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Council Directive of 21 December 1989 on the approximation of the laws of the Member States relating to Personal Protective Equipment (89/686/EEC)

Status: European Directive of the New Approach, published on 1989.12.30 in the Official Journal of the EU L 399

  • new approach directive: European Directive in which only general principles are set out, the technical specifications being left to standardization

Scope: This Directive specifies the conditions to which manufacturers of Personal Protective Equipment (PPE) have to comply before they can circulate their product freely on the European market. The Directive contains provisions on categorization of PPE, procedures of attestation of conformity, marking and basic requirements related to safety and health.

  • manufacturer:The company placing the PPE on the market or its authorized representative established in the Community
  • personal protective equipment (PPE): Any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards. In the larger sense also:
  • a unit constituted by several devices or appliances combined to protect against potentially simultaneous risks;
  • a protective device combined with non-protective equipment;
  • interchangeable PPE components.

Are not considered as PPE under this Directive:

  • work or uniform clothing without specific protective properties;
  • PPE used by the armed forces or in the maintenance of law and order;
  • PPE for self-defence (e.g. aerosol canisters, deterrent weapons);
  • some PPE for private use (headgear, winter- and rainwear, footwear, umbrellas, dish-washing gloves, oven gloves)
  • PPE for protection or rescue on vessels and aircraft, if not worn permanently.

Categorization of PPE

PPE are classified in three categories related to the degree of risk they are designed to protect against. The procedure to prove compliance with the requirements of the Directive is specific for each category and is proportional with the risk.

  • category I: PPE of simple design, where the designer assumes that the user can himself assess the level of protection provided against minimal risks, the effects of which are gradual and can be safely and timely identified by the user.

This concerns explicitly and exclusively PPE protecting against:

  • mechanical action with superficial effects (gardening gloves, thimbles, etc.)
  • cleaning agents of weak action and easily reversible effects (gloves against diluted detergent solutions, etc.)
  • handling of hot components (< 50 °C) not accompanied by dangerous impacts (gloves, aprons for professional use, etc.)
  • atmospheric conditions of neither exceptional nor extreme nature (headgear, seasonal clothing, footwear, etc.)
  • minor impacts and vibrations not affecting vital parts of the body and with reversible effects (anti-scalping helmets, gloves, light footwear, etc.)
  • sunlight (sunglasses)
  • category II: This is an open category which covers all PPE not listed explicitly in the other two categories. Examples for protective clothing: welders’ clothing, high visibility clothing, etc.
  • category III: PPE of complex design intended to protect against mortal danger or against serious and irreversible health risks, which cannot be identified in sufficient time.

This concerns explicitly and exclusively:

  • filtering respiratory devices protecting against solid and liquid aerosols, irritant, dangerous, toxic and radiotoxic gases;
  • respiratory protection devices providing full insulation from the atmosphere (including diving equipment);
  • PPE providing limited protection against chemical attack or against ionizing radiation;
  • equipment for use in hot environments (> 100 °C effective temperature), including the possible presence of infra-red radiation, flames or large projections of molten material;
  • equipment for use in cold environments (< -50°C effective temperature);
  • PPE to protect against falls from a height;
  • PPE against electrical risks and dangerous voltages, or used as insulation in high-tension work.
  • effective temperature: the “real” temperature as perceived by an individual, taking into account factors such as radiant heat, convective heat or wind chill.


Before placing his product on the European market, the manufacturer must go through a certification procedure to prove the compliance of his product with the requirements of the Directive 89/686/EEC. When he has completed the procedure successfully he is allowed to affix the CE marking on his product and to make the EC declaration of conformity.

Compliance with the requirements of the Directive can be proven either by satisfying directly the basic requirements of annex II of the Directive or by satisfying the requirements of the relevant harmonised standard.

  • harmonised standard: A European standard which contains provisions related to the basic requirements of a European Directive. Harmonised standards are made on request of the European Commission and their reference is published in the Official Journal of the EU. The relationship between the provisions of the standard and the basic requirements of the Directive are given in an informative annex of the standard ( the Z-annex). Conformity with a harmonised standard gives a presumption of conformity with the essential safety requirements of the Directive.

The certification procedure is related to the category the PPE belongs to.

  • category I: the manufacturer has to assemble a technical documentation which can, if necessary, be submitted to the competent authorities. This documentation must comprise all relevant data on the means used by the manufacturer to prove compliance with the basic requirements of the Directive.
  • category II: the manufacturer has to satisfy the requirements of category I PPE. In addition he must submit a model of his PPE to a notified body for EC-type-examination. This examination shall be made on the manufacturer’s technical file, including the information to the user, and on the model. If conformity is proven, the notified body issues a certificate of EC type-examination.
  • Notified Body: A body appointed by a Member State of the EU to perform conformity assessment tasks within the scope of a particular Directive (e.g. EC type-examination, control of manufactured PPE) for a particular group of products (e.g. protective clothing). The European Commission assigns a number to each of these notified bodies.
  • category III: the manufacturer has to satisfy the requirements of category II PPE. In addition a system for checking of manufactured PPE should be installed. The manufacturer has the choice between two systems:
  • quality control system for the final product: a notified body carries out the necessary checks at random, at intervals of at least one year, and performs the appropriate tests on the sampled products;
  • quality assurance of production by means of monitoring: a notified body assesses the quality control system of the PPE manufacturer and determines whether it can guarantee compliance with the provisions of the Directive.

EC Declaration of production conformity

To show compliance with the provisions of the Directive the manufacturer must:

  • draw up a declaration, certifying that the PPE he puts on the market complies with the provisions of the Directive, i.e.:
  • it meets the basic requirements, e.g. by proving conformity with the relevant harmonized standard (for all categories of PPE);
  • it is identical with the PPE subject to an EC certificate of conformity issued by a notified body (for PPE categories II and III);
  • it is subject to a control system for manufactured PPE, by a notified body, either by product checks at regular intervals, or by means of monitoring of the manufacturer’s quality control system (for PPE category III).

This declaration has to be submitted to the competent authorities on their request.

  • affix the EC mark of conformity to each PPE. This marking consists of the letters “CE” in a particular style. For category III PPE the number of the notified body responsible for the permanent quality surveillance required for these products.

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Basic health and safety requirements

The basic health and safety requirements applicable to PPE are given in an annex to the Directive. The formulation of these requirements is done in very general terms. The harmonized European standards can be considered as the more quantitative and performance-oriented expression of the basic requirements.

The basic requirements are clustered in three groups:

  • general requirements applicable to all PPE;
  • requirements specific to particular types of PPE;
  • requirements specific to particular risks.

A very important general requirement is the obligation for the manufacturer to supply an informative note to the user. This note must be provided at least in the official language(s) of the EU Member State of destination. It must contain all relevant information on:

  • storage, use, cleaning, maintenance, servicing and desinfection;
  • test results to check the levels of protection offered by the PPE;
  • accessories and spare parts;
  • classes of protection and corresponding limits of use;
  • obsolescence deadline (if appropriate);
  • packaging for transport;
  • the significance of markings and pictogrammes.

The CE-marking consists of the initials “CE”, written in a specific form.

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The CE-marking symbolizes that products conform to the rules and requirements set out in a European Directive, e.g. 89/686/EEC in the case of protective clothing. Member States must refrain from introducting into their national regulations any reference to a conformity mark other than the CE-marking. Products may however bear other quality marks on condition that this can not cause confustion with the CE-marking.

The manufacturer affixes the CE-marking on his products on his own responsibility. The act of putting the marking on a product means more than just a mark. It means that the manufacturer has verified that the product conforms to all the relevant EU-requirements and has been subjected to the appropriate conformity evaluation procedures.

This means in practice for PPE:

  • for category I PPE (simple design, low risk): the manufacturer declares that his product conforms to the essential safety and health requirements, stated in Annex II of the Directive 89/686;
  • for category II PPE (medium risk): the manufacturer declares that the product conforms to the essential safety and health requirements and has been subjected to a CE type approval by a notified body;
  • for category III PPE (complex design, life-threatening risk): the manufacturer declares that the product conforms to the essential safety and health requirements, has been subjected to a CE type approval by a notified body; and that a permanent surveillance system has been installed under supervision of a notified body.

A very convenient way to prove conformity to the essential requirements of a Directive is the use of harmonized European standards. The term harmonized refers to the role of these standards: they have been developed in support of European legislation and their reference number and title have been published in the Official Journal of the European Communities. Conformity to the relevant harmonized European standard confers to the product a presumption of conformity to the essential requirements. In most cases the products will then be marked with the CE-marking and the reference number of the standard. This marking with the reference number of a standard is voluntary unlike the CE-marking, which is compulsory.


We have a complete manufacturing unit comprises of different section, 30 Circular Knitting Machines of different gauges and diameters in KNITTING UNIT 2 Hydraulic Travelling head cutting press in CUTTING UNIT 100 Chain Lock Stitching Machines in STITCHING UNIT. All gloves are being individually checked by quality control department before ironing and packing. All the Sections are being run by fully qualified people, Export Marketing and Management is being controlled by the technically experienced / educated and widely travelled people. .

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