Equipment for use in potentially explosive atmospheres
on Council Directive 94/9/EEC (ATEX) / DS/99/06/073 rev.4
EUROPEAN ATEX NOTIFIED BODIES GROUP (Ex NB) RULES
Note: This version of the ExNB Rules has been prepared following discussions at the 1st ExNB meeting, Brussels, June 1997 and it incorporates decision sheet n°99/06/073/DS.
1.INTRODUCTION
1.1These rules have been drawn up in line with the policy of the European Commission, as elaborated in Document CERTIF 94/6 Rev. 4a dated 1 June 1995.
1.2ExNB is non-profitable organization whose aim is to promote a harmonised practice of the Harmonised European Standards as well as a harmonised application of the relevant European Union Directives (ATEX 95) throughout EU and EFTA between all European Notified Bodies.
Efficiency and transparency of the conformity assessment procedures are also an objective.
1.3The actions of ExNB are based on both the old and new approach directives.
1.4The new approach directives clearly define:
- conformity assessment procedures
- a procedure for the notification of bodies involved in the application of the above-mentioned procedures
- minimum criteria of competence for these notified bodies (NB).
1.5These directives clearly state that :
- It is the responsibility of the Member States to evaluate the competence of the bodies to be notified.
- It is the responsibility of the Member States to notify these bodies to the other Member States and to the Commission.
- It is the responsibility of the Member States to ensure that the NBs fulfil the criteria on a continuous basis.
- It is the responsibility of the Commission to ensure that a close co-operation is established between these NBs so that the modules of the directives are applied on a consistent basis by all NBs.
1.6Among the tasks of the ExNB the following are worth mentioning :
(a)To inform, on a regular basis, the Commission and the Article 6.3 Committee of the on-going work, observations, suggestions, decisions, conclusions, and interpretations arising from the daily application of the directives.
(b)To inform, on the same basis, the relevant standardisation bodies mandated by the Commission – such as CEN and CENELEC – of the relevant information arising from the daily application of the Harmonised European Standards.
(c)To ensure that all NB members of ExNB work to uniform guidelines which have to be established.
2.COMPOSITION OF EXNB
ExNB shall be composed of:
- One Chairman
- Two Vice-Chairmen
- The bodies notified under the old and new approach ATEX Directives
Representatives of the Commission
- Chairman or appointed Rrepresentatives of the Standing Committee set up under Article 6.3 of the new ATEX Directive 94/9/EC (the Standing Committee)
- Representatives of the European Standardisation bodies
- Representatives of European industry associations
- A Technical Secretary
- Observers (only by invitation by the Chairman or Commission).
3.MEMBERSHIP CONDITIONS
3.0Role of the Commission
The Commission will attend the meetings to promote harmonised application of the ATEX directive and will receive all documents.”
3.1Active Members
(a)An Active Member of ExNB is any body that has been notified by a Member State of EU or EFTA for at least one of the following Annexes of Directive 94/9/EC : Annex III, IV, V, VI, VII, IX. Active Members must commit themselves to applying these rules.
(b)When appointed, the Active Members form the Active Members Group (AMG).
(c)In the event of an Active Member failing to fulfil the membership conditions, the Chairman shall inform the Commission who shall institute the necessary action.
d)Active members shall receive all documents.”
3.2Permanent Members
(a)The Permanent Members of ExNB are:
- The Chairman of CLC/TC31 and secretaries of CLC/TC 31 and sub-committees
- The Chairman of CEN/TC 305, the secretary of CEN/TC 305 and convenors of working groups
- Chairman or appointed representative of the Standing Committee
(b)When appointed, the Permanent Members form the Permanent Members Group (PMG). Permanent Members shall receive all meeting documents, final draft clarification sheets (step 5.2.4) and approved clarification and decision sheets .
3.3Observers
The following may be invited to attend meetings of ExNB as Observers by the Chairman or the Commission:
- Bodies notifies under “old” Ex directives but not under ATEX directive
Representatives of the Standing Committee
- Representatives of European industry associations mandated by their organisation
- Mandated representatives of national or international groups of testing and certification bodies practising Ex work. After the first attendance, subsequent invitations are dependent on written reciprocal arrangements covering exchange of information and meeting participation,.
- other technical experts as appropriate.
The mandates shall be sent to the Chairman before the meeting. Observers shall receive all meeting documents and approved clarification and decision sheets.”
4. OBJECTIVES OF Ex NB
4.1To help Active Members to fulfill their responsibilities as NBs.
4.2To provide all members with a forum for technical discussions at a high level to form the basis for consistent interpretation and mutual confidence.
4.3To continue to build on the extensive experience gained over many years by HOTL.
4.4To establish clearly how a specific test in a harmonised standard has to be carried out in order to achieve the necessary harmonised practice and to ensure reproducibility of test results.
4.5to harmonise the design and use of testing equipment recommended by a harmonised standard.
4.6To make recommendations to the relevant TC or SC of CENELEC or CEN for improvements in harmonised standards.
4.7To provide regular opportunities to allow demonstration of testing problems and discussion of them.
4.8To give, on request of the Commission or the Standing Committee, advice and recommendations on the application of the Directives.
4.9To provide the Commission and the Standing Committee with observations, comments, advice and recommendations on the application of the Directives.
4.10To disseminate within ExNB all relevant information concerning harmonisation work carried out at the European level.
4.11To share experience and points of view concerning the application of conformity assessment procedures in order to contribute to a better understanding and a harmonized application of the requirements and procedures.
4.12To bring to light disagreements or discrepancies in the application of the harmonised standards or the Directives, to discuss and propose possible solutions and, where possible, to agree on a common solution or the equivalency of different solutions.
4.13To receive and to consider information issued by the Commission or the Standing Committee or any other relevant information relative to the application of the harmonised standards and the Directives.
4.14To collect and examine questions and problems raised by the practical application of the Directives and to present these to the Commission or the Standing Committee as appropriate.
4.15To appoint, where necessary, a representative to any type of organization concerning notified bodies set up by the Commission.
4.16To inform Member States through proper channels.
4.17To inform manufacturers on matters concerning conformity assessment procedures through the most appropriate channels.
4.18To keep each Active Member informed of the facilities of the other Active Members.
4.19To establish contacts with other relevant notified bodies involved in the application of other Divectives.
4.20For Active Members, to make extracts of all certificates or notifications available to all other Active Members. Extracts may be provided to the Member States and the Commission if requested.
4.21To ensure continuity of HOTL duties during the transitional period.
4.22To organize a procedure for prior consultation of all Active Members when new techniques are on the fringe of or outside existing harmonised standards, in order to avoid as far as possible the use of the safeguard clause of Article 7 by Member States.
4.23To develop a common database and common documents especially in the areas covered by the Directives. Access to the database shall be available to all interested parties subject to the need to preserve the confidentiality of relevant information.
- ExNB IN OPERATION
5.1Meetings
A plenary meeting which all Active and Permanent Members of ExNB shall be entitled to attend shall be organized at least once a year as follows :
5.1.1Each Active Member may appoint up to three delegates one of whom shall be designated as Chief Delegate. This designation shall be recorded prior the meeting starts. This record shall be attached to the minutes of the meeting.
5.1.2A Member, if unable to attend a meeting, may nominate another person as their deputy.
5.1.3The information on the people who will be attending a meeting shall be given to the Administrative and Technical Secretaries of ExNB long enough before the meeting to ensure a proper organisation.
5.1.4Decisions of ExNB shall be arrived at by consensus. Documentation for discussion at a meeting shall be sent to the Chairman in sufficient time to allow consideration for inclusion in the agenda and thence to allow distribution of the document (s) at least four (4) weeks before the meeting.
Documents distributed with less than four (4) weeks to the date of the meeting may be included in the Agenda. They may be discussed if two third or more of the active present members entitled to vote are in favour provided more than 75% of active members are present. If this quorum is not reached process defined in 5.2 applies.
5.1.5Where a consensus cannot be achieved, the topic shall be referred to the appropriate body, i.e. the relevant TC or SC of CENELEC or CEN for matters relating to the harmonised standards or to the Commission or the Standing Committee, as appropriate, for matters relating to the Directives.
5.1.6If ExNB agrees that it is important to revise a test specification of a harmonised standard a proposal describing the changes shall be submitted to the relevant TC or SC of CENELEC or CEN.
5.1.7After the meeting has terminated the Technical Secretary of ExNB shall prepare within six (6) weeks an unapproved report containing the minutes of the meeting (having consulted the Chairman as necessary).
5.1.8The Administrative Secretary of ExNB shall send the unapproved report to all members of ExNB with the drafts of the clarification sheets.
5.1.9The members will have a period of one (1) month within which to send their observations to the Technical Secretary.
5.1.10The Technical Secretary shall amend the report in the light of the observations received in consultation with the Chairman.
5.1.11The Chairman and the two Vice-Chairmen of ExNB shall sign the final report and the Administrative Secretary shall send the final report, together with a collation of the observations received, to all members of ExNB.
5.1.12Reports may cover items like decisions, clarification of standards or request for clarification or explanation of the Directives.
5.2Clarification Sheets or Decision Sheets
Clarification sheets or decisions sheets shall be issued according to the process starting at article 5.2.1 excepted where they are the result of the work of a designated working group. In that case the process shall start at article 5.2.4.
The procedure for the creation of clarification or decision sheets shall be as follows :
5.2.1Any Active Member who has a problem regarding the correct application of the harmonised standards or the Directives may question all Active Members for a common answer or proceed as in 5.2.3.The question should also be relayed to the Technical Secretariat for information. Each Active Member wishing to provide an input shall answer within one (1) month directly to the member who originated the question.
5.2.2Each Active Member wishing to provide an input shall answer within one (1) month directly to the member who originated the question.Deleted
5.2.3The member who originated the question shall provide within one (1) month a proposal for a common answer in the form of a clarification sheet in the form of a clarification sheet or a decision sheet as shown in Annex 1ExNB/ABC/123 ; , including recommendations regarding a date from which the agreed proposal would be introduced, and send it to the Administrative Technical Secretary of ExNB together with a collation of all the answers received.The Technical Secretariat Secretary issues an ExNB-number and sends it to the Administrative Secretary.
5.2.4The Administrative Secretary shall send upon receipt the final proposed Clarification Sheet or Decision Sheet together with the collations of any answers or together with the documents produced by a designated working group having achieved its work, to all members of ExNB (Active and Permanent members where necessary) and where applicable to observers.
Consulted parties shall have one (1) month within which to send their observationscomments, if any, to the Chairman and the Technical Secretary.
5.2.5If a consensus is reached,tThe Chairman shall authorize the issue of the final clarification or decision sheet to all members of ExNB if consensus is reached between active members and the Chairman of the Standing Committee.. If any individual active member or the Chairman of the Standing Committee does not provide a comment within one month then no objection to the Clarification sheet will be assumed.
5.2.6If no consensus is reached the question shall be reported to the next plenary meeting of ExNB for suitable treatment.
5.3Application of decisions and clarification sheets
The approved decisions and clarification sheets shall be applied by all Active Members and shall be made available to all interested parties.
5.4Documents of ExNB
Each document including clarification sheets distributed to ExNB shall be allocated a unique number. This format shall be ExNB/YY/NNN. Where YY is the year and NNN is a sequential serial number issued by the Technical Secretariat. Approved clarification sheets shall also be suffixed with /CS.
6.MANAGEMENT OF ExNB
6.1The Chairman and the two Vice-Chairmen shall belong to bodies who are Active Members, and shall be elected by a simple majority of the members of ExNB.
6.2The Chairman shall be elected for a period of two (2) years and may be re-elected for one further period of two (2) years.
6.3The Vice-Chairmen shall be elected for a period of two (2) years and shall not be eligible for re-election for a period of two (2) years.
6.4The services of an Administrative Secretary and a Technical Secretary shall be provided by the Commission in consultation with ExNB.
6.5Role of the Chairman
6.5.1To represent ExNB where and when necessary (for example to the Commission, the Standing Committee, CEN, CENELEC, other bodies mandated by the Commission, Member States, manufacturer organizations, other notified bodies, other groups of European notified bodies, similar international bodies, involved in the ATEX field, foreign bodies involved in the ATEX field).
6.5.2To administer the ExNB Rules.
6.5.3To promote fair competition between Active Members.
6.5.4To do his best to obtain consensus.
6.5.5To make sure that the rules are properly implemented.
6.5.6To chair the plenary meeting.
6.5.7To fix the date and location of the meeting with the Administrative and Technical Secretaries and the Commission.
6.5.8To set the agenda in accordance with members’ requests and in consultation with the Commission.
6.5.9To co-ordinate work and discussion.
6.5.10To review and authorize the reports and the clarification sheets.
6.5.11The Chairman is required to be neutral and cannot act on behalf of his notified body at a meeting of which he is Chairman.
6.6Role of the Vice Chairmen
6.6.1On written request of the Chairman, to represent ExNB totally or partially.
6.6.2To act in place of the Chairman during a plenary meeting in case of this absence.
6.6.3To participate in the coordination of work and discussion.
6.6.4To review and participate in the authorization of the reports and the clarification sheets.
6.6.5To help the Chairman in his task.
6.6.6Role of the Administrative Secretary.
The Administrative Secretary shall carry out the following tasks:
- To assist the Chairman in organizing meetings of the ExNB from an administrative point of view (booking of meeting rooms, provision of interpretation etc).
- To send out invitations, meeting reports, working documents and recommendations
- To arrange for translations of documents where necessary
- To ensure correct administration and account of funds provided by the Commission (allowance for the Chairman, translation and interpretation costs, operation of the secretariat etc).
6.7Role of the Technical Secretary.
The Technical Secretary supports the Chairman with respect to his tasks and should draw up the technical documentation.
7.CONFIDENTIALITY
Members and observers of ExNB shall keep confidential any confidential information to which they have access through the work of ExNB and shall take appropriate action to bind their staff to preserve that confidentiality.
- MODIFICATION OF THE RULES
8.1Any member can make a proposal to the Chairman to change the ExNB rules.
8.2The Chairman shall ensure that all members are notified of the proposal at least one (1) month before the next following plenary meeting.
8.3A formal vote on the proposal shall be taken at the plenary meeting among the active members. Postal votes may be accepted.
8.4The proposal shall be adopted if two-thirds or more of the active members entitled to vote are in favour.
9.PROCEDURE OF ARBITRATION
This procedure deals only with possible problem of interpretation regarding issued clarification sheet and decision sheet as despite all efforts of clarification local divergences in interpretation may still be met between a notified body and its customer.
To allow a reasonable and fast solution of such a situation the following Procedure of Arbitration shall be followed:
9.1In first instance this divergence shall be brought, in a written form to the ExNB Group Chairman, by one of the interested party.
The Chairman in agreement with the Vice-Chairmen should propose within a period, not exceeding one (1) month, a solution.
If it is not believed to reach this objective this decision is brought in the attention of the parties by the Chairman, and article 9.2 applies immediately.
If it is possible, the proposal signed by the Chairman and the Vice-Chairmen is transmitted to the parties.
Upon receipt of the proposal, each party has one month to accept or refuse.
For being taken into consideration refusal shall be done necessarily in a written form and addressed to the Chairman prior to the end of the month otherwise the proposal is considered to be accepted.
If agreed by the parties the proposal shall be written as clarification or a decision sheet and so immediately issued by the Chairman of the ExNB Group.
If one of the parties still does not accept the proposal then article 9.2 applies.
9.2Board of Arbitration
Where a divergence is not solved through application of article 9.1 the problem is transmitted by the ExNB Chairman to the Board of Arbitration and all concerned parties are informed by the ExNB Chairman.
9.3Constitution of Board of Arbitration
The Board of Arbitration has 4 members and 1 Chairman.
Each member and the Chairman has a deputy.
Elected persons of the Board of Arbitration cannot be simultaneously Chairman or Vice-Chairman of the ExNB Group.
- 2 members, the Chairman and their deputies are issued from Notified Bodies.
They are elected during the plenary meeting for 4 years.