Japan Cosmetics Legislation

  •   8 Jul 2016
  •    Angelita Hu

     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.  

    Contents

    Part 1 Regulatory Framework and Competent Authority

    1 Existing Key Cosmetic Regulations in Japan

    Type

    Regulation

    Effective Date

    Status

    Overarching

    Act for Ensuring Quality, Effectiveness, and Safety of Pharmaceutical and Medical Devices
    (Shortly Pharmaceutical and Medical Devices Law)

    2016-4-1

    In force

    Enforcement Rules of Pharmaceutical and Medical Devices Law

    2016-3-28

    In Force

    Manufacturing

    Good Quality Practice

    2014-11-25

    In Force

    Good Vigilance Practice

    2015-3-26

    In Force

    Standards for Applying for GMP Inspection

    2015-6-18

    In Force

    Licensing for quasi drugs

    Requirements for Applying for Marketing Approval of Quasi Drugs

    2014-11-21

    In Force

    Standards for Accreditation of Foreign Quasi-drug Manufacturer

    2015-6-26

    In Force

    Ingredients

    Standards for Cosmetics

    2001-4-1

    In Force

    Japanese Standards of Quasi-drug Ingredients 2006

    2013-11-6

    In Force

    Ordinance on Tar Color Used in Pharmaceuticals

    2014-11-25

    In Force

    Standards for Ingredients of Biological Origin

    2014-9-26

    In Force

    Advertisement

    Standards for Advertisements of Drugs, Quasi Drugs, Cosmetics and Medical Device

    2002-3-28

    In Force

    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.

    Part 2 Cosmetics

    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 Approval Procedure of Cosmetics

    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:

    • Preservatives,
    • UV absorbents,
    • Anti-oxidants,
    • Heavy metals,
    • Japanese legal color index colorants,
    • Prohibited ingredients.

    Also, some specific tests could be performed, such as pH, viscosity, specific gravity, bacterial count, patch tests, stability tests and more. As there are numerous testing items, the MHLW provides a checklist for manufacturers/importers for confirmation.

    2.2 Comparison of Two Licenses

    Any question?

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