This document provides guidance for the drafting (including the format) of European Standards (EN) intended to be cited in the Official Journal of the European Union under (a) New Approach Directive(s). Those standards are also often referred to as 'harmonised standards' and may be developed in support of essential requirements of New Approach Directives following the issuing by the EC/EFTA of a standardization requests (i.e. mandates).
1.1 Production of a 'harmonised standard'
The term 'harmonised standard' used in the New Approach Directives and in the 'Regulation 1025/2012 on European standardisation' is a legal qualification of documents existing in their own right in the framework of European Standardization.
In this context, CEN (as European Standardization Body) shall treat these so-called harmonized standards in the same way as the other standards produced in accordance with the rules that apply to processing, adopting and publishing European Standards (EN).
1.2 Assistance to Technical Committees
However, it is also true that CEN's own actions are instrumental in the creation of a harmonized standard that then may be referred to, if further conditions are satisfied, for establishing the conformity of products to relevant Directives.
As a consequence,
- with the objective of meeting the expectations of the users of ENs in the best possible way; and
- recognizing that the drafting of standards designed to implement Essential Requirements of New Approach Directives might require specific guidance;
CEN will provide, whenever possible, assistance to the Technical Committees (TC), through the contribution of CEN Consultants.
See CEN/CENELEC Guide 15: Tasks and responsibilities of the New Approach Consultants for more information.
CEN Consultants are recruited in close consultation with the EC and EFTA Secretariat and are required to have considerable expertise in their subject and a very good knowledge of both the relevant directive(s) and the standardization processes.
2 Guidance for drafting
Technical bodies drafting European Standards in support of New Approach Directives are strongly advised to use a checklist during the drafting stage. That checklist documents the relationship between the Essential Requirement(s) of the Directive(s) and the clauses of the draft.
The checklist can enable the technical body to have a clear view on the appropriate coverage of the relevant Essential Requirement(s) because both the relevant Essential Requirement(s) and the technical solution(s) offered in the draft are listed.
It can be useful for evaluating the draft during Enquiry and can be kept by the TC Secretariat, the CEN-CENELEC Management Centre (CCMC) and the national members for answering information requests.
The checklist shall not be confused with the compulsory informative annex (see below).
2.2 Rules of presentation
- The foreword of all standards intended to be cited in the Official Journal of the European Union under (a) New Approach Directive(s) shall include the following sentence:
“This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex Z..., which is an integral part of this document.”
- For each new Approach Directive of which the standard supports Essential Requirements, an informative Annex Z shall be added as an integral part of the standard.
Annexes Z relating to the New Approach Directives shall be drafted in accordance with one of the example formats:
As mentioned above, the Annex Z is an integral part of the standard. This has to be borne in mind when drafting an amendment to a standard that includes an Annex Z. Any modification resulting from the amendment with regard to the range of Essential Requirements covered by the original standard shall be clearly stated in the amendment.