Products | UK Regulatory Outlook July 2025

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UK

Product Regulation and Metrology Bill 2024-25 receives Royal Assent  

Having had its amendments considered and approved by the Lords on 10 July 2025, the Product Regulation and Metrology Bill received Royal Assent on 21 July and subsequently became the Product Regulation and Metrology Act 2025. 

The Act is intended to modernise the UK's management of product and metrology regulations, by allowing ministers to introduce secondary legislation. In practice it is expected to facilitate closer alignment with European Union approaches. The full text of the Act is available, but broadly its key measures, as covered in our September 2024 edition, include: 

• Responsibilities within supply chain – the regulations may impose obligations on: manufacturers; those who market a product (such as distributors and retailers) in, or import a product to, the UK; and a person who controls access to, or contents of, an online marketplace; or an intermediary. It adds that this is not an exhaustive list and requirements may be placed on others carrying out activities in relation to a product.
• Cost recovery – the regulations may include mechanisms for recovering costs incurred by the authorities detailing who is liable and the charge conditions.
• Enforcement – the bill provides for both criminal and civil sanctions to be included in the regulations and also allows for authorities to accept undertakings to secure compliance with the regulations.
• Excluded products – the draft bill does not apply to: food, feed stuff, plants, fruit and fungi, plant protection products, animal by-products, products of animal origin, aircrafts, military equipment, medicines and medical devices. 

The Act also includes provisions in regards to the creation of metrology regulations which gives powers for regulations to be made about: 

• the units of measurement that must be used to express quantities (whether of goods or other things);
• how units of measurement are to be calculated, determined, or must and may be referred to; and
• the quantities in which goods may or must be marketed. 

The Act contains provisions which will require the secretary of state to obtain consent of devolved governments where regulations contain provisions within their devolved competencies – these requirements are stronger than the previous "consultation-only" provisions that were part of the draft bill that was introduced in the Lords.  

Now the Act has royal assent, it is expected that the secretary of state will launch a number of consultations to reform regulations in autumn 2025, including in relation to online marketplaces. Companies are encouraged to engage with these consultations when published, and to be prepared for secondary legislation affecting their products.   

EU  

IMCO reaches provisional agreement on Toy Safety Regulation 

On 26 June 2025, the European Parliament's Committee on Internal Market and Consumer Protection (IMCO) approved the provisional agreement on toy safety, following interinstitutional negotiations that concluded with the final trilogue on 10 April 2025. The provisional agreement aims to decrease the number of unsafe toys sold in the EU single market and better protect children from toy-related risks. 

The full text of the final compromise version of the provisional agreement is available. The agreement strengthens the role of economic operators in improving toy safety and clarifies requirements for safety warnings and the digital product passport (DPP). It expands the list of prohibited substances in toys to include chemicals that pose particular risks to children, such as endocrine disruptors, substances harmful to the respiratory system, and chemicals that are toxic for the skin and other organs. The provisional agreement also bans the intended use of per- and polyfluorinated alkyl substances (PFASs), the most dangerous types of bisphenols, and bans allergenic fragrances in toys for children under 36 months and in toys designed to be placed in the mouth. 

The Council is expected to formally adopt the regulation at first reading, following which the European Parliament will adopt the same text (expected in November). Once this has happened, the final text can be published in the Official Journal of the European Union and enter into force. 

European Parliament calls for stronger controls on non-EU e-commerce goods 

The European Parliament’s Committee on Internal Market and Consumer Protection has adopted a report proposing measures to address the rise in substandard goods entering the EU via e-commerce. The report recommends enhanced customs oversight, digital screening technologies, stricter enforcement of EU rules and increased platform accountability. 

The report also examined the Commission’s proposed €2 handling fee for e-commerce parcels, requesting confirmation of its compatibility with World Trade Organization rules and insisting the fee should not be passed on to consumers. Additionally, MEPs backed the immediate removal of the €150 customs duty exemption for low-value goods. 

To address non-compliance by non-EU sellers, the committee urged strict enforcement of existing rules under the EU Digital Services Act, Regulation (EU) 2023/988 (the General Product Safety Regulation), the EU Digital Markets Act, and Regulation (EU) 2019/1020 (the Market Surveillance Regulation). It also called for legal and financial liability to be extended to the designated "responsible person" representing non-EU traders. 

The report further recommended that member states restrict high-risk non-EU vendors from involvement in critical infrastructure and security procurement, and advocated for public awareness campaigns on online shopping risks. 

The proposal will proceed to a plenary vote, expected to be this month. 

Draft EU legislation: exemptions to prohibiting the destruction of unsold apparel and footwear 

Regulation (EU) 2024/1781 of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products (ESPR) entered into force on 19 July 2024.  

It prohibits the destruction of unsold apparel, clothing accessories and footwear because of the potential environmental impact. To ensure that the prohibition is proportionate, the European Commission has published a draft Act proposing exemptions – situations in which destruction would not be prohibited. 

 Currently, proposed exemptions are for:  

• health, hygiene and safety reasons;
• damage caused to products as a result of their handling, or detected after products have been returned, which cannot be repaired in a cost-effective manner;
• unfitness of products for the purpose for which they are intended, taking into account, where applicable, EU and national law and technical standards;
• non-acceptance of products offered for donation;
• unsuitability of products for preparing for reuse or for remanufacturing;
• unsaleability of products due to infringement of intellectual property rights, including counterfeit products; and
• destruction being the option with the least negative environmental impacts. 

European Commission adopts Chemicals Industry Action Plan and sixth simplification omnibus 

On 8 July 2025, the European Commission published a package of measures aimed at strengthening the competitiveness of the European chemicals sector, including a European Chemicals Industry Action Plan, a sixth simplification omnibus to streamline key EU chemicals legislation, and a proposal for a regulation to modernise the governance of the European Chemicals Agency (which includes proposals to amend the Classification, Labelling and Packaging (CLP) Regulation (1272/2008), the Cosmetic Products Regulation (223/2009) and the Fertilising Products Regulation ((EU) 2019/1009)). 

The European Chemicals Industry Action Plan sets out concrete measures to help secure the global competitiveness of the European chemicals industry, and to maintain and upgrade a strong European production base, including: 

• Establishing a Critical Chemical Alliance between member states and stakeholders to address the risks of capacity closures, expand chemical import monitoring, and align investment priorities.
• Implementing the Affordable Energy Action Plan to reduce high energy and feedstock costs, and to encourage the use of clean carbon sources.
• Highlighting fiscal incentives and tax measures that are available to increase demand for clean chemicals.
• Taking action to minimise PFAS emissions, while allowing their continued use in critical applications. 

Read more details on the plan. 

European Commission consults on revision of new legislative framework 

Following the 2022 evaluation of the New Legislative Framework, which identified areas for greater digitalisation and other improvements, the European Commission has released a call for evidence for an initiative to revise the legal framework for products in the EU, including by updating the rules on notified conformity assessment bodies. 

The aim of the initiative is to tackle the shortcomings that were highlighted in the 2022 evaluation, including: 

• lack of timely information on product compliance (regulatory gap/information failure);
• untapped potential of circularity (regulatory gap/market failure); and
• lack of consumer awareness about the meaning of the CE marking and misleading marking (information failure/behavioural issue). 

European Commission consults on extension of EU CBAM to downstream products 

See ESG. 

Product Sustainability  

UK  

PackUK publishes policies for Extended Producer Responsibility for packaging  

On 27 June 2025, PackUK released several key publications relating to the UK's Extended Producer Responsibility for packaging (pEPR) scheme, including: 

• the 2025 base fees for the pEPR scheme to provide certainty to producers;  
• the first Fee Modulation Policy Statement on driving sustainable packaging choices; 
• a Regulatory Position Statement (Regulatory Decision in Wales) addressing producers’ concerns around the recyclability assessment obligations; and  
• the PackUK interim strategy.  

Base fees 

Nearly all of the most recent fees are lower than the illustrative base fees published in December, with glass down by 20%. PackUK claims that the reductions result from "high levels of industry compliance with reporting obligations and extensive work across the regulators and PackUK to assure and validate the data provided." 

Fee modulation 

The Fee Modulation Policy Statement sets out a three-year framework that adjusts fees for producers depending on the recyclability of their packaging. Recyclability will be assessed through the Recyclability Assessment Methodology (RAM) ratings, with highly recyclable packaging resulting in steadily decreasing fees and poorly recyclable packaging incurring increasingly higher fees. There are also special provisions for medical packaging with limited recyclability due to regulatory requirements.  

Position statement 

This aims to ease the transition to modulated fees by allowing producers to extrapolate their recyclability assessments for the first half of 2025 from second-half data.  

Interim strategy 

PackUK's long-term strategy will be launched later in 2025 and aims to include:  

• more detail on long-term structures and arrangements, including the imminent appointments of chief executive and chief strategy officers;
• developments to UK-wide policy objectives over the coming months; and
• the planned appointment of a Producer Responsibility Organisation by March 2026. 

Enforcement 

As we reported in our May 2025 Regulatory Outlook, the first deadline for producers to assess their RAM ratings is 1 October 2025, however the Environment Agency has confirmed that, for the first year only, PackUK will treat a liable producer's 2025 H2 recyclability assessment report as sufficient evidence of the producer's packaging sustainability by material category for the whole of 2025.  

Online marketplaces to pay costs of WEEE from non-UK suppliers under new regulations 

As reported last month, the Waste Electrical and Electronic Equipment (Amendment, etc) Regulations 2025, were laid in Parliament introducing amendments to the Waste Electrical and Electronic Equipment Regulations 2013.  

The regulations have now been made and will come into force on 12 August.  

The amending regulations place the WEEE financial obligations arising from electrical and electronic equipment (EEE) that is placed onto the UK market by overseas sellers via an online marketplace (OMP) onto the OMP operators. This has been done by creating a new category of producer, known as the "OMP producer." OMP producers will need to register with a Producer Compliance Scheme and submit data on the volumes of EEE being placed on the market by non-UK suppliers on their platforms across all the EEE categories. The OMP producer will then be responsible for the WEEE financial obligations under the regulations.  

In addition, the regulations create a new category of EEE for devices intended to be used for the consumption of tobacco products, nicotine or other substances. This includes e-cigarettes, vapes and heated tobacco devices. The new category has been introduced due to the costs of managing this waste being significantly higher than the waste it is currently categorised with: "toys and other leisure equipment." 

UK-wide Deposit Return Scheme to go ahead  

On 10 July 2025, Huw Irranca-Davies, deputy first minister and cabinet secretary for climate change and rural affairs, confirmed that the Welsh government is prepared to accelerate the implementation timetable for the Deposit Return Service in Wales to align with the rest of the UK, providing interoperability between common materials. 

This marks an about-face for the Welsh government, which had previously withdrawn from the UK-wide implementation over concerns that its desire to include glass in its DRS scheme would require an exclusion from the United Kingdom Internal Market Act. 

With Wales now on board, a UK-wide DRS scheme is set to be introduced by October 2027. More information about the scheme can be found on the UK Deposit Management Organisation Ltd's (UK DMO) website. UK DMO is the official operator for the DRS and is ultimately responsible for designing and delivering the scheme's infrastructure. 

Regulations banning wet wipes containing plastic 

Following the joint consultation on a proposal to ban wet wipes containing plastic across the UK, the Department of Agriculture, Environment and Rural Affairs is seeking views on the draft Environmental Protection (Wet Wipes Containing Plastic) Regulations (Northern Ireland) 2025 which aim to restrict the supply and sale of wet wipes that include plastic (except for exempt purposes) in Northern Ireland. 

The regulations are due to come into force in Northern Ireland 18 months after they are made and will follow the Environmental Protection (Single-use plastic products) (Wet Wipes) (Wales) Regulations 2025 that ban the supply or the offer to supply (including for free) of wet wipes containing plastic to consumers in Wales. The Welsh ban will go into effect on 18 December 2026 and has an exemption for wipes which are "designed or manufactured for use in connection with medical care or treatment." 

On 17 July, the UK government also published draft regulations that intend to ban wet wipes containing plastic in England. The draft regulations has exemptions for pharmacies (provided the wipes are kept out of sight and not advertised to customers), medical purposes, and for suppliers to businesses and local authorities.  

EU  

European Commission moves to accelerate transition to circular economy 

On 2 July 2025, the European Commission launched several initiatives to accelerate the EU's transition to a circular economy and prepare the ground for the EU Circular Economy Act, new legislation expected in 2026 that aims to "enhance competitiveness and economic growth by promoting the reuse, recycling and remanufacturing of materials."  

The Commission will implement a Digital Waste Shipment System to enable companies to move from paper to digital procedures for shipping waste across the EU single market. It is envisaged that digital will fully replace paper from 21 May 2026. There is also a public consultation on the harmonisation of certain waste types. 

The Commission also published an evaluation of the Waste Electrical and Electronic Equipment (WEEE) Directive. It highlights some of the current failings when it comes to collecting and recycling electronic waste, such as low collection rates of WEEE leading to missed opportunities to recover rare earth elements and only 23% of EU recycling facilities having implemented high-quality treatment standards.  

Stop the clock for Sustainable Batteries Regulation: European Parliament adopts amending regulation at first reading 

Please see ESG.    

Life Sciences and Healthcare

Life sciences sector plan published 

On 16 July 2025, the government published its Life Sciences Sector Plan, laying out the direction that it wants the industry to travel and the policy steps that it wants to take to assist.  

The plan outlines several important new interlinked strategies, including: 

• the establishment of a £520 million Life Sciences Innovative Manufacturing Fund to help bring "globally mobile manufacturing investments to the UK".
• streamlining medical procurement by:
  • providing low-friction access to the NHS through a Rules Based Pathway for medtech;
  • creating an NHS "Innovator Passport" to allow medtech products to reach patients more quickly; and
  • launching a Value Based Procurement pilot by the end of 2025.
• the establishment of Regional Health Innovation Zones for large scale development and implementation – with the aim of co-partnering with industry to leverage investment.
• expanding NICE's technology appraisal process to cover devices, diagnostics, and digital products.
• focusing on creating a reformed medical devices regulatory framework that includes an innovation friendly domestic route to achieving UKCA certification. 

Reception to the sector plan so far has been mixed. Tony Wood, the chief scientific officer at GSK, said that he welcomed reforms to incentivise more clinical trials and create a new lab network to accelerate drug discovery and development. However, industry figures are concerned that it does nothing to address the currently unresolved drug-pricing talks that have failed to confirm how much revenue UK sales firms must return to the NHS. 

Government to align with European specifications on high risk in vitro diagnostic devices 

In a bid to reduce regulatory burden, the government announced on 10 July 2025 that it intends to amend the Medical Devices Regulations 2002 to incorporate EU Common Specifications for high-risk in vitro diagnostic (IVD) devices and to repeal regulations on Coronavirus Test Device Approvals (CTDA). 

This move will align UK standards with standards for these devices across Europe, with the dual aims of enhancing patient safety (by enhancing performance standards for IVD devices related to diseases including Hepatitis B, C, and D, and HIV) and also easing the regulatory burden on manufacturers across different markets.   

Medicines and Medical Devices Act 2021 – Stakeholder survey 

On 21 July 2025, the government published a call for evidence, on behalf of the Medicines and Healthcare products Agency (MHRA) and the Department of Health and Social Care (DHSC), to assess the operation and impact of the Medicines and Medical Devices Act 2021. 

The aim of the review is to gather evidence as to whether the legislation is operating as intended by continuing to effectively protect public health and by avoiding imposing excessive regulatory burdens. Specifically, the review focuses on: 

• Human Medicines Regulations 2012 (HMRs): setting out the regime for the manufacture, authorisation, supply, and pharmacovigilance of medicines.
• Medical Devices Regulations 2002 (MDRs): providing the regulatory framework for medical devices, including requirements for safety, performance, and conformity assessment.
• The Medicines for Human Use (Clinical Trials) Regulations 2004: governing the conduct of clinical trials of medicinal products.
• Medicines and Medical Devices (Fees) Regulations: which outline the fees payable to the MHRA in relation to regulatory services. 

The set of survey questions is available here – the deadline for completion is 19 September 2025. The survey acknowledges that additional regulations have been introduced since the 2021 Act was introduced. However, the survey does not cover these legislative changes as they are not yet in force or have been in force for less than six months. These include the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. In December 2024, the MHRA released its revised roadmap towards the future regulatory framework for medical devices, with new pre-market regulations expected in 2026. 

MHRA publishes response to routes to market and in vitro diagnostic devices consultation 

On 22 July 2025, the MHRA published the government's response to the public consultation on future routes to market for medical devices in Great Britain, including in vitro diagnostic devices. 

The response highlights three areas that the government is focusing on to improve: international reliance, UKCA marking, and in vitro diagnostic devices.  

International reliance 

The government aims to provide faster market access for devices that have already received approval in a comparable regulator country, such as the USA, Canada or Australia, by relying on approvals or certificates issued in those countries. It has also announced that the MHRA will consult later in 2025 on the indefinite recognition of CE-marked medical devices, potentially ending the uncertainty over the mark's future. 

UKCA marking 

The government intends to go ahead with removing the requirement for devices to bear the UKCA marking after those devices have been through the conformity process provided that: 

• the devices in question have Unique Device Identification numbers (UDIs); and
• those UDIs are searchable on a public-facing database. 

The government also notes that, provided the above requirements are met, the UKCA marking would become optional, so no re-labelling would be required on already-marked compliant devices. 

in vitro diagnostic devices (IVDs) 

The government is going to move forward with a more risk-based regulatory approach for IVDs, with plans to accept QMS certification based on internationally recognised standards issued by non-UKAS accredited bodies. It also intends to address concerns regarding the differing conformity assessment routes in Northern Ireland and Great Britain. Manufacturers will have five years to adapt to the updated regulations. Read more in-depth details of the changes to IVD regulation.