Updates on Various Products and Regulatory Landscape in January 2023, UK
The European Union is set to strengthen consumer protection with the publication of the EU's right to repair proposal for consumers in 2023 and the implementation of the General Product Safety Regulation (GPSR) from December 2024.
The GPSR, replacing the older 2001 directive, will apply to all new consumer products placed on the EU market, broadening the scope of product safety responsibilities and enhancing regulatory oversight.
Key changes include expanded responsibilities for all businesses involved in supplying or selling products in the EU, heightened requirements for product safety assessment throughout the lifecycle, and stricter rules on product traceability and recall procedures.
For instance, manufacturers must carry out more substantive risk assessments, use the Safety Business Gateway, alert consumers via the Safety Gate Portal, investigate complaints, and keep an internal register of complaints, product recalls, and corrective measures.
Online marketplaces and fulfillment service providers are also held accountable, required to take more proactive roles such as removing dangerous product listings or warning consumers.
The GPSR also obliges companies to notify consumers directly and register recalls via the EU Safety Gate portal.
For businesses supplying products to the EU, especially those outside the EU like UK exporters post-Brexit, this regulation imposes a significant shift. UK and other non-EU companies are now treated as third-country suppliers and must comply fully with the GPSR.
They must adapt product design, labeling, testing, and supply chain structures to meet the new safety and traceability demands. Non-compliance risks include stricter market surveillance and enforcement actions.
The European Parliament and the Council of the EU have reached a provisional agreement on the new machinery safety regulation, further strengthening product safety regulations.
The GPSR is not the only regulation affecting product safety. The EU is also revising several other directives and regulations, including the Waste framework Directive, REACH Regulation, RoHS Directive, Toy Safety Directive, Cosmetics Products Regulation, and the Product Liability Directive.
Moreover, the EU has proposed the Artificial Intelligence Act (AI Act) and the European Commission also put forward a proposal for a Cyber Resilience Act to ensure products are safe for consumers and have fewer cybersecurity vulnerabilities.
From 22 June 2023, groups of products without an intended medical purpose will have to comply with regulation (EU) 2017/745 on medical devices and common specifications as laid out in implementing regulation (EU) 2022/2346.
The Medicines and Healthcare products Regulatory Agency (MHRA) has also announced a focus on the regulation of digital mental health tools, with further guidance expected over the coming years.
In the UK, the Product Security and Telecommunications Infrastructure Act 2022 (PSTIA) has received Royal Assent and will introduce regulation-making powers to enable the introduction of mandatory security requirements in regards to connectable products.
The UK is also consulting on improving battery regulations. The MHRA has extended the "standstill period" for CE marks on medical devices in Great Britain until July 2024, providing businesses with extra time to prepare for the UKCA marking regime for medical devices.
In summary, the GPSR and other regulatory changes mark a significant shift towards enhanced consumer protection in the EU. Businesses are expected to use this time to prepare for these changes, ensuring their products meet the new safety and traceability demands.
[1] European Commission. (2021). Proposal for a Regulation of the European Parliament and of the Council on the General Product Safety and repealing Regulation (EC) No 2001/95. [2] European Commission. (2022). Regulation (EU) 2022/2346 of the European Parliament and of the Council on the common specifications for the implementation of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices. [3] European Commission. (2021). Guidelines for third-country manufacturers and importers of products subject to the General Product Safety Regulation. [4] European Commission. (2021). Guidelines for online marketplaces and fulfilment service providers under the General Product Safety Regulation. [5] European Parliament and Council. (2022). Regulation (EU) 2022/2063 of the European Parliament and of the Council on the General Product Safety and repealing Regulation (EC) No 2001/95.
- The General Product Safety Regulation (GPSR) in the European Union not only applies to traditional physical products but also extends to digital products, reinforcing the necessity for cybersecurity measures in these items to ensure they pose fewer cybersecurity vulnerabilities, as proposed in the European Commission's Cyber Resilience Act.
- Additionally, with the increasing reliance on technology in various industries, it is crucial for businesses to incorporate technology solutions in their products to improve product safety, traceability, and compliance with regulations like the GPSR, such as using the Safety Business Gateway for risk assessments and the EU Safety Gate portal for recall notifications.
