Personal Protective Equipment Regulations (PPE)

Personal protective equipment (PPE) are products that the user can wear or hold, to be protected against risks either at work, at home or whilst engaging in leisure activities. Statistics on fatal and major work accidents underline the importance of protection and prevention, for which personal protective equipment plays an important role.

Regulation (EU) 2016/425 of 9 March 2016 on personal protective equipment (the PPE regulation) covers the design, manufacture and marketing of personal protective equipment. It defines legal obligations to ensure that PPE on the EU internal market provides the highest level of protection against risks. The CE marking affixed to PPE provides evidence of compliance of the product with the applicable EU legislation.

The PPE regulation is applicable from 21 April 2018, replacing the previous Directive 89/686/EEC.

The Regulation defines personal protective equipment (PPE) as:

(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) connection 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.

The products must satisfy the essential health and safety requirements laid down in Annex II.

Before proceeding with the conformity assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or if you have to involve a Notified Body.

For category II PPE, when the Notified Body verifies product’s compliance, it will issue an EU type-examination certificate to confirm this. In case of category III PPE additionally a production control is carried out. The manufacturer will then draw up the Declaration of Conformity (DoC) to declare on his sole responsibility the product’s conformity to the relevant legislation. The establishment of the DoC is a legal obligation.

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