§1.2 What is a safe product?

The GPSR requires that only safe products be placed on the market. This is what we call the general safety requirement. A product is considered safe if, under normal or reasonably foreseeable conditions of use, including the actual duration of use, it either does not present any risk or only presents the acceptable minimum risks compatible with the product’s use, thereby being consistent with a high level of protection of the health and safety of consumers. In line with the definition of health established by the World Health Organization, this definition also includes risks to mental health. For example, the design and the foreseen use of your product should not create risks for consumers’ cognitive abilities or cause depression, anxiety or poor sleep quality. Any environmental risk must also be taken into account, insofar as it entails a risk to the health and safety of consumers. In order to meet the general safety requirement, the product must therefore be subject to an assessment of the potential risks that it can pose to the health and safety of consumers (a risk assessment), taking all relevant aspects of the product into consideration, and be designed to address those risks. A product is presumed to be safe if it complies, for each of the safety risks it may pose, with the relevant applicable European standards the reference to which have been published in the Official Journal of the EU (6) or, in the absence of such standards, with national health and safety requirements contained in the law of the Member State in which it is made available. In other words, such products will benefit from a presumption of conformity with the general safety requirement. (7) What are European standards and how can you use them? In some areas and for certain products, the European Commission requests one of the official standardisation organisations, (CEN, CENELEC and ETSI), to develop standards which embody and transform the general safety requirement contained in the GPSR into technical norms. The references to these standards are published in the Official Journal of the EU. These standards grant a presumption of conformity with this general safety requirement to products that were developed according to these standards for the risks covered by these standards. A list of the standards supporting the GPSR is updated regularly and is publicly available. (8) European standards, the references of which have been published in accordance with Directive 2001/95/EC, continue providing a presumption of conformity with the general safety requirement laid down in the GPSR. These European standards can be found in the catalogue of national standardisation organisations. Although these standards are not legally binding, economic operators are encouraged to use these standards when they exist. This is because compliance with these standards provides a straightforward way for economic operators to fulfil their obligation to place only safe products on the EU market. European standards indeed clearly set out the technical requirements and testing methods that help to ensure the safety of products. Since technical standards are not mandatory, manufacturers can always use other internal methods to demonstrate the safety of their products. However, those products will not benefit from a presumption of conformity with the general safety requirement, and it will be the manufacturer’s responsibility to precisely show how the identified safety risks have been tackled (eliminated or mitigated). Using European standards thus makes compliance easier for businesses regarding the aspects covered by those standards. It can also happen that there is no standard for a given product. Economic operators should then turn to other means to ensure and demonstrate that their products are safe. More practical information can be found on this in section 3.1.1. What does the precautionary principle entail for you? The precautionary principle requires that precautionary measures are taken when there is reason to doubt the safety of a product’s impact on human health. A reference to the precautionary principle figures prominently in Chapter I of the GPSR, highlighting that all actors who are subject to the obligations of the GPSR must take due account of the precautionary principle when implementing these obligations. This means that all businesses (economic operators or providers of online marketplaces) must take due account of the precautionary principle when fulfilling their relevant obligations under the GPSR. Example: if you are a manufacturer, you should take due account of the precautionary principle when carrying out your internal risk analysis and drawing up the technical documentation about your product, or when you need to take corrective measures or to report any indication that your product is dangerous. Already taking the precautionary principle into account during the design stage allows you to ensure that your products are safe by design. In short, the precautionary principle requires all economic operators to proactively prevent hazards to human health, and to foresee, as far as possible, what dangers a product can pose.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07