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Japan Cosmetics Legislation

  •   8 Jul 2016
  •    Angelita Hu
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     Japan Cosmetics Legislation

    Overarching Regulation
    Pharmaceutical and Medical Devices Law
    Competent Authority
    Ministry of Health, Labour and Welfare (MHLW)
    Main Supporting Rules 
    28 March 2016Enforcement Rules of Pharmaceutical and Medical Devices Law
    1 April 2001Standards for Cosmetics
    6 Nov 2013Japanese Standards of Quasi-drug Ingredients 2006

    Japanese cosmetics are regulated under Pharmaceutical and Medical Devices Law (PMDL, formerly Pharmaceutical Affairs Law) supported by a series of subsidiary rules, standards and guidance documents issued by the competent authority, Ministry of Health, Labour and Welfare (MHLW).

    Japan legally classifies cosmetics (in the broad sense of beauty products) into two categories: cosmetics and quasi drugs. The regulations governing each category differ greatly.  

    Outlines

    1. Regulatory Framework and Competent Authority

    1.1 Existing Key Cosmetic Regulations in Japan

    TypeRegulationEffective DateStatus
    OverarchingAct for Ensuring Quality, Effectiveness, and Safety of Pharmaceutical and Medical Devices
    (Shortly Pharmaceutical and Medical Devices Law)
    2016-4-1In force
    Implementation Order of Pharmaceutical and Medical Devices Law2018-12-30In Force
    Enforcement Rules of Pharmaceutical and Medical Devices Law2016-3-28In Force
    ManufacturingGood Quality Practice2014-11-25In Force
    Good Vigilance Practice2015-3-26In Force
    GMP Ministerial Ordinance2014-11-25In Force
    Submission Documents for Application of GMP Compliance Inspection2019-06-17In Force
    Licensing for quasi drugsRequirements for Applying for Marketing Approval of Quasi Drugs2014-11-21In Force
    Standards for Accreditation of Foreign Quasi-drug Manufacturer2015-6-26In Force
    IngredientsStandards for Cosmetics2001-4-1In Force
    Japanese Standards of Quasi-drug Ingredients 20062013-11-6In Force
    Ordinance on Tar Color Used in Pharmaceuticals2014-11-25In Force
    Standards for Ingredients of Biological Origin2014-9-26In Force
    AdvertisementStandards for Advertisements of Drugs, Quasi Drugs, Cosmetics and Medical Device2002-3-28In Force

    1.2 Competent Authorities

    • Ministry of Health, Labour and Welfare is the competent authority regulating cosmetics and quasi drugs, which is responsible for formulating cosmetic and quasi drug regulations and standards.
    • Pharmaceutical Affairs and Food Sanitation Council is MHLW’s back-up expert panel.
    • Pharmaceuticals and Medical Devices Agency (PMDA) focuses on review applications of quasi drugs and cosmetics (foreign manufacturer, importer) notifications, and evaluate the adverse effect reports.
    • Prefectural governments are responsible for licensing, inspection and guidance.

    2. Cosmetics

    2.1 Definition

    Japan defines cosmetics as “articles with mild action on the human body, which are intended to be applied to the human body through rubbing, sprinkling or other methods, aiming to clean, beautify and increase the attractiveness, alter the appearance or to keep the skin or hair in good condition.” There are 6 categories in total:

    Categories

    Products

    Perfume and eau de cologne

    Perfume and eau de cologne

    Makeup cosmetics

    Foundation creams, lipsticks, eye makeup and others

    Skin care cosmetics

    Skin lotion, essence, skin milk, cleansing cream and others

    Hair care products

    Shampoo, hair treatment and others

    Special purpose cosmetics

    Sunscreen, shaving cream and others

    Cosmetic soaps

    Soaps for cosmetics

    2.2 Approval Procedure of Cosmetics

    2.2.1 Ingredients Analysis

    Marketing license holders take full charge for ingredient safety problems. When considering selling products in Japan, they are recommended by the authority to conduct ingredients analysis to ensure conformity with Japanese cosmetic ingredient regulations although the analysis is not mandatory and there is no need to submit related reports prior to marketing. But related reports will be inspected if their products are found unsafe.

    This analysis is performed on samples by “testing and inspection facilities” designated by the MHLW, owned or contracted by manufacturers/importers. The following items are to be tested:

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