RAPEX - Rapid Exchange of Information System
The system for the fast pan-European exchange of information about dangerous products.
The Rapid Exchange of Information System (RAPEX) is the European Union rapid alerts system for dangerous consumer goods, excluding food, medications and medical devices.
The RAPEX system informs about measures taken to prevent or limit the use of dangerous products. These may be, for example, withdrawal or recall actions. RAPEX covers both the measures of the market surveillance authorities of EU Member States and the voluntary measures taken by manufacturers and distributor.
Every Friday, the European Commission publishes an overview of dangerous products reported to it by the Member States. Here you can inform yourself as consumers whether you are dealing with a dangerous product or not. The same applies if you want to sell or import products as a distributors. Many companies are now using the RAPEX overview in order to inform themselves about potential product risks, for example, because they are currently looking to create a risk assessment for their own product.
Risk assessment for market surveillance
In its Decision 2010/15/EU of 16 December 2009, the European Commission set out guidelines for the management of the Community system for the rapid exchange of information. Annex 5 describes as a guideline a method for risk assessment to be used by the authorities of the Member States. It is used to determine the risk level of a product that limits the safety and health of consumers. Depending on the risk profile, the authorities decide whether a RAPEX notification is necessary or not.
The objective of this guideline is to provide a transparent and practicable method which can be used by the Member States’ competent authorities to assess the risks of non-food consumer products. There are other guidelines for chemical, cosmetic, medical or pharmaceutical products. Despite this guideline, the risk assessment of products is a subjective process and should be well documented for reasons of transparancy.
Basic elements of risk assessment
According to the "RAPEX" guideline, a risk is assessed based on the severity of a potential injury to the consumer and the likelihood that such injury will occur. According to this, the risk of a product can be determined as follows:
- Description of at least one injury scenario where the intrinsic product hazard leads to damage to the consumer and determination of the severity of the injury.
- Estimation of the likelihood with which the intrinsic product hazard actually leads to an injury of the consumer.
- Combination of the risk (as a severity of the injury) with the probability (in terms as a fraction) to determine the risk.
An example, which is also included in Annex 5 of the guideline, briefly describes the application of the risk assessment. As an example, a locksmith hammer was selected, which was reported in the RAPEX system under the number 125/06.
Procedure of the RAPEX risk assessment
The method is divided into six steps (see figure: Schematic procedure of risk assessment), which are based on four different tables:
- Table 1: consumer category
- Table 2: dangers, typical injury scenarios and typical injuries
- Table 3: severity of injury
- Table 4: risk level as a result of the combination of severity of injury and probability
Step 1: Describe the product and its hazards clearly and precisely
Please ensure that other persons can clearly identify the product. Product designation, brand name, model designation and country of origin are only a few criteria that you need for a complete product description. Table 2 serves as an orientation guide to identify the product risks. It identifies individual hazard groups, such as size, shape, surface or potential energy. You can derive from these product properties what the risk of the product may be. In addition typical injuries are shown.
The hammer is used in this case by a consumer to knock a nail into a wall. However, since incorrect material has been used, the hammer head does not have sufficient robustness and breaks.
For the example "Hammer", you can derive the following information from Table 2:
- Risk group: Kinetic energy
- Danger (product property): Objects flying around, e.g. fragments, small parts
- Typical injury scenario: The user is hit by the flying pieces and suffers injuries whose severity depends on the energy of the object when it hits the body.
- Typical injuries: bruise, luxation, fracture, cerebral concussion or bruise
Step 2: Select the type of consumer (categories)
The skills and behaviour of the consumer when using a product can have a great impact on the risk rating. You can use the guideline to differentiate the possible consumers (see Table 1). It may be necessary to create injury scenarios with different consumers to reliably determine the highest possible product risk.
|Very vulnerable consumers||Very young children: Children between 0 and 36 months old|
Others: Persons with extensive and complex disabilities
|Vulnerable consumers||Vulnerable consumers Young children: Children above 36 months and below 8 years |
Older Children: Children between 8 and 14 years
Others: Persons with reduced physical, sensory or mental capabilities (e.g. partially disabled, elderly, including those over 65, with some reduction in their physical and mental capabilities), or lack of experience and knowledge
|Others consumers||Consumers other than very vulnerable or vulnerable consumers.|
Note that the following aspects influence the risk level:
- Intendent/non-intended user
- Vulnerable users
- Intended and reasonably foreseeable use
- Frequency and duration of use
- Hazard recognition, protective behaviour and protective equipment
- Consumer behaviour in the case of an incident
- Cultural background
- Human behaviour, human factors
Consumers who are not normally endangered may become vulnerable consumers in certain situations. This may be the case if the instructions or warnings on a product are written in a foreign language that the consumer does not understand. For the example it is assumed that according to Table 1 a "miscellaneous consumer" uses the hammer.
Step 3: Describe the injury scenario
Describe the injury scenario in which the selected product risks cause one or more injuries to the selected consumers. The description should be clear and precise, but without too much detail.
A possible injury scenario is as follows: The breaking of the hammer head causes one of the pieces to be thrown into the eye of the consumer with such force that the latter is blinded. Table 2 provides a concrete help for the description.
Step 4: Determine the severity of injury
Using Table 3 in the guideline, you will determine the severity of injury. It serves as an orientation and contains examples of the type and extent of the injuries in four degrees of severity. These in turn are based on the extent of the necessary medical care.
|1||Injury or consequence that after basic treatment (first aid, normally not by a doctor) does not substantially hamper functioning or cause excessive pain; usually the consequences are completely reversible.|
|2||Injury or consequence for which a visit to A&E may be necessary, but in general, hospitalisation is not required. Functioning may be affected for a limited period, not more than about 6 months, and recovery is more or less complete.|
|3||Injury or consequence that normally requires hospitalisation and will affect functioning for more than 6 months or lead to a permanent loss of function.|
|4||Injury or consequence that is or could be fatal, including brain death; consequences that affect reproduction or offspring; severe loss of limbs and/or function, leading to more than approximately 10 % of disability.|
For the example "hammer" this means:
The injury falls under the category "eye injury, foreign body in eye: Permanent loss of sight (one eye)". Thus, according to Table 3, it is an injury with severity level 3.
Step 5: Determine the probability
To assess the risk, you need to estimate the occurrence probability of the scenario. To do this, you must consider all the individual actions leading to the occurrence of the injury. The guideline distinguishes between eight probability levels for the classification of the overall probability: from < 1/1,000,000 to > 50 % (see table 4, left side).
The example describes the path leading to the injury and the individual probabilities as follows:
- The hammer head breaks when the user tries to knock a nail into awall, because the material of the hammer head is too weak. The weakness was determined in a test and the probability of the hammer head breaking during its otherwise expected lifetime is put at 1/10.
- One of the pieces of the hammer hits the user when it breaks. The probability of this happening is put at 1/10, since the area of upper body exposed to the pieces flying off is considered to be 1/10 of the half-sphere in front of the wall. Of course, if the user were standing very close to the wall, his body would take a larger share of the half-sphere, and the probability would be higher.
- The pieces hit the user's head. The head is estimated to be about 1/3 of the upper body, and the probability is therefore 1/3.
The piece hits the user in the eye. The eyes are considered to be about 1/20 of the area of the head, and therefore the probability is 1/20.
Multiply the individual probabilities of the described steps. The overall probability for the scenario is 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: Risk rating as a result of the combination of severity level of injury and probability
Step 6: Deduce the risk level from Table 4
After you have determined the severity level of injury and the probability of occurrence - if possible for several injury scenarios - you can deduce the risk level from Table 4. This table distinguishes four risk levels: serious, high, medium and low.
Using the values of the severity level 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 level of the injury is "3". This results overall in the risk level "H" or "high".
To complete your risk assessment, you should check the plausibility of the risk level. You can, for example, check whether you have used the best available information for your estimates and assumptions for your risk assessment. Feedback from other experts and colleagues may also be helpful.
Summary: The example described would not require a RAPEX notification. Nonetheless, this is a dangerous product, which must be handled with appropriate measures by the market surveillance authorities.