The new novel food guidance related to Regulation (EU) 2015/2283 was published in September 2024 and will apply as of 1 February 2025. It covers both totally new novel foods and traditional foods from third countries. The new guidance brings new practices and requirements for companies applying for novel food authorisation. In the webinar we will cover only novel foods, not traditional foods.
The new novel food guidance is twice as long as the previous guidance and much more detailed. Especially the sections of Identity, Absorption, metabolism and excretion (ADME), Toxicological information, Nutritional information and Allergenicity have been extended significantly. One major change relates to emphasis to reduce animal testing and use other methodologies to establish safety of novel foods.
In this webinar you will learn what are the major changes of new novel food guidance compared to old guidance. If you are not familiar with the old guidance, you will anyway learn important parts of the novel food requirements.
The webinar is aimed at all interested parties who are planning or preparing a new novel food application from startups to SME and big companies.
Why attend?
- If you already know the old novel food guidance, you will learn the major changes of the new guidance
- If you only have minimum knowledge on novel foods, you will learn the important part or requirements to have a novel food approval
- Learning new requirements is essential to lead to successful novel food authorisation in the EU
The live webinar was fully booked and received excellent feedback. The average rating for the live session was 4.67 / 5.
“This was very informative and very well presented webinar. Many thanks.”
“Thank you for your nice presentation and the Q&A session!”
“It was very clear, perfect for people who are starting navigating in this field.”
“Presenters with high expertise in the topic.”
“Clear and pragmatic in the approach. Really helpful. Thank you.”
Speakers
Mari Lyyra, M.Sc.
Regulatory Affairs Manager, Food and feed
Mari Lyyra has worked for Medfiles since 2014. She graduated as an authorised nutritionist from the University of Kuopio, Finland, with a M.Sc. in Public Health, specialising in clinical nutrition. She has worked with food regulatory tasks for over 25 years, covering traditional foods, novel foods, food additives, food supplements and functional foods with health claims and innovative ingredients.
Since the beginning of her career in 1999, Mari has focused on novel foods, which has become her key competence area. Mari has extensive experience in expert and strategic consulting, with clients in various novel food projects, as well as in other regulatory tasks in the EU and the United States. She has also written numerous articles in food journals and participated in peer-reviewed articles in scientific journals. In recent years, Mari has given several lectures on food regulatory topics at various Nordic events.
Mari Eskola, Ph.D.
Senior Regulatory Affairs Expert, Team leader of Regulatory Science and Reports, Food and feed
Mari Eskola is a former staff member of the European Food Safety Authority (EFSA) and joined Medfiles in 2021. Since then, she has been involved in several projects on food and feed conducted for Medfiles’ clients.
Mari is a food chemist specialised in analytical chemistry and in 2002, she obtained a PhD degree in food science. Mari has over 25 years of international expertise in the chemical and regulatory safety of food and feed from the European Union and European national organisations as well as from the industry. She has worked for 10 years at the EFSA, carrying out EFSA regulatory risk assessments of contaminants in foods and feeds, where she also worked as acting and deputy head of the EFSA Contaminants Unit.
In addition, Mari has food and feed research and regulatory expertise from various other European institutes, such as the European Commission Joint Research Centre (EC JRC), the European Chemicals Agency (ECHA), Teagasc in Ireland, the Austrian University of Natural Resources and Life Sciences and the former Finnish Food Safety Authority. Mari has international experience in managing projects and people, and she has authored several scientific publications comprising also many scientific EFSA opinions and risk assessments.
Ingrid Hagberg, M.Sc.
Regulatory Affairs Expert & Toxicologist, Food and feed
Ingrid joined Medfiles in autumn 2023 as a Toxicologist and Regulatory Affairs Expert. Since then she has been involved in projects relating to food and feed.
Prior to joining Medfiles, Ingrid worked in the evaluation and risk management of chemical substances in food at Health Canada. She also has several years’ experience working as a food inspector for the government of Canada, including regulatory tasks in food safety and labelling. As a native English speaker, she has excellent skills for communicating with international agencies and writing reports.
She has a B.Sc. degree in Food Science from Carleton University in Canada, and a M.Sc. degree in Toxicology from the University of Eastern Finland. Ingrid has a unique skillset in both food science and toxicology which she uses to the benefits of Medfiles’ valued clients.
Medfiles novel food services
The Medfiles food regulatory affairs expert team has extensive experience in the EU Novel Food Regulation. The first Novel Food Regulation in the EU came into force in 1997, and Mari Lyyra, Head of the Food & Feed and Cosmetics unit, has followed the development of the Regulation and the related practices ever since. Today, Medfiles’ five regulatory affairs experts are working daily with many kinds of novel food projects, such as regulatory classifications (novel food or not), official consultation requests, novel food gap analyses and novel food applications. Our goal is to guide our clients through all these phases as smoothly as possible.
Over 20 years of practical experience as well as continuously updating our expertise ensure that we are among the leading experts in novel foods in the Nordics and in Northern Europe. Our expertise covers different types of foods, including chemicals, plants, fungi, marine products (such as fish, crustaceans and algae), fats and oils, fibres, grains and microorganisms, including yeast.
Free webinar: Novel food classification and route to novel food authorisation in the EU
In this webinar, we’ll provide an overview of the classification of potential novel foods, the official consultation procedure, as well as the novel food authorisation process and its requirements – with practical examples from real-life cases. We will also go through a success story of a marine novel food authorisation in which we assisted our client.
