Good Antioxidant NOAEL Data

Rosemary Extract

INCI: ROSMARINUS OFFICINALIS LEAF EXTRACT

CAS Number
84604-14-8
Function
antioxidant, preservative booster, antimicrobial
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes GRAS status confirmed under 21 CFR 182.10 (spice/flavoring) and 21 CFR 182.20 (essential oil/natural extractive). CIR Expert Panel (2018) concluded safe as used when formulated to be non-sensitizing, with <=0.2% as the tested safe leave-on concentration.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

8 study endpoints found for Rosemary 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

CAS 84604-14-8 (EINECS 283-291-9). EU: Permitted under Regulation (EC) 1223/2009; not listed in any restrictive Annex. Contains fragrance allergens linalool and limonene requiring label declaration above thresholds. US: GRAS under 21 CFR 182.10, 182.20, 582.10. CIR 2018 concluded safe as used when formulated to be non-sensitizing at <=0.2% leave-on.

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Concern Level: Low

Regulatory Flags

fragrance-allergen contact-dermatitis-risk eu-allergen-labeling-required botanical eu_children_restricted fda_food_additive

Frequently Asked Questions

Is Rosemary Extract safe in cosmetics?

CAS 84604-14-8 (EINECS 283-291-9). EU: Permitted under Regulation (EC) 1223/2009; not listed in any restrictive Annex. Contains fragrance allergens linalool and limonene requiring label declaration above thresholds. US: GRAS under 21 CFR 182.10, 182.20, 582.10. CIR 2018 concluded safe as used when formulated to be non-sensitizing at <=0.2% leave-on. The EU classifies Rosemary Extract as "permitted". Safety rating: GOOD. 8 toxicological study endpoint(s) are available in our database.

Is Rosemary Extract allowed in the EU?

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

What does Rosemary Extract do in cosmetics?

Rosemary Extract functions as: antioxidant, preservative booster, antimicrobial. It is classified as a Antioxidant in our database. CAS number: 84604-14-8.

What is the Margin of Safety for Rosemary 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.

What is the NOAEL for Rosemary Extract?

The NOAEL (No Observed Adverse Effect Level) for Rosemary 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.

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