Product Safety Law in the UK and Europe
Market Insight 19 October 2023 19 October 2023
UK & Europe
There are significant changes on the horizon in product liability and product safety law where legislation which is over 30 years old is being overhauled in Europe and the UK.
What is the General Product Safety Regulation?
The General Product Safety Regulation (GPSR) is a new key instrument in the EU product safety legal framework which came into force on 12 June 2023.
The GPSR repeals the General Product Safety Directive ('GPSD'), which had been in force since 2001. However, the application of the GPSR and the repeal of the above-mentioned EU Directives will only be effective after a transitional period expiring on 13 December 2024. There is therefore a short transitional period for businesses to grapple with the new system and what it means.
The GPSR modernises the EU general product safety framework and address the new challenges posed to product safety as a consequence of the digitalisation of our economies. In other words, it is designed to address the dangers created by online sales and purchasing and ensures that market surveillance is strengthened to protect purchasers in both the online and offline world.
The GPSR does not apply to pharmaceuticals, medical devices or food which fall under separate legislative regimes. The definition of “product” does, however, apply to any item whether or not it is interconnected to other items.
The key objectives of the GPSR are to:
- Ensure the safety of all products, including those linked to new technologies;
- Address challenges posed by the growth of online sales and in particular via online marketplaces;
- Ensure a better enforcement of the rules and more efficient and even market surveillance; and
- Improve the effectiveness of recalls of dangerous products in the hands of consumers.
Who is impacted?
The GPSR will have an impact for manufacturers, importers, distributors, online marketplaces, authorised representatives and retailers (together “economic operators”) who deal in a traditional way or online.
Economic operators must:
- Only place products which are safe on the market;
- Inform consumers of any risks associated with the products they supply; and
- Make sure any dangerous products present on the market can be traced so they can be removed to avoid any risks to consumers.
The GPSR requires that economic operators should have proportionate obligations concerning the safety of products, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of the health and safety of consumers, while also ensuring the efficient functioning of the internal market. All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they only make available on the market products which are safe and in conformity with the GPSR.
Article 9 of the GPSR sets out the obligations on manufacturers.
- Before placing their products on the market manufacturers should draw up technical documentation regarding the products they place on the market, which should contain the necessary information to prove that those products are safe. The technical documentation should be based on an internal risk analysis carried out by the manufacturer. The amount of information to be provided in the technical documentation should be proportionate to the complexity of the product and the possible risks identified by the manufacturer. In particular, manufacturers should provide a general description of the product and the elements necessary to assess its safety. In the case of complex products or products presenting possible risks, the information to be provided might need a more extensive description of the product. In such cases, an analysis of those risks and the technical means adopted to mitigate or eliminate the risks should also be included. Where the product complies with European standards or other elements applied to meet the general safety requirement laid down in this Regulation, the list of the relevant European standards or the other elements should also be indicated.
- Where a manufacturer considers, or has reason to believe, on the basis of the information in that manufacturer’s possession, that a product which it has placed on the market is a dangerous product, the manufacturer is required to:
a. take the corrective measures necessary to bring in an effective manner the product into conformity, including a withdrawal or recall, as appropriate;
b. inform consumers directly or via a published recall notice, or both; and
c. inform, through the Safety Business Gateway (the new name for RAPEX – please see below), the market surveillance authorities of the Member States in which the product has been made available on the market thereof.
- In addition, Article 9 of the GPSR requires that manufacturers shall ensure that other economic operators, responsible persons, and providers of online marketplaces in the supply chain concerned, are kept informed in a timely manner of any safety issue that they have identified.
- Manufacturers will also need to make publicly available communication channels such as a telephone number, electronic address or dedicated section of their website, taking into account accessibility needs for persons with disabilities, enabling consumers to submit complaints and to inform manufacturers of any accident or safety issue they have experienced with a product.
- There is also a requirement for manufacturers to investigate complaints submitted, and information received on accidents, that concern the safety of products they made available on the market and which have been alleged to be dangerous by the complainant, and shall keep an internal register of those complaints as well as of product recalls and any corrective measures taken to bring the product into conformity. The internal register of complaints shall only store those personal data that are necessary for the manufacturer to investigate the complaint about an alleged dangerous product. Such data shall only be kept as long as is necessary for the purposes of the investigation and in any event no longer than five years after the data have been entered.
A manufacturer, may, appoint by a written mandate an authorised representative. This is commonly used when the manufacturer is based outside the EU.
The authorised representative will, under Article 10 of the GPSR, be responsible for:
a. providing a market surveillance authority, upon that authority’s reasoned request, with all information and documentation necessary to demonstrate the safety of the product in an official language which can be understood by that authority;
b. where the authorised representative considers or has reason to believe that a product in question is a dangerous product, informing the manufacturer thereof;
c. informing the competent national authorities about any action taken to eliminate the risks posed by products covered by their mandate through a notification in the Safety Business Gateway, where the information has not been already provided by the manufacturer or upon instruction of the manufacturer;
d. cooperating with the competent national authorities, at their request, on any action taken to eliminate in an effective manner the risks posed by products covered by their mandate.
Article 11 of the GPSR provides that importers shall ensure that the product they are importing is safe. In the event that the importer considers, or has reason to believe based on information within their possession that the product is not in conformity, the importer must not place the product on the market until the product has been brought into conformity. Furthermore, where the product is a dangerous product, the importer shall immediately inform the manufacturer thereof and ensure that the market surveillance authorities are informed through the Safety Business Gateway (please see section below on market surveillance and recall).
- Provide their name, their registered trade name or registered trademark, their postal and electronic address and, where different, the postal or electronic address of the single contact point at which they can be contacted. That information should be placed on the product or, where that is not possible, on its packaging or in a document accompanying the product. Importers should also ensure that any additional label does not obscure any information required by European Union law on the label provided by the manufacturer;
- Ensure that the product they imported is accompanied by clear instructions and safety information in a language which can be easily understood by consumers, as determined by the member state in which the product is made available on the market, except where the product can be used safely and as intended by the manufacturer without such instructions and safety information;
- Ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its conformity with the general safety requirement;
- Cooperate with market surveillance authorities and the manufacturer to ensure that a product is safe;
- When they consider or have reason to believe, on the basis of the information in that importer’s possession, that a product which it has placed on the market is a dangerous product, the importer shall immediately:
- inform the manufacturer thereof;
- ensure that the corrective measures necessary to bring in an effective manner the product into conformity are taken including withdrawal or recall, as appropriate; where such measures have not been taken, the importer shall immediately take them;
- ensure that consumers are immediately informed via a recall notice or through their warranty record system; and
- inform the market surveillance authorities of the Member States in which the product has been made available on the market thereof, through the Safety Business Gateway
Article 12 of the GPSR requires that before making a product available on the market a distributor needs to verify that the manufacturer and, where applicable, the importer have complied with their obligations under the GPSR, as applicable.
In addition, distributors are required to ensure that whilst a product is under their responsibility, storage or transport conditions that the product is exposed to do not jeopardise its conformity with the general safety requirements of the GPSR. In the event that a distributor considers that a product is not in conformity, the distributor must not make the product available on the market until such time as the product is brought back to conformity.
Where a distributor considers or has reason to believe, on the basis of the information in that distributor’s possession, that a product which it has made available on the market is a dangerous product or is not in conformity the distributor needs to:
a. Immediately inform the manufacturer or the importer, as applicable;
b. Ensure that the corrective measures necessary to bring in an effective manner the product into conformity are taken, including withdrawal or recall, as appropriate; and
c. Ensure that the market surveillance authorities of the Member States in which the product has been made available on the market are immediately informed thereof through the Safety Business Gateway.
What will be deemed “safe”?
Whilst the definition of what is deemed safe is very similar to the old GPSD - namely that the safety of a product should be assessed taking into account all relevant aspects of the product, it has been refined to include digitally connected products which influence the way another item works and states a requirement that such products meet the highest standards of safety, security and privacy by design and that the connections and interrelation that an item might have with external items should not jeopardise its safety.
New technologies have been expressly considered within GPSR on the basis that they might pose new risks to consumers’ health and safety or change the way the existing risks could materialise, such as an external intervention hacking the product or changing its characteristics. New technologies might substantially modify the original product, for instance through software updates, which should then be subject to a new risk assessment if that substantial modification were to have an impact on the safety of the product.
In order to facilitate the effective and consistent application of the general safety requirement laid down in the GPSR, it is important to make use of European standards covering certain products and risks. European standards, the references of which have been published in accordance with Product Safety Directive 2001/95/EC, should continue providing a presumption of conformity with the general safety requirement laid down in the GPSR. In other words, to prevent the placing on the market of dangerous products, it will be compulsory for economic operators to include in their production or marketing activities internal processes ensuring compliance with the relevant requirements of the GPSR. Such internal processes should be determined by economic operators themselves in relation to their role in the supply chain and the type of products concerned and can be based, for example, upon organisational procedures, guidelines, standards or upon the appointment of an ad hoc manager. The establishment and format of such internal processes should remain the sole responsibility of relevant economic operators but guidance can be gleaned from Article 7 of the GPSR (please see further below).
Providers of online marketplaces should also act with due care in relation to the content hosted on their online interfaces that concerns product safety, in accordance with the specific obligations laid down in the GPSR. Accordingly, the GPSR lays down due diligence obligations for all providers of online marketplaces in relation to the content hosted on their online interfaces that concerns product safety. Providers of online marketplaces are required to designate a single point of contact for consumers. That single point of contact should serve as a single window for consumer communications on product safety issues, which can then be redirected to the proper service unit of an online marketplace. This should not prevent additional points of contact for specific services being made available to consumers. The single point of contact under the GPSR might however be the same as the point of contact required under the Digital Services Act (Article 12 of Regulation (EU) 2022/2065).
Article 7 of the GPSR provides that a product shall be presumed to be in conformity with the general safety requirement laid down if:
a. it conforms to relevant European standards or parts thereof as far as the risks and risk categories covered by those standards are concerned; or
b. in the absence of any relevant European standards as referred to in point (a) above, the product conforms to national requirements, as regards the risks and risk categories covered by health and safety requirements laid down in the national law of the Member State in which it is made available on the market, provided that such law is in compliance with Union law.
In the event that the presumption of safety does not apply as articulated under Article 7 of the GPSR, when assessing whether a product is safe the following elements shall be taken into account where available:-
a. European standards
b. international standards;
c. international agreements;
d. voluntary certification schemes or similar third-party conformity assessment frameworks, in particular those conceived to support European Union law;
e. Commission recommendations or guidelines on product safety assessment;
f. national standards drawn up in the European Member State in which the product is made available;
g. the state of the art and technology, including the opinion of recognised scientific bodies and expert committees;
h. product safety codes of good practice in force in the sector concerned;
i. reasonable consumer expectations concerning safety;
j. safety requirements adopted in accordance with Article 7(2) GPSR
How are the challenges of online sales being grappled with?
The GPSR provides that there should be cooperation from all economic operators and providers of online marketplaces with market surveillance authorities in order to eliminate or mitigate risks for the relevant products made available on the market is essential. However, the requests made to them by market surveillance authorities should be tailored to the role they play in the supply chain and with regard to their respective legal obligations.
It is anticipated that by ensuring that manufacturers notify of accidents that are caused by a product they made available on the market this will improve the information available to market surveillance authorities and allow for a better identification of potentially dangerous categories of products. Rules on product liability of economic operators for defective products are laid down in specific European Union law and the notification and collection of data by market surveillance will not be construed as an admission of liability for a defective product or as confirmation of liability under relevant Union or national law; albeit we anticipate that Claimant lawyers will seek to use the collection of such information for their advantage particularly given that the GPSR does not prohibit class/group actions for breaches of the GPSR.
Article 22 of the GPSR provides that providers of online marketplaces shall designate a single point of contact allowing for direct communication, by electronic means, with Member States’ market surveillance authorities in relation to product safety issues; in particular for the purpose of notifying safety issues under the GPSR. The providers of online marketplaces will need to register with the Safety Gate Portal (please see further below) and confirm their single contact point to enable consumers to communicate directly and rapidly with them in relation to product safety issues.
Importantly, Article 22 of the GPSR also requires that providers of online marketplaces should put in place internal processes for product safety in order to comply without undue delay with the relevant requirements of the GPSR and, in the event that they are put on notice of a dangerous product under Article 22(4), respond without undue delay (and in any event within 2 working days) to any demand to remove the product from their market place, disable access to it or provide an explicit warning (subject to what the notice from the authorities requires).
How will market surveillance be strengthened?
Product traceability is fundamental for effective market surveillance of dangerous products and corrective measures.
Under Article 14(4) of the Market Surveillance Regulation (EU) 2019/1020 power is given to market surveillance authorities, where no other effective means are available to eliminate a serious risk, to require the removal of content referring to the related products from an online interface or to require the explicit display of a warning to end users when they access an online interface. In tandem, Article 15 of the GPSR now provides that economic operators need to cooperate with market surveillance authorities regarding actions which could eliminate or mitigate risks that are presented by the products which they made available on the market. Specifically, the GPSR provides that on request by a market surveillance authority, the economic operator shall provide all necessary information, in particular:
a. full description of the risk presented by the product, related complaints and known accidents;
b. a description of any corrective measure taken to address the risk.
Such information is required to be retained for 10 years by the economic operator after they have been supplied with the product or after they have supplied the product, as applicable.
In addition, and on request by the market surveillance authority, the economic operators will also need to identify and communicate the following relevant traceability information for the product:
a. any economic operator who has supplied them with the product, or with a part, a component or any software embedded into the product; and
b. any economic operator to whom they have supplied the product.
Such information is required to be retained for 6 years by the economic operator after they have been supplied with the product, or with a part, a component or any software embedded into the product, or after they have supplied the product, as applicable.
As a consequence of this market surveillance and the obligations imposed by the GPSR, economic operators will need to review their date retention policies.
How will the effectiveness of recalls be improved?
The GPSR requires that there should be effective, speedy and accurate exchange of information concerning dangerous products to ensure that appropriate measures are taken in relation to those products to protect the health and safety of consumers.
Article 20 of the GPSR provides that any accident caused by a product placed or made available on the market is notified, through the Safety Business Gateway, without undue delay from the moment the manufacturer knows about the accident, to the competent authorities of the Member State where the accident has occurred. The notification shall include the type and identification number of the product as well as the circumstances of the accident, if known. The manufacturer is also required, upon request, to provide the competent authorities with any other relevant information they may require.
An accident will trigger a notification through the Business Safety Gateway in the event that the use of the product resulted in an individual’s death or in serious adverse effects on that individual’s health and safety, permanent or temporary, including injuries, other damage to the body, illnesses and chronic health effects. In the event that the knowledge of the accident is with the importers or distributors of the product they have placed or made available on the market, the responsibility is on them to notify the manufacturer without undue delay. The manufacturer shall then make the notification or instruct the importer or one of the distributors to make the notification on their behalf.
The GPSR has sought under Article 25 of the GPSR to further develop, modernise and maintain the rapid alert system for the exchange of information on corrective measures concerning dangerous products and enhance its efficiency. The RAPEX system has been updated to be called the Safety Gate for greater clarity and better outreach to consumers. The Safety Gate comprises three elements: first, a rapid alert system on dangerous non-food products whereby national authorities and the Commission can exchange information on such products (Safety Gate Rapid Alert System); second, a web portal to inform the public and enable them to submit complaints (Safety Gate Portal); and third, a web portal to enable businesses to comply with their obligation to inform authorities and consumers of dangerous products and accidents (Safety Business Gateway). Interfaces should exist between the different Safety Gate elements. The Safety Gate Rapid Alert System is the internal system through which authorities and the Commission exchange information on measures concerning dangerous products, and which can contain confidential information. An extract of alerts should be published on the Safety Gate Portal in order to inform the public about dangerous products. The Safety Business Gateway is the web portal through which businesses inform market surveillance authorities of the Member States about dangerous products and about accidents.
When a product already sold to consumers turns out to be dangerous, it may need to be recalled to protect consumers. Consumers might not be aware that they own a recalled product and, in order to increase recall effectiveness, the GPSR strives to have a better reach to the consumers concerned. Direct contact is clearly the most effective method to increase consumers’ awareness of recalls and encourage action. It is also the preferred communication channel across all groups of consumers. In order to ensure the safety of the consumers, it is important that they are informed in a quick and reliable way. Economic operators and, where applicable, providers of online marketplaces are therefore required under the GPSR to use the customer data at their disposal to inform consumers of recalls and safety warnings linked to products they have purchased.
Therefore, Article 35 of the GPSR provides a legal obligation to require economic operators and providers of online marketplaces to use any customer data already at their disposal to inform consumers of recalls and safety warnings. In that respect, economic operators and providers of online marketplaces should ensure that they include the possibility to directly contact customers in the case of a recall or safety warning affecting them in existing customer loyalty programmes and product registration systems, through which customers are asked, after having purchased a product, to communicate to the manufacturer on a voluntary basis some information such as their name, contact information, the product model or serial number.
At the time of drafting the GPSR it was noted that one-third of consumers continued to use dangerous products despite seeing a recall notice, particularly because recall notices are often drafted in a complex way to minimise the risk at stake. As such, Article 36 of the GPSR requires that any recall notice should be clear, transparent and clearly describe the risk at stake, avoiding any terms, expressions or other elements that may decrease consumers’ perception of the risk. Consumers should also be able to get more information, if needed, through a toll-free telephone number or other interactive instrument.
Remedies for unsafe products
The remedies available to consumers have also been increased under the GPSR. Article 37 provides that without prejudice to Directives (EU) 2019/770 (which focuses on establishing rules on contracts for the supply of digital content or digital services) and (EU) 2019/771 (which focuses on certain aspects concerning contracts for the sales of goods), in the case of a product safety recall initiated by an economic operator, or ordered by a national competent authority, the economic operator responsible for the product safety recall shall offer the consumer an effective, cost-free and timely remedy.
By way of example, and without prejudice to any other remedies that the economic operator responsible for the recall may offer the consumer, Article 37 of the GPSR provides that the Economic operator shall offer the consumer the choice between at least two of the following remedies:
a. the repair of the recalled product;
b. a replacement of the recalled product with a safe one of the same type and at least the same value and quality; or
c. an adequate refund of the value of the recalled product, provided that the amount of the refund shall be at least equal to the price paid by the consumer.
By way of exception to the repair of the recalled product, the economic operator may offer the consumer only one remedy where other remedies would be impossible or, compared to the proposed remedy, would impose costs on the economic operator responsible for the product safety recall that would be disproportionate, taking into account all circumstances, including whether the alternative remedy could be provided without significant inconvenience to the consumer.
The consumer shall always be entitled to a refund of the product when the economic operator responsible for the product safety recall has not completed the repair or replacement within a reasonable time and without significant inconvenience to the consumer.
Article 37 stipulates clearly that a repair by a consumer shall only be considered an effective remedy where it can be carried out easily and safely by the consumer and where envisaged in the recall notice. In such cases, the economic operator responsible for the product safety recall shall provide consumers with the necessary instructions, free replacement parts or software updates.
Article 43 of the GPSR provides that any decision taken pursuant to the GPSR that imposes restrictions on the placing of or making a product available on the market or requires its withdrawal or its recall shall not affect the assessment of the liability of the party concerned, in the light of the national law applicable in the case in question. Article 43 also makes it clear that the GPSR does not affect the Product Liability Directive, 85/374/EEC
Non compliance with the GPSR will result in penalties which will be for each Member State of the EU to impose. However, Article 44 of the GPSR provides that such penalties will need to be effective, proportionate and dissuasive. The Member States have until 13 December 2024 to inform the European Commission of the measures which will be imposed by them.
The Position in the UK
The UK's consumer product safety regulatory regime is broadly derived from EU legislation via the General Product Safety Directive which is implemented in the UK through the General Product Safety Regulations 2005.
As result, from a UK perspective, since the GPSR will come into force well after Brexit, the GPSR will not apply to products placed on the UK market and the UK’s general product safety regulatory framework will remain based on the GPSD and subject to any further amendments that may be made in future.
Practically, this means that businesses supplying products on both the UK and EU markets would be required to comply with two different sets of requirements and, in their current form, the UK Regulations will not offer the same protection to customers as those prescribed by the EU via GPSR.
However, the UK is addressing this:
- On 16 June 2021, the National Audit Office published a Report examining the extent to which the UK’s product safety regime can protect consumers from harm and keep pace with changes in the wider environment and the work of the OPSS (Office for Product Safety and Standards launched in 2018). In that report, the NAO commented that the current product safety regime “…faces major challenges to keep pace with changes in the market…” and ”…until it establishes a clear vision and plan for how to overcome the challenges facing product safety regulation and the tools and data needed to facilitate this, it will not be able to ensure the regime is sustainable and effective at protecting consumers from harm…”
- On 2 August 2023, the UK Government issued a press release confirming that the UK’s product safety rules - which are over 30 years old - are set to be overhauled in a bid to make them fit for emerging technologies and new shopping habits. A consultation was opened to seek views on how the UK can better regulate innovative products like internet connected devices and AI whilst ensuring that businesses are “not stifled by red tape”.
- In addition to the product safety review, a consultation is also being launched on proposed fire safety rules for domestic upholstered furniture, aimed at improving standards for consumers.
- Both consultations are due to close on 24 October 2023.