Products | UK Regulatory Outlook January 2026

Jump to: Life Sciences and Healthcare | Sustainable products

General/digital products  

UK 

Product Regulation and Metrology Act consultations and guidance 

The Product Regulation and Metrology Act 2025 received royal assent on 22 July 2025. It is intended to modernise the UK's management of product and metrology regulations and to facilitate closer alignment with the European Union. The Act allows ministers to introduce secondary legislation with key measures including responsibilities within supply chains, cost recovery, enforcement and excluded products. See our previous update for further details on the Act or read the full text. 

Throughout 2026, we expect to see further consultations and secondary legislation developed under this Act. The government published a Code of Conduct clarifying how it intends to use its new powers, setting out statutory and non-statutory controls to ensure regulations made under the Act are proportionate and evidence-based. Businesses should monitor government announcements for sector-specific regulations that may emerge during the year. 

Government response to the independent review of the Windsor framework 

The government responded to the Independent Review of the Windsor Framework on 16 December 2025, following the Democratic Consent Vote held in the Northern Ireland Assembly in December 2024. The response addresses Northern Ireland's unique regulatory position post-Brexit and provides clarity on how product regulations will apply in Northern Ireland throughout 2026. 

The proposed changes following the review include: 

Democratic scrutiny: 

• Greater discretion for the Democratic Scrutiny Committee over timelines within the existing two month scrutiny period.
• New "triage" process to identify EU regulatory proposals that may apply in Northern Ireland earlier in the EU policymaking cycle.
• New processes to ensure relevant public authorities can provide clearer analysis of EU regulatory proposals and more readily respond to questions. 

Business support and guidance: 

• £16.6 million programme to deliver an enhanced "one-stop shop" facility for Windsor Framework guidance and support.
• Online goods advisor using generative AI to summarise relevant rules for moving goods.
• "Business concierge" online portal to guide businesses through trading steps and provide tailored support.
• New second-line Northern Ireland Trade Resolution Centre to resolve complex, interlocking issues. 

Companies trading with or through Northern Ireland should review the government response carefully to understand implications for their supply chains. 

Call for evidence on the automated vehicles regulatory framework 

On 4 December 2025, the government published a call for evidence on developing the automated vehicles regulatory framework, marking further steps to implement the Automated Vehicles Act 2024. This call for evidence will help inform secondary legislation, guidance and policy development, ensuring the AV regulatory framework remains proportionate, forward-looking and responsive to emerging technologies while upholding strong safeguards for public safety, data protection and responsible operation. 

The call for evidence is split into two chapters covering "getting AVs on the road" and "once AVs are on the road", addressing issues including vehicle type approval, authorisation processes, user-in-charge requirements, transition demands, operator licensing, insurance, in-use regulation, sanctions, incident investigation and cybersecurity. Stakeholder responses will shape the regulatory approach throughout 2026 and beyond. 

EU 

Toy Safety Regulation enters into force 

The new Toy Safety Regulation entered into force on 1 January 2026, following its adoption by the European Parliament and the Council, strengthening children's protection from harmful chemicals in toys and improving enforcement of EU toy safety rules. 

Under the regulation, substances will be banned from toys as soon as they are identified as hazardous, including chemicals that disrupt hormones, harm the lungs, cause skin allergies, or damage specific organs, with the ban also covering per- and polyfluoroalkyl substances (PFAS) and bisphenols. The new rules also strengthen the existing ban on substances that can cause cancer, genetic damage, or harm reproduction (carcinogenic, mutagenic or reprotoxic substances). 

Enforcement will be enhanced through digital tools, with all toys placed on the EU market required to have a digital product passport containing safety and compliance information, accessible to consumers online via a QR code or other data carrier. The new rules will apply from 1 August 2030, providing a transition period for industry compliance. 

Product Liability Directive transposition into national law 

The Product Liability Directive entered into force on 8 December 2024, updating and adapting the EU's liability rules for new technologies, ensuring better protection for victims and greater legal certainty for economic operators. EU Member States have until 9 December 2026 to transpose it into national law. 

The revised directive expands coverage to address digital products, AI systems and software, while clarifying that online platforms can be held liable when they act as one of the economic operators (manufacturer, importer, authorised representative, fulfilment service provider or distributor). Businesses should monitor national implementation measures throughout 2026. 

In parallel, the UK Law Commission is consulting on product liability reform, with a formal public consultation on reform proposals planned for the second half of 2026. This presents an opportunity for UK businesses to influence the development of a modernised product liability regime. 

Life sciences and healthcare 

UK 

Clinical trials regulations 

On 28 April 2026, the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 will come into force, marking a pivotal moment for the evolving clinical trial landscape. The updated regulations are designed to protect trial participants, strengthen patient safety and accelerate approvals by reducing unnecessary burdens on researchers to support high-quality trusted research in the UK. 

The implementation of the latest international Good Clinical Practice (GCP) guidelines (ICH-GCP E6(R3)) will come into force in the UK along with the updated regulations, with all trials needing to adhere to the principles of GCP, and trials for marketing authorisation needing to comply with the full guidelines. 

The Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority published guidance in October 2025 to support implementation, with the MHRA planning to publish draft guidance for Good Clinical Practice in January, and updates to the process for Modification of an Important Detail in March 2026. Sponsors and researchers should ensure their policies, processes, procedures, and systems are updated ahead of the 28 April 2026 implementation date. 

UK-US pharmaceuticals deal to boost NHS access and investment 

A pharmaceutical deal between the UK and US, forming part of the UK-US Economic Prosperity Deal, will give "tens of thousands" of NHS patients faster access to vital drugs and secure medicines supply chains. The UK becomes the only country with zero tariffs on pharmaceuticals to the US, protecting manufacturing and medtech exports. Major firms like Moderna and BioNTech are investing billions, reinforcing the UK's ambition to lead Europe's life sciences by 2030. 

The agreement includes a transformative commitment by the UK government to invest approximately 25% more in innovative, safe and effective treatments – the first major increase in over two decades. This expansion is underpinned by significant reforms to the National Institute for Health and Care Excellence's (NICE) assessment methodology, with cost-effectiveness thresholds increasing from £20,000-£30,000 per quality-adjusted life year (QALY) to £25,000-£35,000 per QALY. NICE will also introduce a new value set for judging health states following consultation, developed from surveying thousands of members of the public about different health conditions. 

The UK has also secured mitigations under the US's "Most Favoured Nation" drug pricing initiative, ensuring continued access to the latest treatments and encouraging pharmaceutical companies to prioritise the UK for early launches of new medicines. Bristol Myers Squibb has already announced plans to invest upwards of $500 million over the next five years across research, development and manufacturing in the UK. The pharmaceutical industry has welcomed these commitments as addressing long-standing concerns about NHS access to medicines and the UK's previously record-high and unpredictable payment rates, though stakeholders acknowledge considerable technical details remain to be worked out. 

Medical devices future regime implementation 

The post-market surveillance statutory instrument was signed into law on 16 December 2024, with the new regulations introducing clearer and more robust requirements that improve patient safety. These requirements came into effect on 16 June 2025. 

Further statutory instruments are expected to follow in 2026 to introduce new pre-market requirements including international reliance, and further enhancements to the regulations. Businesses should monitor MHRA announcements for details of these forthcoming statutory instruments, which will progressively build the future medical devices regulatory framework. 

Indefinite recognition of CE marked medical devices 

Following the government's announcement that it would consult "later this year", in 2025, on proposals to indefinitely recognise CE marked medical devices, no consultation has yet been launched. Under the existing transitional arrangements, the CE mark is recognised in the UK until 30 June 2028 or 2030 (depending on the device classification and legislation complied with). We expect to see this consultation launched at some point this year. 

ABPI announces 2026 VPAG payment rate reduction to 14.5% for newer medicines 

The Association of the British Pharmaceutical Industry (ABPI) has announced that the government has set the 2026 payment rate for newer medicines under the Voluntary Scheme for Branded Medicines Pricing and Access (VPAG) at 14.5%, down from 22.9% in 2025.  

This decline reflects slower growth in NHS use of newer medicines during 2025, with the rate falling below the 15% ceiling agreed in the recent UK-US trade deal. Payment rates for older branded medicines will remain between 10% and 35%, and companies will continue to pay a further 1% voluntary contribution to support investment in UK life sciences infrastructure, bringing the total 2026 rebate for newer medicines to 15.5%.  

The government and the ABPI will begin discussions in early 2026 to develop a more sustainable scheme from 2029 onwards, with companies having until 16 December to opt into VPAG or otherwise enter the statutory scheme, which has a 24.3% payment rate for 2026. 

Outcome of the MHRA consultation on health institution exemptions published 

The MHRA has published the outcome of its call for evidence on health institution exemptions within the medical devices regulatory framework. The survey, which ran from 1 August to 15 September 2025, gathered insights from health institutions across Great Britain on their experience of the exemption, sometimes referred to as in-house manufacturing exemption.  

The MHRA aims to refine the policy to enable exempted devices to be used beyond health institutions, strengthen safety measures through enhanced post-market surveillance and support delivery of care closer to communities. The outcome will inform subsequent consultations, guidance updates and regulatory changes planned for the coming year as part of the Medical Devices Regulatory Reform roadmap. 

EU 

First four EUDAMED modules become mandatory from 28 May 2026 

The European Commission published Decision (EU) 2025/2371 declaring full functionality of the first four EUDAMED modules: actor registration, UDI/device registration, notified bodies and certificates, and market surveillance systems. Under Regulation (EU) 2024/1860 transitional provisions, publication triggers a six-month transition period, after which the modules become mandatory from 28 May 2026. See our Insight for more details. 

Deal on comprehensive reform of EU pharmaceutical legislation 

On 11 December 2025, co-legislators reached a provisional agreement on revamping the EU's pharmaceutical policy framework to boost competitiveness, innovation and security of supply. The deal includes a regulatory data protection period of eight years with one additional year of market protection. Pharmaceutical companies will be eligible for additional periods of market protection of up to 12 months each if products address unmet medical needs, contain new active substances meeting specific conditions, or obtain authorisation for new therapeutic indications bringing significant clinical benefit, with a cap of eleven years on the combined regulatory protection period. 

To combat antimicrobial resistance, negotiators agreed to introduce a transferable data exclusivity voucher for priority antimicrobials giving the right to 12 additional months of data protection, alongside stricter requirements, including compulsory medical prescriptions for all antimicrobials. The updated rules would simplify the European Medicines Agency's internal functioning, with marketing authorisation valid by default for an unlimited period. Companies would be required to put in place shortage prevention plans for certain medicinal products, with shortages monitored at both national and EU levels. 

The Parliament and Council have concluded an early second reading agreement. The Council is now expected to formally adopt its position, which can then be endorsed by the Parliament in second reading. 

European Commission and EIB Group announce €10 billion biotech investment initiative 

The European Commission and the European Investment Bank (EIB) Group announced on 16 December 2025 an initiative to mobilise €10 billion in investment in 2026-27 into the biotech and life sciences sector, aiming to boost the EU's competitiveness in biotechnology by addressing the current investment gap and mobilising public-private investment into promising new health solutions.  

The initiative, BioTechEU, will be part of the EIB Group's TechEU programme, leveraging support from the InvestEU guarantee and other sources, and builds on the EIB Group's current life sciences venture debt portfolio of about €3.5 billion across 135 projects and the EIF's long-standing commitment to European venture capital (approximately €800 million annual investments). The BioTechEU initiative could also lay the foundation for the design of a new EU Health Biotech Investment Pilot, which would attract new private investors and act as a market catalyst. 

European Commission proposes health sector innovation package 

The European Commission proposed on 16 December 2025 an ambitious package of measures to improve the health of EU citizens while ensuring the long-term resilience and competitiveness of the health sector, including a Biotech Act, revised rules for medical devices, and a Safe Hearts Plan.  

The Biotech Act aims to increase Europe's biotechnology potential by supporting the transition of innovative ideas from laboratory to market, exploring new means of funding and investment through a new health biotech investment pilot to be developed with the EIB Group, incentivising companies to conduct research and production within Europe, accelerating clinical trials authorisations across countries, and establishing single regulatory pathways for complex innovative products. 

The Safe Hearts Plan is the first comprehensive EU approach to tackling cardiovascular diseases, which kill 1.7 million Europeans annually and cost the European economy €282 billion, presenting targeted measures to improve prevention, detection and treatment including supporting Member States in developing national cardiovascular health plans, establishing dashboards monitoring health inequalities, and launching an Incubator to speed up the use of AI.  

The medical devices proposals will simplify EU rules, support digitalisation of procedures, introduce timelines to complete conformity assessments to speed up access and guarantee continuous supply, strengthen the EMA's role in coordination and monitoring shortages of medical devices, and ensure uniform rules for medical devices incorporating AI applications, which the Commission claims will lead to overall cost savings of €3.3 billion per year including €2.4 billion annual administrative savings. 

Call on the EU to streamline the potential of biotechnology and life sciences in healthcare 

The Public Health Committee MEPs adopted their contribution to the upcoming EU Biotech Act, calling for streamlined regulation to position Europe as the leading destination for biotechnology investment whilst maintaining safety standards.  

MEPs emphasised policy coherence with pharmaceutical legislation, simplified clinical trials frameworks, and support for regional innovation hubs integrating manufacturing, regulatory expertise and training. The committee calls for increased investment in early-stage development and exploration of an EU Biotech Innovation Fund. The own initiative report was adopted with 25 votes in favour, eight against and three abstentions and will be put to a vote by Parliament during a future plenary session. 

Sustainable products  

UK 

PFAS in the UK and EU in 2026 

In August, the Health and Safety Executive (HSE) launched a consultation on the proposal to remove PFAS in firefighting foam. This consultation closes on 18 February and we expect to see the outcome of this consultation later in 2026 and final decision in 2027.  

Also expected in 2026, as part of the Environmental Improvement Plan 2025 is the National PFAS plan, which will set out a range of regulatory and non-regulatory interventions, measures and initiatives with specific actions and delivery milestones. These will raise understanding and awareness of PFAS in the environment, identify and address releases of harmful PFAS and protect people and the environment from harm relating to PFAS exposure. 

Meanwhile, in the EU, the European Chemicals Agency (ECHA) has proposed a ban on more than 10,000 PFAS substances for all consumer goods. This proposal is currently under review by the Committee for Risk Assessment and the Committee for Socio-Economic Analysis, who are due to issue their opinions to the European Commission by the end of 2026. See our Insight for further details. Please see the Food section for further details on the ban of PFAS in food contact packaging, which comes into force on 12 August 2026. 

EPR in force from 1 January 2026 

The Producer Responsibility Obligations (Packaging and Packaging Waste) (Amendment) Regulations 2025 came into force on 1 January 2026.  

The regulations amend the Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024 (SI 2024/1332), which introduced the extended producer responsibility scheme for packaging waste (pEPR) in the UK, to: 

• enable the appointment of a producer responsibility organisation (PRO) to support the scheme administrator PackUK in running the pEPR scheme and ensure closer producer involvement;
• enable producers to deduct tonnage of recycled food grade plastics packaging waste from their pEPR obligations where they have collected it directly from consumers and sent it for reprocessing in a closed loop recycling system; and
• improve the operational efficiency of the pEPR scheme and clarify producers' obligations, including resolving potential loopholes, removing ambiguity, improving the approach to local authority costs modelling and removing barriers to compliance and enforcement.  

Defra and PackUK have published guidance for organisations on how to apply to be the PRO, with PackUK intending to appoint the PRO in March 2026 and the government has issued a guidance document which covers closed loop recycling under the EPR, with businesses being required to report their closed loop data for 2024 by 28 January 2026. 

Large business in scope of EPR should also be preparing for the next data reporting deadline of 1 April 2026.  

Welsh government seeks exclusion from UK Internal Market Act 2020 for its DRS scheme 

The Welsh deposit return scheme continues to make progress despite its controversial decision to include glass in the scheme. In a written statement published on 27 November, the Welsh government announced: 

• the opening of applications for appointment of a deposit management organisation;
• the implementing regulations will be laid before the Senedd in February 2026; and
• it is seeking exclusion for the DRS from the United Kingdom Internal Market Act 2020. 

The Welsh deputy prime minister has warned that if the exclusion from the IMA is not granted "this would lead to the scenario where there would be no DRS in Wales". 

Consultation on extending the CE marking recognition mechanism for ESPR 

The Department for Energy Security and Net Zero has launched a consultation (closing 20 January 2026) on proposals to extend CE marking recognition to products regulated under the EU's new Ecodesign for Sustainable Products Regulation (ESPR).  

Currently, energy-related products bearing the CE marking can be sold in Great Britain without requiring additional UKCA marking, thereby reducing compliance costs for manufacturers. As the EU transitions from the Ecodesign Directive to ESPR (with first regulations expected mid-2027), the government proposes amending the Ecodesign for Energy Related Products Regulations 2010 to maintain this recognition mechanism. 

Plastic packaging tax – new mass balance approach 

HMRC has released a policy paper outlining measures which introduce a mass balance approach to account for chemically recycled plastic used to make plastic packaging from 1 April 2027. It also addresses a tax loophole by removing pre-consumer waste as a source of recycled content for the purposes of the plastic packaging tax. 

The introduction of a mass balance approach addresses a practical challenge that has prevented businesses from benefiting from chemically recycled plastic despite it being recognised as recycled content since the tax's introduction in April 2022. Chemical recycling enables hard-to-recycle plastics to be processed into high-quality recycled material suitable for applications where mechanically recycled plastic is unsuitable due to regulatory or quality constraints, but the physical mixing of recycled and virgin materials during production has made it difficult to track recycled inputs to outputs.  

To claim relief from PPT, UK manufacturers and importers will need to demonstrate that their supply chain is covered by a commercial certification scheme compliant with PPT mass balance standards, which will set out requirements for material types, allocation processes, certification body accreditation and record keeping. The simultaneous removal of pre-consumer waste from the definition of recycled plastic aims to close a tax loophole and create stronger incentives for using post-consumer waste, which is typically more challenging and costly to recycle but delivers greater environmental benefits. 

Environmental Improvement Plan 2025 

See Environment section. 

EU 

Ecodesign for Sustainable Products Regulation – provisions on destruction of unsold consumer goods  

From 19 July 2026, the Ecodesign for Sustainable Products Regulation (ESPR) prohibits the destruction of certain unsold products, applying to apparel and footwear including items made of leather, knitted or crocheted items, hats and headgear, and various types of footwear. 

The prohibition aims to reduce waste and encourage donation, reuse or recycling of unsold goods, with exemptions for products that cannot be used safely due to health or hygiene concerns, products damaged beyond repair, items legally or technically unfit for use, donations not accepted, products unfit for reuse or refurbishing, intellectual property violations and where destruction has the least environmental impact. The exemptions will be confirmed by delegated legislation which is currently being produced by the European Commission. 

Medium-sized enterprises are required to comply with these rules from 19 July 2030, while micro and small enterprises are currently exempt but encouraged to avoid destroying products.  

In 2026, the European Commission is also expected to develop delegated acts in line with its working plan, expanding the scope of ecodesign requirements to additional product categories, with the plan focusing on textiles, furniture, tyres and mattresses along with intermediate products such as iron and steel, and aluminium. See this Regulatory Outlook for more details on when these requirements are expected to come into force 

Businesses in scope of the ESPR must also publicly disclose information on how they discarded unsold consumer goods during the previous financial year. This is very broad and affects all consumer goods. Businesses must publish the data via their website. Businesses caught by the Corporate Sustainability Reporting Directive (CSRD) can include this information in their sustainability reports and provide a link to it on their website. The European Commission has recently consulted on the implementing regulation that outlines how the information should be formatted. This is expected to be adopted soon. 

To comply with these disclosure requirements, businesses should: 

• Start to collate information on the number and weight of unsold consumer products discarded per year.
• Document why these products were destroyed.
• Understand where to report the information and what format this should be in (guidance to be announced).
• Look into measures to prevent the destruction of unsold consumer products, as this will carry reputational risk and, eventually, the ban on discarding unsold goods will expand to include other types of consumer goods. 

First set of requirements under the EU PPWR come into effect 

A number of new requirements have been introduced by the EU Packaging and Packaging Waste Regulation, with the first coming into effect on 12 August 2026. These include: 

• Harmonised EPR schemes.
• PFAS restrictions for food contact materials.
• Labelling requirements.
• Reuse and refill obligations.
• Restrictions on single use packaging.
• Recyclability conditions.
• Recycled content targets.
• Packaging minimisation and waste prevention. 

EU Postpones CLP Regulation Application Dates to 2028 

Regulation (EU) 2025/2439 was published on 3 December 2025, postponing the application dates of transitional provisions in the CLP Regulation on classification, labelling and packaging of substances and mixtures from 1 July 2026 and 1 January 2027 to 1 January 2028.  

The delayed requirements include: 

• label format and readability standards, such as minimum font size requirements (for example, text height of at least 1.4mm for packaging under three litres) and line spacing of at least 120% of font size;
• advertising and promotional language standards, which prohibit misleading terms such as "non-toxic" and "ecological" in hazardous chemical advertisements and require hazard pictograms and signal words in all advertisements;
• distance selling and online marketplace obligations, requiring complete label elements to be displayed to consumers before purchase, with a supplier established in the EU being responsible for product compliance; and
• fuel station labelling requirements for supplier names and UFI on fuel pump nozzles and portable containers. 

The postponement provides more time and legal certainty to businesses, particularly SMEs, and allows co-legislators additional time to agree on substantive changes in the second part of the Omnibus VI package.  

Guidance released prior to the ban on plastic wet wipes 

In November of last year, the UK government signed into law a ban on the sale of wet wipes containing plastic. It has since released additional guidance on which wipes will be banned, when they can still be sold and how the ban will be enforced. Businesses should review this guidance now to ensure they are ready for the ban, which comes into force on 19 May 2027. 

Sustainable consumption actions from the European Commission's 2030 Consumer Agenda 

On 19 November, the European Commission released its 2030 Consumer Agenda and action plan for consumers in the single market. One of its focuses is sustainable consumption, with a number of actions planned. These include: 

• supporting Member States in the implementation of the directive on empowering consumers for the green transition, Ecodesign for Sustainable Product Regulation and the directive on common rules to promote the repair of goods – with a harmonised notice on the legal guarantee of conformity and a harmonised label for the commercial guarantee of durability expected in Q3 2026;
• supporting the circular economy – exchanging good practices with stakeholders to promote consumer return of goods that are no longer used, second-hand markets, product-as-a-service business models and innovative circular start-ups in 2027; and
• exploring the need for a recommendation on fostering "green by design" features in e-commerce and encourage the development of digital tools and their use in 2027. 

Preparing for EU sustainable battery requirements 

As previously reported, the date of application of the due diligence obligations under the Sustainable Batteries Regulation 2023 has been pushed back to 18 August 2027.  

The European Commission is expected to publish guidance on these due diligence requirements in July 2026. Further, from 18 August 2026 harmonised labelling requirements come into effect for all batteries.  

Also coming into force is the requirement for electric vehicle batteries and industrial batteries over 2 kWh to be electronically registered under the EU Digital Product Passport system from 18 February 2027, which businesses in this sector can start preparing for in 2026.  

Once published, businesses should review the Commission's guidelines on due diligence as well as ensuring they are ready to comply with other requirements of the regulation as they come into force.