The confidentiality assessment process for food and feed applications, excluding pesticides
Niekoľko hodín
Začiatočník
Podrobnosti o kurze
This course provides applicants with practical guidance on how confidentiality is assessed under the EU Transparency Regulation in food and feed applications, excluding pesticide applications.
The course explains the legal framework governing confidentiality, outlines EFSA’s confidentiality assessment process, and clarifies both the procedural and substantive requirements that applicants must fulfil when submitting confidentiality requests. It also offers practical tips, highlights common mistakes, and presents concrete examples to help applicants prepare clear, complete and compliant confidentiality claims.
Cieľová skupina
This course is intended for applicants preparing application dossiers in food regulated areas submitted via the ESFC and Portalino platforms. Pesticide applications (i.e. plant protection product applications covering active substances, microorganisms, and maximum residue levels) are out of scope of this training.
The course is particularly helpful for SMEs and first-time applicants, but it may also be useful for experienced applicants, consultants supporting applicants, industry associations, and other stakeholders involved in the preparation of applications.Vzdelávacie ciele
At the end of this course, you will be equipped to prepare well-substantiated confidentiality requests by:
- Understanding the principles of the EU Transparency Regulation and how confidentiality is treated as an exception to proactive disclosure.
- Identifying which types of information may be claimed as confidential and on which legal grounds.
- Understanding EFSA’s confidentiality assessment process.
- Recognizing procedural and substantive requirements for confidentiality requests and applying them correctly.
- Preparing well-structured and justified confidentiality requests, including appropriate earmarking and redaction of documents.
- Avoiding common errors that may lead to rejection or delays in the confidentiality asses
EFSA is an agency of the European Union set up in 2002 to serve as an impartial source of scientific advice to risk managers and to communicate on risks associated with the food chain.
Harmonogram
- Welcome
- Module 1 - Confidentiality assessment and the Transparency Regulation
- Module 2 - Procedural and substantive requirements
- Module 3 - Tips and tricks to submit confidentiality requests
- Module 4 - Examples
- Module 5 - Frequently Asked Questions
- Module 6 - Final remarks