JAPAN Law and Practice Contributed by: Shingo Yamada, Yugo Komori, Yasuhiro Akita and Takuma Inoue, Oh-Ebashi LPC & Partners
The CAA was established in 2009 to promote the administration of consumer protection in a unified manner. Under the reporting and publication system for product incident information under the CPSA (see 1.4 Obligations to Notify Regulatory Authorities ), the Agency receives and publishes reports of serious product incidents. The CAA may also order manufac - turers or importers that have failed to report serious product incidents to establish the internal systems necessary for appropriately collecting, managing, and providing incident information. Certain products are regulated by other authorities. For example, with respect to products that fall outside the scope of the CPSA as described in 1.1 Product Safety Legal Framework : • the Ministry of Land, Infrastructure, Transport and Tourism (MLIT) has jurisdiction over motor vehicles; and • the Ministry of Health, Labour and Welfare (MHLW) has jurisdiction over pharmaceuticals, cosmetics, medical devices, food and food additives. These regulatory authorities exercise the powers set out in individual laws. For example, these authorities may establish technical standards and other related requirements and order manufacturers to take correc - tive measures, including the implementation of recalls. 1.3 Obligations to Commence Corrective Action Under the Acts described below, if a regulatory authority issues an order to take corrective measures, the relevant business operators are obliged to com - mence those measures. In practice in Japan, however, it is common for business operators to take corrective and other measures voluntarily, without awaiting such order from the regulatory authority. Therefore, it is rare for regulatory authorities to issue orders for correc - tive measures. For example, under the CPSA, only three orders have been publicly disclosed to date. The following paragraphs focus on voluntary correc - tive measures. CPSA Manufacturers and importers of consumer products have certain “best-effort” obligations. First, if a prod -
uct incident has occurred in connection with consum - er products they have manufactured or imported, they are obliged to make efforts to investigate the cause of the incident. In addition, when they consider it neces - sary to prevent the occurrence and spread of harm, they are obliged to make efforts to take measures to prevent such harm, such as recalling the relevant consumer products. Accordingly, where a product incident occurs that may cause or worsen personal injury to consumers, manufacturers and importers are expected to conduct product recalls in a timely manner. In practice, when manufacturers or importers imple - ment product recalls, they usually refer to guidelines, such as the Recall Handbook for Consumer Products issued by METI in 2022, and provide information to consumers accordingly. Food Sanitation Act Food business operators also have certain “best- effort” obligations. First, in order to prevent public health hazards caused by the foods they sell, they are obliged to make efforts to provide prescribed records to the national government, prefectures and other relevant authorities. In addition, they are obliged to make efforts to promptly and appropriately take necessary measures such as disposing of or other - wise handling foods that have caused food sanitation hazards. Where an operator recalls food that violates the FSA, or food that is suspected of violating that FSA, the operator must notify the prefectural governor without delay of the commencement of the recall and the progress thereof. PMDA Holders of marketing approval for pharmaceuticals, quasi-drugs, cosmetics, medical devices or regenera - tive medical products, as well as operators granted special approval for foreign manufacturing of such products, are required to take the following meas - ures. If they become aware that the use of the relevant product may cause or is likely to cause harm to public health or may lead to its spread, they must take nec - essary measures to prevent such harm or its spread, including disposal, recall, suspension of sales, and provision of information. When they conduct recalls, they must report to the MHLW the commencement of
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