112年度市售指甲油中甲醛、甲醇、苯及鄰苯二甲酸酯類成分之品質監測   全文下載

Market Surveillance of Nail Polish for Prohibited Ingredients Including Formaldehyde, Methyl Alcohol, Benzene and Phthalate Esters in 2023

為持續監測市售指甲油是否含有衛生福利部公告化粧品禁用成分甲醛（Formaldehyde）、甲醇（Methyl alcohol）、苯（Benzene）、鄰苯二甲酸二丁酯（Dibutyl phthalate, DBP）、鄰苯二甲酸二（2-甲氧基乙基）酯（Bis（2-methoxyethyl）phthalate, DMEP）、鄰苯二甲酸二正戊酯（Di-n-pentyl phthalate, DnPP）、鄰苯二甲酸二異戊酯（Diisopentyl phthalate, DiPP）、鄰苯二甲酸丁酯苯甲酯（Benzyl butyl phthalate, BBP）、鄰苯二甲酸二（2-乙基己基）酯（Di（2-ethylhexyl）phthalate, DEHP）及鄰苯二甲酸二正辛酯（Di-n-octyl phthalate, DnOP）等成分，衛生福利部食品藥物管理署於112年1至4月期間，委請各地方政府衛生局於轄區內藥粧店、大賣場、公司、百貨商行、商店、美容美髮材料行及美甲店等場所進行市售指甲油化粧品之抽樣，共抽得檢體50件，分別以高效液相層析法（High Performance Liquid Chromatography, HPLC）及氣相層析質譜法（Gas Chromatography/Mass Spectrometry, GC-MS）進行品質檢驗。參考食藥署公開建議檢驗方法檢測化粧品中禁用成分甲醛、甲醇、苯及鄰苯二甲酸酯類等成分。結果顯示，50件檢體（國產品33件，輸入品17件）中47件檢體檢出情形符合相關規定，占94%。有3件檢體不合格，2件檢出苯（均為國產品）及1件檢出甲醛（輸入品），以上不符規定檢體，相關檢驗結果均已函送地方衛生機關依化粧品衛生安全管理法之規定處理，以維護消費者使用化粧品之衛生安全。

In order to ensure nail polish products complies with the Taiwan cosmetic legislation, the Taiwan Food and Drug Administration (TFDA) initiated a market surveillance program of prohibited substances including formaldehyde, methyl alcohol, benzene and phthalate esters in nail polish in 2023. Fifty samples were randomly collected by the local health authorities from drugstores, hypermarkets, shops, department stores and nail salons from January to April, 2023. Samples were analyzed using high performance liquid chromatography (HPLC) and gas chromatography/mass spectrometry (GC-MS) in reference to the analytical methods posted on the TFDA website (www.fda.gov.tw) for formaldehyde, methyl alcohol, benzene and seven phthalate esters including dibutyl phthalate, bis(2-methoxyethyl)phthalate, diisopentyl phthalate, di-n-pentyl phthalate, benzyl butyl phthalate, di(2-ethylhexyl)phthalate and di-n-octyl phthalate. The results showed that of the 50 samples, 94% (47/50) samples complied with the regulation, in which 33 samples were domestic and 17 samples were imported. Two samples were found to contain the prohibited ingredient benzene and one sample was found to have formaldehyde. All of the violated cases were sent to the local health authorities for further administrative processing.