What events or conditions trigger the obligation to notify product safety authorities of problems discovered in products or known incidents of bodily injury or property damage?
Under Regulation 9 of the General Product Safety Regulations 2005 (GDPR)), the trigger for notification is “when a producer or distributor of a product knows that a product he has placed on the market or supplied presents risks for consumers which are incompatible with safety requirements ”, it“ immediately informs an enforcement authority ”.
Regulator or product specific reporting triggers also apply, e.g. for medical devices, vehicles and food:
Competent authority for notification
To which authority should the notification be sent? Does it vary depending on the product in question?
The determination of the competent authorities is based on the applicable regulatory regimes and the type of product in question.
For general consumer products and cosmetics, the competent trade standards authority to which the notification is sent will be the one corresponding to the area in which the producers are located: (https://www.gov .uk / find-local-trading- bureau of standards).
Obligations to provide updates after initial notification
What are the obligations to provide authorities with up-to-date information on risks, or to respond to their requests following a first notification?
The GPSR (Rule 9 (4)) and the recent OPSS guidance on the application of the GPSR after Brexit make it clear that producers and distributors must cooperate with the relevant supervisory authorities.
If the producer or distributor has not been able to provide the complete information required by the GPSR, he has an obligation to provide the missing or updated information as soon as possible after the notification.
Authorities may require producers and distributors to provide additional information and failure to provide the requested information may constitute an offense.
Penalties for failure to notify
What are the penalties for failure to comply with notification obligations?
The GPSR contains the provisions relating to relevant offenses under Regulation 20:
- the placing on the market of dangerous products (by the producer) or the supply (by the distributor) results in liability on conviction on indictment to a term of imprisonment not exceeding 12 months, a fine not exceeding £ 20,000 or both, or on summary conviction to a term not exceeding three months or to an unlimited fine or both;
- producers or distributors who fail to comply with consumer information requirements or mandatory labeling requirements are guilty of an offense and liable on summary conviction to a maximum term of imprisonment three months or an unlimited fine or both; and
- failure by a producer or distributor to notify the authorities may result, on summary conviction, to imprisonment not exceeding three months or to an unlimited fine.
Public disclosure of notification information
Is the content of the notification made public by the authorities? Is the commercially sensitive information contained in the notification protected from public disclosure, or are the authorities otherwise bound by confidentiality?
In the context of the GPSR, for reasons of transparency and in order to inform the general public, the competent authorities must make public information relating to the identification of a product and its safety risks as well as any measure (such as recall or corrective action) taken by producers, distributors or competent authorities to prevent and mitigate risks. For this reason, alerts may be published on the website of the competent authorities regarding particular products (see for example: https://www.food.gov.uk/news-alerts/search/alerts).
Anyone can request information from authorities, including those relating to product safety issues, on the basis of the Freedom of Information Act 2000. Producers and distributors who have provided information to authorities are unable to prevent disclosure. It should be noted, however, that the competent authorities may exercise their discretion and may decide that the disclosure of certain information may be against the commercial interests of a company or undermine a criminal investigation. The Freedom of Information Act includes exceptions that can be used by authorities not to disclose information disclosed to them, including with respect to information provided in confidence, law enforcement and the surveys.
Use of information in prosecution
Can the information notified to the authorities be used in the context of criminal proceedings?
Information reported by producers and distributors to authorities can be used in criminal prosecution / proceedings and is likely to serve as evidence, as is often the case in practice.
Information sharing between regulators
Is notification information shared with other regulators?
From 1 January 2021, replacing the EU system previously in place, in the UK, competent authorities must notify the Secretary of State in the event that a product poses a risk to the health and safety of consumers or is found to be non-compliant. Such notification should be made through the Product Safety Database (PSD). This database is used for reporting and information sharing purposes between different UK authorities. For example, it is understood that OPSS regularly alerts users of the PSD about products presenting a serious risk and carries out recalls following a notification on the PSD.
Following Brexit and in accordance with the Withdrawal Agreement, there is a mechanism for exchanging information with competent authorities and regulators in EU Member States. This is the responsibility of OPSS, which will share the information on behalf of the UK and review the information provided by these EU authorities.
OPSS is also the national contact point at the international level and exchanges information with the competent authorities and regulators of international partner countries and the Organization for Economic Co-operation and Development (OECD).