Post Graduation Diploma in Perfumery and Cosmetics Management

The Pharmaceutical Affairs Act defines cosmetics as follows. "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." Cosmetics are classified into "perfume and eau de cologne" including fragrance, "makeup cosmetics" including foundation creams, lipsticks and eye makeup, "skin care cosmetics" including facial cream, skin lotion, skin milk and cleansing cream, "hair care products" including hair dye, shampoo and hair treatment, and "special-purpose cosmetics" including sunscreen. Under the Act, soaps are classified as cosmetics. Scope of coverage 1. Points to Note in Exports to and Sales in Japan (1) Import Regulations and Procedures The following paragraph describes the regulations and procedural requirements at the time of importation. Importers of cosmetics assume all quality assurance and product liability for cosmetics. Consequently, cosmetic articles should not be imported based on marketability only. It is necessary for them to be ready to take full responsibility for imported cosmetics through regulation analysis and safety testing. The importation of cosmetics is subject to the provisions of the Pharmaceutical Affairs Act, and aerosol products are subject to the provisions of the High Pressure Gas Safety Act. The Customs Tariff Act prohibits the importation of fake name brand products and knock-off copies, and such items are subject to confiscation or destruction at customs, based on the provisions of the Customs Act. Importers can even be subject to criminal penalties, including fines and imprisonment. However, the Pharmaceutical Affairs Act imposes no restrictions on substances that are imported into Japan as raw materials for cosmetics and then subjected to domestic processing. ・Pharmaceutical Affairs Act When importing and distributing cosmetics, under the provisions of the revised Pharmaceutical Affairs Act, which went into effect as of June 1, 2009, the importer must obtain a primary distributor's license for cosmetics. The primary distribution business refers to the sale, rental, or lending of manufactured (including delegated to another, but not including manufacturing conducted for another) or imported cosmetics. Consequently, companies that do not possess their own manufacturing facilities may still obtain a license. The revised Act abolished the importer license classification. Any primary distributor that engages in the final packaging, labeling in the Japanese language, or storage of the imported product, is required to o btain a cosmetic manufacturer's license. Even if the product was labeled overseas in the Japanese language, in addition to obtaining a primary distributor's license, the importer of that product must obtain a cosmetics manufacturer's license (under a classification of "packaging, labeling, and storage only") (excluding the case of manufacturing that is delegated to another licensed manufacturer), because the product must be temporarily stored in a facility that has a manufacturer's license in Japan, and availability of shipment must be judged after the necessary tests. Item Definition HS Code Perfume and eau de cologne Makeup cosmetics Skin care cosmetics Hair care products Special-purpose cosmetics Cosmetic soaps Perfume and eau de cologne Foundation creams, lipsticks, eye makeup, and others Skin lotion, essence, skin milk, cleansing cream, and others Hair dye, shampoo, hair treatment and others Sunscreen, shaving cream and others Soaps for cosmetics 3303 3304.10, 2, 30, 91 3304.99 3305 3307.10, 20, 30, 90 3401.11, 20-010 Cosmetics -Cosmetics- - 2 - Guidebook for Export to Japan 2011 Copyright (C) 2011 JETRO. All rights reserved. [Primary distributor's license] Primary distributor's license applications are filed with the competent prefectural pharmaceutical affairs division with jurisdiction over the business office where the marketing supervisor-general serves. Licenses are to be renewed every five years. Applicants must conform to the Good Quality Practice (GQP) standards and Good Vigilance Practice (GVP) standards, and they must appoint a marketing supervisor-general. The Act clearly assigns responsibility to primary distributors to assure post-marketing product quality, and to undertake appropriate actions for safety management. Applicants are required to obtain a business code number in advance. Documents require d for application include a copy of the corporate registration (in the case of a corporation), a list of the segregation of duties, a medical certificate attesting an applicant, documents certifying the qualifications of the marketing supervisor-general and an employment contract, documents verifying the quality management system and the post-marketing safety management system, a floor plan of the business office and storage facility, and others. Application for a cosmetic manufacturer's license (under the classification of "packaging, labeling, and storage only") requires an outline of the physical facility, a floor plan of the manufacturing facility, documents certifying the qualifications of the responsible engineering manager and an employment contract, a copy of any contract with a testing laboratory (when used). After obtaining the primary distributor's license but before initiating product importation, the primary distributor must file a Notification form of cosmetic manufacture or importation brand name (with the Pharmaceutical and Medical Devices Agency (PMDA)), the Notification form of primary distribution of cosmetics (with the same prefecture as that which has granted the primary distributor's license), and the Import notification form of cosmetics for primary distribution (with the Kanto-Shinetsu Regional Bureau of Health and Welfare, or the Kinki Regional Bureau of Health and Welfare). Either they must attach to those forms an ingredients list from the import supplier manufacturer or, if this list cannot be obtained, a record of the testing and inspection results verifying that the product does not contain any prohibited combination. [Approval for primary distribution by product category] The Cosmetics Standards (Ministerial Notification in September 2000) defines the ingredients that are subject to prohibition or restriction in cosmetics combinations, and those that are allowed in cosmetics combinations in specific ingredient groups. Antiseptics, ultraviolet ray absorbents and tar coloring are subject to a positive list that indicates the maximum mixture quantities. All other ingredients may be used in cosmetics combinations after the safety verification and selection at their own liability, except those covered by a negative list of combinations that either prohibits or limits them. In this regard, however, all ingredient names must be listed in the labeling. Provided the ingredients do not violate the Cosmetics Standards and all the ingredients are indicated on the labeling, approval for primary distribution by product item is not required. However, products containing amounts of ingredients in excess of the notifiable limit, or new ingredients without a history of prior usage, or which contain non-disclosed ingredients, must obtain primary distribution approval for each product item