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11 of Directive 2001/95/EC (the General Product Safety Directive) (notified under document C(2009) 9843) (2010/15/EU) (repealed)

2.2. A risk assessment in three steps

It takes three steps to determine the risk:

1.

Anticipate an injury scenario in which the intrinsic product hazard harms the consumer (see table 1). Determine how severe the consumer’s injury is.

A yardstick for quantifying the intrinsic product hazard is the extent of the adverse effect that it can cause to the health of a consumer. The risk assessor therefore anticipates an ‘injury scenario’ that describes step by step how the hazard leads to the injury of a consumer (see table 2). In short, the injury scenario describes the accident that the consumer has with the product in question, and the severity of the consumer’s injury caused by that accident.

An injury can vary in severity, depending on the hazard of the product, on the way the product is used by the consumer, on the type of consumer who uses the product, and much more (see section 3). The more severe the injury, the more severe the hazard that caused it, and vice versa. The ‘severity of the injury’ is therefore a means of quantifying the hazard. These guidelines propose 4 levels of severity, from injuries that are normally completely reversible to very serious injuries that cause more than approximately 10 % of permanent disability or even death (see table 3).

2.

Determine the probability of the consumer being injured in practice by the intrinsic product hazard.

While the injury scenario describes how the consumer is injured by the hazard, the scenario only happens with a certain probability. The probability can be expressed as a fraction, such as ‘> 50 %’ or ‘> 1/1 000’ (see left-hand side of table 4).

3.

Combine the hazard (in terms of severity of the injury) with the probability (in terms of a fraction) to obtain the risk.

This combination can be made by looking up both values in the appropriate table (see table 4); the table will provide the level of risk in terms of ‘serious’, ‘high’, ‘medium’ and ‘low’ risk.

Where different injury scenarios are foreseeable, the risk for each of those scenarios should be determined the highest risk being labelled as ‘the risk’ of the product. The highest risk is normally crucial because only action on the highest risk can effectively provide a high level of protection.

On the other hand, an identified risk may be lower than the highest risk, but require specific risk reduction action. It is then important also to take measures against that risk so that all risks are effectively reduced.

Once the above steps have been carried out, the risk assessment is basically complete.

A flow chart on building a risk assessment is at the end of section 5.