Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
8 study endpoints found for Zinc Pyrithione. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 0.5 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| LOAEL | 1.39999997616 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 11 mg/kg bw/day | oral | primate | Subchronic | COSMOS_DB |
| LOAEL | 22 mg/kg bw/day | oral | primate | Subchronic | COSMOS_DB |
| NOAEL | 0.20000000298 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| LOAEL | 1 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 0.5 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| LOAEL | 1.5 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
SCCS NOAEL Values
NOAEL/LOAEL values cited in official SCCS opinions for Zinc Pyrithione.
| NOAEL | LOAEL | Route | Species | Study | DA% (SCCS) | Opinion |
|---|---|---|---|---|---|---|
| 2.5 mg/kg/day | 5 mg/kg/day | Oral | Rat | Subchronic (90-day) (90 days (gavage)) | 100 | SCCS/1614/19 (2020) |
| 1 mg/kg/day | 5 mg/kg/day | Oral | Rat | Subchronic (90-day) (90 days) | 100 | SCCS/1512/13 (2013) |
Sensitization Profile
Contact sensitization data for Zinc Pyrithione based on clinical patch test studies and IFRA standards.
Source: ESSCA; IVDK; NACDG
Expert Verdict
Banned in EU as of March 2022 due to CMR 1B reproductive toxicity status under CLP Regulation with no exemption granted under Art.15(2). Remains an FDA-approved OTC active in the US at 0.3–2% rinse-off. Do not use in EU-market products.
Regulatory Flags
Frequently Asked Questions
Is Zinc Pyrithione safe in cosmetics?
Banned in EU as of March 2022 due to CMR 1B reproductive toxicity status under CLP Regulation with no exemption granted under Art.15(2). Remains an FDA-approved OTC active in the US at 0.3–2% rinse-off. Do not use in EU-market products. The EU classifies Zinc Pyrithione as "prohibited". Safety rating: MODERATE. 8 toxicological study endpoint(s) are available in our database.
Is Zinc Pyrithione allowed in the EU?
Zinc Pyrithione EU regulatory status: prohibited. Maximum allowed concentration: 0%. This is based on EU Regulation 1223/2009 and its amendments.
What does Zinc Pyrithione do in cosmetics?
Zinc Pyrithione functions as: Anti-dandruff active; preservative (historical EU). It is classified as a Active Ingredient in our database. CAS number: 13463-41-7.
What is the Margin of Safety for Zinc Pyrithione?
adequate 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.
What is the NOAEL for Zinc Pyrithione?
The NOAEL (No Observed Adverse Effect Level) for Zinc Pyrithione is 0.5 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 8 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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Related Ingredients
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