Source: EURLEX
Language: en
Format: md

### **`COMMISSION OF THE EUROPEAN COMMUNITIES`**

```
                        C0M(91)516 final - SYN 375

                        Brussels, 13 December 1991

                  Proposal for a

                 COUNCIL DIRECTIVE

             on the approximation of the laws

          of the Member States concerning equipment

           and proteotive systems intended for use

            in potentially explosive atmospheres

              (presented by the Commission)

```

```
                   - 2 
 I. General

###### **`i. Aim of the proposal`**

 a. Regulatory aspects

    This proposal for a directive is intended to replace Directives
    76/117/EEC and 79/196/EEC (surface equipment) and Ô2/130/EBC
    (mining equipment), together with their subsequent amendments
    84/47/EEC, 88/571/EEC, 90/487/EEC, 88/35/EEC and 91/269/EEC.

    There were, indeed, certain difficulties in Implementing those
    directives, which only incorporated an intermediate stage for the
    treatment of equipment that could be used in potentially explosive
    atmospheres:

    - the harmonization introduced was only of the "optional" type,
      thus enabling the Member States to majTvha.in a legal system
      parallel to that introduced by the directives. This only
      ensured the free movement of equipment complying with it.
      Nevertheless, when directive 79/196/EEC was adopted the Council
      asked the Commission during a subsequent stage, to study the
      scope for achieving total harmonization and to sent it proposals
      with that in mind (cf. declaration set out in the minute,
      Document 4336/79 of 31 January 1979);

    - the scope of the existing directives is restricted to electrical
      equipment and, in the case of surface equipment, is governed by
      the use of certain specific types of protection. This was
      correct practice in 1979 but it has been unable to take account
      of major technological change and recent discoveries regarding
      physical sources and phenomena relating to ignition. Certain
      risks had either not been encountered or were considered
      harmless and only emerged through experience or detailed
      research.

```

```
                                    3

     the technical annex to the directives is a direct reference to
      the CENELBC standards, thus requiring the long, complicated
     procedure required by the Committee on Adaptation to Technical
      Progress. This means that several years often elapse between
      adaptation of the content of the standards by CENELBC and their
     harmonization via a Commission directive. Manufacturers
      therefore only benefit from free movement after
      disproportionately long delays.

      a particular problem arises from the separate treatment of
      surface and mining equipment in separate directives. It
      therefore becomes difficult to synchronize adaptation to
      technical progress procedures for the two groups of equipment,
      especially since the respective cxanmittees are completely
      different (ministries for industry as :regards surface equipment,
      closed committee within the Safety and Health Commission for the
      Mining and other Extractive Industries). It must also be
      pointed out that the CENELEC standards relating to mining
      equipment have undergone amendments of varying scope in the form
      of a technical annex to Directive 83/130/EEC. The specific
      features of the two groups of often very similar or identical
      forms of equipment could no longer, however, Justify their being
      dealt with in two separate categories? of directive and can be
      subjected to the basic requirements and the typical conformity
      certification procedures by means of equipment categories within
      that single directive.

      Directive 89/392/EBC on machinery [1] has covered machinery that
      can be used in potentially explosive atmospheres or which
      themselves can create such an atmosphere (Annex 1, Item 1.5.7       explosion hazards). The intention of this directive as regards
      those same machines is to fine-tune the essential requirements
      applying to such hazards. Prom this standpoint it will thus
      constitute a separate directive deriving from Article 1(4) of
      the machinery directive.

```

`1` `OJ` _m_ `NO` `L 183, 29.6.1990.`

```
                _ 4 
  - The aim of the Directive is twofold: (a) the removal of
    barriers to trade of which the optional directives were an
    initial stage and (b) the setting of a hj^h uniform level of
    protection. That aim would only be imperfectly achieved if one
    restricted oneself to a sLmple removal of existing barriers to
    trade without taking account of the means of avoiding the
    raising of any such barriers. Following a slow pace of
    technological change during the 1970s the procedure for the
    provision of information set out in Directive 83/189/EEC has
    enabled us to note an increase in the number of notifications of
    a technical nature governing either aspects of or complete
    sectors within the ATEX field. We can quote technical
    regulations in the oil, painting and printing equipment
    industries, measures applying to electrostatic discharges,
    certain measuring instruments, etc. The existence of
    regulations of this type in not all of the Member States can in
    the long term only impede the free movement of ATEX equipment.

b. Technical aspects

    The rapid changes in the situation as regards explosion hazards
    has prompted research into the other possible sources of
    ignition. For the moment it has thus been possible to pinpoint
    13 of these, of which only half have been electrical in nature:

    Of those mainly of the electrical type we can quote electric
    sparks, arcs and flash currents, electrostatic charges,
    electromagnetic waves, and ionizing radiation. Those of a
    mainly non-electric type under consideration are hot surfaces,
    flames and hot gases, mechanically generated sparks, optical
    radiation, ultrasound, chemical flame initiation and adiabatic
    cxampression.

    A taking account solely of electrical hazards would thus appear
    to be a minimalist approach that is inadequate in aiming at

```

```
             - 5 
the high level of protection which Article 100(3) requires from
the Commission in preparing its proposals. Moreover, the
interlinking of scientific disciplines and the superposing of
the technologies applied make the distinction between electric
fl r r>H non-electric equipment highly troublesome and, ultimately,
arbitrary.

Apart from the inclusion of non-electrical equipment the
proposal harmonizes the systems intended to arrest a nascent
explosion or else to limit its consequences to an acceptable
minimum. It is accepted that, despite the upgrading of
equipment, it is impossible totally to exclude any possibility
of explosion. Downstream measures need, to be taken in order to
achieve total safety. Likewise devices located outside
potentially explosive atmospheres, the performance of which,
however, has a direct impact on the safety of equipment within
such atmospheres, are covered.

Annex I to the directive defines five categories of equipment
(three for surface equipment and two for mining equipment) which
take practical form in the essential requirements listed in the
Annex II applying to them. The categories correspond in
structural terms to a hierarchy of protection against explosions
and are thus also linked to appropriate means of certification
of conformity.

The directive also covers equipment designed for environments
containing mixtures of Inflammable dusts. The very usef of
equipment of this type causes national discrepancies
(determination of zones), which is in contrast to use in
potentially explosive gases, and on which a consensus seems to
be forming within the circles involved. Design requirements
will have a positive impact on the aspects linked with the use
and installation of such equipment - an area to be governed in
future by Article 118A directives.

```

```
                   - 6 
2. Economic and SQC&alJlJgrpaat.

A. Economic impact

  ATEX equipment holds considerable économie appeal. It is widely used in
  key sectors of industry: the extraction of solid, liquid and gaseous
  fuels (coal, oil and natural gas), the chemical and metal-working
  industries, the treatment of inflammable organic products (and more
  especially foods), wood and plastic-treatment facilities, printing
  works, eto. Each year roughly 2 500 certificates of conformity are
  issued following tests by the bodies officially appointed for electrical
  equipment. This raises purchase prices - a trend which will continue
  into the future, more particularly since the individual requirements
  will in certain cases require further tests. Moreover, the
  non-repetition of tests of this type on the Community market will reduce
  manufacturers' expenses and, indirectly, those of users, to an
  acceptable level. Although difficult to quantify this is important for
  safety and economic reasons in removing barriers to trade and finding a
  suitable equilibrium. This is why the directive aims to create or
  maintain a high level of safety within reasonable cost limits. As they
  are a considerable asset in rationalizing and improving productivity the
  harmonized standards drawn up by CEN and CENELEC will make a major
  contribution to the success of this proposal, which implements the New
  Approach principle. In parallel to this the directive will be the
  driving force behind speeding up the standardization activities.

B. fiodai aspects

  This proposal will not alter established structures. However,- an
  overall spread of safety which avoids grey areas between differing
  regulations cannot be underestimated with regard to the users of such
  equipment. It should be noted against the same backdrop that this
  "design" directive will be supplemented by a sister directive dealing
  with the use of ATEX equipment, the latter having ;its legal basis in
  Article 118 A.

```

```
                   - 7 
C. Consultation of interested parties

  Government and private experts helped to prepare this directive, the
  latter coming in particular from CRGALIME (the liaison organization for
  the European metal industries), CEFIC (European Council for the Chemical
  Industry Federations), the FIMTM (Federation of Engineering and Metal
  Processing Industries), the European Standardization bodies GEN and
  CENELEC. The European Union of alcohol, brandy and spirit producers^and
  EOEOPLANT have pledged their support for .the Commission in .writing.

  It has been put to and discussed within the Consultative Committee on
  Safety, Hygiene and the Protection of Health at the Workplace and the
  Safety and Health Commission for the Mining and other Extractive
  Industries.

  Two observers from the EFTA secretariat have also been present during
  the discussions.

#### **n . Tte projxml for ft dlrfXTtlvft**

This is a "New Approach" directive which ijmplements the guidelines set out
in the Council Resolution of 7 May 1985. It is based on Article 10QA of
the Treaty of Rome.

1. Scope

  The Directive is broad in scope, covering both the electrical and.non
  electrical fields, protective systems and such devices not in
  potentially explosive atmospheres but having repercussions on equipment
  working in such atmospheres. It covers an enoraious section of industry
  as explained in Chapter 1 and as governed by the Council Resolution of
  7 May 1985.

2. Components.

  The problem of the treatment of components has been acknowledged by the
  Commission. A definition is given in Article 1 and identifies (a) the
  absence of stand-alone operation and (b) any essential contribution to
  equipment safety.

```

```
                   - 8

  The procedures applying to changes in conformity will be governed by
  those for the category for which the œmplete item of equipment is
  intended. Manufacturers will certify cxanpliance with the abovementioned
  procedures in a statement without, however, affixing the EC mark to the
  component

3. Safety and health requirements

A. Annex 1 - Criteria determining the assignment of groups of devices to
  conformity categories.

  Annex 1 to the directive is divided into two groups of device: group 1
  governing mining equipment and group 2 surface equipment. Each group is
  further subdivided into conformity categories i.e. 1, 2 and 3 in the
  case of surface equipment, (M)l and (M)2 for mining. This list is based
  on a hierarchy of protective measures applying to that equipment. Thus
  category 1 covers equipment providing a high level of protection and
  thus able to operate where there is a high probability of potentially
  explosive atmospheres.

  In decreasing order categories 2 and 3 will be intended for environments
  in which potentially explosive atmospheres are less probable. The
  philosophy for group 1 is similar. The idea of probability is of
  crucial importance in the area covered. Users are required to pinpoint
  in their facilities areas within which inflammable gases or dusts are
  likely to be released or present with various degrees of probability.
  The parameters taken into account are contained in either national
  regulations or international standards. Harmonization can only be
 ^contemplated via an Article 118A directive and is not dealt with in this
  proposal. However, the requirement categories set out therein aim, in
  structural and design terms, at an identical intrinsic level-of
  equipment protection. The combination of equipment designed
  specifically in line with certain conformity categories and, its
  installation/use in line with manufacturers' instructions

```

```
                    9 
 must provide a maximum level of safety.

  In an industrial environment the measures intended to protect against
  explosions caused by inflammable dusts have been placed in an
  appropriate category depending upon the potential hazard.

  Thifi does not mean identical design for equipment intended for use in
  dusty atmospheres or gaseous environments. The basic requirements set
  out in Annex II are entirely specif io and relate to the abovementioned
  intended use. In this case assignment to one and the same category
  derives first and foremost from identical conformity certification
  procedures. It is thus suggested that the equipment should be placed in
  Category 1 or 3.

B. Annex II - TVi^-lp safety• rfypilT™imt«

  Annex II sets out the basio general and specific requirements to be met
  by items of equipment in the light of the abovementioned classification.
  The two annexes thus constitute an inseparable whole. The risks
  involved are in principle in direct relation with the explosion of the
  potentially explosive atmosphere. The essential requirements of
  machinery directive 89/392/EEC shall also apply to other risks due, for
  example, to the use of a machine in potentially explosive atmospheres.

4. Conformity assessment procedures

  The procedures described in detail in the following article take the*
  form of a hierarchy relating to the levels of risk for which equipment
  is Intended. As a general rule the choice is left to manufacturers as
  to whether or not to apply quality assurance systems.

```

##### `- 10 -`

```
The procedures can be summarized as follows:

```

`A.` `Equipment.` `1nf>^y11ng` `W^^-PA` _rvneaaaTy._ `rtpwinfla not in potentially`
```
   explosive atmospheres fortr Hnftflfl to ATl1r [imf] ?P [t] ^ P ^ ^ t^T^-tO, and
   Integrated protection systems

   1. Groups I and II, conformity category (M)l and 1

    either EEC type examination (module B) +

         production quality assurance (mod. D)

      or

         on-produot check (mod. F)

     or complete quality assurance (mod. H)

   2. Groups I and II, conformity category (M)2 and 2

    EC type approval (mod. B) +

         conformity with type (mod. C)

      or

         product quality assurance (mod. E)

   3. Group II, conformity category 3

     only applying to surface industries:

         internal manufacturing inspection (mod. A)

B. Autonomously functioning proteotive systems

   EC type examination (mod. B) +

   - conformity to type (mod. C)

    or

       product quality assurance (mod. E)

In all cases manufacturers have the option of resorting to the EC unit
verification procedure (mod. G).

```

###### **`- 11 -`**

```
5. Means of conformity

  The proposal takes account of the most recent situation as regards the
  use of the EC mark. -However, in order to avoid any confusion and to
  draw user attention to the particular characteristics of the equipment,
  provision is made for the addition of further markings. This will
  include, in particular, a specific explosion prevention sign, the
  equipment-group symbol (I - mining, II - surface industries), the
  conformity category M(l), M(2), 1, 2 or 3, the .nature of the potentially
  explosive mixture (G: gas, D: dusts), and all restrictions on the use or
  conditions applying to safe use.

##### 6. P^p^l nf redoing fllxflflUvftf*

  This proposal for a directive completely replaces the harmonization
  introduced by Directives 76/117/EBC, 79/196/EEC, 90/487/EEC and
  82/130/EBC and their successive amendments, which will therefore be
  repealed. Nevertheless, the present system has in the past guaranteed a
  high level of protection which should therefore not be impaired. The
  achievements applying to electrical equipment will therefore in essence
  be retained subject, naturally, to an examination of the scope for
  improvement. The high level already existing will, moreover, be
  extended to cover equipment not currently dealt with by Community law.

##### `7. PmdHne for entry into force`

  The intention is to implement the directive in two stages:

  - optional ijmplementation: 1 July 1993

  - total implementation: 1.1.2003

The optional period is justified for the setting up of any specific test
and certification structures and to avoid massive demand and thus excessive
time lags.

Indeed, although few changes to test facilities seem necessary in the
electrical field the same does not apply to the non-electrical field where
a great deal of work is required, in particular on the preparation of
harmonized standards.

```

```
                   - 12 
               COUNCIL DIRECTIVE

          on the approximation of the laws

     of the Member States concerning equipment and

        protective systems Intended for use In

          potentially explosive atmospheres

THE COUNCIL OF THE EUROPEAN COMMUNITIES

Having regard to the Treaty establishing the European

Economic Community, and In particular Article 100A thereof;

Having regard to the proposal from the Commission-, [1 ]

In cooperation with the European Parliament; [2 ]

Having regard to the opinion of the Economic and Social

Comm11 tee ; 3

Whereas It is the duty of Member States to protect, on their

territory, the safety and health of persons and, where

appropriate, domestic animals and property and, In

particular, that of workers, especially against the hazards

resulting from the use of equipment and systems providing

protection against potentially explosive atmospheres;

1 OJ EC ( ) .

2 0J EC ( ) .

3 0J EC ( ) .

```

```
                     - 13 
W h e r e a s m a n d a t o r y p r o v i s i o n s w i t h i n the Member S t a t e s

d e t e r m i n e the level of safety to be a c h i e v e d by p r o t e c t i v e

e q u i p m e n t and s y s t e m s Intended for use in p o t e n t i a l l y

e x p l o s i v e a t m o s p h e r e s ; w h e r e a s these are g e n e r a l l y

e l e c t r i c a l and n o n - e l e c t r i c a l s p e c i f i c a t i o n s having an

effect on the d e s i g n and s t r u c t u r e of e q u i p m e n t that can be

used in p o t e n t i a l l y e x p l o s i v e a t m o s p h e r e s ;

W h e r e a s the r e q u i r e m e n t s to be met by such e q u i p m e n t differ

from one Member State to another In respect of their extent

and d i f f e r i n g inspection p r o c e d u r e s ; w h e r e a s these

d i f f e r e n c e s are t h e r e f o r e likely to raise b a r r i e r s to trade

w i t h i n the C o m m u n i t y ;

W h e r e a s the r e g u l a t i o n s Intended to remove technical

b a r r i e r s to trade are r e q u i r e d to follow the new a p p r o a c h

p r o v i d e d for In the Council R e s o l u t i o n of 7 May 1 9 8 5, [4 ]

w h i c h r e q u i r e s a d e f i n i t i o n of the e s s e n t i a l r e q u i r e m e n t s

```

**`r e g a r d i n g`** **`s a f e t y`** **`and other`** **`r e q u I r e m e n t s`** _**•**_ **`of`** **`s o c i e t y`** **`w i t h o u t`**

```
r e d u c i n g e x i s t i n g, j u s t i f i e d levels of p r o t e c t i o n w i t h i n the

Member S t a t e s ; w h e r e a s that r e s o l u t i o n p r o v i d e s that a very

 large number of p r o d u c t s be c o v e r e d by a s i n g l e d i r e c t i v e -In'**

order to avoid frequent a m e n d m e n t s and the p r o l i f e r a t i o n of

d i r e c t I v e s ;

W h e r e a s the e x i s t i n g d i r e c t i v e s on the a p p r o x i m a t i o n of the

 laws of the Member S t a t e s r e l a t i n g to e l e c t r i c a l e q u i p m e n t

 for use In p o t e n t i a l l y e x p l o s i v e a t m o s p h e r e s have made >

p o s i t i v e s t e p s t o w a r d s p r o t e c t i o n against

    0J EC No C 1 3 6, 4 . 6 . 1 9 8 5, p. 1.

```

```
                     14 
e x p l o s i o n s via measures linked with the s t r u c t u r e of the

equipment at Issue and which have helped to remove b a r r i e r s

to trade In this area. W h e r e a s, In p a r a l l e l, a revision and

expansion of the existing directives Is n e c e s s a r y s i n c e,

more p a r t i c u l a r l y In an overall context, action must be

taken to guard against the potential hazards arising from

such e q u i p m e n t . This Implies in particular that m e a s u r e s

Intended to guarantee effective protection of users and

third parties must already be contemplated at the design and

m a n u f a c t u r i n g stages;

Whereas the form taken by the hazard, the p r o t e c t i v e

measures and the test methods are often very s i m i l a r, if not

Identical, for both mining and surface e q u i p m e n t ; w h e r e a s it

Is therefore an absolute necessity to cover p r o t e c t i v e

equipment and systems falling within both groups by a single

d i r e c t i v e ;

Whereas the two groups of equipment referred to above are

used in a large number of commercial and industrial sectors

and possess considerable economic s i g n i f i c a n c e ;

Whereas c o m p l i a n c e with the -basic safety and health

requirements is essential in order to ensure the safety of

protective equipment and s y s t e m s ; whereas those r e q u i r e m e n t s

have been subdivided into general and additional

requirements which must be met by protective equipment and

systems; w h e r e a s in particular the additional r e q u i r e m e n t s

are intended to take account of existing or potential

hazards; w h e r e a s protective equipment and systems will

 therefore embody at least one of those r e q u i r e m e n t s where

```

```
                   - 15 
this is necessary for their proper functioning or Is to

apply to their intended use; whereas the notion of intended

use is of prime Importance for the explosion-proofing of

protective equipment and systems; whereas It is essential

that manufacturers supply full Information; whereas

specific, clear marking of said equipment, stating Its use

In a potentially explosive atmosphere, Is also necessary;

Whereas the present Intention is to prepare a directive on

operations in potentially explosive atmospheres that is

based on Article 118A; whereas that additional directive

will, In particular, aim at explosion hazards that derive

from a given use and/or types and methods of Installation;

Whereas judgment will have to be exercised in the

Implementation of those requirements in order to take

account of the technology available at the time of

manufacture ;

Whereas this directive therefore only sets out essential

requirements; whereas in order to ease the task of proving

compliance with the essential requirements standards

harmonized at European level are necessary, more especially

with regard to the non-electrical aspects of protection

against explosions - standards relating to the design,

manufacture and testing of equipment, compliance with which

enables a product to be presumed to meet said essential

requirements; whereas standards harmonized at European level

```

```
                    - 16 
are drawn up by private bodies and must retain their

non-mandatory status; whereas, for this purpose, the

European Committee for Standardization (CEN) and the

European Committee for EIectrotechnica I Standardization are

recognized as being the bodies that are competent to adopt

harmonized standards that follow the general guldelInes for
cooperation between the Commission and those two bodies

signed on 13 November 1984; whereas, for the purposes of

this directive, a harmonized standard Is a technical

specification (European Standard or harmonization document)

adopted by one or other of those bodies, or by both, at the

prompting of the Commission in pursuance of Council

Directive 83/189/EEC of 28 March 1983 providing for a

procedure governing the provision of Information on

technical standards and regulations, [5] as last amended by

Directive 88/182/EEC [6] and In pursuance of the general

guidelines referred to above;

Whereas, in view of the nature of the risks Involved in the

use of equipment in potentially explosive atmospheres it Is

necessary to establish procedures applying to the assessment

of compliance with the basic requirements of the directives;

whereas these procedures must be devised In the light of the

 level of danger which may be Inherent In equipment and/or

against which systems must protect the Immediate

environment; whereas therefore each category of equipment

conformity must be supplemented by an adequate procedure or

a choice between several equivalent procedures; whereas the

procedures adopted are fully as required by the Council

decision of 13 December 1990 [7] concerning the modules for

the various phases of the conform Ity assessment procedures

which are Intended to be used in the technical harmonization

d I rect I ves ;

5 0J No L 109, 26.4.1983, p. 8.

6 0J No L 81, 26.3.1988, p. 75.

7 0J No L 7, 380, 31.12.1990, p. 13.

```

```
                    - 17 
Whereas the Council has provided for the affixing of the EC

mark either by the manufacturer or by his authorized

representative within the Commun Ity or, fallIng that, by the

person responsible for placing that product on the community

market; whereas that mark means that ttie product' complies

with all the basic requirements and assessment procedures

provided for by the Community law applying to that product;

Whereas it is appropriate that the Member States, as

provided for by Article 100a of the Treaty, may take

temporary measures to limit or prohibit the placing on the

market and the use of equipment and protective systems in

cases where they present a particular risk to the safety of

persons and, where appropriate, domestic animals or

property, provided that the measures are subject to a

Community control procedure;

Whereas the recipients of any decision taken as part of this

directive must be aware of the reasons behind that decision

and the means of appeal open to them;

Whereas, on 18 December 1975, the Council adopted a

framework directive on electrical equipment for use in

potentially explosive atmospheres ( 7 6 / 1 1 7 / E E C ) [8] as last

amended by Directive 90/47/EEC [9] and, on 15 February 1982 a

8 0J No L 24, 31.1.1976, p. 45.

9 0J No L 270, 2.10.1990, p. 23.

```

```
                    - 18 
directive concerning electrical equipment for use in

potentially explosive atmospheres in mines susceptible to

fire damp (82/130/EEC) [1] ° as last amended by Directive

91/269/EEC; [1 1] whereas, from the outset of the harmonization

activities, the conversion of the optional and partial

harmonization on which these directives are based Into total

harmonization had been contemplated; whereas this directive

fully covers the scope of the above mentioned directives and

whereas therefore these directives must be repealed;

Whereas the measures Intended gradually to introduce the

internal market must be adopted before 31 December 1992;

whereas the internal market incorporates an area without

internal frontiers within which the free movement of goods,

persons, services and capital Is assured;

Whereas it is necessary to provide for a transitional

arrangement enabling equipment manufactured In compliance

with the national regulations in force at the date of

adoption of this directive to be marketed and placed In

service is necessary,

HAS ADOPTED THIS DIRECTIVE:

10 OJ No L 59, 2.3.1982, p. 10.

 11 OJ No L 134, 29.5.1991.

```

```
                  19 
               Chapter I

Scope, placing on the market and freedom of movement

                Art Icle 1

 This Directive applies to equipment and protective

 systems Intended for use in potentially explosive

 a t m o s p h e r e s .

 Safety dev I ces, • controI I Ing devices- and regulating

 devices for use outside potentially explosive

 atmospheres but required or contributing to the safe

 functioning of equipment and protective systems

 located Inside potentially explosive atmospheres are

 covered by the scope of this D i r e c t i v e .

 For the purposes of this Directive the following

 definitions shall apply:

 Equipment and protective systems intended for use in

 potentially explosive atmospheres

 a) "Equipment" means m a c h i n e s, apparatus and all other

   fixed or mobile d e v i c e s, Including the cable and

   conduit e n t r i e s, control components and

   Instrumentation thereof, which separately or

   Jointly, permanently or o c c a s i o n a l l y are used for

   the g e n e r a t i o n, transfer, d i s t r i b u t i o n, storage,

   m e a s u r e m e n t, control and conversion of energy and

   for the processing of material and capable of

   causing an e x p l o s i o n .

```

```
                - 20 
   b) The term "protective systems" applies to design

      units which are Intended to halt Incipient

      explosions immediately and/or to limit the e f f e c t e d *

      range of explosion flames and explosion pressures to

      a sufficient level of safety. Protective systems can

      be integrated into equipment or separately marketed •

      for trade use as autonomous systems.

    c) "Components" means any item being essential to the

      safe functioning of equipment and protective systems

      but not having an autonomous function.

Explosive atmospheres

Mixture of a Ir and flammable gases, vapours, hazes or dusts

in such proportions under atmospheric c o n d i t i o n s, that,

after ignition has occurred, a reaction involving a

temperature and pressure increase can propagate

independently and can cause a hazard.

Potentially explosive atmosphere

An atmosphere which could become explosive due to local and <•

operational c o n d i t i o n s .

Equipment-groups and Conformity categories

Equipment-group I applies to equipment for use in

underground parts of mines as well as those parts of surface

installations of such mines likely to become endangered by

firedamp and/or combustible dust.

Equipment-group II applies to equipment for use in other

places likely to become endangered by explosive a t m o s p h e r e s .

```

```
                     21 
Conformity categories are defined in Annex I with regard to

the level of protection required for e q u i p m e n t .

Equipment and protective systems may be designed for --as*

particular explosive a t m o s p h e r e . In this case they are

marked accordingly.

Intended use

The use of equipment and protective systems according to the

e q u i p m e n t - g r o u p and the conformity category as well as all

the information necessary to the safety of the equipment

supplied by the m a n u f a c t u r e r .

4. The following are excluded from the scope of this

    D i r e c t i v e :

```

```
med i caI dev i ces

envIronment,

```

```
I ntended for use In med i caI

```

```
equipment and protective systems in so far as the

explosion hazard is exclusively resulting from the

presence of explosive or chemical instable s u b s t a n c e s,

seagoing vessels and mobile offshore units together

with equipment and protective systems on board such

vesseIs or un Its .

means of transport, I.e. vehicles and their trailers

Intended solely for transporting passengers by air or

on road, rail or water networks, as well as means of

transport Insofar as such means are designed for

transporting goods by air, on public road or rail

networks or on w a t e r . Vehicles used In the mineral

extraction industry shall not be excluded.

```

```
                - 22 
               Art Icle 2

Member States shall take all necessary m e a s u r e s to

ensure that the equipment and protective systems

covered by this Directive may be placed on the market

and put Into service only If they do not Jeopardize the

health and safety of persons and, where a p p r o p r i a t e,

domestic animals or property, when properly Installed

and maintained and used for its intended p u r p o s e .

This Directive shall not affect the authority of the

Member States to lay down, with due regard for the

provisions of the Treaty, requirements which they

consider necessary for the protection of persons and in

particular of employees using the révélant equipment

and protective s y s t e m s, provided this does not result

in changes to equipment and protective systems with

respect to the provisions of this D i r e c t i v e .

At trade fairs, e x h i b i t i o n s, d e m o n s t r a t i o n s, etc Member

States shall not prevent the showing of equipment and

protective systems which does not conform to the

provisions of this D i r e c t i v e, provided that a visible-•<*
sign clearly indicates that such equipment and

protective systems do not conform and that It is not

for sale until It has been brought into conformity by

the manufacturer or his authorized r e p r e s e n t a t i v e

established in the Community. During d e m o n s t r a t i o n s,

adequate safety measures shall be taken to ensure the

protection of p e r s o n s .

               Art le le 3

Equipment and protective systems referred to In Article

1 must meet the essential health and safety

requirements set out In Annex II which shall apply to

them, account being taken of their Intended use.

```

```
                - 23 
               Article 4

Member States shall not prohibit, restrict or Impede

the placing on the market and the putting Into service

In their territory of equipment and p r o t e c t i v e systems

which comply with the provisions of this D i r e c t i v e .

Member States shall not prohibit, restrict or Impede

the placing on the market of c o m p o n e n t s w h i c h,

accompanied by a declaration as referred to in Article

8 ( 4 ), are Intended to be incorporated into equipment

or protective systems within the meaning of this

D I rect i ve.

               Art Icle 5

Member States shall presume compliance with the

essential health and safety requirements referred to in

Article 3 for equipment and protective systems for

use In potentially explosive a t m o s p h e r e s If those items

compI y with

 (a) the relevant national standards a p p l i c a b l e to:

     them implementing the harmonized s t a n d a r d s whose

     reference numbers have been published In the

     Official Journal of the European Community.

     Member States shall publish the references of

     national standards transposing harmonized

     standards .

 (b) or the relevant national standards referred to In

     paragraph 2 where there are no harmonized

     standards dealing with the areas covered by those

     s t a n d a r d s .

```

```
                - 24 
Member States shall communicate to the Commission the

texts of their national standards referred to In

paragraph 1(b) which, in their view, meet the essential

requirements under Article 3.

In accordance with the procedure set out In Article

6 ( 2 ), the Commission shall Indicate to the Member

States which of the said standards can be presumed to

conform with the essential safety requirements within

the meaning of Article 3.

               Art Icle 6

Where a Member State or the Commission c o n s i d e r s that

the harmonized standards referred to in Article 5(1) do

not entirely satisfy the essential health and safety

requirements under Article 3, the Commission or the

Member State shall submit the matter to the Standing

C o m m i t t e e, hereinafter called "the C o m m i t t e e ", set up

under Directive 8 3 / 1 8 9 / E E C, giving the reasons

t h e r e f o r e . The Committee shall deliver an opinion

w i thout de I ay .

 In the light of the Committee's opinion, the C o m m i s s i o n

 shall Inform the Member states whether or not It is

 necessary to withdraw the standards In question from

 the list of publications referred to in Article 5 ( 1 ) .

After receipt of the communication referred to In

Article 5 ( 2 ), the Commission shall consult the

 C o m m i t t e e . On the basis of the Committee's o p i n i o n, the

 Commission shall inform the Member States within a

 specified period whether or not conformity can be

```

```
                   - 25

   presumed in the case of the national standards in

   question and whether - should this be the case - a list

   of the sources from which such standards are available

   should be published at national level. The Commission

   shall also publish them in the Official Journal of the

    European Communities.

                   Art Icle 7

1. Where a Member State ascertains that equipment and

    protective systems to which the CE-conformIty mark

    has been affixed correctly installed, maintained and

    used In accordance with their intended purpose

    Jeopardize the safety of persons, and where

    appropriate, domestic animals or property, It shall

    take all appropriate measures to withdraw such

    equipment and protective systems from the market or to

    prohibit or restrict its placing on the market or the

    putting Into service.

    The Member State shall Immediately Inform the

    Commission of any such measure, indicating the reasons

    for its decision and, in particular, whether non
    conformity Is due to:

    (a) non-compliance with the essential requirements

        referred to In Article 3, where the equipment or

        the protective system does not comply with the

        standards referred to In Article 5 ( 1 ) ;

    (b) Incorrect application of the standards referred

        to in Art le le 5(1 ) ;

    (c) shortcomings in the standards referred to in

        Article 5(1) themselves.

```

```
                - 26 ..

   These measures are applicable until the entry Into

   force of the act provided for In paragraph 2.

2. The measures adopted under paragraph 1 shall be

   confirmed and extended, possibly amended, to the whole

   Community or repealed by an act of the Commission.

   However, where the measures were adopted under

   paragraph 1 on the ground of a shortcoming In the

   standards provided for In Article 5, the procedure laid

   down in Article 6(2) is applicable.

3. If a non-conforming Item of equipment or protective

   system bears the CE-conformIty mark, the competent

   Member State shall take appropriate measures against

   whomsoever has affixed the mark and shall Inform the

   Commission and the other Member States thereof.

4. The Commission shall ensure that the Member States are

    Informed of the application and results of this

   procedure.

                 Chapter I I

         Conformity assessment procedures

                 Art icle 8

1. The conformity assessment procedures of equipment

    considering, where necessary, those devices thereof

    referred to In Article 1(2)

```

```
               _ 27 _

as well as integrated protective systems, shall be:

(a) Equipment group I and II, conformity category (M)

    1 and 1

  The manufacturer or his authorised representative
  established In the Community must, In order to affix

  the CE mark, at his own choice:

  I) follow the procedure relating to EC type

      examination (set out in Annex III), coupled

      withthe procedure relating to production

      quality assurance (set out in Annex IV)

  or

      the procedure relating to product verification

      (set out In Annex V)

  II) follow the procedure relating to full quality

      assurance Including design examination (set

      out In Annex IX).

(b) Equipment group I and II, conformity category

    (M)2 and 2

  The manufacturer or his authorized representative

  established in the Community must, in order to affix

  the CE-mark, follow the procedure relating to EC

  type examination (set out in Annex III), coupled

  wi th:

  -the procedure relating to conformity to type (set

  out In Annex VI)

  or

  the procedure relating to product quality assurance

   (set out In Annex VII)

```

```
                   - 28 
   (c) Equipment group 11, conformity category 3

        The manufacturer or his authorized representative

        established in the Community must, in order to

        affix the CE-mark, follow the procedure relating

        to Internal control of production (set out In

        Annex V I M ) .

    (d) EC uni t ver IfI cat ion

        The manufacturer or his authorized representative

        established in the Community can, In order to

        affix the CE-mark, follow the procedure relating

        to EC unit verification (set out In Annex X ) .

2. The provisions of 1(b) or 1(d) above shall be used for

   conformity assessment relating to autonomous protective

   systems.

3. The procedures referred to in paragraph 1 shall be

   applied In respect of components as referred to in

   Article 4(2) with the exception of the affixing of the

   CE-conformIty mark.

   A declaration shall be issued by the manufacturer or

    his authorized representative established In the

   Community attesting the conformity of the components

   with the provisions of this Directive which apply to

    them and stating their characteristics and how they

   must be Incorporated into equipment or protective

    system to assist compliance with the essential

    requirements applicable to finished appliances.

4. Documents and correspondence relating to the procedures

    under the abovementioned paragraphs shall be prepared

    in one of the official languages of the Member States

    in which those procedures are being applied or In a

    language accepted by the notified body.

```

```
                   - 29 
   Where the equipment and protective systems are subject

   to other Community Directives concerning other aspects,

   the CE-conformlty mark referred to in Article 10 shall

    indicate In these cases that the equipment and

   protective systems also fulfil the provisions which

   apply to them of the other Directives.

                  ArtIcle 9

1. Member States shall notify the other Member States and

    the Commission of the bodies which they have approved

    for performance of the tasks in connection with the

    procedures under Article 8 and the specific tasks for

   which the bodies have been approved. In this Directive

    these bodies are referred to as "notified bodies".

    The Commission shall publish a list of the notified

    bodies In the Official Journal of the European

    Communities comprising the Identification number which

    has been allocated to them as well as the tasks for

    which they have been approved.The Commission shall.be

    responsible for updating that list.

2. Member States shall apply the minimum criteria set out

    in Annex XII for the designation of bodies. Bodies that

    satisfy the criteria fixed by the relevant harmonized

    standards shall be presumed to satisfy the relevant

    m i n imum cr I ter i a.

3. A Member State which has approved a body shall withdraw

    such approval where the body no longer fulfills the

    criteria under paragraph 2. It shall Immediately Inform

    the other Member States and the Commission thereof.

```

```
                   - 30 
   The notified body and the manufacturer or his

   authorised representative established within the

   Community shall agree on the procedures and the time

   limit for the execution and completion of the

   evaluation and verification operations referred to in

   the Annexes.

                 Chapter 1 I I

               Conformity marks

                  Art icle 10

1. The CE-conformity mark as well as the additional

   specific marking as shown In Annex XI shall be affixed

    to the equipment and the protective system and as far

    as feasible and appropriate on the sales packaging as

   well as on the Instruction leaflet in a visible,

    legible and Indelible form.

    The CE-conformIty mark must be accompanied by the

    Identification number of the notified body responsible

    for Implementation of the procedures set out In Annexes

    IV, V, V I, VII, IX, X as well as the two last digits of

    the year In which the mark was affixed.

2. It is prohibited to affix any other mark or

    inscriptions which may be confused with the CE
    conformlty mark or the additional specific marking set

    out In Annex XI.

```

```
                   - 31 
                  Art Icle 11

If any Member or notified body finds that the CE-conformIty

mark has been improperly affixed, the equipment or

protective system concerned shall be prohibited or shall no

longer be marketed.

                  Chapter IV

                F InaI provI s Ions

                  ArtIcle 12

Any decision taken pursuant to this Directive which

restricts or prohibits the placing on the market and/or the

putting into service or Imposes the retreat from the market

of an equipment or a protective system shall state the exact

grounds on which It is based. Such a decision shall be

notified forthwith to the party concerned, who shall at the

same time be Informed of the legal rented I es ava I I ab le to him

under the laws In force In the Member State concerned and of

the time limits to which such remedies are subject.

                  Art icle 13

Member States shall ensure that all the parties involved In

the application of the Directive are bound to observe

confidentiality in respect of all the information obtained

 in carrying out their tasks. This does not affect the

obligations of the Member States and of the notified bodies

regarding mutual information and the dissemination of

warn i ngs.

```

```
                - 32 
               Art Icle 14

1. Directive 76/117/EEC* [1] > and Directive 79/196/EEC< [2] >,

   as last amended by Directive 90/487/EEC [(3)] as well as
   Directive 82/130/EEC< [4] > as last amended by Directive
   91/269/EEC< [5] ) shall be repealed as from (1 July 1996).

2. However, EEC-certificates of conformity to the

   harmonized standards obtained in accordance with the

   procedures as laid down in the DI rect I ves referred to

   In the preceding paragraph shall be valid until 31

   December 2002. Their validity shall be limited to only

   those harmonized standards indicated in the said

   D I rectIves.

3. Member States shall take the necessary action to ensure

   that the notified bodies which are responsible pursuant

   to Article 8(1) to (4) for the assessment of the

   conformity of electrical equipment already placed on

   the market prior to the coming Into force of this

   Directive shall take account of the results of tests

   and verifications already carried out under the

   Directives referred to In paragraph 1.

               ArtIcle 15

1. Before [31 December 1992], Member States shall adopt

   and publish the laws, regulations and administrative

   provisions necessary in order to comply with this

   Directive. They shall forthwith inform the Commission

   thereof .

(1) OJ No L 24, 31.1.1976

(2) OJ No L 43, 20.2.1979

(3) OJ No L 270, 2.10.1990

(4) OJ No L 59, 2.3.1982

(5) OJ NO L 134, 29.5.1991

```

```
                  - 33 
   When Member States adopt these measures, they shall

   contain a reference to this Directive or shall be

   accompanied by such reference on the occasion of their

   official publication. The methods of making such a

   reference shall be laid down by the Member States.

   They shall apply these provisions with effect from [1

   July 1993.]

2. However» Member States shall allow for the period until

   [31 December 2002], the placing on the market and the

   putting Into service of equipment and protective

   systems In conformity with the national regulations In

   force In their territory at the date of adoption of

   this dlrectlve.

                 Art Icle 16

This Directive Is addressed to the Member States.

Done at Brussels, For the CounciI

                    The President

```

```
                  - 34 
                  ANNEX I

CRITERIA DETERMINING THE CLASSIFICATION OF EQUIPMENT-GROUPS

INTO CONFORMITY CATEGORIES

1 • Equipment-group I

a) Conformity category (M) 1 comprises equipment designed

   and, where necessary, additionally equipped with

   special protective features to be capable of keeping

   within its operational parameters stated by the

   manufacturer and provide a high level of protection

    for Its Intended use in underground parts of mines as

   well as those parts of surface Installations of such

   mines endangered by firedamp and/or combustible dust.

    Equipment of this category Is required to remain

    functional for safety reasons with an explosive

    atmosphere present and, by virtue of this, it Is

    characterized by Integrated explosion protection

   measures functioning Independently of each other in

    such a way that

      In the event of failure of one integrated measure at

      least a second means of protection provides for a

      sufficient level of safety or

      In the event of two faults occurring Independently

     of each other a sufficient level of safety is

      assured.

    Equipment relating to this conformity category comply

   with the supplementary requirements referred to In

    Annex II 2.0.1.

```

```
                 - S o 
fa) Conformity category (M) 2 comprises equipment designed

   to be capable of keeping within its operational

   parameters stated by the manufacturer and based on an

    Increased level of protection for Its Intended use In

   underground parts of mines as well as those parts of

   surface installations of such mines likely to become

   endangered by firedamp and/or combustible dust.

   The protection measures relating to equipment of this

   category provide for a sufficient level of safety

   during trouble-free operation also In the case of more

   severe operating conditions In particular arising from

    rough handling and changing environmental conditions.

    Equipment relating to this conformity category comply

   with the supplementary requirements referred to in

   Annex II 2.0.2.

2. Equipment-group I I

a) Conformity category 1 comprises equipment designed to

    be capable of keeping within its operational parameters

    stated by the manufacturer and based on a high level of

    protection for Its Intended use considering areas In

    which explosive atmospheres caused by gases, vapours or

    hazes, suspended dust are highly likely to occur.

    Equipment of this category Is characterized by

    integrated explosion protection measures functioning

    Independently of each other In such a way that

      In the event of failure of one integrated measure at

      least a second means of protection provides for a

      sufficient level of safety or

```

```
                - 36 
     In the event of two faults occuring independently of

     each other a sufficient level of safety Is assured.

   Equipment relating to this conformity category comply

   with the supplementary requirements referred to In

   Annex 112.1.

b) Conformity category 2 comprises equipment designed

   to be capable of keeping within its operational

   parameters stated by the manufacturer and based on an

   increased level of protection for its Intended use

   considering areas in which explosive atmosphere caused

   by gases, vapours or hazes are likely to occur.

   The protection measures relating to equipment of this

   category function in such a way to provide for a

   sufficient level of safety also in the event of

   operating malfunctions or dangerous operating

   conditions which normally have to be taken Into

   account.

   Equipment relating to this confomity category comply

   with the supplementary requirements referred to in

   Annex II 2.2.

c) conformity category 3 comprises equipment designed to

   be capable of keeping within Its operating parameters

   stated by the manufacturer and based on a normal level

   of protection for Its intended use considering areas In

   which explosive atmospheres caused by gases, vapours or

   hazes as well as by raising of deposited dust are not

   I Ike ly to occur.

```

```
             - 37 
The design of the equipment of this category provides a

sufficient level of safety during trouble-free

operatIon.

Equipment relating to this conformity category comply

with the supplementary requirements referred to In

Annex II 2.3.

```

```
                   - 38 
                  ANNEX I I

Essential health and safety requirements relating to the

design and construction of equipment and protective systems

intended for use In potentially explosive atmospheres.

PRELIMINARY OBSERVATIONS

A. State of the art refers to the technical knowledge

    commonly available up to that point In time being

    considered, having been proved In practice.

    The technical knowledge which can change very rapidly,

    must be taken Into account as far as possible and be

    utilized Immediately.

B. For devices referred to In article 1 (2) the essential

    requirements shall only apply Insofar as they are

    necessary for the safe functioning and operation of

    these devices.

1. Common requirements for equipment and protective

      systems

1.0. General requirements

1.0.1 Principles of explosion safety integration

      Equipment and protective systems Intended for use In

      potentially explosive atmospheres must be designed

      from the point of explosion safety integration.

      In this connection, the manufacturer must take

      measures:

```

```
                   - 39 
       above all, If it Is possible, to prevent the

       formation of explosive atmospheres which may be

       produced or released by equipment and by

       protective systems themselves;

        to prevent the Ignition of explosive atmospheres

       considering electrical and non-electrical sources

        In any case;

       where an explosion is however likely to occur,

        which may directly or Indirectly endanger persons

        and/or the surrounding area, to halt It

        Immediately and/or to limit the effected range of

        explosion flames and explosion pressures to a

        sufficient level of safety.

1.0.2 Equipment and protective systems should be designed

      and manufactured after due analysis of possible

      errors in order to preclude dangerous Incidents

      relating to equipment and systems as far as

      possIb ie.

      T h e . foreseeable misuse which can reasonably be

      anticipated must be considered.

1.0.3 Special testing and maintenance conditions

      Equipment and protective systems subject to special

      testing and maintenance conditions must be designed

      and constructed with such conditions in mind.

1.0.4 Surrounding area conditions

      Equipment and protective systems must be so designed

      and constructed as to be capable of coping with

      foreseeable surrounding area conditions.

```

```
                   - 40 
1.0.5 Additional specific markings

      All equipment and protective systems and their main

      components and Instrumentation must be fully and

      clearly marked for the purpose of Identification

      referred to in Annex XI, In cases where this seems [1 ]

      to be necessary for the valuation of safety aspects.

1.0.6 Operating Instructions

      Operating instructions for the equipment and

      protective systems which contain all the Information

      necessary to the safety must be drawn up In one of

      the languages of the country In which the equipment

      and protective systems are to be used and supplied

      with the equipment and the protective systems so

      that it is possible to decide beyond any doubt

      whether an item of equipment In a specified

      conformity category or a protective system can be

      used safely In the Intended area under the operating

      conditions to be expected. Such Information should

      Include, for example, data relating to:

        the equipment-group and the conformity category

        putting into service, maintenance, Inspection,

        serviceability checks, repairs, permissible

        normal work and adjustment

        electrical parameters, pressure or other relevant

        limit va lues ;

        the highest surface temperatures;

        where necessary, special conditions of use,

        including indications to possible misuse which

        experience has shown might occur.

```

```
                   - 41 
1.1. Characteristics of materials

1.1.1 The materials used for the construction of the

      equipment and protective systems must comply with

      the requirements to prevent the occurrence of an

      explosion due regard being paid to the operational**

      foreseeable stresses.

      As far as It Is foreseeable by the manufacturer, It

      must not be possible for any reactions to take place

      between the construction materials used and the

      flammable materials which could Impair explosion

      protect Ion.

1.1.2 When selecting suitable combinations of materials,

      due account must be taken, for example, of the

      materials' corrosion behavior, wear resistance,

      electrostatic conductivity, impact strength, ageing

      resistance and the effects of variations In the

      temperature.

1.2. Design and construction

1.2.1 State of the art In respect of technical explosion

      protect ion.

      Equipment and protective systems must be designed

      and manufactured with due regard to the state of the

      art In respect of technical explosion protection so

      that they can be safely operated throughout their

      foreseeable lifetime.

1.2.2 Components to be Inserted into or used as

      replacements in equipment and protective systems

      must be so designed and manufactured that they

```

```
                   - 42 
     function safely for their Intended purpose with

     regard to explosion protection when they are

      installed In accordance with the manufacturer's

      Instruct Ions.

1.2.3 Enclosed equipment systems

      In the design and construction of equipment which

     may release flammable materials provision is to be

      made where appropriate for structures which are as

      enclosed as possible in order to prevent or limit

      the formation of explosive atmospheres.

1.2.4 Prevention of leaks

      The escape of flammable materials from apertures and

      leaks in enclosed equipment must be prevented where

      appropriate so as to ensure that escaping mixtures

      cannot give rise to potentially explosive

      atmospheres or dust depositions as the result of air

      access outside the equipment.

      The equipment must also be sealed In a manner as

      leaktlght as possible In accordance with the state

      of the art at points where the flammable materials

      are Introduced or drawn off.

1.2.5 Prevention of dust deposition

      Equipment and protect Ive systems which are intended

      to be used In areas exposed to dust must be so

      designed that as little dust as possible can

      precipitate on to their surfaces to prevent

      IgnItIons.

      They must be easily cleanable.

```

```
                - 43 
1.2.6 Appropriate protective appliances

      Equipment and protective systems which are assumed,

      for example, to be exposed to major mechanical

      hazards or vibrations In normal use must be

      equipped, . where necessary* with appropriate**

      protective appliances. The equipment must withstand

      relevant stresses, without adversely affecting

      explosion protection.

1.2.7 Safe openIng

      If equipment and protective systems are in a housing

      or a locked container, it must be possible to open

      such housing or container only with 'tools or by

      means of appropriate protection measures.

1.2.8 Protection against other hazards

      Equipment and protective systems must be designed

      and manufactured so as to prevent danger of physical

      or other forms of Injury which might occur,

      particularly the hazards arising from electrocution.

      Where, for equipment and protective systems, these

      risks referred to In this paragraph are wholly or

      partly covered by other Community Directives, this

      Directive shall not apply or shall cease to apply,

      In the case of such equipment and protective systems

      and of such risks on the entry into force of these

      specific Directives.

```

```
                   - 44 
1.3. Potential ignition sources

1.3.1 Hazards arising from different Ignition sources

      Potential Ignition sources such as sparks, flames,

      electric arcs, high surface temperatures, n o i s e - 
      generated energy, radiation In the optical field,

      electromagnetic waves and other relevant ignition

      sources should not occur.

1.3.2 Electrostatic hazards

      Electrostatic charges capable of resulting In

      dangerous discharges must be prevented by means of

      appropriate measures.

1.3.3 Hazards arising from electric stray- and leakage

      currents

      Electric stray- and leakage currents In conductive *'

      equipment parts which could result for example in

      the occurrence of igniting sparks or dangerous

      corrosion must be prevented.

1.3.4 Hazards arising from overheating

      Overheating caused by friction and Impacts
      occurring, for example, between materials and parts

      in contact with each other while rotating, by

      intrusion of foreign bodies and simlliar phenomena

      must be prevented already at the design stage as far

      as possible.

1.3.5 Hazards arising from compression operations

      Compression operations must process In such a way at

```

```
                   - 45 
     the design stage respectively with Integrated

     measurement and control devices that they do not

     give rise to any shock waves and compressions

      capable of causing ignition.

1.4. Hazards arising from external effects

1.4.1 Equipment and protective systems must be so designed

      and constructed as also to be capable of performing

      their intended function In changing environmental

      conditions, under the influence of extraneous

      voltages, in the presence of excessive humidity,

      vibrations, contamination and other external effects

      within the operational conditions stated by

      manufacturers.

1.4.2 Components and instrumentation used must be

      appropriate to the Intended mechanical and thermal

      stresses and capable of withstanding existing or to

      be expected influences of aggressive media.

1.5. Safety-related requirements In respect of equipment

1.5.1 Requirements in respect of safety devices

      Overloading of equipment must be prevented, for

      example, by means of overcurrent cut-off switches,

      temperature llmlters, differential pressure

      switches, flowmeters, time-lag relays, speed

      monitors and/or similar types of monitoring devices

      already at the design stage respectively with

      integrated measurement and control devices.

1.5.2 Safety devices must function independently of any

      measurement and control devices required for

      operat ion.

```

```
                   - 46 
     A safety device failure shall be detected by means

     of approprI ate measures that within a short time

     period a dangerous condition Is not highly likely to

     occur.

     For electrical circuits the fall-safe principle Is

     to be applied when the risks assessment makes this

     necessary.

      If appropriate, the safety-related switching must

      directly Influence the relevant control actuating

      device without software command.

1.5.3 In the event of a safety device failure, equipment

      and/or protective systems shall be put Into safe

      condItIon.

1.5.4 Safety devices should be fitted where appropriate

      with restart lockouts. A new start command may take

      effect In the case of normal operation only after

      the safety cut-off switch has intentionally been

      reset.

1.5.5 Application of ergonomie principles

      Where control and display units are used, they must

      be designed in accordance with ergonomie principles

      In order to achieve the highest possible level of

      operatIng safety.

1.5.6 Requirements in respect of equipment with a

      measuring function for explosion protection.

      Equipment with a measuring function must be designed

      and constructed in particular from the point of

      view of their measuring principles, display time

```

```
                   - 47 
      lag, transverse sensitivity and acceptable accuracy

      limits so that they can cope with the foreseeable

      situations and special conditions of use.

1.5.7 It must be possible to check with su I tab Ie devI ces,

      where necessary, the reading accuracy and

      serviceability of equipment with a measuring

      function.

1.5.8 The design of equipment with a measuring function

      must Incorporate a safety factor which ensures that

      the alarm threshold lies far enough outside the

      explosivity limits of the atmospheres to be

      registered.

1.5.9 Risks arising from software

      In the design of software-controlled equipment,

      special account must be taken from an analytical

      point of view of the risks arising from faults in

      the programme. For electrical circuits the

      requirement 1.5.2 as relevant must be applied. The

      same safety requirements apply to sensor-monitored

      equipment.

1 . Integration of safety requirements relating to the

    system

1.6.1 Manual override of automatic processes must at all

      times be possible to avert hazards.

      In the event of deviation from the Intended

      operation, It must be possible to shut the equipment

      down safely.

```

```
                  - 48 
1.6.2 When the emergency shutdown system Is actuated,

     accumulated energy must be reduced as quickly and

     safely as possible so that It will lose Its

     potentially dangerous effects.

     This does not apply for e I ectrochemIcaI I y stored

     energy.

1.6.3 Hazards arising from power failure

     Where equipment can give rise to additional hazards

      In the event of a power failure, It must be

     possible to restore It to a safe operating state

      Independently of the rest of the Installation.

1.6.4 Hazards arising from connections

      Equipment and product I ve systems must be fitted with "<•

      suitable cable and conduit entries..

     When equipment and protective systems are Intended

      for use In combination with other equipment and

      protect Ive systems, the Interface shall be made in a

      safe manner.

1.6.5 Placing of warning devices as parts of equipment

      Where warning devices are provided for monitoring

      explosive atmospheres In the vicinity of equipment,

      the detectors must be capable of being positioned In

      such a way that a dangerous operatIng condition can

      be readily identified.

```

```
                  - 49 
1.6.6 Areas endangered by pressure relief In the event of

     an explosion

     Areas endangered in front of explosion pressure
     relief devices should be Indicated by the

     manufacturer as far as possible.

```

```
                   - 50 
2. Supplementary requirements in respect of equipment

      which are capable of causing an explosion

2.0. Criteria for conformity category M of equipment group I

2.0.1 Criteria for conformity category (M) 1 of equipment

      group I

2.0.1.1 Equipment must be so designed and constructed and,

      where necessary, additionally equipped with special

      protective features that sources of Ignition do not

      become effective even in the event of rare Incidents

      relating to equipment or two faults occurIng

      Independently of each other.

2.0.1.2 Equipment must be so constructed that, as far as It

      is possible, no dust can penetrate to their

      Interlor .

2.0.1.3 The surface temperatures of equipment parts must be

      kept well below the Ignition temperature of the

      foreseeable dust/air mixtures In order to prevent

      the Ignition of suspended dust and be kept well

      below the glow temperature In the case of deposited

      dust. The thickness of deposited dust and dust

      accumulation on equipment parts should be taken Into

      consideration and offset where appropriate by means

      of temperature limitation In order to prevent a

      heat buiId-up.

2.0.1.4 Equipment must be so designed that the opening of

      equipment parts must be carried out only under non
      active or Intrinsic safety conditions or via

      relevant interlocking mechanisms.

```

```
                   - 51 
2.0.2 Criteria for conformity category (M) 2 of

      equipment group I

2.0.2.1 Equipment must be so designed and constructed that

      sources of Ignition do not become effective during

      trouble-free operation.

2.0.2.2 If after the opening of the enclosure, the exposure

      of components could lead to the Ignition of an

      explosive atmosphere, it must only be possible to

      open equipment under non-active conditions or via

      relevant Interlocking mechanisms.

2.0.2.3 The requirements regarding explosion hazards

      occurring from dust referred to in conformity

      category (M) 1 must be applied.

2.1 . Criteria for conformity category 1 of equipment

      group I I

2.1.1. Explosive atmospheres caused by gases, vapours or

      hazes

2.1.1.1 Equipment must be so designed and constructed that

      sources of Ignition do not occur even in the event

      of rare Incidents relating to equipment or two

      faults ocurring Independently of each other.

2.1.1.2 Equipment with surfaces that are likely to heat up

      should be avoided where possible. Falling this, it

      must be ensured that the stated maximum surface

      temperatures In even the most unfavourable cases

      remain safely. In this connection, temperature rises

      caused by heat build-ups and chemical reactions must

      also be taken into account.

```

```
                   - 52 
2.1.1.3 Equipment must be so designed that the opening of

      equipment parts must be carried out only under non
      active or Intrinsic safety conditions or via

      relevant interlocking mechanisms.

2.1.2. Explosive atmospheres caused by dust . ^ „.

2.1.2.1 Equipment must be so designed and constructed that

      Ignition of existing dust/air mixtures do not occur

      even in the event of rare incidents relating to

      equipment and two faults occurIng independently of

      each other.

2.1.2.2 Equipment must be so constructed that as far as It

      is possible, no dust can penetrate to their

      interlors.

      This requirement must also be met by inlet and

      connecting pieces.

2.1.2.3 The surface temperatures of equipment parts must be

      kept well below the Ignition temperature of the

      foreseeable dust/air mixtures In order to prevent

      the ignition of suspended dust and be kept well

      below the glow temperature in the case of deposited

      dust. The thickness of deposited dust and dust

      accumulation on equipment parts should be taken into

      consideration and offset where approprI ate by means

      of temperature limitation In order to prevent a heat

      buI Id-up.

2.1.2.4 The requirement 2.1.1.3 regarding the safe opening

      of equipment for conformity category 1 also applies

      here.

```

```
                  - 53 
2.2. Criteria for conformity category 2 of equipment

     group "

2.2.1. Explosive atmospheres caused by gases, vapours or

     hazes

2.2.1.1 Equipment must be designed and constructed to

     prevent Ignition, including those caused by

     frequently occurring incidents relating to equipment

     which normally have to be taken into account.

2.2.1.2 Equipment parts must be so designed and constructed

      that their stated surface temperatures to be kept

      safely even where risks arise from foreseeable

      abnormal situations.

2.2.1.3 If after the opening of the enclosure, the exposure

      of components could lead to the Ignition of an

      explosive atmosphere, equipment must be constructed

      so that it must only be possible to open equipment

      under non-active conditions or via relevant

      Interlocking mechanisms.

2.3 Criteria* for conformity category 3 of equipment

      fl [r] ouP ''

2.3.1. Explosive atmospheres, caused by gases, vapours or

      hazes

2.3.1.1 Equipment must be so designed and constructed to

      prevent Ignitions which can occur during trouble
      free operatIon.

```

```
                  - 54 
2.3.1.2 The surface temperatures may not exceed Ignition

     temperatures during Intended operations.

     Temperatures in excess of Ignition temperatures may

     be allowed only If special protective measures are

     taken by the manufacturer.

2.3.2. Explosive atmospheres caused by dust

2.3.2.1 Equipment must be so designed and constructed that

     suspended dust cannot be Ignited by Ignition sources

      likely to exist under normal operating conditions.

     The possibility of ignition of deposited dust during

     rarely occurring Incidents relating to equipment and

      faults must also be precluded.

2.3.2.2 The requirement 2.1.2.3 regarding surface

      temperatures for conformity category 1 also applies

      here.

2.3.2.3 Equipment Including the Inlet parts and connecting

      pieces thereof, must be so constructed that dust

      cannot penetrate and It is impossible for

      potentially explosive dust/air mixtures to develop

      or dangerous dust deposition to occur Inside It.

```

```
                   - 55 
3. Supplementary requirements In respect of protective

      systems

3.0. General requirements

3.0.1 Protective systems Intended to halt Incipient

      explosions and/or to limit the effected range of

      explosion flames and explosion pressures must be

      integrated where necessary into equipment and be so

      designed that those effects are limited to a

      sufficient level of safety.

3.0.2 The protective systems must be so designed and

      capable of being positioned that It is possible to

      prevent explosions from spreading through dangerous

      chain reactions and flashover -and halt the

      transition of Incipient explosions to detonations.

3.0.3 In the event of a power fa ilure, protective systems
      must retain their capacity to function for an

      adequate*- per lod to avoid a dangerous situation.

3.0.4 Protective systems shall not fail under the

      Influence of external effects.

```

```
                   - 56 
3.1. Planning and design

3.1.1 Strength of materials

      At the planning stage, the strength required of the

      materials must be determined on the basis of the

      maximum explosion pressure being the explosion

      pressure to be expected, considering also the

      anticipated heating effect of the flame under

      extreme operating conditions.

3.1.2 Protective systems designed to resist explosions

      must be capable of withstanding the pressure wave In

      question with adequate certainty.

3.1.3 The accessories connected to the protective systems

      must be capable of withstanding the expected maximum

      explosion pressure without losing their capacity to

      funct ion.

3.1.4 Flameproof enclosure systems

    . If parts which can Ignite an explosive atmosphere

      are placed In an enclosure, it must be Insured that

      the enclosure can withstand the pressure developed

      during an internal explosion of an explosive mixture

      and prevents the transmission of the explosion to

      the explosive atmosphere surrounding the enclosure.

3.1.5 Taking account of system reactions

      The reactions caused -by pressures In peripheral

      equipment and connected pipework must be taken into

      consideration In the planning and design of

      protective systems.

```

```
                - 57 
3.1.6 Pressure-relief systems

      If it Is likely that stresses on protective systems

      will exceed their structural strength, provision

      must be made In the design for suitable pressure
      relief devices which do not endanger persons in the

      vicinity.

3.1.7 Explosion suppression systems

      Explosion suppression systems must be so planned and

      designed that they react to an Incipient explosion

      at the earliest possible stage in the event of an

      incident and counteract it to best effect with due

      regard to the maximum rate of pressure increase and

      the maximum explosion pressure.

3.1.8 Explosion decoupling systems

      DecoupI Ing systems Intended to disconnect rapidly

      assigned equipment In case of Incipient explosions

      by means of special appliances must be so planned

     .and designed that they remain proof against non
      transmission of an internal ignition and retain

      their 'mechanical strength under operational

      cond11Ions .

3.1.9 Protective systems must be capable of being

      integrated into a circuit with a suitable alarm

      threshold so that, If necessary, there Is cessation

      of product feed and output.'ând immediate shutdown of

      equipment parts which can no longer function safety.

```

```
                   - 58 
                  ANNEX I I I

Module: EC type-examlniation

1. This module describes that part of the procedure by

    which a notified body ascertains and attests that a

    specimen, representative of the production envisaged,

    meets the relevant provisions of the Directive.

2. The application for the EC type-examination shall be

    lodged by the manufacturer or his authorized

    representative established within the Community with a

    notified body of his choice.

The application shall include:

    the name and address of the manufacturer and, If the 
    application Is lodged by the author I zed représentât I ve,

    his name and address in addition;

    a written declaration that the same application has not *

    been lodged with any other notified body; .^-»

    the technical documentation, as described In point 3.

The applicant shall place at the disposal of the. notified

 body a specimen, respresentatIve of the production envisaged

 and hereinafter called "type". The notified body may request

 further specimens if needed for carrying out the test 
 programme.

 3. The technical documentation shall enable the conformity

    of the product with the requirements of the Directive

    to be assessed. It shall, as far as relevant for such

    assessment, cover the design, manufacture and operation

    of the product and shall contain as far as Is relevant

    for assessment :

```

```
                  - 59 
     a general type-description;

     conceptual design and manufacturing drawings and

     schemes of components, sub-assemblies, circuits,

     etc. ;

     descriptions and explanations necessary for the

     understanding of said drawings and schemes and the

     operation of the product;

     a list of the standards referred to in Article 5,

     applied in full or In part, and descriptions of the

     solutions adopted to meet the essential requirements

     of the Directive where the standards referred to in

     Article 5 have not been applied;

      results of design calculations made, examinations

      carried out, etc.;

      test reports.

4. The notified body sha

4.1 examine the; techn l cal -documentât Ion, verify that, the

    type has been manufactured in conformity with the

    technical document at I on * and Identify the elements which

    have been designed In accordance with the relevant

    provisions of the standards referred to In A r t i c l e ^, [1 ]

    as well as the components which have been designed

    without applying the relevant provisions of those

    standards;

4.2 perform or have performed the appropriate examinations

    and necessary tests to check whether, where the

    standards referred to in Article 5 have not been

    applied, the solutions adopted by the manufacturer

    meet the essential requirements of the Directive-,

4.3 perform or have performed the appropriate examinations

    and necessary tests to check whether, where the

    manufacturer has chosen to apply the relevant

    standards, these have actually been applied;

```

```
                  - 60 
4.4 agree with the applicant the location where the

   examinations and necessary tests shall be carried out.

5. Where the type meets the relevant provisions of the

   Directive, the notified body shall Issue an EC type
   examination certificate to the applicant. ^The*

   certificate shall contain the name and address of the

   manufacturer, conclusions of the examlnI at ion,

   conditions for Its validity and the necessary data for

    Identification of the approved type.

    A list of the relevant parts of the technical

    documentation shall be annexed to the cert IfIcate and a

    copy kept by the notified body.

    If the manufacturer or his authorized representative

    established in the Community Is denied a type

    certification, the notified body shall provide detailed

    reasons for such denial.

    Provision shall be made for an appeals procedure.

6. The applleant shal I Inform the notified body that holds

    the technical documentation concerning the EC type >•

    examination certificate of all modifications to 'the

    approved equipment or protective system which must

    receive additional approval where such changes may

    effect the conformity with the essential requirements

    or the prescribed conditions for use of the product.

    This additional approval Is given In the form of an

    addition to the original EC type-examination

    cert IfIcate .

7. Each notified body shall communicate to the other

    notified bodies the relevant Information concerning the

    EC type-examination certificates and additions Issued

    and withdrawn.

```

###### **`- 61 -`**

```
8. The other notified bodies may receive copies of the EC

   type-examination certificates and/or their additions.

   The annexes to the certificates shall be kept at the

   disposal of the other notified bodies.

9. The manufacturer or his- authorized representative

   established in the Community shall keep with the

   technical documentation copies of EC type-examination

   certificates and their additions for a period ending at

    least ten years after the last equipment or protective

   systems has been manufactured.

   Where neither the manufacturer nor his authorized

   representative Is established within the Community, the

   obligation to keep the technical documentation avallabe

   shall be the responsibility of the person who places

    the product on the Community market.

```

```
                  - 62 
                 ANNEX IV

Module: Production quality assurance

1. This module describes the procedure/ whereby the

   manufacturer who satisfies the obligations of point 2

   ensures and declares that the products concerned are In

   conformity with the type as described In the EC type
   examination certificate and satisfy the requirements of

    the Directive that apply to them. The manufacturer

   shall affix the CE mark to each equipment and draw up

   a written declaration of conformity. The CE mark shall

   be accompanied by the Identification symbol of the

   notified body responsible for EC monitoring as

   specified In point 4.

2. The manufacturer shall operate an approved quality

   system for production, final equipment Inspection and

    testing as specified In paragraph 3 and shall be

    subject to monitoring as specified In point 4.

3. Quai Ity system

3.1 The manufacturer shall lodge an application for

    assessment of his quality system with a notified body

   of his choice, for the equipment concerned.

   The application shall Include:

     all relevant information for the product category

     envisaged;

```

```
                   - 63 
     the documentation concerning the quality system;

   - the technical documentation of the approved type and

      a copy of the EC type-examination certificate.

3.2 The quality system shall ensure compliance of the

   equipment with-the type* as [:] described H n the EC type-^v

    examination certificate and with the requirements of

    the Directive that apply to them.

    All the elements, requirements and provisions adopted

    by the manufacturer sha I I be documented in a systematic

    and orderly manner In the form of written policies,

    procedures and Instructions. The quality system

    documentation must permit a consistent interpretation

    of the qua I 1ty programmes, p I an, manuaIs and records.

    It shall contain in particular an adequate description

    of

    - the quality objectives and the organizational

      structure, responsibilities and powers of the .

      management with regard to equipment quality-,

      the manufacturing, quality control and quality

      assurance techniques, processes and systematic

      actions that will be used;

      the examinations and tests that will be carried out

      before, during and after manufacture, and the

      frequency with which they will be carried out;

      the quality records, such as inspection reports and

      test data, calibration data, qualification reports

      of the personnel concerned, etc.-,

      the means to monitor the achievement of the required

      equipment quality and the effective operation of

      the qua I Ity system.

```

```
                   - 64 
3.3 The notified body shall assess the quality system to

    determine whether It satisfies the requirements

    referred to in point 3.2. It shall presume conformity

    with these requirements in respect of quality systems

    that Implement the relevant harmonized standard.

    The auditing team shall have at least one member with

    experience of evaluation in the equipment technology

    concerned. The evaluation procedure shall Include an

    inspection visit to the manufacturer's premises.

    The decision shall be notified to the manufacturer. The

    notification shall contain the conclusions of the

    examination and the reasoned assessment decision.

3.4 The manufacturer shall undertake to fulfil the

    obligations arising out of the quality system as

    approved and to uphold It so that it remains adequate

    and effIc I ent.

    The manufacturer or his author I zed représentât Ive shaI I

    keep the notified body that has approved the quality

    system Informed of any Intended updating of the quality

    system.

    The notified body shall evaluate the modifications

    proposed and decide whether the amended quality system

    will still satisfy the requirements referred to in

    paragraph 3.2 or whether.a re-assessment Is required.

    It' shall notify Its decision to the manufacturer. The

    notification shall contain the conclusions of the

    examination and the reasoned assessment decision.

```

```
                   - 65 
4. Surveillance under the responsibility of the notified

    body

4.1 The purpose of surveillance is to make sure that the

    manufacturer duly fulfils the obligations arising out

    of the approved qua Iity system.

4.2 The manufacturer shall allow the notified body entrance

    for inspection purposes to the locations of

    manufacture, inspection and testing, and storage and

    shall provide It with all necessary Information in

    part IcuIar

      the quality system documentation

      the quality records, such as Inspection reports and

      test data, calibration data, qualification reports

      of the personnel concerned, etc.

4.3 The notified body shall periodically carry out audits

    to make sure that the manufacturer maintains and

    applies the quality system and shall provide an audit

    report to the manufacturer.

4.4 Additionally the notified body may pay unexpected

    visits to the manufacturer. During such visits the

    notified body may carry out, or cause to be carried

    out, tests to verify that the quality system is

    functioning correctly, if necessary. The notified body

    shall provide the manufacturer with a visit report and,

    If a test has taken place, with a test report.

```

```
                   - 66 
   The manufacturer shall, for a period ending at least

   ten years after the last equipment has been

   manufactured, keep at the disposal of the national

   author 11les :

     the documentation referred to In the second Indent,

     of point 3.1;

      the updating referred to In the second paragraph of

      point 3.4;

      the decisions and reports from the notified body

      which are referred to in the final paragraph of

      point 3.4, point 4.3 and point 4.4.

6. Each notified body shall give the other notified bodies

    the relevant Information concerning the quality system

    approvals issued and withdrawn.

```

```
                   - 67 
                   ANNEX V

Module: Product verification

    This module describes the procedure whereby a

    manufacturer or his authorized representative

    established within the Community checks and attests

    that the equipment subject to the provisions of point

    3 are In conformity with the type as described in the

    EC-type examination certificate and satisfy the

    relevant requirements of the Directive.

    The manufacturer shall take all measures necessary in

    order that the manufacturing process ensures conformity

    of the equipment with the type as described In the EC

    type-examination certificate and with the requirements

    of the Directive that apply to them. He shall affix the

    CE-mark to each equipment and shall draw up a

    declaration of conformity.

    The notified body shall carry out the appropriate

    examinations and tests In order to check the conformity

    of the equipment with the relevant requirements of the

    Directive either by examination and testing of every

    product as specified In point 4 or by examination and

    testing of equipment on a statistical basis, as

    specified in point 5, at the choice of the

    manufacturer.

    The manufacturer or h I s author I zed representative shall

    keep a copy of the declaration of conformity for a

    period ending at least ten years after the last

    equipment has been manufactured.

```

```
                   - 68 
4. Verification by examination and testing of every

   equIpment

4.1 All equipment shall be individually examined and

    appropriate tests as set out In the relevant

    standard(s) referred to In Article 5 or equivalent*

    tests shall be carried out In order to verify their'

    conformity with the type as described In the EC-type

    examination certificate and the relevant requirements

    of the D i rect I ve .

4.2 The notified body shall affix or cause to be affixed,

    Its Identification symbol to each approved equipment

    and draw up a written certificate of conformity

    relating to the tests carried out.

4.3 The manufacturer or his authorized representative shall

    ensure that he is able to supply the notified body's

    certificates of conformity on request..

5. Statistical verification

5.1 The manufacturer shall present his equipment In the

    form of homogeneous lots and shall take all measures

    necessary tin order that the manufacturing process

    ensures the homogeneity of each lot produced.

 5.2 All equipment shall be available for verification in

    the form of homogeneous lots. A random sample shall be

    drawn from each lot. Products in a sample shall b e [1 ]

    Individually examined and appropriate tests as set out

    In the relevant standard(s) referred to In Article 5,

    or equivalent tests, shall be carried out to ensure

    their conformity with the relevant requirements of the

    Directive and to determine whether the lot Is accepted

    or rejected.

```

```
                - 69 
5.3 A sampling plan with the following operating

   characteristics Is applied:

      a standard quality level corresponding to a 95 %

      probability of acceptance with a percentage of non
      conformity between 0,5 and 1,5 %,

      a l i m i t quality correspond ing to a 5 % probabI I Ity,

      of acceptance with a percentage of non-conformity

     • between 5 and 10 %.

5.4 In the case of accepted lots, the notified body shall

    affix, or cause to be affixed, Its Identification

    symbol to each equipment and shall draw up a written

    certificate of conformity relating to the tests carried

    out. All equipment in the lot may be put on the market

    except those products from the sample which were found

    not to be In conformity.

    If a lot is rejected, the notified body or the

    competent author Ity shaI I take appropriate measures to

    prevent the putting on the market of that lot. In the

    event of frequent rejection of lots the not I fled body

    may suspend the statistical verification.

    The manufacturer may, under the responsibility of the

    notified body, affix the latter's identification symbol

    during the manufacturing process.

5.5 The manufacturer or his authorized representative

    shall ensure that he is able to supply the notified

    body's cert I fIcates of conformity on request.

```

```
L_

```

```
                   - 70 
                  ANNEX VI

Module: Conformity to type

    This module describes that part of the procedure

    whereby the manufacturer or his authorized

    representative established within the Community ensures

    and declares that the equipment and protective systems

    are In conformity with the type as described in the EC

    type-examination certificate and satisfy the relevant

    requirements of the Directive. The manufacturer shall

    affix the CE mark to each equipment and protective

    system and draw up a written declaration of conformity.

    The manufacturer shall take all measures necessary to

    ensure that the manufacturing process assures

    compliance of the manufactured equipment and protective

    systems with the type as described in the EC type
    examination certificate and with the relevant,

    requirements of the Directive.

    The manufacturer or his authorized representative shall

    keep a copy of the declaration of conformity for a

    period ending at least ten years after the last

    equipment or protective system has been manufacturerd.

    Where neither the manufacturer nor his authorized

    representative is established within the Community, the

    obligation to keep the technical documentation

    available shall be the responsibility of the person who

    places the equipment or protective system on the

    Community market.

```

```
              - 71 
For each equipment or protective system manufactured

the protection aspects of the product shall be carried

out by the manufacturer or on his behalf. The tests

shall be carried out on the responsibility of a

notified body, chosen by the manufacturer.

On the responsibility of the notified body, the

manufacturer shall affix the former's Identification

symbol during the manufacturing process.

```

```
                   - 72 
                  ANNEX VI I

Module: Product quality assurance

1. This module describes the procedure whereby the

    manufacturer who satisfies the obligations of point 2

    ensures and declares that the equipment and protective

    systems are in conformity with the type as described In

    the EC type-examination certificate. The manufacturer

    shall affix the CE mark to each product and draw up a

    written declaration of conformity. The CE mark shall be

    accompanied by the Identification symbol of the

    notified body responsible for - surveI I Ianee as specified

    in poInt 4.

2. The manufacturer shall operate an approved quality

    system for final equipment and protective system

    Inspection and testing as specified tn paragraph 3 and

    shall be subject to surveI I Iance as specified in point»

    4.

3. Qua Ilty system

    3.1. The manufacturer shall lodge an application for

        assessment of his quality system for the

        equipment and protective systems, with a notified

        body of his choice.

        The application shall include:

          all relevant information for the product

          category envisaged

```

```
               - 73 
      the quality system's documentation

      the technical documentation of the approved

      type and a copy of the EC type-examan I at Ion

      cert IfIcate .

3.2. Under the quality system, each equipment and-*

    protective system shall be examined and

    appropriate tests as set out in the relevant

    standard(s) referred to In Article 5 or

    equivalent tests shall be carried out in order to

    ensure Its conformity with the relevant

    requirements of the Directive. All the elements,

    requirements and provisions adopted by the

    manufacturer shall be documented in a systematic

    and orderly manner in the -form of written

    policies, procedures and instructions. This

    quality system documentation shall ensure a

    common understanding of the quality programmes,

    plans, manuals and records.

     It shall contain in particular an adequate

    descr I pt ion of :

       the quality objectives and the organizational

       structure, responsibilities and powers of the

       management with regard to product quality,

       the examinations and tests that will be

       carried out after manufacture

       the means to monitor the effective operation

       of the qua I Ity system

       quality records,- such as Inspection reports

       and test data, calibration data, qualification

       reports of the personnel concerned, etc.

```

```
                - 74 
3.3. The notified body shall assess the quality system

    to determine whether It s a t i s f i e s the

    requirements referred to in point 3.2. It shall

    presume conformity with these r e q u i r e m e n t s In

    respect of quality systems that Implement the

    relevant harmonized standard.

    The auditing team shall have at least one member

    experienced as an assessor In the product

     technology concerned. The assessment procedure

     shall include an assessment visit to the

    m a n u f a c t u r e r ' s p r e m i s e s .

     The decision shall be notified to the

     m a n u f a c t u r e r . The not I f I cat Ion sha I I* contain the

     conclusions of the examination and the reasoned

     assessment decision.

3.4. The manufacturer shall undertake to discharge the

     obligations arising from the quality system as

     approved and to maintain it In an a p p r o p r i a t e and

     eff I c i ent m a n n e r .

     The manufacturer or his authorized representative

     shall* keep the notified body which has approved

     the quality system Informed of any Intended

     updating of the quality system.

     The notified body shall evaluate the

     m o d i f i c a t i o n s proposed and decide whether the

     modified quality system will still satisfy the

     requirements referred to in paragraph 3.2. or

     whether a re-assessment Is required.

```

```
                   - 75 
        It shall notify its decision to the manufacturer.

        The notification shall contain the conclusions of

        the examination and the reasoned assessment

        dec I s Ion.

4. Surve11 I ance under the respons I b 1 I Ity of the notified

    body

    4.1. The purpose of surveillance is to make sure that

        the manufacturer duly fulfils the obligations

        arising out of the approved quality system.

    4.2. The manufacturer shall allow the notified body

        entrance for inspection purposes to the locations

        of inspection, testing, and storage and shall

        provide it with all necessary Information, In

        par tIcuIar

          the quality system documentation

          the technical documentation

          the quality records, such as inspection

          reports and test data, calibration data,

          qualification reports of the personnel

          concerned, etc.

    4.3. The notified body shall periodically carry out

        audits to ensure that the manufacturer maintains

        and applies the quality system and shall provide

        an audit report to the manufacturer.

```

```
                - 76 
4.4. A d d i t i o n a l l y, the notified body may pay

    unexpected visits to the m a n u f a c t u r e r . At the

    time of such visits, the notified body may carry

    out tests or have them carried out In order to

    check the proper functioning of the quality

    system where necessary; It shall provide tthe

    manufacturer with a visit report and, if a test

    has been carried out, with a test report.

The manufacturer shall, for a period ending at least

ten years after the last equipment or protective system

has been manufactured, keep at the disposal of the

national a u t h o r i t i e s :

  the documentation referred to in the third Indent of

  po I nt 3.1;

  the updating referred to In the second paragraph of

  point 3.4;

  the decisions and reports from the notified body

  which are referred to in the final paragraph of

  point 3.4, point 4.3 and point 4.4.

Each notified body shall forward to the other notified

bodies the relevant information concerning the quality

system approvals Issued and w i t h d r a w n .

```

```
                   - 77 
                  ANNEX VI I I

Module: Internal control of production

1. This module describes the procedure whereby the

    manufacturer or his authorized representative

    established within the Community, who carries out the

    obligations laid down in point 2, ensures and declares

    that the equipment satisfy the relevant requirements of

    the Directive. The manufacturer shall affix the CE mark

    to each equipment and draw up a written declaration of

    conform Ity.

2. The manufacturer shall establish the technical

    documentation described In paragraph 3 and he or his

    authorized representative established with the

    Community shall keep it for a period ending at least 10

    years after the last equipment has been manufactured

    at the disposal of the relevant national authorities

    for inspection purposes.

    Where neither the manufacturer nor his authorized

    representative Is established within the Community, the

    obligation to keep the technical documentation

    available shall be the responsibility of the person who

    places the equipment on the Community market.

3. Technical documentation shall enable the conformity of

    the equipment with the relevant requirements of the

    Directive to be assessed. It shall, as far as relevant

    for such assessment, cover the design, manufacture and

    operation of the product.

    The manufacturer or his authorized representative shall

    keep a copy of the declaration of conformity with the

    technical documentation;

```

```
                   - 78 
5. The manufacturer shall take all measures necessary in

   order that the manufacturing process shall ensure

    compliance of the manufactured equipment with the

    technical documentation referred to In point 2 and with

    the relevant requirements of the Directive.

```

```
                   - 79 
                   ANNEX IX

Module: full quality assurance

1. This module describes the procedure whereby the

    manufacturer who satisfies the obligations of paragraph

    2 ensures and declares that the equipment concerned

    satisfy the relevant requirements of the directive. The

    manufacturer shall affix the CE mark to each equipment

    and draw up a written declaration of conformity. The CE

    mark shall be accompanied by the identification symbol

    of the notified body responsible for the EC

    surve i I Iance .

2. The manufacturer shall operate an approved quality

    system for design, manufacture and final equipment

    inspection and testing as specified in paragraph 3 and

    shall be subject to EC surveillance as specified In

    paragraph 4.

3. Qua I Ity system

3.1 The manufacturer shall lodge an application for

    assessment of his quality system with a notified body.

    The application shall include:

      all relevant information for the equipment category

      env I saged

      the quality system's documentation

3.2 The quality system shall ensure compliance of the

    equipment with the relevant requirements of the

    d i rect i ve .

```

```
                - 80 
All the elements, requirements and provisions adopted

by the manufacturer shall be documented In a systematic

and orderly manner In the form of written policies,

procedures and Instructions. This quality system

documentation shall ensure a common understanding of

the quality policies and procedures such as quality

programmes, plans, manuals and records.

It shall contain in particular an adequate description

of

  the quality objectives and the organizational

  structure, responsibilities and powers of the

  management with regard to design and equipment

  qua I Ity,

   the technical design specifications, Including

   standards, that will be applied and, where the

   standards referred to In article 5 will not be

   applied In full, the means that will be used to

   ensure that the essential requirements of the

   directive that apply to the equipment will be met,

   the design control and design verification

   techniques, processes and systematic actions that

   will be used when designing the equipment,

   the corresponding manufacturing, quality control and

   quality assurance techniques, processes and

   systematic actions that will be used,

   the examinations and tests that will be carried out

   before, during, and after manufacture, and the

   frequency with which they will be carried out,

```

```
                   - 81 
      the quality records, such as Inspection reports and

      test data, calibration data, q u a l i f i c a t i o n reports

      of the personnel concerned, etc.,

      the means to monitor the achievement of the required

      design and equipment quality and the e f f e c t i v e

      o p e r a t i o n of the quality system.

3.3. The notified body shall assess the quality system to

    determine whether it satisfies the requirements

    referred to In paragraph 3.2. It shall presume

    compliance with these requirements in respect of

    quality systems that implement the relevant harmonized

    standard.

    The auditing team shall have at least one member

    experienced as an assessor In the product technology

    c o n c e r n e d . The evaluation procedure shall Include an

    assessment visit to the m a n u f a c t u r e r ' s p r e m i s e s .

    The decision shall be notified to the m a n u f a c t u r e r . The

    n o t i f i c a t i o n shall contain the c o n c l u s i o n s of thfe

    e x a m i n a t i o n and the reasoned assessment d e c i s i o n . •

3.4. The manufacturer shall undertake to fulfil the

    o b l i g a t i o n s arising out of the quality system as

    approved and to uphold It so that it remains adequate

    and eff i c I ent.

    The manufacturer or his authorized r e p r e s e n t a t i v e

    established In the Community shall keep the notified

    body that has approved the quality system Informed of

    any intended updating of the quality system.

    The notified body shall evaluate the m o d i f i c a t i o n s

    proposed and decide whether the amended quality system

    will still satisfy the requirements referred to In

    paragraph 3.2. or whether a re-assessment Is required.

```

```
                   - 82 
    It shall notify Its decision to the m a n u f a c t u r e r . The

   notification shall contain the conclusions of the

   examination and the reasoned assessment d e c i s i o n .

   EC surveI I Iance

4.1. The purpose of EC surveillance is to make sure that the

    manufacturer duly fulfils the obligations arising out

    of the approved quality system.

4.2. The manufacturer shall allow the notified body entrance

    for Inspection purposes to the locations of design,

    m a n u f a c t u r e, inspection and testing, and s t o r a g e, and

    shall provide it with all necessary information, in

    par tIcuIar

      the quality system documentation

      the quality records as foreseen by the design part

      of the quality system, such as results of a n a l y s e s,

      c a l c u l a t i o n s, tests, etc.

      the quality records as foreseen by the m a n u f a c t u r i n g

      part of the quality system, such as inspection

      reports and test data, calibration data,

      qualification reports of the personnel concerned,

      etc.

4.3. The notified body shall periodically carry out audits

    to make sure that the manufacturer m a i n t a i n s and

    applies the quality system and shall provide an audit

    report to the m a n u f a c t u r e r .

4.4. Additionally the notified body may pay unexpected

    visits to the m a n u f a c t u r e r . During such visits full or

    reduced audits may be carried out by the notified body.

    The notified body shall provide a visit report and, if

    a p p l i c a b l e, an audit report to the m a n u f a c t u r e r .

```

```
                - 83

5. The manufacturer shall, for a period ending at least 10

    years after the last equipment has been

    m a n u f a c t u r e r e d, keep at the disposa» of the national

    author 111 es :

   - the d o c u m e n t a t i o n s referred to in the second indent

      of the second subparagraph of point 3.1

      the updatIng refer red to in the second subparagraph

      of poInt 3.4

      the decisions and reports from the notified body

      which are referred to in the final subparagraph of

      point 3.4, points 4.3 and 4.4

6. Each notified body shall publish periodically the

    relevant Information concerning the quality system

    approvals issued and w i t h d r a w n .

7. Pes Ign exam I natI on

a) The manufacturer shall lodge an application for

    examination of the design with a single notified b o d y ^

b) The application sha II enable understanding of the

    design, m a n u f a c t u r e and operation of the product, and

    shall enable assessment of conformity with the relevant

    requirements of the d i r e c t i v e .

    11 sha I I I nc I ude

      the technical design s p e c i f i c a t i o n s, including

      s t a n d a r d s, that have been applied,

      the necessary supporting evidence for their

      adequacy, in particular where the standards referred

      to In article 5 have not been applied In full. This

      supporting evidence shall Include the results of

      tests carried out by the appropriate laboratory of

      the manufacturer or on his behalf.

```

```
                 84 
c) The notified body shall examine the a p p l i c a t i o n and

    where the design meets the provisions of the directive

    that apply to It shall issue an EC design e x a m i n a t i o n

    certificate to the applicant. The c e r t i f i c a t e shall

    contain the conclusions of the e x a m i n a t i o n, c o n d i t i o n s

    for Its val Idlty., the necessary data for Identification.

    of the approved design and, if relevant, a d e s c r i p t i o n

    of the equipment's functioning.

d) The applicant shall keep the notified body that has

    issued the EC design examination certificate informed

    of any modification to the approved design.

    M o d i f i c a t i o n s to the approved design must receive

    additional approval from the notified body that issued

    the EC design examination certificate where such

    changes may affect the conformity with the essential

    requirements of the directive or the prescribed

    conditions for use of the equipment. This additional

    approval is given In the form of an addition to the

    original EC design examination c e r t i f i c a t e . ;

e) The not if led bodies shall publish periodically the

    relevant Information concerning

      the applications for EC design examination received

      the EC design examination certificates and additions

      Issued

      the EC design examination certificates and additions

      refused

      the EC design examination certificates and additions

      wIthdrawn

```

```
                    - 85 
                   ANNEX X

Module: EC unit verification

1. This module describes the procedure whereby the

    manufacturer ensures and declares that the equipment or, :

    protective system, which has been issued with the

    certificate referred to in point 2, conforms to the

    relevant requirements of the directive. The

    manufacturer shall affix the CE mark to the equipment

    or protective system and draw up a declaration of

    conform Ity .

2. The notified body shall examine the Individual

    equipment or protective system and carry out the

    appropriate tests as set out In the relevant

    standard(s) referred to in article 5, or equivalent

    tests, to ensure Its conformity with the relevant

    requirements of the directive. The notified body shall

    affix, or cause to be affixed, its Identification

    symbol on the approved equipment or protective system

    and shall draw up a certificate of conformity

    concerning the tests carried out.

3. The aim of the technical documentation is to enable

    conformity with the requirements of the directive to be

    assessed and the design, manufacture and operation of

    the equipment or protective system to be understood.

    The documentation shall contain:

      a general description of the product

      conceptual design and manufacturing drawings and

      schemes of components, sub-assemblies, circuits,

      etc .

      descriptions and explanations necessary for the

      understanding of said drawings and schemes and the

      operation of the equipment or protective system.

```

```
              - 86 
a list of the standards referred to in article 5,

applied In full or In part, and d e s c r i p t i o n s of the

solutions adopted to meet the essential requirements

of the directive where the standards referred to In

article 5 have not been applied

results of design calculations m a d e, exam Inations

carr I ed out, etc .

test reports.

```

```
                   - 87 
                  ANNEX XI

Conformity marks and additional specific markings

1 . EC conformity mark

   The EC conformity shall consist of the letters CE as the

   symbol shows below and the last two figures of the year

    In which the mark was affixed.

# **C€**

2. Additional specific markings

   Additional markings must enable full! Identification of

   equipment and protective systems to be made. They must at

    least contain the following:

     specific explosion protection mark together with

     the mark Indicating the equipment group, the

     conformity category thereof and, relating to equipment

     group 11, the letter "G" (concerning explosive

     atmospheres caused by gases, vapours or hazes) and/or

      "D" (concerning explosive atmospheres caused by dust)

      as, for example, shown below;

     name and address of the manufacturer or his

      I dent I fI cat ion mark ;

     type and serial number;

     restricted or other safety-related conditions of use;

                I 1 G

```

```
                   - 88

                  ANNEX XI I

MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER STATES

FOR THE NOTIFICATION OF BODIES

1. The body, its director and the staff responsible for

    carrying out the verification tests shall not be the

    designer, manufacturer, supplier or Installer of

    equipment and protective systems which they inspect,

    nor the authorized representative of any of these

    parties. They shall not become either involved directly

    or as authorized representatives In the design,

    construction, marketing or maintenance of equipment and

    protective systems. This does not preclude the

    possibility of exchanges of technical Information

    between the manufacturer and the body.

2. The body and Its staff shall carry out the verification

    tests with the highest degree of professional Integrity

    and technical competence and shall be free from all

    pressures and Inducements, particularly financial,

    which might Influence their Judgement or the results of

    the Inspection, especially from persons or groups of

    persons with an Interest In the result of

    ver i f I cat i ons.

3. The body shall have at Its disposal the necessary staff

    and possess the necessary facilities to enable It to

    perform properly the administrative and technical tasks

    connected with verification; it shall also have access

    to the equipment required for special verification.

```

```
                - 89 
The staff responsible for Inspection shall have:

- sound technical and professional training,

  satisfactory knowledge of the requirements of the

  tests they carry out and adequate experience of such

  tests,

  the ability to draw up the certificates, records and

  reports required to authenticate the performance of

  the tests.

The Impartiality of inspection staff shall be

guaranteed. Their remuneration shall not depend on the

number of tests carried out or on the results of such

tests.

The body shall take out liability insurance unless Its

 liability is assumed by the State In accordance with

national law, or the Member State Itself is directly

responsible for the tests.

The staff of the body shall be bound to observe

professional secrecy with regard to all information

gained In carrying out Its tasks (except vis-à-vis the

competent administrative authorities of the State in

which Its activities are carried out) under this

Directive or any provision of national law giving

effect to It.

```

```
                     - 90 
                 FINANCIAL STATEMENT

            SECTION 1: FINANCIAL IMPLICATIONS

1. Title of opérât Ion

Approximation of the laws of the Member States concerning equipment and
protective systems Intended for use In potentially explosive atmospheres.

2. Budget heading Involved

Article B5-300: completing the Internal market.

3. Legal basis

Article 100a of the Treaty
Council Resolution of 7 May 1985 concerning a new approach to technical

harmonization and standardization.

4. Description of operation

The planned operation consists of contributing to the drafting and prevision
of harmonized standards which will facilitate the appiIcatIon • of the
directive and Increase the competitiveness of European Industry.

5. Classification of expenditure

Differentiated appropriation

Non-compulsory expenditure.

6. Type of expenditure

The above proposal defines essential safety and health requirements.

Article 5 of It refers to harmonized standards.

```

```
                    - 91 
As with the other "New Approach" directives, the Commission plans to assign
to CEN/CENELEC the task of preparing useful harmonized standards. The
mandate required for this task falls within the framework contract signed
on 10 October 1985, which provides for financial support from the
Commission.

7. Financial Impact on appropriations for operations

7.1 Method of calculation

(a) CENELEC

     CENELEC is currently following a policy aimed at decreasing the
     number of operations carried out by the Commission and the
     EFTA Secretariat. The amounts invoiced for the preparation of
     CENELEC standards can therefore be considered to be token values

     which are 30-40% of the actual costs. On this basis, an Initial
     estimate shows that 30 standards need to be revised (actual costs
     ECU 600 000, of which ECU 240 000 has been Invoiced) and 20 new
     standards will be needed (actual costs ECU 576 000, of which
     ECU 128 000 has been Invoiced). The actual cost of the programme
     amounts to ECU 1 176 000, of which ECU 368 000 has been invoiced.
     The Impact on the Commission budget is therefore currently
     estimated to be ECU 368 000. The average price of a CENELEC
     standard is ECU 7 360.

```

```
                     - 92 
(b) CEN

     The same policy is not followed by CEN, however. The method of
     financing calculated on the basis of experience with existing

     mandates shows that each new standard costs the Commission an

     average of ECU 50 000. The number of A/B (product families) CEN
     standards Is provisionally put at 25. However, a safety margin of
     five additional standards has to be allowed. The total impact of
     the programme is therefore estimated to be 30 standards
     representing expenditure of ECU 1.5 million.

(c) The total number of (CEN + CENELEC) standards is 80. The overall

     expenditure can be estimated to be a maximum of ECU 1 868 000.

     This estimate has been made in collaboration with the

     standardization bodies. The technical structures In the electrical

     field have been in place for a number of years, which means that
     undoubtedly more unreliable data can be obtained. This is not
     always the case with non-electrical standardization most of which,
     although some work Is in progress, in particular supported by the
     "machinery" mandate, Is still unchartered territory due to lack of
     experience and In particular of technical forums in which the
     experts are able to cooperate. The CEN amounts should be
     considered in the light of this.
     The amount is to be spread over four years.

7.2 Schedule of commitment appropriations (CA) and payment
     appropriations (PA) (Article B5-300

```

```
  PA

678 000

744 000

248 000

```

```
198 000

```

```
1992

1993

1994

1995

TOTAL

```

```
CA

1 868 000

```

```
1 868 000 1 868 000

```

```
                    - 93 
           SECTION 2: ADMINISTRATIVE EXPENDITURE

The proposal for a directive replaces and extends the existing directives.
The incorporation of non-electrical equipment and mining equipment, which
Is currently dealt with by DG V/E-4 (Secretariat of the Safety and Health
Commission for the Mining and Other Extractive Industries, will create a
need for one additional A-1 eve I official to be appointed either by way of
internal mutation, or by the Commission within the framework of the
allocation of resources. He will be responsible for ensuring the
application of the directive, providing technical liaison between the
Commission and standardization and matters of interpretation of the
essential requirements and monitoring the work of DG V concerning the
Article 118a directive. He will also attend the meetings of the Safety and
Health Commission.

```

```
                    - 94 
        SECTION 3: ELEMENTS OF COST-EFFECTIVE ANALYSIS

The aim of the proposed operation Is fui I harmonization of the ATEX
(electrical) sector In accordance with the statement entered In the minutes
of the meeting of which optional Directive 79/196/EEC was adopted. It is
therefore an obligation for which no alternative has been considered. The
extension to Include other equipment meets technical safety requirements
and is in keeping with the Council Resolution of 7 May 1985 to avoid a
 large number of specific directives.

 It can be noted that about 20 standards have already been produced for the
electrical field, many of which are Included In the technical annexes to
Directive 79/196/EEC, 82/130/EEC and 90/487/EEC. A simple revision of
these standards and the inclusion of any specific measures to meet new
essential safety requirements may suffice in many cases. In addition, a
 large number of I EC publications (In particular the 79 series) have
appeared since work began In 1948. These will continue to provide a firm
basis for European standardization activities.

Furthermore, the work of WG 16 of CEN/TC 114 (Fire and Explosions) which
was set up under the mandate of Directive 89/392/EEC (machinery), has to be
 taken Into account for the non-electrleal field. The standards produced by
.the committee concerned will apply almost directly to the ATEX Directive.

The above considerations will reduce the number of new standards needed

 and, therefore, the Impact on the Commission budget. v

 The figures given are approximate only.

```

```
                    - 95 
               IMPACT ASSESSMENT SHEET

          IMPACT OF THE PROPOSAL ON UNDERTAKINGS AND,
     IN PARTICULAR, ON SMALL AND MEDIUM-SIZED UNDERTAKINGS (SMUs)

1. Principal grounds for the proposal

This proposal for a directive is aimed at the full harmonization of
equipment and protective systems Intended for use In potentially explosive
atmospheres. It Includes the optional system Introduced by
Directive 76/117/EEC, 79/196/EEC, 90/487/EEC and 82/130/EEC, which will be
made complete and provides for a widening to Include equipment and
protective systems not covered by Community legislation.

2. Impact on undertakings

2a Characteristics of the undertakings concerned

There are a considerable number of SMUs in the field of equipment for use
In potentially explosive atmospheres. The high level of specialization In
this field has enabled relatively small undertakings to coexist with the
specific production lines of the major equipment manufacturers. The main
manufactures are in France, Germany and the UK, and users are to be found
in all countries with an industrial (chemicals, oil) and mining sector.
Production of such equipment Is tending to decline following pit closures.
Greater and continuously Increasing interest Is now being shown in surface
equipment, however. As a result of restructuring in the sector concerned
and gearing it towards Industrial applications, European equipment has an
excellent reputation and can only benefit from a larger market, not only
within the Community but also in the EFTA countries and as regards exports
to North America and other countries concerned with the exploitation of
mineral resources.

Are there concentrations In regions eligible for regional aid from the
Member States? No

Are there concentrations In regions eligible under the ERDF? No

```

```
                     - 96 
However, It should be stated that subsidies have made It possible to
maintain certain mining activities and therefore to safeguard local
Industries which supply group I equipment.

3. The obligations on undertakings

The existing optional directives guaranteed free movement of some
electrical equipment within the Community. Companies were not unaware of
this commercial advantage, which was symbolized by the affixing of the
highly estimated Commun!ty mark epsilon- . The general possibility of
free movement for the bulk of equipment and systems produced for use in
potentially explosive atmospheres must be regarded as an additional asset.
It was found during the (modest) extension of the existing directives that
all of the parties concerned approved and that national legislation or
standardization were systematically abandoned.

Since European standardization exists, the need for conformity with
different national provisions and the inherent costs disappear. The
apparently new obligations contained In the new directive will ultimately
only replace those existing at the national level and will help to reduce
the diversity of existing regulations.

4. What are the foreseeable effects

     on employment?

     The effects on employment will tend to be Indirect. The fact Is      and this has been confirmed by experience In the electrical field      that the production of high-quality equipment is an important asset
     which extends even beyond the Community's frontiers. The effect on
     employment, taking account of the high level of specialization of
     the SMUs working In the field, may therefore be beneficial.

     on the compet it Iveness of undertakings?

     The reduction in the number of certificates to be obtained for the

     same Item of equipment and the associated savings, In particular
     for non-electrical equipment, as a result of not having to repeat
     tests will put a limit on the total price and Increase
     competitiveness while guaranteeing equivalent quality.

```

```
                     - 97 
5. Will there be special measures for SMUs?

No. However, the directive does provide for the checking of Individual
units to certify conformity, which may be a satisfactory solution for
special equipment made In limited numbers for part leu Iar app11 cat ions.

6. Have the two sides of Industry been consulted?

The proposed directive has been discussed with experts from the industrial
federations (ORGALIME, ECCMF, FITMT) and European standardization In which
all of the Interests concerned are represented. Furthermore, the Mines
Safety and Health Commission and the Advisory Committee on Safety, Hygiene
and Health Protection at Work have been fully consulted.

A broad consensus emerged from the discussions. Electrotechnlcal
standardization (CENELEC) has a large number of standards, Its
non-electrical partner (CEN) Is at the moment preparing a generic standard
in Its field under the mandate of the "machinery" directive.

It Is only structures which from the beginning have been completely divided
Into electrical and mechanical sections (industrial federations, some
administrations) which find some difficulty In accepting the generalizing
approach of the proposal.

However, the committees which Include the workers' trades unions approve of
this approach for safety reasons.

```

###### **ISSN 0254-1475**

### **COM(91) 516 final**

## **DOCUMENTS**

### **E N 04 06** **Catalogue number : CB-CO-91-591-EN-C** **ISBN 92-77-78935-2**

###### **Office for Official Publications of the Europeaa Communities** **L-2985 Luxembourg**