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European Union (EU) Regulation 2016/425 on Personal protective equipment (PPE)

European Union Regulation for Personal Protective Equipment

To ensure the health and safety of users, personal protective equipment (PPE) for sale or use in Europe must comply with requirements set forth by Regulation (EU) 2016/425. PPE is defined as clothing or equipment worn to protect against injury or infection. Regulation (EU) 2016/425 further addresses regulatory specifications for essential interchangeable PPE components as well as temporary connection systems to external devices or anchorage points.

Annex I of the Regulation establishes the following categories of risk:

  • Category I – Minimal risks
  • Category II – Risks other than those listed in Categories I and III
  • Category III – Severe

Annex II of the Regulation specifies mandatory essential health and safety requirements relating to state-of-the-art design and manufacturing principles for safe, comfortable and effective PPE products. It also provides manufacturer instructions as well as additional requirements applicable to several types of PPE and specific to particular risks. Official guidelines are in place to consider scope and risk classifications for specific PPE such as eye protection or protective clothing.

Annex III provides technical documentation prerequisites to ensure PPE conformity with the applicable essential health and safety requirements brought forth in Annex II.

Annexes IV to VIII describe conformity modules with Module B (‘EU Type Examination’) involving a Notified Body to ascertain and certify that a representative PPE model satisfies the provisions of the Regulation.

TÜV Rheinland is accredited to conduct EU Type-Examinations for a wide range of personal protective equipment products. Make use of our long-term PPE experience in testing and certification for conformity with the Regulation (EU) 2016/425 as well as other regional or local safety regulations and standards.

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Detailed Information

Technical aspects Safety
Market surveillance Conditionally
Obligation Mandatory
Factory inspection Conditionally
Sample testing Yes
Validity

5 years for EU type-examination certificates​

Product Scope

Personal Protective Equipment (PPE) intended to ensure protection of the health and safety of users


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