Open AccessStatement on the safety of EstroG‐100™ as a novel food pursuant to Regulation ( EC ) No 258/97
Author(s) -
Turck Dominique,
Bresson JeanLouis,
Burlingame Barbara,
Dean Tara,
FairweatherTait Susan,
Hein Marina,
HirschErnst Karen Ildico,
Mangelsdorf Inge,
McArdle Harry J,
Naska Androniki,
NeuhäuserBerthold Monika,
Nowicka Grażyna,
Pentieva Kristina,
Sanz Yolanda,
Siani Alfonso,
Sjödin Anders,
Stern Martin,
Tomé Daniel,
Vinceti Marco,
Willatts Peter,
Engel KarlHeinz,
Marchelli Rosangela,
Pöting Annette,
Poulsen Morten,
Schlatter Josef Rudolf,
Turla Emanuela,
Loveren Henk
Publication year - 2017
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2017.4778
Subject(s) - medicine , food safety , european commission , environmental health , toxicity , toxicology , business , european union , pathology , biology , economic policy
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. In its previous scientific opinion of 2016, the Panel concluded that EstroG‐100™, 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‐100™ 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‐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™. After assessing the additional information provided by the applicant, 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.