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 final Opinion on Genistein and Daidzein. It was adopted by written procedure on 16 September 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.
The Scientific Committee issued its preliminary Opinion in January 2022, with a favourable opinion for Genistein (at 0.007%) and an unfavourable opinion for Daidzein.
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
• Genistein, Daidzein: preliminary Opinion of the SCCS, CosmeticOBS, 17 January 2022
This Opinion has been subject to a commenting period of eight weeks after its initial publication (from 13 January to 14 March 2022). Comments received during this period were considered by the SCCS. For this Opinion, the main changes were in the section 3.3.6. mutagenicity and genotoxicity, as well as relevant parts in the discussion, conclusion and reference sections.
Final Opinion
1. In light of the data provided and taking under …