日本香粧品学会誌
250

Vol. 38, No. 4, pp. 250–257（2014）香粧会誌

Vol. 38 No. 4（2014）〈シンポジウム〉『香粧品の更なる安心・信頼を追求するための新しい視点』

動物実験の基本的考え方と関連法規等について
秦野伸二

Principles for Biomedical Research Involving
Laboratory Animals and Their Regulations
Shinji HADANO
Abstract
The use of animals in research, testing, or teaching is an essential part of scientiﬁc and/or educational activities. Animal
experimentations have an enormous impact on progress of disease prevention and cures, and drug development, thereby contributing to human as well as animal health and welfare. However, social resistance against animal experimentations has also
increasingly and globally prevailed, as social attention to the welfare of laboratory animals increases. Thus, the highest scientiﬁc, humane, and ethical principles for animal experimentations must be implemented. The concept of the 3Rs: Replacement, Reduction, and Reﬁnement, proposed by Russel and Burch in 1959 have become an internationally accepted approachfor scientists and educators to use animals. More recently, two international organizations, the Council for International Organization for Medical Science and the International Council for Laboratory Animal Science, have jointly published International Guiding Principles for Biomedical Research Involving Animals to promote laboratory animal welfare and support
high-quality scientiﬁc data. In Japan, The Law Concerning Humane Treatment and Management of Animals revised by theMinistry of Environment（MOE）, in which the 3Rs was clearly speciﬁed, went into operation as of 2006. MOE also made a
notiﬁcation of Standard for Care and Management of Laboratory Animals and Alleviations of Pain. In the same year, The
Basic Policy on Animal Experimentation Performed at Research Organization etc. has been each established by the Ministryof Education, Culture, Sports, Science and Technology, the Ministry of Health, Labour, and Welfare, and the Ministry of Agriculture, Forestry and Fisheries. Furthermore, the Science Council of Japan has published Guidelines on Animal Experimentations. Implementation and extension of policies deﬁned by such framework of laws, regulations, and guidelines will
pave the way towards establishment of a credible animal care and use program in Japan, which meets international standards
in ways judged to be scientiﬁcally and humanely appropriate.
Key words:

1.

laboratory animals, animal experimentation, 3Rs, animal welfare, animal well-being.

はじめにがって，これらの国々において化粧品開発および販売などを行う場合には，動物実験に替わる方法，すなわち動2009 年 3 月 11 日， 欧 州 連 合（European Union; EU）

物実験代替法（Replacement）を用いた各製品の効能，

全 域 で 化 粧 品 原 料 の 動 物 実 験 が 禁 止 さ れ た（Testing

安全性，毒性などについての検査が義務づけられたことban）。さらに，開発・製造の過程で動物実験が行われたになる。近年，動物試験を用いない代替法について，経化粧品の完成品および原料の販売と輸入も同時に禁止さ済開発協力機構（Organisation for Economic Co-operation

れた（Marketing ban）。その際には，「反復投与毒性」，and Development; OECD）テストガイドラインへの登録「生殖発生毒性」，および「毒物動態」については除外項が着々と進み，化粧品などの研究開発においての各種標目となったが，2013 年 3 月 11 日にはそれら例外項目も準的試験が代替法へとシフトしつつあると言える1）。

含めて，EU 全域で化粧品の動物実験の全面的な禁止措

人類は，これまでときには食物として，また，ときに置が取られた。すなわち，現在，EU 加盟国内において，はコンパニオンとしてなどさまざまな形で動物を利用し「化粧品開発は，動物実験を行う正当な理由とならない」ながら高度な文明社会を築いてきた。しかし，近年，動ということが社会的コンセンサスとなるに至った。した物もヒトと同様に命あるものであるとの考えに基づき，* 東海大学医学部基礎医学系分子生命科学〒259–1193 神奈川県伊勢原市下糟屋 143
連絡先 E-mail: shinji@is.icc.u-tokai.ac.jp* Department of Molecular Life Sciences, Tokai University School ofMedicine（143 Shimokasuya, Isehara, Kanagawa 259–1193, Japan）