Abstract
When we compare the laws and regulations governing cosmetics in the United States, European Union and Japan, we notice that the pre-manufacturing approval system of the Ministry of Health and Welfare Japan (MHW) has many unique characteristics. Despite repeated efforts made from outside parties in the past to revise this system in line with the changes recently occurring in other countries, no substantial alterations in the stance of the MHW on efficacy claims of cosmetics have taken place since 1980 when the last drastic amendment of the Pharmaceutical Affairs Law (PAL) was carried out [1,2]. We will provide here information about the PAL, especially about those regulations related to efficacy claims for cosmetics (We use the term of efficacy simply here; however, it can also denote clinical effectiveness, usefulness and even product claims).
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References
The law amending a part of the Pharmaceutical Affairs Law (Law No. 145, August 10,1960): Law No. 56, The Ministry of Health and Welfare, Japan, October 1,1979
Notification No. 1341 from the Director General, Pharmaceutical Affairs Bureau, the Ministry of Health and Welfare, Japan, October 9,1980
Ozawa T, Nishiyama S, Horii I, Kawasaki K, Kumano Y, Nakayama Y (1985) Humectants and their effects on moisturization of skin. Skin Res 27:276–284
Naganuma M, Fukuda M, Arai S, Hirose O, Kawai M, Motoyoshi K, Masaki H, Suzuki T, Yoshii T (1996) Standard test methods for classification and labeling of sunscreen having UVA protective efficacy in Japan. Proceedings of the 19th Congress of the International Federation of Societies of Cosmetic Chemists (available only on CD-ROM), Sydney, Australia, October 1996
Vermeer BJ, Gilchrest BA (1996) Cosmeceuticals. A proposal for rational definition, evaluation, and regulation. Arch Dermatol 132:337–340
Kligman AM (1991) The invisible dermatoses. Arch Dermatol 127:1375–1382
Leveque J-L (1989) Cutaneous investigation in health and disease. Noninvasive methods and instrumentation. Marcel Dekker, New York
Eisner P, Berardesca E, Maibach HI (1994) Bioengineering of the skin: water and the stratum corneum. CRC Press, Boca Raton
Serup J, Jemec GBE (1995) Handbook of non-invasive methods and the skin. CRC Press, Boca Raton
Watanabe M, Tagami H, Horii I, Takahashi M, Kligman AM (1991) Functional analyses of the superficial stratum corneum in atopic xerosis. Arch Dermatol 127:1689–1692
Hara M, Kikuchi K, Watanabe M, Denda M, Koyama J, Nomura J, Horii I, Tagami H (1993) J Geriatr Dermatol 1:111–120
Tagami H (1994) Quantitative measurements of water concentration of the stratum corneum in vivo by high-frequency current. Acta Derm Venereol (Stockh) Suppl 185: 29–330
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© 1999 Springer-Verlag Berlin Heidelberg
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Tagami, H. (1999). Claim Support in Japan: Legal Aspects. In: Elsner, P., Maibach, H.I., Merk, H.F. (eds) Cosmetics. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-59869-2_3
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DOI: https://doi.org/10.1007/978-3-642-59869-2_3
Publisher Name: Springer, Berlin, Heidelberg
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