The Personal Protective Equipment Regulation 2016/425/EU Personal Protective Equipment Regulation is a European Union regulation that governs the design, manufacture, and placing on the market of personal protective equipment (PPE) intended to protect workers and users against health and safety risks. The regulation is based on the protective function of the product and aims to ensure that PPE provides effective protection under its intended conditions of use without adversely affecting human health. In Türkiye, it is implemented under the same framework as the Personal Protective Equipment Regulation and is among the legislations requiring mandatory CE marking.
Regulation (EU) 2016/425 adopts a risk-based approach by classifying PPE into three categories according to the level of risk involved. Simple PPE designed to protect against low risks may be placed on the market based on manufacturer self-declaration, whereas PPE intended for medium and high risks requires the involvement of a Notified Body. In particular, PPE designed to protect against fatal or irreversible health risks is subject to both EU-type examination and ongoing surveillance of the production process. This structure aims to ensure the reliability and consistency of the protective equipment provided to users.
Under the regulation, manufacturers are required to prepare technical documentation covering the design of the PPE, materials used, performance characteristics, and limitations of use. In addition, instructions for use, maintenance information, and limitations must be clearly and comprehensibly provided to the user. The CE marking indicates that the PPE meets the essential health and safety requirements and is eligible for free circulation within the European Union market. An effectively implemented PPE conformity process directly contributes to the reduction of occupational accidents and work-related illnesses.
In terms of standards, Regulation (EU) 2016/425 is a framework legislation, and technical compliance is generally demonstrated through harmonized EN standards. Key examples include EN 166 (eye and face protection), EN 388 (gloves against mechanical risks), EN 407 (gloves against heat and flame), EN 149 (particle-filtering respiratory protection), EN 352 (hearing protectors), EN ISO 20345 (protective footwear), and EN 361 / EN 365 (fall arrest systems for work at height). These standards provide the technical basis for verifying the performance and protection level of PPE.