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Cosmetics and Quasi-Drug Regulations Based on the Pharmaceutical Affairs Act

1900 Regulation on production of non-regulated patent medicines
(Regulation of face lotions, toothpaste, etc., not deemed to be patent medicines)
1916 Regulation on marketing of non-patent medicines [Quasi-drugs]
1932 Regulation on non-patent medicines
1943 With the enactment of the Pharmaceutical Affairs Act preceding the previous one, the name “non-patent medicine” was changed to “quasi-drug.”
1948 With the enactment of the previous Pharmaceutical Affairs Act the “quasi-drugs” category was discontinued

Cosmetics fell within the scope of the Pharmaceutical Affairs Act

Registration was effected at each place of business for cosmetics production (importation)

Dishonest descriptions and false or deceptive advertising became subject to prohibition
1960 Enactment of the current Pharmaceutical Affairs Act. Changes included the revival of “quasi-drugs” category, a switch from registration to a licensing system requiring a license for each product, and the obligation to appoint a technical officer [Cosmetics].
1967 Institution of cosmetics quality standards
Institution of standards for cosmetics ingredients
1980 Introduction of use-by dates, regulation requiring labeling of designated ingredients [Quasi-drugs, cosmetics]
1986 Institution of licensing standard specific to cosmetic types
1991 Institution of approval standards for production (import) of hair dye [Quasi-drugs]
1993 Institution of approval standards for production of permanent wave preparations [Quasi-drugs]
1994 Institution of approval standards for production (import) of medicinal toothpaste [Quasi-drugs]

Introduction of segmented licensing system [Quasi-drugs, cosmetics]

Partial transfer to local level of approval authority for hair-dyes, permanent wave preparations, medicinal toothpaste [Quasi-drugs]

Revision of notifications of cosmetics ingredients requiring approval

Introduction of type-specific approval system [Cosmetics]
1995 Transfer of industry approval authority to prefectural governors
1997 Revision of cosmetic type-specific approval standards
1998 Institution of approval standards for production (import) of bathing preparations [Quasi-drugs]
1999 Switch of topical preparations, stomach tonics, vitamins, etc., from the drugs to quasi-drugs category (newly designated quasi-drugs)
2001 Abolition in principle of cosmetics approval system [Cosmetics]

Introduction of labeling of all ingredients

Institution of cosmetics standards
2004 Switch of antiflatulent, disinfectant, stomach tonics, etc., to quasi-drugs category (new scope of quasi-drugs)
2005 Implementation of production and sale approval system

Separation of production and sales business and production business

Introduction of Good Quality Practices (GQP) and Good Vigilance Practices (GVP) for cosmetics
2014 Reinforcement of Adverse Effect Reporting system, Revision of “Caution” text, [Quasi-drugs, cosmetics]