A TWO DAY SEMINAR

THE PREPARATION OF NOVEL FOOD DOSSIERS IN THE EU UNDER THE TRANSPARENCY REGULATION

May 31 – June 1, 2022

ABOUT

This interactive course has been designed to give practical advice on building and submitting a novel food dossier in the EU. You will gain a comprehensive overview of the entire registration process, from notifying studies to structuring and compiling a novel food dossier, the submission process and how to comply with the latest changes following the Transparency Regulation. We will include a case study based on recent positive EFSA opinions in the alternative protein area. Our guest speaker, Alex Holst will discuss the importance of politics in the success of alternative protein applications.


Learning outcomes
  • Understand the novel food registration process
  • Learn which studies are required to support your novel food dossier
  • Gain a practical insight into using the e-submission food chain platform
  • How to deal with confidential data under the new Transparency Regulation
  • How to manage questions from EFSA during the risk assessment process
  • Consolidate your knowledge with practical exercises

AGENDA
Time
Session title
Speaker/s
Day 1
13:00 - 13:15

Introduction & objectives of the course

Ing. Justyna Pałasińska
13:15 - 14:00

Introduction to Novel Food

- What are Novel Foods (what are Traditional Foods)?
- How to establish if a food is novel (consultation process)?
- How does the approval process look like? Who are the responsible Authorities?
- What are the timelines (theory vs. practice)?

Ing. Justyna Pałasińska
14:00 - 15:00

Novel Food dossier preparation

- Dossier section & data requirements
- What are the key studies to start with
- Issues & solutions
- Submission

Nicoleta Pasecinic ANutr
15:00 - 15:15

Break

15:15 - 15:50

Protection of data

Nicoleta Pasecinic ANutr
15:50 - 16:05

Break

16:00 - 16:30

Why is politics an important tool for novel food registration in the alt protein industry?

Alex Holst
16:30 - 17:00

Q&A/wrap up Day 1

Nicoleta Pasecinic ANutr
Alex Holst
Ing. Justyna Pałasińska
Day 2
13:00 - 13:15

Recap from Day 1

Ing. Justyna Pałasińska
13:15 - 14:45

Transparency regulation

- What is it?
- What are the implications
- Release of information

Nicoleta Pasecinic ANutr
14:45 - 15:00

Break

15:00 - 15:45

TR tools & the differences

- EFSA connect
- ESFC
- Portalino

Ing. Justyna Pałasińska
15:45 - 16:15

Which studies need to be notified & what have we learnt so far ?

Hannes Malfroy
16:15 - 17:00

Novel food life cycle. From study notification/ pre-submission advice to authorisation/ Union list

Ing. Justyna Pałasińska
17:00 - 17:10

Break

17:10 - 17:30

Case study – protein Novel Food approval

Hannes Malfroy
17:30 - 18:00

Q&A & wrap up

Hannes Malfroy
Nicoleta Pasecinic ANutr
Ing. Justyna Pałasińska

SPEAKERS

ING. JUSTYNA PAŁASIŃSKA

Justyna is Pen & Tec’s regulatory expert in human food and nutrition, specialising in novel food product registrations, foods for special medical purposes, food supplements and has extensive experience in the registration of feed additives in the EU and other jurisdictions.  

Justyna has an MSc in food technology and nutrition as well as a degree in biomedical engineering. For over 8 years, Justyna has been supporting Pen & Tec’s clients by managing product approvals, providing regulatory advice and designing training sessions for regulatory teams. 

Justyna has also presented at industry leading conferences on topics such as the novel food approval process in the EU and has delivered live webinars on cellular agriculture and dossier submission to the UK FSA. 

Nicoleta Pasecinic is a nutritionist by background, having graduated in Food and Human Nutrition from Newcastle University, UK. She also holds a Bachelor degree in Marketing, specialising in B2B sales.

Prior joining Pen & Tec in 2017, Nicoleta worked as a research assistant at the Institute for Health & Society at Newcastle University. During that time, she co-authored several research papers investigating maternal BMI data in UK cohorts/datasets and UK national screening policies for Gestational Diabetes.

With over 5 years’ experience in the food and feed regulatory industry, Nicoleta is an expert in EU novel food authorisation and novel food consultations, using her skills in study design, data collection, quantitative and qualitative data analysis and interpretation to help clients achieve faster market access as economically as possible.

Hannes Malfroy

Hannes Malfroy holds a BSc & MSc degree in Biochemistry & Biotechnology from Ghent University, Belgium, specialising in Plant Biotechnology and Microbiology. During his Master thesis, he interned at the Flemish Institute for Biotechnology (VIB), studying the effects of mild drought stress on plant growth.

After finishing his studies, Hannes successfully completed an internship at the R&D department of Plant Response Biotech in Madrid, where he helped developing a screening platform to detect potential biopesticide and/or biostimulant candidates. Hannes gained regulatory experience at Bayer Agriculture BVBA in Brussels, where he worked on pesticide renewal dossiers in the EU and biostimulant registrations in several countries in the EMEA region.

Hannes joined Pen & Tec in 2019 and is currently working on various feed additive and novel food submissions.

Alex Holst

Alex Holst leads the Good Food Institute (GFI) Europe’s regulatory policy work to advance alternative proteins.

GFI is an international nonprofit organisation helping to build a more sustainable, secure and just food system by transforming meat production.

GFI works with scientists, businesses and policymakers to advance plant-based and cultivated meat – making them delicious, affordable and accessible across the world.

Registration Deadline Expired!!

[Note: This event will be held on zoom. Attendee will get zoom meeting URL through email]

Pen & Tec Consulting, S.L.U.
Pl. Ausias March, 1, 4th Floor, D01
08195 Sant Cugat del Vallès, Barcelona

+34 936 758 015

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