CE Marking (CE Mark) for Personal Protective Equipment: EU Council Directive of 21 December 1989 (89/686/EEC) & Annex I, II, ... VI

Brief Introduction of
Directive 89/686/EEC
Personal Protective Equipment

This directive has been amended by the following Council Directives:

1. 92/59/EEC of 29 June 1992 (General Product Safety);

2. 93/68/EEC of 22 July 1993 (CE Marking directive).

* The term 'EC Mark' appeared in this directive is out of date and has been officially replaced by term 'CE Marking' in 1993 in the CE Marking directive 93/68/EEC.

COUNCIL DIRECTIVE of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (89/686/EEC)

Article 1

1. This Directive applies to personal protective equipment, hereinafter referred to as 'PPE'.
It lays down the conditions governing its placing on the market and free movement within the Community and the basic safety requirements which PPE must satisfy in order to ensure the health protection and safety of users.

2. For the purposes of this Directive, PPE shall mean any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards.
PPE shall also cover:
(a) a unit constituted by several devices or appliances which have been integrally combined by the manufacturer for the protection of an individual against one or more potentially simultaneous risks;
(b) a protective device or appliance combined, separably or inseparably, with personal non-protective equipment
worn or held by an individual for the execution of a specific activity;
(c) interchangeable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment.

3. Any system placed on the market in conjunction with PPE for its connection to another external, additional device shall be regarded as an integral part of that equipment even if the system is not intended to be worn or held permanently by the user for the entire period of risk exposure.

4. This Directive does not apply to:
- PPE covered by another directive designed to achieve the same objectives as this Directive with regard to placing on the market, free movement of goods and safety,
- the PPE classes specified in the list of excluded products in Annex I, independently of the reason for exclusion mentioned in the first indent.

Article 2

Article 3

Article 4

1. Member States shall not prohibit, restrict or hinder the placing on the market of PPE or PPE components which satisfy the provisions of this Directive and which bear the EC mark.

Article 5

Article 6

Article 7

CHAPTER II

CERTIFICATION PROCEDURES

Article 8

1. Before placing a PPE model on the market, the manufacturer or his authorized representative established in the Community shall assemble the technical documentation referred to in Annex III so that this can, if necessary, be submitted to the competent authorities.

2. Prior to the series production of PPE other than those referred to in paragraph 3, the manufacturer or his authorized representative established in the Community shall submit a model for EC type-examination as referred to in Article 10.

3. EC type-examination shall not be required in the case of PPE models of simple design where the designer assumes the user can himself assess the level of protection provided against the minimal risks concerned the effects of which, when they are gradual, can be safely identified by the user in good time.
This category shall cover exclusively PPE intended to protect the wearer against:
- mechanical action whose effects are superficial (gardening gloves, thimbles, etc.),
- cleaning materials of weak action and easily reversible effects (gloves affording protection against diluted detergent solutions, etc.),
- risks encountered in the handling of hot components which do not expose the user to a temperature exceeding 50 gC or to dangerous impacts (gloves, aprons for professional use, etc.),
- atmospheric agents of a neither exceptional nor extreme nature (headgear, seasonal clothing, footwear, etc.),
- minor impacts and vibrations which do not affect vital areas of the body and whose effects cannot cause irreversible lesions (light anti-scalping helmets, gloves, light footwear, etc.),
- sunlight (sunglasses).

4. Production of PPE shall be subject:
(a) according to the manufacturer's choice, to one of the two procedures referred to in Article 11 in the case of PPE of complex design intended to protect against mortal danger or against dangers that may seriously and irreversibly harm the health, the immediate effects of which the designer assumes the user cannot identify in sufficient time. This category shall cover exclusively:
- filtering respiratory devices for protection against solid and liquid aerosols or irritant, dangerous, toxic or radiotoxic gases,
- respiratory protection devices providing full insulation from the atmosphere, including those for use in diving,
- PPE providing only limited protection against chemical attack or against ionizing radiation,
- emergency equipment for use in high-temperature environments the effects of which are comparable to those of an air temperature of 100 gC or more and which may or may not be characterized by the presence of infra-red radiation, flames or the projection of large amounts of molten material,
- emergency equipment for use in low-temperature environments the effects of which are comparable to those of an air temperature of 50 gC or less,
- PPE to protect against falls from a height,
- PPE against electrical risks and dangerous voltages or that used as insulation in high-tension work,
- motor cycle helmets and visors;
(b) the EC declaration of conformity referred to in Article 12 for all PPE.

Article 9

EC TYPE-EXAMINATION

Article 10

1. EC type-examination is the procedure whereby the approved inspection body establishes and certifies that the PPE model in question satisfies the relevant provisions of this Directive.

2. Application for EC type-examination shall be made by the manufacturer or his authorized representative to a single approved inspection body in respect of the model in question. The authorized representative shall be established in the Community.

3. The application shall comprise:
- the name and address of the manufacturer or his authorized representative and of the PPE production plant in question,
- the manufacturer's technical file referred to in
Annex III.
It shall be accompanied by the appropriate number of specimens of the model to be approved.

4. The inspection body of which notification has been given shall conduct the EC type-examination in accordance with the undermentioned procedures:
(a) Examination of the manufacturer's technical file
- It shall examine the manufacturer's technical file to establish its suitability with respect to the harmonized standards referred to in Article 5.
- Where a manufacturer has not applied, or has only partly applied, the harmonized standards or where there are no such standards, the body of which notification has been given must check the suitability of the technical specifications used by the manufacturer with respect to the basic requirements before examining the manufacturer's technical file to establish its suitability with respect to these technical specifications.
(b) Examination of the model
- When examining the model, the inspection body shall verify that it has been produced in accordance with the manufacturer's technical file and can be used in complete safety for its intended purpose.
- It shall conduct the necessary examinations and tests to establish the conformity of the model with the harmonized standards.
- Where a manufacturer has not applied or has only partly applied the harmonized standards or where there are no such standards the body of which notification has been given shall conduct the necessary examinations and tests to establish the conformity of the model with the technical specifications used by the manufacturer, subject to their being suitable with respect to these basic requirements.

5. If the model satisfies the relevant provisions, the inspection body shall draw up an EC type-examination certificate and shall notify the applicant to this effect. This certificate shall reproduce the findings of the examination, indicate any conditions attaching to its issue and incorporate the descriptions and drawings necessary for the identification of the approved model.
The Commission, the other approved inspection bodies and the other Member States may obtain a copy of the certificate and, in response to a reasoned request, a copy of the manufacturer's technical file and the reports of the examinations and tests conducted.
The file shall be held at the disposal of the competent authorities for 10 years following the placing of the PPE on the market.

6. Any inspection body which refuses to issue an EC type-examination certificate shall inform the other approved inspection bodies of this fact. An inspection body withdrawing an EC type-examination certificate shall inform the Member State which approved it, to this effect. That Member State shall then inform the other Member States and the Commission, setting out the reasons for the decision.

Article 11

EC DECLARATION OF PRODUCTION CONFORMITY

Article 12

The EC declaration of conformity is the procedure whereby the manufacturer:

1. draws up a declaration using the form laid down in Annex VI certifying that the PPE placed on the market are in conformity with the provisions of this Directive with a view to its submission to the competent authorities;

2. affixes the EC mark of conformity provided for by Article 13 to each PPE.

CHAPTER III EC MARK

CHAPTER IV FINAL PROVISIONS

ANNEX II

BASIC HEALTH AND SAFETY REQUIREMENTS
1. GENERAL REQUIREMENTS APPLICABLE TO ALL PPE
2. ADDITIONAL REQUIREMENTS COMMON TO SEVERAL CLASSES OR TYPES OF PPE
3. ADDITIONAL REQUIREMENTS SPECIFIC TO PARTICULAR RISKS

ANNEX III
TECHNICAL DOCUMENTATION SUPPLIED BY THE MANUFACTURER

ANNEX IV
EC MARK OF CONFORMITY

ANNEX V

ANNEX VI
MODEL EC DECLARATION OF CONFORMITY

Please click the following links to learn more about every CE-Marking-related European Union Directive, Guidelines to Directives, Frameworks of implementation of Directives, and Agreements on Mutual Recognition of conformity assessment between European Union and other countries such as USA, Japan, Canada, Australia, New Zealand and Israel:-

What is CE marking (CE mark)?

The CE marking logo (Free download CE mark logo)

Download of the EC Rep symbol/logo

CE Marking (CE mark) EU/EC Declaration of Conformity: definition and required content

What is a manufacturer? What are the responsibilities of a manufacturer?

Is the Own Brand Labeller or Private Labeller considered as the legal Manufacturer?

Why is CE marking called "European passport"?

Does my product need CE Marking in order to be sold/exported on/to the European Market?

How to obtain CE Marking for my product?

How can Wellkang Tech Consulting help me to obtain CE Marking for my product?

Wellkang can be your Authorized Representative in Europe for CE Marking purpose !

Complete list of all CE Marking Directives and Guidelines to Directives