JAPAN Law and Practice Contributed by: Junichi Ikeda, Takayuki Fujii, Satoyuki Nakano and Tomoaki Kitaguchi, Nagashima Ohno & Tsunematsu
the disposal of the food that caused the food sanitation hazards. Advertising There is no mandatory advertising requirement under the CPSA and FSA. However, under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medi - cal Devices, in cases where holders of market - ing authorisations for pharmaceuticals, quasi- pharmaceutical products, cosmetics, medical devices or regenerative medicine products, or persons with special approval regarding foreign manufacturing, file for a recall, they must – in addition to promptly providing information on the recall to each medical institution, etc – pro - vide such information using the internet. Fur - thermore, under the Road Trucking Vehicle Act, if manufacturers of automobiles file for a recall, they must have the filing published in the jour - nal of the Japan Automobile Service Promotion Association to disseminate information on the recall to providers of automobile repair services. 1.4 Obligations to Notify Regulatory Authorities The CPSA sets out incident-based reporting. If a manufacturer or importer of consumer products comes to know of a serious product incident that has occurred with a consumer product that it manufactures or imports, it must report certain information related to the product and the inci - dent to the CAA. The report must be submitted in the format provided for in the Cabinet Office Order within ten days from the date of learning that a serious product incident has occurred. Even if an incident that occurs involving the con - sumer product is not serious, it is expected by way of an official notice issued by the METI that business operators involved with such consum - er products – eg, manufacturers, importers and
retailers – will report the incident to NITE, which is an independent administrative agency, in the format provided for on NITE’s website. The FSA provides a reporting obligation for food recalls. Under the FSA, if a business operator recalls food, additives, apparatus, or containers and packaging that are, or are suspected to be, in violation of the FSA, it must notify the pre - fectural governor of the initiation of the process of recall without delay, except in cases where the MHLW or a prefectural governor has ordered the business operator to recall the products, or when there is no risk of a food hygiene hazard. When the prefectural governor has received the report, they must report it to the MHLW. 1.5 Penalties for Breach of Product Safety Obligations In cases where a manufacturer or an importer of consumer products fails to send a report to the CAA or sends a false report to the CAA in violation of the obligations explained in 1.4 Obligations to Notify Regulatory Authorities , the competent minister may find it necessary – to secure the safety of the consumer products manufactured or imported by that manufacturer or importer – to order the manufacturer or importer to develop a system for collecting information on serious product incidents that occur in relation to the consumer products manufactured or imported by it, and for the proper management or provi - sion of that information. Failure to observe such an order issued by the competent minister may result in the manufacturer or importer, and their representative, facing imprisonment for up to one year and/or a fine of up to JPY1 million. However, failure to report to the CAA in itself, pursuant to the obligation explained in 1.4 Obli- gations to Notify Regulatory Authorities , does not trigger criminal penalties.
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