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Food Chain Risk Assessment Transparency Regulation In force Unlisted

Overview

Jurisdiction
European Union
Topic
-
Instrument type
Regulation
Reference number
2019/1381
Valid from
2019-09-26
Valid to
2026-08-13
Modified date
2021-03-27
Listed at
Unlisted draft
Withdrawn at
-
Description
Regulates the transparency and sustainability of EU risk assessment in the food chain. Companies must, in particular, notify studies to the European Food Safety Authority (EFSA) before submitting applications or notifications and comply with requirements on transparency, public consultation, standard data formats and protection of confidential information. The main application provisions apply from 27 March 2021.

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Sources

Source URL Crawler Publish date
https://publications.europa.eu/resource/celex/32019R1381 EUR-Lex Crawl 2019-06-20

Logs

Type Status Started at Finished at
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Rule sets

Label Effective
Companies submitting applications, notifications or supporting studies from the application start date 2021-03-27 — 9999-12-31
Applies from milestone:
Application Start (2021-03-27)
Expires at milestone:
-

No conditions.

Questions this regulation asks

Attributes only this regulation asks about — criteria no general attribute expresses. A company answers each once.

This regulation asks no questions of its own — every condition uses a general attribute.

Obligations

Title Kind Rule set
Notify studies supporting applications Reporting -
Description:
Business operators must, without delay, notify the Authority of the title and scope of every study they commission or carry out to support an application or notification, and provide the laboratory or testing facility and the study's starting and planned completion dates.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Applications or notifications for which Union law provides for a scientific output by the Authority
Checking responsibility:
European Food Safety Authority
Check method:
Cross-check of the notification against the application or notification and the identified laboratory or testing-facility data
Rule set:
-
Source reference:
Article 32b(2)
Source excerpt:
For the purposes of paragraph 1, business operators shall, without delay, notify the Authority of the title and the scope of any study commissioned or carried out by them to support an application or a notification, as well as the laboratory or testing facility carrying out that study, and its starting and planned completion dates.
Notify previously unnotified studies Reporting -
Description:
Applicants or notifiers must, upon resubmission, notify previously unnotified studies, including their title, scope, laboratory or testing facility, and starting and planned completion dates, unless a valid justification for the non-notification is provided.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Applications or notifications supported by studies that were not previously notified
Checking responsibility:
European Food Safety Authority
Check method:
Review of study notifications and the justification provided
Rule set:
-
Source reference:
Article 32b(4)
Source excerpt:
Where studies have not been previously notified in accordance with paragraph 2 or 3, and where a valid justification has not been provided, an application or notification may be re-submitted, provided that the applicant or notifier notifies to the Authority those studies, in particular their title and their scope, the laboratory or testing facility carrying them out as well as their starting and planned completion dates.
Submit all previously notified studies Record Keeping -
Description:
Applicants or notifiers must, upon resubmission, submit all previously notified studies unless a valid justification for their omission is provided.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Applications or notifications that omit previously notified studies
Checking responsibility:
European Food Safety Authority
Check method:
Comparison of previously notified studies with the application or notification
Rule set:
-
Source reference:
Article 32b(5)
Source excerpt:
Where the studies which have previously been notified in accordance with paragraph 2 or 3 were not included in the application or notification, and where a valid justification has not been provided, an application or notification may be resubmitted, provided that the applicant or notifier submits all the studies that were notified in accordance with paragraph 2 or 3.
Notify studies for renewal Reporting -
Description:
Potential applicants or notifiers must notify the Authority of the studies they intend to perform for a renewal, including information on how the studies will be carried out to ensure compliance with regulatory requirements.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Studies intended for renewal of an approval or authorisation
Checking responsibility:
European Food Safety Authority
Check method:
Review of the study notification and study-design information
Rule set:
-
Source reference:
Article 32c(1)
Source excerpt:
the potential applicant or notifier for the renewal shall notify the Authority of the studies it intends to perform for that purpose, including information on how the various studies are to be carried out to ensure compliance with regulatory requirements.
Substantiate a confidentiality request Record Keeping -
Description:
Applicants may request confidential treatment of specified information when submitting an application and must provide verifiable justification demonstrating significant potential harm to their interests.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Applications, supporting scientific data and supplementary information
Checking responsibility:
European Food Safety Authority
Check method:
Review of the application, confidential and non-confidential versions, and supporting justifications
Rule set:
-
Source reference:
Article 39a(1)
Source excerpt:
When submitting an application, supporting scientific data and other supplementary information in accordance with Union law, the applicant may request certain parts of the information submitted to be treated as confidential in accordance with Article 39(2) and (3). Such request shall be accompanied by verifiable justification that demonstrates how making public the information concerned significantly harms the interests concerned in accordance with Article 39(2) and (3).
Submit confidential and non-confidential versions Record Keeping -
Description:
Applicants must provide non-confidential and confidential versions of submitted information in standard data formats, clearly mark confidential information and the grounds for confidentiality, and indicate deletions in the non-confidential version.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Information submitted with a confidentiality request
Checking responsibility:
European Food Safety Authority
Check method:
Review of the separate versions, markings and justifications
Rule set:
-
Source reference:
Article 39a(2)
Source excerpt:
Where an applicant submits a confidentiality request, it shall provide a non-confidential version and a confidential version of the information submitted in accordance with standard data formats, where they exist, pursuant to Article 39f. The non-confidential version shall not include the information the applicant deems confidential on the basis of Article 39(2) and (3) and shall indicate the places where such information has been deleted. The confidential version shall contain all information submitted, including information the applicant deems confidential. Information requested to be treated as confidential in the confidential version shall be clearly marked. The applicant shall clearly indicate the grounds on the basis of which confidentiality is requested for the different pieces of information.
Submit applications in standard data formats Other -
Description:
Applicants must submit applications in standard data formats where such formats exist under Article 39f of Regulation (EC) No 178/2002.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Applications for approval or authorisation in the sectors covered by the amending provisions
Checking responsibility:
Competent authorising or assessing authority
Check method:
Check whether the application was submitted in the available standard data formats
Rule set:
-
Source reference:
Article 5(3), introductory wording
Source excerpt:
The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, and shall be accompanied by the following:
Submit active-substance renewal application on time Approval -
Description:
Producers of an active substance must submit the renewal application to a Member State no later than three years before expiry of the approval and provide a copy to the Commission, the other Member States and the Authority.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Applications for renewal of approval of an active substance
Checking responsibility:
Competent Member State and European Commission
Check method:
Check of the submission date against the approval expiry date
Rule set:
-
Source reference:
Article 15(1)
Source excerpt:
The application provided for in Article 14 of this Regulation shall be submitted by a producer of the active substance to a Member State, with a copy to the Commission, to the other Member States and to the Authority, no later than three years before the expiry of the approval.
Provide a standardised dossier summary Record Keeping -
Description:
Applicants must include a summary of the dossier in a standardised form with their application.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Applications under Regulation (EC) No 1829/2003
Checking responsibility:
Competent assessing authority
Check method:
Review of application materials for a standardised dossier summary
Rule set:
-
Source reference:
Article 5(3)(m)
Source excerpt:
a summary of the dossier in a standardised form.
Submit active-substance approval dossier Approval -
Description:
Producers of an active substance must submit an application with a summary and complete dossier, or a scientifically reasoned justification for omitted dossier parts, demonstrating that the active substance meets the approval criteria.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Applications for approval of an active substance or amendment of approval conditions
Checking responsibility:
Rapporteur Member State
Check method:
Review of the application, summary and complete dossier or reasoned justification for omission
Rule set:
-
Source reference:
Article 7(1)
Source excerpt:
An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to a Member State (the rapporteur Member State), together with a summary and a complete dossier as provided for in Article 8(1) and (2) of this Regulation or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4 of this Regulation.

Measures

No measures.

Penalties

No penalties.

Milestones

Date Type Description
2021-03-27 Application Start Start of application of the Regulation; transitional rule for earlier applications and requests
Source reference:
Article 10(1)
Source excerpt:
This Regulation shall not apply to applications under Union law as well as requests for scientific outputs submitted to the Authority before 27 March 2021.
2021-07-01 Application Start Start of application of the amended procedures for appointing the Management Board, Scientific Committee and Scientific Panels
Source reference:
Article 11
Source excerpt:
However, points 4 and 5 of Article 1 shall apply from 1 July 2022.
2025-03-28 Other Deadline for fact-finding missions by Commission experts
Source reference:
Article 61a
Source excerpt:
Commission experts shall perform fact-finding missions in Member States to assess the application, by laboratories and by other testing facilities, of the relevant standards for carrying out tests and studies submitted to the Authority as part of an application, as well as compliance with the notification obligation set out in Article 32b(3), by 28 March 2025.
2026-03-28 Other Deadline for the Commission's first evaluation of the Authority's performance
Source reference:
Article 61(2)
Source excerpt:
By 28 March 2026, and every five years thereafter, the Commission shall evaluate the Authority's performance in relation to its objectives, mandate, tasks, procedures and location, in accordance with Commission guidelines.

Linked regulations

Type Regulation
Amends Regulation (EC) No 178/2002
Amends Regulation (EC) No 1829/2003
Amends Regulation (EC) No 1831/2003
Amends Regulation (EC) No 2065/2003
Amends Regulation (EC) No 1935/2004
Amends Regulation (EC) No 1331/2008
Amends Regulation (EC) No 1107/2009
Amends Regulation (EU) 2015/2283
Amends Directive 2001/18/EC
Cites Directive 2010/63/EU
Cites Directive 2004/10/EC
Cites Regulation (EU) 2018/1725
Cites Regulation (EU) 2016/679
Cites Aarhus Regulation
Cites Environmental Information Directive
Cites Regulation (EC) No 1049/2001
Cites Regulation (EU) No 182/2011
Cites Regulation (EC) No 45/2001