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11 of Directive 2001/95/EC (the General Product Safety Directive) (notified under document C(2009) 9843) (2010/15/EU) (repealed)

2.3. Serious risk

2.3.1. Serious risk

Before an authority of a Member State decides to submit a RAPEX notification, it always performs the appropriate risk assessment in order to assess whether a product to be notified poses a serious risk to the health and safety of consumers and thus whether one of the RAPEX notification criteria is met.

As RAPEX is not intended for the exchange of information on products posing non-serious risks, notifications on measures taken with regard to such products cannot be sent through RAPEX under Article 12 of the GPSD.

2.3.2. Risk assessment method

Appendix 5 to the Guidelines sets out the risk assessment method to be used by Member State authorities to assess the level of risks posed by consumer products to the health and safety of consumers and to decide whether a RAPEX notification is necessary.

2.3.3. Assessing authority

The risk assessment is always performed by an authority of a Member State that either carried out the investigation and took appropriate measures or monitored voluntary action taken with regard to a dangerous product by a producer or a distributor.

Before a RAPEX notification is sent to the Commission, the risk assessment performed by an authority of a Member State (to be included in the notification) is always verified by the RAPEX Contact Point. Any unclear issues are resolved by the Contact Point with the authority responsible before a notification is transmitted through RAPEX.

2.3.4. Risk assessment in business notifications

Notifications on dangerous consumer products submitted by producers and distributors under Article 5(3) of the GPSD to the competent authorities of Member States should include a detailed description of the risk. National authorities receiving such notifications examine their content and analyse the risk assessments provided. If, on the basis of the information provided and an independent risk assessment, an authority of a Member State decides that the notified product poses a serious risk to the health and safety of consumers, a RAPEX notification concerning this product is immediately transmitted to the Commission (the fourth subparagraph of Article 12(1)of the GPSD).

Risk assessments carried out by producers and distributors are not binding on Member State authorities. It is therefore possible for an authority of a Member State to come to a different conclusion regarding the risk assessment from a conclusion drawn in a business notification.