Drafting European standards for citation in the OJEU

This page provides guidance to Technical Bodies and Working Groups (WGs) on horizontal aspects to be considered when preparing harmonized European standards in support of EU harmonization legislation intended to be cited in the Official Journal of the European Union (OJEU). Information on the HAS process and how to interact with the HAS consultants can be found on the page HAS assessment process.
Regulation (EU) No 1025/2012 on European standardization defines a harmonized standard as “a European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation”.

 

1 PREPARATION OF NEW WORK ITEM

The starting point for the development of a harmonized standard is to assess whether it is in the scope of the relevant EU harmonization legislation and whether the standard is covered by a standardization request or mandate which was accepted by the Technical Boards.

If it is covered, the development of harmonized standards follows the normal procedure as for the development of all other European Standards.

The adoption of a New Work Item (NWI) is required for the development of a new or revised harmonized standard. When filling the New Work Item proposal form, the proposal shall include the applicable mandate/standardization request and the relevant EU Directive/Regulation.

If the Technical Body decides to first adopt a Preliminary Work Item for the development of a harmonized standard, the proposal shall also include information about the mandate/standardization request and EU Directive/Regulation.

In line with the flexible standards development process, the target dates for dispatching the First Working Draft (20.60), Enquiry draft (30.99) and Formal Vote draft (45.99) shall be inserted in the NWI form. These target dates shall be aligned with the deadlines for the adoption of harmonized standards in the standardization request (if applicable).

The WG Convenor, with the support of the Qualified Support, is responsible for filling the NWI form, which shall be submitted to the Technical Committee (TC) secretary. The TC secretary will carry out a final check of the filled NWI form and launch the Committee Internal Balloting (CIB) for the approval of the NWI. The approval of a NWI is a BT delegated decision to the TC (see the acceptance criteria for the approval of a NWI).

2 DRAFTING HARMONIZED STANDARDS

2.1 General rules for the preparation of harmonized standards (hENs)

In addition to the generic rules, sector specific guidance can be found under 5.

When drafting homegrown harmonized standards and harmonized standards under Vienna Agreement (VA) with CEN lead in support of EU legislation, Technical Bodies shall check their compliance against a dedicated Checklist.

The dedicated checklist contains aspects that shall be considered by Technical Bodies and Working Groups when drafting harmonized standards in support of EU legislation.

During the Enquiry and Formal Vote procedures, CCMC will reject, as of 2021-10-01, the submission of a (final) draft harmonized standard if the completed checklist or relevant supporting documents/justifications are not submitted.

When drafting harmonized standards under VA, it is strongly recommended that the checklist is used by the Technical Bodies and Working Groups.

The Technical Bodies shall consider the below aspects when drafting harmonized standards.

2.1.1 General

The TC secretary shall confirm that the draft standard is covered by a standardization request or mandate and that the information is correctly displayed on Projex-Online. If not, a possible way forward is to propose the European Commission to add this work item in a (revised) standardization request. In case the information on Projex-Online on a Standardization Request, mandate or the EU legislation needs to be corrected, the TC Secretary needs to contact the CCMC Project Manager.

If the First Working Draft (FWD) HAS assessment was performed, the WG shall answer all the comments from the HAS consultant. The comments of the WG shall be filled in the last column of the HAS assessment report (‘Observations of the secretariat’) to indicate how the comments of the consultant have been addressed.

Furthermore, any requirements covered in the harmonized standard that are not linked with legal requirements of EU legislation must be covered in separate clauses and not tackled in the Annex ZA.

2.1.2 European Foreword

When a TC is revising a standard, the significant changes with respect to the previous edition must be precisely described in the Foreword of the standard. The list of the significant changes with respect to the previous edition is an important element useful to standard users. It should not be vague. When the list of significant technical changes is extensive, it may be included in an Informative Annex. A reference to that annex shall be included in the Foreword, preferably after the generic sentence that refers to the superseded document.

The Foreword text to be used can be found in CEN simple template for drafting standards.

2.1.3 Scope

The scope of the harmonized standard shall be concise and clear and worded as a series of statements of facts. In line with CEN-CENELEC Internal Regulations - Part 3 (IR3) , the scope shall not include requirements, permissions or recommendations. The scope shall be consistent regarding content covered by the standard.

However, the scope of the standard could be broader than the relationship between the standard and the requirements of the EU legislation.

2.1.4 Normative references

CEN-CENELEC Internal Regulations – Part 3 include provisions on the use of normative references (see general Guidance on normative references).

The standards listed in Clause 2 must be normatively referenced within the text. They must be cited in the text in such a way that some or all of their content constitutes requirements of the document, for instance with a “shall”.

The normative references in Clause 2 and in the body of the standard should be dated, active and published. Non-dated normative references are possible if:

  • The normative reference is not relevant for compliance with Essential Requirements, or
  • The normative reference is relevant for compliance with Essential Requirements but the implications of modifications to the referenced document for the compliance with Essential Requirements have been duly considered (to be explained in the justification).

As a general principle, all the normative references should be EN, ISO and IEC standards. If EN, ISO and IEC standards do not exist, exceptionally, other standards could be used under certain conditions:

  • the references must comply with IR3 conditions (see CEN-CENELEC Internal Regulations – Part 3, clause 10.2)
  • a TC decision and justification is needed
  • the documents need to be available for the assessment by the HAS consultant/European Commission.

2.1.5 Requirements

In order to receive a compliant assessment, the standard must contain objectively verifiable requirements and test methods – as described in the ISO/IEC Directives Part 2 and the CEN-CENELEC Internal Regulations - Part 3: “Expression in the content of a document conveying objectively verifiable criteria to be fulfilled and from which no deviation is permitted”.

If compliance with the document is to be claimed, requirements shall be objectively verifiable. Only those requirements which can be verified shall be included. Phrases such as “sufficiently strong” or “of adequate strength” shall not be used because they are subjective statements.

2.1.6 EU legal text in the standard

The terminology used in the standard, including definitions of terms in Clause 3, shall be consistent with the relevant EU legislation. The technical content of the document shall not:

  • contain requirements that contradict relevant EU legislation (e.g.: fails to specify 'technical solutions', allows users of a document to decide on the specification);
  • repeat legal requirements as part of its normative requirements.

Where a definition differs from relevant EU legislation, the difference shall be indicated in the European Foreword and in Annex Z.

2.1.7 Risk reduction

If a harmonized product standard deals with safety aspects, the relevant hazards must be identified and the risks reduced.

2.1.8 Neutrality principle

The draft standard must respect the neutrality principle (see CEN-CENELEC Internal Regulations – Part 3, clause 33).

The standard shall not contain clauses imposing requirements or obligations on or between certain economic operators (e.g. requirements are set to an economic operator and its competence or resources instead of to product design and product properties).

The standard shall not contain clauses imposing first, second- or third-party conformity assessment.

2.1.9 Annex ZA

For the drafting of the informative Annex ZA, the latest template shall be used (see Annex ZA under Forms & Templates).

The rows shall be placed in order of the legal requirements.

If a legal requirement is claimed as covered in the Annex ZA, this requirement shall be clearly addressed by a clause/sub-clause of the standards.

If a standard deals with the aspects which are outside the scope of the EU legislation, clauses/sub-clauses dealing with these aspects shall not be referred to in the informative Annex ZA.

In case the standard covers different EU Directives/Regulations, separate Annexes Z shall be prepared. 

2.2 Drafting up to Enquiry

The drafting stage of harmonized standards is identical to the drafting of all other European Standards up to Enquiry stage.

At the submission of the First Working Draft (FWD) to CCMC, the TC secretary may request a FWD HAS assessment. In the transmission notice, the option 'document is to be submitted to HAS Consultant for indicative assessment' must be filled to trigger the request to the HAS Contractor.

The FWD shall include the first draft of Annex ZA.

The FWD HAS assessment is optional, but strongly recommended to ensure early involvement of the HAS Consultant in the process, so that the Consultant can flag at an early stage any potential compliance issue.

For parallel work with ISO under VA, it is highly recommended that the TC secretary exchanges with the relevant ISO Committee Manager to ensure the circulation of the committee draft is scheduled to allow time for the FWD HAS assessment.

The HAS Consultant will carry out an assessment, by using the relevant assessment report.

The WG shall consider the outcome of the FWD HAS assessment and comments of the HAS Consultant. In case of 'Lack of Compliance', it is recommended that a meeting between the WG and the HAS consultant is organised to discuss the comments received. It is the responsibility of the TC secretary to organise a meeting with the HAS consultant (see clause 2.4 of the HAS assessment process).

TCs are strongly advised to ensure that the items mentioned in the FWD HAS assessment reports under ‘1.2 Critical findings leading to a Lack of compliance‘ are duly considered before submitting the draft harmonized standard to CCMC for Enquiry.

Following the matrix of responsibilities, the WG Qualified Support shall check that the draft complies with standards drafting rules and specific requirements for harmonized standards to be offered for OJEU citation. The WG Qualified Support shall ensure that the checklist for drafting harmonized standards is filled out and supporting documents/justifications are provided (where relevant). When consensus is reached and the draft is ready, the WG Qualified Support or the WG Convenor shall submit the draft standard, the completed checklist and supporting documents/justifications (where relevant) to the TC Secretary.

The TC secretary is responsible for checking that the checklist has been completed and submits it to CCMC together with the draft harmonized standards and the supporting documents/justifications where relevant.

2.3 After Enquiry and before Formal Vote

If the outcome of the Enquiry HAS assessment is Lack of Compliance, it is strongly recommended to organise a meeting between the HAS consultant and the TC or WG to clarify the comments and agree on a way forward.

The standard shall be re-worked considering the comments received at enquiry stage, the HAS consultant comments and the elements covered in section 2.1, including the checklist. It is the responsibility of the TC secretary to organise a meeting with the HAS consultant (see clause 2.4 of the HAS assessment Process).

Following the Matrix of responsibilities, the WG Qualified Support and/or the WG Convenor shall check that the final draft complies with standard drafting rules and specific requirements for harmonized standards to be offered for OJEU citation. The WG Qualified Support shall ensure that the checklist for drafting harmonized standards is filled out and supporting documents/justifications are provided (where relevant). When consensus is reached and the final draft is ready, the WG Qualified Support or the WG Convenor shall submit the following documents to the TC secretary:

  • final draft harmonized standard;
  • the completed Checklist and supporting documents/justifications (where relevant);
  • the Enquiry HAS assessment report with the last column ‘Observations of the secretariat’ filled with the WG comments on how the Consultant comments were addressed.

The TC secretary is responsible for checking that the checklist has been completed and submits it to CCMC together with the draft harmonized standards and the supporting documents/justifications where relevant.

According to decision BT C045/2018, in case of a 'Lack of Compliance' at FV stage, the following procedure applies:

  • The FV is suspended for maximum 12 weeks after the reception of the assessment;
  • The TC Secretariat and the BT member of the National Standardization Body holding the secretariat shall be informed;
  • The TC needs to decide on the way forward within 7 weeks, i.e. if the HAS comments can be resolved and the FV launched or agree on another way forward.

2.4 Formal Vote HAS assessment

2.4.1 Resolving non-compliant Formal Vote HAS assessment

To resolve a non-compliant Formal Vote HAS assessment, the TCs should follow the steps below.

  1. The TC should prepare 
    • HAS Assessment report with the last column 'Observations of the secretariat' filled to indicate how the TC is addressing the comments from the consultant;
    • Re-worked draft in track changes showing the changes made by the TCs in comparison with the version of the FV draft which received a Lack of Compliance assessment.
      The TC assesses whether the HAS consultant needs to be contacted to resolve an assessment. In case of minor comments leading to a lack of compliance assessment a meeting may not be necessary.
  2. The TC secretary provides the documentation, as indicated in 1. above,  to the HAS consultant and if necessary organises a (web) meeting with the consultant (the documentation shall be provided prior to the meeting) to discuss the most important and difficult aspects. For meetings longer than 4 hours the TC Secretary needs to issue the request for the meeting via the dedicated HAS Consultants meeting request page.
  3. The TC secretary records the outcome of the meeting and asks the HAS consultant for feedback, i.e. asks whether the consultant's comments were sufficiently addressed in the revised text of the hEN. This can be done either via email or at the end of the meeting with the Consultant. In the latter case, the confirmation should be reflected in the minutes.
  4. As outcome of the meeting (or interaction with the HAS Consultants if no meeting is needed) the TC agrees on one of the following actions:
  • Revision of the FprEN to resolve the non-compliance assessment

The TC secretary submits the revised draft to CCMC for FV together with the documentation as indicated in 1 above, as well as the HAS Consultant’s feedback (if available) via the submission interface tool. If the FV is positive, the standard will be offered to the EC for citation in the OJEU.

If the non-compliance assessment is received only after start of the FV, the TC may decide to submit a revised FprEN to a 2nd FV. In case of a positive result of the 1st FV, this requires BT approval.

In case of EN ISO standards, the CEN/TC Secretary submits the documentation as indicated in 1 above as well as HAS consultant's feedback (if available) to the ISO Committee Manager, ISO TPM and CCMC Project Manager. The ISO Committee Manager submits the documentation on the ISO submission interface.

  • Adaptation of Annex Z (no additional changes to the FprEN)

The TC Secretary submits the draft with the revised Annex Z to CCMC for FV together with the documentation as indicated in 1,  as well as the HAS Consultant’s feedback (if available) via the submission interface tool. If the FV is positive, the standard will be offered to the EC for citation in the OJEU.

If the non-compliance assessment is received only after start of the FV, the TC may decide to submit a revised Annex Z to BT for approval. Upon BT approval the EN proceeds to publication with the revised Annex Z.

  • Temporary removal of the link to EU legislation

The TC, in cooperation with the ISO Committee in case of EN ISO standards (if applicable), and with the support of CCMC, concludes that harmonization is temporarily not possible and takes a TC decision to request BT to remove Annex Z and any link to legislation (decision BT 008/2020). If BT approves the request, the adapted draft text can proceed to FV and the CCMC Project Manager informs the EC about the de-harmonization of the standard.

If the non-compliance assessment is received only after start of the FV, the relevant TC and BT decisions are taken during or after FV and the text for publication is adapted accordingly.

The TC should initiate an amendment or revision to resolve the non-compliance assessment with the objective of subsequent publication as a harmonized standard.

  • Permanent removal of the link to EU legislation

The TC, in cooperation with the ISO Committee in case of EN ISO standards (if applicable), and with the support of CCMC, concludes that harmonization is not possible and takes a TC decision to request BT to remove Annex Z and any link to legislation (decision BT 008/2020). If BT approves the request, the adapted draft text can proceed to FV and the CCMC Project Manager informs the EC about the de-harmonization of the standard.

If the non-compliance assessment is received only after start of the FV, the relevant TC and BT decisions are taken during or after FV and the text for publication is adapted accordingly.

  • Abandon the work

The TC, in cooperation with the ISO Committee in case of EN ISO standards (if applicable), and with the support of CCMC, concludes that it is not possible to progress the draft standard to FV due to the significant comments of the HAS consultant and takes a TC decision to request BT to discontinue the work and abandon the WI.

The TC can initiate a New Work Item, amendment or revision to resolve the non-compliance assessment with the objective of subsequent publication as a harmonized standard.

2.4 After Formal Vote and before publication

Exceptionally, after the FV stage, a TC could request a HAS assessment (PUB HAS assessment). This shall be considered an exceptional request and this procedure can only be applied if the FV HAS assessment outcome was 'Lack of Compliance'.

Considering that technical comments cannot be taken into account after the FV stage, this procedure shall only be followed for limited cases, e.g. final assessment on the Annex ZA.

If the PUB HAS assessment is Lack of Compliance, the TC will have to analyse the comments from the HAS Consultant and agree on the way forward, e.g.: revise Annex ZA in line with decision BT 043/2017.

3 HORIZONTAL TRAINING MATERIAL

This section lists available horizontal training material.

4 TEMPLATES

5 SECTORAL GUIDANCE

This section lists various sectoral guidance documents and training material to support Technical Bodies and WGs in the drafting of harmonized standards supporting EU legislation.

Construction

Ecodesign

Gas Appliances

  • CEN Guide 18: Gas Appliances and Fittings – Guidelines for the implementation of Essential Requirements of Gas Appliances Regulation 2016/426/EU in European Standards (2021)

Machinery

Pressure equipment

Railway

 

6 KEY ELEMENTS OF THE HAS ASSESSMENT PROCESS

Besides information on the HAS assessment process and interactions with the HAS consultant, there are two key charts on the HAS system:

 

2021-09-21

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