台灣地區化妝品之品質檢驗概況（77~79年度）

REPORT ON LABORATORY FINDINGS OF COSMETIC QUALITY IN TAIWAN, 1988-1990

80年5月立法院通過之化妝品衛生管理條例部份條文修正案，授權衛生署對於一些未含有醫療或毒劇藥品之化妝品，得免除上市前備案許可之程序。衛生署亦於80年8月公告明定化妝品之範圍及種類，並詳列免予申請備查之一般化妝類別品目。化妝品衛生管理自此邁入一新階段，藥物食品檢驗局負責全國各類化妝品之檢驗業務，藉此管理制度新舊更替之際，將現行抽驗化妝品檢驗概況詳加敘述，並依照化妝品類別、抽驗地區等分別統計三年（77～79年度）共1722件抽驗檢體之檢驗結果，分析其不合格原因及其對民眾使用之影響，期能對化妝品製造業或政府之化妝品管理有所助益。統計結果顯示化妝品檢驗不合格率平均達20.3%，而以含藥化妝品之不合格率（平均44.3%）較一般化妝品不合格率（平均11.3%）高出甚多，其中燙髮及染髮用劑最高，分別佔此期間檢驗不合格含藥化妝品之88.0%及8.7%；一般化妝品則以噴髮膠水、定型液及美髮整髮劑不合格較多，不合格情形中，或含有不符規定之氧化染髮、殺菌劑成分（23.9%），或含甲醇、Freon成分（46.5%），或含汞鹽者（5.0%）居多，本報告並就化妝品檢體來源之地區加以分析其不合格率，雖因檢體未具絕對代表性予以統計檢定，其不合格案件之分佈情形仍有其參考價值。（中華衛誌 1994 : 13（5） : 442-450）

Recent Amendment of Law for the Control of Cosmetic hygiene delegates the Department of Health with authority to exempt premarket requirement on certain general cosmetics which do not contain medicinal components. The Department of Health promulgated the Public Announcement defining the scope and categories of cosmetics which are eligible for premarket exemption on August of 1992. The regulatory control of cosmetic hygiene therefore entered a new milestone. As the National Laboratories of Foods and Drugs is required by law to perform testings on cosmetic products, this report on laboratory findings of cosmetic quality was prepared to provide laboratory results of 1722 cosmetic samples collected by local health autorities and analyzed by the National Laboratories of Foods and Drugs during 1988 to 1990. An average rate of 20.3% noncompliance with relevant cosmetic regulations was found, and 44.3% and 11.3% noncompliant rate were found. in Medicated Cosmetics and General cosmetics respectively. Among the concompliant Medicated Cosmetics, hair dye products and hair perms represent the major causes of noncompliance, which shared 88.0% and 8.7% of noncompliant Medicated Cosmetics. As for the General Cosmetics, hair spray. hair liquid, and hair style preparations containing hazardous methanol or freon were the major causes of noncomliance (46.5%), followed by containing unlabelled hair dyes or antiseptic ingredients (23.9%), and facial creams containing mercury components (5.0% ). The report also descreibes the distribution of noncompliant cosmetics among various regions of Taiwan, though the testing samples may not be perfect representative, such results still bear certain reference pruposes for administrative co nsideration for further improvement. (CJPH(Taipei): /994: 13(5): 442-450)