Reporting requirements for defective productsGovernment notification
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?
The Federal Consumer Protection Law provides that in cases where a product can harm or jeopardise the life of a consumer, the manufacturer must give notice to the Federal Consumer Protection Agency as soon as possible.Notification criteria and time limits
What criteria apply for determining when a matter requires notification and what are the time limits for notification?
There is no specific provision in the Federal Consumer Protection Law or in the Federal Standards Act governing the requirements for the notification, a threshold for notification or its time limits; however, we deem that such notification should be made as soon as possible and provide the relevant agency with all the available data to coordinate a recall.Competent authority
To which authority should notification be sent? Does this vary according to the product in question?
For products in general, the relevant authority is the Federal Consumer Protection Agency and, regarding drugs or food products, it must be sent to the Federal Commission for the Protection against Sanitary Risks.Notification information
What product information and other data should be provided in the notification to the competent authority?
There is no specific regulation regarding the contents of the notification, but we deem that said notification should provide all available data that helps to coordinate the recall of the products.Obligations to provide updates
What obligations are there to provide authorities with updated information about risks, or respond to their enquiries?
The Federal Consumer Protection Agency can request that any entity provide information and updates about a product that may result in harm to the life or health of a consumer. The Federal Consumer Protection Agency usually requires a bimonthly update regarding a recall programme.Penalties
What are the penalties for failure to comply with reporting obligations?
Administrative penalties include fines, temporary or permanent closure of establishments or businesses, administrative detention for up to 36 hours, suspension or revocation of the relevant governmental licences.
When determining the penalty to be imposed, the Federal Consumer Protection Agency must take into account the damage caused by the breach, if such action was intentional and if there were any previous incidents.Public disclosure
Is commercially sensitive information that has been notified to the authorities protected from public disclosure?
Commercially sensitive information is considered confidential pursuant to article 113 of the Federal Law for Transparency of Public Information. As such, any authority has the legal obligation to safeguard the confidentiality of such information.Use of information in prosecution
May information notified to the authorities be used in a criminal prosecution?
Yes, if the information provided to an administrative authority is related to a criminal action, the authority has the legal obligation to notify the public prosecutor, which has the legal capacity to use said information as evidence in a criminal prosecution.