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PPE European Regulation (EU) 2016/425
- Aug 18, 2018 -

The timelines of PPE Directive in Europe

1. PPE Directive 89/686/EEC was first published in 1989, and carried out into UK law as the (EC directive) Regulations 1992 and known as the Principal Regulations. The Principal Regulations came fully into force on 01 January 1993.

2. The New PPE Regulation 425/2016 was first adopted on the 12 February 2016 and first published in the Official Journal on 21 April 2016, 20 days later. Now the 89/686/EEC was superseded by 425/2016 New Regulation on 21 April 2018. EC type-examnination certificates remain vaild until 21 April 2013 unless they expire before that date.

Why the PP Directive changes

The PPE Directive now is over 20 years old. With the changing and imrprovement of lost of core health and safety requirments and technologies,the obligation to place on markets PPE complying with conerned standards extends beyond manufacturers, it needs to be updated and revised.

The New Regulations are applible directly for all member states without the need for transposed into eacn member's national law. 

Main changes between 89/686/EEC and New Regulation (EU) 425/2016

1. Moving some items from Category II (intermediate) to Category III (complex). These include products designed to protect against ionising radiation, harmful biological agents, atmospheres with oxygen deficiency, falling from a height, electric shock, live working, cuts by hand-held chainsaws, high-pressure jets, bullet wounds, knife stabs, harmful noise

2. The requirements for a product rish assessment in the technical file

3. Manufacturers should issue declaration of conformity with each PPE or website address that can be accessed

4. A maximum five-year certificates validity

5. Clearly defines the obligations and responsibity of manufacturers, importers, distributors

6. The requirements for manufacturers to list theri name and address on the products

7. Especially states the application for renewal must be submmitted to notified body at the earliest 12 months and at least 6 months prior to the certificates's expiry date

PPE categories of PPE Regulation (EU) 2016/425

PPE CategoryActivity
89/686/EEC(EU) 425/2016

Category I

Simple PPE

Placing product

 on the market

Manufacturers self-declarationModule A (Annex IV)

Category II

Intermediate PPE


Category III 

Complex PPE

Initial product 


Article 10

EC type Examination

Module B (Annex V)

EU type examination plus

Module C (Annex VI)

Category III

Complex PPE only

On-going surveilance through testingArticle 11AModule C2 (Annex VII)

Category III

Complex PPE only

On-going surveilance through factory 


Article 11BModule D (Annex VIII)

Category I - Simple PPE

PPE in this category is designed to protect users against minimal risks in the following inclusion:

  • Superfical mechanical injury 

  • contact with water or cleaning materials of weak action

  • contact with hot surfaces not exceeding 50℃

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

  • atmospheric conditions that are not of an extreme nature

Category II- Intermediate PPE

This category includes risks other than those listed in Category I and III.

The following products are included as examples:

  • Safeyu spectacles and goggles

  • Industrial helmets and bump caps

  • High visibility clothing

Category III - Complex PPE

PPE falling under this category includes exclusively the risks that mat cause very serious consequences such as irreversible damage to health or death relating to the following:

  • Substances and mixtures which are hazardous to health

  • atmospheres with oxygen deficiency

  • harmful biological agents

  • inising radiation

  • high-temperature environments the effects of which are comparable to those of an air temperature of at least 100℃

  • low-temperature environments the effects of which are comparable to those of an air temperature of at least -50℃

  • falling from a height

  • electronic shock and live working

  • drowning

  • cuts by hand-held chainsaws

  • high pressure jets

  • bullet wounds or knife stabs

  • harmful nosie

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