EUProduktsicherheitsstandards

The EU Produktsicherheitsgesetz, officially known as the Product Safety Directive (Directive 2001/95/EC) and its subsequent amendments, is a cornerstone of European Union legislation aimed at protecting consumers from hazards posed by products sold on the internal market. Adopted in 2001, the directive introduced harmonised safety standards for consumer goods, technical products, and other goods that could affect consumer health or safety. It was re‑examined and amended by Directive 2011/65/EU, which reinforced safety obligations for chemical‑containing products and introduced more stringent requirements for medical devices and other high‑risk items.

The directive’s core concepts include mandatory safety requirements for all products, the producer or importer’s obligation to mark goods with the CE certificate when applicable, and the requirement that each product undergo a conformity assessment before entering the market. Manufacturers must maintain technical documentation and ensure ongoing compliance with the rules. National authorities enforce the provisions by inspecting retail outlets and conducting sampling tests; cooperation between Member States is facilitated through the European Commission’s oversight and the European Market Surveillance System.

The legislation has promoted a single market free from technical barriers, enabled cross‑border trade, and increased consumer confidence in product safety. However, critics point to the cost of compliance for small and medium enterprises, the complexity of the regulatory framework, and inconsistency among Member States in enforcement. Future developments include tighter integration with other EU environmental and health directives, the introduction of digital traceability tools, and an expanded scope to cover emerging technology such as artificial‑intelligence‑based consumer products.