Live webinar & recording | 10 November at 14:00-14:45 EET
Health claims are an important tool for communicating the health benefits of foods and food ingredients to consumers in the EU. Many businesses rely on existing authorised health claims, but what if there is no suitable authorised claim for your product or ingredient?
In recent years, a growing body of preclinical and clinical research has been generated on the potential health effects of foods and food ingredients. However, without an applicable authorised health claim, communicating these benefits to consumers can be challenging. For companies with scientific evidence behind their products, applying for a new health claim may therefore provide an opportunity to translate scientific research into an authorised marketing message and differentiate their product from competitors.
Obtaining authorisation for a new health claim requires robust scientific substantiation and a thorough understanding of the assessment criteria applied by the European Food Safety Authority (EFSA). The design of the clinical studies is particularly important: the study population, product characterisation, outcome measures, study duration and statistical methods all need to support the proposed health claim. Equally important is how the totality of the scientific evidence is presented in the health claim application.
In certain cases, applicants may also request protection of proprietary data supporting the application. If the relevant regulatory requirements are met, this may provide the applicant with exclusive use of the protected data for a period of five years.
In this webinar, our experts will take you from the use of existing health claims to the development of the clinical evidence needed to support a new claim:
- Lotta Wickholm, Regulatory Affairs Expert, will discuss the use of generic health claims in food marketing and how an authorised health claim can expand the legal possibilities for communicating product benefits.
- Pia Karjalainen and Mari Lyyra, Senior Regulatory Affairs Experts, will guide you through the EU health claim authorisation process, EFSA’s scientific requirements and the key considerations when building a health claim dossier.
- Essi Sarkkinen, Director Clinical Research, will explain what kind of clinical trials are needed to substantiate a claimed health effect and what should be considered when designing studies intended to support a health claim application.
In the webinar you’ll learn:
- How to make the most of authorised health claims in food marketing
- What information and scientific evidence are needed to support a health claim application
- What to consider when planning and conducting clinical studies for health claim substantiation
- What the key requirements are for a health claim application and its documentation
- How to obtain five-year protection of proprietary data supporting a health claim
Who should attend?
This webinar is designed for professionals working in the food and food supplement industries, particularly those involved in product development, regulatory affairs and marketing.
Please note that the places for the live session are limited, and priority is given to professionals from food and food supplement companies. Medfiles reserves the right to decline registrations from competing consultancy and service providers.
The webinar will take place on 10 November from 14:00 to 14:45 EET. The fastest registrants will have the opportunity to submit questions in advance, which our experts will address during the webinar. A recording of the webinar will be sent to all registrants.
Join us to learn how to turn scientific evidence into a regulatory strategy for communicating the health benefits of your product in the EU.
See also our previous webinar on how to get health claims approved in the EU.
Speakers
Pia Karjalainen | Team leader, Health claims and Nutrition // Senior Regulatory Affairs Expert, Food and feed
Pia Karjalainen has advised companies on various topics within food regulatory and scientific affairs throughout the past 15 years. Since the beginning of her regulatory career, Pia has focused on health claims, which has become her key competence area.
She has gained wide regulatory expertise for a vast range of food categories, such as food supplements, foods for special medical purposes, food additives, novel foods and conventional foods. In recent years, Pia has expanded her areas of expertise to include animal feed. She also has in-depth expertise in designing regulatory strategies for innovative ingredients. Her ability to understand the bigger regulatory picture and work with a solution-oriented attitude has led her to leading and handling many complex projects related to different product categories and borderline products.
Pia has earned a master’s degree in health sciences (nutrition) from the University of Eastern Finland. Prior to joining Medfiles in 2014, she worked with food regulatory affairs and as a registered dietitian in healthcare.
Mari Lyyra, M.Sc. | Regulatory Affairs Manager, Food and Feed
Mari Lyyra has worked for Medfiles since 2014 and led the Medfiles Food & Feed team in 2019-2025. Currently she is working as Regulatory Affairs Manager. Mari holds an M.Sc. in Public Health, specialising in clinical nutrition, and is a licensed nutritionist. Early in her career, Mari began focusing on food regulatory tasks in the EU. With over 25 years of extensive experience, she is well-versed in regulatory and scientific work related to traditional foods, food supplements, functional foods with health claims, food additives, food enzymes, and innovative ingredients.
Since 1999, Mari has concentrated particularly on novel foods, which has become her primary area of expertise. She has been involved in dozens of favourable novel food projects including evaluation of regulatory status of new ingredients, consultation requests and novel food dossiers in the EU. In addition to EU legislation and novel foods, she has also mastered US food legislation and practices, including GRAS and NDI for last 10 years.
Over the past decade, she has also trained in animal feed regulations and contributed to numerous animal feed projects. Mari brings extensive experience in expert and strategic consulting for clients across various projects in both the EU and the United States. She has authored numerous articles for food journals and contributed to peer-reviewed scientific publications. In recent years, Mari has delivered several lectures on food regulation at various Nordic and international events.
Lotta Wickholm | Regulatory Affairs Expert, Food
Lotta joined Medfiles in 2021 and has since been able to apply her expertise to many client projects, especially in the area of food supplement and food legislation. Lotta studied Clinical Nutrition, Food Biotechnology and Marketing at the University of Eastern Finland.
During her career, Lotta has had the opportunity to work specifically on food supplements, including product development, ingredient legality checks, labelling and assessing the legality of health claims made in the marketing of food supplements. Lotta’s expertise also covers regulations concerning food composition and labelling, and reimbursement applications of food for special medical purposes. She also regularly writes marketing and blog texts for clients.
Prior to her current role at Medfiles, Lotta worked in the food and food supplements industry.
Essi Sarkkinen | Director, Clinical Research and Medical Device
Since joining Medfiles in 2014, Essi Sarkkinen has held several leadership positions. She led the Food, Feed, and Medical Device Regulatory Unit, and later the Clinical Unit. In March 2025, she was appointed Director of Clinical Research and Medical Device.
Essi has a PhD in clinical nutrition and she is adjunct professor at the University of Eastern Finland. Essi has published dozens of scientific articles in peer-reviewed journals and supervised four academic dissertations. After her academic career, she has worked for over 15 years managing and leading contract research in the field of food and nutrition. In the beginning of the 2000s, Essi started working with clinical trials for medicinal products and good clinical practice (GCP), as well as regulatory affairs concerning food product, like health claims and novel foods.
Essi has over 30 years of experience in clinical trials and medical writing as well as know-how of R&D and regulatory affairs in the fields of food, medical devices and pharmaceuticals. All in all, she has worked in various leadership positions in contract research organisations for over 25 years.
How can Medfiles support you with nutrition and health claims?
The EU health claims regulation (EC) 1924/2006 came into force in 2007. Medfiles’ nutritionists and regulatory affairs experts have been following the preparation and implementation of the regulation ever since. Today, the Medfiles regulatory experts work daily with health claims and help companies to use existing claims for food products on the market or plan for new claims already at the product development phase.
Over the years, we have gained extensive experience with numerous health claim applications, EFSA assessments and feedback, including health claim applications that have successfully resulted in authorisation. For proposed new health claims, we review the existing scientific evidence to evaluate the potential for obtaining EU authorisation. Based on our experience with health claim applications, we can identify potential gaps in the evidence and ensure that the application contains the information required for a robust submission. We can write the application and propose what would be the best claim wording to optimise the chances of the application being approved.
Our Clinical Trials Team has extensive experience and competence in clinical food trials aimed at substantiating health claims, from the design phase to writing scientific publications. Medfiles helps and guides companies at all stages of the process.
Our over 20 years of practical experience and our commitment to continuously develop our competence ensure our place as the leading health claim experts in the Nordic countries and Northern Europe. Our expertise covers different foods, such as plant- and cereal-based ingredients, fibres and prebiotics, fats and oils, marine products (such as fish, crustaceans and algae), fungi and microorganisms (such as probiotics).
