On 25 March the UK Office for Product Safety and Standards (OPSS), working with BSI and a range of product safety professionals, announced the publication of two important Codes of Practice: a new Code of Practice for Bringing Safe Products to Market (PAS 7050), and an updated version of the Code of Practice for Supporting Better Product Recalls (PAS 7100). The Codes of Practice are relatively unique in the world in terms of their contents and approach, and importantly they reflect what is regarded as best practice by the product safety regulators in the UK, as well as being influential much more widely around the world.
PAS 7100 – Code of Practice for Product Recall and Other Corrective Actions
PAS 7100 was first published in 2018 and has become extremely important in setting the standards for businesses in developing their strategies for managing consumer product recalls and corrective actions. Despite what the name suggests, about two thirds of the Code of Practice is dedicated to how companies should proactively manage product safety and prepare for product recalls as part of their day-to-day business, in case a product safety issue arises in the future. PAS 7100 is divided into two sections: one for businesses, and one for regulators, and is used by regulators to measure the conduct of companies in the UK when assessing whether appropriate corrective actions have been taken.
At the time of its original launch, the OPSS announced that the Code would be reviewed periodically and updated in light of any changes. In some respects this latest update was overdue, but this update does not bring many significant changes to the content of the original PAS 7100. Some points have been further clarified, and there are amendments arising from the UK’s departure from the EU. There are new sections targeted at online marketplace operators and also to explain the expectations on distributors of second hand products in the event they become aware of a product recall.
PAS 7050 – Code of Practice for Bringing Safe Products to the Market
PAS 7050 is intended to be the sister document to PAS 7100, with OPSS describing it as a “landmark” publication to sit alongside PAS 7100. As with the PAS 7100, it is split into two parts: one for businesses and one for regulators, and is intended to provide a similar level of guidance to what is expected of companies when launching products on the UK market.
Our key takeaways are:
- Product safety management plan (PSMP). The Code advises all businesses in the supply chain to have a PSMP in place to identify the steps necessary for the safety of products they sell. Businesses should clearly identify who is responsible for the development and management of the PSMP, and ideally it should be referenced in the business’s quality management system. The PSMP should cover topics including clarity of supply chain responsibilities, product traceability and a commitment from management to product safety. The PSMP should be reviewed at least annually.
- Risk assessments. Risk assessments should be carried out for both suppliers and products themselves. For products themselves, the Code is clear that “Compliance with regulatory requirements is a minimum step in the product safety process. Compliance with a standard does not necessarily mean the product is safe, merely a presumption that it is safe for the hazards identified within the standard.” Therefore, businesses must be alive to new risks, particularly when relying on standards drafted prior to the introduction of new technologies that pose novel risks. The Code advises that a safety assessment must be completed prior to a product being placed on the market, and must take into account unintended but reasonably foreseeable use of the product.
- Traceability. Building on the requirements in legislation that traceability labelling be visible, legible and indelible, PAS 7050 adds that markings should be durable to withstand general wear and tear and, where practical, able to withstand fire and water damage. Traceability is vital for the effectiveness of corrective actions, and the Code recognises the ability of a robust system of traceability to avoid unnecessarily broad corrective actions and potentially reduce costs.
- Review. PAS 7050 advises businesses to monitor for forthcoming legislative requirements. We know that it is a busy time in the world of product safety legislation, particularly as the UK develops it post-Brexit legislative framework, and so it is imperative that businesses have robust processes for tracking legislative developments, to avoid being caught out.
- Enforcement action. In the section of the Code for regulators there is guidance on how a regulator should respond to non-compliance. The Code emphasises a collaborative approach to support businesses in achieving and maintaining compliance, but alludes to the fact that regulators must be prepared to implement enforcement actions where required.
In summary, these Codes offer businesses an important indication of the OPSS’s approach to product safety and the management of responses to product safety issues, and businesses wishing to depart from this guidance should be prepared to explain why they have taken a different path.
Click here to download copies of PAS 7100 and PAS 7050.
New Site for Product Safety Alerts and Recalls
Today, the OPSS has also launched a new product safety alerts, reports and recalls site to help consumers and business identify unsafe products. The new site is similar in format to the EU RAPEX reports that many businesses will be familiar with, and includes the ability to search for previous reports, filter reports to subscribe for instant, daily or weekly updates.
Cooley served on the Steering Groups that drafted PAS 7100 (both in its original form, and the updated version) as well as the new PAS 7050. Please reach out to any member of the Cooley Products Law team for further information or if you have any questions.