Japan: Update on regulatory system under discussion in the wake of amendments to the four Product Safety Acts

In brief

On 26 June 2024, amendments to the four product safety acts (Product Safety Acts)1 were promulgated. The development of a system based on the amendments has since been under discussion targeting a date some time in December 2025 for its entry into force. This Client Alert introduces the major amendments to the Product Safety Acts, summarizes the discussions that have been taking place on the development of the system associated with them and proposes practical measures companies may wish to take in response.


Contents

Major Product Safety Act amendments

The four Product Safety Acts designate potentially harmful products as "Specified Products." Manufacturers and importers of Specified Products are required to comply with technical standards set by the government for these products and to display the PS Mark on the products. In addition, manufacturers and importers of Specified Products are obliged to provide notice when they begin doing business in Japan and also to report serious accidents involving their products to the Consumer Affairs Agency within 10 days of becoming aware of their occurrence.

The amendments were made to address changes in the product safety environment. These include a recent influx of products purchased via the internet from outside Japan whose safety cannot be confirmed and accidents involving products intended for use by children, etc. It has been a challenge to formulate a regulatory response to the rapid growth of internet transactions that also ensures the safety of products intended for use by children.

The new regulations established by the amendments to the Acts focus mainly on the following points.

Amendments made to all of the Product Safety Acts in response to the rapid increase in the number of internet transactions

  1. Regulation of overseas business operators: The amendments clarify that overseas business operators that sell products directly to consumers in Japan (e.g., via a shopping website or other digital transaction platform (Transaction DPF)) are classified as Specified Importers and subject to the notification requirements under the Acts. In addition, overseas Specified Importers are required to appoint a responsible person in Japan (called a "Domestic Supervisor").
  2. System for requesting that Transaction DPF operators remove unsafe products, etc. from their platforms: Where a consumer product sold via a Transaction DPF is determined to be potentially harmful to Japanese consumers and the seller of the product is deemed unlikely to take necessary measures (e.g., a recall, etc.), the Transaction DPF operator may be requested to take measures, including removal of the product from the platform.
  3. Publication of notifications: A system will be established to publicize the names of business operators that file notifications, the classifications of Specified Products and the names of Domestic Supervisors, etc.
  4. Publication of the names of violators: A system will be established to publicize the names, etc. of businesses that violate laws and orders.

Amendments to the CPSA to ensure the safety of toys and other products intended for use by children

  1. Establishment of regulations on products intended for use by children: With respect to Specified Products Intended for Use by Children (i.e., products that will be required to bear indications regarding the age ranges they are intended for and precautions regarding their use mainly in children's daily lives), under the amendments, manufacturers and importers of such products will be required to ensure that the products comply with technical standards set by the government and display warnings such as the intended age range and precautions for use. The sale of products that do not bear indications that these obligations have been met will be prohibited.
  2. Special exception for used Specified Products Intended for Use by Children: A special exception will be made to allow the sale of used Specified Products Intended for Use by Children where business operators establish systems, etc. to ensure safety and raise awareness of risks to safety and risk prevention measures among Japanese consumers.

Development of a system in connection with the amendments to the four Product Safety Acts

The Industrial Structure Council and the Consumer Affairs Council's Subcommittees on Product Safety are currently discussing the development of a system in connection with the amended Acts. Among other topics, the following items are currently under discussion.

Responses being considered to the increasing number of internet transactions

  1. Required qualifications for Domestic Supervisors: A Domestic Supervisor may be a legal entity or individual engaged in any type or category of business. However, Domestic Supervisors are obliged to keep records of technical standards compliance inspections, etc. and are responsible for ensuring the safety of Specified Products in Japan. For this reason, the establishment of certain qualifications for Domestic Supervisors is being discussed to ensure that they are capable of properly discharging their duties. These include having an address in Japan and being able to communicate easily in Japanese. In addition, requiring the submission of certain documents — such as a copy of the contract between the Specified Importer and the Domestic Supervisor and documents showing that the Domestic Supervisor has an address in Japan — is being discussed.
  2. Regulatory effectiveness enhancement measures: Current discussions suggest that Specified Importers will not be required to provide notification of the locations of facilities manufacturing Specified Products, provided that the importers design the products in question, regularly have the products inspected by a third-party inspection agency and are able to promptly provide the location of factories and other information upon request.

Responses being considered to ensure the safety of toys and other products intended for use by children under the CPSA

  1. Designation of Specified Products Intended for Use by Children: Toys for children under three years of age for which a risk of accidental ingestion or choking has become apparent requiring immediate action shall be given first priority for designation as Specified Products and Specified Products for Children.
  2. Technical standards for toys intended for use by children under three years of age: The establishment of technical standards is being discussed to ensure that products are sufficiently durable to withstand use by children and pose no risk of physical injury from sharp edges, protrusions, strings or movable parts.
  3. Consistency with international standards: ISO 8124 (the international standard), EN71 (the de facto legally binding standard in Europe) and ASTM F963 (the legally binding standard in the US) shall be clearly stated as the technical standards to which the technical standards for toys in Japan conform.
  4. Specific rules on intended age standards and precautions with regard to toys intended for use by children under three years of age: An intended age standard is being discussed that would be designed to ensure that products are reasonably appropriate for use by children of the intended age range. Precautions are also being discussed, such as a requirement that products bear indications that they are intended for use only by children of the intended age range and under parental supervision.

Future practical measures

Discussions are ongoing in preparation for the enforcement of the amendments to the Product Safety Acts in December 2025. Businesses are advised to monitor the development of these discussions. Meanwhile, the following practical measures are advisable in light of the measures currently being discussed:

  • Preparation for the appointment of Domestic Supervisors: Overseas businesses operators engaged in direct sales of Specified Products to consumers in Japan should begin considering candidates capable of qualifying as Domestic Supervisors under the criteria currently under discussion (e.g., having an address in Japan and being able to communicate easily in Japanese).
  • Confirmation of compliance with technical standards and standards for toys intended for use by children under three years of age: Business operators engaged in the sale of toys intended for use by children under three years of age that are likely to fall under the category of Specified Products Intended for Use by Children are advised to ensure that they are in compliance with current technical standards and that their products bear warning labels regarding the intended age range and precautions for use, and to strengthen their responses as necessary, to prepare for future obligations to comply with technical standards and warning label requirements in Japan.
  • Monitor discussion of the special exception for used toys intended for use by children under three years of age: Business operators planning to sell used toys intended for use by children under three years of age that are likely to fall under the category of Specified Products Intended for Use by Children are advised to monitor discussions regarding requirements, such as the obligations to ensure safety and raise awareness of risks to safety and risk prevention measures among consumers in Japan.

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If you have any questions about this Client Alert or need advice on improving your compliance program, please feel free to contact us.


1 The Consumer Product Safety Act (CPSA), Gas Business Act (GBA), Electrical Appliance and Materials Safety Act (EAMSA) and the Act on the Securing of Safety and the Optimization of Transaction of Liquefied Petroleum Gas (LPGA).

Contact Information
Yuko Kai
Associate at BakerMcKenzie
Tokyo
Read my Bio
yuko.kai@bakermckenzie.com
Yuka Murata
Associate at BakerMcKenzie
Tokyo
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yuka.murata@bakermckenzie.com

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