Risk Analysis for Product Safety
General Product Safety Regulation (EU) 2023/988 obliges
The General Product Safety Regulation (EU) 2023/988 came into force on June 12, 2023 and replaces the German Product Safety Act (Produktsicherheitsgesetz). This results in numerous new obligations for producers, importers and distributors.
Do I have to conduct a risk analysis?
Until now:
The EU Directive 2001/95/EC on general product safety, implemented in Germany by the Product Safety Act (Produktsicherheitsgesetz), requires risk analyses for electrical and electronic products. In addition, there are documentation requirements from the Low Voltage Directive (LVD) 2014/35/EU and the Electromagnetic Compatibility Directive (EMC) 2014/30/EU). For all other consumer products, it was previously only recommended that a risk analysis be carried out..
Now:
The new General Product Safety Regulation also requires a risk analysis in addition to others such as the Low Voltage Directive 2014/35/EU or the EMC Directive 2014/30/EU, meaning that a risk analysis is mandatory for almost every product.
The GPSR (EU) 2023/988 will apply from December 2024. Article 9 No. 2: Producers must draw up technical documentation for the products they place on the market containing the information necessary to demonstrate the safety of these products. The technical documentation must be based on an internal risk analysis carried out by the producer.
Are there differences for different products?
Different product types require a different scope of risk analysis. For example, fewer risks need to be considered for simple, small products such as books or decorative items than for complex electrical appliances such as drills, as these can naturally be expected to pose greater risks of injury. In addition, there may be different formal requirements depending on the applicable product legislation.
Ideally, a risk analysis should already be carried out during product development, as design specifications, test plans and labelling requirements can be derived from this and implemented directly. However, a risk analysis can be carried out at any time.
Product categories and examples
How does trade-e-bility help?
We prepare a risk analysis for you on the basis of the product information provided (e.g. technical data sheets, design drawings, illustrations, test reports, etc.) and on the basis of a sample including packaging and operating instructions.
You cannot provide a sample? In this case, photos and a description of the product are also sufficient.
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Your advantages
- Fulfilment of your legal obligations, for example documentation obligations for electrical appliances in accordance with the Low Voltage Directive (LVD) 2014/35/EU and the Electromagnetic Compatibility Directive (EMC) 2014/30/EU)
- Optimisation of your testing plan
- Savings on testing costs
- Definition of necessary safety instructions and safety symbols on the product, packaging and in the operating instructions. You can also have these tested independently of a risk analysis in our Labelling Test Fast Lane.
The General Product Safety Regulation also requires producers to specify a responsible person. We will be happy to support you in this regard.