作者

Katie Chandler

合伙人

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Max Kempe

Max Kempe

高级律师

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作者

Katie Chandler

合伙人

Read More
Max Kempe

Max Kempe

高级律师

Read More

2022年3月11日

New guidance for businesses on product safety/recall notifications to the OPSS

  • Briefing

In early March 2022, the Office for Product Safety and Standards (OPSS) published new guidance containing practical advice to help businesses meet the requirements for notifying the regulator about any product safety issues/recalls and/or product regulatory noncompliance (the Guidance).

The Guidance sits alongside the BSI Code of Practice for Supporting Product Recalls (PAS 7100:2018) which was published soon after the OPSS was set up to help businesses in conducting product recalls. 

The PAS 7100 is designed to provide best industry practice for businesses conducting product safety related recalls and other corrective actions. The PAS recommends that a Recall Plan (or PSIP), which outlines the steps to take when addressing a product safety issue is developed. It should cover preparation of the risk assessment, defining key roles and responsibilities within the business to conduct the recall and notifications to help with being product recall ready. The new guidance needs to be read alongside the PAS 7100.

We consider some of the key parts of the Guidance below. 

When is a notification required?

The Guidance contains a useful reminder of the key notification requirements under the legal framework for product safety in Great Britain and Northern Ireland.

The General Product Safety Regulations 2005 (GPSR) require producers or distributors to notify an authority where they know that a product they have placed on the market or supplied to a consumer does not meet the general safety requirement.

Where applicable, additional sector specific legislation (which applies to particular products such as toys, electrical goods, cosmetics etc) requires businesses to notify an authority if they have reason to believe a product they have placed on the market or distributed does not meet the specific safety requirement (known as the essential safety requirements to support the conformity assessment and attachment of a CE/UKCA mark). In particular, the Guidance details the requirements for notifications of safety or compliance issues in the areas of legal metrology, hazardous substances and cosmetics. 

What information should a notification contain?

Where a notification is required, the GPSR requires a business to inform an authority that a product placed on the market/supplied poses risks to the consumer that are incompatible with the general safety requirement and the action taken to prevent those risks. Where the risk is serious, the GPSR prescribes additional categories of information that must be provided to an authority.

Until now, there has been limited guidance to help businesses identify the form and content of a notification to ensure compliance with the relevant legislation. But, Annex B of the Guidance provides a new template for businesses to complete when making a notification to the relevant regulator.

The notification template prescribes the information required for the business, the product, the risk assessment, the corrective action taken/planned and the supply chain. While the use of this template will not guarantee compliance with the notification requirements, it should serve as a helpful tool for businesses when making a product safety or noncompliance notification to increase the likelihood that they are providing an authority with the information necessary for compliance.

The OPSS has also provided guidance on the relevant authority to receive a notification and has provided contact details, including under the sector specific legislation (Annex A) and the differing requirements in Great Britain and Northern Ireland following Brexit.

What happens after a notification?

The Guidance clarifies the purpose of notifications and the role of the authorities. The purpose of product safety and noncompliance notifications is threefold; to support people/the environment, businesses and regulators. To achieve these purposes, the authorities will:

  • review a notification to ensure that people/the environment are protected, that adequate steps are taken to address noncompliance and to minimise the likelihood of future noncompliance
  • advise the business on how to raise awareness of the issue and how to undertake a recall, if the notification concerns a serious safety issue and/or a recall
  • report to the UK Product Safety Database, where required. 

Find out more

If you'd like to discuss any of the issues raised in this article in more detail, please reach out to a member of our Product Liability & Safety team.

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