(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.
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.