日本香粧品学会誌

Vol. 44, No. 4, pp. 289–294（2020）〈一般論文〉

マイクロ波分解–誘導結合プラズマ質量分析法による化粧品中の微量金属不純物分析法の検討
久保田領志 *，秋 山 卓 美，五十嵐良明

Analytical Method for Trace Metal Impurity in Cosmetic Productsby Microwave Digestion-Inductively Coupled Plasma-Mass Spectrometry
Reiji KUBOTA*, Takumi AKIYAMA, Yoshiaki IKARASHI(Accepted: October 7, 2020)

Abstract
Currently, international discussions to establish acceptable trace heavy metal levels in ﬁnished cosmetic products andtheir testing methods are ongoing. In Japan, the testing methods and acceptable levels of heavy metals in raw materials havealready been speciﬁed with the Japanese Standards of Quasi-drug Ingredients, but no speciﬁcation regarding their testing
methods and levels in ﬁnished cosmetic products has been published. In order to assess trace metal impurity in cosmetic
products, an analytical method for determining 13 metals in ﬁnished cosmetic products by using microwave-assisted digestion and inductively coupled plasma-mass spectrometry was developed and validated. Because cosmetic products containingredients in various dosage forms, including various fats, oils, pigments, dyes, and minerals, microwave digestion conditions for the preparation of sample solution were mainly investigated using oil-based reference standard solution and certiﬁed
reference material (CRM) (Lake sediment CRM, for trace elements analysis). In the recovery test using an oil-based reference standard solution, good recovery and repeatability were achieved under the developed acid digestion conditions using
HNO3; HNO3 and H2O2; and HNO3 and HF. However, in terms of recovery from lake sediment CRM, good recovery fromthe CRM was achieved, and high concentrations (the value closest to the true concentration) in the commercial cosmetic
products for each metals were obtained only when using HNO3 and HF for digestion. Therefore, HNO3 and HF were used in
the microwave digestion treatment of commercial 59 lipsticks, 23 lip glosses, and 20 lip liners. The metals detected at highconcentrations and frequencies were Zn, Sr, and Sn for lipstick; Zn and Sn for lip gloss; and Mn, Zn, Sr, and Sn for lip liner.
These metals were likely derived from zinc oxide, tin oxide, and manganese violet those were labeled ingredients on theproduct. Compared to the recommended acceptable levels of Pb, As, Cd, and Sb in cosmetic products by International Cooperation on Cosmetics Regulation (ICCR) and Health Canada, the concentration of Sb in some of the tested products exceeded
the acceptable level.
Key words: cosmetic products, heavy metals, impurity, microwave digestion-ICP-MS, HF.
1.

緒関する法的規制はない。現在，有害不純物に関して，最言終製品中の許容限度値や試験法を定めるよう国際的な化粧品はさまざまな成分で構成されていることから，議論が進められている。とくに金属類については，日

日常的な使用により一般消費者は化粧品に含まれる化学

本，米国，EU，カナダおよびブラジルの規制当局から物質を体内に非意図的に取り込んでいる。そのため，化なる化粧品規制協力国際会議（International Cooperation

粧品の十分な品質管理と安全性の確保が重要となる。わ

on Cosmetics Regulation, ICCR） が 2013 年 に Pb2），2016

が国では，薬用化粧品の成分にもともと含まれる不純物

年に Hg3）の製品中の許容限度値に関する文書を示してや成分の製造工程中の副生成物等について試験法や限度いる。カナダ 4）は 2012 年に Hg, As, Cd, Sb および Pb の値が医薬部外品原料規格 2006 で規定されている 1）。一製品中の許容限度値に関するガイダンスを発出した。韓方で，最終製品を対象としたそれらの試験法や限度値に国 5）では 2017 年に，鉱物由来成分などを含有する製品

国立医薬品食品衛生研究所

生活衛生化学部* Corresponding author：国立医薬品食品衛生研究所 生活衛生化学部，〒210–9501
nihs.go.jp）

川崎市川崎区殿町 3–25–26（E-mail: reijik@

Division of Environmental Chemistry, National Institute of Health
Sciences (3–25–26 Tonomachi, Kawasaki-ku, Kawasaki 210–9501,Japan)