We have no risk analysis for the product

A risk analysis is now a legal document for most consumer products. The General Product Safety Regulation (EU) 2023/988 requires manufacturers, before placing a product on the market, to carry out an internal risk analysis and draw up technical documentation (Article 9(2)). Where appropriate with regard to the possible risks, that documentation contains an analysis of the risks related to the product and the solutions adopted to eliminate or mitigate them, including the outcome of test reports, and the list of standards or other elements applied; partly applied standards are identified by the parts applied. For products subject to Union harmonisation legislation, Article 9 does not apply and the act's own file rules do (Article 2(1), third subparagraph, point (b)).^[1]

The regulation also says what the analysis looks at. Article 6(1) lists the aspects for assessing safety: the characteristics of the product, including design, composition, packaging and instructions for assembly, installation, use and maintenance; its effect on other products and theirs on it; its presentation, labelling, warnings and instructions; the categories of consumers, in particular vulnerable consumers such as children, older people and persons with disabilities; appearance that may lead to unintended use, including resemblance to food or to something appealing to children; and, where the nature of the product requires it, cybersecurity features and evolving, learning and predictive functions. Where no presumption of conformity applies, Article 8(1) adds elements such as other European and international standards, Commission guidelines on product safety assessment, the state of the art and reasonable consumer expectations.^[1]

CE directives built on Module A have asked for the same thing for years. Under the Low Voltage Directive 2014/35/EU, the technical documentation makes it possible to assess conformity and includes an adequate analysis and assessment of the risks; it specifies the applicable requirements and covers the design, manufacture and operation of the equipment (Annex III point 2). The wording comes from Module A in Annex II of Decision No 768/2008/EC, the common framework used across the product directives. The toy directive is more explicit: before placing a toy on the market, the manufacturer analyses its chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards and assesses the potential exposure to them (Directive 2009/48/EC Article 18).^[2][3][4]

The analysis is never finished. The GPSR requires the technical documentation to be kept up to date (Article 9(3)) and procedures to keep series production in conformity (Article 9(4)). The Low Voltage Directive requires changes in product design or characteristics and changes in the standards applied to be adequately taken into account (Article 6(4)). A file without a risk analysis is incomplete, and an authority can require the operator to rectify that formal non-compliance (Regulation (EU) 2019/1020 Article 16(3)(a)).^[1][2][5]