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 [...]
About Emilie-Marie VieubleThis author has not yet filled in any details.
So far Emilie-Marie Vieuble has created 127 blog entries.
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 [...]
a&r’s News Digest – We dedicate this May issue to Vitafoods Europe and some general news. Also, we have decided to repeat our seminar on the regulatory challenges for CBD-based products in the EU. Join us in June! […]
The new regulation on mutual recognition EU 2019/515 will enter into force on 19 April 2020 and will repeal the current EC 764/2008. According to the new regulation, member states will have to accept products that are lawfully marketed in another member state unless they can prove that the product poses a serious risk [...]
French authority agency (ANSES) releases statement that food supplements for joint health should be avoided by certain at-risk populations
A recent warning by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) states that diabetics, pregnant women, children, and those with certain food allergies should stop taking joint health supplements containing glucosamine and/or chondroitin sulfate due to a risk of adverse events. This statement comes as a result of an [...]
analyze & realize GmbH, a regulatory expert for natural health products, offers a seminar on the current regulatory situation for cannabidiol-containing food products in the EU. The interactive seminar provides an overview on the regulatory challenges that food business operators currently face and will explain the requirements for the submission of Novel Food applications [...]