Genistein and Daidzein

SCCS members: U. Bernauer (Rapporteur Daidzein), L. Bodin, Q. Chaudhry (Rapporteur Genistein), P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli (Rapporteur Genistein), B. Granum (former member), E. Panteri, V. Rogiers, Ch. Rousselle (Rapporteur Daidzein), M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz
Contact: SANTE-SCCSec [dot] europa [dot] eu (SANTE-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1641/22
Adopted on: 16 September 2022

A corrigendum to correct the bioavailability oral route for daidzein has been adopted on 11 October 2022

Conclusion of the opinion:

(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of phytoestrogens,
(a) does the SCCS consider genistein safe when used in cosmetic products up to a maximum concentration of 0.007%?
(b) does the SCCS consider daidzein safe when used in cosmetic products up to a maximum concentration of 0.02%?

From the safety assessment based on the available relevant data on the aglycone form of genistein and daidzein, and in consideration of the potential endocrine disrupting properties of phytoestrogens, the SCCS considers that:

a) the use of genistein (CAS No 446-72-0, EC No 207-174-9) in cosmetic products up to a maximum concentration of 0.007% is safe.

b) the use of daidzein (CAS No 486-66-8, EC No 207-635-4) in cosmetic products up to a maximum concentration of 0.02% is safe.

(2) Alternatively, according to the SCCS what is the maximum concentration of genistein and daidzein that is considered safe for individual and combined use in cosmetic products?

/

(3) Does the SCCS have any further scientific concerns with regard to the use of genistein and daidzein or other related phytoestrogens in cosmetic products?

/

Keywords:

SCCS, scientific opinion, genistein (CAS No 446-72-0, EC No 207-174-9), daidzein (CAS No 486-66-8, EC No 207-635-4), Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Scientific opinion on genistein and daidzein, preliminary version of 12 January 2022, final version of 16 September 2022, corrigendum of 11 October 2022, SCCS/1641/22.