Products | UK Regulatory Outlook November 2025
Published on 26th November 2025
General and Digital: European Commission consults on product safety and market surveillance | Council of the EU adopts 'one substance, one assessment' legislative package
Life sciences and healthcare: UK Government unveils roadmap to phase out animal testing | MHRA closes RegulatoryConnect programme | MHRA announces major regulatory overhaul for rare disease therapies | Side effects from drug interactions to be predicted by AI before reaching patients
Sustainable products: UK government considers Internal Market Act intervention over Welsh DRS glass inclusion | Government lays draft regulations to amend Packaging Extended Producer Responsibility Scheme | Ban on the sale of plastic wet wipes to come into force in spring 2027 | GPSR guidance | Omnibus IV
Jump to: Life Sciences and Healthcare | Sustainable products
General and Digital products
UK
European Commission launches consultations on product safety and market surveillance rules
The European Commission, on 12 November 2025, launched two major initiatives to strengthen EU product safety and market surveillance rules to ensure that all products on the EU single market are safe and fit for an increasingly digital and circular economy.
The first is a public consultation on the revision of the New Legislative Framework (NLF), which consists of Decision 768/2008/EC and Regulation (EC) 765/2008. The NLF is a key tool for harmonising EU product legislation and sets out the principles for market access, CE marking and conformity assessment. A 2022 Commission evaluation concluded that while the NLF has improved consistency in EU product legislation, it needs updating to address market developments, circularity and digitalisation. The consultation is particularly aimed at manufacturers, refurbishers, businesses involved in product circularity, and consumer organisations.
The Commission also launched a call for evidence for an evaluation and impact assessment on the revision of the Market Surveillance Regulation ((EU) 2019/1020). The evaluation will address checks in the single market and on products entering the EU market, with the aim of assessing how well the regulation is performing and identifying any shortcomings. Key stakeholders include importers, distributors, fulfilment service providers and SMEs whose products are placed on or enter the single market from non-EU countries.
The feedback period for both initiatives is open until 4 February 2026. The Commission expects to adopt legislative proposals for both initiatives in the third quarter of 2026.
Council of the EU adopts 'one substance, one assessment' legislative package
The Council formally adopted the "one substance, one assessment" legislative package on 13 November 2025, aimed at streamlining chemical safety assessments and bringing greater transparency to EU chemicals rules. The package consists of three acts:
A regulation establishing a common data platform on chemicals, which will be managed by the European Chemicals Agency (ECHA) and provide a one-stop shop for information on chemicals by integrating data from a wide range of EU legislation, including hazards, physico-chemical properties, emissions and uses. The platform will also provide a database of safer alternatives to chemicals of concern and will become operative within three years of the regulation's entry into force.
A directive amending the RoHS Directive (2011/65/EU) to re-attribute scientific and technical tasks to the ECHA.
A regulation amending the Food Safety Regulation ((EC) 178/2002), the European Environmental Agency Regulation ((EC) 401/2009), the Medical Devices Regulation ((EU) 2017/745) and the POPs Regulation ((EU) 2019/1021) to re-attribute scientific and technical tasks and improve cooperation among EU chemicals agencies.
The acts will enter into force 20 days after publication in the Official Journal.
EU
GPSR guidance
On 19 November 2025, the European Commission published guidance for businesses on applying the EU General Product Safety Regulation (GPSR). It is intended to help companies better understand and fulfil their obligations under the regulation. The guidance reiterates that the GPSR’s core objective is to ensure that only safe products are placed on or made available in the EU market, including via online channels.
The guidance resolves several previous grey areas. It confirms the GPSR’s scope includes intangible products (such as apps, chatbots, software as a service, and standalone software) where they are intended for, or foreseeably used by, consumers. It explains that obligations for distance sales apply when an online offer is targeted at EU consumers. It provides practical tools and makes clear that safety assessments must address cybersecurity and evolving/learning functionalities alongside mental‑health risks. It also reiterates accident‑reporting expectations in software contexts and confirms application from 13 December 2024.
However, some uncertainties still remain, notably the practical boundary between “making available” versus “placing on the market” for SaaS and continuously updated services, how to distinguish routine updates from risk‑altering updates, evidentiary approaches to causality for psychological harm, and the practical mechanics of recalls and remedies for intangible products.
With the GPSR now having been in force for nearly a year, businesses placing products on the EU market should already be familiar with its requirements and review this guidance to ensure their safety and compliance measures are robust and in compliance with the regulation.
Omnibus IV
As previously reported, the European Commission published the Commission work programme 2026 on 21 October 2025, titled "Europe's Independence Moment". This report sets out the main plans and priorities for 2026, with a continued focus on simplification initiatives.
The Commission states that it "will continue our work to cut administrative burdens by 25% overall and 35% for SMEs - without lowering standards" through various legislative and non-legislative measures scheduled for implementation between Q1 and Q4 2026. In the context of product regulation, this means a shift towards digitalisation of documentation, and steps to make alternatives for conformity assessments available through so-called common specifications, along with delays to the introduction of due diligence obligations under the Batteries Regulation.
For detailed analysis of the specific proposals and their implications, please see our May 2025 coverage of the Commission work programme 2026.
Life sciences and healthcare
UK
Government unveils roadmap to phase out animal testing
The government has published a strategy to phase out animal testing in science, backed by £75 million in funding, aiming to deliver on its manifesto commitment to improve animal welfare.
The strategy sets out six key objectives:
accelerate the replacement of animals in science to phase out their use;
achieve equal or better research and testing outcomes using alternative methods;
drive private investment in alternative methods to boost innovation and growth;
improve regulatory confidence and acceptance of alternative methods;
create infrastructure and partnerships to unlock value from UK data; and
position the UK as a global leader in alternative methods.
The roadmap recognises that phasing out animal use can only happen where reliable and effective alternative methods can replace them and includes specific commitments with timelines extending to 2030. The strategy will support researchers to adopt alternative methods such as organ-on-a-chip systems, AI-based predictive tools and 3D bioprinted tissues. The strategy will be overseen by a committee chaired by science minister Lord Vallance, with key performance indicators to be published next year.
MHRA closes RegulatoryConnect programme
The Medicines and Healthcare products Regulatory Agency (MHRA) has decided to close its RegulatoryConnect programme. This follows a cost assessment to complete the system, which was proposed last year to make it easier for industry to see and track their regulatory assessments. The agency envisaged users signing into the portal to track the progress of applications and see live licence details, with plans to add the ability to file applications and variations through the service later.
The MHRA has stated that while the functionality to track applications and view live authorisation details through the existing portal will remain available, the programme "no longer offers value for money for UK taxpayers". It is planning a replacement that aligns with the strategy it intends to publish next year.
MHRA announces major regulatory overhaul for rare disease therapies
The MHRA published a policy paper on 2 November 2025 setting out proposals to reform the regulatory framework for rare disease therapies in the UK, with a draft framework anticipated by spring 2026 and public consultation to follow later in 2026.
Key proposals under consideration include exploring whether a single approval could be issued for both clinical trials and marketing authorisation based on limited evidence with mandatory safety monitoring, increased use of real-world data and prior knowledge from related products, flexible licensing structures to accommodate individualised medicines and platform technologies, and enhanced post-market surveillance through national registries and international data sharing.
The initiative is being developed with input from a newly formed Rare Disease Consortium comprising patients, patient representatives, academics, industry stakeholders and health system partners including NICE and NHS England, with the objective of aligning regulatory processes with Health Technology Assessment and NHS commissioning frameworks to facilitate patient access while maintaining safety standards.
Side effects from drug interactions to be predicted by AI before reaching patients
The MHRA has announced three government-backed projects using AI-driven approaches to make medicines safer and bring treatments to patients more quickly. A new study will use artificial intelligence and NHS data to predict side effects from drug combinations before they reach patients. Scientists from the MHRA will work with PhaSER Biomedical and the University of Dundee, backed with £859,650 funding from the UK government's Regulatory Innovation Office's AI Capability Fund, using AI to spot interactions by looking for patterns in anonymised NHS data showing how different medicines behave when used together, focusing on cardiovascular medicines.
The goal is a reliable tool that doctors can use to better understand how combinations of medicines affect people in real life, improving how treatments are prescribed together so patients get the safest and most effective care tailored to them more quickly. This personalised approach could potentially help to prevent some of the side effects linked to medicines, which are estimated to cause around one in six hospital admissions in England and cost the NHS more than £2 billion every year.
The MHRA will also pilot the use of AI-assisted tools to support experts in scientific advice, clinical trial assessments and licensing decisions through the AI for Regulatory Insight, Safety, and Efficiency (ARISE) programme. This will be funded by £1,000,000 via the Regulators' Pioneer Fund, aiming to improve efficiency and consistency while keeping all final decisions in human hands.
Another MHRA project will pilot the use of synthetic patient data to support clinical trials in cancer, inflammatory bowel disease and rare paediatric seizure conditions, funded by £259,250 from the Regulators' Pioneer Fund, testing how synthetic data can safely and responsibly supplement evidence for regulatory decisions.
According to the MHRA, together, these three projects – supported by over £2 million in government funding – represent a step change in how medicines and medical technologies are approved and regulated in the UK. It believes the findings will help to shape the next generation of clinical trials and approvals and inform upcoming guidance, including the MHRA's National Commission into the Regulation of AI in Healthcare.
Sustainable products
UK
UK government considers Internal Market Act intervention over Welsh DRS glass inclusion
The UK government is reportedly considering action under the Internal Market Act that could derail Wales's plans to include glass in its deposit return scheme from day one in October 2027, while other UK nations' DRS exclude glass.
The Department for Environment, Food and Rural Affairs (Defra) is concerned about potential chaos if Wales proceeds with its proposal, which includes a phased approach with zero deposits for single-use glass containers to avoid changes to labelling, production or distribution systems. However, the British Retail Consortium has criticised the plans as "antiquated", warning that without deposits there will be no incentive for consumers to return bottles while retailers would still face significant infrastructure investment.
Negotiations are reportedly continuing to persuade Wales to reconsider, with rumours of a potential Internal Market Act intervention similar to the intervention that blocked Scotland's DRS plans.
Government lays draft regulations to amend Packaging Extended Producer Responsibility Scheme
The draft Producer Responsibility Obligations (Packaging and Packaging Waste) (Amendment) Regulations 2025 were laid before Parliament on 3 November 2025 and will come into force on 1 January 2026.
The regulations will 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.
On the same date, Defra and PackUK published guidance for organisations on how to apply to be the PRO, with PackUK intending to appoint the PRO in March 2026.
Ban on the sale of plastic wet wipes to come into force in spring 2027
On 18 November 2025, the government signed into law a ban on the sale of wet wipes containing plastic. The draft regulations were laid before Parliament for approval in September and will make it an offence to supply or offer single-use wet wipes containing plastic to consumers in England, with exceptions for pharmacies, for medical purposes and supply to businesses or local authorities.
On 3 November 2025, the General Committee debated the draft regulations, outlining that 95% of respondents to a 2023 public consultation agreed or strongly agreed with the proposed ban. During the debate, cross-party support was expressed for the regulations. They highlighted that over 11 billion wet wipes are used annually in the UK, causing 93% of sewer blockages and fatbergs, with water companies spending approximately £100 million per year clearing them. The chair of the Secondary Legislation Scrutiny Committee confirmed that the statutory instrument passed scrutiny with "flying colours".
The regulations were subsequently considered by the House of Lords Grand Committee on 10 November 2025, where they received broad support but attracted concerns about the implementation timeline and scope. Peers questioned why the ban does not extend to manufacture and export of plastic wet wipes, and whether the government should go further by banning all wet wipes from being flushed regardless of plastic content. The government acknowledged that plastic-free wet wipes also contribute to sewer blockages and confirmed it is considering recommendations from the Independent Water Commission on whether an extended producer responsibility scheme for wastewater and mandatory product labelling will be necessary to prevent wrongful flushing.
The regulations are expected to come into force in May 2027, following an 18 month transition period.
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