SCCS/1641/22 4 NOAEL rows Safety conclusion

codes ............................................... 10, Genistein and Daidzein

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1641/22.

Opinion Number

SCCS/1641/22

NOAEL Rows

Substances Covered

Substance(s) Covered

codes ............................................... 10 Genistein and Daidzein

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
codes ............................................... 10 446-72-0	NOAEL	100 mg/kg bw/d	repeated dose toxicity pig oral 28-day	SCCS Opinion p.27
codes ............................................... 10 446-72-0	NOAEL	100 mg/kg bw/d	repeated dose toxicity pig oral 28-day	SCCS Opinion p.27
codes ............................................... 10 446-72-0	NOAEL	100 mg/kg bw/d	repeated dose toxicity pig oral 28-day	SCCS Opinion p.27
codes ............................................... 10 446-72-0	NOAEL	100 mg/kg bw/d	repeated dose toxicity pig oral 28-day	SCCS Opinion p.27

Safety Conclusion

sccs_opinions Max Genistein: 0.007%; Daidzein: 0.02%

safe with restrictions

Key concerns: Phytoestrogen - endocrine disrupting properties; estrogenic activity; applies to aglycone forms only; combined aggregate exposure considered safe

Opinion date: 16 September 2022

safety_opinions general Max 0.007

safe

e and justified than the data from oral studies. The SCCS considers that the calculation of margin of safety (MoS) for daidzein based on the data from subcutaneous route would provide a more reliable indicator of SCCS/1641/22 Final version Corrigendum October 2022 Opinion on genistein and daidzein

Opinion date: 16 September 2022

Source Citation

Primary source https://health.ec.europa.eu/scientific-committees/scientific-committee-consumer-safety-sccs/sccs-opinions_en