a&r’s News Digest – We dedicate this month’s issue to regulatory news on the recent changes on maximum levels for vitamins and minerals in Belgium, substance-based Medical Devices and the urgent need to conform to the new regulation, an overview on the nutraceutical market place, and a&r at CPhI.



Belgium’s new Royal Order on upper levels for vitamins and minerals

At the end of October, Belgium modified its maximum levels for certain vitamins, minerals, and trace elements in food supplements and fortified foods. This amendment to the Royal Order of 3 March 1992 has been in force since November 10th, but there is a two-year transition period for the products that are already on the market.

Main changes for Vitamin levels:

  • Elimination of the existing maximum levels for vitamin B1 (thiamin), vitamin B2 (riboflavin), vitamin B12, pantothenic acid, biotin, and chloride.
  • Increase of the maximum levels of vitamin C (1000 mg), vitamin D (75 µg), vitamin E (39 mg), vitamin K (210 µg), and folic acid (500 µg).
  • Decrease of the maximum levels for 2 forms of vitamin B3 (nicotinic acid and inositol hexanicotinate) from 54 to 10 mg.

Main changes for Mineral levels:

  • New maximum levels for boron (3 mg) and fluoride (1.7 mg).
  • Increase of the maximum levels of iron (45 mg) and copper (2 mg).
  • Decrease of the maximum levels for manganese to 1 mg (from 5.25 mg).

Several warnings are now mandatory on the labelling of foods that contain a daily dose exceeding the levels for certain nutrients like vitamin E, vitamin K, potassium, and zinc. For more detailed information on the decree, please visit: https://www.health.belgium.be/en/node/24581

When it comes to EU mutual recognition, a written application can be submitted to the Belgium authorities showing evidence that the product has been legally marketed in another Member State.

Belgium is not the only EU country setting maximum levels for vitamins and minerals. Other countries have either already adopted (e.g. Italy) or are working on new maximum levels of vitamins and minerals, e.g. Germany.

Medical Devices Regulation (MDR)

Early this year, the European Union has adopted a new Regulation on Medical Devices that entered into force in May and replaces the existing Directive – Regulation (EU) 2017/745.

The new regulation will handle borderline products more strictly. As a consequence, substance-based Medical Devices can no longer be classified as class I, but will be at least class II-a or II-b. Probiotics (live bacteria) are explicitly mentioned as no longer being acceptable as ingredients for Medical Devices. This means that many of the currently marketed oral Medical Devices will have to either be re-classified or transferred to a new product category.

For a time period of 3 years following entry into force of the Regulation on Medical Devices, manufacturers may decide to certify their products either under the new MDR or under the old Medical Device Directive (MDD). However, after 2020, this will no longer be possible.

Marketers should be prepared to upgrade their substance-based products. Do not wait for 2020; be ready now! If you need support for updating the technical documentation of your products (e.g. biological and clinical evaluation, literature based or based on your own clinical data), we are here for you. Please contact us for more information.

We will run a webinar on this topic early next year. More information will follow soon. Stay tuned!

NutraBusiness Intel

Relevium signs pre-agreement to acquire nutraceutical brand

Relevium has signed a non-binding agreement to acquire an American nutraceutical e-brand that sell their products mainly through Amazon.

Relevium is a publicly traded company focused on growth through the acquisition of businesses, products and/or technologies with a focus on e-commerce in the growing health and wellness market. The value of this transaction is currently estimated at 1,15 mill EUR and it is foreseen to be closed on the 30th of November this year.

Last summer, Relevium completed the acquisition of BioGanix, another e-commerce brand and they have plans to conclude more transactions with e-retail brands in the future.

MeriCal acquires GHI to become leaders in Probiotics

MeriCal, a contract manufacturer and packager of high quality probiotics and nutritional supplements, has recently signed a final commercial agreement to acquire Global Health Industries (GHI).

GHI is highly specialized in the manufacturing of probiotics. MeriCal’s acquisition of GHI will increase market competitiveness and will drive international expansion.

Roha Acquires New Food Industry S.p.A

In September, color-ingredients manufacturer Roha (India) completed the acquisition of New Foods Industry S.p.A., an Italian company.

Roha is a leader in the color-ingredients market worldwide, and New Foods Industry is specialized in dry ingredients for the food and beverage industries.

This is the third acquisition for Roha during this year, enabling its further consolidation in the color business.

CPhI Worldwide, Frankfurt

a&r take home message

CPhI Worldwide took place between November 24th and 26th, co-locating once again with ICSE, P-MEC, InnoPack and FDF. With about 45,000 pharma industry professionals from over 150 countries participating, this is one of the most important pharmaceutical trade shows. Even though the focus of this trade show is more on synthetic-chemical medicinal products and their production, visitors interested in natural health products will also benefit from visiting.

There were 194 exhibitors for natural extracts from all over the world, 13 probiotic exhibitors, several exhibitors focused on TCM medicine, and even several CBD/hemp based products. Impressive was the large Brazilian corner in Hall 11. The importance of EU quality standards for natural extracts has more or less reached all foreign manufacturers.

New delivery forms are also of importance for natural health products.

The main observed trends:

  • More and more exhibitors for “tasty”, “treat yourself” medicine/health products in dosage forms of gummies, drops, chocolate or lollipops.
  • Roll-on applications in place of creams or salve
  • Single-use dosages
  • Trends moving in the direction of convenience, but unfortunately not so much in the direction of sustainability.

If you are planning to attend this fair next year, get ready for a half marathon exploring the halls, or just let us be your eyes and ears! Please feel free to contact us if you have any specific question or request related to our visit at CPhI.

a&r 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/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

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