Products | UK Regulatory Outlook October 2023
Published on 31st Oct 2023
European Parliament committees approve Product Liability Directive to better protect consumers against defective products | Draft regulation for EU common criteria-based cybersecurity certification scheme | MHRA publishes labelling and packaging guidance under Windsor Framework
European Parliament committees approve Product Liability Directive to better protect consumers against defective products
On 9 October 2023, the European Parliament's Legal Affairs Committee and Internal Market and Consumer Protection Committee approved their position on the regulation of economic operators' liability for damage caused by defective products.
The new Product Liability Directive will replace the existing product liability framework (under directive 85/374/EEC), and we expect it to have completed the legislative procedure by the end of 2024.
The European Parliament will now need to adopt the draft mandate as a whole at the next plenary session, before talks with EU member states on the final Product Liability Directive can start.
Key goals under the new legislation include :
- ensuring that even when something defective was bought outside the EU, there is an EU-based business that can be held liable for the damage it causes;
- an easier compensation procedure, including a simplified procedure around burden of proof; and
- extended liability so that claims can be made not only against physical damage but also against (1) medically recognised psychological damage, and (2) the destruction or irreversible corruption of data (such as deletion of files from a hard drive) when the economic loss exceeds €1000.
For further information, please see our previous Regulatory Outlook.
Draft regulation for EU common criteria-based cybersecurity certification scheme
On 12 October 2023, the European Commission published a draft regulation setting out the European Common Criteria-based cybersecurity certification scheme (EUCC) developed under the EU Cybersecurity Act.
The draft regulation follows a consultation held in 2020 by the European Union Agency for Cybersecurity (ENISA), and is of interest for organisations in the IT sector operating in the EU. Once adopted, the regulation will apply to all information and communication technologies products, including their documentation, which need to be submitted for certification under the EUCC.
For further information on the EU's cybersecurity strategy for IT product design please see our Insight.
MHRA publishes labelling and packaging guidance under Windsor Framework
The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.
This guidance ensures that medicines can be approved and licensed on a UK-wide basis by the MHRA, with medicines using the same packaging and labelling across the UK.
New streamlined notification scheme for lowest-risk clinical trials
The MHRA has introduced a new streamlined clinical trials system. The new scheme aims to reduce the time taken by the MHRA to approve the lowest-risk clinical trials by more than 50% (that is, within 14 days instead of the statutory 30 days).
The scheme follows the MHRA's clinical trials consultation, the outcome of which was published on 21 March 2023, and forms part of the regulator's reform of the regulation of clinical trials. An estimated 20% of UK initial clinical trial applications are expected to be eligible for the scheme. However, applications for clinical trial amendments will not be eligible.
Safety warnings to be provided with valproate-containing medicine
On 11 October 2023, the government announced that valproate-containing medicines will be dispensed in the manufacturer's original full pack, following changes to the Human Medicines Regulations 2012.
The aim is to ensure that patients always receive the latest safety warnings and pictograms each time a prescription is dispensed. This will include a patient card and patient information leaflet, contained in the manufacturer's original full pack. These materials are recognised as a key part of the safety messaging and specifically alert patients to the risks to the unborn baby if valproate-containing medicines are used in pregnancy.
OPSS releases exemption process guidance for cosmetic products with CMR substances
On 5 October 2023, the Office for Product Safety and Standards (OPSS) released guidance on the exemption process for the use of substances classified as carcinogenic, mutagenic and toxic for reproduction (CMR) in cosmetic products.
The document describes the exemption process and timelines for the continued use of CMR substances in cosmetic products. The exemption can only be granted by the Secretary of State where all criteria for exemption are fulfilled, and ultimately there needs to be sufficient evidence to show that the substance is safe for use in cosmetic products.
EU MEPs adopt position on revision of CLP Regulation for chemical substances
On 4 October 2023, the European Parliament adopted its position on the revision of the Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008) which introduces new rules to classify, label and package chemical substances and mixtures.
It aims to better identify and classify hazardous chemicals, improve communication on chemical hazards and address legal gaps and high levels of non-compliance. The European Parliament will now start negotiations with EU Member States on the final law.
Government proposes tobacco products ban; consultation to tackle smoking and youth vaping
On 4 October 2023, the government announced proposals for the introduction of new legislation that will make it an offence for anyone born on or after 1 January 2009 to be sold tobacco products, effectively raising the smoking age by a year each year until it applies to the whole population.
The Department of Health and Social Care (DHSC) also published a command paper setting out the proposed actions the government will take to tackle smoking and youth vaping. The paper also sets out wider measures to support existing smokers to quit smoking, and ensure the law is enforced.
On 12 October 2023, the government launched a consultation on the proposals, focusing on questions in three areas for which new legislation would be needed:
- Creating a smokefree generation: consulting on the smokefree generation policy and its scope.
- Tackling youth vaping: consulting on several options to ensure we take the most appropriate and impactful steps, building on England’s analysis of the youth vaping call for evidence.
- Enforcement: consulting on the proposal to introduce new powers for local authorities in England and Wales to issue fixed penalty notices to enforce age of sale legislation of tobacco products and vapes.
The consultation closes on 6 December 2023.
Consultation opens on improving alcohol treatment services
The DHSC has launched a consultation seeking views on the first UK-wide clinical guidelines for alcohol treatment. The draft guidelines aim to develop a clear consensus on best practice for treatment for alcohol dependence, to improve outcomes for patients.
In particular, the alcohol clinical guidelines will provide:
- a detailed framework to support providers with high quality alcohol treatment guidance to help inform the quality of their services;
- guidance for health and social care staff involved in helping people experiencing alcohol dependence or drinking at harmful levels;
- guidance on managing and supporting treatment pathways, such as between hospitals or prisons and the community; and
- a reference point for national regulatory bodies when inspecting alcohol treatment services.
The consultation closes on 8 December 2023.
Consultation opens on proposed ban of wet wipes containing plastic
Please see Environment.
New ban on single-use plastics comes into force
Please see Environment.
Defra announces household goods will start carrying water efficiency labels
Following consultation, on 29 September 2023 Defra announced that products including toilets, sinks, dishwashers and washing machines will soon be sold with new water efficiency labels with the aim of helping consumers reduce their water wastage and save money. The labels will mimic energy efficiency labels, with a category rating from A to F on household goods.
See more on the government's Plan for Water here.
Defra offers £50m for businesses to meet Windsor Framework labelling requirements
On 29 September 2023, Defra announced that the government is offering up £50 million in funding through the Transitional Labelling Financial Assistance Scheme, for businesses registered on the Northern Ireland Retail Movement Scheme who have to prepare for new labelling rules under the Windsor Framework.
The government also confirmed the extension of the Movement Assistance Scheme until 30 June 2025. The scheme provides support to traders moving agri-food commodities and live animals from Great Britain to Northern Ireland and offers a remuneration scheme to cover traders’ certification costs, where they continue to apply.
FoodDrinkEurope supports proposals to remove PFAS from food contact materials
Please see Food.
FSA consultation on Food Contact Materials Regulations
Please see Food.
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View the full Regulatory Outlook
Regulatory law affects all businesses. Osborne Clarke’s updated Regulatory Outlook provides you with high level summaries of important forthcoming regulatory developments to help in-house lawyers, compliance professionals and directors navigate the fast-moving business compliance landscape in the UK.