There is one month left before the new EU transparency regulation!
This will mean big changes to the way that food business operators/applicants write & submit their dossiers for all regulated products in the food chain, including feed and food dossiers.

The main changes include:

• All studies used to support the dossier must be notified to EFSA
• A new procedure for feed additive renewals
• All confidential data must be fully justified at the time of dossier submission
• EFSA will decide on confidentiality
• A non-confidential version of the dossier will be made publicly available

Whilst we anticipate that there will be more bureaucracy & timelines may be affected initially, there are some real benefits which will help applicants. These include:

• Applicants can request pre-submission advice from EFSA
• E-submission of dossiers via FSCAP using standardised templates
• Open EFSA platform to track the status of your application
• A more transparent & trusted food chain

During this short webinar, we will share the latest updates provided by European authorities regarding the key points that will affect applications for requesting authorisations for food and feed products in the EU – notification of studies to the new EFSA database, public consultations, as well as dossier preparation and submission. 

• What studies do you have to notify? And when?

• How to claim confidentiality for certain parts of the dossier? 

• Regulatory affairs Managers
• Business Development Managers
• R&D Scientists
• Product development Managers
• Project Managers
• Scientists in CROs where clients demand EFSA-compliant studies

Dr Eliana Henriquez Rodriguez 

Eliana is an Agricultural Engineer with applied experience in animal production and research. Eliana holds a MSc in Animal Breeding and Reproduction Biotechnology as well as a PhD in Agricultural and Food Science and Technology. Throughout her professional and academic life, Eliana has developed skills in animal production management, molecular genetic techniques, experimental design, statistical analysis and scientific writing.

In her role at Pen & Tec Consulting, Eliana is responsible for providing internal & external regulatory & scientific training for EFSA- compliant studies, and manages feed additive registration projects.