Draft NORMAPME Position on annexes Z

Please kindly send your comments on this draft NORMAPME position to r.orth@normapme.com before February 22nd, 2011

Annexes Z are found with standards for products falling under “New Approach Directives”. They indicate the relation between the harmonised standard and the relating “New Approach Directives”.

Annexes Z also eventually provide practical information for the user of the standard on what needs to be done for the related product to comply the directive’s essential requirements, and on the steps that the manufacturer needs to take in order to CE-mark the product. CE marking allows a product falling under a “New Approach Directive” to be fit for export throughout the European single market.

The CEN Advisory Board for Health Standards has launched a survey on the Annexes Z in order to assess the actual usage of the Annexes Z in standards. NORMAPME warmly encourages you to complete this survey. NORMAPME welcomes this initiative and takes this opportunity to raise awareness on the potential usefulness of Annexes Z for SMEs.

Please find below the draft NORMAPME position on Annexes Z as well as the proposed NORMAPME answers to the survey..

For more information, please do not hesitate to contact NORMAPME directly (contact person: Mr. Rémi Orth, r.orth@normapme.com, +32 2 282 0537).

NORMAPME position on Annexes Z

Background

Annexes Z are found with standards for products falling under “New Approach Directives”[1]. They indicate the relation between the harmonised standard and the relating “New Approach Directives”.

Annexes Z also eventually provide practical information for the user of the standard on what needs to be done for the related product to comply the directive’s essential requirements, and on the steps that the manufacturer needs to take in order to CE-mark the product. CE marking allows a product falling under a “New Approach Directive” to be fit for export throughout the European single market.

The CEN Advisory Board for Health Standards[2] has launched a survey[3] on the Annexes Z in order to assess the actual usage of the Annexes Z in standards. NORMAPME welcomes this initiative and takes this opportunity to raise awareness on the potential usefulness of Annexes Z for SMEs.   

Abstract

NORMAPME believes that Annexes Z can be a very helpful tool for enterprises. However, from one standard to another, Annexes Z are currently disparate in their content. NORMAPME believes that a certain level of details should be maintained in all annexes Z, in order to make them a reliable and useful tool for all users of standards.

Position on Annexes Z

NORMAPME believes that discrepancies between Annexes Z should be avoided, and that standards writers should strive to achieve a consistent level of practicality and detail in all Annexes Z. 

Such level of preciseness should be attained by including the information listed below. Numerous annexes Z already provide such information; however NORMAPME considers that this best practice should be generalized to all annexes Z. NORMAPME trusts that this would improve user-friendliness of harmonised standards for all users.

Information that should be included in annexes Z:

- a table linking the essential requirements to the relevant articles in the standard and including all  additional relevant information or comments. If the standard relates to several specific products, there should be one table per product. The table should also include a definition of the product as well as a definition of the foreseen use of the product.    

- a warning relating to other requirements and other EU directives that may be applicable to the product(s) falling within the scope of the standard.

- a table explaining the conformity assessment system and tasks. The table should separate the tasks for the manufacturer and the tasks for the notified body. The tasks should be listed, their content described and the relative conformity clauses within the standards should be indicated.  If the standard relates to several specific products, there should be one table per product.  

- a sub-annex describing clearly and extensively the steps that the manufacturer has to take in order to declare conformity of his product.

- a sub-annex describing clearly and extensively the steps that the manufacturer has to take in order to CE mark his product.

- an example of CE marking information to be given on the product, label, packaging and/or commercial documents.

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Response to the CEN ABHS survey[4] on Annexes Z

NORMAPME encourages you to answer the above survey (deadline: February 28th, 2011). For your convenience, please find below the NORMAPME answers to the survey.

- Do you currently understand the significance of an Annex Z at the end of a standard?

* Yes

- How often do you refer to the Annex Z?

* Autre: annexes Z can prove useful to refer to when the standard is harmonised under the new approach, in order to understand the conformity assessment process and the CE marking

- How useful is the information given in Annex Z?

* Autre : it depends on the standard and on the completeness of the information provided in the annex. An annex Z with complete information is essential for the user.

- Can you give an example of a ‘good’ / "well defined" Annex Z?

- A good annex Z includes the following practical information:

- a table linking the essential requirements to the relevant articles in the standard and a definition of the product as well as of the foreseen use of the product.   

- a warning relating to other requirements and other EU directives

- a table explaining the conformity assessment system and tasks.

- a sub-annex describing the steps that the manufacturer has to take in order to declare conformity of his product.

- a sub-annex describing clearly and extensively the steps that the manufacturer has to take in order to CE mark his product.

- an example of CE marking information to be given on the product, label, packaging and/or commercial documents.

- Examples:

- EN 845-1:2003+A1:2008 Specification for ancillary components for masonry – part 1: ties, tension straps, hangers & brackets      

- EN 14351-1:2006 Windows & doors

- Can you give an example of a "poor" / "ill-defined" Annex Z?

- A poor annex Z does not include all the practical information listed above

- If the Annex Z information was available in the body of the standard, instead of the end, would this be....

    * .... worse

- If the Annex Z information was available elsewhere, free of charge, would this be.....

    * .... better

- Should Annex Zs be removed?

    * No

- Should Annex Zs give more detailed information?  Please describe

A first step would be that all annexes Z are drafted according to the current best practices. This would entail much added value for users.

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