Risk Assessment

A product shall present no risk or only the minimum risks inherent in its reasonably foreseeable use. Therefore, the manufacturer should carry out a risk assessment of the product before placing it on the market.

If, after placing a product on the market, the economic operator receives information or new evidence indicating that the product may be dangerous, it must reassess the risk and determine whether the product poses a risk to consumers.

When determining whether a product is considered unsafe in accordance with the prescribed requirements, several factors should be considered, including the intended use of the product, the type of risk involved, the user groups exposed to the product, previous experience with similar products, and other relevant factors.

The level of risk may depend on a number of factors, including the user group and the vulnerability of users, the likelihood and severity of health hazard, and the extent to which the manufacturer has taken measures to protect users from hazards and to provide warnings about hazards that are not apparent.