1. GENERAL REQUIREMENTS APPLICABLE TO ALL PPE

PPE must provide adequate protection against the risks against which it is intended to protect. PPE must be designed and manufactured so that, in the foreseeable conditions of use for which it is intended, the user can perform the risk-related activity normally whilst enjoying appropriate protection of the highest level possible. The optimum level of protection to be taken into account in the design is that beyond which the constraints imposed by the wearing of the PPE would prevent its effective use during the period of exposure to the risk or the normal performance of the activity. Where differing foreseeable conditions of use are such that several levels of the same risk can be distinguished, appropriate classes of protection must be taken into account in the design of the PPE. PPE must be designed and manufactured so as not to create risks or other nuisance factors under foreseeable conditions of use. The materials of which the PPE is made, including any of their possible decomposition products, must not adversely affect the health or safety of users. Any part of the PPE that is in contact or is liable to come into contact with the user when the PPE is worn must be free of rough surfaces, sharp edges, sharp points and the like which could cause excessive irritation or injuries. Any impediment caused by PPE to the actions to be carried out, the postures to be adopted and sensory perceptions shall be minimised. Furthermore, use of the PPE must not engender actions which might endanger the user. PPE must be designed and manufactured in such a way as to facilitate its correct positioning on the user and to remain in place for the foreseeable period of use, bearing in mind ambient factors, the actions to be carried out and the postures to be adopted. For this purpose, it must be possible to adapt the PPE to fit the morphology of the user by all appropriate means, such as adequate adjustment and attachment systems or the provision of an adequate range of sizes. PPE must be as light as possible without prejudicing its strength and effectiveness. PPE must satisfy the specific additional requirements in order to provide adequate protection against the risks for which it is intended and PPE must be capable of withstanding environmental factors in the foreseeable conditions of use. If the same manufacturer places on the market several PPE models of different types in order to ensure the simultaneous protection of adjacent parts of the body, they must be compatible. Protective clothing containing removable protectors constitutes PPE and shall be assessed as a combination during conformity assessment procedures. In addition to the name and address of the manufacturer, the instructions that must be supplied with the PPE must contain all relevant information on: instructions for storage, use, cleaning, maintenance, servicing and disinfection. Cleaning, maintenance or disinfectant products recommended by manufacturers must have no adverse effect on the PPE or the user when applied in accordance with the relevant instructions; performance as recorded during relevant technical tests to check the levels or classes of protection provided by the PPE; where applicable, accessories that may be used with the PPE and the characteristics of appropriate spare parts; where applicable, the classes of protection appropriate to different levels of risk and the corresponding limits of use; where applicable, the month and year or period of obsolescence of the PPE or of certain of its components; where applicable, the type of packaging suitable for transport; the significance of any markings (see point 2.12); the risk against which the PPE is designed to protect; the reference to this Regulation and, where applicable, the references to other Union harmonisation legislation; the name, address and identification number of the notified body or bodies involved in the conformity assessment of the PPE; references to the relevant harmonised standard(s) used, including the date of the standard(s), or references to the other technical specifications used; the internet address where the EU declaration of conformity can be accessed. The information referred to in points (i), (j), (k) and (l) need not be contained in the instructions supplied by the manufacturer if the EU declaration of conformity accompanies the PPE.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-01 · Text as adopted (Official Journal); later amendments are not incorporated in this text.