🧫 Product Risk Assessment

Low Risk
Medium Risk
High Risk

🛡️ Preservative Selection

Traditional
Natural
Broad Spectrum
Specialty

🔬 Challenge Testing

Bacteria
• Pseudomonas aeruginosa
• Staphylococcus aureus
• Escherichia coli
Yeasts & Molds
• Candida albicans
• Aspergillus niger
• Saccharomyces cerevisiae

Challenge Test Protocol

ISO 11930 / USP 51 Standards:
• Initial inoculum: 10⁵-10⁶ CFU/g
• Test duration: 28 days
• Sampling: 0, 1, 2, 7, 14, 28 days
• Temperature: 20-25°C
• Pass criteria: ≥3 log reduction

⚖️ Regulatory Compliance

Key Regulatory Limits

EU (Annex V): Maximum concentrations defined
FDA: Generally recognized as safe (GRAS)
Health Canada: Cosmetic Ingredient Hotlist
JFRL: Positive list system
NMPA China: Approved preservatives list

💡 Safety Considerations

  • Always use minimum effective concentration
  • Consider synergistic combinations to reduce individual levels
  • Monitor for sensitization potential in sensitive populations
  • Validate efficacy through proper challenge testing
  • Document all safety assessments and testing