JAPAN Law and Practice Contributed by: Junichi Ikeda, Takayuki Fujii, Satoyuki Nakano and Tomoaki Kitaguchi, Nagashima Ohno & Tsunematsu
1. Product Safety 1.1 Product Safety Legal Framework The Consumer Product Safety Act (CPSA) is the main law for product safety in Japan. Consumer products are generally subject to the CPSA. The term “consumer products” , as used in the CPSA, has a very broad scope and means any product supplied mainly for use by general consumers in their everyday lives, excluding certain prod - ucts listed in the table appended to the CPSA. Excluded products include: • medical products, cosmetics and medical devices, which are regulated by the Act on Securing Quality, Efficacy and Safety of Prod - ucts Including Pharmaceuticals and Medical Devices; • automobiles, which are regulated by the Road Trucking Vehicle Act; and • food, food additives and cleaning agents, which are regulated by the Food Sanitation Act (FSA). Consumer products that are found to be highly likely to cause harm, particularly to the lives or health of general consumers, are defined as “specified products” under the CPSA; these include climbing ropes, autoclaves and pressure cookers for household use, riding helmets and portable laser application devices. The relevant competent authority establishes the technical standards necessary for the specified products to prevent the lives or health of general consum - ers being endangered. The regulatory framework under the CPSA is as described in the following.
Product Safety of Consumer Products (PSC) Mark System The PSC mark system is a pre-marketing meth - od to ensure product safety by regulating the sale and display of specified products, for sale purposes, through labelling requirements. If a manufacturer or an importer of specified prod - ucts has submitted the required notification, ensured the products conform to certain tech - nical standards set by the competent authority and had the products inspected (and kept the inspection record), they can affix the PSC mark on the specified products. The sale or display, for the purpose of selling, of these products is prohibited unless the PSC mark is placed on the specified products. Reporting Obligations A manufacturer or importer of consumer prod - ucts that becomes aware of a serious product accident that has occurred in relation to a con - sumer product that it manufactures or imports must report specific information related to the product, and the accident, to the Secretary Gen - eral of the Consumer Affairs Agency (CAA) within ten days. For non-serious product accidents, manufacturers and importers of consumer prod - ucts, as well as retailers and other parties who are involved with such products, are expected to report the accident to the National Institute of Technology and Evaluation (NITE), an independ - ent administrative agency, by an official notice issued by the Ministry of Economy, Trade and Industry (METI). For serious product accidents, the Secretary General of the CAA will publish certain informa - tion related to the relevant product and accident if the Secretary General finds this necessary to prevent serious danger, or an increase in danger, to consumers. For non-serious product acci -
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