Personal Protective Equipment (PPE) Certification

In 2016, the EU issued the new PPE Regulation (EU) 2016/425, which came into force on April 21, 2018 and replaced the old Directive 89/686/EEC. All personal protective products must obtain CE certification in accordance with the PPE regulation before exporting to the EU market.

Definition of PPE

Any device or appliance worn or held by a person for protection against one or more health and safety risks during activities.

Scope of PPE

01 Head Protection

Such as occupational helmets, industrial helmets, sports helmets, work caps, dust caps, waterproof caps, cold-proof caps, safety helmets, anti-static caps, high-temperature resistant caps, anti-electromagnetic radiation caps, insect-proof caps, bump caps, etc.
02 Eye Protection

Such as sunglasses, filter lenses, welding goggles and face shields, furnace goggles and face shields, impact-resistant eye protectors, etc.
03 Hand Protection

General protective gloves, waterproof gloves, cold-proof gloves, chemical-resistant gloves, anti-static gloves, high-temperature resistant gloves, X-ray resistant gloves, acid and alkali resistant gloves, oil-proof gloves, shockproof gloves, cut-resistant gloves, insulating gloves, etc.
04 Respiratory Protection

Dust masks and gas masks, divided into filtering type and isolating type by structure.
05 Hearing Protection

Earmuffs, earplugs, noise-proof helmets and other hearing protection products.
06 Foot Protection

Such as dust-proof shoes, waterproof shoes, cold-proof shoes, impact-resistant shoes, anti-static shoes, high-temperature resistant shoes, acid and alkali resistant shoes, oil-proof shoes, scald-proof shoes, anti-slip shoes, puncture-proof shoes, electrically insulating shoes, shockproof shoes, etc.
07 Torso Protection

Such as general protective clothing, waterproof clothing, cold-proof clothing, anti-collision back protectors, chemical-resistant clothing, flame retardant clothing, anti-static clothing, high-temperature resistant clothing, anti-electromagnetic radiation clothing, acid and alkali resistant clothing, oil-proof clothing, life jackets, insect-proof clothing, wind and sand resistant clothing, etc.
08 Fall Protection & Chemical Protection Equipment

PPE Certification Categories

PPE is classified into three categories according to structural complexity and protection level:

Category I: Simple products for minimal recognizable risks with basic protection (10% of PPE), such as garden gloves and cleaning gloves.

Category II: All PPE excluding Category I and Category III, with moderate complexity and protection performance (80% of PPE), such as knitted gloves and thin solvent-resistant lined gloves.

Category III: Complex-designed equipment protecting against fatal risks or irreversible serious health damage (10% of PPE), such as high-performance chemical-resistant gloves and hot rolling gloves.

CE Certification Procedures for Each PPE Category

01 Category I

Comply with basic health and safety requirements

Compile technical documentation

Issue EU Declaration of Conformity

Affix CE marking
02 Category II

Comply with basic health and safety requirements

Compile technical documentation

Complete EU type examination and testing

Issue EU Declaration of Conformity

Affix CE marking
03 Category III

Comply with basic health and safety requirements

Compile technical documentation

Complete EU type examination and testing

Implement product control or quality system per Article 11

Issue EU Declaration of Conformity

Affix CE marking

Technical Documentation (Category II & III)

Technical documents shall contain sufficient information for product identification, including general assembly drawings, component lists, materials and material grades. If products are assessed against non-harmonized standards, documents shall explain compliance with all applicable essential requirements. A testing and inspection plan shall also be included.

Quality Documentation (Category III)

Manufacturers of Category III PPE (Article 8(4)) must adopt quality management measures in accordance with Annex 11.A or 11.B. The submitted manual shall outline compliance methods. Product and quality system supervision requirements:

Annex 11.A requires product surveillance documents and annual random sampling for independent testing.

Annex 11.B provides annual assessment and monitoring of the quality system, with ISO 9001 as the minimum standard.