WEBINAR ON NOVEL FOOD APPLICATIONS

WEBINAR ON

NOVEL FOOD

APPLICATIONS

26 OCTOBER 2023

WEBINAR | 26/10/2023

WELCOME AND INTRODUCTION

• To help applicants better understand the

procedure for novel food applications and the

support activities provided by EFSA during the

pre-submission phase

• To present the most common issues identified

during the suitability check of a novel food

application, based on two years of experience

with implementing the Transparency

Regulation

• To address questions from participants

regarding EFSA’s procedures and common

issues related to novel food applications

OBJECTIVES

WHO WE ARE

• Presenters

Patricia Romero Fernandez, Silvia Federici

• Contributors

Federico Morreale, Irene Baratto, Ellen Van

Haver, Costanza Casiraghi, Catalina Manieu,

Sara De Berardis, Ilaria Mangerini, Oscar

Gonzalez, Maja Gorgieva

• Moderator: Goran Kumric

• Event organizer: Carolina Vastola

• Event producer: Marina Canale

• Technical support: Margherita Olivieri

AGENDA

Time

Topic

Speaker

10.30-10.35

Introduction and outline of the webinar

Goran Kumric

10.35-10.55

Overview of the procedure for novel food applications and EFSA

support activities

Silvia Federici

10.55-11.20

Most common issues identified during the suitability check

Patricia Romero Fernández

11.20-11.40

Q&A session

11.40-11.45

Conclusion

Goran Kumric

HOUSE KEEPING RULES

• You are automatically connected to the audio broadcast. One-way audio (listen only mode).

• The event is in English. Questions should be submitted in English via the Q&A chat;

• This event is being recorded and recordings will be published on EFSA’s website

• After the event, attendees will receive a link to a survey to evaluate EFSA’s event & services

Novel Food Application Procedure

• Under EU Regulations, a novel food is any food that was not consumed to a significant

degree within the Union prior to May 1997

• As a first step, you should first verify whether or not the product you want to place on

the EU market, falls under the scope of Regulation (EU) 2015/2283

• You can consult the Union list of novel foods on the European Commission website, to

see whether your product is an already authorised novel food

• If you are unsure whether your product is a novel food or not, you can contact the

Competent Authority of the Member State where you first intend to place the food on

the market. EFSA is not in charge of deciding whether a food is novel or not

IS YOUR PRODUCT A NOVEL FOOD?

• If your product qualifies as novel food, you must submit an application to the European

Commission, complying with Regulation (EU) 2015/2283 and Regulation (EU)

2017/2469

NOVEL FOOD APPLICATION

• The application must be submitted through

the e-submission food chain platform (ESFC)

• No fees will be charged for the submission

and the scientific assessment of an

application

• The application must fulfil the data

requirements described in the EFSA guidance

documents

NOVEL FOOD OVERVIEW AND PROCEDURE

NOVEL FOOD GUIDANCE DOCUMENTS

• Administrative

guidance: with

detailed description

of the procedure for a

novel food

application

• Scientific guidance:

with detailed

description of the

data requirements for

a novel food

application

NOVEL FOOD APPLICATION PROCEDURE IN A NUTSHELL

1010

Pre-submission

phase*

Submission phase &

Suitability check

Risk assessment

phase

Post-adoption

phase

Legend:

Potential applicant / applicant

EC: European Commission

EFSA: European Food Safety Authority

* As defined in EFSA’s Practical Arrangements on pre-submission phase and public consultations

NOVEL FOOD APPLICATION PROCEDURE IN A NUTSHELL

1111

Pre-submission

phase*

• Potential applicant

requests general

pre submission

advice (optional)

• Potential applicant

notifies studies

commissioned or

carried out as of

27/03/21

(mandatory)

Submission phase &

Suitability check

Risk assessment

phase

Post-adoption

phase

Legend:

Potential applicant / applicant

EC: European Commission

EFSA: European Food Safety Authority

* As defined in EFSA’s Practical Arrangements on pre-submission phase and public consultations

NOVEL FOOD APPLICATION PROCEDURE IN A NUTSHELL

1212

Pre-submission

phase*

•Potential applicant

requests general pre

submission advice

(optional)

•Potential applicant

notifies studies

commissioned or

carried out as of

27/03/21 (mandatory)

Submission phase &

Suitability check

•Applicant submits the

application to EC

•EC may consult EFSA for

the suitability check and

make the application

available to EFSA

•EFSA performs the

suitability check of the

application

Risk assessment

phase

Post-adoption

phase

Legend:

Potential applicant / applicant

EC: European Commission

EFSA: European Food Safety Authority

30 working days for

suitability check +

possible requests for

information

* As defined in EFSA’s Practical Arrangements on pre-submission phase and public consultations

NOVEL FOOD APPLICATION PROCEDURE IN A NUTSHELL

1313

Pre-submission

phase*

•Potential applicant

requests general pre

submission advice

(optional)

•Potential applicant

notifies studies

commissioned or

carried out as of

27/03/21 (mandatory)

Submission phase &

Suitability check

•Applicant submits the

application to EC

•EC may consult EFSA for

the suitability check and

make the application

available to EFSA

•EFSA performs the

suitability check of the

application

Risk assessment

phase

•EC validates the application

•EFSA launches public

consultation on the non-

confidential application

dossier

•EFSA performs thorough

risk assessment

•EFSA Panel adopts the

scientific output

Post-adoption

phase

Legend:

Potential applicant / applicant

EC: European Commission

EFSA: European Food Safety Authority

9 months for risk

assessment +

requests for additional

information

30 working days for

suitability check +

possible requests for

information

* As defined in EFSA’s Practical Arrangements on pre-submission phase and public consultations

Confidentiality decision-

making and proactive

disclosure

NOVEL FOOD APPLICATION PROCEDURE IN A NUTSHELL

1414

Pre-submission

phase*

•Potential applicant

requests general pre

submission advice

(optional)

•Potential applicant

notifies studies

commissioned or

carried out as of

27/03/21 (mandatory)

Submission phase &

Suitability check

•Applicant submits the

application to EC

•EC may consult EFSA for

the suitability check and

make the application

available to EFSA

•EFSA performs the

suitability check of the

application

Risk assessment

phase

•EC validates the application

•EFSA launches public

consultation on the non-

confidential application

dossier

•EFSA performs thorough

risk assessment

•EFSA Panel adopts the

scientific output

Post-adoption

phase

•EFSA publishes the

scientific output

•Based on EFSA's advice

the EC takes the decision

on granting authorisation

of the novel food for

placing it on the EU

market

Confidentiality decision-

making and proactive

disclosure

Legend:

Potential applicant / applicant

EC: European Commission

EFSA: European Food Safety Authority

9 months for risk

assessment +

requests for additional

information

30 working days for

suitability check +

possible requests for

information

* As defined in EFSA’s Practical Arrangements on pre-submission phase and public consultations

Pre-submission activities

CONNECT.EFSA PLATFORM

Dedicated IT platform for engaging with EFSA

and performing different activities, including:

- Notification of studies

- request General pre-submission advice

- Ask a Question to EFSA

- Participate in public consultations

• Important to register in advance to Connect.EFSA to be ready to perform

activities. Registration will require a verification step by EFSA and may

take a few days

• Important to get familiar with the user guides on how to perform pre-

submission activities: user guide on pre-application ID and user guide on

notification of studies

PRE-SUBMISSION ACTIVITIES

Prior to initiating any pre-submission activity,

applicants must request a pre-application ID.

Pre-submission activities can be performed from the

pre-application ID:

- Notification of studies

- Request for general pre-submission advice (GPSA)

NOTIFICATION OF STUDIES (NOS)

• Potential applicants must notify without delay the studies carried out or commissioned to

laboratories and other external testing facilities for regulatory purposes and for which,

pursuant to Union law, EFSA may or shall be requested to provide a scientific output,

including a scientific opinion

Article 32b of the General Food Law

• Studies must be notified before their starting date. Delayed notification or non-notification

must be justified

• All notified studies must be included in the application. Non-inclusion of notified studies

must be justified

• A justification is needed for studies that have been notified and then withdrawn from the

database

Obligations

• No response is foreseen from EFSA after the submission of a study notification. Compliance

is verified during suitability check

• In case of non-compliance with NoS obligations, the application is declared non-valid

• If the non-valid application is resubmitted, the suitability check will start after 6 months from

the resubmission

Compliance with NoS obligations

NOTIFICATION OF STUDIES (NOS)

• After two years’ experience of the notification obligation of Article 32b of the General Food

Law*, it is understood that some analytical measurements should be exempted from the

NoS obligations (Question 4, Part B of updated Q&A)

Update of the Q&A on EFSA Practical Arrangements

• Analysis to assess the identity/composition of a product, including the determination of its

impurities and whole genome sequencing

• Analysis to determine physico-chemical properties

• Method validation studies

Studies exempted with the updated Q&A

• Ongoing applications

• Future applications

Applicability

* Regulation (EC) No 178/2002

General Pre-

Submission

Advice (GPSA)

Non-mandatory (but highly

recommended)

Do you have questions,

while preparing your

application, regarding the

applicable rules and the

content in guidance

documents?

Non-committal for the applicants nor

for EFSA and its Scientific Panels

Available for all kind of applications

Can be requested any time before

sending the application

Only a succinct summary of the

advice is published together with

the application upon its validation

Written advice given within 30

working days (35, if the advice is

given in a telemeeting)

SUPPORT TO APPLICANTS – GENERAL PRE-SUBMISSION ADVICE

More information on how to request a GPSA can be found in section 3.11 of the User guide on pre-application ID and in this video tutorial

Ask a

Question

Not necessarily related to an

application

Do you have questions

regarding the status of

applications, procedural

steps, administrative/

scientific requirements

and/or IT tools*?

Can be submitted anytime, not only

during the pre-submission phase

Questions out of scope are those

related to rules and content for a

future application and to risk

management and interpretation of

EU legislation

Replies given within 15 working days

SUPPORT TO APPLICANTS – ASK A QUESTION

* Requests for technical assistance on ESFC should be addressed to sante-e-submission-food-chain@ec.europa.eu

Under development / pilot - General pre-submission advice:

• fast processing: 15 working days instead of 30

• responses in tele-meeting instead of in writing

Already in place - Ask a Question fast processing:

• responses within 7 working days instead of 15

Ask a

question

GPSA

SUPPORT TO APPLICANTS – INITIATIVES FOR SMES

Most common issues in suitability check

MOST COMMON ISSUES IDENTIFIED IN SUITABILITY CHECK

Missing or incomplete information

Notification of studies (NOS)

Metadata of files in support of an application

Confidentiality and Sanitization

Replying to Request For Information (RFI)

Administrative issues

• Description of steps are not detailed enough

• When different productions process are used not all of them are completely described

• Quality control and safety assurance are not properly described

Production process

• Number of batches analysed is not enough (according to the EFSA GD should be

preferably at least 5 batches)

• Information on batches in main text does not match with the certificates of analysis

included or certificates are not provided

• Description and validation of “in house” methods are often not provided

Compositional data

MISSING OR INCOMPLETE INFORMATION

• Literature review not provided

• Search strategy of literature review not provided

History of use of the novel food

• Information does not match with what is included in Cover letter and/or in section

“Proposed entry in the Union list”

Proposed uses and use levels

• Laboratory accreditation or justifications are missing

• GLP certifications are not properly signed or not included

Quality and certifications

MISSING OR INCOMPLETE INFORMATION

NOTIFICATION OF STUDIES (NOS)

• Notification should be done before the starting date of the study

• Studies commissioned/performed before 27 March 2021 do not require a

notification, still they can be used in support of an application with simple

justification referring to the commission date

• Notification can be done even if the laboratory is not registered in Connect.EFSA

General information on NoS and tools

• Timepoints part of a study do not need a separate notification (E.g. In Stability

studies no need to notify each timepoint separately)

One study – One notification

• Justifications for non-notification, non-inclusion, withdrawal, delayed notification of

studies or any deviation should be provided as detailed as possible

• Provide all the supporting evidences for any justification as part of the submission

of the application (E.g. proof that EU was not the original market by providing

evidence of the submission of the specific study to another regulatory agency)

Justifications

NOTIFICATION OF STUDIES (NOS)

• Justifications for non-inclusion of studies notified or justifications for study withdrawn

NOTIFICATION OF STUDIES (NOS)

• Justifications for non-notification of studies submitted in the dossier

NOTIFICATION OF STUDIES (NOS)

• Justifications for delay notification of studies submitted in the dossier

Studies are not notified/notified with delay due to lack of knowledge of applicable NoS

obligation requirements (Article 32b(2) of the General Food Law)

Studies are not notified/notified with delay because they were performed after EC/EFSA

request for information

Self-declaration for non-notification/notified with delay of a study as EU was initially not

considered as a potential market (additional supporting evidence should be provided)

Studies not notified/notified with delay as initially performed for research purposes only

when conducted according to OECD test guidelines and/or GLP

EXAMPLES OF JUSTIFICATIONS NOT ACCEPTED

NOTIFICATION OF STUDIES (NOS)

• Resubmit a new application in ESFC as soon as all issues have been solved

providing the dossier/question number of the previous application declared non-

valid

• 6 months penalty starts from the moment of the resubmission of the

application and not the declaration of non-validity

Resubmission of an application after non-validity due to NoS

Publicly available

Document type

Study identification

FILES METADATA

FILES METADATA: PUBLICLY AVAILABLE

Publicly available

• YES (for all published documents as e.g. publicly available reports, bibliographic references)

• Yes, IPR owned/acquired – applicant has the rights to disseminate the content

➢ Include a full text copy that will be made available in Open EFSA after validation

• Yes, IPR NOT owned – applicant does not have the rights to disseminate the content

➢Include a full text copy that will be used for assessment purposes only

➢Include the bibliographic citation in the free-text box that will be made available in Open EFSA after

validation

• NO (when documents are not published)

Publicly available

Document type

Study identification

FILES METADATA: PUBLICLY AVAILABLE

IPR - Intellectual Property Rights

FILES METADATA: DOCUMENT TYPE

Document type

1.Technical dossier

2.Study report

3.Publication

4.Certificate of analysis

5.Laboratory accreditation certificate

6.Scientific summary

7.Raw data

8.Literature search

9.Code for statistical analysis

10.Data sharing agreement/Access letter

11.Copyright licenses

12.Flow charts

13.Graphs/Images

14.Cover letter

15.List of annexes

16.List of references

17.Check list

18.Other supporting documents

Document type

FILES METADATA: DOCUMENT TYPE

Study identification

Publicly available

Document type

FILES METADATA: STUDY IDENTIFICATION

General information for submission of confidential information

Sanitization of confidential information and personal data

CONFIDENTIALITY AND SANITIZATION

• Identify parts on which confidentiality is requested in a clear and consistent manner

•Confidential version and public version must always be submitted and should match

• Ensure information claimed confidential in one part is not visible in another part of the

document

• Do not include watermark ‘confidential’ on parts of documents that you do not claim

confidential

• Properly name documents to distinguish between confidential and non-confidential version

• Refer to correct legal basis. If qualification is not self-evident, justify why the element falls

under that legal basis

• No unfounded confidentiality requests or requests on publicly available information

General information for submission of confidential information

CONFIDENTIALITY AND SANITIZATION

CONFIDENTIALITY AND SANITISATION

General information for submission of confidential information

EFSA user guide on

confidentiality

• Use permanent sanitization in non-confidential version of documents for masking

confidential information and for personal data

• Earmarking/boxing of confidential information in confidential version of documents

Sanitization of confidential information and personal data

• Identify parts on which confidentiality is requested in a clear and consistent manner

• Confidential version and public version must always be submitted and should match

• Do not include watermark ‘confidential’ on parts of documents that you do not claim

confidential

• Properly name documents to distinguish between confidential and non-confidential version

• No unfounded confidentiality requests or requests on publicly available information

• EFSA user guide on confidentiality

General issues on submission of Confidential information

CONFIDENTIALITY AND SANITIZATION

• Confidential version

• Non – confidential version

• Use permanent sanitization in non-confidential version of documents for masking

confidential information and for personal data

• Earmarking/boxing of confidential information in confidential version of documents

Sanitization of confidential information and personal data

• Identify parts on which confidentiality is requested in a clear and consistent manner

• Confidential version and public version must always be submitted and should match

• Do not include watermark ‘confidential’ on parts of documents that you do not claim

confidential

• Properly name documents to distinguish between confidential and non-confidential version

• No unfounded confidentiality requests or requests on publicly available information

• EFSA user guide on confidentiality

General issues on submission of Confidential information

CONFIDENTIALITY AND SANITIZATION

➢ Permanent sanitization does not mean highlighting in different colours, nor masking with

a black/white box

➢ Personal data includes names and addresses of natural persons involved in toxicological

studies and any other personal data including names, addresses, and/or signatures of

natural persons, contained in the different documents (e.g. certificates, studies)

Where to include the information requested by EFSA

How to request to have a section unlocked in ESFC

How to request an extension of deadline

REPLYING TO REQUEST FOR INFORMATION (RFI)

• An updated document should be submitted including the requested information

• Do not use the text box to provide replies to the request for information as it will not

allow the publication as part of the dossier as required by the Transparency

Regulation and will not be considered for the risk assessment

Where to include the information requested by EFSA

How to request to have a section open

• Extension of DL should be requested using ESFC

How to request an extension of DL

REPLYING TO REQUEST FOR INFORMATION (RFI)

• An updated document should be submitted including the requested information

• Do not use the text box to provide replies to the request for information as it will not

allow the publication as part of the dossier as required by the Transparency

Regulation and will not be considered for the risk assessment

Where to include the information requested by EFSA

How to request to have a section open

• Extension of DL should be requested using ESFC

How to request an extension of DL

REPLYING TO REQUEST FOR INFORMATION (RFI)

• An updated document should be submitted including the requested information

• Do not use the text box to provide replies to the request of information as it will not

allow the publication as part of the dossier as required by the Transparency

Regulation and will not be considered for the risk assessment

Where to include the information requested by EFSA

How to request to have a section open

• Extension of DL should be requested using ESFC

How to request an extension of DL

REPLYING TO REQUEST FOR INFORMATION (RFI)

• If the application is with the applicant after a request for information

• Reply to the request for information and include the sections to be opened

• A new request for information will follow opening the relevant sections

• If the application is with EFSA after received replies of Request for information

• Contact EFSA staff by email at FDP@efsa.europa.eu indicating the sections to be

unlocked

• A new request for information will follow opening the relevant sections

• Do not contact: SANTE-E-SUBMISSION-FOOD-CHAIN@ec.europa.eu

How to request to have a section unlocked in ESFC

REPLYING TO REQUEST FOR INFORMATION (RFI)

• Use ESFC tool to request an extension of use to provide requested information

How to request an extension of deadline

How to request to have a section open

• Extension of DL should be requested using ESFC

How to request an extension of DL

REPLYING TO REQUEST FOR INFORMATION (RFI)

• Use ESFC tool to request an extension of use to provide requested information

How to request an extension of deadline

How to request to have a section open

• Extension of DL should be requested using ESFC

How to request an extension of DL

REPLYING TO REQUEST FOR INFORMATION (RFI)

• Use ESFC tool to request an extension of use to provide requested information

How to request an extension of deadline

How to request to have a section open

• Extension of DL should be requested using ESFC

How to request an extension of DL

REPLYING TO REQUEST FOR INFORMATION (RFI)

• Use ESFC tool to request an extension of use to provide requested information

How to request an extension of deadline

How to request to have a section open

• Extension of DL should be requested using ESFC

How to request an extension of DL

ADMINISTRATIVE ISSUES

Lack of signature, starting date in study reports

Documents submitted in languages different from English

Annexes with wrong document type

Documents electronically non-searchable

Q&A Session

Q&A

• How is the review process organized? Can we expect

multiple rounds of questions or will all questions be

addressed in a single round (unless questions arise of

course from the answers provided)?

Q&A

• Notified studies that are now exempt from notification,

can/should be withdrawn from Connect.EFSA? under

the new interpretation, which studies should be notified?

Q&A

• Will a detailed database be available where all the novel

food applications and dossier are collected and freely

consultable?

OpenEFSA PORTAL

https://open.efsa.europa.eu/

TIMELINE & SUPPORTING DOCUMENTS

PUBLIC VERSION OF NOVEL FOOD DOSSIERS

Q&A

• Does the obligation to notify stability studies imply that

such studies need to be performed by an external and

certified lab?

Q&A

• What advice would you offer to applicants on how to

prepare a thorough and robust submission?

HOW TO ADDRESS QUESTIONS DIRECTLY TO EFSA

• Request a General Pre-Submission

Advice by following the instructions in

section 3.11 of the User guide on pre-

application ID and this video tutorial

• Send a query to Ask a Question

via the Ask a Question service

THANK YOU FOR ATTENDING OUR EVENT

• In case we did not manage to answer all your questions, please feel free to re-submit

them via EFSA Ask a question webform (EFSA.Connect at:

https://connect.efsa.europa.eu/RM/s/askefsa)

• The recording of today’s webinar will be available on the EFSA website in coming days.

• Please take few minutes to fill out the satisfaction survey that you will receive shortly in

your inbox. Your feedback is essential to improve our future webinars

• We hope that this webinar will help you to better understand the procedure and

requirements for novel food product applications.

A space where you will find:

• Information and support materials

• Updates on the developments and progress of IT tools and platforms

• Alerts on new training material and upcoming events

• Clarifications to the most frequently asked questions received by

applicants

• A space for interaction with your peers with more than 1000 members.

https://www.linkedin.com/groups/9083910/

“EFSA support to applicants”

JOIN OUR LINKEDIN GROUP

USEFUL LINKS

• Novel food and traditional food applications

https://www.efsa.europa.eu/en/applications/novel-food-traditional-food

• Applicants Toolkit

https://www.efsa.europa.eu/en/applications/toolkit

• Services for applicants

https://www.efsa.europa.eu/en/applications/about/services

• Webinar on novel food applications 2021

https://www.efsa.europa.eu/en/events/webinar-novel-food-applications

• Last webinar on notification of studies

https://www.youtube.com/watch?v=NB2Ajn_2R74

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