An extract of three herbal roots, Cynanchum wilfordii, Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai (EstroG -100™) just received a novel food authorization under Regulation (EU) 2015/2283 (21st March 2018). This novel food ingredient can be used in food supplements intended for post-menopausal women. Prior to the authorization, there was a safety assessment by EFSA [...]
About Emilie-Marie VieubleThis author has not yet filled in any details.
So far Emilie-Marie Vieuble has created 64 blog entries.
Borderline cases in medical devices are considered to be those where it is not clear from the outset whether a given product is or is not a medical device. The European Commission released recently an update of the manual on borderline cases. Despite the fact that this is not legally binding, there is a high [...]
Let's meet at Vitafoods Europe 2018 – Booth E75! Do you have questions regarding regulations, scientific marketing, strategic innovation, licensing and matchmaking, or clinical research? Our team is passionate about the power of natural health products. We bring our expertise, enthusiasm, and creativity to delivering tailor-made innovation solutions that make [...]
Substance based MD, herbal combination as Novel Food, Union List update and proof of traditional use after Brexit
a&r’s News Digest – We dedicate this month’s issue to borderline cases for substance-based medical devices, novel food authorization for triple root extract, corrections to the Union List of Novel Foods and proof of tradition after UK’s withdrawal from the Union. […]
However, nine years after its enforcement in 2009, an evaluation by the EU Commission brought to light that, in practice, this regulation does not work satisfactorily. The EU has now agreed on an action plan to facilitate the Mutual Recognition process. The Mutual Recognition regulation EU 764/2008 was set up to support the free [...]
Due to the lack of action from the EU Commission defining maximum levels for vitamins and minerals, as was foreseen in the directive 2002/46/EC, more and more Member States are setting their own maximum levels. After Belgium, Norway, Denmark, Italy, and France, now the Spanish Council of Ministers has approved a decree containing maximum [...]
A large clinical trial with 900 subjects included over three winter seasons has been successfully completed for the Swedish company Probi AB to investigate the immune enhancing impact of the probiotic immune concept Probi Defendum®. For more information, please click here. Immune health is one of a&r's core competencies – please contact us if you are interested [...]
a&r’s News Digest – We dedicate this month’s issue to the mutual recognition guidance and EFSA’s scientific opinion on health claims. […]
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 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 [...]