Safe non-food consumer Products in the EU and China
Risk Assessment Guidelines (RAG) tool
The European Commission has created the Risk Assessment Guidelines tool, also known as the RAG tool. The tool is based on the Commission Decision (EU) 2019/417, which sets out guidelines for the Safety Gate. These guidelines have an annex that describes the risk assessment method behind the RAG tool.
The tool is divided into two sections:
1) ‘General information and overview’ that covers the product name, product category and the description of the product.
2) Scenarios that focus attention on hazards, injury and user types.
Risk is the combination of the severity of an injury and the probability that this injury happens. The RAG tool supports the estimation of the risk level by assisting the user in selecting the appropriate injury severity level and estimating the probability. This takes place in the following stages:
1) the user identifies the product hazard, the type of injury that it can cause and the user type.
2) the user must consider how the hazard will lead to the injury. This is described in an injury scenario. An injury scenario is a sequence of events that need to occur for the product to cause injury. This will usually consist of several steps.
3) the user must estimate probabilities for each of the steps in the injury scenario.
When these steps have been accomplished, the RAG tool will calculate the risk level for the user.
The user is advised to test the robustness of the risk assessment by making variations of the probabilities and the risk level to see how much the input parameters can change before the risk level is altered. This is called sensitivity analysis in the tool.
There is a template library feature that can be accessed using the ‘Template library’ button located in the box headed ‘Actions’ on the right side of the screen. They address specific product hazards and the types of injuries that these can cause. Everything that the user needs is contained in the template except for the probability of each step in the injury scenario. This is highly dependent on the characteristics of the product and on the consumers who are likely to be using it. This is the part that the risk assessor must complete and enter to determine the risk associated with the product hazard.
Example
An electrocution hazard exists in a table-top oven due to ineffective insulation. The electrocution hazard is not present all the time, but if the insulation becomes damaged or becomes ineffective, the external parts of the product will become live and can cause harm.
When developing the injury scenario, the risk assessor must anticipate the foreseeable ways in which the consumer will use the product, and how they may become injured by it. Once the user has estimated the probability value for each of the steps in the injury scenario, the Safety Gate/RAPEX tool will complete a calculation using the formula provided in Commission Decision (EU) 2019/417 and assign a rating for the risk – either low, medium, high or serious.
Learn more about risk assessment for Safety Gate/RAPEX
The RAPEX Guidelines (Commission implementing decision (EU) 2019/ 417) that describe how the European Safety Gate cooperation works. They include an annex with a detailed description of risk assessment guidelines for consumer products.
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