EFSA’s latest updates on practical arrangements for regulated products are now available

Posted 30 August, 2023


After 2 years of experience with Transparency Regulation, EFSA has finally released updates on questions & answers in an effort to help clarify the main obligations of food/feed business operators that must submit food or feed dossiers in the EU.

Basic updates you should keep your eyes on:

  1. Which studies should be notified and what happens with method validation studies? What is meant by ‘’intended studies’’?
  2. How does the registration of entities in the system developed by EFSA to support pre-submissions activities work and how can more associated accounts be entitled to each entity?
  3. Which information should be provided by applicants, when submitting a pre-submission advice request to EFSA?
  4. On which basis will EFSA decide whether to reply in writing or to organise a meeting in response to a request for general pre-submission advice? When EFSA may request clarification data in order to decide on the acceptability of the pre-submission advice request?
  5. When is the summary of the general pre-submission advice made public? Do the background information and list of questions are subject to proactive disclosure even after the corresponding application has been considered valid or admissible?
  6. Under which circumstances the pre-submission activities related to the renewal pre-submission advice can be interrupted by EFSA?
  7. In which cases do the Article 32b notification obligations apply? What EFSA considers for studies conducted according to OECD test guidelines and/or according to GLP (e.g. toxicity studies)? Which studies do not need to be notified to EFSA?
  8. Can the laboratory be the first entity to notify the study, even before the applicant does?
  9. Which evidence will be needed for justification of studies notified with delay?

Pen & Tec is an expert on food and feed applications and can help decipher the complexity of the new updates on practical arrangements!

Questions and Answers on EFSA Practical Arrangements

Last updated: 28 August 2023The “Questions and Answers on EFSA Practical Arrangements” provides answers to questions frequently asked  on Practical Arrangements (PAs) formulated by EU Member States.

Link: https://www.efsa.europa.eu/en/corporate-pubs/questions-and-answers-efsa-practical-arrangements