EFSA s Catalogue of support initiatives during the life-cycle of applications for regulated products. European Food Safety Authority (EFSA)

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1 TECHNICAL REPORT APPROVED: 22 April 2016 AMENDED: 17 July 2017 doi: /sp.efsa.2016.en-1025 EFSA s Catalogue of support initiatives during the life-cycle of applications for regulated products Abstract European Food Safety Authority (EFSA) As part of EFSA s ongoing commitment to engage with its stakeholders and to increase understanding of its scientific risk assessment work, EFSA s Scientific Evaluation of Regulated Products (REPRO) Department has developed a customer-oriented approach to stakeholders in the area of applications for regulated products with the aim of establishing an interactive and responsive evaluation process. The current EFSA Catalogue provides a list of harmonised support initiatives targeted to applicants that are currently implemented in EFSA during the entire life-cycle of applications for regulated products. The description of each initiative includes the nature and the scope of the, the phase in the life-cycle of the application, the format, the unit in charge, the date from which the is in place, when it is applicable, the participants involved, the type of outcome expected, who can request the, when and how to access the, and the staff member/s in charge. By describing the details of each support initiative, EFSA wishes to increase awareness of the initiative and especially encourage an active accessibility to the different s in place for applicants when possible and needed. The current Catalogue (version 2017) supersedes the previous version (version 2016). The Catalogue will be reviewed and updated regularly as needs arise and in line with resource availability in EFSA. European Food Safety Authority, 2016 Key words: applicants, stakeholders, applications, support initiatives, regulated products, APDESK Unit, REPRO Department Requestor: EFSA Question number: EFSA-Q Correspondence: APDESK.applications@efsa.europa.eu EFSA Supporting publication 2016:EN-1025

2 Acknowledgements: EFSA wishes to thank the following people for the support provided to this output: Margherita Guidi, Karine Lheureux, Guilhem de Seze, Valeriu Curtui, Simone Gabbi, Claudia Roncancio Peña, Jose Tarazona, Manuela Tiramani, Elisabeth Waigmann and the APDESK unit for the support provided to this output. Amendments: Editorial amendments were carried out that do not materially affect the content or outcome of this Supporting publication. To avoid confusion, the older version has been removed from the website, but is available upon request, as is a version showing all the changes made. Suggested citation: EFSA (European Food Safety Authority), EFSA s Catalogue of support initiatives during the life-cycle of applications for regulated products. EFSA supporting publication 2016:EN pp. doi: /sp.efsa.2016.en-1025 ISSN: European Food Safety Authority, 2016 Reproduction is authorised provided the source is acknowledged. 2 EFSA Supporting publication 2016:EN-1025

3 List of modifications to the technical report Note that minor editorial changes are not specified in this section content revision Section Status Action Section 1.1. Background updated Context shortened Section 1.3. Structure updated Legal disclaimer included Section updated Title, description, scope, participants and duration revised Section updated expanded Section updated expanded Section updated reduced Section updated expanded Annex A updated Working groups and pesticides information updated 2016 content revision Section Status Action Section 1.2 Purpose updated clarified Figure 1 and 2 updated New initiatives included, layout revised Section new Section new Section new Section updated broaden Section updated broaden Section updated Timeline broaden Section updated broaden Appendix A updated Links updated 3 EFSA Supporting publication 2016:EN-1025

4 Summary EFSA and its Scientific Evaluation of Regulated Products (REPRO) Department are developing an EFSA customer-oriented approach towards stakeholders in the area of applications for regulated products, targeted particularly at the needs of applicants. The aim is to enhance dialogue with applicants and to enhance understanding on regulated products topics and processes. To achieve this objective, the Applications Desk Unit has developed a multiannual project aimed at a continuous increase of interaction and responsivity. On one hand, by promoting a set of coordinated activities supporting EFSA stakeholders on regulated products and, on the other hand, by regularly monitoring the satisfaction level of interested parties. This approach is part of EFSA s effort and ongoing commitment to engage with all its stakeholders and to increase understanding of its scientific risk assessment work. The current Catalogue of support initiatives during the life-cycle of applications for regulated products (hereafter referred to as the Catalogue ) is one of many initiatives undertaken by EFSA on this direction. The current EFSA Catalogue provides the list of harmonised support initiatives that are currently implemented in EFSA for applicants during the life-cycle of applications for regulated products (presubmission, completeness/suitability check, risk assessment, adoption and publication of the scientific output). It is a comprehensive list, even though not exhaustive, of the support provided by EFSA in the area of regulated products. The description of each initiative includes the nature and the scope of the, the phase in the life-cycle of the application, the format (e.g. physical meeting, telephone conference, etc.), the unit in charge, the date from which the is in place, when it is applicable, the participants involved, the type of outcome expected, who can, when and how to access the and the staff member/s in charge. The harmonised support initiatives presented in the Catalogue are listed below: Pre-submission phase and/or during the entire life-cycle of the application EFSA guidance document: production, revision and update of EFSA guidance documents (including explanatory notes) EFSA Info session on applications: EFSA Info session on applications on administrative and scientific issues to improve the understanding of the application process Roundtable with industry associations: meeting between EFSA, European Commission and representatives of the industry associations on food and feed regulated products to increase transparency and dialogue during EFSA s risk assessment processes Ad hoc meeting with industry representatives: meeting between EFSA and industry representatives organised on a case by case basis to exchange views on issues which are unique to a particular scientific area Workshop and conference on scientific topics as a forum for dialogue with the scientific community REPRO webinar on applications: information sessions conducted online consisting of presentations, video, question and answer sessions (Q&A), chat messages and audio conferencing all taking place over the web EFSA APDESK web form to increase understanding on general and specific requirements for submitting applications (under the correct legal framework), procedural steps, status of applications, etc.; follow-up of EFSA APDESK web form queries to clarify administrative and scientific requirements 4 EFSA Supporting publication 2016:EN-1025

5 Submission Submission and update of applications and related documents for regulated products to EFSA by electronic means only (CD ROMs, DVDs or USB keys) Completeness/suitability check phase Clarification teleconference when EFSA needs to clarify any outstanding issues on the application or when the request for missing information by EFSA during the completeness check is not clear to the applicant Risk assessment phase Clarification teleconference when the request for additional information by EFSA during the scientific assessment is not clear to the applicant Applicants hearing provides the applicant with the possibility to clarify the additional data submitted or to clarify any outstanding issues on the application by attending, as applicants hearing, an agenda point of the EFSA Working Group or Panel meetings Adoption and publication of a scientific output Notification to the applicant on the adoption of the scientific output Pre-notification of adopted scientific output before publication on the EFSA website Post-adoption teleconference to clarify the scientific rationale of the final EFSA output The Catalogue intends to create awareness about the support initiatives provided by EFSA for applicants and interested parties with the aim to enhance understanding on regulated products topics and processes. At the same time the EFSA Catalogue describes the different stages of the application life-cycle in which such initiatives may be accessed by the different stakeholders. By describing the details for each support initiative, EFSA wishes to encourage accessibility to the different s in place for applicants and interested parties. The proposed support initiatives presented within the EFSA Catalogue will be reviewed and updated regularly, based on arising needs and resource availability in EFSA. 5 EFSA Supporting publication 2016:EN-1025

6 Table of contents Abstract... 1 List of modifications to the technical report... 3 Summary Introduction Background Purpose Structure The Catalogue Phase 1 Pre-submission EFSA guidance document EFSA scientific opinions and guidance document for Pesticides Info session on applications Roundtable with the industry associations Ad hoc meeting with industry representatives Scientific workshop/conference on scientific issues REPRO webinar EFSA APDESK web form Follow-up on EFSA APDESK web form queries Phase 2 Submission Submission by electronic means Phase 3a Completeness check/suitability check Clarification teleconference during completeness/suitability check Phase 3b Risk assessment Clarification teleconference during risk assessment Clarification teleconference during Peer Review for Pesticides Applicants hearing Phase 4 & 5 Adoption and publication of a scientific output Notification on adoption of scientific output Pre-notification of adopted scientific output before publication Post-adoption teleconference Conclusions Abbreviations EFSA Supporting publication 2016:EN-1025

7 1. Introduction 1.1. Background In the framework of supporting innovation in the European Union, customer satisfaction becomes a key indicator for the European Food Safety Authority (EFSA) to respond to stakeholders needs and interests. In its EFSA Strategy 2020, one of the five strategic objectives aims to prioritise public and stakeholder engagement in the process of scientific assessment. The REPRO Department and its Application Desk Unit will continue to streamline administrative procedures associated with applications, from reception to adoption. It will take additional steps to improve interactions with applicants, to ensure a high level of fairness and accountability in the operations that affect third parties and to simplify the application workflows 1. EFSA has been developing a multiannual project on Interactions with stakeholders Development of a customer oriented approach for applications for regulated products 2 comprising a set of coordinated activities supporting EFSA stakeholders in the area of applications for regulated products. This project aims at establishing an evaluation process that is more interactive and responsive by promoting and supporting high quality submission of applications and by regularly monitoring and measuring the satisfaction level of interested parties. The current Catalogue of support initiatives during the life-cycle of applications for regulated products (hereafter referred to as the Catalogue ) is one of the many initiatives undertaken by EFSA in this direction Purpose The current Catalogue provides an overview of the support initiatives currently implemented in EFSA and targeted to applicants. The Catalogue aims, on one hand, to actively inform all stakeholders on the overview of support initiatives currently in place in EFSA on regulated products. On the other hand, it aims to create awareness and mutual understanding around the various opportunities for interaction and dialogue among all parties involved on regulated products applications. The Catalogue presents support initiatives which in some cases are specific for applicants, and in other cases, are addressed to various interested parties Structure The description of each initiative includes the nature and the scope of the, the phase in the life-cycle of the application, the format (e.g. physical meeting, telephone conference, etc.), the unit in charge, the date from which the is in place, when it is applicable, the participants, the type of outcome, who can access the, when and how to access the, the staff member/s in charge. The Catalogue s users shall be informed that recordings or making any written transcript of the teleconference/webinar/meeting is not allowed by EFSA. Failure to obtain ex ante agreement by EFSA for such recording results in the breach of EU data protection regulation and applicable sectoral EU food law. Views expressed during the teleconference/webinar/meeting are solely of the concerned individuals, do not necessarily represent EFSA s views or positions and are without prejudice to the assessment of a future dossier by the competent EFSA s Scientific Committee, Panel, Working group or staff. To the aim of best presenting the range of support initiatives available within EFSA on regulated products, the life-cycle of an application has been divided into 5 phases: Phase 1: Pre-submission Phase 2: Submission Phase 3: Evaluation 1 EFSA Single Programming Document ( 2 Mandate EFSA-M EFSA Strategy 2020, Transparency and Engagement in Risk Assessment, Stakeholders Engagement Approach 7 EFSA Supporting publication 2016:EN-1025

8 3a: Completeness/suitability check 3b: Risk assessment Phases 4&5: Adoption and publication of the scientific output Figure 1: Overview of EFSA support initiatives available during the life-cycle of an application for food and feed regulated products, except Pesticides Figure 2: Overview of EFSA support initiatives available during the life-cycle of an application for Pesticides 8 EFSA Supporting publication 2016:EN-1025

9 1.4. Legal notice Without prejudice to the legal notice applicable to EFSA s website available here, the following legal notice applies to the Catalogue, initiatives listed therein, and any documents, information or opinions obtained from or ancillary to the related support initiatives. You are advised to read this legal notice carefully before acceding, participating to initiatives, using or reading any document or information made available in this context, or making any other use of the Catalogue. EFSA makes no representations or warranties about the accuracy or suitability of any information provided during the provision of the support initiatives and related materials (such as explanations, hand-outs, presentation documents, minutes, etc). The materials, documents, data or information provided in the support initiatives are not intended to constitute advice of any kind or the rendering of consulting, or other professional s of any kind. Requesting to participate, either in person or remotely, to one of the initiatives only constitutes an agreement to attend the event, and not a contract for consultancy or advice, and it does not establish any contractual relationship with EFSA. If appropriate, you should consult with an attorney, food consultant or other professional to determine what may be best for your individual needs. Opinions and views expressed during the initiatives are solely of the concerned individuals, do not necessarily represent EFSA s views or positions or of any other EU Institution or body and are without prejudice to the assessment of a future dossier by the competent EFSA s Scientific Committee, Panel, Working group or staff. To the extent permitted by EU law, EFSA and its agents and experts exclude any and all liability for any loss, claim or damage, cost or expense, including any indirect or consequential damages or lost profit, whether arising in negligence or otherwise, suffered in connection with the access to, participation in, or use of the Catalogue by you or any other person. By having recourse to any of the s provided in the Catalogue, users acknowledge that recordings or making any written transcript of the teleconference/webinar/meeting is not allowed by EFSA. Failure to obtain ex ante agreement by EFSA for such recording results in the breach of EU data protection regulation as well as applicable sectoral EU food law. By having recourse to any of the s provided in the Catalogue, you acknowledge EFSA will keep records of papers and any other material submitted for auditing purposes. You also acknowledge that the information and materials shared with you may contain inaccuracies or errors. The content of the information provided is for your general information and use only. It is subject to change at any time and without prior notice. The Catalogue or the materials provided may include links to other resources, such as websites. These links are provided for your convenience only, and do not signify that EFSA endorses, approves, or makes any representation or claim regarding the accuracy, copyright compliance, legality, or any other aspects of, the resource(s) or website(s). The provision of documents by third parties to EFSA in the framework of support initiatives is without prejudice to the obligations EFSA has under Regulation (EC) No 1049/2001 on public access to documents. Accordingly, you are advised to clearly state and justify any confidentiality claim related to the information released and documents provided to EFSA, which might undermine commercial interests or may fall under any other exception listed in Article 4 of Regulation (EC) No 1049/2001. EFSA commits to consulting with the document owner prior to taking any decision with respect to the disclosure of documents 9 EFSA Supporting publication 2016:EN-1025

10 By participating to any of the initiatives included in the Catalogue, participants acknowledge and agree that EFSA may use for institutional purposes as per Regulation (EC) No 178/2002 other than those pertaining to the relevant initiative any document, data or information shared by participants. Note on processing of personal data in the context of the Catalogue: Regulation (EC) No 45/2001 regarding the processing of personal data is applicable in the context of personal data processed in the framework of any of the support initiative included in the Catalogue. By requesting and attending any of the support initiatives, the participant agrees to the following: personally identifiable information of participants may be heard, seen, read, collected, or used by EFSA as the organiser and the other participants; any communication or information shared, such as voice, instant messages, or presentations are available to, and may be further used by, EFSA for institutional purposes as per Regulation (EC) No 178/2002. EFSA collects personal information in the framework of support initiatives included in the Catalogue exclusively to the extent necessary to fulfil the purposes outlined above. The information will not be re-used for any incompatible purposes. Personal data will only be kept for the time necessary to fulfil the purpose of collection or further processing EFSA Supporting publication 2016:EN-1025

11 2. The Catalogue 2.1. Phase 1 Pre-submission Please note that all the initiatives listed under this chapter are also applicable throughout the entire life-cycle of the application EFSA guidance document name available from Participants Duration Who can request the When to request the How to request the Staff in charge EFSA guidance document Units of the REPRO Department 2003 The production, revisions and updates of EFSA guidance documents are performed regularly and on an ad hoc basis, by the EFSA and the scientific Panels of the REPRO Department depending on the need to explain certain administrative or scientific requirements. Two types of guidance documents are produced: technical guidance documents and administrative guidance documents. The production of new guidance documents depends on an identified need or a new topic. The update of an existing EFSA guidance document can include: i) more examples or case studies; ii) detailed data requirements (e.g. checklists); iii) list of scientific evidence to be submitted; etc. Explanatory note documents to an existing EFSA guidance are supplementary documents including detailed explanation of key principles and examples of good studies/reporting that could be helpful to better understand the data requirements specified in the guidance documents. The production and revision of guidance documents aim at explaining the administrative and scientific requirements for the submission of an application for regulated products in a specific thematic area, by providing detailed information on administrative, scientific and technical topics. New guidance documents, updated ones and explanatory notes are published on the EFSA website/applications section/regulations and guidance page under each scientific area. They are also incorporated on the table on the Relevant regulatory framework, administrative and scientific guidance documents per regulated product area under the Applications Helpdesk section EFSA Supporting publication 2016:EN-1025

12 EFSA scientific opinions and guidance document for Pesticides name Participants Duration Who can When to How to request the Staff in charge EFSA scientific opinions and guidance documents for Pesticides Pesticides Unit 2003 The production, revisions and updates of EFSA guidance documents as well as of guidance documents issued by the Panel on Plant Protection Products and their Residues (PPR Panel) are performed regularly and on an ad hoc basis, according to the priorities established at the Pesticide Steering Network. The PPR Panel self-mandates itself for updating the scientific assessments and can also receive mandates from the European Commission. Two types of documents are produced: Specific guidance documents issued by EFSA or the PPR Panel. The guidance documents after being adopted by EFSA are submitted for discussion and possible comments to the Standing Committee on Plants, Animals, Food and Feed (PAFF Committee), which decides on the regulatory implementation of the guidance document Scientific opinions covering the state of the art of pesticides risk assessment. They are usually the starting point for a guidance development but they are not part of the formal regulatory implementation. Nevertheless they offer EFSA s recommendations for the scientific assessment of pesticides The production and revision of guidance documents aim at explaining the risk assessment process to be followed by the applicant, the rapporteur Member State and EFSA. Guidance documents formally adopted in the regulatory context are the European Commission web site. The EFSA s scientific opinions and new or updated guidance documents are published on the EFSA Journal and are the EFSA website/applications section/pesticides/regulations and guidance EFSA Supporting publication 2016:EN-1025

13 Info session on applications name Participants Duration Who can participate When to request participation How to request participation Staff in charge EFSA Info session on applications Applications Desk Unit together with REPRO scientific units November 2012 EFSA Info sessions on applications are technical meetings organised by the APDESK Unit together with the scientific units in REPRO. They are targeted to applicants and open to Member States and any other interested parties. The technical meetings can cover administrative and scientific issues related to the preparation and presentation of applications for regulated products. They represent a forum to discuss: i) the outcome of public consultations; ii) finalised administrative and scientific guidance documents; iii) specific scientific topics of relevance for the REPRO Department The technical meetings aim at setting up a dialogue between EFSA, applicants and various stakeholders involved with regulated products, by improving the understanding and the communication on the application process. They provide applicants and interested parties with an opportunity to exchange views and enhance an open dialogue on specific scientific issues related to applications for regulated products. These technical meetings do not provide pre-assessment on upcoming or ongoing applications. EFSA experts of Working Groups/Panels members EFSA staff European Commission representatives (on an ad hoc basis) Online registrants Possible options: Half a day, one day, one and a half day Publication on EFSA website/events section of: Anybody4 The final agenda of the Info session All presentations A short post-event summary with the main points of discussion Once public registration to an Info session is opened on EFSA website Online registration on EFSA website APDESK staff: APDESK.applications@efsa.europa.eu 4 In case the maximum number of participants is reached for a dedicated event, EFSA reserves the rights to select participants in order to ensure a thorough discussion to the meeting. No web stream is foreseen EFSA Supporting publication 2016:EN-1025

14 Roundtable with the industry associations name Participants Duration Who can participate When to request participation How to participate Staff in charge Roundtable with the industry associations Applications Desk Unit together with REPRO scientific units and External Relations Unit 2013 The roundtable with the industry associations is an annual meeting between EFSA, the European Commission and the representatives of the industry associations on food and feed regulated products to increase transparency and dialogue during EFSA s risk assessment processes. The meeting can cover administrative, scientific, managerial, communication issues and challenges linked to applications for regulated products. The roundtable aims at enhancing engagement and openness by setting up a direct communication and an open dialogue with the industry associations directly impacted by EFSA s work on regulated products. EFSA staff European Commission representatives Industry associations (registered stakeholders 5, category Business and Food Industry) Half a day Publication on EFSA website/events section of: final agenda of the annual roundtable all presentations list of participants short post-event summary Industry associations representatives (registered stakeholders Business and Food Industry) Upon invitation by EFSA APDESK Unit invites all EFSA s registered stakeholders, category Business and Food Industry (see registered stakeholders list) APDESK staff and Stakeholders relations staff: Roundtable.Industries@efsa.europa.eu EFSA Supporting publication 2016:EN-1025

15 Ad hoc meeting with industry representatives name Participants Duration Who can participate When to request participation How to request participation Staff in charge Ad hoc meeting with industry representatives Units of the REPRO Department 2003 Ad hoc meetings with industry representatives are organised on a caseby-case basis to exchange information and views between EFSA and the food and feed regulated products applications sector. Issues discussed during these meetings could be related to i) methodological and procedural aspects, ii) scientific requirements; iii) approach(es) which are unique to particular scientific areas and cannot be handled with already available support initiatives. The meeting can be organised in person or via teleconference. On an ad hoc basis participation of EFSA s experts might be considered by EFSA. These meetings aim at setting up a direct communication and an open dialogue on methodological aspects, scientific requirements, approach(es) which are unique to a particular scientific area. EFSA staff Industry representatives European Commission representatives (on an ad hoc basis) From 1 up to 4 hours (indicative timeline) Publication on EFSA website/events section of: final agenda of the ad hoc meeting all presentations list of participants Industry representatives Throughout application life-cycle to the Head of the scientific unit (contact details) copying the Head of APDESK Unit REPRO scientific units staff: contact details APDESK staff: APDESK.applications@efsa.europa.eu 15 EFSA Supporting publication 2016:EN-1025

16 Scientific workshop/conference on scientific issues name Participants Duration Who can participate When to request participation How to request participation Staff in charge Scientific workshop/conference EFSA units 2003 Scientific workshops and conferences provide a forum for dialogue, exchange of information and views on scientific food and feed safety issues of interest to the scientific community. The scientific topics are not strictly related to applications for regulated products and can cover various topics linked to the scientific assessment of all risks associated with the food chain (methodology, design of study, reporting activity, presentation of a document for public consultation). These conferences and workshops aim at setting up a direct communication and an open dialogue with interested parties on specific and tailored scientific topics. EFSA aims to create a forum for discussion among various experts to increase awareness on specific scientific issues in order to allow exchange of views on topics of interest to the scientific community and to the consumers. EFSA experts of Working Groups/Panels members EFSA staff European Commission representatives (on an ad hoc basis) Online registrants Publication on EFSA website/events section of: the final agenda of the workshop/conference all presentations the list of participants the event report Anybody 6 Once public registration to a workshop/conference is opened on EFSA website Online registration on EFSA website 6 In case the maximum number of participants is reached for a dedicated event, EFSA reserves the rights to select participants in order to ensure a thorough discussion to the meeting EFSA Supporting publication 2016:EN-1025

17 REPRO webinar name Participants Duration Who can participate When to request participation How to request participation Staff in charge REPRO webinar Applications Desk Unit together with REPRO scientific units November 2015 A webinar is an informative or educational presentation with interactive features (such as question and answer sessions (Q&A) and chat messages) which take place over the web. REPRO webinars are targeted to applicants and are open to Member States and any other interested parties. They can cover administrative and scientific issues related to the preparation and presentation of applications for regulated products. They are organised by the APDESK Unit together with the scientific units of the REPRO Department. The webinar represents a forum to discuss: i) administrative and scientific aspects of guidance documents; ii) case studies; iii) functional tools used for the scientific assessment; iv) practical scientific topics of relevance for the REPRO Department. Webinars are highly accessible and aim at engaging in more interaction and dialogue with applicants and other interested parties involved with regulated products. By reaching larger audiences in a faster way they provide an opportunity to exchange views and enhance an open dialogue on practical scientific issues and tools related to applications for regulated products. Webinars do not provide pre-assessment on upcoming or ongoing applications. EFSA experts of Working Groups/Panels members EFSA staff European Commission representatives (on an ad hoc basis) Online registrants Possible options: 30 minutes, one hour, 2 hours (indicative timeline) Publication on EFSA website/events section of: final agenda of the webinar presentations short post-event summary webinar recording (EFSA s YouTube Channel) Anybody 7 Once public registration to a webinar is opened on EFSA website Online registration on Adobe Connect platform EFSA Webinar Team: webinars@efsa.europa.eu 7 For technical reasons, participation is limited to a maximum of 500 participants, on a first-come, first-served basis EFSA Supporting publication 2016:EN-1025

18 EFSA APDESK web form name Participants Duration Who can submit a request When to submit a request How to submit a request Staff in charge EFSA APDESK web form on regulated products Applications Desk Unit November 2011 Front office and support desk activity promoting a direct communication channel through which requestors can submit queries to EFSA related to regulated products matters (including administrative and scientific issues, EU regulatory framework, guidance documents requirements, procedural steps, status of specific applications, etc.). The Application Helpdesk, in consultation with the scientific units in the REPRO Department, provides answers to all requestors within a maximum of 15 working days. The web form aim is to boost communication between EFSA and its stakeholders and seeks to provide a direct communication channel. It strives to increase the understanding of the regulatory framework of regulated products, EFSA s scientific and administrative requirements for the submission of applications on regulated products. Additionally, it also aims at providing timely responses to requestors on the status of specific applications and clarifications on further steps of the assessment procedure. Responses to web form requests are provided within 15 working days The Application Helpdesk provides answers to all requestors within 15 working days from receipt Any stakeholder interested in the work of EFSA on regulated products Throughout the entire application life-cycle Fill in the web form available on EFSA s Applications Helpdesk web section 18 EFSA Supporting publication 2016:EN-1025

19 Follow-up on EFSA APDESK web form queries name Teleconference following an EFSA APDESK web form query Applications Desk Unit July 2014 As a follow-up to complex requests on applications received through the web form, APDESK might decide to set up ad hoc telephone conferences with the requestor to further clarify the issue raised in the web form query. This teleconference, organised by EFSA, aims at enhancing dialogue with stakeholders and interactivity, improving understanding of scientific and administrative requirements for the submission of applications in the area of regulated products. Such telephone conferences do not provide pre-assessment on possible data submission by the applicant on a specific application. Participants EFSA APDESK staff Web form requestor Duration On a case-by-case basis To whom the is provided When the is provided How to Staff in charge APDESK staff sends an to the requestor certifying that the teleconference took place including the date and the time of the phone call Anybody 8 who has sent queries via the web form After several exchanges via the EFSA APDESK web form. The decision is reserved to EFSA. By filling-in the web form available on EFSA s Applications Helpdesk web section APDESK staff: APDESK.applications@efsa.europa.eu 8 Depending on the subject of concern, the organisation of the teleconference is subject to EFSA staff decision 19 EFSA Supporting publication 2016:EN-1025

20 2.2. Phase 2 Submission Submission by electronic means name Participants Duration To whom the is provided When the is provided How to request information on the Staff in charge Submission of applications and related documents by electronic means Applications Desk Unit September 2014 The applications for regulated products and related documents are submitted to EFSA by electronic means such as CD ROMs, DVDs or USB keys. The updates of applications and response to requests for missing/additional information from EFSA are also submitted by electronic means. All applications and related documents submitted to EFSA (either by an applicant, a Member State or the European Commission) shall include the original of a signed cover letter listing all annexes, their tables of content and the mandate. The submission by electronic means aims at minimising the administrative burden for applicants and delivering efficiency gains by streamlining the submission of applications and related documents for regulated products in view of the development of a comprehensive IT tool for the electronic management of applications. The submission by electronic means only applies to the submission of applications and related documents addressed to EFSA as per legal requirements. This is without prejudice to the legal requirements imposed on applicants with regards to other institutions or bodies involved in the procedure. Applicants, Member States, European Commission involved EFSA letter/ of acknowledgement of receipt, including contact person details and format of submission An applicant submitting an application, an update, missing/additional information of an application for regulated products to EFSA Throughout the application life-cycle During initial submission and completeness/suitability check, contact the APDESK Unit: APDESK.applications@efsa.europa.eu Phone: APDESK person responsible of the application. The contact name and details are specified in the EFSA letter to applicant During the risk assessment phase, contact the REPRO scientific units: The contact name and details are specified in the EFSA letter to applicant During initial submission and completeness/suitability check, APDESK staff: APDESK.applications@efsa.europa.eu During the risk assessment phase, REPRO scientific units: The contact name and details are specified in the EFSA letter to applicant 20 EFSA Supporting publication 2016:EN-1025

21 2.3. Phase 3a Completeness check/suitability check Clarification teleconference during completeness/suitability check name Clarification teleconference during completeness/suitability check 9 Applications Desk Unit July 2014 A clarification teleconference is a telephone conference organised between EFSA APDESK staff and the applicant following a letter from EFSA requesting missing information to the applicant or to clarify any outstanding issues during the completeness/suitability check (CC) phase (Figure 1 - phase 3a). It is organised upon request by the applicant and/or by EFSA. In exceptional circumstances, the clarification teleconference might be organised in person. The clarification teleconference is organised in case a request for missing information by EFSA is not clear to the applicant or in case EFSA seeks clarification during the completeness check of the dossier. This teleconference can be requested to: i) clarify administrative and scientific rationale of individual questions raised during the completeness/suitability check; ii) ensure understanding of the question to be answered by the applicant; iii) clarify outstanding issues. Participants EFSA APDESK staff Applicant Duration 30 minutes (indicative timeline) Who can When to How to Staff in charge: EFSA APDESK staff sends an acknowledging that the teleconference took place indicating the date and duration of the teleconference An applicant who has an application filed within EFSA and/or a staff of the EFSA Applications Desk Unit Upon reception of an EFSA letter requesting missing information or at any time during the completeness/suitability check phase (Figure 1 - phase 3a) Contact the APDESK Unit via: APDESK.applications@efsa.europa.eu Phone: APDESK person responsible of the application. The contact name and details are specified in the EFSA letter to applicant (i.e. missing information letter) APDESK staff: APDESK.applications@efsa.europa.eu 9 This is not applicable for applications for Pesticides (i.e. Peer Review, MRL) as, according to the applicable Regulations, the first phase of the risk assessment of the application is performed by the Rapporteur/evaluating Member State (see Figure 2) EFSA Supporting publication 2016:EN-1025

22 2.4. Phase 3b Risk assessment Clarification teleconference during risk assessment name Clarification teleconference during risk assessment Scientific unit of the REPRO Department July 2014 A clarification teleconference during risk assessment is a telephone conference organised between EFSA staff of the scientific REPRO units and the applicant, following a letter from EFSA requesting additional information to the applicant during the risk assessment (RA) phase (Figure 1 - phase 3b). It is organised upon request by the applicant and/or by EFSA. In exceptional circumstances, the clarification teleconference might be organised in person and on an ad hoc basis participation of EFSA s experts might be considered by EFSA. The clarification teleconference is organised in case a request for additional information by EFSA is not clear to the applicant. This teleconference can be requested to: i) clarify the scientific rationale of individual questions raised during the risk assessment; ii) ensure understanding of the question to be answered by the applicant. This meeting does not provide pre-assessment on upcoming responses to be submitted by the applicant. Participants EFSA staff Applicant Duration 1 hour (indicative timeline) Who can When to How to Staff in charge EFSA staff from the scientific REPRO unit sends an to all participants acknowledging that the teleconference took place indicating the date and duration of the teleconference An applicant who has an application filed within EFSA Upon reception of an EFSA letter requesting additional information during the risk assessment of an application (Figure 1 - phase 3b) or phone call the contact person responsible of the application in the Scientific unit. Contact details are specified in the EFSA letter to applicant (i.e. request for additional information). REPRO scientific units staff: Contact details are specified in the EFSA letter to applicant (i.e. request for additional information) EFSA Supporting publication 2016:EN-1025

23 Clarification teleconference during Peer Review for Pesticides name Participants Duration Who can When to How to Staff in charge Clarification teleconference during Peer Review Pesticides Unit July 2014 A clarification teleconference is a telephone conference organised between EFSA staff of the Pesticides Unit and the applicant, following a letter from EFSA requesting additional information to the applicant during the peer review phase (Figure 2 - Phase 3c). It is organised upon request from the applicant and/or EFSA. In exceptional circumstances, the clarification teleconference might be organised in person. The clarification teleconference is organised to clarify scientific rationale of individual questions raised during the peer review process and when the additional information requested by EFSA is not clear to the applicant. This teleconference can be requested to: i) clarify scientific rationale of individual questions raised during the peer review; ii) ensure understanding of the questions to be answered by the applicant. This meeting does not provide pre-assessment on upcoming responses to be submitted by the applicant. EFSA Pesticides staff Applicant Rapporteur/evaluating Member State (on an ad hoc basis) 1 hour (indicative timeline) EFSA sends an to all participants certifying that the teleconference took place indicating the date and duration of the teleconference An applicant who has an application filed in a Member State and for which a peer review has been requested to EFSA Upon reception of an EFSA letter requesting additional information during the peer review phase (Figure 2 - phase 3c) or phone call the contact person responsible of the peer review in the Pesticides Unit. Contact details are specified in the EFSA letter to applicant (i.e. request for additional information). REPRO scientific units staff: Contact details are specified in the EFSA letter to applicant (i.e. request for additional information) 23 EFSA Supporting publication 2016:EN-1025

24 Applicants hearing name Participants Duration Who can When to How to participate Staff in charge Applicants hearing at Working group and Panel s plenary meetings during risk assessment 10 (upon request from EFSA only) Scientific unit of the REPRO Department July 2014 Upon request from EFSA, an applicant is invited, as hearing expert, to attend a specific agenda item of the Authority s Working groups or Panels meetings - either in person or via teleconference - to answer questions about the submitted data and to clarify any outstanding issues on the application. The participation of an applicant as applicants hearing at Working group and/or Panel plenary meetings is organised after examining the written response from the applicant to the Authority s request for additional information. An applicant hearing can also be organised, at any time, in case the experts of the Working group and/or Panel need to clarify any outstanding issues on the application. The aim of the applicants hearing is to clarify the additional data or supplementary information provided by the applicant during the risk assessment phase, when considered not appropriate or unclear by the members of Working groups and/or Panels and/or EFSA staff or to clarify any outstanding issues on the application raised by the members of Working groups and/or Panels and/or EFSA staff. Experts of Working groups/panels members EFSA staff Applicant 2 hours (as a maximum) The participation of an applicant to a Working group/panel meeting as applicants hearing is reported in the Working group/panel meeting minutes published on EFSA s website. After the teleconference/meeting, EFSA staff sends a follow-up letter to the applicant clarifying the main points discussed and the outcome of the discussion to ensure mutual understanding. EFSA s Working groups, EFSA s Panels members EFSA Working groups and/or Panel members decide if it is necessary to hear the applicants after examining the written response provided following the Authority s initial request for additional or supplementary information. It can also be requested in case clarifications of outstanding issues on the application are needed for the risk assessment purpose EFSA invites applicants to attend specific agenda items of the meetings of the Authority s Working groups or Scientific Panels as hearing experts REPRO scientific units staff: Contact details are specified in the EFSA letter to applicant (i.e. request for additional information) 10 This is not applicable for Pesticides (i.e. Peer Review, MRL) as, according to the applicable Regulations, the risk assessment of the additional information is performed by the Rapporteur/evaluating Member State EFSA Supporting publication 2016:EN-1025

25 2.5. Phase 4 & 5 Adoption and publication of a scientific output Notification on adoption of scientific output name Notification on adoption of scientific output 11 Participants Duration To whom the can be provided When to How to Staff in charge Scientific unit of the REPRO Department July 2014 Within one working day after adoption of a scientific output on applications, EFSA s staff sends a notification to the applicant informing on the adoption of the scientific output by the EFSA scientific Panel. At this stage EFSA cannot disclose any information on the outcome of the assessment (this applies to all applications irrespectively from the conclusion). Inform the applicant on a timely manner that the output related to his/her application has been adopted by the Panel EFSA staff of the respective scientific unit of the REPRO Department sent by EFSA staff to applicants informing on the adoption of the scientific output by the EFSA scientific Panel An applicant who has an application filed within EFSA REPRO scientific units staff: Contact details 11 This is not applicable for Pesticides (i.e. Peer Review, MRL) as, according to the applicable Regulations, the process of adoption and publication of scientific outputs follows a different procedure (see Figure 2). The pre-notification of adopted scientific output before publication is instead offered EFSA Supporting publication 2016:EN-1025

26 Pre-notification of adopted scientific output before publication name Participants Duration Who can When to How to Staff in charge Pre-notification of adopted scientific output before publication Scientific unit of the REPRO Department 2008 At least 36 hours prior to publication, EFSA staff informs, under embargo, the applicant and selected recipients of the upcoming publication of the scientific output adopted by EFSA, providing a copy of the adopted scientific output. EFSA website remains the official reference site where to seek confirmation of the final adopted output. The pre-notification aims at informing in a timely manner the applicant, the European Commission and other selected stakeholders of the publication of the adopted scientific output on the EFSA website. Scientific unit of the REPRO Department sent, under embargo, by EFSA with the adopted scientific output on applications in attachment (pdf format) REPRO scientific units staff 26 EFSA Supporting publication 2016:EN-1025