Moderate Active Ingredient

Bee Venom

INCI: APIS MELLIFERA (BEE) VENOM

CAS Number
8031-67-2
Function
lip plumping agent, skin-conditioning
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes FDA permits bee venom in cosmetics under FD&C Act provided product is safe under labeled conditions. Therapeutic claims (e.g., arthritis treatment) reclassify the product as a drug requiring FDA approval. No GRAS status (GRAS is food-only). FDA issued warning letter (Bee Delightful, Dec 2020) for unapproved drug claims. MoCRA PFAS/heavy metals provisions do not specifically target bee venom.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Bee venom is permitted in cosmetics under EU and US regulations but contains documented major allergens (phospholipase A₂, hyaluronidase, Api m 10) with high sensitization prevalence and anaphylaxis risk in atopic or previously sensitized individuals; apamin component is neurotoxic; therapeutic claims trigger drug classification.

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Concern Level: High

Regulatory Flags

no-sccs-opinion no-cir-review eu-permitted-no-annex major-allergen anaphylaxis-risk neurotoxin-component animal-derived drug-claim-risk

Frequently Asked Questions

Is Bee Venom safe in cosmetics?

Bee venom is permitted in cosmetics under EU and US regulations but contains documented major allergens (phospholipase A₂, hyaluronidase, Api m 10) with high sensitization prevalence and anaphylaxis risk in atopic or previously sensitized individuals; apamin component is neurotoxic; therapeutic claims trigger drug classification. The EU classifies Bee Venom as "permitted". Safety rating: MODERATE.

Is Bee Venom allowed in the EU?

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

What does Bee Venom do in cosmetics?

Bee Venom functions as: lip plumping agent, skin-conditioning. It is classified as a Active Ingredient in our database. CAS number: 8031-67-2.

What is the Margin of Safety for Bee Venom?

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.

Compliance Tools

Check Bee Venom compliance across multiple jurisdictions:

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Ingredient Decoder
Paste a full ingredient list for instant analysis
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
Check compliance across 55 jurisdictions
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
Compare limits across jurisdictions

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