webinar on the application procedure for active substances

Webinar on the application procedure for active substances in pesticides and maximum residue levels (MRLs)

28 October 2021

APDESK webinars

Tentative Agenda

Time Topic SpeakerSpeaker

1100-1105 Welcome and introduction Margherita Guidi

1105-1200

Lifecycle of an applicationbull Account creation and managementbull Pre-application ID Pre-submission advice

and Notification of Studiesbull IUCLID dossier submissionbull Portal updates and updates of applicationsbull Confidentiality in the context of actives substances

in pesticides and MRLsbull Public consultationbull Peer review adoption and publication

Karine LheureuxSilvia MazzegaSimone Gabbi

1200-1230 QampA session and conclusions

Stefano CappeacuteSara De BerardisAngelo ColagiorgiMatthias HaslerDimitra Kardassi

Goran KumricChiara MacchiRemigio MaranoAlessia VeraniFrancesca Volpi

Welcome and Introduction

bull What is the goal of this webinar The aim is to explain the arrangements steps and the tools of the application procedure for Active Substances in Pesticides and MRLs implemented by EFSA following the entry into application of the Transparency Regulation

bull Address questions encountered by applicants in recent months following the entry into application of the Transparency Regulation

bull Out of scope Clarifications about aspects of the authorisation process which have not been affected by the Transparency Regulation

Presenters of this webinarbull Karine Lheureuxbull Silvia Mazzegabull Simone Gabbi

Who we are

Goals

Webinar moderatorbull Margherita Guidi

QampA contributorsbull Stefano Cappeacutebull Sara De Berardisbull Angelo Colagiorgibull Matthias Haslerbull Dimitra Kardassi

bull Goran Kumricbull Chiara Macchibull Remigio Maranobull Alessia Veranibull Francesca Volpi

4

bull You are automatically connected to the audio broadcast One-way audio (listen only mode)bull You can submit questions throughout the webinar via the dedicated QampA tab on the top right

navigation barbull The webinar is in English and questions should be submitted in English through the platformbull Some questions will be answered in written and some others will be answered livebull Is some questions remain unanswered you can resubmit them via the Ask a question

ConnectEFSA tool (httpsconnectefsaeuropaeuRMsaskefsa)

bull This webinar is being recorded

Presentationwindow

QampA box For any

questions related to

the topic or unexpected

IT issues

Webinar guide for attendees

Lifecycle of an application

Transparency Regulation from 27th March 2021

Improve coordination between risk assessors and risk managers to ensure better communication to stakeholders and general public

Member States will contribute more to EFSAs governance and scientific Panels

EFSA will have more access to relevant scientific evidence in requests for authorisation

Better access to scientific studies

Effective risk communication

4 pillars

Better governanceMore reliable

independent studiesTransparency

Applicable For - New dossierapplications submitted on or after 27th March 2021

Click here to access the Factsheet rdquoA Modern and Sustainable Food Law in the EUrdquo

7

Pesticides Peer review workflow

0101

bull Pre-intake activities (NoS PSA)

bull Receipt of application dossier for approval or amendment of approval conditions

bull Withdrawal of dossier

bull Validity check during admissibility step by RMS

bull Publication of non-confidential dossier

bull Assessment of confidentiality requests on the admissible dossier

bull Consultation of the public on non-confidential dossier additional evidence

bull Receipt of DARRAR by RMS

Mandate amp Dossier intake01

bull EFSA preparatory steps

bull Consultation of the public and stakeholders on the DARRAR

Preliminary activities to Risk

Assessment02bull Preparation of the

reporting Table

bull Request for Additional Data Request (ADR)

bull Assessment of confidentiality requests on submittedADR (if applicable)

bull Preparation of the draft scientific output and subsequent finalisation (Conclusion)

bull Approval of the scientific output (Conclusion)

Peer Review

03

03

bull Notification on approvedscientific output

bull Editorial checks and corrections

bull Pre-notification of scientific output

bull Publication of scientific outputs and supporting evidence

bull Correction of a published scientific output (if applicable)

Output publication amp dissemination

04

Pesticides MRL workflow


bull Receipt of Application Dossier

bull Withdrawal of application

bull Validity check during admissibility step by EMS




bull Receipt of Evaluation Report by EMS

Mandate amp Dossier intake

01



Assessment02


bull Preparation of the firstdraft scientific output(Reasoned Opinion)

bull Finalization of the scientific output (Reasoned Opinion)

bull Approval of the scientific output (Reasoned Opinion)

bull Assessment of confidentiality requests on submitted ADR (if applicable)

Risk Assessment (RA)

03

bull Notification of the approved scientific output


bull Publication of scientific output and supporting evidence


Output publication amp

dissemination n04

New TOOLS for Business Operators

Dossier eSubmission(Pesticides PPP MRL basic substances)

Additional Data request (ADR)

Follow-up lifecycle

IUCLID

Monitoring of riskassessment flow

Disseminationportal

Proactive disclosure of information

OpenEFSA

Notification of Studies (NoS)

Pre-submission Advice (PSA)

AskAQuestion Public access to

document Public and

targeted consultation

Connect EFSA

Used by legal or natural persons for submitting confidentiality requests related to applications datasets and documents supporting the generic mandates

PORTALINO

Account creation and management

Registration Process

11sup1) Practical arrangements on pre-submission phase and public consultations

Sarah

Business OperatorPotential Applicant

Third Parties

Martin

LaboratoriesTesting facilities

John

In order to initiate a pre-submission activity a potential applicant or a laboratory or testing facility to which a study has been commissioned shall first register in the system hellipsup1 1

Third parties representing one or more entities shall also register in the Authority system supporting pre-submission activities hellipsup1 and obtain the authorization by represented entities to act on their behalf

2

Registered entities shall ensure that all information provided is reported accurately and kept up-to-datesup1 3

The public(during PC or once studies

are published)

ConnectEFSA Portal - Account Registration

The potential applicant starts the registration in

the portal

The potential applicantmust register as the

entity heshe is representing (eg a

company)Sarah

The account name will then be the entity (company) name

Click here to register

1

1


Information related to the contact person of the account Theinformation and the e-mail address must be person specific andlinked to the entity registered No functional and genericmailboxes (eg gmail)

Each account can register a maximum of 6 contact persons(NEW since 30 June)

Information related to the organisation (eg company) Thename inserted will be the account name

A complete billing address is essential for a clear identificationof the company

As regards multinational companies made up of several entities any of these entities may register provided that the registered entity is recognised as having a separate legal personality under the national law of the country in which it has its registered office

After the registration the account and the contact(s)

are not active yet

Upon registration EFSA performs a security check of

the account in few days

Once the account is considered valid EFSA

activate the account and the contact(s) inside

The applicant is ready to use the functionalities of the

portal

Authorisation of delegation to third parties

14

Third Parties

Martin

Sarah

Business OperatorsPotential Applicants

Database of Study Notifications

Martin send a notification on behalf of Sarah

Creates an account relationshipldquoMy Detailsrdquo page ldquoManage Relationshiprdquo button

Example A consultant creates a pre-application ID and add the business operator (the potential applicant not the consultant) in the lsquoBusiness Operatorrsquo field The consultant shares the pre-application ID with other business operator(s)

The third party must notify studies indicating as business operator the applicant they represent Additional applicants of a group of applicants can be indicated with ldquoshare withrdquo functionality

Organisations playing multiple roles

15

SarahBusiness OperatorsPotential Applicants

Third Parties

Martin


John

Sarah

Business Operator

Laboratory Third Party

Applicants + laboratories and third party can choose when submitting studies if they are submitting them as Business Operator or laboratory

Pre-Application IDPre-Submission AdviceNotification of Studies

Pre-Application Identification

Intended Area

Subject of the application

Business Operator(s)

Sarah

General Pre-Submission Advice

19

The potential applicant gets the pre-application-

ID

Step 1Pre-application ID

The potential applicantcan ask pre-submission

advice anytime

Sarah

EFSA and RMSEMSprovide advice

Step 2General Pre-Submission Advice

Pre-Submission Advice tool

ConnectEFSA

Step 3Validation of application

EFSA publishes summary of Pre-Submission advice after application is declared validadmissible

National CA

General Pre-submission Advice

Potential applicants may request general pre-submission advice

at any time Sarah

EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities

1

The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member

State

3 The designated rapporteur Member Stateco-rapporteur Member State

2The intended evaluating Member State

Requests for general pre-submission advice

Submitto EFSA

National Authority

Cooperation

General Pre-submission Advice - EFSA and CAs

Step 3 Provide the Advice

The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request

The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request

Receipt of the general pre-submission advice

form

Step 1Administrative Check

EFSA verifies that the related questions fall within the scope

Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected

Step 2 Written or meeting

EFSA prepares the advice and the related summary in close cooperation with the relevant CAs

Step 4Summary of the PSA

EFSA creates a summary providing an overview of the advice and sends it to the requester


Step 3Admissibility of application

EFSA publishes study notifications with related studies after confidentiality decision making process

Step 2 Submission of application

RMSEMS performs the admissibility of the application

The Business Operator gets the Pre-Application-ID

Step 1Pre-submission phase

Both actorsNotify Studies(Article 32b)

Sarah

Notification of Studies

Renewal applicationsRenewal Pre-submission Advice

Notification of Studies for renewal application


Step 1Application renewal

The potential applicant gets the

Pre-Application-ID

The potential applicant submit the list intended studies and study design

(Article 32c1)

EFSAProvides advice

Step 2 Public consultation and R-PSA

Sarah

The potential applicant notifies studies (Article 32b)

Step 3Notify studies

Sarah

Intended Study

29

Link to the EFSA question number of the application related to the authorisation to renew

For renewal the potential applicant should also prefill some information for the pre-application ID

Pre-application-ID for Renewal fill in intended study information

Fill in relevant information for intended studies

Once all intended studies are

completed submit the list of

intended studies for renewal

Public consultation on intended studies for renewal

Step 2 Consultation

The consultation of third parties shall remain open for a period of three weeks

Step 3 Comments

All comments received by stakeholders and the public shall be made public by EFSA

Receipt of the list of intended studies for

renewal

Step 4Summary of R-PSA

The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice


EFSA launches the consultation of third

parties on the intended studies for renewal

Including on the proposed design

of the studies

IUCLID E-Submission

E-submission in IUCLID

IUCLID

- Software application to record store maintain and exchange data on chemical substances

- Implements the OECD Harmonised Templates

- Standard data format for EU PPP applications

- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool

Dossier Creation Process From Mixture Dataset to Dossier Creation


URL for IUCLIDHyperlink

Video TutorialsHyperlink

IUCLID TrainingsHyperlink

IUCLID 66 First pesticides release in October 2020 (IUCLID 65)

EFSA received in May 2021 the first pesticide dossiers in IUCLID format

The software is updated bi-annually IUCLID 66 release on 27 October 2021

More information are available on the Applications Toolkit webpage

The IUCLID 66 release includes

o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food

o Ability to print robust study summaries in RTF format

o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation

o Export of very large dossiers (gt1GB)


Hyperlink

IUCLID 66 rarr E-Submission

bull TR compliance NoS Confidentiality assessment Dissemination

bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)

bull Single point of entry for Applicant European Commission Member States

Application types currently supported

bull Active substance application

bull Microorganisms - active substanceapplication

bull Maximum Residue Levels (MRL)application

bull Basic substances application

Background Material

o IUCLID Active Substance Application Manual

o IUCLID Microbial Active Substances Manual

o IUCLID MRL Application Manual

o IUCLID Basic Substance Application Manual

o Crosswalks IUCLID 65 EU PPP (link link)


An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier

If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022

Contact hypercareiuclidefsaeuropaeu for support

Application lifecycle ndash early phases

Mandate and Dossier Intake for Active substance and MRL

o Receipt of dossiersapplications in IUCLID

o RMSEMS performs Admissibility check (+ NoS check)

o Application registered - Question (dossier + mandate)

o Visible in OpenEFSA Portal

o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)

o Assessment of confidentiality requests

Confidentiality in the contextof Active Substances in pesticides and MRLs

General considerations ndash main changes post-TR

49

As of 27 March 2021

bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID

bull Transparency is the rule confidentiality is the exception

bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible

bull EFSA publishes the application as received once declared admissible

bull Confidentiality decision making starts after admissibility

General considerations ndashwho assesses confidentiality

50

EFSANew active substances

RMS

Renewals and Maximum Residue Levels

EFSA

IUCLID1 Applicant submits confidentiality request(s)

bull See subsequent slides on how to submit confidentiality requests in IUCLID

bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests

2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment

bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009

3 Request for clarification to applicant (optional)

bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS

bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS

bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned

IUCLID

4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)

5 Notification of draft decision on confidentiality request(s) to EFSA for comments

6 Notifiction of draft decision on confidentiality request(s) to applicant

7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)

bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification

bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay

8 Decision adopted and notified to applicant

9 Legal action (optional)

bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law

Main procedural steps underlying confidentiality assessment ndash New active substances

51

Technical means deemed appropriate by RMSEMS


Technical means deemed appropriate by RMS





2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment

bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality

E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)

bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA

bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA

bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned

IUCLID


E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant

E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)

bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification


E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant

E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)

bullApplicant may file a confirmatory application asking EFSA to reconsider its decision

bullConfirmatory applications cannot contain new confidentiality requests

bullMust be submitted within 2 calendar weeks of the notification of the contested decision

bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended

E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)

bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted

bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay

bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU

Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs

52

Setting a flag

bullSelect confidentiality flag at appropriate level

bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)

Justification

bullClearly identify the information including personal data claimed confidential

a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field

or attachment subject to the confidentiality request

b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential

bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential

bullProvide a verifiable justification

bullDo not use the template currently available (see slide 8)

Submission of confidentiality requests in IUCLID - General

53

Submission of confidentiality requests in IUCLID ndashJustification positive list

Confidentiality requests only on items in closed positive list

54

Submission of confidentiality requests in IUCLID ndash Justification substantive requirements

Information publicly available

For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided

b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings

Declaration that information was acquired legitimately

a) Novelty presumption statement indicating whether info is up to five years old

Potential harm to a significant degree

Verifiable justification

Environmental information

c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree

55

Article 39e(1) GFL

bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter

bullInformation to be proactively published by EFSA confidentiality requests not admissible

Article 39e(2) GFL

bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information

bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential

Article 39e(3) GFL

bullResidual category including eg signatures names of study directors or GPS coordinates

bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data

bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why

Certain IUCLID fields should never contain personal data

bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)

bullNo personal data must be inserted in these sections or fields

Submission of confidentiality requests in IUCLID ndash Personal Data

56

Submission of confidentiality requests in IUCLID ndash Justification procedural requirements

Current justification template not to be used

bull Applicants are not supposed to use the confidentiality

templates currently available in IUCLID as they are not adapted to

EFSArsquos regulatory framework

8

Submission of attachments in IUCLID

58

For each attachment a public version

bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo

bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted

Confidentiality request on attachment

bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request

bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment

bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments

bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request

Sanitisation of personal data in

attachments

bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments

bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted

How to verify your confidentiality requests

59

Generate the Confidentiality Report

bull The Confidentiality Report is available under the lsquoUploaded IUCLID

reportsrsquo

60

The Confidentiality Report allows the applicant to identify

1) the IUCLID sub-sections andor fields where a

confidentiality flag has been set (with hyperlink)

2) the corresponding justification provided


How to verify attachments

61

Generate Attachments Report

bull To have an overview on the correct submission

of attachments you can use the IUCLID report

lsquoAttachments Full Metadatarsquo

Public Consultation

EFSArsquos (main) types of PCs

Draft scientific output

DARRAR (PEST)

List of intended studies for application for renewal

Non-confidential version of a validated application

Draft Risk Assessment Protocol

Overview of the process

PC on the list of intended studies for application renewal

Business operator

10 working days max

Business operator

10 working days max

1

2

Submits the list of intended studies for renewal

Administrative check

3

Public consultation

4Publication of third-

party comments

5

Promotion

OpenEFSA Dissemination

portal

Right after the PC

Promotion


portal

Right after the PC

Publication of consultationrsquos

outcomeAnnex to the PSA

summary

Together with the PSA

summary

Annex to the PSA

summary


summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant

When Pre-application phase (ahead of renewal)

Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant


3 calendar weeks for NAS and MRL60 days for AIR


1

2

Business operator

Submits an application requests confidentiality

Confidentiality assessment

Business operator


Confidentiality decision


3

4

5

Public consultation

Promotion

Publication of third-party comments

OpenEFSADissemination

portal

Right after the PC


outcomeAnnex to

the opinion

Together with the final

scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific outputAim Collect new or additional evidencedatainformation to assess an application

When After the confidentiality assessment of the dossier

Aim Collect new or additional evidencedatainformation to assess an application


if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped

PC on the non-confidential version of an admissible dossierapplication

Public interface The ConnectEFSA community portal

Screen

Click this link httpsconnectefsaeuropaeuRMspublicconsultation

How to access the portal

1

Click on lsquoPublic Consultationsrsquo2

2

1

3

Display the list of plannedopenclosed consultations

3

The portal is easily accessible from the EFSA

website

Leave a comment

Also not registereduser can accessupcoming open andclosed publicconsultations

The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested

Leave a comment - Submission

To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice

The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox

User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation

Open EFSA - Publishing of comments

Open EFSA

CalendarClosed

consultations

Public consultation

details including all comments

Peer Review Adoption and Publication

Risk assessment Peer Review Phase (Active substance MRL)

Additional data request (ADR)

Assessment of confidentiality requests on

submitted ADR

ApprovalAdoption of the scientific output

(Conclusion Reasoned Opinion)

Preparation of draft scientific output and

subsequent finalisation

Peer review (RA)

03Preparation of the reporting table (for

AS)

Output Publication amp Dissemination phase(Active substance MRL)

Notification on approvedadopted scientific output

Publication of scientific output and supporting evidences

Correction of a published scientific output (if applicable)

04Output

Publication amp Dissemination

Editorial check and corrections

FAQ from Active Substances and MRLs applicants

Question and answer (1)

75

We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740

Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021

How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March

bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted

bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations

bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements

According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay


76

We applied for a New Pre-application ID for Renewal last week

However the status is still as draftldquo and an error message is displayed when trying to notify the study

How to solve this issue

bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal

bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies

bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies

However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy

This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation


77

I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator

How do I mention all companies in the notification

In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure

bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps

Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party

organisation

bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)

bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)

bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications


78

How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)

bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study

bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL

In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output

Questions amp answers session

Join our new LinkedIn group

ldquoEFSA support to applicantsrdquo

A space where you will find

bull Information and support materials

bull Updates on the developments and progresses of IT tools and platforms

bull Alerts on new training material and upcoming events

bull Answers to the most frequently asked questions

bull Clarification from your peers

httpswwwlinkedincomgroups9083910

In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)

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Tentative Agenda

Time Topic SpeakerSpeaker

1100-1105 Welcome and introduction Margherita Guidi

1105-1200

Lifecycle of an applicationbull Account creation and managementbull Pre-application ID Pre-submission advice

and Notification of Studiesbull IUCLID dossier submissionbull Portal updates and updates of applicationsbull Confidentiality in the context of actives substances

in pesticides and MRLsbull Public consultationbull Peer review adoption and publication

Karine LheureuxSilvia MazzegaSimone Gabbi

1200-1230 QampA session and conclusions

Stefano CappeacuteSara De BerardisAngelo ColagiorgiMatthias HaslerDimitra Kardassi

Goran KumricChiara MacchiRemigio MaranoAlessia VeraniFrancesca Volpi






Who we are

Goals




4





Presentationwindow

QampA box For any



IT issues









4 pillars





7


0101














reporting Table





Peer Review

03

03







04











01



Assessment02







03






dissemination n04




Follow-up lifecycle

IUCLID


Disseminationportal


OpenEFSA




document Public and


Connect EFSA


PORTALINO




Sarah


Third Parties

Martin


John



2



are published)



the portal



company)Sarah



1

1








are not active yet






portal


14

Third Parties

Martin

Sarah








15


Third Parties

Martin


John

Sarah

Business Operator





Intended Area



Sarah


19


ID



advice anytime

Sarah




ConnectEFSA



National CA



at any time Sarah


1


State




Submitto EFSA

National Authority

Cooperation






form
















Sarah







Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected






Who we are

Goals




4





Presentationwindow

QampA box For any



IT issues









4 pillars





7


0101














reporting Table





Peer Review

03

03







04











01



Assessment02







03






dissemination n04




Follow-up lifecycle

IUCLID


Disseminationportal


OpenEFSA




document Public and


Connect EFSA


PORTALINO




Sarah


Third Parties

Martin


John



2



are published)



the portal



company)Sarah



1

1








are not active yet






portal


14

Third Parties

Martin

Sarah








15


Third Parties

Martin


John

Sarah

Business Operator





Intended Area



Sarah


19


ID



advice anytime

Sarah




ConnectEFSA



National CA



at any time Sarah


1


State




Submitto EFSA

National Authority

Cooperation






form
















Sarah







Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected

4





Presentationwindow

QampA box For any



IT issues









4 pillars





7


0101














reporting Table





Peer Review

03

03







04











01



Assessment02







03






dissemination n04




Follow-up lifecycle

IUCLID


Disseminationportal


OpenEFSA




document Public and


Connect EFSA


PORTALINO




Sarah


Third Parties

Martin


John



2



are published)



the portal



company)Sarah



1

1








are not active yet






portal


14

Third Parties

Martin

Sarah








15


Third Parties

Martin


John

Sarah

Business Operator





Intended Area



Sarah


19


ID



advice anytime

Sarah




ConnectEFSA



National CA



at any time Sarah


1


State




Submitto EFSA

National Authority

Cooperation






form
















Sarah







Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected








4 pillars





7


0101














reporting Table





Peer Review

03

03







04











01



Assessment02







03






dissemination n04




Follow-up lifecycle

IUCLID


Disseminationportal


OpenEFSA




document Public and


Connect EFSA


PORTALINO




Sarah


Third Parties

Martin


John



2



are published)



the portal



company)Sarah



1

1








are not active yet






portal


14

Third Parties

Martin

Sarah








15


Third Parties

Martin


John

Sarah

Business Operator





Intended Area



Sarah


19


ID



advice anytime

Sarah




ConnectEFSA



National CA



at any time Sarah


1


State




Submitto EFSA

National Authority

Cooperation






form
















Sarah







Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected

7


0101














reporting Table





Peer Review

03

03







04











01



Assessment02







03






dissemination n04




Follow-up lifecycle

IUCLID


Disseminationportal


OpenEFSA




document Public and


Connect EFSA


PORTALINO




Sarah


Third Parties

Martin


John



2



are published)



the portal



company)Sarah



1

1








are not active yet






portal


14

Third Parties

Martin

Sarah








15


Third Parties

Martin


John

Sarah

Business Operator





Intended Area



Sarah


19


ID



advice anytime

Sarah




ConnectEFSA



National CA



at any time Sarah


1


State




Submitto EFSA

National Authority

Cooperation






form
















Sarah







Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected











01



Assessment02







03






dissemination n04




Follow-up lifecycle

IUCLID


Disseminationportal


OpenEFSA




document Public and


Connect EFSA


PORTALINO




Sarah


Third Parties

Martin


John



2



are published)



the portal



company)Sarah



1

1








are not active yet






portal


14

Third Parties

Martin

Sarah








15


Third Parties

Martin


John

Sarah

Business Operator





Intended Area



Sarah


19


ID



advice anytime

Sarah




ConnectEFSA



National CA



at any time Sarah


1


State




Submitto EFSA

National Authority

Cooperation






form
















Sarah







Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected




Follow-up lifecycle

IUCLID


Disseminationportal


OpenEFSA




document Public and


Connect EFSA


PORTALINO




Sarah


Third Parties

Martin


John



2



are published)



the portal



company)Sarah



1

1








are not active yet






portal


14

Third Parties

Martin

Sarah








15


Third Parties

Martin


John

Sarah

Business Operator





Intended Area



Sarah


19


ID



advice anytime

Sarah




ConnectEFSA



National CA



at any time Sarah


1


State




Submitto EFSA

National Authority

Cooperation






form
















Sarah







Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected




Sarah


Third Parties

Martin


John



2



are published)



the portal



company)Sarah



1

1








are not active yet






portal


14

Third Parties

Martin

Sarah








15


Third Parties

Martin


John

Sarah

Business Operator





Intended Area



Sarah


19


ID



advice anytime

Sarah




ConnectEFSA



National CA



at any time Sarah


1


State




Submitto EFSA

National Authority

Cooperation






form
















Sarah







Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected



the portal



company)Sarah



1

1








are not active yet






portal


14

Third Parties

Martin

Sarah








15


Third Parties

Martin


John

Sarah

Business Operator





Intended Area



Sarah


19


ID



advice anytime

Sarah




ConnectEFSA



National CA



at any time Sarah


1


State




Submitto EFSA

National Authority

Cooperation






form
















Sarah







Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected








are not active yet






portal


14

Third Parties

Martin

Sarah








15


Third Parties

Martin


John

Sarah

Business Operator





Intended Area



Sarah


19


ID



advice anytime

Sarah




ConnectEFSA



National CA



at any time Sarah


1


State




Submitto EFSA

National Authority

Cooperation






form
















Sarah







Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected


14

Third Parties

Martin

Sarah








15


Third Parties

Martin


John

Sarah

Business Operator





Intended Area



Sarah


19


ID



advice anytime

Sarah




ConnectEFSA



National CA



at any time Sarah


1


State




Submitto EFSA

National Authority

Cooperation






form
















Sarah







Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected


15


Third Parties

Martin


John

Sarah

Business Operator





Intended Area



Sarah


19


ID



advice anytime

Sarah




ConnectEFSA



National CA



at any time Sarah


1


State




Submitto EFSA

National Authority

Cooperation






form
















Sarah







Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected



Intended Area



Sarah


19


ID



advice anytime

Sarah




ConnectEFSA



National CA



at any time Sarah


1


State




Submitto EFSA

National Authority

Cooperation






form
















Sarah







Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected


19


ID



advice anytime

Sarah




ConnectEFSA



National CA



at any time Sarah


1


State




Submitto EFSA

National Authority

Cooperation






form
















Sarah







Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected



at any time Sarah


1


State




Submitto EFSA

National Authority

Cooperation






form
















Sarah







Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected






form
















Sarah







Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected









Sarah







Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected






Pre-Application-ID


(Article 32c1)

EFSAProvides advice


Sarah



Sarah

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected

Intended Study

29









Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected







Step 2 Consultation


Step 3 Comments



renewal







of the studies

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected

IUCLID E-Submission


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected


IUCLID




















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected















Hyperlink










Background Material




















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected















49

As of 27 March 2021







50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected


50


RMS


EFSA










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected










IUCLID











51














IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected










IUCLID

















52

Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

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Setting a flag



Justification









53



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected



54











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected











55

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected

Article 39e(1) GFL



Article 39e(2) GFL



Article 39e(3) GFL








56






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected






8


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected


58










attachments




59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected


59



reportsrsquo

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected

60







61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected


61





Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected

Public Consultation



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected



DARRAR (PEST)






Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected



Business operator

10 working days max

Business operator

10 working days max

1

2



3

Public consultation


party comments

5

Promotion


portal

Right after the PC

Promotion


portal

Right after the PC



summary


summary

Annex to the PSA

summary








1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected


1

2

Business operator



Business operator




3

4

5

Public consultation

Promotion



portal

Right after the PC


outcomeAnnex to

the opinion


scientific output

Public consultation


Promotion



portal

Right after the PC


outcomeAnnex to

the opinion









Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected


Screen



1


2

1

3


3


website

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected

Leave a comment








Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected







Open EFSA

CalendarClosed

consultations

Public consultation






submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected





submitted ADR





Peer review (RA)


AS)





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected





04Output





75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected



75









76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected


76










77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected


77






organisation





78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected


78


















Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected














Subscribe to


efsaeuropaeuenrss

Receive job alerts



efsa_eu

plants_efsa

methods_efsa

animals_efsa

Follow us Linked in


Contact us


Stay connected

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