confidentiality for applicants
TRANSCRIPT
14 April 2021
Confidentiality for Applicants
Webinar
Welcome and introduction
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Agenda
Time Topic Speaker
11:00 – 11:05 Introduction and webinar outlineSimone Gabbi
11:05 – 11:30Confidentiality decision making by EFSA -an overview
11:30 – 11:35Confidentiality request submission in the E-submission Food Chain Platform
Caroline Fabre
11:36 – 11:46 Confidentiality request submission in IUCLID Chiara Macchi
11:47 – 11:55 Confidentiality request submission on “Portalino” Sorina Puiu
11:55 – 12:00 ConclusionSimone Gabbi
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Introduction and webinar outline
Presentation window1
Screen Action
1 2
Q&A box: For any questions related tothe topic or unexpected IT issues
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• This webinar is being recorded
• The webinar is in English and questions should be submitted in English through the platform (see hereunder).
• You are automatically connected to the audio broadcast. One-way audio (listen only mode).
• You may ask questions at any time in the dedicated chat providing nickname and context. A team will strive to
address the questions received, also by grouping them.
Proactive disclosure under the Transparency Regulation - Main Features
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Extensive proactive disclosure requirements1
Disclosure on OpenEFSA portal2
Accessibility of documents, information and studies upon acceptance of “Terms of Reference”
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For EFSA no law enforcement powers4
Exception for items granted confidential status or personal data as per Article 39e of Regulation (EC) No 178/2002 or scientific publications
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Importance of sound confidentiality submission and assessment process6
Confidentiality decision making by EFSA -an overview
Scope of EFSA’s confidentiality decision making
EFSA`s Practical Arrangements concerning transparency and confidentiality
EFSA’s Practical Arrangements concerning confidentiality in
Regulation (EC) No 1107/2009
Excluding:
• requests under Article 25 of Directive 2001/18/EC
• requests under Regulation 1331/2008 when EFSA not consulted
• requests under Regulation 2015/2283 when EFSA not consulted
• requests under Regulation 257/2010 when EFSA not consulted
• requests under Article 7 of Regulation 1107/2009
Procedural Requirements for the Submission of a confidentiality request
May be submitted in the context of the procedural steps
Submission ONLY through the IT tools indicated on EFSA`s website
Concerning ONLY to certain parts of the submitted dossiers
Including verifiable justification
Providing clarifications ONLY if requested to do so by EFSA
Modifications of submitted requests not allowed
Submit clarifications within the deadline set by EFSA
No fees
Substantive Requirements for the submission of a confidentiality request
Identifying clearly the information claimed confidential, possibly references
Indicating the legal basis (grounds)
Information not publicly available
Explain why you deem the item should be kept confidential:
Negligible harm – rebuttable presumption
Clarification on whether «environmental information»
Potential harm to a significant degree
Novelty – rebuttable presumption
Information acquired legitimately
Procedural Aspects of Decision Making
STEP
Mandatory consultation with applicant on the draft decision
Communication of the final decision
Possibility to file confirmatory application by writing to
EFSA may review its decisions in case output identifies foreseeable effects on human health, animal health or the environment
“Legal remedies”
OR
Lodging a case before the
General Court of the EU challenging legality of the
decision on the confirmatory
application
Lodging a complaint to the
European Ombudsman
Implementation of Confidentiality Decisions
EFSA sanitises the information, data sets, documents etc in accordance with the confidentiality decisioni
For dossiers submitted via IUCLID: sanitisation of dossier is temporarily delegated to applicant until further update of IUCLID
EFSA may share the sanitised information prior to its dissemination with the applicant for verification
The publication of the sanitised information will take place on OpenEFSA Portal at the earliest two weeks after notification of the confidentiality decision
Withdrawal of application dossiers
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Prior to the adoption of the confidentiality decision
After the adoption of the confidentiality decision
Compliance with initial confidentiality requests
Deletion of published information or data
If decision not implemented yet, sanitisation put on hold
Deletion of published data
“Architecture” - confidentiality decision making
IUCLID for pesticides
“Portalino”
E-Submission Food Chain
Platform
EFSA confidentiality decision making
Sanitisation & Publication
Submission of confidentiality request via E-submission Food Chain Platform
Scope of E-Submission Food Chain Platform
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Food Additives
Food Enzymes
Food Flavourings
Smoke Flavourings
Feed Additives
GMO Food and Feed (Regulation (EC) 1829/2003)
Deliberate release into the environment of GMOs
other than higher plants (Directive 2001/18/EC)
Deliberate release into the environment of GM higher plants (Directive 2001/18/EC)
Infant Formulae & Follow-on formulae (IF&FOF) manufactured from protein hydrolysates
Substances other than potable water used to remove surface contamination from products of animal origin,
according to Article 3(2) of Regulation (EC) 853/2004
Food allergens
Nutrient sources
Health Claims
Novel Foods
Traditional Food Notification
FCM: Regenerated Cellulose Film
FCM: Substance to be used in plastic materials
FCM: Recycling Processes
FCM: Active and Intelligent Materials
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Please watch the video in presenting mode
Video
Confidentiality request submission in IUCLID
Overview
MRL applications
Basic substances
Active substances (new & renewal)
IUCLID for pesticides is used for the following:
Every field used in pesticide submissions in IUCLID has been assigned a preliminary filter rule
Filter rules in IUCLID
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Determines whether the underlying information will be published or not
The excel file with the filter rules currently implemented is available online
Hyperlink
Filter rules in IUCLID
PUBLISHED
UNLESS_CONF
A small number of more sophisticated filter rules is used in specific cases
Currently, the following rules are mainly used:
Default rule
Implies publication
The information is published unless claimed confidential
If claimed confidential, the information will not be published pending the outcome of the confidentiality assessment by EFSA/RMS
If the claim is rejected, the flag must be changed and the underlying data will subsequently be published
Dissemination preview
It is strongly recommended to use thistool before submitting a dossier, tosimulate which information will bepublished
Screen Action
The dissemination preview enables the applicant to simulate which information from their dossier is likely to be made publicly available by EFSA
1
The dissemination preview is run from a dossier (not a dataset) and the output is a file in excel format (XLSX)
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Dissemination preview report
Screen
Action
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1 Depending on your needs, you caneither search for a given section ofthe dossier or copy the path for aspecific field from the IUCLID manual
The tool also produces a report,listing for all information whether itwas removed or left in the filtereddossier
Requesting confidentiality in IUCLID
Set a confidentiality flag in therelevant IUCLID entity, summary,record or section
1
Screen Action
Depending on the IUCLID documentyou are in, the flag can be field-specific or can refer to a section(e.g. the Administrative data)
1
Claiming certain fields confidential if they are subject to the UNLESS_CONF filter rule
2
2
Requesting confidentiality in IUCLID
It can also selectively be appliedwithin repeatable blocks of data bychoosing the item to apply it to andthen setting it
1
Screen Action
1
Requesting confidentiality in IUCLID
Justifications must be submittedexclusively via IUCLID and a separate justification must be associated to each confidentiality request/flag
1
Screen Action
Fill in a justification for each confidentiality request in compliance with the
standards set out in the Practical Arrangements
1
Confidential Business
Information should be selected
as this is in alignment with the
transparency regulation
Confidentiality request submission on “Portalino”
Please watch the video in presenting mode
Video
Conclusion
Provide the requested content for each confidentiality request.
Take-Home Messages
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If you submit information, documents or data to EFSA, consider it will be published unless yousubmit a confidentiality request through the appropriate tool, and this is confirmed by EFSA.
React swiftly to requests for clarifications or consultations on draft decisions.
Consider the possibility of submitting confirmatory application.
There is more out there - Useful documents
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Legal documents
Transparency Regulation: Regulation (EU) 2019/1381
General Food Law: consolidated text of Regulation (EC) No 178/2002
Pesticides Regulation: consolidated text of Regulation (EC) No 1107/2009
PAs on transparency and confidentiality: here
PAs on confidentiality decision-making for pesticide dossiers: Practical Arrangements concerning confidentiality in accordance with Articles 7(3) and Article 16 of Regulation (EC) No 1107/2009
Guidance/training materials
Q&As on PAs: Questions and Answers on the EFSA Practical Arrangements
Updated administrative guidance for regulated products: Administrative guidance for the processing of applications for regulated products (update 2021)
Updated administrative guidance for pesticides: Administrative guidance on submission of dossiers and assessment reports for the peer‐review of pesticide active substances and on the maximum residue level (MRL) application procedure
Updated sectoral administrative guidance documents: here
Training material, including video introductions/tutorials and webinar recordings, are available under the dedicated section “Transparency Regulation Implementation Training Programme” on the EFSA website
Practical instructions on submission of confidentiality requests through IUCLID: in preparation
Toolkit - Home Page
EFSA Europa application toolkit home page
Hyperlink
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Acknowledgements
o Natalie Bergmanno Delphine Gerbaudo Matthias Haslero Gunda Krizo Jane Richardson
o Zorka Vargao Edoardo Manfréo Eliana Pagnutti
EFSA Staff Contractors
Thank you for attending our webinar!
The recording of today's webinar will beavailable on the EFSA website in a few days
For questions related to IT issues, pleasewrite to [email protected]
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