Products | UK Regulatory Outlook April 2024

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General/ digital products

UK

Government introduce legislation to indefinitely recognise the CE mark

On 15 April, the draft Product Safety and Metrology etc. (Amendment) Regulations 2024 were laid before Parliament.

These regulations amend 21 product regulations, including toys and radio equipment (see the full list), by removing the expiry of the provision that recognises the EU conformity assessment (that is, CE marking). This means that businesses can continue to use either the CE or UKCA mark indefinitely when placing products covered by the regulation on the Great Britain (GB) market. 

The regulation also introduces a new "fast track" UKCA process, allowing manufacturers to use the UKCA marking to demonstrate compliance in GB with either UKCA or recognised EU conformity processes. This process is optional and can only be used for placing products on the GB market.

It allows manufacturers to rely on EU conformity assessment procedures for the purposes of the UKCA regime. This recognition provision is aimed to help avoid costly and duplicative testing for all regulations that apply to a product, especially in cases where products are subject to multiple regulations, even if the EU regime continues to be recognised for some of those regulations.

Certain sectors, such as medical devices and construction products, have specific arrangements led by relevant government departments and are not covered by these measures.

29 April 2024: Are you ready for the security regime for connected products?

The Product Security and Telecommunication Infrastructure Act introduces new security requirements for connected products which come into force on 29 April 2024 (see this Regulatory Outlook). Our Eating Compliance for Breakfast session on Thursday 25 April will cover what these new requirements are and what you need to be doing in order to comply with the new regime from 29 April. Register here.

Further import checks from 30 April 2024

Following recent media speculation that health and safety checks for EU imports would not be coming into force, Defra has stated that this is not the case and that the checks will come into place from 30 April 2024. This means that from 30 April, health certification on imports of medium-risk animal products, plants, plant products and high-risk food and feed of non-animal origin from the EU will be required.

Pre-notification requirements for low-risk plant and plant products from the EU will be removed. These checks are being introduced under the Border Target Operating Model.

EU

Consultation launched on indicators for reporting on the General Product Safety Regulation

The European Commission has opened a four-week feedback period on the indicators for reporting on the General Product Safety Regulation (GPSR). These indicators will be implemented by Member States in order to communicate the application of the GPSR, the results of their investigations and the measures imposed for breaches of the regulation.

Businesses operating in the EU that will be subject to the GPSR should review the draft implementing regulation on these indicators and decide whether they wish to provide feedback. The feedback period closes on 14 May 2024.

Product sustainability

EPR: enforcement action to start from next month (31 May)

The UK is in the process of introducing a system of extended producer responsibility (EPR) for packaging. This means that packaging producers are now responsible for covering 100% of the net cost associated with processing their packaging waste.  

While the payment of EPR fees was delayed until October 2025, the reporting obligations for packaging under the new extended producer responsibility scheme (EPR) have already begun.

Large organisations were required to submit their data on 1 October 2023 for the period of 1 January to 30 June 2023, and another submission was due on 1 April 2024 for the period of July to December 2023. However, the government announced last September that no enforcement action would be taken for late data submission until 31 May 2024.

This deadline for data reporting is fast approaching. It is crucial for businesses to ensure they have assessed which packaging they are responsible for and submit the relevant data in accordance with the new regulations and guidance to avoid any potential enforcement measures being taken against them from next month.

Government to ban wet wipes containing plastic

The government has published its response to the consultation on wet wipes containing plastic. It confirms that legislation will be introduced later this year to ban the supply and sale of wet wipes containing plastic across the UK. The legislation is expected to be in place by the end of 2024 and will include an exemption for the supply and sale of wet wipes containing plastic for industrial and medical purposes. There will also be an 18-month transition period to allow manufacturers adequate time to transition to producing plastic-free wet wipes.

The consultation response notes that manufacturing wet wipes containing plastic will not be in scope of the ban due to the size of the industry in the UK. UK manufacturers will be able to continue to export wet wipes containing plastic to other countries that do not have the same restrictions.

Potential further delay to implementation of DRS

The implementation of deposit return schemes (DRS) in the UK has been continually pushed back over the past few years.

Most recently, on 26 March, the Secretary of State for Environment, Food and Rural Affairs, Steve Barclay told the Environment, Food and Rural Affairs Committee that the 2025 implementation date is unrealistic. He stated: "Given this balance between the benefits of the scheme versus the benefits of having something interoperable, I don’t think 2025 is now realistic, and certainly I don’t think business would view it as a realistic deadline. It is an issue that is still an ongoing area of discussion within Government, but I suspect, if I was pushed on it, that a 2027 deadline is probably more likely." This announcement of further delay has been welcomed by supermarkets.

Following on from this comment, Scottish Circular Economy Minister, Lorna Slater, has sent Mr Barclay a letter setting out her concerns about further delays and notes that had the UK government not stopped the Scottish DRS from going ahead (see this previous Regulatory Outlook) they would now have an operational DRS. She added that the government should set "a realistic timescale for delivery which is agreed across the four nations, rather than creating speculation without consultation."

At time of writing there has not been any further communication of this delay from the government, but businesses should continue to keep abreast of the development of DRS across the UK.

HSE launches call for evidence on PFAS in firefighting foams

The Health and Safety Executive (HSE) has launched a call for evidence on firefighting foams which contain per- and polyfluoroalkyl substances (PFAS).

This follows the Regulatory Management Option Analysis published by the HSE last year, which recommended that action should be taken to restrict the use of PFAS in firefighting foams. The consultation closes on 3 June 2024. Businesses that deal with firefighting foams (manufacturers, importers, distributors, retailers) should review this call for evidence and decide whether they wish to respond.

This call for evidence is the first step following the review on the regulation of PFAS and, while focused on firefighting foams, it illustrates the forthcoming change for the use of PFAS.  We are still awaiting the UK Chemicals Strategy, which is the cross-governmental strategy for the UK, which we anticipate may provide further information on future changes to the regulation of PFAS and will provide further updates once this has been published. 

Guidance on workplace recycling in Wales

On 6 April 2024, new rules came into force in Wales which legally requires all businesses, charities and public sector organisations to separate collections of waste materials for recycling. In line with this, new statutory guidance has been published for organisations on the rules.

The following materials will need to be separated for collection, and collected separately: food; paper and card; glass; metal, plastic and cartons; unsold textiles; and unsold small waste electrical and electronic equipment.

There is also a ban on sending food waste to sewer (any amount); separately collected waste going to incineration and landfill; and all wood waste going to landfill.

The guidance also notes that paper and card can be mixed in the same container together, and metal, plastic and cartons can be mixed together. Businesses in Wales should make sure that their waste is being separately collected otherwise enforcement action may be taken.

Life Sciences and healthcare

New guidance on medicines under the Windsor Framework

The Medicines and Healthcare products Regulatory Agency (MHRA) has published two new guidance documents ahead of the changes to medicines being implemented under the Windsor Framework in 2025.

Labelling and packaging

Guidance has been published on the labelling and packaging of medicinal products for human use under the Windsor Framework. From 1 January 2025 all  new medicines and medicines in Northern Ireland that currently fall under the scope of the EU Central Authorisation Procedure will be authorised by the MHRA for the UK market. See further guidance on the transition of licences.

These products will only be able to be sold in the UK, and will not be available on the market in Ireland, or elsewhere in the EU. Those products for the UK market must carry a clearly legible "UK Only" label to be allowed onto the UK market, including in Northern Ireland.

The guidance outlines that the "UK Only" statement can be applied via a sticker for a limited period of six months, to 30 June 2025, but after this date, "UK Only" must be printed directly onto the packaging.

In addition, from 1 January 2025, the EU Falsified Medicines Directive (FMD) will no longer apply in Northern Ireland. Therefore, medicines entering Northern Ireland will not need to display features required under the FMD, including 2D barcodes and serialisation numbers, but the marketing authorisation can choose to apply them.

The MHRA will continue to encourage anti-tamper devices to be used on medicine packaging.

Parallel Import Licences

Under the Windsor Framework, from 1 January 2025, the MHRA will license all medicines across the whole of the UK. Currently, Parallel Distribution Notices (PDNs) remain valid when placing medicines on the NI market.

PDNs are notice letters which parallel distributors must obtain from the European Medicines Agency before placing a centrally authorised product on the market. They are no longer valid in Great Britain and were replaced by Parallel Import Licences (PLPIs) which allow the products to be marketed in Great Britain only.

From 1 January 2025, PDNs will no longer be valid in Northern Ireland. This means that:

• all parallel imports (including Centrally Authorised Products) will be authorised to be marketed across the whole of the UK;
• all parallel imports will need a valid PLPI licence; and
• all PLPIs with a current territorial limitation of GB will be converted to UK-wide authorisation automatically. Including all previous PDNs that were converted to UK PLPIs and any other PLPI licences that have a current GB territorial limitation. A variation will not be required to change the territory from GB to UK-wide.

The medical technology strategy: one year on

In February last year, the Department of Health and Social Care (DHSC) published its first medical technology (medtech) strategy (see this Regulatory Outlook) which aims to ensure health and care systems and patients have access to innovative medical technologies.

The DHSC has published a report The medical technology strategy: one year on which looks at what it has achieved over the past 12 months as well as next steps. The report outlines that the core regulatory changes for medical devices are expected to be laid in Parliament in 2025, see our Insight for more.

Additionally, it sets out that in 2024 the next phase of the "Design for Life" programme to support a move towards a circular economy for medtech will be launched. Businesses should keep an eye on further developments in this space.

Medical technology innovation classification framework

In line with the above strategy, and after consultation with stakeholders across the sector, the DHSC has also published the medical technology innovation classification framework.

The framework will establish a common language for discussing innovation across the medical technology sector, establish clear criteria for a device to be described as innovative in different forms, clearly convey the change in a device compared to what already exists on the market and benefits to patients and the system, and support prioritisation and adoption of the most impactful innovations. The framework applies to medical devices and only applies to devices that are incremental, transformative or disruptive. 

In the first instance, the framework is to be used as guidance to support the classification of innovative technologies and in six months' time, the DHSC will seek feedback on the "relevance and utility" of the framework.

Those in the medtech sector should review the framework and decide whether it applies to their products and if so, what type of innovation applies to their products.

Decision time for UK medical device regulation: diverge or converge with the EU?

As the MHRA progresses with its roadmap, industry will be looking forward to receiving more information on proposed new UK medical devices regulations. Read more.

European Parliament adopts proposal on reforming EU pharmaceutical legislation

On 10 April, the European Parliament adopted its position on proposals to reform the EU pharmaceutical legislation which consists of a new directive and regulation.

Measures include orphan drugs benefiting from up to 11 years of market exclusivity if they address high unmet medical needs, a minimum data protection period of seven and a half years for new medicines, along with a two-year market protection period after authorisation. The file will now be followed up by the new Parliament after the 6 - 9 June European elections.