EU Parliament, Council / 03.12.2001 / 15.01.2004, at the latest
European Union Directive to be implemented by all Member States by by transposition of the legislation and enforcement with their means.
The purpose of this Directive is to ensure that products placed on the market are safe.
Safe product is defined as any product which, under normal or reasonably foreseeable conditions of use, does not present any risk or only the minimum risks compatible with the product’s use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons.
Safety is defined not only according to the intrinsic properties of the product but also taking into account the labeling, warnings and instruction for its use and disposal, as well as consumer at risk, particularly children and elderly.
The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product to be ‘dangerous’.
Where products are subject to specific safety requirements imposed by Community legislation, this Directive shall apply only to the aspects and risks or categories of risks not covered by those requirements.
Annex II provides guidelines on notification to the Commission of measures taken by Member States to restrict the placing on the market or to withdraw a product in case it is dangerous or poses a serious risk (serious risks require rapid intervention by the public authorities and rapid information by the EU rapid alert system called RAPEX).
According to this Annex, where a Member State takes measures to limit the marketing or use of a substance or preparation, it shall provide references of the relevant data relating to the substance considered and to known and available substitutes, where such information is available.
Substitution is presented as a possible action in the context of measures taken to restrict the placing on the market and use of dangerous products.
Manufacturers and distributors have to produce and place on the market only safe products. If any of them discovers that a product does not comply with the general safety requirement stated by the Directive, they must notify the competent authorities appointed for this purpose in the Member States.
Last update: 01.08.2011