Products | UK Regulatory Outlook May 2025

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General

UK

Call for views launched on enterprise connected device security

The government has launched a call for views on the security of enterprise connected devices. "Enterprise connected devices” (or “IoT devices”) are devices used by businesses and organisations such as office printers, internet-connected telephones, building entry systems and room booking systems.

In 2022, the government created 11 principles to guide manufacturers in the secure design of enterprise connected devices, but awareness of the principles has been low. Therefore the government is now proposing to turn the principles into a new voluntary Code of Practice for Enterprise Connected Device Security on which it is seeking views. This code aims to guide manufacturers in designing secure devices and includes guidelines on updates, authentication, data protection, device integrity, and more.

Subject to feedback, following the publication of the code, the government will then look to take the following next steps:

• Creating a voluntary pledge that manufacturers can sign up to and require them to publicly commit to showing measurable progress against some (or all) of the principles outlined in the code.
• Creating a new global standard based on the code, similar to ETSI EN 303 645, which currently exists for consumer IoT devices.
• Introducing new legislation, which could be done via an update to the Product Security and Telecommunications Infrastructure Act 2022 (PSTIA) to broaden the scope of the PSTIA regime to cover both consumer and enterprise devices.

The call for views closes on 7 July 2025, after which a government response with an overview of the key themes will be published.

RIO delivers latest round of funding for regulators to increase innovation and cut red tape

On 22 May, the government announced that the fourth round of the Regulators’ Pioneer Fund opened. The aim of this funding is to "help bring innovations in critical sectors such as healthcare and transport to market quicker" and to cut red tape. Building on the success of 24 previously-backed projects, including AI to boost clinical trials, drones for emergency medical deliveries, and pioneering regulatory guidance to expedite access to innovative medicines and treatments, the government claims this round continues to support its Plan for Change by speeding up access to new technologies that will enhance public services.

With a total funding of £5.5 million, this round is intended to support regulators and local authorities across the UK in key growth areas such as AI in healthcare, engineering biology, space, and connected and autonomous vehicles. Projects may include smarter ways to test new treatments, manage airspace for drones, or support technologies like lab-grown foods, ensuring regulations are fit for purpose to bring innovations to market.

Science minister, Lord Vallance, stated: "By backing this kind of innovation, we’re helping to make the UK the best place in the world to launch, test and scale new ideas, and drive the economic growth we need to improve lives and deliver our Plan for Change."

Product Regulation and Metrology Bill: Committee stage concludes

The Product Regulation and Metrology Bill has now completed its committee stage in the House of Commons. During this stage, various amendments were put forward, including around issues with aligning with the EU and extending liability for online marketplaces, but most of the amendments were rejected. The bill now moves to the report stage where further amendments will be considered. 

New guidance on amending furniture and furnishings fire safety regulations

The Office for Product Safety and Standards (OPSS) has published new guidance for businesses to assist them in implementing the Furniture and Furnishings (Fire) (Safety) (Amendment) Regulations 2025, which come into force on 30 October 2025, updating the Furniture and Furnishings (Fire) (Safety) Regulations 1988 to:

• remove certain baby and young children’s products from scope of the regulations;
• remove the requirement for manufacturers to affix a display label to new products; and
• extend the time frame for instituting legal proceedings from 6 – 12 months.

These changes are being made following a review of the Furniture and Furnishings (Fire) (Safety) Regulations 1988 (see this Regulatory Outlook for more).

Senior executives potentially to face personal liability for failure to remove illegal knife-related content

Please see Digital regulation.

EU

EU's single market strategy and simplification omnibus outlines major reforms to product regulation

The European Commission has published its new 'Single Market Strategy' which aims to tackle 10 most harmful barriers reported by businesses – the “terrible ten”: complicated business establishment and operations; complex EU rules; lack of ownership by Member States; limited recognition of professional qualifications; lack of common standards; fragmentated rules on packaging; lack of product compliance; restrictive and diverging national services regulation; burdensome rules for posting of workers in low-risk sectors; unjustified territorial supply constraints causing high prices for consumers.

Alongside this, it also adopted its fourth simplification omnibus "to take the first steps toward aligning EU product legislation with the digital age".

Key updates from these announcements include the digitalisation of product compliance documentation, the introduction of common specifications, and the postponement of battery due diligence requirements.

Digitalisation of product compliance documentation

One of the most impactful changes is the shift towards digitalisation of product compliance documentation. Businesses will no longer be required to provide product compliance documentation in paper format. Instead, they can opt to provide instructions digitally. The Commission is proposing a "digital by default" principle for product legislation, including documents such as declarations of conformity and instructions.

The Digital Product Passport (DPP), set to first become operational for batteries by 2027 and progressively rolled out to other product categories, will serve as a digital container for essential product information. Additionally, QR codes will be permitted for use by businesses. This digital transformation is expected to streamline processes, reduce administrative burdens, and significantly cut costs for businesses.

Modernising product legislation

The Commission acknowledges that the New Legislative Framework, which provides the principles for harmonised product legislation, requires improvement. This includes defining the responsibilities of economic operators involved in product circularity, embracing digital solutions, and aiming to align enforcement actions across the EU, potentially establishing an EU Market Surveillance Authority.

Introduction of common specifications

The simplification proposal aims to introduce common specifications for products as a legally recognised fallback option, marking another major development. Harmonised standards are the primary method for businesses to demonstrate product conformity with essential EU requirements. However, when these standards are unavailable, businesses face costly and complex conformity assessment procedures. The new common specifications will provide an alternative means for demonstrating conformity. The Commission hopes that these changes will enable businesses to operate efficiently even in the absence of harmonised standards, avoiding unnecessary delays and costs.

Delay of battery due diligence requirements

The simplification proposal looks to delay the due diligence obligations under the battery regulations from 2025 to 2027. Guidelines on these obligations will be published a year before the requirements take effect, giving businesses time to prepare.

The Commission hopes that these changes will streamline compliance processes, reduce costs, and enhance the efficiency and competitiveness of businesses.

EU Critical Raw Materials Act legislation to apply in Northern Ireland under Windsor Framework

The Cabinet Office and European Commission have issued a joint statement following the latest Withdrawal Agreement Joint Committee meeting. It outlines the new EU legislation to be added to Annex 2 to the Windsor Framework and therefore will apply in Northern Ireland.

Among these is the Critical Raw Materials Act (CRMA). The CRMA aims to secure sustainable and resilient supplies of critical raw materials for the EU while addressing supply chain vulnerabilities and reducing dependences on non-EU sources for such materials. Critical raw materials are contained in an evolving list continually reviewed by the EU Commission. There are currently 34 critical raw materials.

Under the CRMA, by 24 May 2025, EU Member States will identify large companies (those with 500 or more employees and over €150m turnover) exposed to strategic raw material shortages in key technologies. These companies must then conduct a supply chain risk assessment every three years.

Sustainable products

UK

PackUK publish updated version of the EPR Recyclability Assessment Methodology

PackUK, the scheme administrator for the extender producer responsibility (EPR) scheme for packaging, has published an updated version of the Recyclability Assessment Methodology (RAM). The RAM is to be used by large packaging producers to assess the recyclability of their household packaging and produce a red/amber/green output which will inform the level of fee modulation payable for that material from year 2 of extended producer responsibility (EPR) (in 2026).

Producers are required to apply the methodology for household packaging placed on the market from 1 January 2025, with the first reporting deadline being 1 October 2025.   

Version 6 of EPR agreed positions and technical interpretations guidance

Version 6 of the "Extended producer responsibility (EPR) for packaging: Regulators’ agreed positions and technical interpretations" has been published. A list of all the updates made can be found in Appendix 10. These include:

• New and revised examples for improved clarity and to reflect regulatory changes.
• New sections on "When a person ceases to be a producer" and "Small producers".
• New appendices that include the regulators’ position on mid-year changes, and a self-managed packaging waste flow diagram to help large producers identify their packaging waste as self-managed organisation waste, or self-managed consumer waste. 

Version 6 applies to 2025 reporting obligations onwards.

Amendments to EPR legislation to be introduced later this year

In its latest circular economy newsletter, Defra outlined that amendments to the EPR regulations are to be laid before parliament in November to come into force ahead of year 2 of the EPR (that is, before October 2026).

Amendments include: 

• Enabling the appointment of a producer responsibility organisation (PRO) – "supporting closer producer involvement in the scheme. This has been a critical request from industry and aligns with international best practice for pEPR to be producer led."
• Extending closed-loop offsetting provisions to food grade plastic, which will aim to reduce the UK's reliance on virgin plastic material by incentivising producers to establish or continue to deliver closed loop systems that preserve the quality of recyclate.
• Minor operability changes to enable more efficient operations, which includes:
  • Amending the fibre-based composite (FBC) material definition for EPR by introducing a threshold to exclude paper and card with plastic content equal to or below 5%.
  • Clarity on how obligations apply to each class of producer obligated, including to give clarity on how obligations are transferred when a company is merged or acquired.
  • Removing barriers to compliance and enforcement: provides regulators with powers to request information from organisations that are connected to obligated parties and to request data for previous assessment years for historic freeriders so that PackUK can invoice these producers. These changes also update regulator fees to account for new compliance duties.
  • Minor changes to provide flexibility in the approach to modelling, and more accurately model local authority costs for running an efficient waste management service.
  • Minor drafting improvements resolving potential loopholes and removing ambiguity.

The update also flags issues raised by obligated producers regarding assessing recyclability for packaging under the Recycling Assessment Methodology (which the first assessments are due by October 2025). Defra states it is addressing these concerns and working with compliance schemes and producers on options to reduce the reporting burden. Details on this will be shared soon.

Wales introduce legislation to ban the supply of wet wipes containing plastic

The Welsh government has laid regulations to prohibit the supply (including for free) and offer to supply of single-use wet wipes containing plastic. It is anticipated that these will come into force in December 2026.

In its written statement, the Welsh government states that they "expect this timetable to be broadly in line with the other UK nations and believe any small difference in timing arising throughout the UK is manageable for manufacturers and retailers." However, the UK government has not provided an update on when similar regulations will be introduced.

Deposit Return Scheme for drinks containers: policy statement

The UK Deposit Management Organisation (UK DMO) for the Deposit Return Scheme (DRS) has been established. The DMO is a not-for-profit, business-led entity appointed by the government to develop and implement the scheme. You can visit their site here.

The DMO's responsibilities include meeting collection targets set by legislation, managing and overseeing the scheme's material and financial flows, producing and sharing technical information for businesses, engaging with stakeholders to contribute to the scheme's design, raising consumer awareness, and creating an easy process for users to raise queries.

New EPR guidance for small producers

Defra has published new guidance for small producers explaining what must be recorded, reported and paid under the Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024 (that is, the EPR regulations).

A "small producer" is an organisation that either:

• Has an annual turnover of more than £1 million and up to £2 million and supplies more than 25 tonnes of packaging in the UK.
• Has an annual turnover of more than £1 million and supplies more than 25 tonnes and no more than 50 tonnes of packaging in the UK.

Lifesciences and healthcare

UK

Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025

The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 will now come into force on 28 April 2026, instead of 10 April 2026. The government updated its press release to note that the date change was due to a technical issue during the final processing of the statutory instrument meaning it needed to be re-signed on 28 April 2025. See here for more on the regulations.

EU

Commission launches consultation on functioning of Cosmetic Products Regulation

On 5 May, the European Commission launched a consultation on the functioning of the Cosmetic Products Regulation. This forms part of the evaluation launched back in February.

Views are being sought from a range of stakeholders to gather information, opinions and experience on the implementation of the Cosmetic Products Regulation and the extent to which it has met its objectives, views on the regulation’s relevance, considering scientific, economic, social and other developments. The consultation closes on 28 July 2025. Commission adoption of the evaluation results is planned for the Q2 of 2026.