CEN/TC 12

CEN/TC12's EXPECTATIONS OF EUROPEAN PROJECT LEADERS

Note: the text below is reproduced from first article in the European Project Leader Manual.  The complete EPL Manual including all articles and Annexes is available to TC12 members at the CEN/TC12 website c/o AFNOR.
Click here for the EPL Checklist

CEN/TC 12 has many work items on its work programme for which the responsibility has been transferred to ISO/TC 67 under the Vienna Agreement. CEN/TC 12 has appointed a European Project Leader (EPL) for each work item that is transferred to ISO. The EPL is normally a European expert who is already a member of the relevant ISO Work Group. The EPL may also be either the ISO Work Group Convenor or ISO Project Leader; or not.

Objective

The objective of the European Project Leader is to facilitate adoption of the ISO Standard in Europe without modification. This may require influencing the ISO TC, SC or Work Group to include European requirements within the ISO Standard.

The scope of CEN/TC12 includes the words "the standardisation is to be achieved wherever possible by the adoption of ISO Standards". The EPL is therefore required to advise TC12 if adoption is possible, and by what process, and to sign a letter stating that checks have been done for Europe including checks to avoid conflict with requirements of European Directives.

Specific Tasks for the EPL

• Be familiar with the Reference Documents (see CEN/TC12 EPL Manual)
• Strive for full participation by CEN Members in the ISO Work Group (note: a minimum of 5 CEN Members should have experts participating)
• Check, as far as is reasonably practicable, that there is no conflict with European Directives (or identify any conflict that will require a European Modification (see below))
• Identify, as far as is reasonably practicable, other European Standards that may overlap in scope, and check for any potential conflicts;
• For relevant standards, ensure that the Introduction to the ISO Standard includes the agreed paragraph regarding further or differing requirements and alternative equipment (note: the judgement on which standards are "relevant" is best made by the EPL, but in general are those such as for rotating machinery where the standard may prescribe a requirement in order to indicate the standard required but where the market is such that some manufacturers/suppliers have alternative equipment that is sometimes acceptable to a user/purchaser);
• Ensure that the CEN policy on 'Normative References' is followed (see Reference Documents). A useful check list may be found in document ISO/TC67 N 435;
• Advise CEN/TC 12 on the recommended CEN Adoption Process (see below);
• Sign the appropriate letter to CEN/TC12;
• Ensure that European comments made at CEN Enquiry are brought to the attention of the ISO Work Group;
• Facilitate progress, through to final publication in CEN.

Guidance for EPLs on European Directives

The EPL should take reasonable steps to identify European Directives relevant to the subject matter of the Standard under consideration, remembering that the goal of CEN/TC12 is to publish standards that are useful and useable in Europe. A short-list of Directives, that is likely to include the most relevant Directives, is included in later sections of the CEN/TC12 EPL Manual together with guidance on the issues likely to be of relevance to CEN/TC12 documents. The EPL should select the Directive (or Directives) where it is obvious that conflict would bring the fitness of the Standard into question; for example, Standards for machinery should be checked against the Machinery Safety Directive.

It may be helpful to think of three categories of European Directives, as follows:

1. 'Public Procurement' Directives. These Directives, such as the 'Utilities' Procurement Directive 93/38, define a "standard" (for the purposes of the Directive) as being a "technical specification" i.e. a document containing requirements. The Directives contain no specific requirements regarding the content of this type of standard. When developed selecting the appropriate parts of ISO and CEN procedures (ISO/IEC Directives and CEN Internal Regulations) the standard will not be in conflict with this category of European Directives. Therefore it is not expected that the EPL should need to check the content of any proposed European Standard against the 'Public Procurement' Directives. And it is the responsibility of the ISO Project Leader, ISO Secretaries etc. to ensure compliance of the ISO Standard with the ISO Directives.
2. Article 100A Directives for Trade/Supply ('New Approach'). These contain an Annex with 'essential requirements' for health, safety and environmental protection. Relevant Directives should be checked to ensure that the proposed European Standard does not contain requirements that conflict with the particular 'essential requirements'.
3. Article 118A Directives for Employment/Workplace Safety. These include minimum requirements, to which member states may add. If the proposed standard includes requirements for handling, operation etc. the EPL should take reasonable steps to identify relevant Directives for example "Use" Directives such as "Use of Work Equipment", and check in case the proposed European Standard may not meet the minimum requirements.

When checking against Directives, it may be useful for the EPL to remember that the user of the standard, not the EPL, is responsible for complying with the legal requirements. The EPL should be making reasonable checks for obvious conflicts but it is not intended that the EPL must investigate every possibility.

EPLs should also note that the CEN/TC12 Standards are not classed as "harmonised" standards. They are not being developed to provide a presumption of conformity with these Directives. Therefore it is not required to follow the procedures for harmonised standards nor to develop an 'Annex Z'. There is no expectation of "compliance" with the Directives.

Some of the issues and questions that are often raised with respect to acceptability of the ISO Standards, particularly those developed based on API Standards, are addressed in document ISO/TC67/SC6 N 274.

Guidance on European Modifications (if Unavoidable)

Modifications to the text of the ISO Standard, resulting in TC12 adopting different text for the European Standard, should be considered only in the following circumstances:

1. Conflict with national legislation implementing European Directives: European Directives are implemented as national legislation in all member states of the European Union but it should be necessary to check only the text of the original European Directive. This situation will require that European modifications be made to the text of the ISO Standard. Note that this should not apply to draft Directives, where experience shows that changes may occur before implementation, in particular to technical requirements.

2. Conflict with national legislation other than implementing European Directives: the particular country(ies) should agree that Europe should adopt the ISO Standard without modification and should request an A-deviation (see CEN Internal Regulations Part 2 clauses 3.1.9 and 4.4).

3. Conflict with other European Standards: it is desirable to avoid conflict with other, existing European Standards. The European Project Leader's options are as follows:
a) recommend that the TC12 standard should change: a request should be made to the responsible ISO TC, SC or WG to change (draft in progress) or revise (standard published) the ISO Standard but if the ISO Work Group does not agree, this situation will require that European modifications be made to the text of the ISO Standard;
b) recommend that the TC12 standard should proceed with the text of the ISO Standard without modification, with the different requirements. Request TC12 to discuss the situation with the CEN TC responsible for the conflicting standard, with recommendations for the changes required (e.g. in the delineation of its scope).

If conflict is found at the European level (cases 1 and 3 above), every effort should first be made to resolve it at ISO level. The preference is for adequate technical requirements to be agreed internationally, by the experts at ISO level, and to be integrated into the ISO Standard. Otherwise the development of a 'Regional Annex' to the ISO Standard, or the development of a new Part (normative) to the ISO Standard, may be considered by the experts at ISO level, on a case-by-case basis.

As a last resort, modifications to the text of the ISO Standard should be made at European level (e.g. by CEN/TC 12) before CEN enquiry or voting. Wherever possible, the European modifications should be contained in an Endorsement Notice (ref. CEN Internal Regulations Part 3, 5.3) to the European Standard while the remainder of the text of the ISO Standard is unchanged. Otherwise, if modifications are made throughout the text, there should be an Informative Annex that summarises all the changes from the text of the ISO Standard.

In exceptional cases there may be a need to develop a harmonised European Standard, under a mandate from the Commission, either as an additional Part or as a supplementary Standard to the adopted EN ISO Standard, in order to provide a document that will give a 'presumption of conformity' with a particular European Directive. Before embarking on this course, particular advice should be sought from the Secretariat of CEN/TC 12.

Guidance on Selecting the CEN Adoption Process

1) ISO Work in Progress:

Parallel Approval: the preferred adoption procedure is the Parallel Approval Procedure (ref. Vienna Agreement, clause 5). This applies to drafts in progress. All comments made at European level should be passed to the ISO TC, SC or WG for resolution.

2) ISO Standard published:

UAP: the preferred adoption procedure is the UAP Procedure (ref. CEN Internal Regulations Part 2, clause 4.6). In the UAP procedure, all votes are unconditional and if the result is positive the document is adopted as an European Standard. Therefore the UAP Procedure should be used when sufficient participating European members have already approved the ISO Standard and if no conflicts are expected at European level (ref. cases 1 and 3(b) above). European members voting should not submit any comments except where they have problems that fall within the cases 1, 2 or 3 above).

PQ/UQ: The Questionnaire Procedure (PQ for a new ISO Standard, UQ for a revision) should be used where it is expected that European needs have not been adequately addressed, and that there may be a need to add an European supplement or to modify the text of the ISO Standard. In considering whether to use PQ/UQ, it is treatment of Europe-specific requirements that is important. The PQ/UQ should not be used just because general requirements with minority support have been found non-persuasive by the relevant ISO committee. Remembering the goal of adopting the ISO Standard without modification, the Questionnaire Procedure should be used only by exception.
___________________________________________________________________________

This document was developed as Doc. No. CEN/TC12 AH4 N 37 and was completed in May 1998 to become the introduction to the "CEN/TC12 European Project Leaders Manual". The EPL Manual is maintained by the Secretary of CEN/TC12 and is distributed to a controlled distribution list.