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 CEN – 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).
2 BASIC PRINCIPLES FOR THE ASSESSMENT
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 tasks to coordinate 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 substantially longer.
The outcome of the assessment can be:
- ‘Compliant': The publication of the references in the OJEU is normally possible without any specific notice.
- 'Partial compliance': The publication of the references in the OJEU could be possible with a notice; such a notice shall be outlined in the report for already adopted standards and for documents assessed before Formal Vote (FV).
- '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 CEN, 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, CEN 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.
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 CEN ‘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.
NOTE 2: ‘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 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 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
Requesting this ‘indicative assessment’ is not compulsory but it is recommended.
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 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 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:
- 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.
- 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 'Compliance'
This might prompt the Technical Body to consider skipping Formal Vote (FV), if other criteria are met.
Assessment report giving as an outcome 'Partial compliance' or ‘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’ or ‘partial-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 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, 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.
- 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, the Technical Body Secretary shall download the Assessment Report from the Livelink area and distribute 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 outcome 'Compliant'
The FprEN with the Assessment Report are sent to Formal Vote.
In case of 'Partial compliance' or ‘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 Technical Body decision, the Technical Body Secretary sends a request for review of the assessment to 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.
3.6 Missing or late assessment