Products | UK Regulatory Outlook February 2024

General / digital products

UK

Guidance on implementing new connectable product security requirements

On 29 April 2024, the new connectable product security regime comes into effect. The Office for Products Safety and Standards (OPSS) has published new guidance for businesses that need to be complying with the new requirements.

The guidance outlines the products covered (those that can connect to the internet or a network), to whom the regulations apply and the security requirements imposed on manufacturers of connectable/digital products which are:

• restricting the use of default passwords;
• providing information to consumers on how to report security issues; and
• providing information on minimum periods for which devices will receive security updates.

The OPSS has also updated its guidance on enforcement actions and associated rights under the connectable product security regulations. It outlines the enforcement powers the OPSS has under the Product Security and Telecommunications Infrastructure Act which includes the service of a compliance notice, stop or recall notice, monetary penalties and application for a forfeiture order. It also sets out that the appeals process will be to the First-tier Tribunal (General Regulatory Chamber).

Businesses that place connected products onto the UK market should be preparing themselves for these upcoming changes and ensure that products in scope are compliant with these regulations come the end of April.

Retained EU Law – forthcoming product and medicine updates

On 22 January, the Department for Business and Trade published a report on the progress the government has made in reforming and revoking retained EU Law (now known as assimilated law) over the last six months. It also sets out, from page 23 onwards, the assimilated law updates it plans to introduce in 2024, which includes changes for product regulation and medicines.

Product regulation

• Introduce legislation to indefinitely recognise the CE mark for products (for example, toys and machinery);
• introduce digital labelling, such as a QR code, which will allow importers and manufacturers the ability to include relevant details and information via a digital label attached to the product; and
• introduce a "fast track UKCA" process, allowing manufacturers to use the UKCA marking to demonstrate compliance, in Great Britain, with either UKCA or recognised EU conformity processes.

Also see this government press release on these upcoming changes.

Medicines

• Facilitate a new point of care manufacturing regulatory framework for medicines manufactured at or close to the place of administration;
• remove the current power in the Human Medicines Regulations 2012 for the Medicines and Healthcare products Regulatory Agency (MHRA) to rely on the decision of the European Commission alone to approve a medicine in Great Britain;
• reform UK clinical trials legislation;
• reform the Ionising Radiation (Medical Exposure) Regulations 2017, noting that changes will "better reflect the UK healthcare delivery model and permit the use of artificial intelligence"; and
• reform the Veterinary Medicines Regulations 2013 to modernise the rules to reflect technological advancement and reduce regulatory burdens.

Plans to ban sale and supply of disposable vapes

The government has published its response on legislating to create a smokefree generation which outlines that legislation will be brought forward at the "earliest opportunity" to introduce regulations to restrict flavours, point of sale and packaging and product presentation for vaping products (nicotine and non-nicotine) as well as other consumer nicotine products, such as pouches. It also adds that separately, the UK government, the Scottish government and the Welsh government intend to introduce legislation to implement a ban on the sale and supply of disposable vapes. Businesses that place disposable vapes on the UK market should remain vigilant about any forthcoming regulatory change in this area.

Autonomous Vehicles Bill finishes reading in House of Lords

The Autonomous Vehicles Bill completed its reading in the House of Lords on 19 February, just over three months after it was first introduced. The bill now moves onto the House of Commons and had its first reading on 20 February, with its second due to be scheduled, with its second reading scheduled for 5 March 2024.  

EU

Revised Product Liability Directive

Following informal negotiations, the final compromise text of the revised Product Liability Directive has been published. See our previous Regulatory Outlook for a reminder of the changes being made by the new legislation.

In terms of next steps, the European Parliament now needs to formally adopt the text, after which (if done at first sitting) the Council will also adopt the text, following which will the legislation will be adopted. The new rules will apply to products placed on the market 24 months after entry into force. The next plenary sitting date is scheduled for 11 March 2024.

European Parliament Committee agrees position on new toy safety regulation

The Internal Market and Consumer Protection Committee of the European Parliament has approved its position on the update to the EU Toy Safety Directive, which, following the revision, will become a regulation.

The committee's position agrees with the European Commission's proposal to ban harmful chemicals, including carcinogenic, mutagenic and toxic substances. In addition, MEPs agreed that manufacturers will need to create digital product passports for each toy. However, they have added that consumers should have easier access to information, giving the example of using QR codes.

The MEPs specify that there are to be no overlaps with existing EU legislation. In relation to the AI Act, the committee states that digital toys with AI will need to comply with the Act, which will mean third-party assessments, risk management, transparency and human oversight. In line with the EU Cyber Resilience Act, this will require third-party conformity assessments for internet-connected toys with social interactive features, such as speaking or filming. It also adds that toys must comply with the General Product Safety Regulation.

The draft report will be put to a vote at an upcoming plenary session and will constitute the Parliament’s position at first reading. Following this, the file will then be followed up by the new Parliament after the European elections on 6-9 June.

Adoption of EU common criteria-based cybersecurity certification scheme

On 31 January 2024, the European Commission adopted Implementing Regulation (EU) 2024/482 laying down rules for the European common criteria-based cybersecurity certification scheme (EUCC).

As previously reported, the EUCC scheme, developed under the EU Cybersecurity Act, will apply on a voluntary basis to all information and communication technologies products within the EU, focusing on certifying the cybersecurity of these products within their lifecycle. Certain provisions of the EUCC will enter into force on 27 February 2024, with remaining provisions applying from 27 February 2025. For further information on the EU's cyber security strategy for IT product design, please see our Insight.

Potential delay to Cyber Resilience Act

Please see Cyber security.

Council adopts position on banning products made with forced labour

Please see Modern slavery.

Product sustainability

UK

UK REACH 23/24 programme prioritises PFAS restrictions

The UK REACH (UK regulation on the registration, evaluation, authorisation and restriction of chemicals) Programme 2023/2024 has been published and sets out the Health and Safety Executive (HSE)'s "operational activities" it will take in the financial year 2023 to 2024.

The HSE has identified five priorities, with one being "a proposal to begin the development of a restriction on Per- and polyfluoroalkyl substances (PFAS) in fire-fighting foams (FFFs), and to explore restrictions on further wide dispersive uses of PFAS and PFAS likely to be released from consumer articles." This follows on from the HSE's regulatory management option analysis (RMOA) on PFAS conducted last year, see this previous Regulatory Outlook.

While the initial restriction is focused on fire-fighting foams, the prioritisation of PFAS restrictions demonstrates that the HSE is actively seeking to further restrict the use and release of PFAS in order to address the potential risks associated with these substances. As such, businesses should start to understand the risks associated with PFAS and evaluate the extent of PFAS use within products and explore whether alternatives could be used as regulatory change is on the horizon with regard to restrictions on PFAS.

For information, the other four priorities set out in the work programme for 2023 to 2024 are as follows:

1. Formaldehyde and formaldehyde releasers in articles – continue the RMOA initiated under the 2022 to 2023 work programme and consider its recommendations.
2. Bisphenols in thermal paper – continue the RMOA initiated under the 2022 to 2023 work programme and consider its recommendations.
3. Hazardous flame retardants – develop the risk assessment on flame retardants and consider the recommendations.
4. Intentionally added microplastics – monitor progress of the evidence project initiated and commissioned under the 2022 to 2023 work programme.

Extended Producer Responsibility amending regulations

On 17 January 2024, the Draft Packaging Waste (Data Reporting) (England) (Amendment) Regulations 2024 were laid before Parliament and will be effective from 1 April 2024. These regulations amend the Packaging Waste (Data Reporting) (England) Regulations 2023, which will eventually be replaced by the Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations which will implement the extended producer responsibility scheme for packaging. The key changes introduced by the amending regulations are:

• Requiring the Environment Agency to publish a public list of large producers.
• Shifting the obligation of reporting from the brand owner of empty packaging to the person who packs or fills the packaging.
• Making the importer responsible for imported, branded packaging unless the brand owner specifically requests the importation, and providing a clearer definition of importer to ensure proper obligations for importers who discard imported empty packaging.
• Imposing reporting obligations on distributors who supply unfilled packaging to a large producer, who then supplies it to a small or non-obligated producer. Currently, no one is required to report this packaging, and these amendments will place the obligation on the distributor.

Businesses that fall within the scope of the extended producer responsibility scheme should review these new regulations to determine if their obligations are affected.

EU

Feedback period opened on EU restriction on BPA in food contact materials

The European Commission has opened a feedback period on its proposed regulation to ban the use of BPA in food contact materials (FCMs), including plastic and coated packaging. The regulation address the use of other bisphenols in FCMs to avoid replacing BPA with other harmful substances as well as imposing monitoring and reporting obligation on manufacturers. The feedback period closes on 8 March 2024 and Commission adoption of this draft regulation is planned for the first quarter of 2024.

Businesses that manufacture food contact materials should take the opportunity to give feedback on the regulation as this is likely to be their only opportunity to do so, as after the Commission adopts its draft, it will enter the legislative process between the EU institutions.   

Provisional agreement reached on the right to repair

Earlier this month, EU negotiators reached a provisional agreement on the Right to Repair Directive (RTR), which will make repair mandatory for defective products, and impose new obligations on all businesses placing products on the EU market. While the final version of the text of the agreement is not yet available, the EU institutions' press releases have provided some clarification as to what the agreed text will look like:

1. Manufacturer obligations: manufacturers will be obligated to repair those products which have ecodesign requirements in place, such as washing machines, vacuum cleaners and smartphones. This reverts back to the original scope put forward by the Commission's proposal, as the European Parliament wanted to expand the scope of the RTR by giving the Commission the power to expand the list of the products the RTR applied to, outside of ecodesign requirements. However that proposal has not been taken forward and the RTR will only apply to products where ecodesign regulations are already in place. Over time though, this list will expand with the introduction of the Ecodesign for Sustainable Products Regulation, whereby the European Commission will be able to introduce delegated acts setting out ecodesign requirements for more products.
    
2. Spare parts at a reasonable price: manufacturers will have to make spare parts and tools available at a reasonable price and will need to provide this information on their website. In addition to this, manufacturers will be prohibited from using contractual clauses, hardware or software techniques to obstruct repairs and should not impede the use of second-hand or 3D issued spare parts by independent repairers.
    
3. Consumer awareness: manufacturers must inform consumers about their duty to repair and consumers will be able to request this information from manufacturers.
    
4. Temporary replacements: consumers will have the option to borrow a device while their own is being repaired or choose a refurbished unit as an alternative.

See the Consumer law section for the consumer aspects of the RTR.

In terms of next steps, the European Parliament and Council both need to formally adopt the text, following which it will be published in the EU Official Journal. We anticipate this will happen ahead of the European Parliament elections in June 2024. Once in force, Member States will have 24 months to transpose the RTR into national law.

We will be provide a fuller update once the final version of the text has been published, but for the time being, businesses should understand what this new legislation could mean for them. For more information, see the following press releases from the European Commission, European Parliament and European Council.

Proposals to reduce food and textile waste across EU

The Environment Committee of the European Parliament has adopted new measures to support the circular economy and reduce waste from food and textiles in the EU. The adopted measures include more ambitious targets for reducing food waste. The proposed targets are to achieve at least a 20% reduction in waste from food processing and manufacturing (compared to the current 10%) and a 40% reduction per capita in retail, restaurants, food services and households (compared to the current 30%).

These targets would need to be achieved by EU countries at the national level by 31 December 2030. Additionally, MEPs have called for the evaluation of higher targets for 2035, aiming for at least a 30% and 50% reduction.

In terms of textile waste, the new rules introduce extended producer responsibility (EPR) schemes. Under these schemes, economic operators that make textiles available on the EU market would be responsible for covering the costs of separate collection, sorting, and recycling. Member States would need to establish these schemes within 18 months of the directive's entry into force. Furthermore, EU countries would be required to ensure the separate collection of textiles for re-use, preparing for re-use, and recycling by 1 January 2025.

The rules cover various textile products, including clothing, accessories, blankets, bed linen, curtains, hats, footwear, mattresses and carpets. This also includes products that contain textile-related materials such as leather, composition leather, rubber or plastic.

The next steps involve the full European Parliament voting on its position during the March 2024 plenary session. After the European elections in June, the file will be followed up by the new Parliament.

EU Parliament and Council formally adopt their positions on directive to empower consumers for the green transition

The European Parliament has formally adopted a legislative resolution for a directive "empowering consumers for the green transition" at first reading. Following this, the Council of the EU has given its final approval for the directive. After this, it will be published in the Official Journal of the EU and will be subject to a transposition period of 24 months after directive comes into force to allow Member States to implement the changes.

The new directive, among other things, prohibits the display of sustainability labels on products that have not been certified via a certification scheme. The legislation notes that sustainability labels can remain without a certification scheme where they have been established by a public authority, such as logos.

In addition to this, the directive introduces the requirement of a harmonised label that will inform consumers about the producer's commercial guarantee of the durability of the good. The use of a harmonised label only applies to commercial guarantees of durability that offer a period of more than two years and will be offered at no additional cost. The label will need to be placed in a "prominent manner" and be clearly visible, such as on the packaging of the product.

The new directive also imposes bans on misleading ads and generic environmental claims. Please refer to the Advertising and marketing section for more information.

Lifesciences and healthcare

UK

Eight companies given funding under the new The Innovative Devices Access Pathway

As detailed in this previous Regulatory Outlook, the Medicines and Healthcare products Regulatory Agency last year launched the Innovative Devices Access Pathway (IDAP) pilot which aims to help businesses bring innovative medical devices into the UK market.

It has now announced, on 14 February, that eight companies have been given part of the £10 million funding package. The companies and medical devices benefiting from this investment include a blood test for Alzheimer's Disease by Roche Diagnostics Ltd, a device to predict hospitalisation risk for chronic obstructive pulmonary disease by Lenus Health Ltd, and an innovative approach to oxygen level monitoring by EarSwitch.

Other technologies such as a multiple sclerosis fatigue app, a self-test for neutropenia and an algorithm infection predictor will also receive funding.

Consultation response on reforms to the Veterinary Medicines Regulations 2013

Following its consultation last year on the review of the Veterinary Medicines Regulations 2013, the Veterinary Medicines Directorate (VMD) has responded saying it will implement most of the proposed changes put forward, with some proposals being amended. For manufacturers, feed business operators and professional keepers of animals this will mean a change in the regulatory framework for veterinary medicines.

Changes include:

• EU Alignment: Single dossier submissions and labels will be permitted across GB and the EU - another example of (re)alignment with the EU.
• Medicated feed: The VMD's proposal for collection and disposal of medicated feed has been scrapped but it is still unclear what will be potentially introduced instead.
• UK generics market: The VMD has confirmed that there will be an extension of some data protection periods awarded to veterinary medicines, in a bid to encourage innovation and support generics.

Read our Insight for more.