Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to update its scientific opinion on the safety of EstroG-100™ as a novel food (NF) in the light of additional information submitted by the applicant.
EstroG-100™ is 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. In its previous scientific opinion of 2016, the Panel concluded that EstroG-100™ is safe for the use in food supplements at the maximum intake level of 175 mg/day in post-menopausal women, which is lower than the maximum intake level proposed by the applicant (514 mg/day). The Panel reached its conclusions based on the effects of EstroG-100™ on liver and haematology (liver weight, reticulocytes, erythrocytes, albumin and total protein levels) as observed in several oral toxicity studies, the lack of information on liver and haematological parameters in human studies and the absence of chronic toxicity data. In particular, the effects of EstroG-100™ on liver were observed in a 28-day and 90-day oral toxicity study with EstroG-100™, and in 90-day oral toxicity studies with two of the three single constituents of EstroG-100™.
In view of the Panel’s conclusion on the safety of EstroG-100™, the applicant has now provided additional information on haematological and liver parameters for the human intervention study with EstroG-100™ and historical control data related to the subchronic 90-day oral toxicity study with EstroG-100™.
The Panel considers that historical control data may be used to assess the validity of the concurrent control group but do not per se invalidate the findings in an animal experiment, in particular if these findings were supported by those in other relevant studies.
The data provided on the human intervention study with EstroG-100™, which lasted only 12 weeks, reported no changes in liver and haematological parameters. However, the Panel considers that the absence of changes in liver parameters in the short-period human intervention study is not enough to dismiss the concerns on the effects of EstroG-100™ on liver which were consistently observed in four repeated-dose oral toxicity studies (28-day and 90-day oral toxicity studies with EstroG-100™ and 90-day oral toxicity studies with two of the three single constituents of EstroG-100™). Likewise, the absence of changes in haematological parameters in the same human intervention study is not enough to dismiss the concerns from the Panel on the effects of EstroG-100™ on haematological parameters which were observed in the subchronic 90-day toxicity study with EstroG-100™.
Thus, the Panel reconfirms that the no-observed-adverse effect level (NOAEL) derived from the subchronic 90-day oral toxicity study with EstroG-100™, which was supported by observations in other studies, is 500 mg/kg body weight (bw) per day. By applying the uncertainty factor of 200 to the NOAEL, the Panel has derived the maximum intake level of 2.5 mg/kg bw per day for the NF, which corresponds to 175 mg/day for an adult of 70 kg bw.
After assessing the additional information provided, the Panel considers that the conclusion of the scientific opinion on the safety of EstroG-100™ does not need to be revised and thus the Panel reconfirms that the NF is safe for the use in food supplements at the maximum intake level of 175 mg/day in post-menopausal women.
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