This page specifies the actions required to prepare, approve and implement homegrown European Standards (EN) intended to be cited in the Official Journal of the European Union. It only covers the additional actions that are required when the EN is intended to be cited in the Official Journal. All processes relevant to ENs in general are applicable as well.
The objective of this page is to clarify the process for practical implementation of the relations between CENELEC – CCMC, members, Technical Bodies, 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 April 2018.
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).
The HAS Contractor is the formal contact point towards EC and ESOs, with 3 main tasks:
The HAS Contractor will be managing the pool of harmonised standards consultants 'HAS Consultants'.
The HAS Consultant is an independent expert selected and hired by the HAS Contractor to perform the following main tasks:
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).
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 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.
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.:
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.
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.
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'):
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.
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.
The drafting stage is identical to Drafting of European Standards up to Enquiry stage with following additions:
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.
The Enquiry for harmonized standards is identical to Enquiry in general with the following additions:
The Assessment Report is added by CCMC to the documents for the Enquiry vote, together with the draft.
This might prompt the Technical Body to consider skipping Formal Vote (FV), if other criteria are met.
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.
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.
The Formal vote process for harmonized standards is identical to Formal Vote in general with the following additions:
The FprEN with the Assessment Report are sent to Formal Vote.
Start of the vote is suspended for maximum 12 weeks after reception of the assessment, to allow for the actions below to be initiated:
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:
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.