各類化妝保養品中生菌數及病原菌之檢出和菌種類別

Total Viable Counts and Pathogens/Contaminants Recovered from Various Types of Cosmetics in Taiwan

劉梅玉(Mei-Yu Liu) ； 蔡岳廷(Yueh-Ting Tsai) ； 蔡文城(Wen-Cherng Tsai)

《檢驗及品保雜誌》 3卷1期 (2014/01) Pp. 1-7

https://doi.org/10.6573/JTQA.201401_3(1).01

摘要

化妝保養品在生產過程，常因各種因素導致最終產品的汙染，本研究以台灣衛生福利部食品藥物管理署公告的化妝品微生物容許量基準為依據，利用美國食品藥物管理局（Food and Drug Administration）出版的Bacteriological Analytic Manual（簡稱為FDA/BAM）所介紹的化妝品微生物檢測方法，評估自2012年1月至12月間由台美檢驗科技有限公司所檢測871件化妝保養品的衛生品質及安全。結果指出有109 件檢體受到細菌的汙染（佔12.5%，109／871）；根據各個檢體類別進行分析，結果顯示汙染率分別為：化妝水9.8%（10/102）、乳液26.1%（12/46））、乳霜6.2%（9/146）、面膜18.9%（20/106）、彩妝17.6%（18/102）、盥洗類7.4%（15/203）、按摩油0%（0/12）、香氛類14.8%（4/27）、藥膏類33.3%（1/3）、染髮劑0%（0/13）及其它18.02%（20/111）。若以生菌數評估化妝保養品的衛生狀況，發現菌量超過10^3CFU/g或mL（不合格標準）佔5.1%（44/871）。871件檢體中共有16件（1.84%）分離出不可含有或潛在的致病性，以香氛類及乳液類檢出的比例最高，分別為14.8%（4/27）及10.9%（5/46）；若以病原菌菌種類別來看，革蘭氏陰性桿菌佔62.5%（10/16），其次為革蘭氏陽性桿菌佔31.25%（5/16）；分析分離菌種類，以芽孢桿菌（Bacillus spp.）為最常見（5/16），其次為洋蔥伯氏菌（Burkholderia cepacia）（4/16）。根據上述檢測結果，吾等建議化妝保養品的生產廠家應嚴格遵守化妝品GMP規範，並嚴格監控最終產品的品質。同時，衛生主管單位應隨時抽檢市售化妝保養品的衛生安全狀況，以避免消費者受到感染。

關鍵字

化妝保養品污染率 ； 生菌數 ； 病原菌

並列摘要

During the manufacturing process for cosmetics, many factors may result in the final cosmetic products being contaminated by various kinds of microbes. Based on the ＂microbiological acceptance standards＂ promulgated by the Food and Drug Administration, Department of Health and Welfare, Taiwan, we conducted microbiological testing on various types of cosmetics by using the ＂microbiological methods for cosmetics＂ introduced in the ＂Bacteriological analytic manual＂ published by the Food and Drug Administration, U.S.A. Our survey on cosmetic quality and safety was conducted from January to December of 2012, and included the results for 871 specimens tested by Super laboratory Co. We found that 109 specimens (12.5%, 109/871) were contaminated by aerobic microorganisms. Further analysis of the cosmetic specimens by type indicated that the contamination rates were 9.8% (10/102) for the lotions tested, 26.1% (12/46) for emulsions, 6.2% (9/146) for creams, 18.9% (20/106) for masks, 17.6% (18/102) for make up products, 7.4% (15/203) for toiletries, 0% (0/12) for massage oils, 14.8% (4/27) for fragrances, 33.3% (1/3) for ointments, 0% (0/13) for hair dyes, and 18.0% (20/111) for all other products. We evaluated the sanitation conditions according to the total viable counts in the cosmetic samples. Those samples with counts of over 103 CFU/g or mL (nonconformity) accounted for 5.1% (44/871) of the total. A total of 16 (1.84%) objectionable or potential pathogens were isolated from among the 871 specimens. The higher contamination rates with objectionable organisms among type of cosmetics were fragrance and emulsion, i.e. 14.8% (4/27) and 10.9% (5/46), respectively. When further analyzed in terms of microbial category, Gram negative bacilli accounted for the highest percentage of pathogens at 62.5% (10/16), followed by Gram positive bacilli at 31.25% (5/16). When analyzed in terms of microbial species, the most frequently encountered species was Bacillus spp.s, followed by Burkholderia cepacia (4/16). Based on the above findings, we suggest that a cosmetics factory should strictly observe ＂good manufacturing practices＂ (GMPs) during their manufacturing process and pay special attention to monitoring the quality of their products. At the same time, a sanitation stakeholder department in the local government should periodically or not periodically select various types of cosmetic products sold in markets at random to test their sanitary conditions so as to prevent consumers from being infected by those frank or potential pathogens.

並列關鍵字

Cosmetics contamination rate ； Total viable count ； Objectionable microorganism