# C_2021080EN.01000101.xml

| 9.3.2021 | EN | Official Journal of the European Union | C 80/1 |
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9.3.2021

EN

Official Journal of the European Union

C 80/1

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COMMISSION NOTICE

on the submission of notifications under Articles 13 and 17 of Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC and under the relevant provisions of Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381

(2021/C 80/01)

Table of contents

| 1. | Introduction | 1 |
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1.

| 2. | General pre-submission advice | 2 |
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2.

| 3. | Notification of studies | 4 |
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3.

| 4. | Renewal notifications supported by new studies | 7 |
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4.

| 5. | Submission of notifications in the appropriate format | 9 |
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5.

| 6. | Procedural aspects regarding confidentiality | 10 |
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6.

1.   Introduction

In 20 June 2019, the European Parliament and the Council adopted Regulation (EU) 2019/1381 (1) on the transparency and sustainability of the EU risk assessment in the food chain (Transparency Regulation). The Transparency Regulation amends, among others, Regulation (EC) No 178/2002, (2) (General Food Law) as well as Directive 2001/18/EC (Directive). (3) The Transparency Regulation will apply from 27 March 2021.

Pursuant to Article 22(5)(c) of the General Food Law, the mission of European Food Safety Authority (‘Authority’) also includes the provision of scientific opinions on products other than food and feed relating to Genetically Modified Organisms (‘GMO’) as defined by the Directive.

Certain provisions of the Transparency Regulation apply to notifications, in relation to which Union law contains provisions for the Authority to provide a scientific output. Consequently, as of 27 March 2021, these provisions apply to all notifications submitted under Articles 13 and 17 of the Directive, including notifications concerning GMOs for non-food and feed uses. The Directive does not contain provisions for the Authority to provide a scientific output on notifications under Part B of the Directive (deliberate release of GMOs for any other purpose than for placing on the market). Consequently, the relevant provisions of the Transparency Regulation do not apply to notifications submitted under Article 6 of the Directive.

The Transparency Regulation has introduced significant changes to the procedures for approval of placing on the EU market of GMO as or in products under the Directive. Due to the specificities of these procedures, in certain cases clarifications are needed on how the new provisions of the Transparency Regulation should be applied in the context of the Directive. This Notice is meant to address only the procedural changes introduced by the Transparency Regulation.

Under the Transparency Regulation, the role of the Authority in enhancing the transparency and the sustainability of the EU risk assessment has been strengthened across several sectors, including the placing on the market of GMOs under the Directive. Amongst others, the practical arrangements laid down by the Authority, in accordance with the provisions of the General Food Law are, to a certain extent, applicable to the procedures for approving the placing on the market of GMOs under the Directive. In the present Notice, reference is made to the following decisions of the Authority:

| i. | Decision of the Executive Director of the European Food Safety Authority laying down the practical arrangements concerning transparency and confidentiality (4) (‘Authority’s practical arrangements on transparency and confidentiality’); |
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i.

Decision of the Executive Director of the European Food Safety Authority laying down the practical arrangements concerning transparency and confidentiality (4) (‘Authority’s practical arrangements on transparency and confidentiality’);

| ii. | Decision of the Executive Director of the European Food Safety Authority laying down the practical arrangements on the pre-submission phase and the public consultations (5) (‘Authority’s practical arrangements on pre-submission phase and public consultations’). |
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ii.

Decision of the Executive Director of the European Food Safety Authority laying down the practical arrangements on the pre-submission phase and the public consultations (5) (‘Authority’s practical arrangements on pre-submission phase and public consultations’).

This Notice includes the views expressed during exchanges between the Commission’s Health and Food Safety Directorate-General (DG SANTE) and experts from the Member States in the context of the Regulatory Committee for Directive 2001/18/EC (6) as well as with the Authority.

The purpose of the Notice is to facilitate the implementation of the Directive in the context of the amendments introduced by the Transparency Regulation and more specifically, to provide interpretation/guidance both to business operators that intend to submit notifications under Part C of the Directive (placing on the market of GMO as or in products) and to the competent authorities of the Member States that receive such notifications.

2.   General pre-submission advice

2.1.   
  Relevant provisions

| i. | Article 13(1), 13(2) and 14 of the Directive |
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i.

Article 13(1), 13(2) and 14 of the Directive

| ii. | Article 17(1), 17(2) and 17(3) of the Directive |
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ii.

Article 17(1), 17(2) and 17(3) of the Directive

| iii. | Article 28(1) of the Directive |
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iii.

Article 28(1) of the Directive

| iv. | Article 32a of the General Food Law |
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iv.

Article 32a of the General Food Law

According to Article 13(1) of the Directive, before a GMO is placed on the market for the first time, the notifier submits a notification to the competent authorities of a Member State (the notified Member State). The notified Member State, after acknowledging that the notification is in accordance with Article 13(2), examines the notification and prepares an assessment report, indicating whether the GMO in question should be placed on the market, as requested by Article 14 of the Directive.

According to Article 17 of the Directive, to renew a consent for placing on the market a GMO, the consent holder submits a notification to the competent authority that received the original notification. The notified Member State checks whether the notification is in accordance with Article 17(2) and prepares an assessment report, indicating whether the GMO should remain on the market, as requested in Article 17(3) of the Directive.

Pursuant to Article 28(1) of the Directive, the Authority provides a scientific output on a notification only in case where another Member State or the Commission raises and maintains an objection against the assessment report of the notified Member State, or where the assessment report referred to in Article 14 of the Directive indicates that the GMO should not be placed on the market.

Under the new Article 32a of the General Food Law, the staff of the Authority shall provide pre-submission advice, at the request of a potential applicant or notifier, where Union law contains provisions for the Authority to provide a scientific output (general pre-submission advice).

2.2.   
  Guidance for the application of the relevant provisions

Under Article 32a(1) of the General Food Law, general pre-submission advice for the purposes of a future notification under Articles 13 and 17 of the Directive (product notification) shall be provided by the Authority, upon request of a potential notifier. Nevertheless, it is for the notified Member State to assess the product notification and to conclude at first level whether the GMO should be placed/remain on the market. Therefore, to ensure that business operators benefit from the provisions of the General Food Law on general pre-submission advice in a comprehensive manner, in relation to requests for general pre-submission advice addressed to the Authority, effective collaboration between the competent authorities of the intended notified Member State and the Authority is necessary.

The provisions of the Transparency Regulation on general pre-submission advice do not affect any other channels of pre-submission advice to potential notifiers, provided solely by national competent authorities, according to national rules and procedures.

2.2.1.   Business operators’ requests

Potential notifiers may request the Authority for pre-submission advice pursuant to Article 32a(1) of the General Food Law, following the steps and conditions laid down in Articles 3, 4 and 7 of the Authority’s practical arrangements on pre-submission phase and public consultations. The requester is recommended to include in the request to the Authority an indication of the Member State to which it intends to submit the product notification, so that this Member State may participate in the provision of the pre-submission advice. This should not prevent the requester from submitting its product notification to a Member State different from the one indicated in the request of pre-submission advice.

2.2.2.   Provision of general pre-submission advice

Upon receipt of the request, the Authority should send, without delay, a copy of this request to the intended notified Member State, where the requester has indicated such a Member State. The Member State should, without delay, inform the Authority whether it will participate in the provision of general pre-submission advice.

Where the relevant Member State participates in the provision of general pre-submission advice, Article 9 of the Authority’s practical arrangements on pre-submission phase and public consultations should apply with the following adaptations:

| a. | Following the administrative check, pursuant to Article 8 of the Authority’s practical arrangements on pre-submission phase and public consultations, the Authority shall inform the relevant Member State whether the request for general pre-submission advice is accepted and whether it will be replied to in writing or in the context of a meeting. The Authority should also keep the relevant Member State in copy of all communication with the requester. |
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a.

Following the administrative check, pursuant to Article 8 of the Authority’s practical arrangements on pre-submission phase and public consultations, the Authority shall inform the relevant Member State whether the request for general pre-submission advice is accepted and whether it will be replied to in writing or in the context of a meeting. The Authority should also keep the relevant Member State in copy of all communication with the requester.

| b. | The Member State should provide the Authority with its proposed pre-submission advice within 15 working days the acceptance of the request. |
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b.

The Member State should provide the Authority with its proposed pre-submission advice within 15 working days the acceptance of the request.

| c. | The Member State and the Authority should endeavour to agree on the content of the written advice. In case the Member State disagrees with the Authority on one or more replies, the written advice should reflect both opinions. The pre-submission advice agreed between the Authority and the Member State should be sent to the requester by the Authority, within 20 working days from the acceptance of the request. |
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c.

The Member State and the Authority should endeavour to agree on the content of the written advice. In case the Member State disagrees with the Authority on one or more replies, the written advice should reflect both opinions. The pre-submission advice agreed between the Authority and the Member State should be sent to the requester by the Authority, within 20 working days from the acceptance of the request.

| d. | Where the Authority intends to convene a meeting with the requester, the Authority should prepare this meeting in close cooperation with the Member State. Both the Authority and the Member State should participate and provide their advice at the meeting. In this case, it is not necessary for the Member State to provide the proposed reply of point b. |
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d.

Where the Authority intends to convene a meeting with the requester, the Authority should prepare this meeting in close cooperation with the Member State. Both the Authority and the Member State should participate and provide their advice at the meeting. In this case, it is not necessary for the Member State to provide the proposed reply of point b.

| e. | The Member State should also draw up a proposed draft summary of the pre-submission advice referred to in Article 38(1)(i) of the General Food Law and send it to the Authority within 15 working days from receiving the copy of the request (if the advice is given in written) or after the meeting (if the advice is given in a meeting). |
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e.

The Member State should also draw up a proposed draft summary of the pre-submission advice referred to in Article 38(1)(i) of the General Food Law and send it to the Authority within 15 working days from receiving the copy of the request (if the advice is given in written) or after the meeting (if the advice is given in a meeting).

| f. | The Member State and the Authority should endeavour to agree on the content of the summary of the pre-submission advice. In case the Member State disagrees with the Authority on one or more replies, the summary should reflect both opinions. The summary of the pre-submission advice agreed between the Authority and the Member State should be sent to the requester by the Authority. |
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f.

The Member State and the Authority should endeavour to agree on the content of the summary of the pre-submission advice. In case the Member State disagrees with the Authority on one or more replies, the summary should reflect both opinions. The summary of the pre-submission advice agreed between the Authority and the Member State should be sent to the requester by the Authority.

The provision of any general pre-submission advice shall be without prejudice and non-committal as to the subsequent assessment reports of the Member State or any Authority’s scientific output and non-binding for the potential notifier.

The Member State and the Authority must take all the necessary measures so that any information received is kept confidential.

The participation of the Member States in the provision of pre-submission advice is highly recommended, so that national transposition provisions and rules are taken into account in the pre-submission advice. This would facilitate the assessment of product notifications by the relevant Member States and therefore would be beneficial for both the notifier and the Member States. In case the intended notified Member State does not participate in the provision of general pre-submission advice, Article 9 of the Authority’s practical arrangements on pre-submission phase and public consultations shall apply without adaptations.

The Member States should undertake all measures necessary to avoid any conflict of interests of the staff providing the pre-submission advice.

2.2.3.   Access of the Member State to the general pre-submission advice and its summary

When a product notification is submitted to a Member State and this Member State was not engaged in the provision of pre-submission advice, the notified Member State may ask the Authority whether pre-submission advice was provided to the notifier(s) for this product notification. If this is the case, the Authority should make sure, without delay, that the notified Member State has access to the summary of the pre-submission advice and to the written pre-submission advice provided by the Authority, where the Authority replied to the requester in writing.

2.2.4.   Public disclosure of the summary of general pre-submission advice

When the notified Member State concludes that the product notification is in accordance with Article 13(2) of the Directive (for original notifications) or Article 17(2) of the Directive (for renewal notifications), the notified Member State should immediately inform the Authority, which must make the summary of the general pre-submission advice public without delay, in accordance with Article 38(1) of the General Food Law and Article 5(2)(f) of the Authority’s practical arrangements on transparency and confidentiality.

3.   Notification of studies

3.1.   
  Relevant provisions

| i. | Article 13(1), 13(2) and 14 of the Directive |
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i.

Article 13(1), 13(2) and 14 of the Directive

| ii. | Article 17(1), 17(2) and 17(3) of the Directive |
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ii.

Article 17(1), 17(2) and 17(3) of the Directive

| iii. | Article 32b of the General Food Law |
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iii.

Article 32b of the General Food Law

According to Article 32b(2) of the General Food Law, business operators must notify to the Authority without delay the studies that they commission to laboratories/testing facilities or that they carry out in their own laboratories/testing facilities, with a view to support an application or notification in relation to which Union law contains provisions for the Authority to provide a scientific output. According to Article 32b(3), the laboratories/testing facilities located in the Union which are commissioned to carry out such studies must also notify them to the Authority.

This obligation of Article 32b of the General Food Law is also imposed on all potential notifiers for the placing on the EU market of a GMO as or in products under the Directive and the relevant laboratories/testing facilities that are commissioned to carry out such studies.

According to Article 32b(4) and (5) a notification shall not be considered valid where it is supported by studies which have not been previously notified to the Authority or where studies that have been previously notified to the Authority were not included in the notification. In these cases, a completed notification may be re-submitted. The assessment of the validity of a re-submitted notification must not start before the expiry of the six-month period following the notification of the relevant studies pursuant to Article 32b(4) of the General Food Law or following the submission of the studies that were notified in accordance with Article 32b(2) and (3) of the General Food Law.

The notified Member State, after acknowledging that the notification is in accordance with Article 13(2) for original notifications or with Article 17(2) for renewal notifications, must prepare an assessment report, indicating whether the GMO in question should be placed on the market (for original notifications) or remain on the market (for renewal notifications).

3.2.   
  Guidance for the application of the relevant provisions

3.2.1.   Business operators’ notification to the Authority

Business operators intending to submit a notification pursuant to Article 13 of the Directive or Article 17 of the Directive (product notification) must comply with Article 32b of the General Food Law, as specified in chapter IV, section 1 of the Authority’s practical arrangements on pre-submission phase and public consultations.

These requirements apply to studies that are commissioned as of 27 March 2021 or, when they are carried out by the business operators in their own testing facilities, that start as of that date.

3.2.2.   Submission of relevant information to the Member States

It is necessary to ensure that Member States are duly informed of the studies notified to the Authority at pre-submission phase, in order to assess compliance of the product notifications with Article 32b of the General Food Law. For this reason, when submitting a product notification, the notifiers should include in the product notification all the information necessary to verify the compliance with the obligations for study notification of Article 32b(2) and (3) of the General Food Law and the relevant practical arrangements laid down by the Authority. In particular, notifiers should submit the elements listed in EFSA practical arrangement on pre-submission phase and public consultations, chapter IV, section 1, Article 21.

In the case where the notifier re-submits to the notified Member State a product notification in line with Article 32b(4) of the General Food Law, the re-submitted product notification should:

| a) | make reference to the previous notification and |
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a)

make reference to the previous notification and

| b) | be complemented with the study IDs generated by the Authority database for the studies that were included in the previous product notification without having been previously notified to the Authority according to Article 32b(2) and 32b(3) of the General Food Law. |
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b)

be complemented with the study IDs generated by the Authority database for the studies that were included in the previous product notification without having been previously notified to the Authority according to Article 32b(2) and 32b(3) of the General Food Law.

In the case where the notifier re-submits a product notification in line with Article 32b(5) of the General Food Law, the re-submitted product notification should:

| a) | make reference to the previous notification and |
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a)

make reference to the previous notification and

| b) | be complemented with the studies that had been notified in accordance with Article 32b(2) and 32b(3) of the General Food Law but were not included in the previous product notification. |
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b)

be complemented with the studies that had been notified in accordance with Article 32b(2) and 32b(3) of the General Food Law but were not included in the previous product notification.

3.2.3.   Verification of compliance with Article 32b of General Food Law

Article 32b(4) and (5) of the General Food Law does not specify which public authority or entity must verify the compliance of an application or notification with the requirements of Article 32b(2) and (3) of the General Food Law and implement the six months delay of the validation or admissibility assessment. Therefore, the provisions must necessarily be read as applying to whichever public authority is responsible for making the assessment of validity or admissibility of the notification or application. In the case of notifications under Part C of the Directive, these are the Member States competent authorities.

To implement Article 32b(4) and (5) of the General Food Law, the examination provided for in the second subparagraph of Article 13(1) of the Directive (for original notifications) or in the second subparagraph of Article 17(2) of the Directive (for renewal notifications) should be considered as the assessment of validity of the product notification.

After the acknowledgement of a product notification and in view of complying with the 90 days deadline of Article 14(2) of the Directive, the Member State may initiate without delay and convene in parallel the verification of compliance under this section and the risk assessment of the product notification received.

The notified Member State should check the compliance of the product notification with Article 32b(2) and (3) of the General Food Law. In particular, the notified Member State should verify that:

| a) | all studies included in the product notification had been notified in accordance with Article 32b(2) and (3) of the General Food Law and the Authority’s practical arrangements on pre-submission phase and public consultation; |
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a)

all studies included in the product notification had been notified in accordance with Article 32b(2) and (3) of the General Food Law and the Authority’s practical arrangements on pre-submission phase and public consultation;

| b) | all studies that had been notified in accordance with Article 32b(2) and (3) of the General Food Law and the Authority’s practical arrangements on pre-submission phase and public consultation are included in the product notification; |
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b)

all studies that had been notified in accordance with Article 32b(2) and (3) of the General Food Law and the Authority’s practical arrangements on pre-submission phase and public consultation are included in the product notification;

| c) | if relevant, valid justifications are provided to explain deviations from the requirements as referred in the Authority’s practical arrangements on pre-submission phase and public consultations, chapter IV, section 1, Article 21, b, i) to v). |
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c)

if relevant, valid justifications are provided to explain deviations from the requirements as referred in the Authority’s practical arrangements on pre-submission phase and public consultations, chapter IV, section 1, Article 21, b, i) to v).

In order to conduct the verification referred to in points a) and b) above, the notified Member State should, without delay, inform the Authority about the acknowledgement of a product notification and request access to the relevant information available to the Authority. Within 10 working days after the request of the Member State, the Authority should provide access to this information on a need-to-know basis and for the period necessary to complete this verification. The notified Member State should assess the validity of any justifications provided by the notifier referred to in point c) above.

The notified Member State should endeavour to complete the verification and inform the notifier accordingly, as soon as possible. The notified Member State should, if needed, set a deadline for the notifier to provide additional elements of clarification or justifications for any non-compliance with the requirements outlined in the above (a), (b) and (c). In line with Article 14(4) of the Directive, the period during which the Member State is waiting for these additional elements of clarification or justifications shall not be taken into account for the calculation of the 90 days period of Article 14(2) of the Directive.

Where valid justifications have not been provided within that deadline, the product notification must be considered as not complying with Article 32b(2) and Article 32b(3) of the General Food Law and consequently not in accordance with Article 13(2) (for original notifications) or Article 17(2) (for renewal notifications) of the Directive. In those cases, Article 32b(4) and (5) of the General Food Law apply. The six months period of Article 32b(4) and (5) of the General Food Law shall not be taken into account for the calculation of the 90 days period of Article 14(2) of the Directive.

The notified Member State should also check, as early as possible, whether the notified studies are submitted in full. If the notified Member State detects, during the validity assessment, that a study is not submitted in full and in the absence of valid justifications of the notifier to that effect, the product notification should not be considered valid and the procedural consequences of Article 32b(5) of the General Food Law should apply.

At any time during the assessment of the product notification, the Member State may request the notifier to provide additional elements of justification or clarification.

3.2.4.   Public disclosure of the justifications by the Authority

In cases where the Authority is requested to provide an opinion on a notification according to Article 13 or 17 of the Directive and discloses the notification pursuant to Article 28(4) of the Directive, at the same time, the Authority should also disclose any justifications referred to in point c) of section 3.2.3 above, which have been considered valid by the notified Member State.

4.   Renewal notifications supported by new studies

4.1.   
  Relevant provisions

| i. | Article 17 of the Directive |
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i.

Article 17 of the Directive

| ii. | Article 32b (4) and (5) of the General Food Law |
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ii.

Article 32b (4) and (5) of the General Food Law

| iii. | Article 32c(1) of the General Food Law |
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iii.

Article 32c(1) of the General Food Law

Article 32c(1) of the General Food Law provides that potential applicants or notifiers for a renewal shall notify the Authority of intended studies, including studies submitted on a voluntary basis. The Authority shall launch a public consultation on the intended studies and take the comments received into account when delivering to potential applicants or notifiers (renewal) pre-submission advice on the content of the intended renewal application as well as the design of the studies.

The notification obligations of Articles 32b(2) and (3) of the General Food Law and the procedural consequences of Article 32b(4) and (5) of the General Food Law (outlined in section 3.1.) apply to all notifications submitted under the Directive, including notifications under Article 17 of the Directive, supported by new studies.

According to Article 17(2) of the Directive, a consent holder that wishes to renew its consent should submit a renewal notification at the latest nine months before the expiry of the consent.

4.2.   
  Guidance for the application of the relevant provisions

4.2.1.   The notification of intended studies, in view of supporting a renewal

As of 27 March 2021, when a consent holder intends to perform new studies in view of supporting a renewal notification, the consent holder shall notify the intended studies to the Authority in line with Article 32c(1) of the General Food Law and Article 12 of the Authority’s practical arrangements on pre-submission phase and public consultation. . EFSA will inform without delay the relevant Member State about the notification of intended studies.

4.2.2.   The provision of renewal pre-submission advice

Following the public consultation of Article 13 of the Authority’s practical arrangements on pre-submission phase and public consultation, all comments received by stakeholders and the public are made public by the Authority without delay (7). Therefore, the Member State, which received the original notification, has access to the comments received from the stakeholders and the public through the relevant EFSA webpages.

Where the Member State, which received the original notification participates in the provision of renewal pre-submission advice, Article 14 of the Authority’s practical arrangements on pre-submission phase and public consultation should apply, with the following adaptations:

| a. | The Authority should provide to the relevant Member State with the information notified by the potential notifier pursuant to Article 12 of the Authority’s practical arrangements on pre-submission phase and public consultations and the comments received during the consultation with third parties referred to in Article 13 thereof. The Authority should also keep the relevant Member State in copy of all communication with the potential notifier of the renewal and with any external experts consulted for the purpose of providing the renewal pre-submission advice. |
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a.

The Authority should provide to the relevant Member State with the information notified by the potential notifier pursuant to Article 12 of the Authority’s practical arrangements on pre-submission phase and public consultations and the comments received during the consultation with third parties referred to in Article 13 thereof. The Authority should also keep the relevant Member State in copy of all communication with the potential notifier of the renewal and with any external experts consulted for the purpose of providing the renewal pre-submission advice.

| b. | After the publication of the comments, the Member State should, without delay, inform the Authority whether it will participate at the provision of the renewal pre-submission advice. The Authority shall then inform the relevant Member State whether the renewal pre-submission advice will be given in writing or in the context of a meeting. The Member State should provide the Authority with its proposed renewal pre-submission advice within 20 working days after the closure of the consultation, taking into account the comments submitted during the public consultation. |
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b.

After the publication of the comments, the Member State should, without delay, inform the Authority whether it will participate at the provision of the renewal pre-submission advice. The Authority shall then inform the relevant Member State whether the renewal pre-submission advice will be given in writing or in the context of a meeting. The Member State should provide the Authority with its proposed renewal pre-submission advice within 20 working days after the closure of the consultation, taking into account the comments submitted during the public consultation.

| c. | The Member State and the Authority should endeavour to agree on the content of the renewal pre-submission advice. In case the Member State disagrees with the Authority on one or more replies, the written advice should reflect both opinions. The renewal pre-submission advice agreed between the Authority and the Member State should be sent to the potential notifier by the Authority. |
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c.

The Member State and the Authority should endeavour to agree on the content of the renewal pre-submission advice. In case the Member State disagrees with the Authority on one or more replies, the written advice should reflect both opinions. The renewal pre-submission advice agreed between the Authority and the Member State should be sent to the potential notifier by the Authority.

| d. | Where the Authority intends to convene a meeting with the potential notifier, the Authority should prepare this meeting in close cooperation with the Member State. Both the Authority and the Member State should participate at the meeting and provide their advice at the meeting. In this case, it is not necessary for the Member State to provide the proposed renewal advice of point c) above. |
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d.

Where the Authority intends to convene a meeting with the potential notifier, the Authority should prepare this meeting in close cooperation with the Member State. Both the Authority and the Member State should participate at the meeting and provide their advice at the meeting. In this case, it is not necessary for the Member State to provide the proposed renewal advice of point c) above.

| e. | The Member State should also provide the Authority with a proposed summary of the renewal pre-submission advice within 20 working days from the closure of the consultation (if the advice is given in written) or after the meeting (if the advice is given in a meeting). The Member State and the Authority should endeavour to agree on the content of the summary. In case the Member State and the Authority disagree about one or more replies, both opinions should be reflected in the summary. The summary of the renewal pre-submission advice agreed between the Authority and the Member State should be sent to the potential notifier by the Authority. |
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e.

The Member State should also provide the Authority with a proposed summary of the renewal pre-submission advice within 20 working days from the closure of the consultation (if the advice is given in written) or after the meeting (if the advice is given in a meeting). The Member State and the Authority should endeavour to agree on the content of the summary. In case the Member State and the Authority disagree about one or more replies, both opinions should be reflected in the summary. The summary of the renewal pre-submission advice agreed between the Authority and the Member State should be sent to the potential notifier by the Authority.

This advice is without prejudice and non-committal as to the subsequent assessment reports of the Member State or any Authority scientific output and non-binding for the consent holder.

The Member State and the Authority should take all the necessary measures so that information received is kept confidential.

The participation of the Member States in the provision of renewal pre-submission advice is highly recommended, so that national transposition provisions and rules are taken into account in the renewal pre-submission advice. This would facilitate the assessment of renewal notifications by the Member States and therefore would be beneficial for both the notifier and Member States. If the intended notified Member State does not participate in the provision of renewal pre-submission advice, Article 14 of the Authority’s practical arrangements on pre-submission phase and public consultation shall apply without adaptations.

The Member States should undertake all measures necessary to avoid any conflict of interests of the staff providing the renewal pre-submission advice.

Before the submission of a renewal notification the consent holder may also benefit from general pre-submission advice in line with section 2 of this Notice.

4.2.3.   Access of the Member State to the renewal pre-submission advice and its summary

When a renewal notification is submitted to a Member State and this Member State was not engaged in providing renewal pre-submission advice, the notified Member State may ask the Authority whether renewal pre-submission advice was provided to the notifier(s) for this notification. If this is the case, the Authority should make sure, without delay, that the notified Member State has access to the summary of the renewal pre-submission advice and the written renewal pre-submission advice provided by the Authority, where the Authority replied to the notifier in writing.

4.2.4.   Public disclosure of the summary of renewal pre-submission advice

When the notified Member State concludes that the renewal notification is in accordance with Article 17(2) of the Directive, the notified Member State should immediately inform the Authority, which would make the summary of the renewal pre-submission advice public, without delay, in accordance with Article 38(1) of the General Food Law and Article 5(2)(f) of the Authority’s practical arrangements on transparency and confidentiality.

4.2.5.   Timeline of the renewal notification, when supported by new studies

Section 3 of this Notice applies also to renewal notifications supported by new studies. When notifiers intend to conduct a study in view of supporting the renewal notification, they should ensure that the nine months deadline of Article 17(2) of the Directive is met, taking also into account the following steps introduced by the Transparency Regulation:

| — | Notification of intended studies for renewal, according to Article 32c(1) of the General Food Law and the Authority’s practical arrangements on pre-submission phase and public consultation; |
| --- | --- |

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Notification of intended studies for renewal, according to Article 32c(1) of the General Food Law and the Authority’s practical arrangements on pre-submission phase and public consultation;

| — | Public consultation on the intended studies for renewal, including on the proposed study design; |
| --- | --- |

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Public consultation on the intended studies for renewal, including on the proposed study design;

| — | Provision of the Authority’s renewal pre-submission advice; |
| --- | --- |

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Provision of the Authority’s renewal pre-submission advice;

| — | Notification of studies according to Article 32b of the General Food Law and Section 1 of chapter IV of Authority practical arrangements on pre-submission phase and public consultations ; |
| --- | --- |

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Notification of studies according to Article 32b of the General Food Law and Section 1 of chapter IV of Authority practical arrangements on pre-submission phase and public consultations ;

| — | Possible procedural consequences of Article 32b(4) and (5) of the General Food Law, in line with section 3 of this Notice. Where the notification obligation of Article 32b(2) and (3) of the General Food Law has not been complied with, the assessment of the validity of a re-submitted renewal notification may only start after the expiry of the six-month period following the date of re-submission and provided that that point in time is no later than nine months before the expiry of the consent of the concerned GMO. If that point in time is later than nine months before the expiry date of the consent of the relevant GMO, the resubmitted renewal notification must be considered not compliant with the requirements of Article 17(2) of the Directive and therefore the consent must not be renewed. |
| --- | --- |

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Possible procedural consequences of Article 32b(4) and (5) of the General Food Law, in line with section 3 of this Notice. Where the notification obligation of Article 32b(2) and (3) of the General Food Law has not been complied with, the assessment of the validity of a re-submitted renewal notification may only start after the expiry of the six-month period following the date of re-submission and provided that that point in time is no later than nine months before the expiry of the consent of the concerned GMO. If that point in time is later than nine months before the expiry date of the consent of the relevant GMO, the resubmitted renewal notification must be considered not compliant with the requirements of Article 17(2) of the Directive and therefore the consent must not be renewed.

5.   Submission of notifications in the appropriate format

5.1.   
  Relevant provisions

| — | Article 13(1) and 13(2a) of the Directive |
| --- | --- |

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Article 13(1) and 13(2a) of the Directive

| — | Article 17(2) of the Directive |
| --- | --- |

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Article 17(2) of the Directive

| — | Article 28(4) of the Directive |
| --- | --- |

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Article 28(4) of the Directive

| — | Article 38(1), last subparagraph of the General Food Law |
| --- | --- |

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Article 38(1), last subparagraph of the General Food Law

| — | Article 39f of the General Food Law |
| --- | --- |

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Article 39f of the General Food Law

The Transparency Regulation inserted a new paragraph 2a in Article 13 of the Directive, providing that the notification under the Directive shall be submitted in accordance with standard data formats, where they exist under Union law.

Article 39f of the General Food Law provides that standard data formats shall be adopted to ensure compliance with regulatory requirements.

Article 38(1), last subparagraph of the General Food Law specifies that the information the Authority shall make public shall be available to be downloaded, printed and searched through in an electronic format.

5.2.   
  Guidance for the application of the relevant provisions

5.2.1.   Submission of notifications

Notifiers should submit their notifications under Articles 13 and 17 of the Directive (product notifications) and all supporting information, including supplementary information, through the electronic submission system provided by the Commission and accessible through the website of the European Commission.

Notifications should be submitted in accordance with the applicable data standard formats, where they exist, pursuant to Article 39f of the General Food Law. Regardless the existence of standard data formats, the notifiers should submit product notifications and all supporting information, including supplementary information, in the appropriate format to allow for this information to be downloaded, printed and searched through, in case this becomes publicly available, in accordance with Article 28(4) of the Directive.

When submitting a product notification in the electronic submission system, the notifier should make, if applicable, reference to the pre-application identification associated with the specific GMO, which is subject of the product notification

5.2.2.   Verification of compliance

Before the notification is forwarded to the Commission in line with the third subparagraph of Article 13(1) of the Directive or last subparagraph of Article 17(2) of the Directive, the notified Member State must check that the product notification was submitted in accordance with standard data formats, where they exist under Union law.

For the implementation of Article 28(4) of the Directive read in conjunction with Article 38(1), last subparagraph of the General Food Law, at the latest before the Authority is consulted on a product notification, the notified Member State should ensure that the product notification is submitted in an electronic format, allowing the information to be downloaded, printed and searched, where it would be required to be made publicly available.

In line with Article 14(4) of the Directive, the period during which the Member State is waiting additional information from the applicant regarding the data format of the notification shall not be taken into account for the calculation of the 90 days period of Article 14(2) of the Directive.

6.   Procedural aspects regarding confidentiality

6.1.   
  Relevant provisions

| — | Article 28(4) of the Directive |
| --- | --- |

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Article 28(4) of the Directive

| — | Article 25 of the Directive |
| --- | --- |

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Article 25 of the Directive

| — | Article 39c of the General Food Law |
| --- | --- |

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Article 39c of the General Food Law

The notifier may submit a request to the notified Member State to treat certain parts of the notification as confidential, accompanied by verifiable justifications. The Member State shall assess the confidentiality request submitted by the notifier, in accordance with Article 25 of the Directive.

According to Article 28(4) of the Directive, the Authority, if consulted on a notification, will make public the notification, including relevant supporting information and any supplementary information supplied by the notifier, with the exception of any information assessed as confidential by the notified Member State.

In accordance with Article 25(7)(b) of the Directive, information included in the notification will be made public when it relates to foreseeable effects on human health, animal health or the environment and forms part of the conclusions of the Authority scientific output or the conclusions of the assessment reports of the Member States. In this case, Article 39c of the General Food Law shall apply.

In accordance with Article 39c of the General Food Law, before issuing its scientific output, the Authority shall review whether information that has previously been accepted as confidential may be made public, when this information forms part of Authority scientific output and relates to foreseeable effects on human health, animal health or the environment.

6.2.   
  Guidance for the application of the relevant provisions

6.2.1.   Submission of confidentiality requests

Notifiers should submit to the notified Member State, through the electronic submission system provided by the Commission any confidentiality requests concerning their notification under Articles 13 or 17 of the Directive (product notification), the relevant supporting information and the supplementary information requested by the notified Member State. The confidentiality requests must be accompanied by verifiable justifications in accordance with Article 25(3) of the Directive.

6.2.2.   Confidentiality assessment by the notified Member State

The notified Member State shall assess the confidentiality requests in accordance with Article 25 of the Directive, decide which information is to be treated as confidential and introduce in the electronic submission system its confidentiality decision. The confidentiality decision of the notified Member State should indicate the possibility of the notifier to withdraw the product notification as well as the legal remedies available to the notifier.

In order to ensure equal treatment of the business operators, a minimum consistency of the confidentiality assessments performed by Member States as well as by the Authority is needed. In this respect, Member States could consider for their assessments the cumulative requirements in Article 10 of the Authority’s practical arrangements on transparency and confidentiality as well as the measures provided in Articles 11 and 12 thereof.

Following the confidentiality decision, either the notifier or the Member State must prepare a non-confidential version of the product notification dossier. The notified Member State must verify that the non-confidential version of the product notification dossier complies with the confidentiality decision (i.e. that information that has been granted confidential treatment is not disclosed and that information for which confidentiality requests have been rejected is disclosed).

The Member State should start the confidentiality assessment, as soon as possible after the receipt of a product notification. At the latest when the Authority is consulted on the product notification, the notified Member State should provide in the electronic submission system the non-confidential version of the product notification dossier. The Authority would then have access to the confidentiality decision of the notified Member State as well as to the non–confidential version of the product notification dossier, in the electronic submission system, for the purposes of public disclosure, in accordance with Article 28(4) of the Directive.

In case the Authority is requested to provide a scientific output on the product notification and if the Authority asks the notifier to submit supplementary information, the notifier should submit the supplementary information together with relevant confidentiality requests, if any, in the electronic submission system provided by the Commission. The notified Member State shall then assess these confidentiality requests, issue a confidentiality decision and ensure the non-confidential version of the supplementary information is uploaded in the electronic submission system.

6.2.3.   Confidentiality assessment by the Authority

Before the Authority issues its scientific opinion, the Authority reviews whether information that has previously been accepted as confidential by the notified Member State may nevertheless become public in accordance with Article 39c of the General Food Law. When the conditions set out in Article 14 of the Authority’s practical arrangements on transparency and confidentiality are met, the Authority shall issue a decision determining which elements previously considered confidential must be made publicly available pursuant to Article 39c of the General Food Law. In this case, Articles 11 to 13 of the Authority’s practical arrangements on transparency and confidentiality apply mutatis mutandis.

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(1)  OJ L 231, 6.9.2019, p. 1.

(2)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

(3)  Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

(4)  https://www.efsa.europa.eu/sites/default/files/corporate_publications/files/210111-PAs-transparency-and-confidentiality.pdf

(5)  https://www.efsa.europa.eu/sites/default/files/corporate_publications/files/210111-PAs-pre-submission-phase-and-public-consultations.pdf

(6)  Committee of Article 30 of Directive 2001/18/EC.

(7)  By way of derogation from this general principle, upon receipt by the Authority of a request for anonymity submitted by an individual having submitted comments in a personal capacity, the identity of that individual shall not be disclosed.

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