Statutory regulations for EU-wide market access
The prerequisite for personal protective equipment (PPE) to fulfil its protective function and to be placed on the market is that it must comply with statutory regulations. This page set outs these requirements in greater detail.
The legal framework for the placing of new PPE on the market is Directive 89/686/EEC (Council Directive of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment). In Germany, this Directive is implemented in the form of the Eighth Ordinance to the Product Safety Act (Ordinance on the Making Available of Personal Protective Equipment on the Market - 8th ProdSV). The PPE Directive regulates the conditions for the placing on the market and free movement of PPE within the European Community. It also formulates the basic safety requirements that PPE must meet in order to protect users' health and guarantee their safety. These requirements are defined in Annex II to the aforementioned Directive 89/686/EEC and apply regardless of the intended use (private or commercial).
On 20 April 2016, the new European PPE Regulation entered into force (official title: "Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC"). This Regulation will gradually replace the PPE Directive 89/686/EEC. After a transitional period of two years, the PPE Directive is repealed with effect from 21 April 2018, from which time the new PPE Regulation will apply.