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 covers both the measures of the market surveillance authorities of EU Member States and the voluntary measures taken by manufacturers and distributors.

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

In its Implementing Decision (EU) 2019/14 of 8 November 2018, the European Commission set out guidelines for the management of the community system for the rapid exchange of information. As a guideline, Annexe 5 describes 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, authorities decide whether a Safety Gate 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 transparency.

When the European General Product Safety Regulation (EU) 2023/988 comes into force on 13 December 2024, it will replace the previous Directive 2001/95/EC on general product safety. New guidelines for the administration of the EU rapid alert system Safety Gate are also expected at this time.

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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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