Products | UK Regulatory Outlook July 2023
Published on 26th Jul 2023
Large producers to submit EPR data by 1 October 2023 | European Parliament strengthens ecodesign rules on product lifespan | New machinery products regulation published in the EU Official Journal
Large producers to submit EPR data by 1 October 2023
Large businesses who are in scope of the extended producer responsibility (EPR) scheme for packaging need to report their packaging data by 1 October 2023. Reporting obligations differ in relation to the size of an organisation and how much packaging they import or supply and businesses should refer to the government guidance to identify what rules apply to them. The government also has an online service for businesses to check if they need to report packaging data. Businesses can also find out if they are classified as a small or large organisation here.
The "Extended producer responsibility for packaging: who is affected and what to do" guidance page states that the service for reporting data is scheduled to go live in August 2023. Producers will be able to create an account from 16 August and upload the relevant data. Those large businesses who fall within the scope need to ensure that they have collected and submitted this data by 1 October 2023 and if missed, may need to pay a penalty charge.
The reporting period for 1 October 2023, is for the period January to June 2023, but if businesses do not have all the required data recorded from 1 January 2023, they must report all of their data from 1 March to June 2023.
On 25 July, a decision was made to defer the EPR packaging fees for one year. Producers are still required to report their packaging data for 2023, but instead of having to pay the fees under EPR in October 2024, fees will now need to be paid in October 2025. The government will give further information of what the material fees will be which will vary depending on the materials reported.
European Parliament strengthens ecodesign rules on product lifespan
On 12 July, the European Parliament adopted its position on the new Ecodesign for Sustainable Products Regulation (see more in our May issue of the Regulatory Outlook). Within this the European Parliament strengthened the measures proposed by the Commission to ensure longer product lifespans and better-informed consumers.
The European Parliament states that "the lifetime of a product should not be limited through design features. Software updates, consumables (e.g. ink cartridges, light bulbs, coffee pads), spare parts and accessories must also be available for an appropriate period." In their negotiating position, MEPs also included a specific ban on destroying unsold textiles and electrical and electronic equipment.
Negotiations will now begin between Parliament and the Council to agree on a final version of the regulation before it can be formally adopted.
New machinery products regulation published in the EU Official Journal
On 29 June 2023, Regulation (EU) 2023/1230, the Machinery Products Regulation was published in the Official Journal of the European Union. The regulation repeals the existing Machinery Directive 2006/42/EC and Council Directive 73/361/EEC, see our earlier Regulatory Outlook for more on the new regulation. The Machinery Products Regulation enters into force on the 20th day following its publication and will apply from 14 January 2027.
EU sustainable batteries regulation formally adopted by Council
As discussed in our previous Regulatory Outlook, the European Parliament approved new rules for the design, production and waste management of all types of batteries sold in the EU. This month the Council of the European Union adopted the proposal on 10 July without any further amendments. The regulation will be signed and published in the Official Journal of the European Union and enter into force 20 days after.
CE marked medical devices to be accepted on the Great Britain market beyond 30 June 2023
The Medical Devices (Amendment) (Great Britain) Regulations 2023, that enable CE marked medical devices to be accepted in Great Britain for defined periods beyond 30 June 2023, came into force on 30 June 2023. For a reminder of the revised timelines, please see our May issue of the Regulatory Outlook. The government press release states that the Medicines and Healthcare products Regulatory Agency also intends to lay a statutory instrument later this year that will put in place enhanced post-market surveillance requirements.
Implementation of Windsor Framework
As detailed in our previous Regulatory Outlook, the retail movement scheme comes into force from 1 October 2023, including some labelling requirements. The Northern Ireland Retail Movement Scheme guidance page outlines that further guidance will be published in July 2023 outlining the requirements for the General Certificate alongside the scheme terms and conditions, as well as information on how businesses can pre-register for the Northern Ireland Retail Movement Scheme between 31 July and 24 August 2023. This pre-registration will fast-track scheme membership. Full online registration will launch on 1 September 2023.
All businesses involved in the sale or movement of food and drink for consumption in Northern Ireland will be eligible to benefit from the scheme's arrangements, and should consider whether they want to take advantage of the opportunity for pre-registration.
The Product Security and Telecommunications Infrastructure (Security Requirements for Relevant Connectable Products) Regulations 2023
The draft Product Security and Telecommunications Infrastructure (Security Requirements for Relevant Connectable Products) Regulations 2023 have been laid before Parliament and set out the security requirements that manufacturers of relevant connectable products have to comply with in relation to the consumer connectable product security regime included in Part 1 of the Product Security and Telecommunications Infrastructure Act 2022 (PSTIA). The draft regulations also set out the technical standards which will allow for a presumption of conformity with the requirements.
Manufacturers subject to the duty in section 8 of the PSTIA must comply with these requirements, and confirm that they have complied with these requirements in the statement of compliance accompanying the product. These regulations will come into force in line with the new security regime that enters into force on 29 April 2024.
MHRA publishes corporate plan for 2023 to 2026
The Medicines and Healthcare products Regulatory Agency (MHRA) has recently published its corporate plan for 2023 to 2026. From the plan, we can expect to see the MHRA:
- Increase regulatory oversight of high-risk products, with a parallel reduction in regulatory oversight of lower risk products. This is "risk proportionate regulation", where the MHRA's focus will be on products where potential side-effects are more significant.
- Introduce regulations "in parallel" with the development of innovative products. This seems to imply recognition of the fact regulators can struggle to keep up with innovation. The MHRA is aiming to address this by using new legislation and guidance to create "faster risk proportionate, and predictable pathways"
- By 31 March 2025: introduce "new recognition pathways" for some medicines and medical devices that have been approved by overseas regulators. This is to put into effect the chancellor's announcement in the Spring Budget that the MHRA would move to a new model for the approval of medical products that have already been approved by regulators in jurisdictions such as the EU, US and Japan. The MHRA has previously stated that the recognition framework for medicines will be in place by Q1 2024.
- During 2024/25: introduce new guidance and legislation, aiming to boost innovation. The MHRA confirmed earlier this month that core aspects of the future regime for medical devices will apply from 1 July 2025.
The MHRA adds that this Plan is only a "high-level roadmap" and that more detailed Annual Business Plans will be published with the key actions for each financial year. Nevertheless, industry will see in this plan some clarity over the direction of medical devices regulations over the next few years.
Consultation launched on opioid-containing cough medicine
The MHRA has published a consultation on the on the reclassification of codeine linctus, which is used to treat a dry cough, to a prescription-only medicine. This is in response to reports that the medicine was being used for its opioid effects rather than for its medical purpose which therefore poses a risk of addiction.
Views are being sought by the regulator on the change in classification of this medicine and businesses who manufacturer cough syrups may wish to respond. The consultation closes on 15 August 2023.
VPAS judicial review dismissed
The High Court has handed down its judgment on the judicial review brought by the British Generic Manufacturers Association (BGMA) dismissing the claim that the organisation should not have been excluded from negotiations between the government and the pharmaceutical industry regarding the next iteration of the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS). Our Insight (published before the judgment was issued) looks at the wider issues concerning the operation of VPAS as it affects the pricing of medicines used in the NHS.
HMRC consults on chemical recycling and adoption of a mass balance approach under PPT
HMRC has published a consultation on the potential adoption of a mass balance approach for chemically recycled plastic in the Plastic Packaging Tax (PPT). Views are being sought on the impacts of chemical recycling for plastics and the potential use of a mass balance approach to account for chemically recycled content for PPT.
In line with responses received, the government will then develop an approach which aims to "support business, innovation and growth while maintaining the integrity of the tax." The consultation closes on 10 October 2023.
Single use plastic bans in England and Wales
From 1 October 2023, the further single use plastics ban in England comes into force, see our previous Regulatory Outlook for more.
Similar bans will also be introduced in Wales from the autumn and businesses should ensure that over the summer break they take the time to understand the restrictions in both England and Wales and what changes they need to be making to comply with the new regulations.
Call to action
EPR - Large businesses who are required to collect and report their packaging data under the EPR scheme must ensure that they have collected and submitted this data by 1 October 2023.
Medical devices (GB market) - Review the updated timelines published by the MHRA that govern the period during which CE marked medical devices will be continue to be accepted on the Great Britain market. Assess the cost/benefit analysis of continuing with CE marking, while it remains an option, compared to adopting UKCA marking.