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11 of Directive 2001/95/EC (the General Product Safety Directive) (notified under document C(2009) 9843) (2010/15/EU) (repealed)

4. From risk to action

Once the risk assessment is complete it will normally be used to decide whether action needs to be taken to reduce the risk and thus prevent harm to a consumer’s health. Although action is separate from risk assessment, some points are raised here to illustrate the possible follow-up of identified risks.

Within market surveillance, action will often be taken in contact between the authority and the manufacturer, importer or distributor. This can help the authority to determine the most effective and efficient way of managing the risk.

With a serious risk in a consumer product, measures to reduce the risk may include withdrawal from the market or recall. Lower levels of risk normally lead to less rigorous measures. It may then be sufficient to add warning labels on the product or to improve the instructions to make the product safe. Thus, whatever the level of risk, the authority should consider whether to take action, and if so, what action.

Nevertheless, there is no automatic link from risk to action. When a product shows several less-than-serious risks, and its overall risk is thus not serious, urgent action may be necessary since any of the risks may materialise quite quickly. The pattern of risks in the product may indicate a lack of quality control in production.

It is also important to take account of exposure of the population as a whole. Where there are a large number of products on the market and the product is therefore used by a large number of consumers, even a single less-than-serious risk may require quick action to avoid adverse effects to the health of consumers.

Less-than-serious risks may also require action when the product concerned could cause fatal accidents, even though such accidents may be extremely unlikely. This could be the case with a fastening on a beverage container, which could come loose and be swallowed by a child, causing the child to choke to death. A simple change of design to the lid could eliminate the risk, and no further action might be required. Even a selling-off period may be granted if the risk of a fatal accident were indeed extremely small.

Other risk-related aspects may be the public perception of risk and its likely consequences, cultural and political sensitivities and how it is portrayed in the media. These aspects may be especially relevant when the consumers concerned are vulnerable, in particular children. It will be up to the national market surveillance authority(ies) to determine what measures are required.

Taking action to counteract a risk may also depend on the product itself and the ‘minimum risks compatible with the product’s use, considered to be acceptable and consistent with a high level of protection’(1). This minimum risk will probably be much lower for toys, where children are involved, than for a chain-saw, which is known to be so high-risk that solid protective equipment is required to keep the risk at a manageable level.

Finally, even if there is no risk, action may be necessary, for example, when a product is non-compliant with the applicable regulation/legislation (e.g. incomplete markings).

In conclusion, there is no automatic link from risk to action. Surveillance authorities will take account of a range of factors such as those indicated above. The principle of proportionality always has to be considered, and action has to be effective.

(1)

This is taken from the definition of ‘safe product’ in Article 2(b) of Directive 2001/95/EC.