In accordance with Article 26 of Regulation (EU) 2023/988 (GPSR), Member States of the European Union must report corrective measures for dangerous products that pose a serious risk within the meaning of the GPSR, as well as those based on Articles 19 and 20 of Regulation (EU) 2019/1020 (Market Surveillance Regulation). The notification is made via the Safety Gate Rapid Alert System.
In both cases, a serious risk is identified by a risk assessment. The criteria for this assessment were to be adopted by the Commission by means of a delegated act. This was done on and with effect from 13 December 2024 by Delegated Regulation (EU) 2024/3173. The criteria for assessing the level of risk can be found in Annex II and largely follow those of the previous decision (RAPEX Guidelines) (EU) 2019/417, with the exception of Section 4: ‘Presumption of a serious risk’.
In the cases specified there, a risk posed by a product is still required, but it is presumed to be a serious risk without the Member States having to carry out an individual risk assessment.
The Presumption of a Serious Risk
The risk is actually determined by the combination of the severity of the harm and its probability of occurrence. According to Section 3, Member States are no longer required to carry out this assessment, but may do so. Taking into account the English and French versions, this assumption can be refuted by a risk assessment that is nevertheless carried out. The presumption is controversial because Article 19(1) of the Market Surveillance Regulation generally provides for the recall or withdrawal from the market of products that pose a serious risk.
For example, it is considered a serious risk if the distributor of a product or the provider of an online marketplace assumes that there is a serious risk (Section 4.1(b)). The same applies if a product is voluntarily removed from a website (Section 4.1©). A serious risk is also assumed if a product contains a chemical substance that should not be present under Union law (Section 4.1(d)).
Unlawfulness of the Delegated Regulation
Although the Commission is tasked with establishing the criteria for assessing the level of risk, it may only supplement the GPSR, not amend it. The very concept of risk (Art. 3 No. 4 GPSR) presupposes a relationship between the probability of a hazard occurring and the degree of severity of that harm. For the Commission, on the other hand, it is sufficient that a product is to be associated with a probable level of damage of 3 or 4 if consumers cannot be reasonably expected to take the necessary precaution measures – the probability of occurrence is irrelevant. And the concept of a serious risk refers to ‘a risk which, based on a risk assessment (…)’ is considered to require rapid intervention by the market surveillance authorities.
The fact that the Commission is exceeding its powers in this regard was the subject of intense debate during this year’s Product Compliance Dialogue.
Since 5 March 2025, a lawsuit has been pending before the ECJ with the aim of declaring Annex II, Section 4 of Delegated Regulation (EU) 2024/3173 null and void (Case T‑154/25).
Conclusion
If the action is admissible, it has a good chance of success. The ECJ has already ruled that legal remedies must be available against incomplete RAPEX notifications (Case C‑626/21). And an incorrect product classification can justify a claim for remedial action (VG Münster, judgment of 13 November 2019 – 9 K 2514/16). However, the Member States are initially bound by the Commission’s requirements.
The Delegated Regulation does not apply to economic operators. Manufacturers are already required to report any assumption that a product is dangerous. However, this is done via the Safety Business Gateway. In the accompanying manual, the Commission recommends that risk assessments be based on the Delegated Regulation.
It remains to be seen how the authorities will implement the guidelines. They still have the right to carry out an individual risk assessment that refutes the presumption.
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