Confidentiality and sanitisation

Intro

Regulation (EU) 2019/1381 (“Transparency Regulation”), which has been in application since 27 March 2021, strengthens the principle of transparency regarding the risk assessment process in the food chain. Among several regulatory innovations, it stipulates the proactive public disclosure of all information supporting any request for a scientific output to be delivered by EFSA, with the exception of duly justified confidential data.

This page aims to give applicants and other interested parties an overview of the general and specific procedures for the submission and assessment of confidentiality requests in relation to information submitted by applicants as defined in Article 3 of EFSA’s Practical Arrangements concerning transparency and confidentiality. It outlines the main procedural steps and requirements and provides useful links to further information.

General procedure

Confidentiality requests

(For requests in the areas of pesticides and GMO, see further below.)

Confidentiality can be claimed for all documents submitted in the context of applications found valid or admissible, mandates accepted under Article 29 of Regulation (EC) No 178/2002 (General Food Law, “GFL”), or closed calls for data. Confidentiality can also be claimed when submitting information, documents, or data to EFSA for evaluation during the risk assessment or scientific evaluation process at EFSA’s request.

Confidentiality requests may be submitted only for certain items, which are included in the closed positive list provided in the Annex of EFSA's Practical Arrangements concerning transparency and confidentiality.

During the confidentiality decision making, as an optional procedural step, EFSA may ask applicants to provide clarifications.

Before adopting its final decision on confidentiality requests, EFSA notifies applicants of the draft decision and gives them the possibility to state their views in writing or withdraw the application within two calendar weeks of the notification of the draft decision. 

Upon notification of the final decision on confidentiality requests, applicants may submit a confirmatory application within two calendar weeks to ask EFSA to reconsider its decision (see detailed information under the heading ‘Confirmatory applications’ below).

For further instructions and information, please refer Article 9 to 11 of EFSA's Practical Arrangements concerning transparency and confidentiality, the Q&As on the Practical Arrangements, and to the user guide.

Confirmatory applications

To challenge EFSA's decisions rejecting confidentiality requests or EFSA's review decisions as per Article 39(c) of the GFL, applicants may submit a confirmatory application. Within two calendar weeks of EFSA's notification, they may ask EFSA to reconsider its decision. An action before the General Court of the European Union is available to applicants only against a decision on a confirmatory application. When a confirmatory application is submitted, EFSA puts on hold the implementation of its related confidentiality decision.

A confirmatory application must be limited to the review of the contested decision and must not result in new confidentiality requests, which were not part of the original confidentiality request subject to the confirmatory application.

Once the confirmatory decision is adopted, EFSA notifies the applicant, indicating the possibility for the applicant to withdraw its application as well as the legal remedies available.

For detailed guidance and instructions, see Article 12 of EFSA’s Practical Arrangements concerning transparency and confidentiality, the Q&As on the Practical Arrangements, and the user guide regarding the submission of confidentiality requests.

Withdrawal of the application

At any time during or after the confidentiality assessment, applicants may withdraw dossiers on which they do no longer wish EFSA to issue a scientific opinion. As a consequence, the confidentiality assessment and the scientific evaluation, if initiated, stop without reaching their conclusion, and EFSA will not make public information for which confidentiality treatment was requested by the applicant.

For detailed guidance and instructions, see Article 15 of EFSA’s Practical Arrangements concerning Transparency and Confidentiality, the Q&As on the Practical Arrangements and the user guide on submission of confidentiality requests.

Specific procedures

New pesticide active substance

In the context of assessing a new pesticide active substance for authorisation, the Rapporteur Member State (RMS) is in charge of adopting confidentiality decisions on requests received by the applicant and consults EFSA on its draft decision. EFSA provides its comments in accordance with the relevant legislation and in compliance with the Practical Arrangements concerning Articles 7 and 16 of Regulation (EC) No 1107/2009.

For instructions, see the Practical Arrangements concerning Articles 7 and 16 of Regulation (EC) No 1107/2009, the Q&As on the Practical Arrangements and the user guide on submission of confidentiality requests.

Renewal of approval of a pesticide active substance, or evaluation of pesticides maximum residue level (MRL)

Confidentiality can also be claimed for information in admissible applications for the renewal of authorisation of a pesticide active substance or during the evaluation of maximum residue levels (MRL), microorganisms or basic substances.

For detailed guidance and instructions, see EFSA’s Practical Arrangements concerning transparency and confidentiality, the Q&As on the Practical Arrangements and the user guide on submission of confidentiality requests.

Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms

Confidentiality can also be claimed for information in GMO application dossiers submitted under Directive 2001/18/EC and received by EFSA from a national competent Authority. The competent national Authority will take the confidentiality decision and notify EFSA of it. EFSA may review the decision taken by the national Authority in the case its output identifies foreseeable public health, animal health or environmental concerns.

For detailed guidance and instructions, see EFSA’s Practical Arrangements concerning Transparency and Confidentiality, the Q&As on the Practical Arrangements, the dedicated webinar, and the user guide on submission of confidentiality requests.

Review of previously adopted confidentiality decisions

EFSA may review its previously adopted decisions accepting confidentiality requests with the aim to ensure that information relating to foreseeable effects on human and animal health or the environment is available to the public. EFSA may do so upon adoption, approval or endorsement of an EFSA scientific output highlighting safety concerns, environmental concerns or animal health concerns related to information that has been granted confidential status.

In the review of its previous decisions, EFSA follows the general procedure outlined above.

For detailed guidance, see Article 14 of EFSA’s Practical Arrangements concerning Transparency and Confidentiality, the Q&As on the Practical Arrangements and the user guide on submission of confidentiality requests.

Content Sanitisation

The process of masking or unmasking scientific data, studies and other information, including personal data, in accordance with a confidentiality request or decision is called content sanitisation.

Content sanitisation takes place when an EFSA confidentiality decision is issued. In the case the relevant EFSA decision confirms and accepts a confidentiality request, no additional content sanitisation is needed as the relevant elements have already been sanitised by the applicant, and the version published on the OpenEFSA Portal remains as it was provided by the applicant.

In the case the relevant EFSA decision (entirely or partially) rejects a confidentiality request, additional content sanitisation (unmasking of information) is performed after the confidentiality decision is issued to ensure its proper implementation. Following content sanitisation, EFSA makes the resulting documents publicly available on the OpenEFSA Portal.

For detailed guidance and instructions, see EFSA’s Practical Arrangements concerning Transparency and Confidentiality, and the dedicated user guide.

See also

Legal framework & rules

• Article 15 of the Treaty of the functioning of the European Union
• Consolidated Regulation (EC) No 178/2002 ("General Food Law")
• Regulation (EU) 2019/1381 ("Transparency Regulation")
• Practical Arrangements concerning transparency and confidentiality
• Practical Arrangements concerning confidentiality in accordance with Articles 7(3) and 16 of Regulation (EC) No 1107/2009

Guidance on EFSA confidentiality decision-making & content sanitisation

• Questions and Answers on EFSA Practical Arrangements
• User guide – submission of confidentiality requests
• Webinar: Webinar on confidentiality assessment and content sanitisation in the context of the Transparency Regulation– September 2022
• Webinar: Confidentiality for applicants/business operators – April 2021
• Webinar: Post-Transparency Regulation confidentiality GMO Part C risk assessment and confidentiality workflows – September 2022

Guidance on IT tools used for EFSA confidentiality decision-making & content sanitisation

• Toolkit for applicants – overview of all EFSA portals
• Quick guide – submission of confidentiality requests via the Portalino
• The Portalino – confidentiality requests
• E-Submission Food Chain (ESFC) Platform – confidentiality
• IUCLID training for applicants
• IUCLID videos on most common mistakes (part 1)

Services for applicants and sectoral guidance

• Applications helpdesk – useful resources for applicants
• Administrative guidance for the processing of applications for regulated products
• Administrative guidance for the preparation of applications on additives for use in animal nutrition
• Administrative guidance for the preparation of applications on substances to be used in plastic food contact materials
• Administrative guidance for the preparation of applications on food improvement agents (food enzymes, food additives and food flavourings)
• Administrative guidance for the preparation of applications on genetically modified plants
• Administrative guidance for the preparation of applications on novel foods pursuant to Article 10 of Regulation (EU) 2015/2283
• Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances and on the maximum residue level (MRL)application procedure

Other useful links

• Transparency – EFSA website
• Transparency Regulation – EC website