As the leading European consultancy in nutrition and health, Nutraveris has worked with the Korean company Naturalendo Tech Co., Ltd in order to obtain the authorization to put EstroG-100® on the European market. Estro-G100® is a hot-water extract of a mixture of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz and Angelica gigas Nakai), already used in Korea, USA and Canada for the management of menopausal symptoms. After an initial evaluation from Ireland that didn’t raise any safety concern, EFSA was mandated by the European Commission at the request of some Member States for a scientific evaluation.
EFSA has now recognized that EstroG-100® is safe for the use of food supplements intended for post-menopausal women. The application provided a full characterization of the three botanicals as of the combination. Moreover, the safety of EstroG-100T® was substantiated by in vitro and in vivo studies conducted either with EstroG-100® or single herbs. The applicant provided also two human clinical trials highlighting the safe use of EstroG-100® in post-menopausal women.
This success demonstrates once again the strengths of Nutraveris, either in the preparation and submission of Novel Food applications, and in its follow-up during Member States and EFSA evaluations.
Do not hesitate to contact our team to obtain authorization for your ingredients.