Following the mandate given by the European Commission to the SCCS in the context of the safety assessment of substances with potential endocrine disrupting properties, the Scientific Committee has just published its preliminary Opinion on Genistein and Daidzein. It was adopted by written procedure on 12 January 2022 and is open for comments until 14 March 2022.
Background
Phytoestrogens are plant-derived compounds with structural similarity to 17β-estradiol, the primary female sex hormone. Among the phenolic compounds classified as phytoestrogens are isoflavones.
Among the most common isoflavones are Genistein (CAS No.446-72-0, EC No.207-174-9) and Daidzein (CAS No.486-66-8, EC No.207-635-4).
Currently, Genistein and Daidzein are not regulated under the Cosmetic Regulation (EC) No.1223/2009.
During the call for data, stakeholders submitted scientific evidence to demonstrate the safety of Genistein and Daidzein in cosmetic products.
For an exhaustive background information, see the articles
• Endocrine disruptors: 2nd call for data from the European Commission, CosmeticOBS, 22 February 2021
• Endocrine disruptors: 5 new requests for SCCS Opinions, CosmeticOBS, 15 March 2021
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, and in consideration of the potential endocrine disrupting properties of phytoestrogens, the SCCS considers that:
a) The use …
