In the third in a series of blogs on the General Product Safety Regulation, the Cooley products team unpacks the new accident reporting obligations being introduced across the European Economic Area (EEA) – made up of European Union Member States, plus Iceland, Liechtenstein and Norway – and Northern Ireland.
New rules under the General Product Safety Regulation (EU) 2023/988 (GPSR) apply from 13 December 2024 across the European Economic Area (EEA) – made up of European Union Member States, plus Iceland, Liechtenstein and Norway – and Northern Ireland. The GPSR is a significant piece of legislation that introduces a number of reforms. In the third in a series of blogs, the Cooley products team takes a look at the introduction of accident reporting obligations under the new rules.
Scope: The GPSR applies in full to consumer products that are not already subject to EU harmonisation legislation (i.e., non-CE marked products) and covers gaps in product safety regulation for consumer products subject to certain EU harmonisation legislation (i.e., CE marked products). The accident reporting obligations under the GPSR will apply to all consumer products in scope of the GPSR – including consumer products regulated by EU harmonisation legislation – to the extent that the sector-specific legislation does not provide for its own accident reporting obligations.
Who needs to do what?
Manufacturers: Have an obligation to report accidents meeting a certain threshold of seriousness to the relevant authority. We’ll cover this threshold in the next section.
“Responsible person”: Where the manufacturer is not established in the EU, the “responsible person” in the EU who has knowledge of an accident meeting the required threshold must ensure a report to the relevant authority is made – i.e., either ensuring that the manufacturer has reported or by reporting itself. The “responsible person” is a legal concept from the Market Surveillance Regulation (EU) 2019/1020 (MSR). The “responsible person” can differ depending on the supply chain, and there are guidelines in the MSR to assist in understanding the requirements and determining which entity in a supply chain this will be. Unfortunately, recently published FAQs on the GPSR are inconsistent with the guidelines on the MSR on when an authorised representative can be appointed as the “responsible person”. We hope the upcoming guidelines on the GPSR will provide some clarity.
Importers and distributors: Will be required to inform the manufacturer of reports of accidents they become aware of involving products supplied by them. It appears that there is no threshold of seriousness tied to this obligation, meaning information about any accident may be required to be passed on. If the threshold to report accidents to the relevant authority is triggered, the manufacturer may then make the report or instruct the importer or distributor to report.
In addition, where the importer also is the “responsible person”, the importer will need to ensure that an accident meeting the required threshold of seriousness is reported to the relevant authority in line with the obligation on the “responsible person” discussed above.
Providers of online marketplaces: There is a separate obligation on providers of online marketplaces to report accidents that they have been informed about, over a certain threshold of seriousness, caused by a product made available on their online marketplace. Providers of online marketplaces also will need to let manufacturers know.
In addition, there also is a wider obligation on providers of online marketplaces to pass information onto traders and “economic operators” (this includes manufacturers, authorised representatives, importers and distributors) that they have received about “accidents or safety issues” – where they have knowledge that the product was offered by those traders through their online marketplace. Again, it appears that there is no threshold for this wider obligation to pass on information.
Thresholds for reporting to the authorities: Not all accidents will trigger the requirements to report to the authorities.
The threshold under the GPSR for the manufacturer’s (or the responsible person’s) obligation to report to the authorities is described as “[o]ccurrences associated with the use of a product that 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”.
The threshold for the obligation on providers of online marketplaces to report is described as “any accident … resulting in a serious risk or actual damage to the health or safety of a consumer”.
The two thresholds appear to be different, with the obligation on online marketplaces being broader in scope – it covers incidents resulting in a “serious risk”, even if no injury actually occurred. This will give rise to challenges for manufacturers to navigate, especially where a provider of an online marketplace reports an accident to the authorities that the manufacturer considers does not meet the required threshold for reporting under the manufacturer’s obligation.
How: Reports under the manufacturer’s (or responsible person’s) obligation, and by providers of online marketplaces, are to be made using the European Commission’s Safety Business Gateway – part of the Safety Gate portal. Currently, it looks like the only way to do this is by using the form ‘Notify a dangerous product to the authorities’. However, we do not think that form properly correlates with the accident reporting criteria under the GPSR, and this presents challenges for those looking to report accidents. We hope that there will be clarifications made around this point very soon.
Where: The manufacturer’s (or responsible person’s) report is to be directed to the competent authorities of the EEA country (or Northern Ireland) where the accident occurred. This is not expressly mentioned in the provisions laying down the obligation on providers of online marketplaces – their obligation is simply to report via the Safety Business Gateway.
Timing: Reports to authorities will need to be made “without undue delay” from the moment the relevant entity knows about the accident.
Content: The GPSR sets out the information thata report made under the manufacturer’s (or responsible person’s) obligation will need to include – the type and identification number of the product, along with the circumstances of the accident, if known. The competent authorities may request further information.
The GPSR does not go into detail as to what will be required for reports made by providers of online marketplaces.
What’s next: Upcoming guidelines on the GPSR and the updated Safety Business Gateway are expected.
What are the implications?
- Manufacturers and providers of online marketplaces will need to ensure that they have the appropriate procedures in place to promptly identify accidents reported by consumers, as well as ensuring they are escalated effectively and in a timely manner internally to determine if the accident is reportable and for the necessary report to be made. Where the manufacturer is established outside of the EU, it should co-ordinate with the “responsible person” appointed in the EU regarding who will make the report and ensure it has oversight of the content.
- Importers and distributors will need to ensure they also have processes in place to promptly pass on information about accidents to the manufacturer. An importer also should ascertain whether it will be deemed to be the “responsible person” or not – and, if so, put in place procedures to ensure reports for accidents that trigger the reporting obligation are made.
- Providers of online marketplaces also will need procedures in place to comply with requirements to promptly pass on information to traders and “economic operators” about accidents or safety issues.
The new accident reporting obligations are part of broader reforms made by the GPSR to gather more information about potentially dangerous products. This information may be used by the European Commission in a number of ways – e.g., to determine if specific traceability requirements should be laid down for certain types of products.
Like to know more?
Get in touch with any member of the Cooley products team to find out more about the new rules under the GPSR and how they may impact your products.
This is the third in a blog series where the Cooley products team explores the new rules under the GPSR. See the first post in the series, “What’s New?”, along with the second post, “An Expanded Concept of Safety”.
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