The risk assessment methodology implements Article 20 of Regulation (EC) No 765/2008. The primary purpose of the methodology is to assist the market surveillance authorities during the compliance assessment process of products subject to the EU harmonisation legislation. As a foundation of the methodology is used the RAPEX system, which further is extended in two aspects, as follows:
- To ensure that the wide-ranging categories of public risk protected under the EU legislation are taken into account;
- To reflect the particular legal requirements on harmonised products.
For the risk assessment methodology are of importance the following terms:
- Risk – it refers to the combination of the probability and occurrence of a hazard that generates harm in a given scenario.
- Harm – it relates to the event of any injury or damage to the health of consumers, economic damage to consumers, damage to property and environment, as well as to the security and other aspects specified in the scope of the CE Directives.
- Hazard - it is the potential source of harm.
- Risk level – that is the degree of risk, and it can be ‘serious’, ‘high’, ‘medium’ or ‘low’.
The risk assessment methodology is exclusively for the European market surveillance activities. Therefore, manufacturers, distributors or importers should not use it to carry out their own products’ risk assessments.
On the one hand, the economic operators should perform a comprehensive risk assessment before introducing the products to the single market. The risk assessment is a mandatory part of the conformity assessment process, and economic operators need to consider all relevant product hazards to reduce all the risks to acceptable levels.
On the other hand, the European market surveillance authorities are responsible for checking the CE compliance of products already placed on the market. They need to use the risk assessment methodology to determine whether the requirements of Article 20 are fulfilled or not. Usually, market surveillance authorities perform a risk assessment on the notified non-compliant products.