The purpose and scope of the Regulation states requirements for the design and manufacture of personal protective equipment (PPE) to be made available on the market in order to ensure protection of the health and safety of users.
The Regulation does not apply to PPE:
- designed to be used for self-defence, with the exception of PPE intended for sporting activities,
- designed for private use to protect against atmospheric conditions that are not of an extreme nature and damp and water during dishwashing,
- for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in Member States,
- for head, face or eye protection of users, that is covered by Regulation No 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motor cycles and mopeds.
For the purposes of the Regulation, PPE means:
- equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety,
- interchangeable components for equipment referred to in the previous indent which are essential for its protective function
- connexion systems for equipment that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use.
As for the obligations of economic operators (manufacturers, importers, distributors),
manufacturers and importers shall, when deemed appropriate with regard to the risks presented by PPE, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.
Manufacturers shall:
- ensure that the PPE is accompanied by the instructions and information, as well as any labelling, shall be clear, understandable, intelligible and legible;
- either provide the EU declaration of conformity with the PPE or include in the instructions and information the internet address at which the EU declaration of conformity can be accessed;
- further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the PPE with this Regulation.
The CE marking shall be affixed before the PPE is placed on the market. The CE marking and, where applicable, the identification number of the notified body may be followed by a pictogram or other marking indicating the risk against which the PPE is intended to protect. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.
