Notification Requirements
Criteria for notificationWhat events or conditions trigger a requirement to notify the product safety authorities of issues discovered in products, or known incidents of personal injury or property damage?
Under Regulation 9 of the General Product Safety Regulations 2005 (GPSR)), the trigger for notification is ‘where a producer or distributor of a product knows that a product it placed on the market or supplied poses risks to consumers that are incompatible with the general safety requirement’ it ‘shall forthwith notify an enforcement authority’.
Regulator or product-specific reporting triggers also apply, for example in respect of medical devices and vehicles and foods:
- A food business must notify its local authority and the Food Standards Agency if it has a reason to believe that its food is not compliant with the safety requirements and should immediately be subject to a withdrawal or recall (see the Guidance on Food Traceability, Withdrawals and Recalls within the WRUK Food Industry from March 2019 for additional information).
- The vehicle safety defects and recalls: code of practice from the Driver and Vehicle Standards Agency (DVSA) (November 2019 - https://www.gov.uk/government/publications/code-of-practice-on-vehicle-safety-defects-and-recalls/vehicle-safety-defects-and-recalls-code-of-practice#notification-to-dvsa-of-safety-defects) requires that any safety defect must be notified by the producer or distributor to the DVSA. This must take place as soon as the safety defect has been confirmed.
To which authority should notification be sent? Does this vary according to the product in question?
Determination of competent authorities is based on applicable regulatory regimes and the type of product in question.
In respect of general consumer products and cosmetics, the relevant trading standards authority to which notification is sent will be which is relevant to the area in which producers are located: (https://www.gov.uk/find-local-trading-standards-office).
Obligations to provide updates after initial notificationWhat obligations are there to provide authorities with updated information about risks, or respond to their enquiries following an initial notification?
The GPSR (regulation 9(4)) and the recent OPSS guidance on the application of the GPSR post-Brexit makes it clear that producers and distributors must cooperate with the relevant enforcement authorities.
If the producer or distributor has been unable to provide complete information as required by the GPSR, it has an obligation to provide the missing or updated information as soon as possible after the notification has been made.
The authorities can require producers and distributors to provide additional information and failure to provide the requested information may amount to an offence.
Penalties for failure to notifyWhat are the penalties for failure to comply with notification obligations?
The GPSR contains the relevant offence provisions under Regulation 20:
- placing unsafe products on the market (by producer) or supply (by distributor) results in liability on conviction on indictment to imprisonment for a term not exceeding 12 months, a fine not exceeding £20,000 or to both, or on summary conviction to imprisonment for a term not exceeding three months or to an unlimited fine or to both;
- producers or distributors failing to comply with consumer-facing information requirements or mandatory labelling requirements are guilty of an offence and liable on summary conviction to imprisonment for a term not exceeding three months or to an unlimited fine or to both; and
- a producer or distributor’s failure to notify authorities can result in liability on summary conviction to imprisonment for a term not exceeding three months or to an unlimited fine.
Is the content of the notification publicly disclosed by the authorities? Is commercially sensitive information contained in the notification protected from public disclosure, or are the authorities otherwise bound by confidentiality?
Under the GPSR, for transparency reasons and in order to inform the general public, the relevant authorities must make publicly available the information relating to the identification of a product and its safety risks as well as any measure (such as a recall or corrective action) taken by the producers, distributors or relevant authorities to prevent and mitigate the risks. For this reason, alerts may be published on the relevant authorities’ website about particular products (see for instance: https://www.food.gov.uk/news-alerts/search/alerts).
Any person may request information from the authorities, including that relating to product safety issues, on the basis of the Freedom of Information Act 2000. The producers and distributors that provided information to the authorities are not able to prevent disclosure. It should however be noted that the relevant authorities can exercise discretion and may decide that the release of some information may be adverse to a business’ commercial interests or prejudice a criminal investigation. The Freedom of Information Act includes exceptions which can be used by the authorities not to release information disclosed to them, including in relation to information provided in confidence, law enforcement and investigations.
Use of information in prosecutionMay information notified to the authorities be used in a criminal prosecution?
Information notified by producers and distributors to the authorities may be used in a criminal prosecution/criminal proceedings and it is likely that it will be used as evidence, as is often the case in practice.
Information sharing between regulatorsIs notification information shared with other regulators?
As of 1 January 2021, replacing the EU system previously in place, in the UK the relevant authorities must notify the Secretary of State in the event that a product poses a risk to consumers’ health and safety or is found to be non-compliant. Such notification needs to be done via the Product Safety Database (PSD). This database is used for reporting and information sharing purposes between the different authorities in the UK. For instance, it is understood that the OPSS regularly alerts PSD users about products with a serious risk and recalls following notification on the PSD.
Following Brexit and in accordance with the Withdrawal Agreement, there is a mechanism of exchange of information with the relevant authorities and regulators of the EU’s member states. This falls on the OPSS, which will share information on behalf of the UK and will review the information which is provided by those EU authorities.
The OPSS is also the national point of contact at an international level and exchanges information with the relevant authorities and regulators of international partner countries and the Organisation for Economic Co-operation and Development (OECD).