Both the General Product Safety Regulation and the Market Surveillance Regulation start from the same definition of risk: the combination of the probability of an occurrence of a hazard causing harm and the degree of severity of that harm. A serious risk is a risk which, based on a risk assessment and taking into account the normal and foreseeable use of the product, is considered to require rapid intervention by the market surveillance authorities, including cases where the effects of the risk are not immediate (GPSR Article 3(5); Regulation (EU) 2019/1020 Article 3(20), phrased for a “product presenting a serious risk”). The last clause matters: a chemical exposure with long-term health effects can be a serious risk even though nobody is hurt at the point of sale.
Article 19(2) of the Market Surveillance Regulation adds that the decision must be based on an appropriate risk assessment that takes account of the nature of the hazard and the likelihood of its occurrence, and that the feasibility of obtaining higher levels of safety or the availability of safer products are not grounds for considering that a product presents a serious risk.
The classification triggers the strongest procedures. Authorities must ensure that a product presenting a serious risk is withdrawn or recalled or that its being made available is prohibited (Article 19(1)), and must notify the measure through the Safety Gate Rapid Alert System within four working days, after which the other Member States report their follow-up (GPSR Article 26). For companies, the Safety Business Gateway notifications and the recall duties follow the same distinction, so an internal risk assessment that documents severity and probability is the first step whenever a safety issue is reported.