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Investigation on the Safety of Hydroquinone and Preservatives among Whitening Functional Cosmetics Containing Albutin in Korea

국내 유통 알부틴 함유 미백 기능성화장품 중 히드로퀴논 및 살균보존제 안전성 조사

  • Cho, Joong Hee (Division of Pharmaceuticals Analysis on the Food and Drug Administration, Institute of Public Health and Environment in Incheon Metropolitan City) ;
  • Kim, Ji Hyeung (Division of Pharmaceuticals Analysis on the Food and Drug Administration, Institute of Public Health and Environment in Incheon Metropolitan City) ;
  • Eom, Sun Ah (Division of Pharmaceuticals Analysis on the Food and Drug Administration, Institute of Public Health and Environment in Incheon Metropolitan City) ;
  • Kang, Min Jeong (Division of Pharmaceuticals Analysis on the Food and Drug Administration, Institute of Public Health and Environment in Incheon Metropolitan City) ;
  • Han, Young Sun (Division of Pharmaceuticals Analysis on the Food and Drug Administration, Institute of Public Health and Environment in Incheon Metropolitan City) ;
  • Hur, Myong Je (Division of Pharmaceuticals Analysis on the Food and Drug Administration, Institute of Public Health and Environment in Incheon Metropolitan City)
  • 조중희 (인천광역시 보건환경연구원 식의약연구부 약품분석과) ;
  • 김지형 (인천광역시 보건환경연구원 식의약연구부 약품분석과) ;
  • 엄선아 (인천광역시 보건환경연구원 식의약연구부 약품분석과) ;
  • 강민정 (인천광역시 보건환경연구원 식의약연구부 약품분석과) ;
  • 한영선 (인천광역시 보건환경연구원 식의약연구부 약품분석과) ;
  • 허명제 (인천광역시 보건환경연구원 식의약연구부 약품분석과)
  • Received : 2019.12.03
  • Accepted : 2019.12.26
  • Published : 2019.12.30

Abstract

Arbutin, which is used as a whitening ingredient, can produce hydroquinone, known as causing skin disease and carcinogen. Preservatives are essential to prevent microbial contamination during long-term storage and use of cosmetics, but safety issues such as toxicity and skin irritation are being raised. This study was conducted to determine hydroquinone and 21 preservatives levels in 40 arbutin-containing whitening functional cosmetics sold on-line and off-line. Result showed that 9 products contained hydroquinone. The concentrations in 7 products were ranged from 0.3 to 0.9 ppm, which were within the maximum allowed amount established by the Ministry of Food and Drug Safety. However, 2 products were 8.4 and 50.5 ppm and exceeded the allowed amount. Preservatives were detected 20 products. Detected items and ranges were phenoxy ethanol 0.1 ~ 0.7% (N = 15), Methyl paraben 0.19 ~ 0.21% (N = 2), Chlorphenesin 0.13% (N = 1), chlorhexidine 0.006% (N = 1), Propyl paraben 0.06% (N = 1), which were within maximum allowed amount established by the Ministry of Food and Drug Safety. Also, in cases of functional cosmetics the phrase "functional cosmetics" should be expressed on the primary or secondary package of cosmetics by cosmetics act. However, 1 product did not state the phrase as functional cosmetics. This study suggest that preservatives were safely managed. However, hydroquinone in hydroquinone-detected products could be produced by the decomposition of arbutin. Thus, further studies on the decomposition of arbutin are required to improve the quality control of the cosmetics.

미백 성분으로 사용되는 알부틴은 피부질환 및 발암물질로 알려진 히드로퀴논을 생성할 수 있으며, 살균보존제는 화장품을 장기간 보관 및 사용 중 미생물의 오염을 방지하기 위해 필수적이기는 하지만 독성 및 피부 자극 등 안전성의 문제가 제기되고 있다. 이번 연구에서는 온·오프라인으로 판매되는 알부틴 함유 미백 기능성화장품 40건을 대상으로 히드로퀴논과 살균보존제 21종에 대하여 함량 및 사용실태를 조사하였다. 그 결과, 히드로퀴논은 9건이 검출 되었으며, 이 중 7건에서 0.3 ~ 0.9 ppm으로 식품의약품안전처에서 설정한 기준에 적합하였으나, 2건에서는 8.4 ppm, 50.5 ppm으로 검출이 되어 기준을 초과하였다. 살균보존제는 40건 중 20건에서 검출되었으며, 검출 항목 및 범위는 페녹시에탄올 0.1 ~ 0.7% (15건), 메틸파라벤 0.19 ~ 0.21% (2건), 클로르페네신 0.13% (1건), 클로르헥시딘 0.006%(1건), 프로필파라벤 0.06% (1건) 로 모두 기준 이내로 검출되었다. 또한 화장품 중 기능성 화장품의 경우 화장품법에 의하여 1차 또는 2차 포장에 기능성 화장품이라는 단어를 표기해야 하지만 40건 중 1건에서 표기가 되어 있지 않았다. 실험 결과 살균보존제는 안전하게 관리 되는 것으로 판단되지만, 히드로퀴논이 검출된 제품은 알부틴이 분해되어 생성되었다고 사료 되어 알부틴의 분해에 대한 추가적 연구 및 품질관리의 개선이 요구된다.

Keywords

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