Reporting requirements for defective products in Japan

Reporting requirements for defective products

What requirements are there to notify government authorities (or other bodies) of defects discovered in products, or known incidents of personal injury or property damage?

If a manufacturer is made aware of any serious accident caused by a product, it is required by the CPSA article 35(1) to report it to the relevant authority. It is assumed, however, that retailers will report such knowledge to the manufacturers or importers of the product. Recently, the METI has established an online version of the reporting system on its website (www.meti.go.jp/product_safety/form/index.html) (Japanese only). If the accident caused by a product is not serious or it is clear that the accident is caused by something other than a product, it should be reported to the National Institute of Technology and Evaluation (the NITE, one of the independent administrative agencies in Japan).

Furthermore, under article 63-3(1) of the RTVA, automobile manufacturers must notify the Ministry of Land, Infrastructure and Transportation (MLIT) of any defects discovered in the design or manufacturing process. This notification must be made before any necessary remedial measures are taken.

The ASSCC requires manufacturers of medicines, cosmetics and medical devices to notify the Minister of Health, Labour and Welfare (MHLW) if they initiate a product recall or are made aware of any adverse effects caused by such medical products or devices (ASSCC articles 68-10(1)).

The FSA requests food business operators to endeavour to prevent public health hazards by taking any necessary measures appropriately and immediately, such as providing central or local government with the records of retailers they have supplied (FSA article 3(3)).

What criteria apply for determining when a matter requires notification and what are the time limits for notification?

Under the CPSA, a matter requires notification where it constitutes a ‘serious product accident’, namely, an incident that satisfies the criteria provided for under the Ordinance for the Enforcement of the CPSA (Act No. 48 of 1974, as amended). These criteria relate to the danger posed by, and the type of, the accident, and, in so doing, target accidents involving serious actual or potential danger (CPSA article 2(6)).

Under the Ordinance for the Enforcement of the CPSA (Cabinet Office Ordinance of the reporting of a serious accident caused by a product required by the CPSA, No. 47 of 2009 (the CPSA Cabinet Office Ordinance)), the reporting of a serious accident caused by a product required by the CPSA article 35 should be submitted to the relevant authority, within 10 days of the date the reporter came to know of the accident, in the prescribed form described in question 7 (CPSA Cabinet Office Ordinance article 3).

The Ordinance for Enforcement of the ASSCC (Ordinance of the Ministry of Welfare (the MOW, predecessor of the MHLW), No. 1 of 1961 (the ASSCC Ordinance)) requires a manufacturer to report to the MHLW as soon as it initiates a product recall programme (ASSCC Ordinance article 228-22(1)).

To which authority should notification be sent? Does this vary according to the product in question?

The relevant authority to which the notification should be sent depends on the product as follows:

• consumer products, electric appliances, gas appliances and combustion appliances to the Consumer Affairs Agency (CAA);
• medical products, cosmetics and medical devices to the MHLW;
• automobiles to the MLIT; and
• food, additives and the like to the CAA.

In addition to notifying the relevant authority, as required by law, it is highly recommended that other relevant authorities and local governments are notified as well.

What product information and other data should be provided in the notification to the competent authority?

Article 3 of the CPSA Cabinet Office Ordinance, which refers to the CPSA article 35(1), requests that the notification be made in the prescribed form (Form I) and contain the following information:

• name of the product, brand, number of models and the country of production;
• details of the human injury or injuries;
• situation of the accident (ie, facts, causes, measures taken to prevent future accidents, contact person or organisation that conducted the investigation and the holder of the products);
• date that the supplier reported the accident, and the background to such reporting;
• place of the accident;
• period and total volume of production, imports and distribution;
• company name and address of the product manufacturer or importer; and
• relevant industry association.

RTVA article 63-3(1) and ASSCC Ordinance article 228-22(1) also set forth information to be provided to the relevant authority.

What obligations are there to provide authorities with updated information about risks, or respond to their enquiries?

Under article 51-2 of the Ordinance for Enforcement of the RTVA (Ordinance of the Ministry of Transport, No. 74 of 1951 (the RTVA Ordinance)), manufacturers must update information about risks every three months until remedial measures are completed.

The CPSA does not impose an obligation on manufacturers to update information, but manufacturers are expected to keep the relevant authorities updated regarding the status of the product recall programme.

What are the penalties for failure to comply with reporting obligations?

Manufacturers that fail to report or who submit false reports in violation of the CPSA article 35(1) may be ordered by the relevant authority to establish systems to collect information on serious product accidents, if this is regarded as necessary by the relevant authority (CPSA article 37). Violation of these orders risks imprisonment with (or without) work for not more than one year or a penalty of ¥1 million, or both (CPSA article 58(v)).

Manufacturers that fail to report or that submit false reports in violation of the RTVA article 63-4(1) risk imprisonment with (or without) work for not more than one year, a fine of not more than ¥3 million, or both (RTVA article 106-4(3)).

A person producing food or additives who fails to report or who submits false reports in violation of the FSA article 28(1) risks a fine of not more than ¥500,000 (FSA article 75(2)).

Is commercially sensitive information that has been notified to the authorities protected from public disclosure?

In cases where the competent minister receives a report in accordance with CPSA article 35(1), or otherwise comes to know of the occurrence of a serious product accident, if he or she finds it necessary to prevent serious danger to general consumers, he or she will, in principle, make a public announcement of information such as the name and type of the relevant consumer product, the details of the accident, and so on, so as to minimise the dangers associated with the use of said product. However, commercially sensitive information will not necessarily be disclosed in such announcements. See question 20.

As a general rule, administrative organisations shall disclose administrative documents upon request (Act on Access to Information Possessed by Administrative Organs, Act No. 42 of 1999, as amended (AAI)). Administrative documents are defined in the AAI; however, the AAI excludes several kinds of information from disclosure (AAI article 5). Such information includes confidential business information which if disclosed could have a harmful effect on the competitive position of a certain business entity. Commercially sensitive information is assumed to be generally covered by this category; however, the AAI also sets out a category for absolute disclosure if disclosure is necessary for the protection of life, health, livelihood and property (AAI article 5(ii)). In the context of product recall, most of the information provided by manufacturers is likely to fall within the scope of absolute disclosure. It is uncertain whether such commercially sensitive information can be kept undisclosed.

May information notified to the authorities be used in a criminal prosecution?

As a general rule, information that is acquired through an administrative procedure may not be used in a criminal investigation. The CPSA expressly sets out the rule that on-site inspections conducted by the relevant authority may not be regarded as criminal investigations (CPSA article 41(12)).