Statement on the safety of EstroG-100TM as a novel food pursuant to Regulation (EC) No 258/97

TY - JOUR

T1 - Statement on the safety of EstroG-100TM as a novel food pursuant to Regulation (EC) No 258/97

AU - Sjödin, Anders Mikael

AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)

N1 - EFSA 2017 4778

PY - 2017/5/8

Y1 - 2017/5/8

N2 - 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-100TM as a novel food (NF) in the light of additional information submitted by the applicant. In its previous scientific opinion of 2016, the Panel concluded that EstroG-100TM, which is a hot-water extract of a mixture of three herbal roots, 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-100TM on liver and haematology 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 view of the Panel’s conclusion on the safety of EstroG-100TM, the applicant has now provided additional information on haematological and liver parameters for the human intervention study with EstroG-100TM and historical control data related to the subchronic 90-day oral toxicity study with EstroG-100TM. After assessing the additional information provided by the applicant, the Panel considers that the conclusion of the scientific opinion on the safety of EstroG-100TM 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.

AB - 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-100TM as a novel food (NF) in the light of additional information submitted by the applicant. In its previous scientific opinion of 2016, the Panel concluded that EstroG-100TM, which is a hot-water extract of a mixture of three herbal roots, 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-100TM on liver and haematology 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 view of the Panel’s conclusion on the safety of EstroG-100TM, the applicant has now provided additional information on haematological and liver parameters for the human intervention study with EstroG-100TM and historical control data related to the subchronic 90-day oral toxicity study with EstroG-100TM. After assessing the additional information provided by the applicant, the Panel considers that the conclusion of the scientific opinion on the safety of EstroG-100TM 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.

KW - Faculty of Science

KW - EstroG-100TM

KW - Cynanchum wilfordii

KW - Phlomis umbrosa

KW - Angelica gigas

KW - Novel food

KW - Safety

U2 - 10.2903/j.efsa.2017.4778

DO - 10.2903/j.efsa.2017.4778

M3 - Journal article

SN - 1831-4732

VL - 15

JO - E F S A Journal

JF - E F S A Journal

IS - 5

M1 - 4778

ER -