The Rapid Exchange of Information System ( RAPEX ) is the European Union’s rapid alert system for dangerous consumer products, excluding food, medicines and medical devices.
The RAPEX system provides information on measures taken to prevent or restrict the use of hazardous products. These can be, for example, withdrawal or recall actions. Here, RAPEX covers actions taken by national market surveillance authorities as well as voluntary actions taken by manufacturers and distributors.
Every Friday, the European Commission publishes an overview of dangerous products that have been reported to it from the member states. Here is where you, as a consumer, can find out whether or not you are dealing with a hazardous product. The same applies if you as a dealer want to sell or import products. Many companies now also use the RAPEX overview to obtain basic information about possible product risks, for example, because they are about to prepare a risk assessment for their own product.
Risk assessment for market surveillance
Also, Commission Implementing Decision (EU) 2019/417 of 8. November 2018 establishing guidelines for the management of the Community Rapid Information System "RAPEX" in accordance with Article 12 of Directive 2001/95/EC on general product safety and for the notification system related thereto, which Decision 2010/15/EU of 16 December 2010 on the notification of dangerous products is based on. December 2009, includes the guidance described here.
Basic elements of risk assessment
According to" RAPEX"-guide, a risk results from the severity of a potential injury to the consumer and the likelihood of that injury occurring. Accordingly, the risk posed by a product can be determined as follows:
- Describing at least one injury scenario where the inherent product hazard results in injury to the consumer and determining the severity of the injury.
- Estimate the likelihood that the inherent product hazard will actually result in injury to the consumer.
- Combine the hazard (stated as severity of injury) with the probability (stated as a fraction) to determine the risk.
An example, which is also included in Annex 5 of the Guideline, briefly describes the application of risk assessment. As an example, a locksmith’s hammer was chosen, which was notified in the RAPEX system under the number 125/06.
RAPEX risk assessment process
The method is divided into six steps (see Figure: Schematic flow of risk assessment), based on four different tables:
- Table 1: Consumer category
- Table 2: Hazards, typical injury scenarios, and typical injuries
- Table 3: Severity of injury
- Table 4: Degree of risk as a result of the combination of severity of injury and probability
Schematic flow of risk assessment
Step 1: Clearly describe the product and its hazards
Make sure that other people can also clearly identify the product. Product name, brand, model name and country of origin are just some of the criteria you need for a complete product description. To help you identify product hazards, Table 2 serves as your guide. In it, individual hazard groups are distinguished, such as size, shape, surface or potential energy. From these product characteristics, you can deduce the possible danger posed by the product. In addition, examples of typical injuries are shown there.
In this case, the hammer is used by a consumer to hammer a nail into the wall. However, because unsuitable material was used, the hammer head does not have sufficient strength and breaks.
For the example "Hammer you can obtain the following information from Table 2:
- Hazard group: Kinetic energy
- Hazard (product characteristic): flying objects, z. B. Fragments, small parts
- Typical injury scenario: user is struck by the flying object and suffers injuries, the severity of which depends on the energy of the impact of the object on the body.
- Typical Injuries: Contusion, dislocation, fracture, concussion, or contusion
Step 2: Select consumer category(ies)
The consumer’s skills and behavior when using a product can have a major impact on the degree of risk. On the basis of the guide, you can distinguish the possible consumer groups (see Table 1). You may need to create injury scenarios with different consumer groups to reliably determine the highest possible product risk.
Very young children: children between 0 and 36 months of age
Other: persons with severe disabilities or multiple disabilities
Note that the following aspects influence the level of risk:
- Designated/non-designated user
- Users in need of protection
- Intended and reasonably foreseeable use
- Frequency and duration of use
- Perception of hazard, protective behavior and protective equipment
- Consumer behavior in the event of an incident
- Cultural background
- Human Behavior, Human Factors
Consumers who are not normally at risk may become vulnerable consumers in certain situations. This may be the case if the instructions or warnings on a product are written in a language that the consumer does not understand. For the example, it is assumed that, according to Table 1, an "Other consumer" is uses the hammer.
Step 3: Describe the injury scenario
Describe the injury scenario in which the selected product hazards cause one or more injuries to the selected consumer group. The description should be clear and precise, but without becoming too detailed.
A possible injury scenario is as follows: The breakage of the hammer head causes one of the fragments to be hurled into the consumer’s eye with such force that the consumer is blinded. Table 2 provides specific guidance in the description process.
Step 4: Determine the severity of the injury
Use Table 3 in the guide to determine the severity of the injury. It serves as a guide and contains examples of the type and extent of injuries in four degrees of severity. These, in turn, are based on the level of medical care needed.
|1||Injury or sequelae that, after immediate measures have been taken (first aid, usually not by a physician), do not cause significant functional impairment or. Does not cause great pain; usually the sequelae are completely reversible.|
|2||Injury or sequelae requiring outpatient but usually not inpatient treatment. Function may be impaired for a limited period of time (maximum six months); near full recovery is possible.|
|3||Injury or sequela that usually requires hospitalization and results in functional impairment for at least six months or permanent loss of function.|
|4||Injury or sequelae resulting in or likely to result in death, including brain death; reproductive toxicity; loss of limb or serious functional impairment resulting in disability of more than ca. 10 % leads|
For the example "Hammer this means:
The injury falls under the category of "Eye injury, foreign body in the eye: permanent loss of vision (one eye)". Thus, according to table 3, it is an injury with severity level 3.
Step 5: Determine the probability
To consider the risk, you need to estimate the probability of occurrence of the scenario. To do this, you need to consider all the individual actions that lead to the occurrence of the injury. The guide distinguishes eight probability levels to classify the overall likelihood: of< 1/1 000 000 to> 50% (see Table 4, left side).
The example describes the path to injury and the individual probabilities as follows:
- The hammer head breaks when trying to drive a nail into the wall because the material of the hammer head does not have sufficient strength. The lack of strength was determined by testing and the probability of the hammer head breaking during its otherwise expected life is given as 1/10 given the strength value determined.
- One of the fragments of the hammer hits the user. The probability of this event is given as 1/10. It is assumed that the area of the upper body exposed to the fragments thrown away is equal to 1/10 of the hemisphere lying in front of the wall. Of course, the closer the user is to the wall, the larger the part of the hemisphere his body will occupy and the higher the probability of.
- The fragment hits the user in the head. The head is estimated to be about 1/3 of the torso, so the probability is 1/3.
- The fragment hits the user in the eye. The eyes are assumed to be about 1/20 of the area of the head, so the probability is 1/20.
Multiply the individual probabilities of the described steps. The scenario results in an overall probability of
P = 1/10 x 1/10 x 1/3 x 1/20 = 1/6 000.
This corresponds to the category> 1/10 000.
Table 4: Degree of risk as a result of the combination of severity of injury and probability
Step 6: Take the risk level from table 4
After you have determined the severity of the injury and the probability of occurrence – if possible for several injury scenarios – take the risk level from Table 4. This distinguishes four degrees of risk: serious, high, medium and low.
Using the values for the severity of injury (here: 3) and the probability of occurrence (here: 1/6000), you can now determine the probability of damage during the expected lifetime of the product.
The probability is within the class">1/10.000", the severity of the injury is "3". This results in an overall risk level of "H respectively. "high".
To conclude your risk assessment, you should check the plausibility of the risk level. For example, you can check whether you have used the best available information for your estimates and assumptions for your risk assessment. Feedback from other professionals and colleagues may also be helpful.
To summarize: For the example described, no RAPEX notification would be required. Nevertheless, it is a dangerous product that must be addressed with appropriate measures by the market surveillance authorities.