Drafting EN IEC standards for citation in the OJEU

This page provides guidance to Technical Bodies and Working Groups on horizontal aspects to be considered when preparing EN IEC harmonized standards, in support of EU harmonization legislation, intended to be cited in the Official Journal of the European Union (OJEU). 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”.

For the purpose of this page, the term 'Technical Body' (TB) refers to Technical Committees (TC), Sub-committees (SC), Reporting Secretariats (SR) and Task Force of the Technical Board (BTTF).

1 PREPARATION OF NEW WORK ITEM (NWI)

Under the Frankfurt Agreement, the standards are developed by IEC under parallel procedure with CENELEC (unless exempted from parallel procedures through a BT decision). Once the proposal is approved by the IEC P-Members of the IEC Technical Body, the corresponding work item is created by CCMC in the CENELEC Technical Body work programme. For further information, see the provisions of the Frankfurt Agreement – Day to Day management between IEC/CO and CCMC

The starting point for the development of a harmonized standard is to assess whether it is in the scope of relevant EU harmonization legislation and whether the standard is covered by a Standardization Request or Mandate which was accepted by CENELEC. If it is in its scope, the Technical Body Secretary shall contact the relevant CCMC Project Manager - to formally link the NWI to a Standardization Request (or mandate) work programme and to plan the next harmonization steps. CCMC keeps IEC informed on those work items that are intended to be cited in the OJEU.

The development of the EN IEC harmonized standard under parallel procedure follows the normal procedure as for the development of all other European Standards, with some additional considerations that are further detailed in this page.

The drafting of the EN IEC harmonized standard is carried out by the IEC Technical Body (see Frankfurt Agreement), therefore the CENELEC Technical Body must closely monitor the evolution of the work item at IEC level (and in the corresponding CENELEC Technical Body work programme). The Secretary is invited to contact the relevant CCMC Project Manager for advice and to trigger appropriate actions.

2 DRAFTING HARMONIZED STANDARDS

2.1 General rules for preparation of harmonized standards (hENs)

In addition to the generic rules, sector specific guidance can be found under chapter 7.

When drafting harmonized standards, it is strongly recommended that the Common checklist is used by the Technical Bodies. For specific European Commission's sectoral checklists see section 5 of this page.

The Common Checklist contains aspects that will help Technical Bodies and Working Groups when drafting harmonized standards in support of EU legislation.

2.2 Evolution of the EN IEC standard

In the case of EN IEC harmonized standards, the relationship between the CENELEC Technical Body and the IEC Technical Body is of particular importance to ensure that the compliance-related comments from the HAS consultants) are addressed by subsequent versions of the IEC draft. This connection can be made through the CLC TB secretary, providing the relevant assessment elements to the IEC WG’s European experts (which NCs are member of CENELEC), and inviting them to take them into consideration. The CLC TB secretary may also directly contact the IEC convenor, as relevant.

2.3 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 (and ISO/IEC Directive Part 2), 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.

2.4 Normative references

The CEN-CENELEC Internal Regulations – Part 3 include provisions on the use of normative references. Additional requirements must be followed when drafting harmonized standards (see Guidance on normative references in harmonized standards).

The standards listed in Clause 2 are normatively referenced within the text of the standard. The normative references in Clause 2 of the EN IEC standard and in the body of the standard shall be dated, active and published. This is the role of the CENELEC Annex ZA, which links normative references to international publications to their corresponding European publications. Most often, the normative references are not dated in the IEC standard, therefore they must be dated through the Annex ZA.

Non-dated normative references are exceptionally 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 a dedicated Technical Body justification, which will have to be provided to the HAS consultant).

As a general principle, all normative references must be EN, ISO or 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 the ISO/IEC Directives Part 2
The document needs to be available for possible consultation by the HAS consultant or the European Commission.

The process for handling the Annex ZA by the CENELEC Technical Committee is described in BT Decisions D160/020 and D160/021.

2.5 Requirements

The EN IEC standard shall contain objectively verifiable requirements and test methods – in line with the CEN-CENELEC Internal Regulations Part 3 and the ISO/IEC Directives Part 2: “Expression in the content of a document conveying objectively verifiable criteria to be fulfilled and from which no deviation is permitted”.

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.

Furthermore, technical requirements that are not linked to the EU legislation’s essential requirements shall be covered in separate clauses in the standard. Similarly, separate EU-related requirements (e.g. EMC and LVD) shall be covered in separate clauses. This particular point of attention may require some evolutions in the structure of some EN IEC standard.

2.6 Risk reduction

If a harmonized product standard deals with safety aspects, the relevant hazards must be identified and the risks reduced. This particularly applies in the case of the Low-Voltage Directive, for which a risk assessment shall be provided together with the Annex ZZ for assessment purposes. There is no particular template for such a risk assessment, however it must rely on the CENELEC Guide 32 ‘Guidelines for safety related risk assessment and risk reduction for low voltage equipment’. See also an example on how CLC/TC 23E uses CENELEC Guide 32 for its risk analysis and self-assessment.

For further information, see the CENELEC Webinar: https://www.cencenelec.eu/news/videos/Pages/VIDEO-2019-029.aspx

2.7 Neutrality principle

For compliance purposes, the draft standard (as developed by the IEC TB) must respect the neutrality principle – in line with the ISO/IEC Directives Part 2, clause 33.1.

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.

2.8 Annex ZZ

The Annex ZZ is an informative Annex demonstrating the relationship between the clauses of the harmonized standards and the requirements of the EU legislation aimed to be covered. For the drafting of the informative Annex Z, the latest template shall be used (see Forms and Templates - Annex ZZ). The rows shall be placed in order of the legal requirements, which is considered a best practice. If a legal requirement is claimed as covered in the Annex ZZ, this requirement shall be clearly addressed by a clause/sub-clause of the standards.

If a standard deals with 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 ZZ.

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

For further information on the drafting of Annex ZZ, see the Webinar on Annexes ZA/ZZ to CEN/CENELEC Harmonized Standards.

2.9 Further specific rules

Specific rules and requirements can apply to specific sectors/directives. Those are reproduced in dedicated sectorial “checklists”, which the Technical Body needs to consider when developing harmonized standards. These checklists are used by the HAS consultant when assessing the standard, which the consultant provides with its assessment.

3 BASIC PRINCIPLES FOR THE ASSESSMENT

3.1 Assessment Request

A maximum of 4 HAS assessments are allowed per work item:

CD Draft,
parallel CDV,
parallel FDIS,
Last Confirmatory Assessment (LCA, in case of lack of compliance at parallel FDIS stage, should be exceptional).

If a CD consultation is performed at IEC level, then the CD assessment is mandatory. In consultation with the CCMC Project Manager, the TB secretary timely provides all the appropriate elements for assessment (in particular the Annex ZZ).

Assessment requests are submitted by CCMC to the HAS Contractor. After this submission, the HAS Contractor has normally 5 weeks (35 calendar days) to reply to the ESOs.

The HAS Consultant will carry out an assessment, by using the following Assessment template: Generic Common Checklist. TBs are strongly advised to ensure that the items mentioned in those reports under Part A – 1.1 ‘Criteria for ESOs Only’ and Part B.3 – ‘Common criteria for EC/HAS and ESO’ are duly considered before submitting the draft harmonized standard to CCMC for Quality Check, assessment request.

The Technical Body shall answer all the comments from the HAS consultant at each assessment stage. The feedback of the Technical Body shall be filled in the last column of the HAS assessment report to indicate how the comments of the consultant have been implemented or addressed.

3.2 Assessment Outcome

The outcome of the assessment can be:

“Compliant”: If the same conclusion is done by the Commission, the publication of the reference in the OJEU is normally possible without any specific notice.
“Lack of compliance”: If the same conclusion is done by the Commission, the publication of the reference in the OJEU is likely not possible without adaption of the document- a publication of the reference in the OJEU with a notice would also be a possible option in some cases.
“Conditional Compliance”: to be used only in case of issues related to the dates of normative references to other inter-linked standards and meaning that, if the identified issue(s) is positively addressed by the ESO after the assessment, and if the same conclusion is done by the Commission the publication of the reference in the OJEU is normally possible without any specific notice.

NOTE: during the development of the harmonized standards, normative references can be draft standards if the normative references and the hEN are being developed exactly at the same time and stage (as a package) and are submitted together to CCMC for Enquiry or Formal Vote stages

3.3 Request a meeting with the HAS Consultant

Should there be a need for clarification on the outcome of the assessment, the TB can request a meeting between the WG and the HAS consultant. The meeting shall be requested 3 to 4 weeks in advance via the HAS Contractor Meeting Request Tool. See the guide on the interaction between TBs and HAS consultants.

During the meeting the HAS Consultants are allowed to:

Participate in expert group meetings or committees chaired by the European Commission upon explicit and justified invitation by the relevant EC services.
Convey the messages received by the relevant EC services and other guidance documents as well as provide clarification on the Guidance documents developed by the EC services.
Clarify previous comments issued in the process of HAS assessments.
Guide Technical Bodies on the expected results of standardization work requested by the EC and ensure a correct understanding of the role of standardization requests and the legal requirements to be supported by harmonized standards.

On the other hand, during the meeting the HAS Consultants are not allowed to:

Participate in the drafting of standards or carry out any work on behalf of the ESOs or technical bodies.
Participate in consensus-building activities.
Perform assessment activities on request of the ESOs during clarification meetings or any activities which would go beyond their normal assessment tasks. This includes (non-exhaustive): providing legal/technical/scientific advice beyond the normal assessment tasks provided in the EC Guidance documents, guiding/instructing Technical Bodies.
Participate in meetings of AdCo groups of market surveillance authorities, and of coordination groups of notified bodies.
Provide presentations during webinars, events and training organised by the ESOs.

The meetings’ request is subjected to coordination and agreement with the HAS Contractor and a confirmation notification should be received via email.

3.4 CCMC Quality Check (QC) on the European Elements (European Foreword, Annex ZA and Annex ZZ)

The Quality Check, performed by CCMC, is a new step in the development process of a Harmonized Standard developed in parallel with IEC. The goal is to further help TBs identify elements in the European elements, that could potentially lead to a lack of compliance assessment. The QC has to be performed within 10 working days, and will be based on the ESOs/EC Common Checklist.

The TB should deliver the revised Annexes ZA and ZZ within 2 weeks after receiving the QC feedback. The QC will be only performed at CD stage (only if there’s a CD consultation at IEC).

4 DRAFTING HARMONIZED STANDARDS SUPPORTING EU LEGISLATION

4.1 Drafting EN up to Enquiry

The drafting stage for harmonized standards is identical to the drafting of EN IEC standards up to Enquiry stage (i.e. parallel CDV). The IEC TC drafts the standard. Therefore, the CENELEC Technical Body needs to closely monitor the standard’s development at IEC level and thus prepare the European elements (Annexes ZA and ZZ) in parallel with the development of the draft. It can be monitored notably through the relevant page on the IEC website, which provides the planning for the development of the IEC standard (see standards development – technical committees and subcommittees – and then relevant standards from the IEC Technical Body). Some information is also reflected in Projex-Online working area.

If a Committee Draft (CD) is circulated at IEC, the latter will be made available to CCMC for requesting a CD assessment and performing a CCMC Quality Check on the European Annexes (if the CD duration is at least 12 weeks).

To minimize the impact on the international development timeframes, a CCMC QC on the Annexes ZA and ZZ will be performed only if the CD consultation is at least 12 weeks. If the CD consultation is 8 weeks, a CD assessment will be directly requested.

It is key the CENELEC TB closely monitors the standard’s development at IEC level, so that the EU Annexes are ready on time. Without the European elements (Annexes ZA and ZZ, risk assessment if applicable), it will not be possible to request a HAS assessment.

Here are the steps to follow for the handling of the CD if the consultation is 12 weeks or more:

At submission of the CD draft to CCMC for the QC, the TB Secretary will provide relevant documentation (e.g. new Common Checklist for hENs, justification of normative references, risk assessment, sectoral specific arrangements, etc) that could support the QC. These elements shall be provided by email to the Harmonised Standards Compliance team (hsc@cencenelec.eu).
CCMC has 10 working days to submit the Quality Check feedback to the TB Secretary from the moment all the necessary elements are received. The TB Secretary provides the QC feedback to the TB and to the Convenor and Secretary (if applicable) of the relevant Working Group for the purpose of circulation in the Working Group.
The TB shall consider the QC comments and review the EU Annexes as appropriate. The CCMC comments related to normative references shall be implemented.
When delivering to CCMC the updated EU Annexes (following QC feedback) for the HAS assessment request, the TB Secretary will also provide relevant documentation (e.g. justification of normative references, risk assessment, sectoral specific arrangements, etc.) that could support the assessment. These elements shall be provided by email, 2 weeks after receiving the QC feedback, to the Harmonised Standards Compliance team (hsc@cencenelec.eu).
CCMC will submit the CD draft with relevant documentation for assessment to the HAS Contractor. This will trigger the HAS Contractor for an assessment.
The HAS Contractor has 35 calendar days to deliver the HAS assessment report. The CENELEC TB Secretary will receive an email notification when the HAS assessment report is available, that includes the report as an attachment. The TB Secretary provides the Assessment Report to the TB and to the Convenor and Secretary (if applicable) of the relevant Working Group for the purpose of circulation in the Working Group. The assessment report will be transmitted to IEC TC.

Here are the steps to follow for the handling of the CD if the consultation is 8 weeks:

At submission of the CD draft to CCMC for the assessment request, the TB Secretary will provide relevant documentation (e.g. new Common Checklist for hENs, justification of normative references, risk assessment, sectoral specific arrangements, etc) for the CD assessment request. These elements shall be provided by email to the Harmonised Standards Compliance team (hsc@cencenelec.eu).
CCMC will submit the CD draft with relevant documentation for assessment to the HAS Contractor. This will trigger the HAS Contractor for an assessment.
The HAS Contractor has 35 calendar days to deliver the HAS assessment report. The CENELEC TB Secretary will receive an email notification when the HAS assessment report is available, that includes the report as an attachment. The TB Secretary provides the Assessment Report to the TB and to the Convenor and Secretary (if applicable) of the relevant Working Group for the purpose of circulation in the Working Group. The assessment report will be transmitted to IEC TC.

Summary of the conditions for performing a CCMC QC on the CD draft and for requesting an assessment and timeframes:

Conditions for Quality Check

Timeframe for CD consultation

The Technical Body shall consider the outcome of the assessment and the comments of the HAS Consultant. In case of Lack of Compliance, it is recommended that the Technical Body calls for a meeting involving the HAS Consultant and potentially the CCMC Project Manager, as described in 3.3.

The European experts involved in the CENELEC and IEC Technical Bodies are strongly advised to ensure that the items mentioned in the CD HAS assessment reports under section 1.2 of part B.3 are duly considered before prEN IEC is submitted to Enquiry (CDV). In case those findings cannot be considered and addressed by the IEC TB, experts from European NCs in the IEC TB together with the CLC TB shall consider the preparation, as early as possible, of European Common Modifications.

Requesting a HAS assessment at Public Enquiry (CDV in IEC) is mandatory in the process. Before the start of the Public Enquiry, the CENELEC Technical Body provides the necessary European elements for harmonization: Annex ZA, Annex ZZ, risk assessment (as relevant) and the Technical Body responses (“observations from the secretariat”) to the previous assessment (i.e. on the CD). Annex ZA can be prepared by CCMC (and checked by the TB); all other elements are the responsibility of the TB.

At the start of the parallel Enquiry (at the very latest), the CENELEC TB secretary provides these European elements to CCMC through the Submission Interface. The TB Secretary will also provide relevant documentation (e.g. justification of normative references, risk assessment, Annex ZZ, filled checklist…), that shall be duly identified in the Submission Interface.

At all stages, the HAS consultant has 35 days to deliver the assessment.

For further information, see the Frankfurt Agreement Day2Day management, notably clause 5.3.2.3.

4.2 After Enquiry and before Formal Vote

If the outcome of the Enquiry HAS assessment is 'lack of compliance', it is again recommended to organise a meeting with the HAS consultant to clarify the comments and agree on a way forward (in view of the next standardization step: the parallel FDIS, i.e. the CENELEC Formal Vote).

In view of the assessment request at the Formal Vote stage, the Technical Body shall ensure that the adequate elements are timely provided to CCMC. The CENELEC TB secretary is notified by CCMC when the IEC final draft is ready to proceed to parallel FDIS (i.e. Formal Vote). At this moment, the CENELEC Technical Body secretary, in consultation with the relevant TB officers and members, shall submit to CCMC the following documents (through the Submission Interface):

Annex ZZ (even if unchanged compared to the ENQ assessment);
Annex ZA (even if unchanged);
Risk assessment (as relevant);
The enquiry HAS assessment report with the last column ‘Observations of the secretariat’ filled with the Technical Body comments on how the consultant comments were addressed.

For further information, see the Frankfurt Agreement Day2Day management, notably clause 5.3.2.4.

Resolving ’lack of compliance’ assessments at Formal Vote

It has to be noted that, unlike CENELEC homegrown standards, where the start of the Formal Vote is suspended in case of ‘lack of compliance’ assessment (so that the Technical Body can modify the final draft before it is submitted to Formal Vote), this is not possible in the case of EN IEC standards.

Therefore, the FV assessment is requested at the start of the Formal Vote (IEC FDIS) at the latest. When the IEC FDIS approval procedure has started, the EN IEC could not be modified anymore (except through Common Modifications). If modifications are required on the Annex ZA or Annex ZZ only, the CENELEC Technical Body can proceed with such modifications. Those new Annexes will then have to be approved by the BT before they can be made available by CENELEC.

Following a ‘lack of compliance’ assessment at FV, if the text of the EN IEC standard needs updates to address the comments from the HAS consultant, the EN IEC will not be offered for citation as the text cannot be modified anymore. The CENELEC Technical Body will have to consider the development of Common Modifications to address the remaining compliance issues (leading to different EN and IEC standards) or the Technical Body should wait for a future amendment/revision at IEC level to address the remaining compliance issue.

The possibility to develop Common Modifications can be an appropriate interim solution, allowing the citation of the (modified EN IEC) standard, and pending a future amendment/revision at IEC level that would possibly integrate the necessary elements for compliance.

Like at previous stage, it is recommended that the Technical Body calls for a meeting involving the HAS Consultant and potentially the CCMC Project Manager, as described in 3.3, to help clarify the final comments.

Depending on the remaining comments and following the meeting with the HAS consultant, the TB needs to assess 3 different options and decide on a way forward:

Option 1: the Technical Body concludes, with the support of CCMC, that the standard addresses all the comments (in practice through the modification of the Annex ZA or Annex ZZ) from the HAS consultant and therefore the HAS assessment is “resolved”. The standard can proceed to Publication and will be offered to the EC for citation.

Option 2: the Technical Body, with the support of CCMC, Project Manager concludes that the reworked standard includes all the remarks from the HAS consultant. CCMC can request a Last Confirmatory assessment (LCA HAS assessment) prior to publication to have a formal ‘validation’. The LCA should only be requested by CCMC, on the advice of the CENELEC TB, in limited cases for a final check.

Option 3: the Technical Body concludes that harmonization is not possible and takes a decision to request BT to remove the link to legislation, either temporarily or permanently. If BT approves the request, the standard (without Annex ZZ) will proceed to Publication and the CCMC Project Manager informs the EC about the “de-harmonization” of the standard.

4.3 After Formal Vote and before publication

This step will follow Option 2 as presented above. Exceptionally, after the Formal Vote stage, a Technical Body could request a Last Confirmatory HAS assessment before Publication (LCA 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 Formal Vote stage, this procedure shall only be followed for limited cases, e.g. final assessment on the new version of the Annex ZZ/ZA.

If the LCA HAS assessment is 'lack of compliance', the Technical Committee will have to analyse the comments from the HAS consultant and agree on the way forward (i.e. considering Common Modifications or waiting for a new amendment or revision at IEC level).

4.4 Ratification and making available

When there are no obstacles for ratification at European level, CCMC triggers the process for making the related EN project available in CENELEC. The finalized EN is then submitted to the responsible Technical Body secretariat for the proofing period. During this period and at least by the deadline, the secretary shall respond to any questions from CCMC and confirm the Technical Body’s approval to make the EN available.

When the secretariat has given its approval, CCMC makes the EN available in the three official language versions of CENELEC and distributes the files for implementation to the CENELEC members.

In case the standard:

Has received a 'compliant assessment', or if the ‘lack of compliance’ assessment has been resolved: it will be offered by CCMC to the European Commission for citation (i.e. CCMC provides the standards and their references to the European Commission for final validation).
Has received a ‘lack of compliance’ assessment that can’t be resolved, it will not be offered by CCMC to the European Commission for citation. In such case, the CENELEC Technical Body will have to consider European Common Modifications to address the compliance issues or wait for the next amendment or revision cycle at IEC to address those.

5 HORIZONTAL TRAINING MATERIAL

This section lists available horizontal training material.

2024-03-21: Webinar ‘New process for harmonized standards under parallel development’
2023-07-07: Webinar ‘Matrix of responsibilities for requesting common modifications to IEC standards and the inclusion of Annex Z/(ZA) in IEC Standards
2023-06-23: Webinar 'Presentation of the new EC/HAS ESOs Common checklist
2023-05-16: Webinar ‘The functioning of the HAS system, interactions with HAS consultants and best practices
2022-11-22: Webinar ’Drafting harmonized standards - IR3 rules, requirements and normative references’

6 TEMPLATES

7 SECTORAL GUIDANCE

This section lists some sectoral guidance documents and training material to support Technical Bodies and Working Groups in the drafting of harmonized standards in support of EU legislation.

2025-03-05