PPE

Personal Protective Equipment (PPE) protects against one or several risks to a person’s health or safety.

According to the definition  Regulation (EU) 2016/425 Article 3 (1) PPE means:

(a) 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;

(b) interchangeable components for equipment referred to in point (a) which are essential for its protective function;

(c) connexion systems for equipment referred to in point (a) 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;

Beginning in 2018, PPE must comply with Regulation (EU) 2016/425 requirements. This Regulation defines the Risk Categories of PPE (Annex I). In addition, the manufacturers must issue a Declaration of Conformity (DoC) with each PPE. The obligations for importers and distributors of PPE are provided in Articles 10 and 11, respectively.

To claim conformity with the Regulation (EU) 2016/425., the manufacturer must meet all the applicable Essential Health and Safety Requirements in Annex II and draft up a Declaration of Conformity. Manufacturers must establish a compliant technical file for their PPE, as outlined in Annex III. The technical file includes the list of applicable Essential Health and Safety Requirements, design and manufacturing drawings of the PPE, applicable test reports, and a copy of the manufacturer’s instructions.

Risk Categories

Annex I of EU 2016/425 lays down the categories of risk against which PPE is intended to protect users.

Category I includes exclusively the following minimal risks:

(a) superficial mechanical injury;

(b) contact with cleaning materials of weak action or prolonged contact with water;

(c) contact with hot surfaces not exceeding 50 °C;

(d) damage to the eyes due to exposure to sunlight (other than during observation of the sun);

(e) atmospheric conditions that are not of an extreme nature.

Category II includes risks other than those listed in Categories I and III;

Category III includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health relating to the following:

(a) substances and mixtures which are hazardous to health;

(b) atmospheres with oxygen deficiency;

(c) harmful biological agents;

(d) ionising radiation;

(e) high-temperature environments the effects of which are comparable to those of an air temperature of at least 100 °C;

(f) low-temperature environments the effects of which are comparable to those of an air temperature of – 50 °C or less;

(g) falling from a height;

(h) electric shock and live working;

(i) drowning;

(j) cuts by hand-held chainsaws;

(k) high-pressure jets;

(l) bullet wounds or knife stabs;

(m) harmful noise.

BioReg experts can help PPE manufacturers comply with specific PPE requirements in the EU for all risk categories.