The Safety Gate Portal informs about measures taken to prevent or limit the use of dangerous products. These may be, for example, withdrawal or recall actions. Safety Gate records both the measures taken by national market surveillance authorities and the voluntary measures taken by manufacturers and retailers.

Daily, and especially every Friday, the European Commission publishes an overview of dangerous products reported to it by the Member States. Here you can obtain consumer information of whether or not you are dealing with a dangerous product. The same applies if you want to sell or import products as a distributor. Many companies are now using the Safety Gate Portal in order to get informed 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

Risk assessments are carried out by the market surveillance authorities of the Member States after products have been placed on the market. The authorities use random sampling to check whether the safety requirements defined in regulations and directives are being complied with. If these checks identify a potential risk to consumers, measures are subsequently taken to mitigate it. The European Commission publishes guidelines that are to be applied by the Member States’ market surveillance authorities when conducting risk assessments. The previous Directive on general product safety (2001/95/EC) was replaced once the European General Product Safety Regulation ((EU) 2023/988) entered into force on 13 December 2024. The guidelines laid down in Appendix 6 to Implementing Decision (EU) 2019/417, which set out a risk assessment method, were also formally repealed on 26 March 2025. The European Commission has defined new criteria for the assessment of the level of risk in Annex II to Delegated Regulation (EU) 2024/3173. 

The aim pursued with Regulation (EU) 2024/3173 is to continue to make a transparent, practical procedure available that can be implemented by the competent authorities of the Member States for the assessment of risks from non-food consumer products.

Despite this support, product risk assessment is a subjective process and should be well documented to ensure its verifiability.

The European Commission has made changes to the procedure that are intended, on the one hand, to extend its scope and, on the other hand, to simplify the assessment process in certain cases. The main changes are explained briefly below.

Otherwise, the risk assessment method set out in Annex II to Regulation (EU) 2024/3173 follows the familiar pattern, but does not include a level of detail that would allow assessments to be differentiated to a greater degree. At present, the European Commission is therefore drawing up a Safety Gate Handbook, which will explain the procedure by looking at examples, useful tools, and how risk assessment is embedded in the “Safety Gate galaxy”. Until such further information is published, the general advice and reference tables provided for the application of the “old” RAPEX method offer helpful guidance and can still be accessed from this page.

Comparison of Annex II to (EU) 2024/3173 and the RAPEX Guidelines ((EU) 2019/417)

Annex II to Regulation (EU) 2024/3173 has brought in three major changes in comparison to the predecessor document. 

1. The term “harm” has been newly introduced. It replaces “injury” and denotes various kinds of negative effects, on end users’ quality of life for example. Opening up the method in this way has expanded the range of possible harms that are relevant. Specific mention is made of effects on protected interests such as animals, energy resources, property, and economic transactions, which are to be taken into account by the party carrying out the risk assessment. Consideration could also be given to, for example, (long-term) mental consequences and monetary losses as negative effects. The schema used to classify the severity of injuries has been adjusted accordingly and now also includes descriptions that define the level of harm.
   

   

   
   
   
2. The Commission has introduced “shortcuts” into the assessment procedure for certain products and cases. “The national authorities notifying products through the Safety Gate Rapid Alert System should be able to take account of the fact that in certain situations or as regards products with certain characteristics there is already a well-established evidence, such as statistics, outcomes of market surveillance or risk assessments, allowing to presume the existence of a serious risk posed by such products. In such situations, the national authorities should not be required to submit individual risk assessments for the purposes of the notification through the Safety Gate Rapid Alert System” (Recital 11 (EU) 2024/3173).
   
   

   

   Nonetheless, it continues to be possible for products to be assessed by means of an individual risk assessment, with potentially discrepant results being reached. 
   
   
3. Qualitative expressions for the quantitative probabilities of harm have been added. 
   
   

   

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Basic elements of risk assessment

According to the guideline (Implementing Decision (EU) 219/417), 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:

1. Description of at least one injury scenario where the intrinsic product hazard leads to harming the consumer and determination of the severity of the injury.
2. Estimation of the probability with which the intrinsic product hazard actually leads to an injury of the consumer.
3. Combination of the risk (as a severity of the injury) and the probability (in terms as a fraction) to determine the risk.

An example, which is also included in Annexe 5 of the guideline, briefly describes the application of risk assessment. As an example, a locksmith hammer was selected, which was reported in the reporting system under the number 125/06.

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Procedure of the 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

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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. From these product properties, you can deduce what possible risk might arise from the product. In addition typical injuries are shown.

In this case, a consumer uses a hammer to drive a nail into the wall. Due to the use of unsuitable material, the hammer head does not have the sufficient strength and breaks.

For the example "hammer", you can derive the following information from Table 2:

• Risk group: Kinetic energy
• Danger (product property): Flying objects, e.g. fragments, small parts
• Typical injury scenario: The user is hit by the flying object and suffers injuries whose severity depends on the object’s energy when it hits the body.
• Typical injuries: Bruise, luxation, fracture, cerebral concussion or contusion.

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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.

Consumer	Description
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
Other consumers	Consumers other than very vulnerable or vulnerable consumers.

Please note that the following aspects influence the risk level:

• Intended/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 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.

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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 concrete help for the description.

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Step 4: Determine the severity of injury

Using Table 3 from the guideline, 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.

Severity	Description
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 almost 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.

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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:

1. The hammer head breaks as the user tries to drive a nail into a wall, since the material of the hammer head does not possess the necessary strength. The lack of strength was determined in a test and the probability of the hammer head breaking during its otherwise expected lifetime is put at 1/10.
2. One of the pieces of the hammer hits the user when it breaks. The probability of this incident is put at 1/10. It is assumed that the area of upper body exposed to the pieces flying off is considered to be 1/10 of the semi-sphere in front of the wall. Naturally, the nearer the user stands to the wall, the higher the probability, since the share of the semi-sphere his body takes becomes larger.
3. A piece hits the user's head. The head is estimated to be about 1/3 of the upper body, and the probability is therefore 1/3.
4. 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.
   Table 4: Risk rating as a result of the combination of severity level of injury and probability

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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. The 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". In total, this results 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 in your risk assessment. Feedback from other experts and colleagues may also be helpful.
In summary: The example described would not require a notification in the EU rapid alert system. Nonetheless, it is a dangerous product, which must be handled with appropriate measures by the market surveillance authorities.

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