Notifying product safety and compliance to the regulator is now subject to Gov.UK Guidance

United Kingdom

In early March 2022 the national regulator for product safety and legal metrology, the Office for Product Safety and Standards (the “OPSS”), published Guidance for industry to help specify the information to be supplied to the regulator regarding compliance matters. The Guidance will add flesh to the bones of the legal obligation to notify regulatory authorities according to the General Product Safety Regulation 2005 (applicable in Great Britain and Northern Ireland) as well as certain product-specific legislation.

What’s new?

The new Guidance makes a number of changes, which can be briefly summarised as follows:

  • The instance when notification is needed has been broadened from the identification of a risk to safety, to include compliance with laws.

  • There is a new detailed template notification proforma addressed to industry, for the first time, and it has over thirty matters to be addressed (see below for a bit more detail).

  • The aim of notifications now includes the safety of the environment, by ensuring that corrective actions and steps are taken to reduce the risks to consumers and users.

  • The Lead Authorities are clearly allocated to Articles of Regulations.

  • There is recognition of recent changes to the rapid alert system amongst Market Surveillance as a result of the UK’s EU Exit, with links to reporting sites for Northern Ireland or where EU Member States are impacted.

Focus on compliance notifications

If we can focus on the changes to the notifications, as this is a shift for those used to notifying, according to current expectations of the OPSS. There was previously a Government guide in place but one addressed to Market Surveillance to assist in regulation, and so arguably not binding for industry. Interestingly the template notification proforma in that guide which was published just months ago in October 2021 looked quite different to the current one, and only had around a third of the number of matters to be addressed. The new template is significantly more detailed than before and now invites the following submissions:

  • Product description and details of the risk identified.

  • Details of associated safety incidents, and how the risk was identified, along with risk assessment findings. This could include when it was originally placed on the market and safety testing commissioned on the identification of a potential risk to safety.

  • Evidence of safety testing, and the legal provisions and designated standards against which the product is tested and whether it passed or not. This would include initial testing as well as further tests associated with the identification of risk.

  • The supply chain.

  • Link to the website regarding remedial measures taken or to be taken.

  • Date of placing on the GB market and whether it was before 1 January 2021, so whether it was subject to EU or UK laws when first sold, as well as whether it is sold in Northern Ireland and other parts of the UK.

The template breaks down the above headings and lists the expected information to be provided under each one.  It also expresses that notifications are to be made in a timely manner to the relevant authority, although what is meant by this is not clear.

What does this mean for businesses?

This new Guidance is to sit alongside PAS 7100, a Code of Practice for product safety recall which sets out practical guidance for businesses on monitoring safety and traceability, how to go about putting in place incident plans, and managing corrective action situations.  The Code of Practice also provides guidance on the role of the Market Surveillance Authorities in order to support businesses being able to meet the code’s requirements.

The new Guidance will hopefully be a useful mechanism when notifying the relevant authority of any issues regarding a product’s safety or risk of compliance levels.

Please do get in touch if we can assist with product safety and compliance.