Products | UK Regulatory Outlook April 2023

General Product Safety Regulation adopted

On 25 April, the Council of the European Union adopted the General Product Safety Regulation (GPSR) which will replace the General Product Safety Directive. The new regulation, among other things, aims to enhance product safety online by imposing new duties on online marketplaces, and enhances rules for economic operators. A summary of some of the key changes are as follows:

• online marketplaces are now firmly within the product safety framework, with interface, cooperation and process requirements, including dedicated contact points for regulators and consumers;
• many of the requirements imposed by the Market Surveillance Regulations now apply to all products;
• strict deadlines for taking action in response to non-compliance; and
• enhanced documentation and information requirements for all products sold in the EU.

Member States will have 18 months to implement the GPSR, so businesses should expect the new rules to be in place by late 2024. While this may feel like a long time off, businesses will need to become accustomed to the changes on the horizon and understand the measures they need to put in place in order to comply.

New sentencing guidelines for retailers who sell knives on the UK market come into effect

As of 1 April 2023, new sentencing guidelines came into effect in relation to the unlawful sale of knives by retailers (in-store or online) to under 18s. Although the there is no statutory limit on the amount of any fine, the guidelines indicate that for a "large" organisation (turnover of £50m and over), that does not have a proper due diligence system in place, the appropriate range is between £200k-£1m. "Very large" organisations should expect fines in excess of that range.

Having a robust due diligence system in place to try and prevent underage sales is critical. For in-store sales this is a combination of signage, effective training of staff and age verification checks. For online sales, there should be age verification checks on delivery.

UK government publishes draft proposals for new border controls

On 5 April, the government published its plan for new border controls set out in the draft Border Target Operating Model.

The model sets out a new risk-based approach to security controls (which applies to all imports) and sanitary and phytosanitary controls (which applies to imports of live animals, germinal products, animal products, plants and plant products). The government has said that the new model will "prevent delays at the border through a reduction in the need for physical checks for many types of goods, and by ensuring that checks take place away from ports where this is needed to allow traffic to flow freely."

The model will be implemented between the end of October 2023 and 31 October 2024 via the following three stages:

• 31 October 2023 – health certification will be introduced on imports of medium risk animal products, plants, plant products and high risk food (and feed) of non-animal origin from the EU.
• 31 January 2024 – documentary and risk-based identity and physical checks on medium risk animal products, plants, plant products and high risk food (and feed) of non-animal origin from the EU to be introduced. Imports of Sanitary and Phytosanitary goods from the rest of the world will also be subject to the new risk based model.
• 31 October 2024 – safety and security declarations for EU imports will come into force as well as the introduction of reduced datasets for imports.

The government is currently seeking feedback on the draft proposals before the final version is published in June.

The Food Standards Agency (FSA) has welcomed the new proposals. FSA chair Susan Jebb stated: "These controls are critical to maintaining the UK’s high food and feed safety standards. They will help the FSA and its partners to more rapidly track down unsafe food or feed and help stop it being sold."

Goods moving into Northern Ireland from Great Britain will follow arrangements set out in the Windsor Framework, see our summary of this.

Extension of the MDR transitional period and removal of the ‘sell off’ periods

The European Commission has published a Q&A document on the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) regarding the transitional provisions for certain medical devices and in vitro diagnostic medical devices (see our previous Regulatory Outlook for more). Questions include what devices can benefit from the extension of the transitional period and removal of the "sell-off" date, and what applications need to be lodged by manufacturers.

The UK government has also published a further update on the EU's decision to extend the transitional period, noting that certificates that have been extended will also be recognised as valid for placing CE marked devices on the GB market. We also expect the UK government to publish a statutory instrument in due course that will allow manufacturers to continue to place CE marked devices on the Great Britain market after 1 July 2023 (see our previous Insight for more). 

MHRA issue new guidance on defining intended purpose for Software as a Medical Device

The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.

The MHRA has said that as part of this guidance, manufacturers must produce an intended purpose statement to specify what a product does, a description of the people it is designed to benefit, who should use it, and where it should be used.

An inappropriate intended purpose statement can lead to non-compliance with the law and possible safety concerns. The guidance outlines how manufacturers should produce an appropriate intended purpose statement for SaMD which businesses should familiarise themselves with.

Commission adopts new ecodesign rules for electrical appliances in 'standby' mode

On 17 April, the European Commission adopted a new regulation which will amend the 2008 ecodesign regulation on standby, off mode and networked standby.

The aim of the new rules is to reduce energy consumption of products when they are in "standby mode" by requiring them to have reduced electricity consumption when in low power modes. Changes include extending the scope of the 2008 rules to include products with a low voltage external power supply, such as wireless speakers.

The new regulation will soon be published in the Official Journal and will enter into force 20 days later, after which there will be a two-year transition until the rules apply fully. However, some limits will be applied in two stages, with the final rules applicable after four years. 

Scottish DRS postponed to March 2024

Scottish first minister Humza Yousaf has announced that the go live date of the deposit return scheme (DRS) in Scotland will now be pushed back to 1 March 2024. Mr Yousaf has delayed the launch of the DRS (which was due to go live this August) in order to give businesses more time to prepare, but stated that he remains committed to the scheme as a way of increasing recycling and meeting net zero targets. See our earlier Regulatory Outlook for what the DRS will entail.

The Scottish government has also announced a number of changes to the scheme which are:

• drinks containers of under 100ml will be excluded, removing miniatures and other smaller containers from the scheme;
• products that sell fewer than 5,000 units per year will be excluded, which will particularly benefit craft producers;
• all hospitality premises that sell the large majority of their drinks products for consumption on the premises will be exempt from acting as a return point; and
• the online application process for retailers to apply for an exemption from providing a return point has been simplified.

EU Machinery Regulation adopted by European Parliament

As flagged in our January issue, a new machinery safety regulation has been going through the EU ordinary legislative procedure. The regulation has been adopted by the European Parliament and will now have to be formally approved by the Council, following which the new legislation will be published in the Official Journal of the European Union and will enter into force on the 20^th day after publication.

The new regulation will replace the current directive and will ensure the new rules are fit for emerging digital technologies. For example, it introduces a stricter mandatory third party conformity assessment procedure for specific categories of machinery before they are placed on the EU market. These categories are set out in Annex I, Part A of the new regulation, an example being machinery with self-evolving behaviour (based on machine learning). Conformity checks of those products listed in Annex I, Part A will have to be carried out by a third party. For the majority of products (listed under Annex I, Part B), the manufacturer itself can carry out the conformity assessment.

Manufacturers of products supplied on the Union market, and which are subject to the machinery directive, must be aware and familiarise themselves with these new changes.

Limiting the use of PFAS in the UK

The government outlined in its recently published Plan for Water that new proposals will be introduced to restrict the use of PFAS in line with the Health and Safety Executive's report. See more in the Environment section.

European Parliament adopts regulation on deforestation-free supply chains

Please see ESG.