European Standards for citation in the Official Journal

2 BASIC PRINCIPLES FOR THE ASSESSMENT

2.1 Actors

2.1.1 HAS Contractor (Ernst & Young) 

The HAS Contractor is the formal contact point towards EC and ESOs, with 3 main tasks:

• Administrative and logistical coordination of the tasks and work of the consultants including recruitment
• Horizontal verifications and checks of non-technical nature with regard documents to be assessed by the consultants
• Evaluation of the assessment results and the effectiveness of the assessment concept in order to make recommendations to the EC.

The HAS Contractor will be managing the pool of harmonised standards consultants 'HAS Consultants'.

2.1.2 HAS Consultant

The HAS Consultant is an independent expert selected and hired by the HAS Contractor to perform the following  main tasks:

• ‘Compliance assessment' of the documents drafted by the ESOs,
• 'Communication' to the technical bodies of the ESOs to give advice in order to contribute to the compliance of the drafted documents with the EC's Standardisation Requests.

NOTE: Early 2018, the EC has estimated the division between ‘Compliance assessment'  and 'Communication' to be about 80/20, which could be adjusted according to the effective needs (at discretion of the EC).

2.2 Assessment request and outcome

Assessment requests are submitted by CCMC to the HAS Contractor by uploading a file with all necessary elements on relevant Livelink area. After this upload, the HAS Contractor has normally 5 weeks (35 calendar days) to reply to the ESOs.

NOTE 1: In August and in the last week of December the period for assessment is extended for about 10 days.

NOTE 2: Experience shows that the timeframe for delivering the assessment may be longer.

The HAS Consultant will carry out an assessment, by using of one of the following Assessment Reports: general, Machinery Directive, CPR. Technical Bodies are strongly advised to ensure that the items mentioned in those reports under ‘1.2 Critical findings leading to a Lack of compliance‘ are duly considered before submitting the draft harmonized standard to CCMC for ENQ and FV.

The outcome of the assessment can be:

• ‘Compliance': The publication of the references in the OJEU is normally possible without any specific notice.
• 'Lack of compliance' the publication in the OJEU is likely not possible before the document is revised.

The EC and the HAS Contractor have agreed to bilaterally validate each ‘Assessment’ before providing it to  CENELEC, this within the 5 weeks (35 calendar day) timeframe.

NOTE: When the ESOs offer the references of harmonized EN (hEN) for citation, the EC verifies and assesses each new and revised/amended hEN taking into account assessment report(s) and other possibly available evidence. It will then take the final position on publication of the references of a hEN in the OJEU.

2.3 Review of the assessment

Should there be a disagreement on the outcome of the assessment, CENELEC can challenge it and request for a review.

These challenges should not relate to any formally agreed aspects of harmonized work (e.g. requirements of the Vademecum, the Standardization Request, format of Annexes ZA/ZZ, 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 particular 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 by uploading a file with all necessary elements on relevant Livelink area. The HAS Contractor has 3 weeks (21 calendar days) to reply to the ESO with a reviewed assessment. This reviewed assessment can confirm the original assessment or any of the other outcomes as specified in 2.2.

2.4 Interacting with the HAS Consultant

Technical Bodies can interact and meet with the HAS Consultants within the frame of an assessment activity  (e.g. discussion on adequately addressing the HAS Consultants comments given in their assessment report).

In principle the TC Secretary can contact the HAS Consultant directly for written exchanges (e.g. requiring clarifications by e-mail directly to the consultant) or for phone calls and short video calls foreseen to last less than 4 hours.

For other cases, the TC Secretary shall use the online-form provided by the HAS Contractor and this at least 4 weeks prior to the scheduled meeting.

The meeting can be requested by the Secretary of the CENELEC Technical Body (also for FA-projects), but can be for a meeting with the TC or a Working Group. Where relevant, the meeting can be requested for interaction with IEC Technical bodies.

It is reminded that the HAS Contractor gives preference to remote meetings  and requests to clearly schedule the intervention of the HAS Consultant in a meeting with a wider agenda (e.g. full TC meeting)

It has to be noted that in principle - to ensure that an assessment would not fail because of missing information - the HAS Consultant is encouraged to seek contact with the Technical Body during his assessment activities. In that context it is advised that the TC Secretary can remind the Consultant of this possibility.

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 (‘Compliance assessment'): 

• ‘Indicative’ Assessment at CENELEC ‘Working Draft – 20.60’ (for ease of reading the term FWD (First Working Draft) is used throughout the page)
• Assessment at Enquiry stage
• Assessment at Formal Vote stage

Possible requests for ‘review of assessment’ will follow the same cycle.

NOTE 1: Technical Bodies can meet with the HAS Consultants within the frame of an assessment activity - see 2.4. 

NOTE 2: ‘Normative References’, i.e. published projects in the catalogue of CEN, CENELEC, ISO and IEC that are needed for the assessment, are provided to the HAS Contractor on an ‘as needed’ basis into a separate section of Livelink. To optimise resources and deal with recurrent requests for ‘popular’ normative references, they will remain there as long as they are relevant for the work.

3.2 Work Items for Harmonized Standards

The harmonized standards (hEN) development follows the normal procedure as for the development of European Standards. To trigger any of the assessments, the WI needs to be linked to the relevant legislation and to the mandate/standardization request in the database and, if relevant, to be registered in an EC approved Work Programme for the Standardization Request at hand.

3.3 Drafting stage

The drafting stage is identical to Drafting of European Standards up to Enquiry stage with following additions:

• At submission of the FWD to CCMC, the Technical Body Secretary may request an ‘indicative assessment’ in its transmission notice (comments section).
  Requesting this ‘indicative assessment’ is not compulsory but it is strongly recommended to ensure early involvement of the HAS Consultant in the process.
  CCMC will then submit the document via the relevant Livelink area. This will trigger the HAS Contractor for an assessment.
   
• The draft submitted will have to include the first draft of Annex ZA/ZZ or an indication of how the Essential Requirements are intended to be covered.
   
• The HAS Contractor has normally 5 weeks (35 calendar days) to reply.

The Technical Body shall consider the outcome of the assessment and the comments of the Consultant.

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

When the Technical Body can duly justify a challenge to the assessment (for instance after a non-conclusive discussion with the HAS Consultant), the Technical Body may decide to do so. On such Technical Body decision, the Technical Body Secretary sends a request for a review of the assessment to the CCMC Project Manager. CCMC will then submit the request via the relevant Livelink area. 

The HAS Contractor has normally 3 weeks (21 calendar days) to reply with a reviewed assessment.

3.4 Enquiry

The Enquiry for harmonized standards is identical to Enquiry in general with the following additions:

• When delivering the prEN for Enquiry to CCMC, the TC secretary will also provide relevant documentation. This could include a justification for the used normative references, in particular when undated, and any form of pre-assessment by the TC, e.g. risk assessment, sectoral specific arrangement, etc. These elements shall be duly identified in the comments section of the transmission notice.
  It is reminded that it is necessary to resubmit to CCMC all necessary elements, those provided for earlier stages cannot be taken into account as they may have been changed following technical work in the Technical Body.
  Particular attention shall be paid for FA projects, where timing of the submission of those elements, such as Annex ZA (see D160/020), is critical. Through decision D160/022, BT invited the CENELEC Technical body Secretaries (including SRs) to closely monitor the work programme of their corresponding IEC Technical bodies in order to anticipate the timely submission of documents. In case of any issues relating to the timing of projects, the TC Secretary is invited to consult the CCMC Project Manager in charge of the Technical Body.
• When launching the translation procedure, CCMC will submit the prEN with the relevant documentation for assessment via the relevant Livelink area. This will trigger the HAS Contractor for an assessment.
• The HAS Contractor has normally 5 weeks (35 calendar days) to reply. As from the Livelink notification of the reply, the Technical Body Secretary shall download the assessment from the Livelink area and distribute it to the technical body members. 

The Assessment Report is added by CCMC to the documents for the Enquiry vote, together with the draft.

Assessment report giving as an outcome 'Compliant'

This might prompt the Technical Body to consider skipping Formal Vote (FV), if other criteria are met.

Assessment report giving as an outcome ‘Lack of Compliance’

• The launch of the Enquiry vote is not delayed.
• When the Technical Body can duly justify a challenge to the assessment (for instance after a non-conclusive discussion with the HAS Consultant), the Technical Body may decide to do so. On such Technical Body decision, the Technical Body Secretary sends a request for a review of the assessment to the CCMC Project Manager. CCMC will then submit the request via the relevant Livelink area.
• The HAS Contractor has normally 3 weeks (21 calendar days) to reply with a reviewed assessment.

The Formal Vote may be skipped only  when the negative outcome of the assessment, including a possible review of that assessment, is resolved before or as a result of the 'Comments Resolution Meeting' (CRM) involving the HAS Consultant and/or the EC Desk Officer, without technical changes to the standard as submitted to Enquiry.
The report of this meeting shall be added to the transmission notice stating the TC decision to skip the FV. When there is no possibility to resolve a negative outcome without technical changes, the Formal Vote shall not be skipped.

Preparation of final draft after Enquiry

In consideration of all comments received and if deemed necessary, the Technical Body Chair, supported by the Technical Body Secretary, will call for a ‘Comments resolution meeting’ involving the HAS Consultant and/or the EC Desk Officer, to be held at the latest 4 months after the closure of the Enquiry.

NOTE: the TC may delegate the resolution of comments to the relevant SC or WG.

Should the ‘Comments resolution meeting' not succeed to have an outcome eventually leading to a ‘compliant’ result in the next assessment phase, the meeting should lead to a decision on the future of the project, e.g. proceeding as a non-harmonized standard. In this case, BT shall be consulted to endorse the decision and CCMC informs the EC.

See some practical tips on how to help preventing a partial compliance or lack of compliance of an assessment.

3.5 Formal vote

The Formal vote process for harmonized standards is identical to Formal Vote in general with the following additions:

• When delivering the FprEN for Formal Vote to CCMC in view of the assessment, the TC Secretary will also provide relevant documentation. This could include the outcome of the CRM and how all the HAS Consultant comments were reviewed, a justification for the used normative references, in particular when undated, and any form of pre-assessment by the TC, e.g. risk assessment, sectoral specific arrangement, etc.  These elements shall be duly identified in the comments section of the transmission notice.
  It is reminded that it is necessary to resubmit to CCMC all necessary elements, those provided for earlier stages cannot be taken into account as they may have been changed following technical work in the Technical Body.
  Particular attention shall be paid for FA projects, where timing of the submission of those elements, such as Annex ZA (see D160/020), is critical. Through decision D160/022, BT invited the CENELEC Technical body Secretaries (including SRs) to closely monitor the work programme of their corresponding IEC Technical bodies in order to anticipate the timely submission of documents. In case of any issues relating to the timing of projects, the TC Secretary is invited to consult the CCMC Project Manager in charge of the Technical Body.
• When launching the translation procedure, CCMC will submit the FprEN with the relevant documentation for assessment via the relevant Livelink area. This will trigger the HAS Contractor for an assessment.
• The HAS Contractor has normally 5 weeks (35 calendar days) to reply. As from the Livelink notification of the reply, CCMC shall distribute the Assessment Report to the Technical Body Secretary who distributes it to the Technical Body members.
• The Assessment Report is added to the documents for Formal Vote, together with the FV draft.

In case of 'Compliant' outcome 

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

In case of ‘Lack of Compliance’

Start of the vote is suspended for maximum 12 weeks after reception of the assessment, to allow for the actions below to be initiated:

• The BT Member/Permanent Delegate of the NSB/NC holding the secretariat shall immediately be informed.
• The Technical Body shall do its utmost to resolve any issues and the TB Secretary shall ensure that the CCMC Project Manager is properly informed should any changes to the text be necessary.
• Within 4 weeks of reception of an assessment with partial or lack of compliance, the Technical Body needs to decide, with due justification, whether it will challenge the assessment. On such a Technical Body decision, the Technical Body Secretary sends a request for review of the assessment to the CCMC Project Manager.  CCMC will then submit the request via the relevant Livelink area.
• The HAS Contractor has 3 weeks (21 calendar days) to reply with a reviewed assessment by uploading the assessment results on the relevant Livelink area, which will trigger a notification of CCMC who distributes it to Technical Body Secretary.

NOTE: See also the Guidance document for technical bodies on practical measures when dealing with a negative assessment at Formal Vote stage.

Regardless of the request for a reviewed assessment, two possibilities exist:

• When issues can be resolved by the Technical Body within 7 weeks after reception of the original assessment at FV, BT is informed and the Formal Vote is started.
• When issues cannot be resolved by the Technical Body within 7 weeks after reception of the original assessment at FV, a proposal on the way forward is circulated to BT. This can range from reverting to a second Enquiry to proceeding with a (temporary) de-harmonized project.

This input is sent by the Technical Body Secretary to the CCMC Project Manager who will take care of submitting it to BT.

In case CCMC does not receive any input from the Technical Body within 7 weeks after the original assessment at FV,  CCMC shall trigger the BT Member/Permanent Delegate of the NSB/NC holding the secretariat for due action, i.e. to provide CCMC with a proposal to BT within one week after being triggered.