Safety of EstroG-100™ as a novel food pursuant to Regulation (EC) No 258/97

ollowing a request from the European Commission, the EFSA Panel on Dietetic Products, Nutritionand Allergies (NDA ) was asked to deliver an opinion on EstroG-100TMas a novel food (NF) submittedpursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council. The NF isEstroG-100TM, a hot-water extract of a mixture of three herbal roots (Cynanchum wilfordii Hemsley,Phlomis umbrosa Turcz. and Angelica gigas Nakai), which is concentrated and spray-dried. Theinformation provided on the composition, specifications and sta bility of the NF is sufficient, and doesnot raise safety concerns. The applicant intends to use EstroG-100TMin food supplements, with aproposed maximum intake level of 514 mg/day. The target population is post-menopausal women. ThePanel considers that the information provided does not raise safety concerns as regards thegenotoxicity of the NF. The Panel considers that the no-observed-adverse effect level (NOAEL) derivedfrom the subchronic 90-day oral toxicity study with EstroG-100TM, which was supported by observationsin other studies, is 500 mg/kg body weight (bw) per day. Taking into account the NOAEL and theproposed maximum intake level, the Panel considers that the margin of safety of 68 is not sufficient.Based on the absence of chronic toxicity data, increase in effects with exposure duration in toxicitystudies, and the absence of investigatio ns of liver parameters and haematology in human studies, thePanel applies the uncertainty factor of 200 to derive the maximum safe intake level for the NF. Thus,the Panel concludes that the NF, EstroG-100TM, is safe for the use in food supplements at the maximumintake level of 175 mg/day for an adult of 70 kg bw.