Products | UK Regulatory Outlook September 2026

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UK

Tobacco and vapes: retail licensing, packaging and age of sale update

The Department of Health and Social Care has confirmed, in response to a written parliamentary question, that the government plans to consult on proposals for a retail licensing scheme for tobacco, vapes and nicotine products in 2027.

The scheme is intended to strengthen enforcement and support law-abiding retailers, while addressing those who break the law; a breach of a licence condition or other statutory requirement could lead to revocation. The grounds on which a licence may be granted, suspended, revoked or varied will themselves be subject to consultation.

Separately, in response to the government's consultation on packaging, appearance and display requirements under the Tobacco and Vapes Act 2026, the Chartered Trading Standards Institute (CTSI) has backed the proposals to tighten regulation of tobacco, vaping and nicotine products, including extended plain packaging, health warnings and restrictions on branding, flavours, product appearance and retail displays. The CTSI argues that robust, future-proof definitions are essential to close loopholes, particularly for heated tobacco devices, vaping products and flavour descriptors, and it calls for clear enforcement provisions, consistency across product categories, child-resistant packaging, limits on promotional branding, and implementation periods capped at 12 months.

Two further sets of regulations under the Tobacco and Vapes Act 2026 have also been laid. The Tobacco and Vapes Act 2026 (Display of Tobacco Products) (Consequential Amendments) Regulations 2026 amend the Tobacco Advertising and Promotion Act 2002 to update the age-related exemption from display restrictions in shops in England, Wales and Northern Ireland, aligning it with the new age of sale offence for anyone born on or after 1 January 2009. The Tobacco and Vapes Act 2026 (Age of Sale Notices and Consequential Amendments) (England) Regulations 2026 set minimum size requirements for the age of sale notices that retailers in England must display from 1 January 2027, amend the equivalent notice requirements for bulk tobacconists, and make consequential changes to the rules restricting the display of tobacco products and price lists to reflect the new age of sale.

OPSS publishes guidance on asbestos in sand-containing toys

The Office for Product Safety and Standards (OPSS) has published an advisory note clarifying its expectations of businesses placing sand-containing toys on the UK market. Responsibility for product safety rests with the business placing the product on the market, and nothing should be placed on the market unless its safety can be assured.

Testing alone is not enough. Given the nature of asbestos contamination and the limitations of sampling, the guidance treats testing as only one part of a wider assurance approach. This should include obtaining assurance from suppliers, understanding where raw materials come from, and maintaining quality controls during manufacture and processing. The advisory note also points businesses to the British Standards Institution's PAS 7050, a published specification setting out good practice for bringing safe products to market.

Businesses are expected to control this risk throughout their supply chain, keep appropriate records, and be ready to share technical documentation with regulators on request.

OPSS has confirmed it will continue its own market surveillance and compliance work to check that these expectations are being met. Where the absence of asbestos cannot be assured, the toys should not be supplied; where it is found, businesses must notify regulators, tell affected customers and carry out withdrawals and recalls.

OPSS launches Product Regulation Sandbox programme

The Office for Product Safety and Standards (OPSS) has launched a new Product Regulation Sandbox programme. It lets a company developing an innovative product work directly with OPSS at an early stage, rather than waiting until it is ready for market.

Through the programme, a business can explore how existing rules apply, test approaches to gathering the evidence it needs and identify problems before bringing the item to market. OPSS has said the initiative is also intended to help it understand new technologies and the regulatory challenges they raise, so that its own approach keeps pace with innovation.

The first sandbox, the Cosmetics Sandbox: Bioengineered Ingredients, is open to companies developing cosmetic ingredients using bioengineering methods such as precision fermentation, synthetic biology and cell culture technology. It is aimed at those that have run into regulatory uncertainty, safety assessment issues, or questions about how the UK's retained version of the EU Cosmetic Products Regulation (1223/2009/EC) applies to their products. Selected participants will work directly with OPSS teams to address these issues and support bringing their ingredients to market.

Expressions of interest close on 4 December 2026, and OPSS has said it plans to launch further sandboxes covering other products and sectors in future.

EU

Leaked European Product Act would give the Commission direct enforcement powers and expose marketplaces to authorised-representative liability

A draft of the European Product Act (EPA) has been leaked ahead of the Commission's expected formal proposal on 6 October 2026. The EPA will consolidate the New Legislative Framework and the Market Surveillance Regulation into a single directly applicable regulation covering conformity assessment, digital product passports and market surveillance. The draft is broad, but three changes stand out:

• Online marketplaces that fail to verify a product has a valid digital product passport or product responsibility record before listing it will, where no EU-established economic operator is responsible for the product, assume the obligations and liabilities of an authorised representative.
• The European Commission will gain direct investigation and enforcement powers over non-compliant products entering the EU from third countries, bypassing national authorities, including the ability to order recalls, restrict online content and impose financial penalties.
• National penalties for infringements will be set between 1% and 6% of annual worldwide turnover, with a separate Union-level penalty of up to 6% available to the Commission when it acts directly, applying in addition to national fines.

As with any leaked text, the draft may change before the formal proposal and during the legislative process. However, online marketplace operators, manufacturers of regulated products and importers should begin assessing their exposure now.

EU Right to Repair Directive becomes applicable, with extraterritorial relevance for UK businesses

The EU Right to Repair Directive ((EU) 2024/1799) became applicable across EU member states on 31 July 2026, having entered into force on 31 July 2024.

The directive amends the Goods Directive ((EU) 2019/771) to incentivise consumers to choose repair over replacement when exercising rights against sellers, and separately obliges manufacturers of goods subject to EU legislative repairability requirements to repair those goods once the seller's liability under the Goods Directive expires, to provide consumers with repair information, and not to impede third-party repairs.

The rules extend to manufacturers established outside the EU where they sell in-scope goods into the EU, in which case their EU authorised representative (or, absent one, their importer or distributor) becomes responsible for repair and information obligations. A new online European repair platform, to help consumers find repairers, is expected to become operational in 2027.

European Commission publishes guidance on Digital Battery Passport data requirements

The European Commission has published updated guidance to help stakeholders prepare for the Digital Battery Passport, ahead of the requirement applying from 18 February 2027. It brings together 71 data points across battery identity, sustainability, performance, safety and circularity, showing their legal sources, and indicates for each battery category (electric vehicle (EV), light means of transport (LMT) and industrial batteries) whether a data point is mandatory, optional, applicable only in specific circumstances, or does not have to be completed or displayed as of February 2027.

The guidance is aimed primarily at manufacturers, importers and other businesses in the battery supply chain responsible for making information available through the passport, though conformity assessment bodies and market surveillance authorities may also find it useful.

Life sciences and healthcare

UK

MHRA publishes National Commission recommendations on regulating AI in healthcare

The Medicines and Healthcare products Regulatory Agency (MHRA) has published the recommendations of the National Commission into the Regulation of AI in Healthcare, which was established to advise government on a future regulatory framework. The commission's final report, published on 10 September 2026, sets out 44 recommendations following 761 responses to a public call for evidence.

The commission looked beyond the regulation of safe and effective software and AI-enabled medical devices to wider issues, including accountability, transparency, clinical practice, organisational governance and system-wide assurance. Its recommendations are grounded in a research and engagement programme, including a call for evidence, public deliberation events, work with seldom-heard groups, and professional, industry and specialist working groups. That programme also involved further discussion across government and the health system.

Key proposals include requiring manufacturers to set out, in supply contracts, how safety-related responsibilities are shared with healthcare providers. The report also recommends a staged authorisation route, allowing AI products to reach the market within a defined scope before progressing to full authorisation as real-world evidence builds. A further proposal is an opt-in "Master File", letting developers of underlying AI models share technical information with the MHRA once, rather than each manufacturer resubmitting it separately.

A cross-government response will follow separately, setting out how government and system partners will consider and take forward the recommendations.

Health Bill outlines reforms to legislation governing medicines and medical devices

The government has published a fact sheet outlining reforms to the legislation governing medicines and medical devices in the Health Bill. The bill will give the MHRA and the government new tools to keep the regulatory framework up to date, covering regulatory reform, information sharing, and powers to establish a future medical device licensing regime.

On regulatory reform, the bill will allow greater use of "ambulatory references", so that legislation can refer to external technical documents in a way that automatically reflects future updates without needing legislative amendment. It also introduces a more proportionate approach to consultation and the negative parliamentary procedure for minor and technical changes, while significant policy changes will still require full consultation and the draft affirmative procedure.

In relation to information sharing, updated powers will let the MHRA share select information with UK and international partners, including some commercially sensitive material, subject to existing data protection safeguards.

For medical devices, the bill creates powers for a future licensing regime allowing the MHRA to directly assess and licence devices and related businesses, with the detail to follow in subsequent regulations.

MHRA Regulatory Sandbox: call for expressions of interest

The MHRA has launched a call for expressions of interest for its London Region I Regulatory Sandbox, run with NHS England (London) and the London Health Innovation Networks. The sandbox will bring together up to 10 AI-enabled medical device manufacturers and NHS organisations to deploy technologies in live clinical settings under MHRA oversight. It will focus on devices supporting preventative care such as heart health, community-based support and digital access to health services.

Expressions of interest are welcome from AI-enabled medical device manufacturers, NHS provider organisations in Greater London and manufacturer-provider partnerships, with no application fee. The call stays open until 10 devices have been selected, assessed and deployed.

MHRA clarifies regulatory status of ambient voice technologies in healthcare settings

The MHRA has published guidance, developed with NHS England, clarifying how existing medical device law applies to ambient voice technology (AVT) products used in health and care settings in Great Britain.

AVT products used solely for transcription, summarising clinical conversations, drafting letters or suggesting clinical codes for clinician review are not regulated as medical devices; those intended to support diagnosis, treatment or prevention, or that take automated action without clinician review, are.

The guidance does not change the law, and clinicians remain responsible for reviewing and verifying AI-generated outputs before use in patient care.

EU

IMDRF publishes final guidance on predetermined change control plans for medical device software

The International Medical Device Regulators Forum (IMDRF) has published final technical guidance on predetermined change control plans (PCCPs) for medical device software, aimed at international convergence without replacing national laws or regulations.

A PCCP allows manufacturers to obtain advance authorisation for a series of predetermined changes as part of an initial or existing submission. Once mutually agreed with regulators, and provided the device's original intended use is unchanged, this removes the need for a separate regulatory submission for each change.

PCCPs are expected to be focused, risk-based, evidence-based and transparent, and comprise three elements: a description of planned changes and their rationale; a change plan setting out evaluation methods and deployment procedures; and an impact assessment of benefits, risks and mitigations.

The guidance is limited to software, leaving non-software PCCPs without equivalent international guidance for now, though IMDRF has acknowledged the concept could extend to other medical technologies.

Sustainable products

UK

HMRC publishes guidance on mass balance approach for chemically recycled plastic in Plastic Packaging Tax

HMRC has published guidance on using a mass balance approach to account for chemically recycled plastic in Plastic Packaging Tax (PPT) returns, alongside separate guidance on the minimum certification requirements for using that approach.

From 1 April 2027, businesses that manufacture packaging components in the UK using chemically recycled plastic, or import finished components made this way, must use a mass balance approach for that content to count for PPT purposes. Otherwise, it will be treated as virgin plastic.

The approach is only available where the recycling process changes the chemical structure of the plastic waste. Every business in the supply chain must hold certification from a scheme meeting HMRC's minimum requirements, supported by attribution declarations and records kept for six years. HMRC has said it will publish more detailed guidance, including on penalties, in early 2027.

PPT came into force on 1 April 2022. It applies to plastic packaging components manufactured in or imported into the UK that contain less than 30% recycled plastic by weight, at a rate of £200 per tonne. Manufacturers and importers that meet the relevant threshold must register with HMRC and pay the tax. Other businesses in the supply chain must carry out due diligence to avoid being held jointly and severally liable for unpaid PPT.

Windsor Framework inquiries: end-of-life vehicles and food supply chain

The Northern Ireland Assembly's Windsor Framework Democratic Scrutiny Committee published two reports in late August 2026.

The first concerns Regulation 2026/1738 on circularity requirements for vehicle design and end-of-life vehicles. The committee, which was established under schedule 6B to the Northern Ireland Act 1998, found that the replacement EU act differs in part from the instruments it amends or replaces, but concluded that it would not have a significant negative effect on everyday life in Northern Ireland.

The second report covers the replacement Regulation (EU) 2026/1739, which amends Regulations (EU) No 1308/2013, (EU) 2021/2115 and (EU) 2021/2116 on strengthening the position of farmers in the food supply chain. Several provisions in the replacement regulation apply in Northern Ireland under the Windsor Framework. Having considered its commissioned legal advice, the committee concluded that the replacement EU act does not significantly differ from the relevant parts of the instruments it amends and would not have a significant lasting effect on everyday life in Northern Ireland. The scrutiny periods for both reports ran until 24 September.

Any changes to the committee's conclusions could affect businesses involved in vehicle manufacture, end-of-life vehicle management or the food supply chain that operate in or trade with Northern Ireland.

EU

Environment Agency consults on updated enforcement and sanctions policy

The Environment Agency (EA) has published a consultation on proposed updates to its enforcement and sanctions policy, closing on 4 October 2026. The EA says it needs to update the policy to ensure it is ready to enforce a number of new legal requirements.

Annex 4 will be updated to cover the EA's enforcement approach for the extended producer responsibility for packaging (pEPR) regime, under the Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024. The same annex will also cover the deposit return scheme (DRS) for drinks containers, under the Deposit Scheme for Drinks Containers (England and Northern Ireland) Regulations 2025. It will additionally set out the EA's proposed enforcement approach for the first phase of digital waste tracking, introduced under the Digital Waste Tracking (England) Regulations 2026.

The consultation also proposes a new enforcement penalty principle to protect victims' interests, and a new Annex 5 on civil sanctions under the Water (Special Measures) Act 2025. A further proposal clarifies the control of mercury regime under Annex 3.

Those affected by the pEPR and DRS should consider reviewing and responding to the consultations before the 4 October deadline.

European Commission consults on implementing the Packaging and Packaging Waste Regulation

The European Commission has opened four consultations on measures to implement the Packaging and Packaging Waste Regulation ((EU) 2025/40). Three ran from 14 August to 16 September 2026, with adoption planned in the fourth quarter. The measures are intended to support the shift to recycled and sustainably sourced plastic packaging across the EU market.

The first sets out sustainability criteria for plastic recycling technologies to deliver the greatest environmental benefit. The second establishes methodological rules for assessing, verifying and certifying plastic materials collected or recycled outside the EU as equivalent to the bloc's own system for use in packaging imports. The third harmonises rules for calculating and verifying recycled content in plastic packaging, aiming to reduce administrative burden and give the recycling industry legal clarity for investment.

A fourth consultation ran from 6 August to 10 September, covering rules on national registers of producers with the aim of harmonising parts of extended producer responsibility schemes for packaging across EU member states by setting requirements for national registers and producers' reporting obligations.

EU's revised End-of-Life Vehicles Regulation enters into force

The End-of-Life Vehicles (ELV) Regulation entered into force on 13 August 2026, revising the rules governing vehicle design, production, collection and end-of-life treatment, and replacing Directive 2000/53/EC and Directive 2005/64/EC.

The regulation sets mandatory recycled plastic content targets of 15% from 2032 and 25% from 2036, with recycled content targets for steel and aluminium to be set by the Commission applying from 2033. It strengthens traceability and enforcement, clarifies the criteria distinguishing used vehicles from end-of-life vehicles, and introduces measures to improve recovery of critical raw materials, particularly aluminium, copper and rare earth elements.

From mid-2031, only roadworthy vehicles may be exported outside the EU. The regulation also strengthens extended producer responsibility, requiring producers to contribute to end-of-life collection and treatment costs, and extends its scope to additional vehicle categories including lorries, buses and motorcycles.

European Commission invites feedback on Omnibus Regulation simplifying energy and tyre labelling rules

Following its proposal to simplify the EU's energy and tyre labelling frameworks, the European Commission has invited feedback on an Omnibus Regulation amending the Energy Labelling Regulation ((EU) 2017/1369) and the Tyre Labelling Regulation ((EU) 2020/740), adopted in June 2026.

The proposal simplifies rules for suppliers and dealers, improves compliance and enforcement through greater use of digital options, aligns with digital product passports under the Ecodesign for Sustainable Products Regulation (ESPR), and repeals two obsolete regulations implementing the lapsed US-EU Energy Star agreement. Affected businesses should consider responding before the 15 October 2026 deadline.