While both laws update and replace existing laws, it would be wrong to assume that historical compliance will automatically result in future compliance – depending on your place in the supply chain, you may find your duties are now different.
While we have been talking to clients about these changes since before the EU GPSR has been agreed, it coming into force gives a good chance to reflect on where you are and where you need to get to in the coming weeks and this note aims to highlight some of those key changes you need to be aware of.
This note is a high-level overview of some of the key obligations contained in the GPSR. If further information on the below, or anything related to the below, is required please do not hesitate to contact us.
What is new with the General Product Safety Regulation?
The General Product Safety Regulation 2023/988 (the 'GPSR') comes into force from 13 December 2024 and governs the safety of products placed on the EU market and made available on the EU market after that date.
What about goods placed on the market prior to 13 December 2024?
The good news is that this is not a hard stop – goods that were placed on the market prior to 13 December can continue to be sold through. The concept of being 'placed on the market' while pervasive in product law is also one that leads to much confusion. Here, if you have the goods in your supply chain and they are ostensibly for sale, they are placed on the market – they need not even be in the EU for this to occur. For example, the goods can be under order awaiting shipment from China to your EU business and provided that the order was made and the goods existed prior to 13 December then they will be on the market. Get in touch if you need specific advice on this point.
It is now a regulation, does that matter?
The first change is that unlike its predecessor, the EU GPSR is now a regulation, and as such applies as drafted across the EU and the various versions of the General Product Safety Directive that were implemented across the EU will cease to have effect. The move to a regulation means that the law should be more consistent and consistently applied and it will only be actual enforcement that varies from state to state.
Does this apply in the UK?
The GPSR does not apply to products being placed on, or made available to, the GB market. Those products will continue to be regulated by the 2005 General Product Safety Regulations (GB GPSR).
Under the terms of the Windsor Framework, GPSR will be implemented as required in Northern Ireland in December 2024, replacing the GB GPSR as it applied to Northern Ireland.
What product categories does the EU GPSR apply to?
As under the previous regimes, the GPSR only applies to products where there are no specific provisions with the same objective under Union law. This means that the below commentary won't apply in general to certain products such as food, cosmetics, toys, medicines etc. which in general continue to be governed by their own specific regulations.
However, note that where the GPSR does apply, it applies to a wider range of aspects relating to the products, including addressing safety concerns for connected devices and software updates. The GPSR also applies to new, used, repaired, or reconditioned products.
Greater clarity on application on the EU GSPR to product sold outside EU
As noted above, when a product is 'placed on the market' can be challenging to determine. This is particularly where a product is ordered from a third country domiciled entity under a contract formed under a third country law and shipped as a single postal packet to the EU based consumer, as ostensibly all of the steps take place outside of the EU. The GPSR adds some clarity. It states that online or other distance sales shall be considered placed on the EU market if a relevant economic operator targets its operations by any means to one of more member states – that means in practice operating or placing products on a .de or .eu type web store is likely to be enough to be in scope.
There must always be a responsible person
The GSPR also specifically states that a product may not be placed on the EU market unless there is a responsible person established in the EU, as defined by the Market Surveillance Regulation. This is a hierarchy which starts with the manufacturer and then moves on to importer, manufacturer's representative and ends with a fulfilment services provider if none of the others are present.
This provision potentially causes challenges for marketplace operators who are also bound by the provisions of the Digital Services Act which prohibit the display of illegal products, which potentially puts an obligation on the marketplace to conduct additional diligence.
Additional Manufacturer duties
As before, manufacturers may only place safe products on the EU market. They are required to carry out an internal risk analysis and draw up technical documentation containing at least a general description of the product and its essential characteristics relevant for assessing its safety. This assessment must be kept up to date.
In the context of manufacturers, there is a similar duty which applies when placing products on the market, to ensure they have been designed and manufactured in accordance with the general safety requirement. If they believe a product to be unsafe, the duties include immediately taking corrective measures to make product safe, inform customers, inform the relevant market surveillance authorities and inform relevant entities in the supply chain (i.e. other economic operators, responsible persons and online marketplaces).
In addition to their contact details, manufacturers are required to make publicly available communication channels which allow consumers to submit complaints and inform the manufacturer of any accident or safety issues. Manufacturers are then under a duty to investigate all complaints received regarding safety or accidents regarding the products and keep an internal register of those complaints and what was done to bring the product in to conformity.
Additional distributor duties
The new obligations include, in the context of distributors, a general safety requirement to only make safe products available on the market (which previously only applied to producers, as defined above, under the GPSD).
More onerously, there is now a positive obligation on distributors to verify that manufacturers have complied with their obligations before placing products on the market and providing manufacturer details and the means of product identification on product displays. Such a duty previously only occurred in some product specific legislation. This means that all retailers QA systems will now need to be updated to reflect this.
New rules for online marketplaces
As flagged above, the GPSR introduces new responsibilities on online platforms, including the following:
(a) Designation of a single point of contact to cooperate with MSAs.
(b) Registration with the Safety Gate Portal.
(c) Receive information from MSAs and act accordingly where a dangerous product is flagged.
(d) Block traders who frequently offer dangerous products for sale on the platform.
(e) Ensure that they have internal processes for product safety in place in order to comply without undue delay with the relevant requirements of the GPSR.
(f) Design and organise the online interface in a way that enables traders offering the product to provide certain mandatory information on the product listing.
This is a significant shift from the previous lack of direct responsibilities under the GPSD, and online marketplaces will be required to put in place measures which facilitate the above obligations and builds for the voluntary Product Safety Plus pledge signed by many of the larger marketplaces.
Enhanced labelling
The GPSR also requires enhanced labelling obligations. Under the GPSD, information on labels was required so far as it made the product safe. There was not the same level of detail as to what the label should contain, as we now see under the GPSR. For example, one such requirement includes an obligation on manufacturers to ensure that products bear identification mark, manufacturer contact details (including electronic address which means any electronic address (such as an email address) or website that provides direct communication, e.g., via a contact template. A static website would not suffice), as well as clear instructions and safety information where required.
Although digital labelling (i.e. QR codes) can be used, the GPSR makes clear that it has to be in addition to (not instead of) the physical format.
Consumer protection
The GPSR provides increased protection for vulnerable groups like children and the elderly. Manufacturers/authorised representatives are to conduct a risk assessment on products and in assessing the safety of a product, the risk should be assessed for such vulnerable groups as well as the impact of gender differences on health and safety.
Although the GPSD defined "serious risk" as that which had a somewhat circular definition of "any serious risk, including those the effects of which are not immediate, requiring rapid intervention by the public authorities", the GPSR introduces a new definition for "risk", meaning "the combination of the probability of an occurrence of a hazard causing harm and the degree of severity of that harm". This better defines the concept of risk and indicates the emphasis authorities are likely to have on the risk assessment undertaken by economic operators, not just regarding the product itself but the potential harm for different consumer groups.
Product recalls and if something goes wrong
The GPSR seeks to improve the product recall process by increasing its effectiveness amongst consumers. In turn, this increases the obligations on the economic operators.
In particular, the GPSR requires consumers to be offered an effective, cost-free, and timely remedy in case of a product recall. There is a new form to be completed too.
If a product safety recall is required, all affected consumers are to be identifiable and notified directly without undue delay. Where customer data is collected, this is to be used to identify and notify them.
Enhanced market surveillance
The GPSR gives market surveillance authorities ('MSAs') more power to identify and remove dangerous products, reinforcing the market surveillance rules. Under the GPSD, the aim of achieving effective market surveillance was delegated to Member States, without the same level of prescription introduced by the GPSR. In contrast, under the GPSR distributors and manufacturers are under an express duty to cooperate with MSAs to eliminate or mitigate product safety risks and must notify MSAs of accidents via Safety Business Gateway.
Where a dangerous product is identified, where requested by MSAs, distributors are to provide information on other products produced using the same procedure, containing the same components or being part of the same production batch, which are affected by the same risk. This means distributors (including online marketplaces where relevant) necessarily need to know information on product traceability and be actively involved in MSA investigations, where they may previously have been able to take a more "hands off" approach.
Recalls were of course a concept within the GPSD, however there was not the same level of detail in the requirements and there was more deference to member state discretion as to how recalls were to be implemented.
Next steps
The GPSR is aimed at increasing the overall safety of products in light of new digital products, and online marketplace sales channels. It also aims to increase the effectiveness of market surveillance investigations and recalls where issues do arise. The practical impact of these changes is an increase in responsibilities for more actors in the supply chain, as well as a potential increase in enforcement activity.
While many of the duties are similar to those from before, they are not identical – more express risk assessment duties for manufacturers and duties to verify on a distributor for example.
Businesses should verify that they have the necessary systems in place to address these changes.
If you have any questions, please don’t hesitate to contact us.
Co-authored by Alicia Barrett.
