Good Active Ingredient

EGF

INCI: SH-OLIGOPEPTIDE-1

CAS Number
62253-63-8
Function
Cell-communicating polypeptide (~6.2 kDa); binds EGFR driving keratinocyte and fibroblast proliferation; attenuates pro-inflammatory cytokines IL-1, IL-8, and TNF-ฮฑ in keratinocytes; wound re-epithelialization support; anti-aging active
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA distinguishes cosmetic vs drug based on intended use claims. Purely aesthetic claims (hydration, appearance) are permissible. Claims such as accelerates wound healing or promotes cell regeneration may trigger drug classification requiring CDER approval under 21 CFR. No GRASE classification (not a sunscreen active). No specific restrictions in 21 CFR for cosmetic use.

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

SH-Oligopeptide-1 (EGF); CAS 62253-63-8; ~6 kDa molecular weight. EU: permitted with responsible person safety assessment required. US: permitted for cosmetic claims only; therapeutic/drug claims trigger classification as drug. Limited systemic absorption due to high molecular weight restricting stratum corneum penetration. No allergic reactions or significant sensitization observed in clinical trials; genotoxicity and mutagenicity negative.

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Concern Level: Low

Regulatory Flags

no-sccs-opinion china-banned-variant drug-cosmetic-boundary claims-sensitive peptide-stability-required limited-dermal-absorption

Frequently Asked Questions

Is EGF safe in cosmetics?

SH-Oligopeptide-1 (EGF); CAS 62253-63-8; ~6 kDa molecular weight. EU: permitted with responsible person safety assessment required. US: permitted for cosmetic claims only; therapeutic/drug claims trigger classification as drug. Limited systemic absorption due to high molecular weight restricting stratum corneum penetration. No allergic reactions or significant sensitization observed in clinical trials; genotoxicity and mutagenicity negative. The EU classifies EGF as "permitted". Safety rating: GOOD.

Is EGF allowed in the EU?

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

What does EGF do in cosmetics?

EGF functions as: Cell-communicating polypeptide (~6.2 kDa); binds EGFR driving keratinocyte and fibroblast proliferation; attenuates pro-inflammatory cytokines IL-1, IL-8, and TNF-ฮฑ in keratinocytes; wound re-epithelialization support; anti-aging active. It is classified as a Active Ingredient in our database. CAS number: 62253-63-8.

What is the Margin of Safety for EGF?

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 EGF 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

Related Ingredients

Keratinocyte Growth Factor (KGF)
Good
Coffea Arabica Seed Extract
Good
Homosalate
Moderate
Thioctic Acid
Good
Acetyl Tetrapeptide-5
Excellent
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