Products | UK Regulatory Outlook November 2024

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Autumn Budget 2024

On 30 October, the UK chancellor, Rachel Reeves, delivered the Autumn Budget which contained a number of announcements relevant to general/digital products, product sustainability and products within the life sciences and healthcare sector.

General/digital products

Earlier this month, the government released a new  industrial strategy green paper which outlines the government's commitment to developing a long-term and targeted industrial strategy. This strategy identifies eight growth-driving sectors, including advanced manufacturing. The Budget indicates that the full strategy will be published next year, detailing individual plans for each of these sectors. Further, investment in advanced manufacturing includes £975 million for the aerospace sector and over £2 billion for the automotive sector up to 2030 and the Made Smarter Innovation Programme will receive up to £37 million in 2025-26 to assist firms in integrating digital technologies into manufacturing.

Product sustainability

The government reaffirms its commitment to a zero-waste economy and the implementation of the Collection and Packaging Reforms Programme, noting that the extended producer responsibility for packaging is expected to generate over £1 billion annually. As the government advances its plans towards a zero-waste economy, businesses will need to stay informed about new initiatives and adapt their operations to comply with the reforms. This may involve changes in packaging materials and waste management practices, among other adjustments.

Additionally, the Plastic Packaging Tax (PPT) rate will increase for 2025-26 in line with CPI inflation. It also confirmed that PPT businesses will be allowed to use a mass balance approach to evidence recycled content in chemically recycled plastic for PPT. These changes will mean that businesses will, in due course, pay less if they reduce the amount of packaging and use recycled materials.  With the upcoming increase in the tax rate, exploring more sustainable packaging alternatives will become increasingly important.

Life sciences and healthcare

Significant developments for the life sciences and healthcare sector were set out in the budget, including £1.5 billion for new surgical hubs and diagnostic scanners and up to £520 million of longer-term funding being made available for a new Life Sciences Innovative Manufacturing Fund. Read our Insight for more.

General / digital products

UK

Product Regulation and Metrology Bill starts committee stage

The Product Regulation and Metrology Bill started it Lords committee stage on 20 November, and it is this stage which is the most opportune point in the legislative procedure for significant amendments to be introduced: it is the most detailed part of the bill's scrutiny in the Lords without a fixed time limit, and every clause has to be agreed in a line-by-line review before the bill moves on.

Following its second reading, over 100 proposed amendments were made, covering topics from jurisdictional scope, environmental considerations, the definition of a product, the definition of an online marketplace, enhancements to consumer safety, reviews of technical standards, and enforcement powers. Considering the number of concerns and amendments raised with the bill so far, it is anticipated that the committee stage will take some time.

Government publishes response to the Product Safety Review

The government has published its response to the Product Safety Review. The response highlights the current challenges with the product safety framework including the mass of technical legislation regarding product safety, limited powers in domestic legislation to update legislation, and the need for regulations to be updated in line with technological advancement. These were also reasons for the introduction of the Product Regulation and Metrology Bill and as such the response links back to how these issues will be rectified with the introduction of the new bill.

The response sets out what was found both from the call for evidence in 2019 and the public consultation that ran last year. This included addressing the growth of online markets and the need for better enforcement, and consumer safety and the need for a more responsive framework to emerging hazards.

In terms of next steps, under the Product Regulation and Metrology Bill the government intends to introduce new requirements on online marketplaces at the earliest opportunity to clarify online marketplace responsibilities. It will also monitor changes to EU product and metrology legislation and notes that new legislation may be introduced in line with its two call for evidences on noise measurement from outdoor equipment and common charger (see the previous Regulatory Outlook).

The government also flags in its response cross-cutting hazards, such as the choking hazard of button batteries and the fire hazard of lithium-ion batteries, as an area where further legislation could be needed in the next year. The government is also considering whether to move wholesale towards the provision and sharing of product safety information digitally by default. Longer term, it will consider how technological advancements can be integrated into the existing framework, aligning with the industrial strategy to be published in spring 2025. Further consultation and secondary legislation is expected in all these areas.

Tobacco and Vapes Bill

The Tobacco and Vapes Bill has been introduced and had its first reading on 5 November. The bill introduces a number of provisions relating to the sale and distribution of tobacco and vapes including, among others, a provision prohibiting the sale of tobacco to people born on or after 1 January 2009 and provision about the licensing of retail sales and the registration of retailers; to enable product and information requirements to be imposed in connection with tobacco, vapes and other products; and to ban the manufacturing and sale of oral tobacco products such as snus. The bill passed its second reading on 26 November. View further documents including the explanatory notes.

While subject to change as it progresses through parliament, businesses who will be affected by this legislation should familiarise themselves with the bill and its effect on them.

To note, the bill sits separately to the recently introduced regulations banning the supply and sale of single-use vapes from 1 June 2025 (see the previous Regulatory Outlook).

EU Regulation prohibiting products in the Union market made using forced labour receives final approval

Please see Modern slavery.

EU

EU Product Liability Directive published in the Official Journal of the EU

On the 18 November, the EU Product Liability Directive was published in the Official Journal of the EU. Member States will have until 9 December 2026 to implement the directive into national law. This means that products placed on the Union market or put into service from 9 December 2026 will be subject to the new directive. Those products are already on the market or put into service before 9 December 2026 will still be subject to the former Product Liability Directive.

If you would like to receive our infographic which sets out the incoming changes and practical steps you can be taking now, then please get in touch.

You can also track the directive on our Digital Regulatory Timeline.

EU Cyber Resilience Act published in Official Journal

The EU Cyber Resilience Act (CRA) was published in the Official Journal and will enter into force on 10 December 2024. The CRA has a 36-month transition period, meaning it will apply from 11 December 2027.

The CRA introduces stringent cybersecurity requirements for products with digital elements, such as connected home devices. Potential fines for non-compliance with the CRA is up to €15m or 2.5% of the worldwide annual turnover. Key elements include:

• EU-wide cybersecurity standards for hardware and software.
• CE marking to indicate compliance.
• Application to all connected products, with some exceptions.

With the CRA now in force, manufacturers that place products with digital features on the EU market will need to understand what their obligations are under the new legislation and what they will need to do to ensure compliance. Businesses who are already complying with the UK's Product Security and Telecommunications Infrastructure Act 2022 will see some similarities in a few of the compliance requirements, see our Insight for a comparison of the two.

You can also track the directive on our Digital Regulatory Timeline.

Product sustainability

UK

Wales pulls out of UK-wide Deposit Return Scheme

On 18 November, the Welsh government issued a statement announcing its decision to withdraw from the UK-wide deposit return scheme (DRS), which is due to be rolled out in October 2027. The statement highlights unresolved issues regarding the inclusion of glass in the scheme leading to Wales's decision not to participate in the UK-wide initiative. However, the Welsh government reaffirmed its commitment to developing a DRS for Wales, specifically noting that it will consider the inclusion of glass containers.

The UK government published a statement in response reiterating its commitment to implementing a DRS across England, Northern Ireland and Scotland in October 2027. Additionally the government has published draft regulations for the scheme, confirming its intention to adhere to the current timeline.

This development suggests that the UK-wide and Welsh DRS could differ in terms of the materials in scope, especially given Wales's intention to include glass. It will be interesting to observe the UK government's response to this and businesses that will be affected by the introduction of the DRS should keep on top of developments. 

EU

Update of the EU's PHAS restriction process

On 20 November, the European Chemicals Agency (ECHA) published an update on the restriction proposal for per- and polyfluoroalkyl substances (PFAS) (see our Insight for more). As a reminder, this proposal looks at restricting around 10,000 PFAS which would be on the manufacture, placing on the market and use of PFAS. The initial PFAS restriction contains two restriction options: a full ban or a ban with time limited derogations (where alternatives are not yet available).

Following the 2023 consultation on the proposal, the five authorities who submitted the proposal, along with ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC), have been considering the 5,600 comments received. These responses have highlighted uses of PFAS that were not specifically named in the original proposal, including sealing applications, technical textiles, printing applications and other medical applications, such as packaging and excipients for pharmaceuticals. Additionally, consideration is also now being given to whether restriction options other than a ban may help to reduce PFAS emission following these comments.

The update outlines that work is to progress during 2025 which will lead to an opinion of the RAC and a draft opinion of the SEAC. Following this, a consultation will be held on the draft opinion of the SEAC.

Although the ECHA is to continue its work on PFAS restrictions into next year meaning draft legislation may not be ready until later into 2025, businesses should be using this time now to prepare for new law which will phase-out PFAS. Businesses should be having internal conversations around PFAS and looking at what changes may need to be made to supply chains as well as looking to mapping out areas of risk.

Consultation on the DPP rules for service providers

The European Commission has launched a consultation in regards to a delegated act it intends to adopt which will set out the rules on the operation of digital product passport (DPP) service providers. The DPP is set out in the Ecodesign for Sustainable Products Regulation and so will be gradually introduced for product groups being placed on the EU market. Additionally, from 18 February 2027, a DPP will be mandatory for certain types of batteries.

The delegated act will outline the requirements for DPP service providers, who will store and process DPP data for economic operators that opt not to do it themselves. For those who host the DPP themselves, service providers will store a mandatory backup copy. The Commission will conduct an impact assessment to evaluate potential options, effects, and the feasibility of a certification scheme to ensure compliance. Comments are to be made by 10 December 2024.

European Commission establish Ecodesign Forum

On 29 October 2024, the Commission Decision (EU) 2024/2779, which establishes the Ecodesign Forum under the Ecodesign for Sustainable Products Regulation (ESPR) was published in the Official Journal of the EU. This forum is a group of experts on ecodesign for sustainable products and energy labelling who will act as an advisory body to the Commission in relation to the ecodesign requirements they will introduce under the ESPR. The forum will be consulted on all key steps of the ecodesign process, including the development of ecodesign requirements and the preparation of ESPR working plans, which will set out the products and measures to be addressed over a given period.

Members will be individuals appointed to represent a common interest, organisations, Member States' authorities, or other public entities. Those wishing to apply to the forum must meet a selection criteria and follow the instructions set out in the call. The call for applications for members of the forum opened on 7 November 2024 and closes at noon on 5 December 2024. Businesses should review the call to see whether they fit the criteria and wish to apply.

EU Deforestation Regulation delayed by a year and goes back to trialogue

Please see ESG.

Life sciences and healthcare

UK

Government to refresh post-market surveillance requirements for medical devices

On 22 October 2024, the draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 were laid before Parliament. These draft regulations amend the Medical Devices Regulations 2002 to impose more stringent requirements and obligations on manufacturers to undertake post-market surveillance (PMS) practices on their medical devices. Changes being introduced include to PMS system and plan, preventative actions and reporting obligations. We explore this further in our Insight.

Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on forthcoming regulations on routes to market for medical devices and in vitro diagnostic (IVD) devices.

The MHRA is seeking views on four areas:

International reliance – introduce an international reliance scheme, that would complement the UKCA process, aimed to expedite GB market access for certain devices approved in countries with comparable regulatory systems to the UK: Australia, Canada, the EU and the USA.

UKCA marking - removing the current requirements for devices which undergo the UK conformity assessment process to bear a UKCA marking and instead assign devices with a Unique Device Identification (UDI) to allow for traceability of medical devices. The conformity assessment process would not be impacted by this proposal.

In vitro diagnostic devices – amending the IVD system to classify IVD devices into four risk classes based on patient and public health risk they pose. This will closely align with the structure used by the International Medical Device Regulators Forum and EU in order to support global harmonisation and assist in providing a risk-based approach to classification of IVD devices.

Assimilated EU law - proposal to remove the revocation date of four pieces of assimilated law as the regulations are still in use and need remain in place until the transition to an updated medical devices regime:

• Commission Decision 2002/364 on the common specifications for in vitro diagnostic medical devices
  • Commission Regulation [EU] No 207/2012 on electronic instructions for use of medical devices
  • Regulation [EU] No 722/2012 concerning particular requirements for medical devices manufactured utilising tissues of animal origin
  • Regulation [EU] No 920/2013 on the designation and the supervision of approved bodies.

The consultation closes on 5 January 2025. Businesses should review the consultation and determine whether they wish to respond.

Guidance on supply and advertisement of medicines in the UK after 1 January 2025 published

On 1 January 2025, new arrangements for human medicines introduced by the Windsor Framework come into effect. From 1 January 2025, all medicines in the UK will be licensed by the MHRA and authorised under the Human Medicines Regulations 2012.

The MHRA has published new guidance on the main changes being introduced by the framework and businesses placing medicines on the UK market should be aware of the changes coming into force on 1 January 2025 and how these will impact them. See this earlier Regulatory Outlook for more.

New guidance has been also published providing information on the advertising and promotion changes coming into effect. Products that were eligible for authorisation by the European Commission in Northern Ireland will now be authorised by the MHRA. The guidance states that marketing authorisation (MA) holders can still obtain an NI MA, and the MHRA may issue GB MAs after 1 January 2025 in exceptional circumstances to protect patients' health in the UK. It adds that the vast majority of MAs will be UK-wide, meaning that these medicinal products can be advertised across the UK, except in exceptional circumstances where a medicinal product is only licensed in part of the UK.

In regards to licence numbers, from 1 January 2025, the EU licence number assigned to licences in respect of NI will no longer apply and suggests that the number should be phased out "at the earliest available opportunity".