JAPAN Law and Practice Contributed by: Shingo Yamada, Yugo Komori, Yasuhiro Akita and Takuma Inoue, Oh-Ebashi LPC & Partners
Other Laws – Consumer Safety Act The Consumer Safety Act (CSA) provides for the col - lection of information on consumer incidents and for measures to prevent the occurrence and spread of consumer harm in order to prevent harm to consum - ers and ensure their safety. Because the CSA was enacted in connection with the establishment of the CAA, the CSA primarily defines the roles and functions of the Agency. Nevertheless, the CSA also provides for measures such as recommendations and orders issued to business operators, as well as prohibitions or restrictions on transfer and orders for product recalls. In this sense, it serves as a safety net for situations in which it is difficult to respond under the individual acts described above. 1.2 Regulatory Authorities for Product Safety The Ministry of Economy, Trade and Industry (METI) is the principal regulatory authority for products subject to the Four Product Safety Acts. The CAA also plays an important role with respect to the reporting and publication of serious product incidents. Manufacturers and importers of products subject to the Four Product Safety Acts may file a business notification with METI. In addition, if they fulfil obliga - tions such as conducting inspections for compliance with technical standards and preparing and retaining inspection records, they may affix specific marks, such as the PSC mark under the CPSA, to their products. In order to verify whether notified businesses are properly fulfilling their legal obligations, METI con - ducts “market surveillance testing”, whereby products in circulation on the market are purchased at random and inspected. Where a non-conforming product is identified in the course of such testing, METI directs the notified business of that product to take correc - tive measures and implement preventive measures to avoid recurrence. If necessary, METI may take admin - istrative actions under the Four Product Safety Acts, including improvement orders, prohibition of affixing the applicable marks (which in practice amounts to a suspension of shipment and sale), and orders to pre - vent harm. Furthermore, METI may order the business to take corrective measures, including the implemen - tation of product recalls.
ulation under specific acts. The following are some examples. Food Sanitation Act The Food Sanitation Act (FSA) provides regulations from a public health perspective to ensure food safety. As to ex ante regulation, business operators engaged in activities that significantly impact public health (eg, restaurants) are required to obtain a permit after meeting the prescribed facility standards. Under the FSA, the sale of unsanitary foods is prohibited. In addition, foods, additives and related products for which standards, manufacturing requirements, label - ling requirements, and ingredient specifications are established must not be sold if they do not conform to those requirements or standards. In respect of ex post regulation, the regulatory authori - ties may order necessary measures, such as disposal of food that has caused an incident, in order to pre - vent the spread of harm and the recurrence of similar incidents after an incident has occurred. Pharmaceuticals and Medical Devices Act The Pharmaceuticals and Medical Devices Act (PMDA) regulates pharmaceuticals, quasi-pharmaceutical products, cosmetics, medical devices and regenera - tive medical products for public health by ensuring their quality, efficacy and safety. These products are subject to more stringent regulation than other prod - ucts at every stage, including development, approval, manufacturing, distribution and use, because of their inherent nature of containing both efficacy effects and side effects. Road Transport Vehicles Act The Road Transport Vehicles Act (RTVA) provides for systems for the registration and inspection of vehicles and provides regulations concerning vehicle mainte - nance in order to ensure their safety and promote their proper use. Under the RTVA, as an ex ante regulation, motor vehicles must be confirmed to comply with the safety standards prescribed by the government and are required to be registered before being put into use on the road. In addition, as an ex post regulation, the government may recommend that manufacturers take corrective measures, including the implementa - tion of recalls.
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