Commission Decision of 16 December 2009 laying down guidelines for the management of the Community Rapid Information System ‘RAPEX’ established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive) (notified under document C(2009) 9843) (2010/15/EU) (repealed)

5. How to prepare a risk assessment – in brief

1. Describe the product and its hazard.

Describe the product unambiguously. Does the hazard concern the entire product or only a (separable) part of the product?

Is there only one hazard within the product? Are there several hazards? See table 2 for guidance.

Identify the standard(s) or legislation applicable to the product.

2. Identify the type of consumer you want to include in your injury scenario with the hazardous product.

Start with the intended user and the intended use of the product for your first injury scenario. Take other consumers (See table 1) and uses for further scenarios.

3. Describe an injury scenario in which the product hazard(s) you have selected causes an injury(ies) or adverse health effect(s) to the consumer you selected.

Describe the steps to the injury(ies) clearly and concisely, without exaggerating the details (‘shortest path to injury’, ‘critical path to injury’). If there are several concurrent injuries in your scenario, include them all in that same scenario.

When you describe the injury scenario, consider the frequency and duration of use, hazard recognition by the consumer, whether the consumer is vulnerable (in particular children), protective equipment, the consumer’s behaviour in the case of an accident, the consumer’s cultural background, and other factors that you consider important for the risk assessment.

See section 3.3 and table 2 for guidance.

4. Determine the severity of the injury.

Determine the level of severity (1 to 4) of the injury to the consumer. If the consumer suffers from several injuries in your injury scenario, estimate the severity of all those injuries together.

See table 3 for guidance.

5. Determine the probability of the injury scenario.

Assign a probability to each step of your injury scenario. Multiply the probabilities to calculate the overall probability of your injury scenario.

See left-hand side of table 4 for guidance.

6. Determine the risk level.

Combine the severity of the injury and the overall probability of the injury scenario and check the risk level in table 4.

7. Check whether the risk level is plausible.

If the risk level does not seem plausible, or if you are uncertain about the severity of injury(ies) or about the probability(ies), move them one level up and down and recalculate the risk. This ‘sensitivity analysis’ will show you whether the risk changes when your input changes.

If the risk level remains the same, you can be quite confident of your risk assessment. If it changes easily, you may want to err on the safe side and take the higher risk level as ‘the risk’ of the consumer product.

You could also discuss the plausibility of the risk level with experienced colleagues.

8. Develop several injury scenarios to identify the highest risk of the product.

If your first injury scenario identifies a risk level below the highest risk level set out in these guidelines, and if you think that the product may pose a higher risk than the one identified,

• select other consumers (including vulnerable consumers, in particular children);

• identify other uses (including reasonably foreseeable uses),

in order to determine which injury scenario puts the product at its highest risk.

The highest risk is normally ‘the risk’ of the product that allows the most effective risk management measures. In specific cases, a particular hazard may lead to a less-than-highest risk and require specific risk management measures. This has to be taken duly into account.

As a rule of thumb, injury scenarios may lead to the highest risk level set out in these guidelines where:

• the injury(ies) considered are at least at levels 3 or 4;

• the overall probability of an injury scenario is at least > 1/100.

See table 4 for guidance.

9. Document and pass on your risk assessment.

Be transparent and also set out all the uncertainties that you encountered when making your risk assessment.

Examples for reporting risk assessments are provided in section 6 of these guidelines.