Good Antioxidant NOAEL Data

ROSMARINUS OFFICINALIS LEAF EXTRACT

CAS Number
84604-14-8
Function
Botanical antioxidant preservative and active from Rosmarinus officinalis (rosemary) leaves. Active constituents: carnosic acid and carnosol (diterpene phenols — primary chain-breaking antioxidants), rosmarinic acid (polyphenol — radical scavenger and anti-inflammatory), ursolic acid, and caffeic acid. Multiple antioxidant mechanisms: HAT (carnosic acid/carnosol), SET (rosmarinic acid), and chelation of pro-oxidant metal ions. ISO 16128 NI=1. Used as natural alternative to synthetic antioxidants (BHT, BHA) for product stabilisation and as anti-inflammatory skin active. Anti-microbial secondary activity (limited broad-spectrum efficacy vs synthetic preservatives).
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes Permitted without restriction. GRAS for food use (rosemary extract). ISO 16128 NI=1. CRITICAL STABILITY WARNING: rosemary extract (ORE) acts as a pro-oxidant at 40°C in fatty acid/oil systems (documented in raspberry seed oil nanoemulsion stability study). This is temperature-sensitive behaviour not seen with synthetic antioxidants (BHT remained stable at 40°C in the same study). Stability testing at 40°C/75% RH is mandatory for products using rosemary as primary antioxidant. MoCRA safety substantiation required.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
moderate
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

8 study endpoints found for ROSMARINUS OFFICINALIS LEAF EXTRACT. 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 200 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 130 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 130 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 1500 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
dose_tested 200 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
dose_tested 130 mg/kg bw/day oral rat Developmental COSMOS_DB
dose_tested 130 mg/kg bw/day oral rat Developmental COSMOS_DB
dose_tested 1500 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB

Expert Verdict

Rosemary extract is a widely used natural antioxidant with genuine efficacy as a product stabiliser and anti-inflammatory skin active. ISO 16128 NI=1 — fully natural, COSMOS-approved. A comparative stability study of rosemary extract (ORE) vs BHT in raspberry seed oil nanoemulsions found both were stable at 5°C and 25°C, but ORE became pro-oxidant at 40°C while BHT remained protective. This is a temperature-dependent failure mechanism that could destroy product batches stored or used in warm climates. For any formulation using rosemary extract as primary antioxidant: mandatory accelerated stability testing at 40°C/75% RH; consider BHT/BHA or mixed tocopherol co-antioxidant for thermal protection. Efficacy as a broad-spectrum antimicrobial preservative is inferior to synthetic systems — not a standalone preservation solution.

⚠️
Concern Level: Low

Regulatory Flags

antioxidant natural-source iso-16128-ni1 pro-oxidant-at-40c temperature-sensitive stability-risk not-standalone-preservative anti-inflammatory cosmos-approved warm-climate-caution eu_children_restricted fda_food_additive

Frequently Asked Questions

Is ROSMARINUS OFFICINALIS LEAF EXTRACT safe in cosmetics?

Rosemary extract is a widely used natural antioxidant with genuine efficacy as a product stabiliser and anti-inflammatory skin active. ISO 16128 NI=1 — fully natural, COSMOS-approved. A comparative stability study of rosemary extract (ORE) vs BHT in raspberry seed oil nanoemulsions found both were stable at 5°C and 25°C, but ORE became pro-oxidant at 40°C while BHT remained protective. This is a temperature-dependent failure mechanism that could destroy product batches stored or used in warm climates. For any formulation using rosemary extract as primary antioxidant: mandatory accelerated stability testing at 40°C/75% RH; consider BHT/BHA or mixed tocopherol co-antioxidant for thermal protection. Efficacy as a broad-spectrum antimicrobial preservative is inferior to synthetic systems — not a standalone preservation solution. The EU classifies ROSMARINUS OFFICINALIS LEAF EXTRACT as "permitted". Safety rating: GOOD. 8 toxicological study endpoint(s) are available in our database.

Is ROSMARINUS OFFICINALIS LEAF EXTRACT allowed in the EU?

ROSMARINUS OFFICINALIS LEAF EXTRACT EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does ROSMARINUS OFFICINALIS LEAF EXTRACT do in cosmetics?

ROSMARINUS OFFICINALIS LEAF EXTRACT functions as: Botanical antioxidant preservative and active from Rosmarinus officinalis (rosemary) leaves. Active constituents: carnosic acid and carnosol (diterpene phenols — primary chain-breaking antioxidants), rosmarinic acid (polyphenol — radical scavenger and anti-inflammatory), ursolic acid, and caffeic acid. Multiple antioxidant mechanisms: HAT (carnosic acid/carnosol), SET (rosmarinic acid), and chelation of pro-oxidant metal ions. ISO 16128 NI=1. Used as natural alternative to synthetic antioxidants (BHT, BHA) for product stabilisation and as anti-inflammatory skin active. Anti-microbial secondary activity (limited broad-spectrum efficacy vs synthetic preservatives).. It is classified as a Antioxidant in our database. CAS number: 84604-14-8.

What is the Margin of Safety for ROSMARINUS OFFICINALIS LEAF EXTRACT?

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 ROSMARINUS OFFICINALIS LEAF EXTRACT?

The NOAEL (No Observed Adverse Effect Level) for ROSMARINUS OFFICINALIS LEAF EXTRACT is 200 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 8 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

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