Saw Palmetto Extract

INCI: SERENOA SERRULATA FRUIT EXTRACT

CAS Number
84604-15-9
Function
5-alpha-reductase inhibitor; DHT modulator; hair-loss active; anti-androgenic
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes No FDA restriction for cosmetic use. Saw palmetto is regulated as dietary supplement under DSHEA when ingested; topical cosmetic use is unrestricted. Hormonal mechanism (5-alpha-reductase inhibition) is relevant for oral exposure; systemic concern low for topical formulations.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Saw palmetto extract (CAS 84604-15-9) is permitted in the EU without restriction and not listed on the FDA prohibited/restricted cosmetic ingredient list for topical use, with low systemic absorption and minimal sensitization risk.

โš ๏ธ
Concern Level: Low

Regulatory Flags

hormonal-activity pregnancy-caution rare-sensitizer no-cir-assessment 5-alpha-reductase-inhibitor

Frequently Asked Questions

Is Saw Palmetto Extract safe in cosmetics?

Saw palmetto extract (CAS 84604-15-9) is permitted in the EU without restriction and not listed on the FDA prohibited/restricted cosmetic ingredient list for topical use, with low systemic absorption and minimal sensitization risk. The EU classifies Saw Palmetto Extract as "permitted". Safety rating: GOOD.

Is Saw Palmetto Extract allowed in the EU?

Saw Palmetto Extract EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Saw Palmetto Extract do in cosmetics?

Saw Palmetto Extract functions as: 5-alpha-reductase inhibitor; DHT modulator; hair-loss active; anti-androgenic. It is classified as a Active Ingredient in our database. CAS number: 84604-15-9.

What is the Margin of Safety for Saw Palmetto Extract?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

๐Ÿ“ฑ

Is Saw Palmetto Extract in Your Products?

Scan any product label with Piro โ€” our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free โ†’

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Saw Palmetto Extract in your formulation.