Transparency Regulation and stakeholder engagement
EFSA has interacted with stakeholders during the main implementation phase of Regulation (EU) 1381/2019, the ‘Transparency Regulation’, until entry into application in accordance with an engagement framework jointly agreed and aligned between EFSA and DG SANTE. This interaction has been separate and in addition to the Stakeholder Engagement Approach (SEA), which continued 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.
Following the conclusion of the main implementation phase leading up to the entry into application of the Transparency Regulation, EFSA will continue its stakeholder engagement on the Transparency Regulation through the fora foreseen by the Stakeholder Engagement Approach (SEA).
During the main implementation phase leading up to the entry into application of the Transparency Regulation, EFSA followed the following engagement framework.
Applicable principles/framework during the main implementation phase
- Independence: No undue influence has been allowed at any time during the implementation. DG SANTE and EFSA have informed stakeholders about the implementation of the Transparency Regulation in dedicated fora. No details regarding the implementation have been discussed with stakeholders, nor has any material been produced jointly with stakeholders. No substantive reply has been 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 have provided timely and clear information on the implementation to all stakeholders.
- Inclusiveness: The dedicated fora in which the implementation has been discussed has been inclusive and stakeholders have been treated equally in the discussions. In meetings of a general nature all stakeholder categories have been invited. In technical meetings where expertise of one or more specific stakeholders’ categories was needed, other categories have also been invited as observers.
- Flexibility: Physical and/or on-line meetings will be complemented by dedicated public consultations where needed.
- Non-duplication: There has been, 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 during the main implementation phase
EFSA has engaged with stakeholders on the implementation through two main channels - the Sounding Board and technical groups.
- Sounding Board: The objective of the Sounding Board was 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 was 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 are composed of relevant stakeholders representatives of EU agencies, Member States, the European Commission and observers.
Meetings with and written input from stakeholders received during the main implementation phase
Written input from stakeholders:
- Documents received from stakeholders have been published with the title of the document and the name of the stakeholder organisation clearly identified. Documents have been published on the website of the receiver (EFSA or DG SANTE). The related EFSA and DG SANTE webpages are linked to allow stakeholders to have a clear overview of all documents received by both entities. Publication of documents has taken place only with the consent of the relevant stakeholder organisation sending the document. If the sender did not give their consent, the webpage indicated 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 have been 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 has been 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) have been addressed in specific technical groups with the relevant stakeholder categories, as appropriate (e.g. EFSA technical user groups).
Sounding Board and Technical Groups
The Sounding Board will conclude its activities following the conclusion of the main implementation phase leading up to the entry into application of the Transparency Regulation on 27th March 2021 and a Sounding Board Concluding Report and infographic about EFSA’s engagement activities that took place in the context of the TR implementation are published below together with the Sounding Board meeting documents. The Technical Groups on IUCLID for pesticides and Notification of Studies Database will conclude their work in line with their Terms of Reference.
Members - updated in May 2020
EFSA has established two technical groups, 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
In line with its Terms of Reference (ToR), the TG IUCLID has concluded its activities. The engagement will continue through a group set up to continue the technical exchanges under the umbrella of the Pesticides Steering Network: Pesticide Steering Network – IUCLID sub-group.
Notification of Studies Database
Terms of reference - updated April 2020
Members - updated April 2020
In line with its Terms of Reference (ToR), the Technical group on Notification of Studies Database has concluded its activities. The engagement will continue through the Technical group on the Tools related to the application of the Transparency Regulation (TG TOOLS) set up to continue the technical exchanges: TG TOOLS.
Transparency Regulation Implementation Training
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.
In order to help stakeholders better understand the new arrangements and provisions of the Transparency Regulation, EFSA has produced a range of supporting materials:
- Information about training opportunities and other resources is available at the Applicants’ Toolkit page of the EFSA website.
- Training materials relating to confidentiality issues are available on the Legal Notice page.
- Materials on the application procedure for regulated products can be found in the Applications workflow pages of the relevant regulated product area in the Applications section.
As part of the implementation process, EFSA has published detailed arrangements for how the new rules and measures specified in the Transparency Regulation operate in practice.
The “Practical Arrangements” (PAs) EFSA published on 11 January 2021 cover areas such as proactive transparency, confidentiality, notification of studies, pre- submission advice and consultation of third parties.
The PAs on the processing of applications for access to documents held by EFSA were published in 2020 following the adoption of this document by EFSA’s Management Board by March 27 2020, in line with the timeline laid down by the Transparency Regulation.
The “Questions and Answers on EFSA Practical Arrangements” published on 30 March 2021 provides answers to questions frequently asked (FAQs) on the PAs. Questions on the interpretation of the provisions of the Transparency Regulation are out of the scope of this document, which exclusively focuses on the EFSA PAs.
Updated Guidance documents on Regulated Products
EFSA has updated its scientific and administrative guidance documents to reflect the new provisions introduced by the Transparency Regulation in the pre-submission phase and application procedure.
Updated scientific and administrative guidance documents can be accessed from the Applications section under the Regulations and guidance pages of each regulated product area as soon as they become available.
The European Commission 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, in consultation with EFSA and Member States. EFSA’s Working Group on Social Research Methods and Advice drafted a scientific report following a review of scientific literature. A public consultation on the draft of the scientific report took place from 19 November 2020 until 24 January 2021 (more info here). The Working Group analysed the feedback and finalised the report , which has been published in the EFSA Journal in April 2021.
EFSA produced three additional reports to support the Commission, which have been published together with the scientific report. The three reports comprise:
- Mapping the coordination and cooperation mechanisms of risk communication on feed/food safety in the EU
- Catalogue of Communication Tools and Dissemination Guidelines – Benchmarking current practice in EU and Members State bodies
- Engagement Toolkit – Methods, tips and best practices to design effective participatory processes.
More information about the reports and links to the publications in the EFSA journal are available here.
Celebratory event for the entry into application of the Transparency Regulation
In order to mark the entry into application of the Transparency Regulation, the European Commission and the Portuguese Presidency, in collaboration with the European Food Safety Authority (EFSA), organised a celebratory event on 30 March 2021.
The video recording of the event and opening remarks are available on the DG SANTE website.
Calendar of meetings
Meetings may be subject to change.
- Training programme - as from January 2021
- Regulated products: webinar series to support applicants – as from June 2021
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
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