Background – What changed from MDD to MDR? What are the main implications for substance-based medical devices? In May 2017, the Medical Device Regulation (EU) 2017/745 (MDR) entered into force, replacing the old Medical Decide Directive (MDD; 93/42/EEC medical devices). So theoretically, for a time period of 3 years following the entry into force [...]
We dedicate this August issue to how to keep your substance-based medical devices on the market. We can support you! […]
Let's meet at Vitafoods Asia – Booth P18! Vitafoods Asia is the No. 1 nutraceutical trade show in Asia, bringing together science, business, and government agencies. If you are planning to be in Singapore between the 25th and 26th of September, meet our team of experts at booth P18 during Vitafoods Asia. [...]
Under EU regulations, any food that was not consumed “significantly” prior to May 15, 1997 is considered to be a Novel Food (EU) 2015/2283) and requires a pre-market authorization. According to the Novel Food Regulation, two types of applications – for “typical” Novel Foods (Article 10) and for traditional foods from third countries (non-EU) [...]
The new Medical Devices Regulation (EU) 2017/745 (MDR) entered into force in May 2017, replacing the old Medical Decide Directive (MDD; 93/42/EEC medical devices). For a time period of 3 years following the entry into force of the MDR, manufacturers can decide to certify their products either under the new MDR or under the [...]
We dedicate this July issue to the current situation regarding the insufficient number of certified Notified Bodies under the new Medical Device Regulation (MDR). Also, recent innovations from traditional foods from third countries will be discussed. […]
The EFSA Panel on Nutrition, Novel foods and Food Allergens (NDA) just published a scientific opinion on chia seeds (Salvia hispanica L.) powders as novel foods (NFs) pursuant to Regulation (EU) 2015/2283. According to the EFSA panel, the partially defatted powders of whole chia seeds are considered safe under the assessed conditions of use. [...]
NEWS DIGEST by a&r | June 2019 We dedicate this issue to regulatory news on EFSA new scientific opinion on Chia powders. Also, an overview on current mergers and acquisitions (M&A) in the sector is provided. […]
EFSA will extend their dedicated services to applicants from small and medium-sized enterprises (SMEs). SMEs will now be able to access support from EFSA when preparing, submitting, and monitoring their applications for regulated products. EFSA will use the experience gained in providing these new forms of support to decide whether to include them in [...]
Vitafoods Europe is the perfect place to learn what is happening in the nutraceutical market. The show offers an excellent opportunity to engage in in-depth conversations with clients about opportunities in natural health products innovation. We hope you were able to find some time to stop by our booth and meet the team. We [...]
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.
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.
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.
Earlier this month, Nestlé announced that it agreed to acquire Atrium Innovations (transaction to be completed Q1 2018). Atrium is globally recognized for the development, production, and commercialization of innovative and scientifically-proven natural health products. Its strategy is complementary with Nestlé science-based natural solutions for consumers and health care professionals. With this acquisition, Nestlé will extend its consumer healthcare nutrition portfolio, and Atrium will compete more effectively in the global market place.
A clear evidence that silos between industries will be breaking down in the future.
Walgreens has announced that it will invest $416 million to acquire 40% stake in Sinopharm Holding GuoDa Drug Store Co., Ltd (GuoDa). Walgreens is the second-largest pharmacy store chain in the US behind CVS Health. GuoDa retails pharmaceutical and healthcare products across China.
Walgreens was already present in China through Alliance Boots. This new investment highlights the interest of Walgreens in the Chinese fast-paced retail pharmacy business.
Walgreens investment took place in the same week that CVS announced to spend $69 billion to buy Aetna, the third largest health insurer in the U.S. CVS also has international operations but has not revealed interest in China yet.
Frutarom licensed AB-FORTIS in 2012 and now is buying the patent. AB-Fortis is a micro-encapsulation system that allows delivering 100% of the recommended daily amount of iron in a single dose, with high bioavailability and no adverse effects in taste or during digestion. “AB-Fortis expands Frutarom’s diverse product portfolio in the growing field of specialty healthy ingredients,” says Dr Raimund C. Hoenes, General Manager of Frutarom Health. With this transaction, AB-BIOTICS will focus on its probiotics business, which represents 87% of its total sale. In addition, the sales of AB-FORTIS will support the great R&D investment that AB-BIOTICS has done to reinforce their current probiotics concepts.
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.
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.