Products | UK Regulatory Outlook June 2023

General Product Safety Regulation enters into force

Following its publication in the Official Journal of the European Union (EU) on 23 May, the General Product Safety Regulation (GPSR) entered into force on 12 June. As noted in our previous Regulatory Outlook, an 18-month transition period is in place, meaning businesses have until 13 December 2024 to ensure compliance with the new obligations and requirements.

Council of the EU adopt position on new Product Liability Directive

On 14 June, the Council of the EU adopted its negotiating mandate for a new EU law on liability for defective products.

Changes made from the Commission's original proposal include extending the entitlement to compensation to 20 years from 15 years, in respect of those cases where the symptoms of a personal injury are slow to emerge, and streamlining the burden of proof so that the claimant is only required to prove the likelihood that the product was defective or that its defectiveness is a likely cause of the damage.

The European Parliament now needs to adopt its own position and then the two bodies can agree on the final text.

Scottish DRS delayed to October 2025

Following the UK government's refusal to agree to a full exclusion from the Internal Market Act, namely that the UK government would not allow glass to be included in the Scottish deposit return scheme (DRS), the Scottish government has announced that Scotland's DRS will be delayed until at least October 2025.

Sustainable batteries regulation adopted by European Parliament

On 14 June, the European Parliament approved new rules for the design, production and waste management of all types of batteries sold in the EU. Key measures include:

• a compulsory carbon footprint declaration and label for electric vehicles (EV) batteries, light means of transport (LMT) batteries (for example, for electric scooters and bikes), and rechargeable industrial batteries with a capacity above 2kWh;
• designing portable batteries in appliances in such a way that consumers can themselves easily remove and replace them;
• a digital battery passport for LMT batteries, industrial batteries with a capacity above 2 kWh, and EV batteries; and
• a due diligence policy for all economic operators, except for SMEs.

The Council of the EU will now have to formally endorse the text before its publication in the EU Official Journal shortly after and its entry into force.

Commission proposes new energy labelling rules for mobiles and tablets

The European Commission has, on 16 June, proposed new rules to make phones and tablets more durable, energy efficient and easier to repair, to help consumers make more sustainable choices.

The new regulation sets requirements for the energy labelling of smartphones and tablets to contribute to the EU climate and energy targets and to the material efficiency objectives set out in the Circular Economy Action Plan 2020. Devices that are put onto the Union market will have to display information on their energy efficiency, battery endurance, protection from dust and water, and resistance to accidental drops, as well as displaying a repairability score.

These energy labelling rules will now be submitted to the European Parliament and Council for a two-month scrutiny period, after which they will be formally adopted, subject to any objections. After their entry into force, there will be a 21-month transition period before the requirements become applicable. 

MEPs call on the Commission and EU countries to end 'fast fashion'

On 1 June, the European Parliament adopted recommendations for the EU strategy for sustainable and circular textiles calling for "textile products sold in the EU to be more durable, easier to reuse, repair and recycle." MEPs have called on the Commission to:

• Ban the destruction of unsold and returned textile goods in the upcoming revision of the ecodesign regulation.
• Provide clearer rules to stop greenwashing by producers through, for example, the ongoing legislative work related to empowering consumers in the green transition and regulating green claims.
• Include specific separate targets for textile waste prevention, collection, reuse and recycling in the upcoming revision of the Waste Framework Directive.

MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced new regulatory recognition routes for medicines using approvals from Australia, Canada, the EU, Japan, Switzerland, Singapore and the US.

Its press release states that the recognition routes, which have been facilitated by existing international partnerships (such as the Access Consortium and Project Orbis), mark the start of a new international recognition framework for medicines that will be in place by the first quarter of 2024.

It adds that the MHRA will still be responsible for approving all "recognition route" applications under the new framework, ensuring that all products are safe and of sufficient quality to be licensed in the UK. The MHRA will maintain rigorous scrutiny and retain the authority to reject applications if the evidence provided is considered insufficiently robust.

This announcement is focused on medicines, but it states that work is under way to establish similar routes for medical devices and a targeted consultation on medical devices will be launched to gather views, including recognising conformity assessments or approvals from international regulatory partners.

Government publishes information and guidance on implementation of Windsor Framework

The UK government has published further detail and new guidance on the arrangements giving effect to the Windsor Framework relating to trade flows within the UK internal market.

It sets out how the Windsor Framework will work in practice, and operational information on the relevant legal obligations that apply. Guidance and policy papers are provided relating to moving goods from Great Britain (GB) to Northern Ireland (NI) in general; movement of sanitary and phytosanitary products; the supply of medicines into Northern Ireland and subsidiary control. The guidance pages will be updated in due course. The implementation of the framework will happen in stages into 2025.

The government has published guidance on how the retail movement scheme will work. This will be relevant to those businesses that move prepacked retail goods such as food, drink, cut flowers and pet food from GB to NI. Guidance on the labelling requirements under the scheme can also be found here. It comes into force in three phases:

• Phase 1 – from 1 October 2023 all meat products and some fresh dairy products that are moving from Great Britain to Northern Ireland will need to be individually labelled.
• Phase 2 - From 1 October 2024, in addition to the phase 1 products, all milk and dairy products moving to Northern Ireland under the Retail Movement Scheme will need to be individually labelled.
• Phase 3 - From 1 July 2025, composite products, fruit, vegetables and fish moving to Northern Ireland under the Retail Movement Scheme will also need to be individually labelled.

A separate government announcement was also published on the medicines aspect of the Windsor Framework noting that the new measures will commence on 1 January 2025, meaning that:

• New medicines for the UK market will be authorised by UK authorities, and UK packaging must carry a clearly legible "UK only" label to be allowed onto the UK market, including in Northern Ireland.
• 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.
• Medicines entering Northern Ireland will not display features required under the EU Falsified Medicines Directive (FMD) including 2D barcodes and serialisation numbers that are compliant with the EU FMD Directive.
• The MHRA will expect anti-tamper devices to remain on all medicine packaging.

MHRA launches consultation on ICH Good Clinical Practice Guideline

The MHRA has published a consultation on the International Council for Harmonisation (ICH) E6 (R3) Good Clinical Practice (GCP) guidelines to gain feedback for the ICH. It is seeking views as to whether resolutions set out in the ICH reflection and concept papers have been achieved, as well as any further comments and views on the guidelines. The focus is around encouraging a proportionate risk-based approach to quality management of trials, addressing innovation in trial design and using new technologies. Feedback received as part of the consultation will inform the UK Clinical Trials Regulations.

The consultation closes on 31 August 2023.

Innovative Device Access Pathway to launch later this year

The MHRA has recently announced plans for an Innovative Devices Access Pathway (IDAP), which is set for launch later in 2023, that will help to bring innovative technologies into the NHS via an integrated support services for developers.

The IDAP will be operated by the MHRA, the National Institute for Health and Care Excellence, Health Technology Wales and Scottish Health Technology Group. It will create an "end-to-end visible framework that supports innovators generate the evidence they need to achieve regulatory approval, heath technology assessment decisions, and patient access in the NHS."

Businesses that are innovators of medical technology should register for further information ahead of the launch later this year.

Draft regulations laid ahead of further single-use plastic bans in England

Please see Environment.

Deforestation regulation published in the Official Journal of EU

Please see ESG.