FDA 2014 survey of eye area cosmetics for microbiological safety

Abstract

In an attempt to assess cosmetics containing ‘nontraditional’ preservatives, 93 eye area cosmetic products were selected based on labelled or marketed claims that these products were ‘green’, ‘natural’, ‘paraben‐free’, ‘preservative‐free’ or contained nontraditional preservatives (e.g. botanical extracts). Products were analysed for water activity, pH and microbiological content, which included enumeration of aerobic micro‐organisms, detection of microbial growth after a 7‐day enrichment and identification of microbial isolates. The survey found that 60% (56/93) of the eye area cosmetics were free of microbiological growth under test conditions, 32% (30/93) showed the presence of micro‐organisms at low levels (<100 CFU per ml or g) and 8% (7/93) showed microbiological growth at higher levels (> 100 CFU per ml or g). Gram‐positive bacteria such as Bacillus and Staphylococcus were the dominant genera identified in these cosmetic products, whereas Gram‐negative species were relatively uncommon. The survey found a positive association between lower water activity cosmetics and the presence of micro‐organisms in these products. Similarly, colour cosmetics were more likely to contain micro‐organisms than noncolour cosmetics. The most represented micro‐organisms in the survey were from genus Bacillus, suggesting that the natural raw materials are the likely source of observed microbial loads. Significance and Impact of the Study In the United States, cosmetic products are regulated postmarket; therefore, surveillance programmes are one of FDA's most important tools for monitoring microbiological safety of cosmetics. ‘Traditional’ preservatives, such as parabens and formaldehyde releasers, are perceived unfavourably by some consumers, resulting in cosmetic manufacturers increasingly using ‘nontraditional’ preservatives. FDA conducted an analytical survey of eye area cosmetics that claimed to be free of traditional preservatives and determined microbiological loads in tested products. This study explores the association of microbial loads with the physical and chemical characteristics of the cosmetic products, and points to the limits of preservative activity in cosmetics.

Microbiological Safety of Non-Food Products: What Can We Learn from the RAPEX Database?

“…The opportunistic pathogen S. aureus was identified in cosmetics and toys. Both intrinsic and extrinsic contaminations of cosmetics have been described [17,31,32]. However, a direct link between human infections and S. aureus -contaminated non-food products has not been reported yet.…”

Effect of leave‐on cosmetic antimicrobial preservatives on healthy skin resident Staphylococcus epidermidis

“…The global cosmetics market size was valued at $380.2 billion in 2019 and is projected to reach $463.5 billion by 2027 at an estimated annual growth rate of 5.3% 1 . Microorganism contamination presents a major challenge in the safety and quality of cosmetic products, thus preservatives are added to inhibit or kill the microbial infestation and extend their shelf‐life 2,3 . To ensure cosmetic safety and limit overuse of preservatives, agencies have used toxicological data to enlist certain preservatives and their maximum doses that could be added in cosmetics 2,4 …”

“…1 Microorganism contamination presents a major challenge in the safety and quality of cosmetic products, thus preservatives are added to inhibit or kill the microbial infestation and extend their shelf-life. 2,3 To ensure cosmetic safety and limit overuse of preservatives, agencies have used toxicological data to enlist certain preservatives and their maximum doses that could be added in cosmetics. 2,4 Human skin is the largest epithelial surface (approximately 30 m 2 ) that interacts with microbes.…”