In our previous blog, we discussed the key regulatory changes proposed under the European Biotech Act and what they could mean for EU food and feed regulation. One of these concerns the role of the European Food Safety Authority (EFSA), particularly in the area of human nutrition.
Historically, EFSA’s mandate has focused primarily on food and feed safety, risk assessment and scientific evaluations supporting EU legislation. However, a proposed amendment to the General Food Law would explicitly empower EFSA to provide “scientific advice and scientific and technical support on human nutrition.”
This would broaden EFSA’s current mandate beyond its established role in food safety and risk assessment and give human nutrition a more explicit place in its responsibilities. The proposal reflects the increasing importance of nutrition and diet-related health issues in Europe, as well as developments in the food sector, including novel ingredients, alternative proteins and foods produced using new biotechnological processes.
For food companies, this could mean a stronger focus on nutritional science alongside safety when new foods and ingredients are evaluated. Nutrition expertise is, however, already important across several regulatory areas: substantiating health effects and planning supporting clinical studies, establishing the nutritional rationale for Foods for Special Medical Purposes (FSMPs), assessing the nutritional aspects of novel foods, and ensuring compliant nutrition-related food information and labelling.
Nutrition science is essential for health claim substantiation
Health claims play an important role in communicating the health benefits of food products to consumers. If no applicable health claim is available in the European Commission’s (EC) Health Claims Register, companies may consider applying for the authorisation of a new health claim. At Medfiles, we have observed growing interest in health claim applications, driven by novel ingredients and new areas of potential health benefit.
Nutrition science is at the core of health claim substantiation. Scientific evidence must demonstrate that a specific nutrient, ingredient or food contributes to a beneficial physiological effect. This requires an understanding of both the nutritional characteristics of the product and the scientific evidence behind the intended effect. Product characterisation, scientific evaluation and the relevance of the evidence to the intended target population are therefore important already when assessing whether a health claim is feasible.
Health claim substantiation is not only a regulatory exercise but also a nutrition science challenge. Medfiles combines regulatory and nutrition science expertise to assess the available evidence, identify evidence gaps and develop substantiation strategies for new health claims, building on more than 20 years of experience in nutrition and health claims.
Nutrition expertise helps align clinical studies with the intended health claim
Human clinical studies are often needed to demonstrate that the food or ingredient produces the intended beneficial physiological effect. Nutrition expertise is important in translating the intended health benefit into a study design that can generate relevant evidence for the health claim.
The food or ingredient needs to be sufficiently characterised, and the study population, endpoints, comparator and outcome measures need to be appropriate for the nutritional effect being investigated. Inadequate study design, insufficient scientific evidence and poor characterisation of the food or ingredient can prevent the generated evidence from adequately supporting the intended claim.
For this reason, nutrition, clinical and regulatory expertise should be brought together when studies are planned. Medfiles’ Clinical Research team works together with our nutrition and regulatory experts in clinical study planning and the drafting and review of study protocols to help ensure that the generated evidence is relevant to the intended health claim. Medfiles has over 10 years of experience in conducting clinical studies with food products, backed by experts with up to 35+ years of experience in clinical research and nutrition. Our experience includes dietary interventions with foods and ingredients such as cereals, drinks, fibres, probiotics, bioactive peptides and polyphenols.
Nutrition science provides the basis for FSMP classification and development
Foods for Special Medical Purposes (FSMPs) are specifically formulated to meet the nutritional requirements of patients with a disease, disorder or medical condition whose dietary management cannot be achieved by normal foods alone. Unlike conventional foods and food supplements, FSMPs are not permitted to bear health claims.
Nutrition science is therefore at the core of determining whether a product can be appropriately positioned as an FSMP. This requires an understanding of disease-related nutritional needs, nutrient metabolism and dietary management, as well as scientific and clinical evidence demonstrating that the product is suitable for its intended nutritional purpose.
Nutrition expertise is needed throughout the FSMP lifecycle, from product formulation and assessment of FSMP status to clinical evaluation, labelling, notification and market access.
Medfiles combines nutrition and regulatory expertise to assess whether a product fulfils the requirements for an FSMP and to support its development, notification and market access in the target country.
Nutritional impact is an important part of novel food assessment
Nutrition is an important element of novel food applications under Regulation (EU) 2015/2283. In addition to safety, the assessment considers whether consumption of a novel food would be nutritionally disadvantageous under the proposed conditions of use.
Nutrition expertise is needed to assess the composition of the novel food in the context of its intended use and expected dietary intake. Depending on the product, this may include the assessment of nutrients and antinutritional factors, bioavailability and the contribution of the novel food to the overall diet.
A robust nutritional assessment therefore forms an important part of the scientific evidence supporting a novel food application. This is particularly relevant when the characteristics or intended use of a new ingredient could affect consumers’ nutritional intake.
Medfiles has over 25 years of experience in novel food projects, including regulatory classification, consultation requests, novel food applications and traditional food notifications. Our multidisciplinary team combines expertise in nutrition, food chemistry, food science, food technology, toxicology, risk assessment and regulatory affairs.
Nutrition expertise supports accurate and compliant food labelling
Nutrition expertise is also important when translating the characteristics of a food product into accurate and compliant information for consumers. Nutrition declarations, nutrition and health claims and information for specialised product categories all need to reflect both the product’s nutritional characteristics and the applicable regulatory requirements.
Nutrition science and regulatory expertise therefore need to work together to ensure that nutrition-related information is scientifically sound, accurate and compliant.
Medfiles supports companies with nutrition-related food information and labelling, including nutrition declarations, nutrition and health claims and the specific requirements of specialised food categories.
Medfiles’ multidisciplinary expertise brings nutrition, regulatory and clinical perspectives together
Medfiles has broad experience in nutrition-related regulatory and scientific projects. Our Food & Feed team includes clinical nutritionists as well as experts in regulatory affairs, food science, food chemistry, food technology, toxicology and risk assessment. When clinical evidence is needed, our nutrition and regulatory experts work together with Medfiles’ Clinical Research team.
This multidisciplinary expertise allows nutritional, scientific and regulatory aspects to be considered together, helping companies identify the appropriate regulatory approach and evidence needs for their product at an early stage.
Medfiles continues to follow the development of the European Biotech Act and what the proposed expansion of EFSA’s role in human nutrition may mean for food companies.
Author: 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.
