Transparency Regulation implementation and stakeholder engagement

EFSA will interact with stakeholders during the implementation of Regulation (EU) 1381/2019, the ‘Transparency Regulation’, period until entry into application in March 2021 in accordance with an engagement framework jointly agreed and aligned between EFSA and DG SANTE. This interaction will be separate and in addition to the Stakeholder Engagement Approach, which will continue to be carried out in line with the Management Board Decision on the criteria for establishing a list of stakeholders and the establishment of the Stakeholder Forum and Stakeholder Bureau.

Applicable principles/framework

  • Independence: No undue influence will be allowed at any time during the implementation. DG SANTE and EFSA will inform stakeholders about the implementation of the Transparency Regulation in dedicated fora. No details regarding the implementation will be discussed with stakeholders, nor will any material be produced jointly with stakeholders. No substantive reply will be provided to individual stakeholder input outside the dedicated fora.
  • Transparency: Full transparency will be ensured throughout the process. DG SANTE and EFSA will address stakeholders’ questions, positions, comments or feedback in the relevant fora in full transparency. A calendar of planned events will be communicated to stakeholders.
  • Openness: DG SANTE and EFSA will provide timely and clear information on the implementation to all stakeholders.
  • Inclusiveness: The dedicated fora in which the implementation will be discussed will be inclusive and stakeholders will be treated equally in the discussions. In meetings of a general nature all stakeholder categories will be invited. In technical meetings where expertise of one or more specific stakeholders’ categories is needed, other categories will also be invited as observers.
  • Flexibility: Physical and/or on-line meetings will be complemented by dedicated public consultations where needed.
  • Non-duplication: There should be, as far as possible, no duplication between the existing stakeholder engagement fora and the fora dedicated to implementation of the Transparency Regulation.

Main engagement fora

EFSA will engage with stakeholders on the implementation through two main channels - the Sounding Board and technical groups.

  • Sounding Board: The objective of the Sounding Board is to keep stakeholders informed about the state of play of implementation in general, to collect comments stakeholders may have and to address questions where possible. It will be composed of the Stakeholder Bureau members and up to one additional member per stakeholder category, Advisory Forum representatives and the European Commission.
  • Technical groups: The objective of technical groups is to inform stakeholders about the implementation process and to gather input on a specific technical area. The technical groups will be composed of relevant stakeholders representatives of EU agencies, Member States, the European Commission and observers.

Meetings with and written input from stakeholders

Written input from stakeholders:

  • Documents received from stakeholders will be published with the title of the document and the name of the stakeholder organisation clearly identified. Documents will be published on the website of the receiver (EFSA or DG SANTE). The related EFSA and DG SANTE webpages will be linked to allow stakeholders to have a clear overview of all documents received by both entities. Publication of documents will take place only with the consent of the relevant stakeholder organisation sending the document. If the sender does not give their consent, the webpage will indicate the title of the document, the name of the stakeholder organisation, and a reference that the relevant sender did not give their consent for the publication on the website.

Meetings with stakeholders:

  • To ensure full transparency and equal treatment of all stakeholders, content and questions on substance will be addressed in the dedicated fora in the presence of all stakeholder categories (e.g. Sounding Board set up by EFSA), and not bilaterally with EFSA and/or DG SANTE. Full transparency must be ensured (e.g. through publication of agendas, reports or notes from the meeting and participant lists). More technical questions (such as those concerning standard data formats) will be addressed in specific technical groups with the relevant stakeholder categories, as appropriate (e.g. EFSA technical user groups).

Sounding Board

The Sounding Board was launched on 18 December 2019 through a call for expression of interest for participation with the deadline of 21 January 2020. The Sounding Board membership has been confirmed and the first Sounding Board meeting took place on 23 March 2020.

Terms of reference

Members - updated in May 2020

1st meeting - 23 March 2020 - Documents and presentations

Technical groups

Technical groups will be established as needed. To date, two technical groups have been established, one focusing on usage of ECHA’s IUCLID cloud for pesticide dossiers and the second on the Notification of Studies Database.

IUCLID for pesticides

Terms of reference - updated April 2020

Members

1st meeting - 6/7 November 2019 - Documents and presentations

2nd meeting - 26/27 February 2020 - Documents and presentations

3rd meeting - 21/22 April 2020 - Documents and presentations

Notification of Studies Database

Terms of reference - updated April 2020

Members - updated April 2020

1st meeting – 19/20 February 2020 - Documents and presentations

Calendar of meetings

Meetings may be subject to change.

IUCLID for Pesticides Technical Group meeting

17-18 June 2020
Virtual meeting

2nd Sounding Board meeting

July 2020
Virtual meeting

Notification of Studies Database Technical Group meeting

September 2020

3rd Sounding Board meeting

September 2020

IUCLID for Pesticides Technical Group meeting

October 2020

Notification of Studies Database Technical Group meeting

January 2021

IUCLID for Pesticides Technical Group meeting

January 2021

Position papers received from stakeholders

The following Position Papers have been received:

Contact

For questions or queries, please contact us at: TransparencyRegulationImplementation [at] efsa.europa.eu .