The new Product Safety Regulation 2023/988 covers consumer products and products likely to be used by consumers under reasonably foreseeable conditions, even if they are not intended for them.
It applies from December 13, 2024 (Art. 52). The provision in Art. 9 (2) of the GPSR (General Product Safety Regulation) now requires the manufacturer to prepare a risk analysis:
"Before placing their devices on the market, manufacturers shall carry out an internal risk analysis and prepare a technical documentation containing at least a general description of the device and its essential characteristics relevant for the assessment of its safety.
Where appropriate in view of the risks which the device may present, the technical documentation referred to in the first subparagraph shall also include, where applicable
(a) an analysis of the risks which the device may present and the solutions adopted to eliminate or reduce those risks, including the results of any reports of tests carried out by the manufacturer or by a third party; and
(b) a list of all relevant European standards referred to in Article 7(1)(a) and the other elements referred to in Article 7(1)(b) or Article 8 which have been applied to meet the general safety requirement referred to in Article 5.
Where European standards, health and safety requirements or elements referred to in Article 7(1) or Article 8 have been applied only in part, manufacturers shall indicate which parts have been applied."
In individual discussions with customers as well as experts, the question arises as to how, in the case of very simple consumer products that are not subject, for example, to any further legal requirement for CE marking (e.g., a hole punch, and before questions arise: No, a hole punch is not a machinery) such a risk analysis is to be carried out with a reasonable effort. The GPSR neither specifies the methodology of a risk analysis nor the scope of a documented risk analysis. In this respect, it is the manufacturer's own responsibility to consider a procedure and thus also offers all degrees of freedom to determine the effort himself.
Guidelines, technical reports and standards on the methodology of a risk analysis exist in numerous forms. Already in 2016, the "Working Party on Consumer Product Safety" within the OECD (Organisation for Economic Co-operation and Development) published a summary of workshops and meetings with the title "PRODUCT RISK ASSESSMENT PRACTICES OF REGULATORY AGENCIES - Summary of discussions at Workshops and Meetings of the OECD Working Party on Consumer Product Safety" on January 19, 2016. Among other things, it refers to ISO 10377:2013-04 "Consumer product safety - Guidelines for suppliers".
This standard provides a good overview of what needs to be done from the manufacturer's perspective and refers to numerous other technical publications. The basic methodology is as follows:
The risk in relation to the hazard under consideration
depends on the
extent of damage that can result from the hazard under consideration
and
the probability of such damage occurring.
In the case of the punch, for example, there are mechanical hazards that can lead to crushing or there are chemical hazards because the punch is painted. Annex C of ISO 10377 contains examples of "hazard and risk evaluation".
In the risk evaluation, the manufacturer must decide whether the risk is acceptable. If not, risk-reducing measures must be taken. The manufacturer cannot cede this responsibility. All phases of the product's life must be taken into account. In this respect, product monitoring after the product has been placed on the market is an essential task that is part of a "product safety management plan" (Annex D in ISO 10377).
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Author
Dipl.-Ing. (FH) Michael Loerzer
Regulatory Affairs Specialist, certified Product Compliance Officer (PCO)
