Products | UK Regulatory Outlook May 2023
Published on 25th May 2023
Publication of the new EU General Product Safety Regulation | EU directive on empowering consumers for the green transition: durable products | UK government extends timeframe for acceptance of CE marked medical devices | Twelve month countdown for new product security regime begins
Publication of the new EU General Product Safety Regulation
On 23 May 2023, the General Product Safety Regulation (GPSR) was published in the Official Journal of the European Union. The GPSR will enter into force on the 12 June 2023. The GPSR will bring a number of changes to the world of product safety, such as the following:
- Online marketplaces are now firmly within the product safety framework, with interface, cooperation and process requirements, including designating a single point of contact for regulators and consumers. They will also be required to perform random checks on products, have internal process in place for product safety, and identify affected consumers in the event of product recalls.
- Many of the requirements imposed by the Market Surveillance Regulation now apply to all products.
- Strict deadlines have been introduced for taking action in response to non-compliance, as well as reports from regulators and consumers.
- Enhanced documentation and information requirements for all products sold in the EU.
The GPSR will bring significant developments in the area of product safety, with an 18-month transition period in place. Businesses therefore have until 13 December 2024 to ensure compliance with these wide-reaching new obligations and requirements. Regulators also have new information gathering powers and can impose dissuasive penalties for breaches.
If you missed our recent Eating Compliance for Breakfast session on the GPSR, then you can find the recording here and the slide here. If you did not initially register for this session, please click "register here" in the right hand summary column and then you will be able to access it.
Council adopts position on ecodesign for sustainable products
On 22 May, the Council of the EU adopted its position on the proposed regulation establishing a framework for setting ecodesign requirements for sustainable products. As noted in our Insight, these new reforms will amend the current ecodesign requirements to encourage consumers to buy more sustainably friendly products by introducing the following:
- For all products in the EU will have a "Digital Product passport" to provide a single point of truth about products and their environmental characteristics, to make it easier to repair or recycle products and to facilitate tracking substances of concern along the supply chain.
- Measures to end the destruction of unsold consumer goods, in which certain exemptions will be applied.
- The Council's mandate introduces a direct prohibition against the destruction of unsold apparel or clothing accessories, with a 4-year exemption for medium-sized companies, and a general exemption for small and micro companies.
The European Parliament still needs to adopt its position, following which negotiations will begin between the two legislative bodies before a final version of the Regulation is adopted and can enter into force. The Council's position sets out that an 18 month transition period will be implemented after the regulation enters into force in order to give businesses time to adapt to the new requirements. So whilst it will be a further few months before the regulation enters into force, businesses should start familiarising themselves with these changes in order to prepare ahead of implementation.
EU directive on empowering consumers for the green transition: durable products
The Council of the European Union and the European Parliament have adopted their respective positions on the proposal for a directive to empower consumers for the green transition amending the Unfair Commercial Practices Directive 2005 and the Consumer Rights Directive.
The proposal aims to help consumers make environmentally friendly choices with new provisions to encourage consumers to choose more environmentally sustainable products. Under the adopted text, manufacturers will need to ensure consumers are informed of the repairability of a product and should provide information on repairability restrictions, such as the unavailability of repair services and the unavailability of spare parts.
Additionally, MEPs want to ban practices which lead to the shortening of a product's lifespan as well as prohibiting features that lead to goods malfunctioning prematurely. In line with this, they have proposed introducing a new guarantee label which will set out the length of the legally required guarantee and also the length of any possible guarantee extensions offered by producers. This is to help consumers choose products that will last longer and can be repaired, while also encouraging businesses to focus on durability.
The new directive also imposes bans on misleading ads and generic environmental claims, see the advertising and marketing section for more.
As the Council of the EU has also adopted its position, negotiations between the European Parliament and Member States on the final wording of the directive can begin soon.
Packaging Waste (Data Reporting) (England) (Amendment) Regulations 2023
The draft Packaging Waste (Data Reporting) (England) (Amendment) Regulations 2023, which introduce reporting requirements under the Extended Producer Responsibility (EPR) scheme that is due to come in in 2024, have recently been made to correct errors in the Packaging Waste (Data Reporting) (England) Regulations 2023.
Changes have been made to clarify when a brand owner is a producer in relation to packaging, to assign responsibility for certain packaging to packer/fillers (rather than brand owners) and to importers, and makes a further provision in relation to offences under the regulations.
The draft explanatory memorandum to the amending regulations can be found here and notes that further guidance will be published in line with the clarifications as set out in these amending regulations.
For a reminder on the EPR scheme for packaging, please see our January issue of the Regulatory Outlook.
Twelve month countdown for new product security regime begins
On 29 April, the Department for Science, Innovation and Technology announced that the UK’s consumer connectable product security regime will come into force on 29 April 2024.
The regime will require manufacturers of UK consumer connectable products to comply with minimum security requirements and ensure those businesses within the supply chain of relevant products are following measures to prevent insecure products from being sold to UK consumers and businesses.
The consumer connectable product security regime includes Part 1 of the Product Security and Telecommunications Infrastructure Act 2022 (PSTIA) and the draft Product Security and Telecommunications Infrastructure (Security Requirements for Relevant Connectable Products) Regulations 2023. Currently, Part 1 of PSTIA as no legal effect until the security regulations come into force.
The security regulations can be found here and set out the minimum security requirements they must comply with. These security requirements are set out in Schedule 1 of the regulations and include information on minimum security update periods, banning of default passwords and information on how to report security issues.
Consumers may also be entitled to legal remedies where cybersecurity vulnerabilities lead to the loss or corruption of data or when a safety issue arises due to a lack of security updates after a product has been sold. Exceptions within the regulations apply to products which are made available for supply in Northern Ireland and medical devices. The regulations will be introduced to Parliament when parliamentary time allows.
Once the regulations are passed, the compliance obligations will fall on manufacturers, importers and distributors of all connectable products, who will need to comply with the new security requirements.
UK government extends timeframe for acceptance of CE marked medical devices
At the end of last month, a statutory instrument was laid in Parliament that, subject to approval, will extend the timeframe for acceptance of CE marked medical devices on the GB market beyond the current deadline of 30 June 2023, to July 2025.
In line with this, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its "Regulating medical devices in the UK" guidance which outlines that, subject to approval, the following measures will be introduced before 30 June 2023 and will provide that certain CE marked medical devices may be placed on the GB market:
- general medical devices compliant with the EU medical devices directive or EU active implantable medical devices directive with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028;
- in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030; and
- general medical devices including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until 30 June 2030.
While this extension was expected, this confirmation from the government will be welcomed by businesses. In practice this means CE marked devices can continue to be placed on the GB market; after these deadlines expire, devices will need to be marked with the UKCA mark.
Commission proposes revision of the EU pharmaceutical legislation
On 26 April, the European Commission put forward a proposal to review the EU's pharmaceutical legislation. Aims of the proposal include creating a single market for medicines, reducing administrative burdens and authorisation times of medicines, and ensuring an innovative framework for research, development, and production of medicines in Europe. The full list of objectives and a Q&A can be found here.
Elements of the proposal include: better access to innovative and affordable medicines for patients and national health systems; promoting innovation and competitiveness through an efficient and simplified regulatory framework; effective incentives for innovation; addressing shortages of medicines and ensuring security of supply; stronger protection of the environment; and tackling antimicrobial resistance. Read our Insight for more.
A feedback period on the proposal is open until 22 June 2023.
Reporting adverse incidents involving Software as a Medical Device under the vigilance system
The MHRA has published new guidance for manufacturers of Software as a Medical Device outlining those events that may cause harm and subsequently need to be reported.
Examples are provided of those adverse incidents that may be reportable, such as failure to perform according to the performance characteristics specified by the manufacturer and failure of diagnostic tools. Incidents such as these should be reported to the MHRA and this new guidance provides details on this which manufacturers should refer to where such adverse incidents arise.
How will the Retained EU Law Bill affect UK and international businesses?
The government announced a U-turn in its Retained EU Law (Revocation and Reform) Bill. It stated that it is amending the REUL Bill "to be clear which laws we intend to revoke at the end of this year." Our recent Insight considers the potential impact of the bill on business.
The changes include scrapping the "sunset clause" and instead, the amended bill sets out a list of legislation that will be revoked at the end of 2023. The Chartered Trading Standards Institute (CTSI) has welcomed this decision noting that the "legislation covering vital protections for food, product safety laws and regulations affecting animal health and welfare are now safe from being lost at the end of 2023."
The bill has now completed its reading in the House of Lords and has returned to the House of Commons. If you missed our recent Eating Compliance for Breakfast session on the current status and implications of the bill, then you can find the recording here and the slides here. If you did not initially register for this session, please click "register here" in the right hand summary column and then you will be able to access it.
EU Council adopts regulation on deforestation-free supply chains
Please see ESG.