Personal Protective Equipment

Specialised clothing such as goggles, gloves, helmets or masks that are intended to protect the wearer from inherent hazards have a broad spectrum of applications from heavy machinery environments to sports. These hazards may include biohazards, heat, physical, electrical, heat, chemicals or airborne.

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EU Legislation on PPE

Personal protective equipment (PPE) includes products to wear or hold that protect people against safety and health risks. In the European Union, the regulatory framework for personal protective equipment is Personal Protective Equipment Regulation EU 2016/425. The PPE Regulation covers products used the protect individuals during work, home, or leisure activities.

The PPE Regulation classifies the risks that personal protective equipment protects from into three categories (category 1, 2, and 3), from the lowest (category 1) to the highest risk (category 3).

Category 1 (lowest risk) entails superficial mechanical injury, contact with cleaning materials of weak action or prolonged contact with water, contact with hot surfaces not exceeding 50 °C, damage to the eyes due to exposure to sunlight (other than during observation of the sun), and risks given by atmospheric conditions that are not of an extreme nature.

Category 2 includes all risks that are not classified as Category 1 or Category 3.

Category 3 comprises risks that can cause very serious consequences such as death or irreversible damage to health. As such, the PPE Regulation defines Category 3 PPE as those that protect from substances and mixtures which are hazardous to health, atmospheres with oxygen deficiency, harmful biological agents, ionising radiation, extremely high-temperature environments or low-temperature environments, falling from a height, electric shock and live working, drowning, cuts by hand-held chainsaws, high-pressure jets, bullet wounds or knife stabs, and harmful noise.

Manufacturers who want to sell in the EU, whether based in the EU or not, must comply with the PPE Regulation. Among other things, manufacturers must:

  • Compile the technical documentation
  • Follow the conformity assessment path applicable to their products
  • Draw the Declaration of Conformity
  • Fulfil post-market surveillance obligations

Additionally, as the PPE Regulation falls under the scope of the Market Surveillance Regulation it is required for non-EU manufacturers to appoint an economic operator, such as an authorised representative, to take care of post-market activities. Furthermore, Obelis as your authorised representative can assist you in the completion of the technical documentation and guaranteeing compliance for your PPE products.

The conformity assessment of personal protective equipment varies based on the risk category.

  • Category 1 products are subject to internal production control
  • Category 2 products have to undergo a EU type-examination and internal production control
  • Category 3 products also must undergo an EU type-examination and either an internal production control or a quality assurance of the production process.

PPE belonging to the Category 2 or Category 3 requires the involvement of a notified body, a third-party conformity assessment body.

In the case any personal protective equipment is found to be non-complaint with the applicable legislation, the main consequences include, among others:

  • Being publicly reported to Safety Gate
  • Warehousing fees
  • Requested withdrawal
  • Mandated withdrawal
  • Product recall (from end-users and/or the market)
  • Complete ban on marketing of the product
  • Destruction of the product
  • Fines

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