Regulatory Status
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Safety Data
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Expert Verdict
Bromelain is an effective proteolytic exfoliant with a documented sensitisation rate of 2.3%, significantly higher than papain, compounded by cross-reactivity risk in latex-allergic individuals. Stability validation throughout shelf life is mandatory, and use is contraindicated on compromised skin or in latex-sensitive consumers.
Regulatory Flags
Frequently Asked Questions
Is Bromelain safe in cosmetics?
Bromelain is an effective proteolytic exfoliant with a documented sensitisation rate of 2.3%, significantly higher than papain, compounded by cross-reactivity risk in latex-allergic individuals. Stability validation throughout shelf life is mandatory, and use is contraindicated on compromised skin or in latex-sensitive consumers. The EU classifies Bromelain as "permitted". Safety rating: MODERATE.
Is Bromelain allowed in the EU?
Bromelain EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Bromelain do in cosmetics?
Bromelain functions as: Proteolytic enzyme from Ananas comosus (pineapple). Hydrolyses keratin protein bonds for controlled exfoliation with lower irritation than acid peels. Activity quantified in GDU/CDU units. Demonstrates effective proteolytic activity for stratum corneum removal. Formulation instability (pH- and temperature-dependent enzyme activity) remains a key technical challenge. EU CPSR compliance requires enzyme activity unit documentation and shelf-life stability data.. It is classified as a Active Ingredient in our database. CAS number: 9001-00-7.
What is the Margin of Safety for Bromelain?
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.
Compliance Tools
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Related Ingredients
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