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Asia Personal Care & Cosmetics Market Guide 2016

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COSMETICS MARKET READINESS ASSESSMENT<br />

JAPAN<br />

<strong>Cosmetics</strong> Definition<br />

<strong>Cosmetics</strong> refer to 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<br />

appearance or to keep the skin or hair in good condition. Products in this category include: perfume, makeup, skin care (lotion and cleansing creams), shampoo and shaving creams. So long as these products do not include ingredients on<br />

Japan’s prohibited lists, the product does not have to be registered in Japan. Japan only requires notification via their online system.<br />

Requirements Notes<br />

Local Registration<br />

Legal Representative Yes Companies intending to import on a commercial basis must register for a license in partnership with a local company. This must be done at the appropriate local government<br />

office for each business location.<br />

Product Registration or Notification Notification Pharamceutical and Medical Devices Act (PMD Act) only requires notification for cosmetics, so long as the product formulation meets Japan's Standard for <strong>Cosmetics</strong> :<br />

Notification No.331/2000. Products which do not meet the Standard can be registered/approved by Ministry of Health, Labor and Welfare (MHLW) on condition that proper<br />

safety assessment is submitted. Standard includes: Negative list (prohibited ingredients), and Positive list (preservatives, UV filters and Japanese legal color index colorants,<br />

etc).<br />

Frequency Yes Once before first importation<br />

By Product or Product Group Yes By Product<br />

Product Specification Requirements<br />

Safety Assessment No No legal requirement, but the marketer (distributor) assumes responsibility.<br />

Raw Material Registration No Not required by law<br />

Formula: Quantitative, Qualitative or Both No Not required by law, but the marketer (distributor) require quantitative information.<br />

Material Safety Data Sheet: Raw Materials No Not required by law<br />

Material Safety Data Sheet: Product No Not required by law<br />

Preservative Efficacy No Not required by law<br />

Nationally Certified Testing Facility No Not required. Qualified testing facility can be used by the marketer (distributor) as appropriate.<br />

Animal Testing No Not required<br />

Packaging Assessment No Not required<br />

Product Stability No No required<br />

Good Manufacturing Practice No No legal requirement. This is a voluntry industry standard imposed by Japan Cosmetic Industry Association (JCIA) based on ISO22716. Compliance with GQP (Good Quality<br />

Practice) and GVP (Good Vigilance Practice) are statutory requirements .<br />

Proof of Claims No Claims have to be within the designated list: Iyakuhatsu No. 1339/2000 and Yakusyokuhatsu No.0721-1/2011.<br />

Trademark Registration No Not required to market the product in Japan, but it may be advised to protect the product and company's intellectual property.<br />

Product Sample<br />

No<br />

Labeling<br />

Country of Origin<br />

Yes<br />

Nominal Content: Weight or Volume Yes Standard weight or volume per unit<br />

Registration Number<br />

No<br />

Manufacturing Number<br />

Yes

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