Microbiological Testing Requirements
Cosmetic products must meet an array of increasingly strict quality and safety requirements. Ensuring compliance across your product range, and its destination markets is complex.
SGS can help you to ensure cosmetic products meet all relevant microbiological requirements. Our experts have an in-depth understanding of the global regulatory landscape and will work with you to devise a program of microbiological testing that will assess the safety or efficacy of raw materials, components, ingredients and final products.
We can help you to understand the market and the requirements you will need to comply with.
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International ISO Standards
Test methods ISO Standard Preservative efficacy testing – Challenge test ISO 11930 Aerobic mesophilic bacteria – Total plate count ISO 21149 Yeast & mold ISO 16212 Pseudomonas aeruginosa ISO 22717 Staphylococcus aureus ISO 22718 Candida albicans ISO 18416 Escherichia coli ISO 21150 Microbiology low-risk products ISO 29621 Microbiological limits ISO 17516 -
China
Test methods Standard Standard plate counts GB/T 7918.2 Fecal coliforms GB/T 7918.3 Pseudomonas aeruginosa GB/T 7918.4 Staphylococcus aureus GB/T 7981.5 Aerobic plate count, fecal coliform, staphylococcus aureus, pseudomonas aeruginosa, molds and yeast Chinese Safety and Technical Standard of Cosmetics -
Europe
Test methods Standard Preservative efficacy testing – Challenge test EN ISO 11930 Aerobic Mesophilic Bacteria – Total plate count EN ISO 21149 Yeast and mold EN ISO 16212 Pseudomonas Aeruginosa EN ISO 22717 Staphylococcus aureus EN ISO 22718 Candida Albicans EN ISO 18416 Escherichia coli EN ISO 21150 Bactericidal activity EN ISO 13727 Bactericidal activity – Hygienic and surgical handrub and handwash EN 12054 Total aerobic microbial count (TAMC) – Microbial limit tests EU Pharmacopeia Total combined yeast and molds count (TYMC) – Microbial limit tests EU Pharmacopeia Pseudomonas aeruginosa/staphylococcus aureus/Escherichia coli EU Pharmacopeia Bile-tolerant gram-negative bacteria/salmonella/clostridia/candida albicans EU Pharmacopeia Microbiologically low-risk products EN ISO 29621 Microbiological limits EN ISO 17516 -
USA
Test methods Standard Aerobic plate count, aerobic mold and yeast count, staphylococcus aureus, pseudomonas aeruginosa, Enterobacteriaceae, anaerobic plate count FDA-BAM Chapter 23 Microbial limit tests: total aerobic microbial count, total combined yeasts and molds count US Pharmacopeia 61 Pseudomonas aeruginosa/staphylococcus aureus/Escherichia coli US Pharmacopeia 62 Bile-tolerant gram-negative bacteria/salmonella/clostridia/candida albicans US Pharmacopeia 62 Preservative efficacy testing – Challenge test US Pharmacopeia 51 -
Association of South East Asian Nations (ASEAN)
Test methods Standard Preservative efficacy test ASEAN ACM MAL 08 -
India
Test methods Standard Total plate count, aerobic mesophilic bacteria IS 14648 Yeast and mold IS 14648 Pseudomonas aeruginosa IS 14648 Staphylococcus aureus IS 14648 Candida albicans IS 14648 Escherichia coli IS 14648