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.
1st meeting - 23 March 2020 - Documents and presentations
2nd meeting - 20 July 2020 - Documents and presentations
3rd meeting - 30 November 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
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
4th meeting - 17/18 June 2020- Documents and presentations
5th meeting- 9 November 2020- Documents and presentations
Notification of Studies Database
Terms of reference - updated April 2020
1st meeting – 19/20 February 2020 - Documents and presentations
2nd meeting – 20/21 October 2020- Documents and presentations
Risk communication
The European Commission has asked EFSA to provide technical assistance in the field of risk communication to inform the ‘General Plan on Risk Communication’ [Mandate: M-2020-0059]. The General Plan is intended to enhance the coordination and consistency of risk communication on food safety. The Commission is required to implement the General Plan under Article 8c of the Transparency Regulation. EFSA’s Working Group on Social Research Methods and Advice will deliver a scientific report following a review of scientific literature. The public consultation on the draft of the scientific report was launched on 19 November 2020 and will be closed on 17 January 2021 (more info here). Following the consultation, EFSA’s Working Group on Social Research Methods and Advice will analyse the feedback and finalise the report, scheduled for completion by 31 March 2021.
Transparency Regulation Implementation Training Programme
On 19 November 2020, EFSA held the public Webinar “Implementing the Transparency Regulation. Requirements, tools and services” with the purpose of introducing the main aspects of the Transparency Regulation and outlining the new requirements as well as the new services available for business operators as of March 2021. More information and meeting’s recording are available on EFSA’s website.
On 11 January 2021, EFSA published the Practical Arrangements, which specify the details for the implementation of required processes.
To help stakeholders better understand and prepare for the new arrangements, EFSA will be producing a range of supporting materials such as animated tutorials and holding a series of training sessions which will be taking place as from January 2021. More information as well as the calendar of training activities will be made available on the dedicated webpage.
Calendar of meetings
Meetings may be subject to change.
Notification of Studies Database Technical Group meeting
IUCLID for Pesticides Technical Group meeting
Stakeholder questions, comments and position papers
The following written communication has been received:
- European Crop Protection Association (ECPA), received on 3rd September 2019: “ECPA key questions on implementation of Commission proposal on transparency and sustainability of EU risk assessment model".
- Redebel Regulatory Affairs (RRA), received on 27th January 2020: “Questions about the set up of the Transparency regulation for testing facilities”.
- EuropaBio, received on 20th February 2020: “EuropaBio questions to EFSA on the implementation of Regulation (EU) 2019/13811 on the transparency and sustainability of EU risk assessment in the food chain”
- Written communication from ERM received on 25 February 2020
- European Network of Scientists for Social and Environmental Responsibility (ENSSER), received on 16th March 2020: “Written communication from Sounding Board member in response to 1st Sounding Board draft agenda circulated on 13 March 2020”
- EU Association of Specialty Feed Ingredients and their Mixtures (FEFANA) on behalf of the Business and Food Industry stakeholder category received on 18th March 2020: “Written communication from Sounding Board member in response to 1st Sounding Board draft agenda circulated on 13 March 2020”
- EuropaBio, received on 28th April 2020: “EuropaBio concerns regarding provisional practical arrangements on Articles 38 and 39 of Regulation (EU) 2019/1381”
- EU Association of Specialty Feed Ingredients and their Mixtures (FEFANA) on behalf of the Business and Food Industry stakeholder category received on 28th April 2020: “Business and food industry” EFSA stakeholder group call for a higher level of engagement in the implementation process of the Transparency Regulation”
- Written communication from Charles River received on 26 May 2020
- Written communication from EuropaBio received on 29 June 2020
- EU Association of Specialty Feed Ingredients and their Mixtures (FEFANA) on behalf of the Business and Food Industry stakeholder category received on 15 July 2020: “Written communication from Sounding Board member in response to 2nd Sounding Board draft agenda circulated on 13 July 2020”
- Association of Veterinary Consultants (AVC) on behalf of the Practitioners Associations stakeholder category received on 20 July 2020: “Written communication from Sounding Board member”
- ClientEarth received on 5 August 2020: “Implementing the reform of the General Food Law. Recommendations on the Practical Arrangements for confidentiality decisions”
- European Crop Protection Association (ECPA), received on 8th September 2020: “ECPA questions on the implementation of the Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain”
- Written communication from Cyton Biosciences Ltd - a knoell company received on 21 September 2020
- Pollinis, received on 23rd September 2020: “Comments on the Practical Arrangements implementing Regulation (EU) 2019/1381”
- Written Communication from Association of Veterinary Consultants (AVC) received on 27 September 2020
- Written communication, EU Association of Specialty Feed Ingredients and their Mixtures (FEFANA), received on 30 September 2020
Contact
For questions or queries, please contact us at: TransparencyRegulationImplementation [at] efsa.europa.eu .
