HAS assessment process (Innovative process)

The objective of this page is to clarify the process for practical implementation of the relations between CEN – CCMC, Members, Technical Bodies (TBs), Technical Body secretariats and Officers - the European Commission (EC), HAS Contractor and HAS Consultants during the preparation of European Standards. This process is in line with Article 10(5) of Regulation (EU) No 1025/2012 on European standardization, and the new HAS Framework as specified in the EC Tender that entered into force on 1 August 2022.
The main responsibilities to meet all conditions for timely delivery of standards to be offered for citation in the OJEU lie with the Technical Body secretariats in close cooperation with CCMC in order to fulfil the Standardization Requests as accepted by the Technical Board(s).

1 DEFINITION AND BASIC PRINCIPLE

EC Consultant: The independent experts selected by the Commission, or its contractor, to perform assessment of compliance of the documents drafted by the ESO’s and provide communication to the TB of the ESO’s to give clarification and advice to contribute to the compliance of the drafted documents. Several kinds of EC consultant may exist, the most popular of which is the HAS consultant.

HAS Consultant: the EC consultant, selected and hired by the HAS Contractor.

HAS Contractor: The formal contact point towards EC and ESO’s concerning the HAS consultants. The Contractor manages the pool of harmonized standards HAS Consultants.

Common checklist: This horizontal checklist is the basis for ESOs and their Technical Bodies for self-assessment of standards under a Standardization Request (SReq)/mandate to ensure fulfilment of an SReq/mandate, EU legislation requirements and other possible European Commission (EC) criteria.

Interaction with EC Consultant: The Technical Body (TB) will be duly informed via email notification, upon the completion and availability of the Assessment report (e.g. HAS Assessment report). Should the TB need clarifications about the comments from the assessment report, a meeting with the EC consultant can be requested. It is advised for the TB to schedule the meeting at least 4 weeks prior to the proposed date. To request a meeting with a HAS consultant, the TB should use the HAS meeting request tool.

2 BASIC PRINCIPLES FOR THE ASSESSMENT

2.1 Assessment request

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.

NOTE 1: The months of August and December may affect the normal timeframe and lead to delays on the delivering of Assessment Reports.

NOTE 2: Waiting time due to missing documents or to the absence of other essential information to complete an assessment is not counted in the calculation of the calendar days needed for the completion and delivery of the Assessment Report.

NOTE 3: Missing documents or absence of other essential information can lead to the Rejection of the assessment request.

The HAS Consultant will carry out an assessment by using one of the following Assessment Reports: Generic Common Checklist or CPR Checklist. Technical Bodies 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, ENQ and FV.

2.2 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 problems related to the dates of normative references to other interlinked 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 (hEN), 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

2.3 Review of the assessment

2.3.1 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.

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 EY and a confirmation notification should be received via email.

2.3.2 Request a challenge on the outcome of the HAS assessment

Should there be a disagreement on the outcome of the assessment, CEN can challenge it and request for a review. On such TB decision, the TB Secretary sends a request for a review of the assessment to the CCMC Project Manager

These challenges should not relate to any formally agreed aspects of harmonized work (e.g. requirements of the Vademecum, the Standardization Request, format of Annex ZA, Blue Guide,…). Therefore, it is important that a decision to request a review of an assessment is supported by a consultation of CCMC, relevant Sector Fora, etc.

A challenge of an assessment shall be as specific as possible and related to the work item (WI) at hand and could relate to, e.g.:

interpretations of guidance that have not been agreed upon.
debatable interpretations of Essential Requirements (ER) and their consequences for specific products covered in the respective standard.
the Consultants interfering in the drafting and consensus building processes of the ESOs.
providing scientific, legal or technical comments which would go beyond normal assessment tasks.
deviation from sector specific arrangements that have been validated with the EC.

Should the type of challenge become ‘generic/systematic/repetitive’, CCMC shall explore other ways to clear the issue in a structural way (to be validated by the Technical Board (BT) where relevant).

Challenges to assessments are submitted by CCMC to the HAS Contractor. The HAS Contractor has 3 weeks (21 calendar days) to reply to the ESO with a reviewed assessment. The 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. This reviewed assessment can confirm the original assessment or any of the other outcomes as specified in 2.2.

2.4 CCMC Quality Check (QC)

The Quality Check, performed by CCMC, is a new step in the development process of a homegrown Harmonized Standard. The goal is to further help TBs identify elements in the draft, or the related Annexes, that could potentially lead to a lack of compliance assessment. The QC has to be performed within 15 working days, and will be based on the ESOs/EC Common Checklist.

The TB should deliver the reviewed draft within 4 weeks after receiving the QC feedback. The QC will be performed on a Mature draft and as well on the pre-FV draft.

The new steps, before a HAS assessment is requested, are as follows:

The TB Secretary provides the draft to CCMC for the QC (together with the European elements).
CCMC performs the QC and sends the QC feedback to the TB Secretary.
TB reviews the QC comments, and updates the draft as needed. QC comments related to CEN-CENELEC Internal Regulations - Part 3 (IR3), normative references shall be implemented.
The TB Secretary provides the draft to CCMC for the assessment request together with the Common Checklist outcome/comments.

3 PROCESS

3.1 Introduction

The process steps defined here cover the parts related to the assessments performed by the HAS Consultants at various stages of the work:

Mature Draft assessment, a mandatory assessment to be performed before the Enquiry assessment. The Mature Draft is a draft standard that technically is ready to be circulated for Enquiry.
Assessment at Enquiry stage.
Pre-Formal Vote assessment, to be performed before the Formal Vote. The Pre-Formal Vote draft is a draft almost ready to be circulated to Formal Vote.
Last Confirmatory Assessment (LCA), additional assessment after receiving a Lack of Compliance outcome from the assessment at Pre-Formal Vote stage. This assessment of the revised final draft may be preferably requested before the launch of the Formal Vote, or in last case after the Formal Vote.

NOTE: ‘Normative References’, i.e. published projects in the catalogue of CEN, CENELEC, ISO and IEC that are needed for assessment, are provided to the HAS Contractor by CCMC.

3.2 Drafting stage

The drafting stage is identical to Drafting of European Standards up to Enquiry stage (following the CEN procedure for hENs) with following additions:

At submission of the Mature 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 15 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 draft as appropriate. The CCMC comments related to IR3 and normative references shall be implemented. The TB shall provide a justification, through the QC checklist, for those QC comments not integrated in the draft standard.
When delivering to CCMC the updated Mature draft (following QC feedback) for the HAS assessment request, including the comments on the QC feedback, 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, 4 weeks after receiving the QC feedback, to the Harmonised Standards Compliance team (hsc@cencenelec.eu).
CCMC will submit the Mature 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 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.

3.3 Enquiry

Mature Draft Assessment report giving 'Compliant' outcome

The technical Body delivers to CCMC the Mature draft for Enquiry through the Submission Interface. The TB Secretary will also provide relevant documentation (e.g. justification of normative references, risk assessment, Annex ZA, filled checklist …), that shall be duly identified in the Submission Interface.

Mature Draft Assessment report giving ‘Lack of Compliance’ outcome

If deemed necessary, the TB Secretary may call for a meeting involving the HAS Consultant and potentially the CCMC Project Manager, as described in 2.3.1.

Any challenge of the assessment described in 2.3.2, leading to a request to review it, should be exceptional at this stage and be initiated through the responsible CCMC Project Manager.

The Enquiry for homegrown harmonized standards is identical to the Enquiry stage of European Standards (following the CEN procedure for CEN hENs) in general with the following additions:

When delivering the prEN for Enquiry to CCMC (through the Submission Interface), including the Common Checklist for hENs, the TB Secretary will also provide relevant documentation (e.g. justification of normative references, risk assessment, sectoral specific arrangements, Mature draft HAS assessment report with the last column 'Observations of the secretariat' filled (where relevant), etc.) that could support the assessment. These elements shall be duly identified in the Submission Interface.
When launching the translation procedure, CCMC will submit the prEN 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 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 is added by CCMC to the documents for the Enquiry vote, together with the draft.

NOTE: See Figure 1 of the CEN Assessment Outcomes.

Assessment report giving 'Compliant' outcome

This might prompt the TB to consider skipping Formal Vote (FV), if all the following criteria are met:

Enquiry Vote is positive.
The previous assessment result is ‘Compliant’ or ‘Conditional compliance’ OR the ‘lack of compliance’ could be solved
No technical changes are made.
The Technical body decides by simple majority to skip Formal Vote and proceed to publication.

This decision shall be communicated to CCMC via the transmission notice.

Assessment report giving 'Conditional Compliance' outcome

This might prompt the TB to consider skipping Formal Vote (FV), if the identified issue(s) is addressed by the ESO after the assessment and the criteria described in the paragraph above are met.

This decision shall be communicated to CCMC via the transmission notice.

Assessment report giving ‘Lack of Compliance’ outcome

The launch of the Enquiry vote is not delayed.

For clarifications on the outcome of the Enquiry assessment the TB can request a meeting with the HAS consultant, as described in 2.3.1.

When the TB can duly justify a challenge to the assessment (for instance after a non-conclusive meeting with the HAS Consultant), the TB may decide to do so, as described in 2.3.2.

NOTE: See Figure 2 of the CEN Assessment Outcomes.

3.4 Formal Vote

The Formal Vote process for homegrown harmonized standards is identical to the Formal Vote stage (following the CEN procedure for hENs) in general with following additions:

At submission of the pre-Formal Vote draft to CCMC for the QC, the TB Secretary will provide relevant documentation (e.g. Common Checklist for hENs, justification of normative references, risk assessment, sectoral specific arrangements, report with the last column 'Observations of the secretariat' filled (where relevant), etc.) that could support the QC. These elements shall be provided by email to the CCMC Harmonised Standards Compliance team (hsc@cencenelec.eu).
CCMC has 15 working days to submit the Quality Check feedback, by email, to the TB Secretary.
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 draft as appropriate. The CCMC comments related to IR-3 and normative references shall be implemented. The TB shall provide a justification, through the QC checklist, for those QC comments not integrated in the draft standard.
When delivering the updated pre-FV draft (following QC feedback) for the HAS assessment request to CCMC, the TB Secretary will also provide relevant documentation that could support the assessment (e.g., comments on QC feedback, justification of normative references, risk assessment, sectoral specific arrangements, etc.). These elements shall be provided by email, 4 weeks after receiving the outcome of the QC, to the CCMC Harmonised Standards Compliance team.
CCMC will submit the pre-FV 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 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 is added by CCMC to the documents for the Formal Vote, together with the draft.

Assessment report giving 'Compliant' outcome

The FprEN with the Assessment Report are sent to Formal Vote.

Assessment report giving 'Conditional Compliance' outcome

The FprEN with the Assessment Report are sent to Formal Vote if the identified issue(s) is addressed by the ESO after the assessment.

Assessment report giving ‘Lack of Compliance’ outcome

Start of the vote is suspended after reception of the assessment, to allow for the actions below to be initiated:

the Permanent Delegate of the NSB holding the secretariat shall immediately be informed.
The TB shall do its utmost to resolve any issues and the TB Secretary shall ensure that the CCMC Project Manager is properly informed whether any changes to the text are necessary.
Within 4 weeks of reception of an assessment with lack of compliance, the TB needs to decide, with due justification, whether it will request for a meeting with the HAS Consultant described in 2.3.1, or/and challenge the assessment as described in 2.3.2.
The HAS Contractor has 21 days to reply with a reviewed assessment by uploading the assessment results in the relevant section of the HAS platform, which will trigger a notification to TB Secretary.

Regardless of the request for a reviewed assessment, four possibilities exist (see also Figure 3 of the CEN Assessment Outcomes):

Option 1 (no LCA needed):

When issues can be resolved by the TB within 7 weeks after reception of the original assessment at FV, BT is informed, and the Formal Vote can be started without requesting LCA. The TB Secretariat submits to CCMC, through the Submission Interface, the revised draft together with following documents:
New Common Checklist for hENs.
HAS Assessment report with the last column 'Observations of the secretariat' filled to indicate how the TB addressed the comments from the HAS Consultant.
Re-worked draft in track changes showing the changes made by the TBs in comparison with the version of the Formal Vote draft which received a Lack of Compliance assessment.

Option 2 (LCA needed):

When issues cannot be resolved by the TB within 7 weeks after reception of the original assessment at FV, the TB Secretariat submits to CCMC, through the Submission Interface, the revised draft to request the LCA together with following documents:

New Common Checklist for hENs.
HAS Assessment report with the last column 'Observations of the secretariat' filled to indicate how the TB addressed the comments from the HAS Consultant.
Re-worked draft in track changes showing the changes made by the TBs in comparison with the version of the Formal Vote draft which received a Lack of Compliance assessment.

CCMC will submit the revised FprEN and relevant documentation to the HAS Contractor. This will trigger the HAS Contractor for an additional assessment before the launch of the Formal Vote.

The HAS Contractor has 35 calendar days to deliver the HAS assessment report. The 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/Secretary of the relevant Working Group for the purpose of circulation in the Working Group.

If the LCA assessment outcome is ‘compliant’, the FV ballot process can resume.

If the LCA assessment outcome is 'Lack of compliance', the TB needs to agree on the way forward, i.e., to revise the FprEN to address the final comments of the HAS consultant or proceed with Option 3 or Option 4 (see below) within 7 weeks in total, including submission of documents to CCMC (where relevant).

Option 3 (exceptional):

Should the comments resolution meeting between the HAS Consultant and the TB not succeed to solve all the HAS Consultant’s comments, a meeting between the HAS Consultant, EC and TB could be organized by CCMC (EC-HAC-TB 'Concerted Group').

If the remaining comments are successfully resolved, the TB Secretariat submits to CCMC, through the submission interface, the re-worked draft in track changes showing the changes made by the TBs in comparison with the version of the Formal Vote draft which received a Lack of Compliance assessment.

If the remaining comments are not resolved, the TB should proceed with Option 4 (see below).

Option 4:

When issues of the assessment could not be resolved by the TB, a proposal on the way forward is circulated to BT for approval:

Unlink the EN temporarily from legislation, i.e. remove any link to legislation and Annex ZA, and initiate an amendment or revision of the EN in order to resolve the lack of compliance assessment.
Unlink the ENn permanently from legislation, i.e. remove any link to legislation and Annex ZA. In this later case, the EC will need to be informed.
Abandon the project. In this later case, the EC will need to be informed.

NOTE: See Figure 3 of the CEN Assessment Outcomes.

2024-03-04