The EU novel food application for the mix of three herbal root extracts Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz and Angelica gigas Nakai was filed by French consultancy and CRO Nutraveris on behalf of the Korean company Naturalendo Tech back in 2014.
Following concerns over the potential estrogenic action of the herbal mix marketed as EstroG-100 the initial application to the Irish authority was forwarded to EFSA.
EFSA’s Dietetic Products, Nutrition and Allergies (NDA) panel put those concerns to rest by concluding the botanical mix is safe for the use in food supplements at the maximum intake level of 175 mg per day for adults weighing 70 kg.
“Based on the observations from animal and in vitro studies on potential oestrogenic effect of the novel food, the Panel considers that EstroG-100 does not exhibit classical oestrogenic effects,” EFSA wrote in its opinion.
The Korean current
Dr Jérôme le Bloch, scientific project manager for Nutraveris, told us: “The application is significant since it’s the first Korean ingredient authorised in Europe through the novel food procedure."
Fellow South Korean company Daesang Corp may be close on Naturalendo's tail, with the UK Food Standards Agency (FSA) recently drafting a positive novel food verdict for its DHA-rich algal oil, claiming ‘substantial equivalence’ to an already-approved oil produced by DSM-owned Martek Biosciences.
EFSA is also looking at a novel food application for seaweed phlorotannins from Korean firm Botamedi.
Naturalendo's botanical ingredients are not listed on the BELFRIT list of about 1,000 botanicals deemed safe by scientists in Belgium, France and Italy.
le Bloch said the mixture of the three herbs had been used for centuries in Korea.
"As far as I know this is the first time that a novel food containing three herbs is authorised. This explains why the application has been so difficult and so long, and why we are proud of this approval.”
The ingredient is already marketed in Korea, the US and Canada for the management of menopausal symptoms.
“EstroG-100 has a significant impact on hot flashes and night sweats, vaginal dryness, insomnia, nervousness, feeling blue, dizziness, and fatigue—and some women see noticeable improvements within just 7-10 days. All other botanical choices take six weeks,” according to the herbal's US website, claims which have not been verified by the US Food and Drug Administration (FDA).
EU novel food assessments do not address the efficacy of an ingredient, rather their safety profile.