Products | UK Regulatory Outlook May 2024

Jump to: General / digital products | Product sustainability | Life sciences and healthcare

The upcoming general election on 4 July means the dissolution of Parliament on 30 May. As a result, any legislation that was not passed during the recent wash-up period will no longer be considered. It remains uncertain whether the newly elected government will reintroduce these bills, as it is not obligated to do so.

During the wash-up, the Tobacco and Vapes Bill (see previous Regulatory Outlook) was not passed and so will fall away. It will now be down to the new government as to whether it wishes to resurrect this or not.  For more on the wash-up period, read our Insight.

There are also a number of pieces of secondary legislation, regulations, that were also due to be introduced to Parliament which now will not be. For products these are as follows:

• The draft Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024 – these had not been introduced into Parliament and cannot be introduced until a new government is formed. This raises the question as to whether there will be further delay to the extended producer responsibility scheme for packaging.
• Deposit Return Schemes – in a recent joint statement (see product sustainability section for more), the implementation had been delayed to 2027. However the new government is not obligated to bring these changes in and so this may be revisited.
• Medical Devices amending regulation- the amending regulations had not yet been published or laid in Parliament so this regulatory reform will need to be taken up by the new government.

For all of the above, we will have to wait to see what the new government will intend to do in these areas and will  be providing further updates on this.

While no legislation had yet been drafted or introduced, the announcement of the general election is also likely to affect the progress of the UK's product safety review: publication of the government's consultation response is still awaited. Even so, it will be for the new government to decide what legislation is to be introduced under this review.

General/digital products

UK

The Product Safety and Metrology etc. (Amendment) Regulations 2024

The Product Safety and Metrology etc. (Amendment) Regulations 2024 were made on 23 May and come into force on 1 October 2024.  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.

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

The Department for Business and Trade has also updated its guidance pages "'Placing manufactured products on the market in Great Britain", "Using the UKCA marking" and "CE marking" in line with the new legislation which continues the recognition of the EU conformity assessment (see last month's Regulatory Outlook). Manufacturers should refer to this guidance when placing products on the market and for guidance on using either the CE or UKCA mark.

Updated guidance on consumer connectable product security regime

The government has released additional guidance on the security regime for consumer connectable products which came into force on 29 April 2024.

The new guidance specifies that the product's statement of compliance (SoC) must be "accompanied" by the product itself, and defines the SoC as a "document". However, the terms "document" and "accompany" are not clearly defined in the PSTIA (Product Security and Telecommunications Infrastructure Act). Therefore, each business that falls under the regime must determine how it will comply with the requirements for their individual products.

The guidance also mentions that certain categories of products may be exempted from the regime. Amending regulations introducing these have been drafted and exempt the following categories of products: motor vehicles agricultural, two- or three-wheel vehicles and quadricycles and forestry vehicles. These regulations are in draft form and were debated in the House of Commons on 21 May and will need to be approved by the House of Lords before they can enter into force.

If you missed our recent Eating Compliance for Breakfast Webinar on the new regime, you can request the recording.

Automated Vehicles Bill receives Royal Assent

The Automated Vehicles Bill received Royal Assent on 20 May.

This new legislation will introduce a regulatory framework for automated vehicles which will require self-driving vehicles to achieve a level of safety at least as high as careful and competent human drivers.

It will also place liability on the companies for the behaviour of the vehicles on the road when in self-driving mode, rather than the driver of the vehicles. This will mean that businesses such as manufacturers and software developers will be held responsible for the behaviour of the car.

The government has also recently published its response to its consultation on safety ambition. Respondents on the topic of regulation noted that the safety standards should be aligned with European and international regulations. The Department for Transport will use the consultation responses to inform the development of secondary legislation and guidance which a series of consultations will be launched on in due course now the bill has become law.

UK government announces two new codes of practice for cybersecurity and AI

Please see Cyber security.

EU

Council adopts position on updated toy safety regulation

The Council of the EU has, on 15 May 2204, adopted its position on the updated toy safety regulation. The Council’s negotiating mandate aligns the obligations of economic operators with the general product safety regulation (GPSR) and sets out toy-specific obligations for providers of online marketplaces, in addition to those required by the existing legal framework (like the digital services act (DSA) and the GPSR). The Council's position also ensures that toys sold online that do not conform with the toy safety regulation will be regarded as illegal content for the purposes of the DSA.

With regard to chemicals, as well as the ban on the presence of substances classified as carcinogenic, mutagenic or toxic for reproduction (as set out in the Commission's proposal), the Council's position also introduces a ban on certain categories of skin sensitisers (chemical substances that provoke an allergic response following skin contact), a ban on toys that have a biocidal function, and a ban on the treatment of toys with biocidal products.

Negotiations between the Council and European Parliament (which adopted its position in March) will start as soon as the new Parliament adopts its position later this year.

Ecodesign and energy labelling requirements for computers

The European Commission has launched consultations on energy labelling and ecodesign requirements for computers. The consultation pages sets out that a review of the current Ecodesign Regulation 617/2013 on computers and computer servers is ongoing and a suitable testing method for assessing computer's energy efficiency is now available and therefore the introduction of an Energy Labelling Regulation for computers may be required. The consultation is seeking views from both consumers and stakeholders on the introduction of energy labelling for computers. Both consultations close on 18 July 2024.

Product sustainability

UK

Government confirms delay of DRS to 2027

As reported last month, there was speculation that the deposit return scheme (DRS) would be delayed by two years, which the Department for Environment Food & Rural Affairs (Defra) has now confirmed in a joint policy statement: implementation of the DRS will be delayed to October 2027.

The statement also highlights that the scope of drinks containers in England and Northern Ireland, Wales, and Scotland will include drinks containers made of polyethylene terephthalate (PET), steel, and aluminium cans. It adds that the position on glass containers will be set out in separate statements issued by each administration. Wales has already confirmed in a statement that it will also be including glass within its DRS when the scheme is launched in 2027.

The joint policy statement also confirmed that online takeback will not be a requirement under the DRS in the UK.

It should be noted that the general election may affect the implementation of the DRS as the new government is not obligated to introduce the DRS and so it may be revisited.

Government publishes updated draft EPR regulations

On 1 May 2024, the government published the updated draft Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024 which were amended following the consultation last year and stakeholder engagement. These will introduce the extended producer responsibility regime (EPR) for packaging in the UK which is due to come into force in October 2025.

Defra ran a webinar earlier this month on the updated regulations and explained that these have been reworked extensively to provide further clarity, but the obligations have not changed. Some of the key changes are as follows:

• mandatory recyclability labelling requirements are to come in from April 2027, this will not be retrospective (it was previously expected that these would be introduced in 2026);
• they have removed the provision on take back disposable cups, but this will be introduced via a separate statutory instrument (SI);
• binned waste and litter payments will also be introduced via a separate SI, but Defra remain committed to introducing these obligation in 2026 (year two of EPR);
• the provision for fee modulation exemption for online marketplaces has been removed and replaced with a power that enables the Scheme Administrator to decide whether to defer the introduction of modulation of fees for online marketplaces;
• there is a new provision on the implementation of DRS noting that should these schemes be delayed beyond 1 January 2028, then producers of drinks containers made of PET, aluminium and steel will be subject to the EPR regulations; and
• the recycling targets for 2025-2030 have been added (see Schedule 5).

With the announcement of the general election, these will not be introduced due to the dissolution of Parliament and we will have to wait and see what the newly elected government intends to do. In a recent stakeholder update, Defra outlined that the notification process of the regulations will proceed, with further steps to be determined post-election.

EPR enforcement to start at the end of this month

As reported last month, after 31 May 2024 enforcement action will be taken for late submission of an organisation's details for the EPR for packaging.

Defra has also recently updated its guidance on organisation details providing more detail about what turnover and total tonnage mean, as well as clarifying the difference between "primary and secondary packaging" and "primary and secondary packaging activities".

Businesses that have not done so already should review the updated guidance and assess the packaging they are responsible for and ensure they have reported the necessary information by the end of this month.

In a stakeholder update on the impact of the general election, Defra outlined that producers should continue to enrol and submit packaging data for EPR.

EU

European Parliament adopts position on right to repair

The European Parliament has adopted its final position on the Common rules promoting the repair of goods directive. Under the new rules, manufacturers will be required to repair those products which are repairable under EU law (those that have repairability requirements), even if the legal guarantee has expired. This includes items like washing machines, vacuum cleaners and smartphones and this list can be expanded in the future.

Manufacturers will also be required to provide spare parts and tools at a reasonable price which does not "deter" access to spare parts. They will be prohibited from using contractual clauses, hardware, or software techniques that hinder repairs. This means they cannot prevent independent repairers from using second-hand or 3D-printed spare parts, nor can they refuse to repair a product for economic reasons or because it was previously repaired by someone else.

Once the directive is formally approved by Council and published in the EU Official Journal, Member States will have 24 months to transpose it into national law. See the full text.

European Parliament and Council formally adopt Ecodesign for Sustainable Products Regulation

The European Parliament has formally adopted its position on the Ecodesign for Sustainable Products Regulation. The new regulation will extend the current ecodesign framework to all physical goods placed on the EU market which will be introduced by the European Commission via delegated acts.

The adopted position includes to prioritise a number of product groups in its first working plan, including iron, steel, aluminium, textiles (notably garments and footwear), furniture, tyres, detergents, paints, lubricants and chemicals.

The regulation will also ban the destruction of unsold consumer products, which will come into force two years after the regulation enters into force. Digital product passports will be required for all products and the European Commission will manage a public web portal allowing consumers to search and compare information included in product passports.

The Council adopted the regulation without any further amendments on 27 May 2024. After being signed by the President of the European Parliament and the President of the Council, the regulation will be published in the Official Journal of the European Union and will enter into force on the 20th day following that of its publication. It will apply from 24 months after the entry into force.

European Parliament adopts position on Packaging and Packaging Waste Regulation

The European Parliament has formally adopted its position on the Packaging and Packaging Waste Regulation. Under the new rules certain single-use plastic packaging types will be banned from 1 January 2030. These include packaging for unprocessed fresh fruit and vegetables, packaging for foods and beverages filled and consumed in cafés and restaurants, individual portions (for example condiments, sauces, creamer, sugar), accommodation miniature packaging for toiletry products and very lightweight plastic carrier bags (below 15 microns).

The regulation also includes a ban on the use of PFAS above a certain threshold in food contact packaging. Further, all packaging (except for lightweight wood, cork, textile, rubber, ceramic, porcelain and wax) will have to be recyclable by fulfilling a strict criteria which will be set out in implementing acts and delegated acts.

In terms of next steps, the Council now needs to formally approve the law before it can come into force.

European Parliament adopts amending CLP regulation

The European Parliament has formally adopted the regulation on classification, labelling and packaging of chemical substances and mixtures (CLP Regulation). Under the new rules, changes include to labelling (including setting minimum dimensions in millimetres of labels, pictograms and font size found on packaging, as well as rules on voluntary digital labelling) and related technical requirements, such as the information being searchable, accessible in less than two clicks to all users in the EU, free of charge and for a period of at least ten years.

The rules also ban the use of "green claims" for substances or mixtures classified as hazardous - advertisements must not contain statements such as "non-toxic", "non-harmful", "non-polluting", "ecological" or any other inconsistent with their classification.

The Council now needs to formally adopt this regulation before it can enter into force.

Life sciences and healthcare

UK

Medicines and Healthcare products Regulatory Agency outlines AI strategy

As requested in the government's response to its white paper, "A pro-innovation approach to AI regulation", the Medicines and Healthcare products Regulatory Agency (MHRA) has published its strategic approach to AI. The strategy outlines how the MHRA is, and will be, implementing the principles of the white paper: safety, security and robustness; appropriate transparency and explainability; fairness; accountability and governance; and contestability and redress.

The MHRA's AI strategy focuses on three perspectives: as a regulator of AI products, as a public service organisation delivering time-critical decisions, and as an organisation making evidence-based decisions that impact public and patient safety.

The MHRA recognises the opportunities that AI offers and the regulatory reform that is required to ensure safety while embracing the advantages of AI, such as through the launch of the AI Airlock. Read our Insight for more.

MHRA announce international recognition of medical device

On 21 May, the MHRA published a statement outlining a draft policy for international recognition of medical devices in Great Britain. Under this policy, the MHRA will be able to "utilise the expertise and decision-making of other regulatory partners" via international recognition which will see the UK government recognising regulatory approvals of medical devices from Australia, Canada, the EU and the US. The press release notes that the MHRA will continue to review the list of comparable regulator countries, with Japan currently being considered. Interestingly, unlike the international recognition procedure for medicines (see this Regulatory Outlook), Singapore and Switzerland are not yet being considered.

The draft policy also provides a number of conditions that have to be met to be eligible for the proposed framework, including having English language labelling and packaging and having a UK responsible person. The policy is still in draft form and the proposed framework is expected to come into force along with the new medical device regulations (see our Insight for more).

Consultation launched on common specifications requirements for IVDs

The MHRA has launched a consultation on introducing amendments to the Medical Devices Regulations (MDR) 2002 to introduce common specification requirements for in vitro diagnostic devices (IVDs). Currently, in the UK, there is a list that determines the classification of IVDs. However, this system is currently in the process of being reformed in that instead of using a fixed list, the classification will be based on the level of risk associated with the device. This means that certain high-risk IVD devices, previously classified as List A, will now be classified as Class D devices. The problem is that with this change, the common technical specifications that ensure the safety of high-risk IVD devices will no longer apply. This creates a gap in the regulations.

Therefore the government are proposing to introduce common specification requirements as a means for certain class D IVD devices in the future regulation to demonstrate conformity with applicable essential requirements. The common specifications the MHRA are proposing to adopt are to:

• introduce common specification requirements for certain Class D IVD devices to be consistent with EU Commission Implementing Regulation 2022/1107. This is to ensure that manufacturers have enough safety checks in place for certain Class D devices that are the highest risk to patient safety;
• introduce the inclusion of common specification requirements in a Post Market Performance Follow-up (PMPF) Plan. In the In Vitro Diagnostic Medical Device Regulation 2017, a PMPF plan must be submitted as part of the technical requirements for an IVD device before it can be placed on the market; and
• remove the requirements for COVID-19 test devices from the MDR 2002.

The consultation closes on 14 June 2024. Manufacturers should review the consultation and decide whether they wish to submit their views on the introduction of common specification requirements to the regulatory framework before IVD devices can be placed on the GB market.

The general election may affect the outcome of this consultation.

New veterinary medicines regulation come into force

On 17 May 2024, the new Veterinary Medicines (Amendment etc.) Regulations 2024 came into force. These amend the Veterinary Medicines Regulations 2013 in a bid to modernise them.

The amending regulations set out the controls on the marketing, manufacture, distribution, possession, and administration of veterinary medicines and medicated feed. Changes include giving the Secretary of State power to require a marketing authorisation holder, manufacturer, wholesale dealer, keeper of food-producing animals, feed mill or vet to provide information on the sales and usage of antibiotics.

It also allows the submission of a single dossier for marketing authorisation for the European region and tightens advertising rules, including that medicines can only be advertised if they are authorised to be marketed. The government has published updated guidance in line with these changes.

FSA progresses two novel food applications for CBD products

Please see Food law.