive 2002/46/EC on food supplements envisages the setting of maximum and minimum amounts of vitamins and minerals in supplements. Although, in recent years, different models for maximum quantity derivations have been developed and discussed in Germany and other European countries, there are no legally binding maximum levels at a European level. At EU level, EFSA provides scientific advice on the setting of tolerable upper levels of intakes for vitamins and minerals to the European Commission (for more information please check EFSA tolerable upper intake levels for vitamins and minerals and overview on tolerable upper intake levels.

There are nevertheless EU countries that set their own maximum levels in national regulations based on the risk assessment of their local scientific bodies, e.g. Belgium (to know more about it, click here).

In January 2018, the Federal Institute for Risk Assessment (BfR) in Germany published their revised recommendations on maximum levels for vitamins and minerals in food supplements on the basis of new scientific findings. To have access to their latest recommendations, please click here (in German only). There are concerns that these safety limits are to some extent conservative (read more). In spite of this, these recommendations are not legally binding.

EFSA updated scientific guidance for health claims on antioxidants, oxidative damage and cardiovascular health

During this month, EFSA published the final guidance on the scientific requirements for health claims related to antioxidants, oxidative damage, and cardiovascular health. This guidance replaces the one from 2011. The guidance supports applicants in the preparation of their applications for the authorisation of health claims related to the antioxidants, oxidative damage, and cardiovascular health. For a full overview on the guidance, please click here.

EFSA and Nanotechnologies draft guidance

On the 12th January, EFSA opened a public consultation on its draft guidance for the risk assessment of nanoscience and nanotechnologies in the food and feed chain (Part 1: human and animal health). Please contribute! You have until March 4 to submit your comments.

NutraBusiness Intel

DSM buys BioCare Copenhagen

Global ingredients company DSM has acquired Biocare Copenhagen, expanding their gut health portfolio for an undisclosed price. With this acquisition, DSM will increase its gut health portfolio with probiotics. The company has showed interest in gut health ingredients beyond the well-known indications for digestive and immune health.

GSK considering Pfizer move

GSK has declared that they are looking at Pfizer consumer healthcare, but this not a business priority. Pfizer’s consumer division has been for sale since last year. It includes well-known brands such as Advil, Chapstick lip balm, and Centrum vitamins, and it could cost more than $15 billion.

Nestle takes the lead over Mylan, Reckitt in Merck KGaA’s OTC sale

It has been reported by Bloomberg that Nestle is currently the top bidder for Merck KGaA’s, offering up to $5 billion. According to the sources, companies previously interested in this business have dropped out of the bidding, including Perrigo and Bain and Cinven, while Reckitt Benckiser and Mylan are still in the running. Nestle, frontrunner at the moment, has been strengthening its health business, and acquired Atrium Innovations for $2.3 billion last month.

a&r dedicated services

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 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

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