Effective participation of Annex III Organizations in Standardization

This page describes the process supporting the Annex III Organizations’ right to submit an Opinion

1 INTRODUCTION

Standards have a broad impact on SMEs and society, in particular on the safety and well-being of consumers, environmental protection, workers’ safety and working conditions and accessibility. Regulation (EU) 1025/2012, amended by EU Regulation 2022/480, stresses the importance of participation of societal stakeholders and SMEs at national level and complementing this through support at the European level from the recognized European organizations representing consumers (ANEC), environmental interests (ECOS), social interests (ETUC) and SME interests (SBS). The active contribution of these organizations is valuable for European standardization, in particular as the expertise needed to represent societal stakeholders and SMEs effectively in the process of standards development at national level is often weak or absent.
CEN and CENELEC in partnership with ANEC, ECOS, ETUC and SBS have looked into new measures to enable these organizations to play ‘a more central role in the standardization process’, to raise their profile and understanding of their role in standardization, and to create a more distinct working relationship. In particular, CEN & CENELEC agreed to grant them the right of Opinion.

2 RIGHT TO SUBMIT AN OPINION 

From 1 January 2017 on, Societal Stakeholder Organizations (SSO) that are referred to as Annex III organizations in EU Regulation 1025/2012 and that signed a partnership agreement with CEN or CENELEC - ANEC, ECOS and ETUC - have the right to submit an Opinion on (final) draft standards. The right of Opinion was also granted to SBS, by the CEN and CENELEC Administrative Boards during the annual meeting on 24-27 June 2024, to be applicable from 2 September 2024 (69/2024 & 168/10).

The Annex III Organizations fill in a template to submit their Opinion. Apart from information on the submitting organization, details on the technical body, the work item, at what stage the standard is, and the Opinion itself, the submitter also provides information on the participation of the Annex III Organization in the development of the standard and comments already submitted (if any).

Annex III Organizations are encouraged to submit an Opinion on (final) draft standards where they have participated in the work. Annex III Organizations should convey their Opinion in a sensitive and constructive way for the relevant (J)TC to take it on-board.

The Opinion does not form part of the ballot and does not affect the outcome of the vote, nor does it affect the national delegation principle or challenge the consensus building. There is a clear distinction between an Opinion and a comment. There is no change regarding the right to submit comments during the standards development process.

In 2022, CEN/BT agreed to implement the digitalization project of the Opinion Mechanism (Decision BT 012/2022) by integrating the submission of an Opinion within the eBalloting platform, as to simplify and automate the mechanism for all users involved in the process. The below information has been updated reflecting the deployed digitalized mechanism.

3 OPINION MECHANISM AND TIMEFRAME

3.1 Opinion during Enquiry

• This process applies to CEN/TCs and CEN-CLC/JTCs under CEN Member Secretariat.
• The Annex III Organizations Secretariat has the right to submit an Opinion during the Enquiry phase by accessing the eBalloting platform (table ‘Societal Opinions’) and uploading the filled in template.
• The submitted Opinion will be visible for all voters, including the TC/SC Chairperson and Secretary, while the ballot is open on eBalloting.
• Upon closing of the ballot, the Opinion result is in a table which is integrated into the ‘result of voting’ (new dedicated table). 
• CCMC also manually attaches the filled-in Opinion template to the ‘Result of Voting’ (in eTrans), which is made available on Projex-Online.
• The Opinion needs to be considered together with all the comments submitted during Enquiry.
• The TC/SC decides on the follow up to be given to the Opinion.
• Should the Annex III Organization wish to introduce changes to the text of the standard under development, this is done through the regular commenting process i.e. through the submission of comments.

3.2 Opinion during Formal Vote

• This process applies to CEN/TCs and CEN-CLC/JTCs under CEN Member Secretariat.
• The Annex III Organization Secretariat has also the right to submit an Opinion during the Formal Vote by accessing the eBalloting platform (table ‘Societal Opinions’) and uploading the filled-in template.
• The submitted Opinion is visible for all voters, including the TC/SC Chairperson and Secretary, while the ballot is open.
• Upon closing of the ballot, the Opinion result table is integrated into the ‘results page’ (new dedicated table).
• CCMC also manually attaches the filled-in Opinion template to the ‘Results of Voting’ (in eTrans), which is made available on Projex-Online.
• The TC/SC agrees on the follow up to be given to the Opinion. The Opinion, especially if Not-Favourable, needs to be considered during the first occasion the TC/SC has, which will in most cases be its next meeting.
• Any possible residual comment on the text of the final draft standard is submitted through the regular commenting process.

3.3 Information to BT

CCMC provides BT with an annual update on the Opinion mechanism (‘Register of Opinions’), which allows tracking of the Opinion for all BT participants, including the Annex III Organizations. Similar report can be provided to the Board, when relevant.

3.4 Information to Annex III Organizations on follow-up

Annex III Organizations are informed of the follow up given to the Opinion via the BT channel and through the CEN-CENELEC Societal Stakeholder Group or the SME-Working Group in which they participate.