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PPE

About personal protective equipment

Personal protective equipment (PPE) affords the user protection from hazards encountered at work, at home or during leisure activities. In the professional context, they are instruments for achieving what the EU considers a fundamental right, that of health and safety in the workplace.

European Union policy with regard to PPE is aimed to define the basic health and safety requirements to be fulfilled by manufacturers and remove barriers to trade in these products within the internal market.

The presence of the CE marking on PPE is an indication that it meets these harmonised requirements and can be sold anywhere in the European Economic Area (made up of the EU countries plus Norway, Iceland and Liechtenstein) as well as in Turkey. This also applies to products manufactured in third countries.

CE marking and the Regulation on Personal Protective Equipment

Regulation (EU)2016/425 defines PPE as 'any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards'.

The Regulation makes a distinction between PPE of "simple design", "complex design" and neither of these, the last being the third Category. Whilst the Regulation does not explicitly define these three groups as Categories, it is common practice to use the terms category I, III and II respectively. Category I is listed in ANNEX I and consists of products designed to protect the user against gradual or unexceptional risks. They includes, among other things, sunglasses, gardening gloves and thimbles. Category III is listed in ANNEX I and includes for example emergency equipment for use in very high or very low temperatures, respiratory devices and PPE to protect against falls from a height. Category II PPE includes PPE not defined in the above two Articles.

The Regulation does not apply to PPE (a) specifically designed for use by the armed forces or in the maintenance of law and order; designed to be used for self-defence, with the exception of PPE intended for sporting activities; (c) designed for private use to protect against: (i) atmospheric conditions that are not of an extreme nature, (ii) damp and water during dishwashing; (d) for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in Member States; (e) for head, face or eye protection of users, that is covered by the Regulation No 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motorcycles and mopeds.

The health and safety requirements that PPE must meet in order to be sold in the EU are set out in detail in Annex II of the Regulation.

Scope

  • Equipment providing eye protection
  • Equipment providing face protection
  • Exhaust emissions
  • Equipment providing foot, leg and anti-slip protection
  • Equipment providing head protection
  • Equipment providing respiratory system protection
  • Equipment providing hand and arm protection
  • Protective Equipment against falls from heights
  • Protective equipment against chemical agents
  • Specialized areas of competence: Firemen suits

On the road to CE marking – conformity assessment

The conformity assessment procedures to be followed for each of the risk categories set out in Annex I of the Regulation are as follows:

(a) Category I: internal production control (module A) set out in Annex IV of the Regulation;

(b) Category II: EU type-examination (module B) set out in Annex V of the Regulation, followed by conformity to type based on internal production control (module C) set out in Annex VI of the Regulation;

(c) Category III: EU type-examination (module B) set out in Annex V of the Regulation, and either of the following:

(i) conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VII of the Regulation;

(ii) conformity to type based on quality assurance of the production process (module D) set out in Annex VIII of the Regulation. By way of derogation, for PPE produced as a single unit to fit an individual user and classified according to Category III, the procedure referred to in point (b) may be followed.

Need more information?

Download
Regulation on personal protective equipment (PPE)

Download Factsheet :
FILE.1_ce_personal_protective_equipment_en.pdf
ce_equipment_protective_systems_en.pdf

For further information on Regulation (EU)2016/425 on Personal protective equipment please visit the DG ENTR website dedicated to this sector by following this link:
http://ec.europa.eu/growth/sectors/mechanical-engineering/personal-protective-equipment/index_en.htm

For more information about PPE, download the guidelines
http://ec.europa.eu/DocsRoom/documents/13241/attachments/1/translations/en/renditions/native