UK: UK regulator publishes new codes of practice for product safety
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On March 25, the UK Office for Product Safety and Standards (OPSS), together with BSI and various 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 to support better product recalls (PAS 7100). The Codes of Practice are relatively unique in the world in terms of content and approach, and most importantly they reflect what is considered best practice by product safety regulators in the UK, as well as being far more influential in 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 companies to develop their consumer product recall and corrective action management strategies. Despite what the name suggests, about two-thirds of the code of practice is devoted 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. . The PAS 7100 is divided into two sections: one for businesses and one for regulators, and is used by regulators to measure business conduct in the UK when assessing whether appropriate corrective action has been taken.
At the time of its initial launch, OPSS announced that the Code would be reviewed periodically and updated in light of any changes. In some ways, this latest update was late, but this update doesn’t make many significant changes to the content of the original PAS 7100. Some points have been further clarified, and there are changes resulting from the UK’s departure from the EU. New sections are aimed at operators of online marketplaces and also explain what to expect from distributors of used products in the event that they become aware of a product recall.
PAS 7050 – Code of practice for placing safe products on the market
PAS 7050 is intended to be the sister document to PAS 7100, with OPSS describing it as a “benchmark” publication alongside PAS 7100. As with PAS 7100, it is divided into two parts: one for business and one for regulators, and aims to provide a level of guidance similar to what is expected of companies when launching products on the UK market.
Our main takeaways are:
- Product Safety Management Plan (PSMP). The Code advises all companies in the supply chain to have a PSMP in place to identify the steps necessary to ensure the safety of the products they sell. Companies should clearly identify who is responsible for developing and managing the PSMP, and ideally it should be referenced in the company’s quality management system. The PSMP should cover topics such as clarity of supply chain responsibilities, product traceability, and a management commitment to product safety. The PSMP must be reviewed at least once a year.
- Risk assessments. Risk assessments should be carried out both for suppliers and for the products themselves. For the products themselves, the Code specifies that “Compliance with regulatory requirements is a minimum step in the product safety process. Compliance with a standard does not necessarily mean that the product is safe, but merely a presumption that it is safe for the hazards identified in the standard.” Therefore, companies need to be aware of new risks, especially when relying on standards written before the introduction of new technologies that pose new risks. The Code indicates that a safety assessment must be carried out before a product is placed on the market and must take into account the unintended but reasonably foreseeable use of the product.
- Traceability. Building on legislation requirements that traceability labeling should be visible, legible and indelible, PAS 7050 adds that markings should be durable to withstand general wear and, where possible , capable of withstanding fire and water damage. Traceability is vital to the effectiveness of corrective actions, and the Code recognizes the ability of a robust traceability system to avoid unnecessarily extensive corrective actions and potentially reduce costs.
- Review. PAS 7050 advises businesses to monitor upcoming legislative requirements. We know this is a busy time in the world of product safety legislation, especially as the UK develops its post-Brexit legislative framework, and so it is imperative that companies have robust processes for monitoring legislative developments to avoid being caught off guard.
- Enforcement measures. In the section of the Code for Regulators, there is guidance on how a regulator should respond to non-compliance. The Code emphasizes a collaborative approach to help companies achieve and maintain compliance, but hints that regulators must be prepared to implement enforcement action if necessary.
In summary, these codes provide companies with an important indication of the OPSS approach to product safety and the management of responses to product safety issues, and companies wishing to deviate from these guidelines should be ready to explain why they took a different path.
Click here to download copies of PAS 7100 and PAS 7050.
New Site for Safety Alerts and Product Recalls
Today, OPSS also launched a new Product Safety Alerts, Reports and Recalls site to help consumers and businesses identify unsafe products. The new site is similar in format to the EU RAPEX reports that many companies are familiar with, and includes the ability to search past reports, filter reports to subscribe to instant, daily or weekly updates.
Cooley was part of the steering groups that drafted PAS 7100 (both in its original form and the updated version) as well as the new PAS 7050. Please contact a member of the Cooley Products Law team for further details. information or if you have any questions.
The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.
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