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A guidance document on microbiological control of cosmetic products

Contents

Preface

Sammenfatning og konklusioner

Summary and conclusions

1 Introduction

• 1.1 Background
• 1.2 Legislation
• 1.3 Definitions
• 1.4 Human Safety
• 1.5 Dossier
• 1.6 Good Manufacturing Practice
• 1.7 Durability labeling

2 2 Microbiological control

• 2.1 Microbiological control of final product
• 2.2 Microbial contamination
  • 2.2.1 During manufacturing
  • 2.2.2 After opening
• 2.3 Preservation

3 Laboratories

• 3.1 Quality Management
  • 3.1.1 Quality management standards
  • 3.1.2 Approach to quality management in microbiology laboratories
  • 3.1.3 Requirements to quality management

4 Analytical Methods

• 4.1 Standards under development
• 4.2 Neutralization and preparation of water-immiscible samples.
• 4.3 Examination of microbial quality of products
  • 4.3.1 ISO 21149 Cosmetics – Microbiology – Enumeration and detection of aerobic mesophilic bacteria
  • 4.3.2 ISO 18415 Cosmetics – Microbiology – Detection of specified and non-specified micro-organisms.
  • 4.3.3 ISO- methods for the detection of specific microorganisms: E. coli (ISO 21150), Pseudomonas aeruginosa (ISO 22717), Staphylococcus aureus (ISO22718) and Candida albicans (ISO 18416).
  • 4.3.4 ISO/FDIS 16212 Cosmetics – Microbiology – Enumeration of yeast and mould.
• 4.4 Efficacy of preservation – Proposal for a Challenge test-not validated
  • 4.4.1 Proposed procedure for challenge testing

5 References

Appendix 1: Standardisation mandate assigned to CEN concerning good manufacturing practice for cosmetics products

• 1. MOTIVATION
• 2. DESCRIPTION OF THE MANDATED WORK
• 3. BODIES TO BE ASSOCIATED
• 4. EXECUTION OF THE MANDATED WORK

Appendix 2: Challenge test of water miscible cosmetic products

• 1.1 Purpose
• 1.2 Principle
• 1.3 Scope
• 1.4 References
• 1.5 Equipment
• 1.6 Test organisms
• 1.7 Chemicals and substrates
• 1.8 Procedure
  • 1.8.1 Preparation of inocula
  • 1.8.2 Preparation of challenge test samples
  • 1.8.3 Sampling and incubation
  • 1.8.4 Analysis of samples
• 1.9 Validity criteria
  • 1.9.1 Validity of analyses
  • 1.9.2 Validity of test organisms and neutralising agent
• 1.10 Acceptance criteria

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Version 1.0 January 2010, © Danish Environmental Protection Agency