Nutrition science is about researching and understanding the power of food and how the right diet can help us become the best version of ourselves. ‘The best’ diet looks different for everybody due to individual genes, preferences, lifestyles, and routines. Personalised nutrition, the tailoring of nutrition products, services or advice to individual characteristics such as genetics, phenotype, nutritional intake and/or exercise routine, has the potential to support consumers to achieve their health goals and to improve overall public health. This article gives an overview of the current European Union (EU) regulatory framework with regard to personalised nutrition.
Personalised Nutrition means adhering to a diet that is in line with your own genetic, phenotypic, or demographic characteristics. It has developed rapidly over the last 5 years. This rapid growth has left policymakers struggling to keep up and led to a fragmented, sometimes confusing legal environment around personalised nutrition. Unfortunately, it is not as simple as just following one piece of legislation. Rather, many directives, regulations, and guidance documents that apply to different concepts must be pieced together to cover all aspects of personalised nutrition. While EU law lays the foundation for national legislation, additional provisions and slight deviations occur and every personalised nutrition offer must be evaluated in the light of national member state law. Four main regulatory areas that need to be tackled:
Service and advice
Sale of personalised foods and drinks
Personalisation needs data, data needs protection
With any kind of personalisation, the basis is customer data – lots of it. To ensure the safety of sensible information, EU data protection rules apply wherever an individual can be identified from the data. From collecting, handling, processing, and storing information, appropriate privacy measures must be taken.
Not only the data itself but also the tools that are used for data collection are regulated. These can be collection instruments (like swabs) used by the customer directly, but also software like apps and data processing programs are considered tools. Often it is difficult to determine whether the devices are used for a medical or lifestyle-related purpose, which in turn determines the applicable laws and requirements the tools must fulfill. A new EU directive that can hopefully help to clear the confusion will enter into force starting May 2021. Until that point, personalised nutrition providers will have to comb through several separate guidance documents provided by the European Commission to see what regulations are attached to the tools they are planning to use. In some member states, additional even stricter measures might apply. In Germany, for example, the Gendiagnostikgesetz requires genetic testing for medical reasons to be conducted only by specialized doctors and after consultation with the client.
Who can give what advice? It depends…
When the testing and analysis has been done, the next step is often to provide personalised advice. Many personalised nutrition services fall somewhere between healthcare services and non-healthcare services. This is a regulatory grey area, and every case must be assessed separately. What is offered? Who is involved? What are national regulations? As a simple rule of thumb, one could say that wherever a healthcare professional is involved in a service that aims to “assess, maintain, or restore” health, the service is considered healthcare. Of course, doctors and nurses are healthcare professionals everywhere in the EU, but other professions like nutritionists and dietitians might be regulated differently in individual member states. To assess a professional’s status across member states, the EU regulated professions database can help.
Evidence is coming to justify marketing claims
Personalised nutrition is a relatively new concept and the science around it is being researched intensely. As a rapidly developing field, we can soon expect research outcomes that will justify personalised diet or lifestyle recommendations. Until then, personalised nutrition providers find themselves in somewhat of a marketing dilemma. The dominant legal requirement for marketing is for it not to mislead the consumer in any way. So, what is misleading? How much evidence is enough evidence? And what if it was not enough and the advice does turn out to be wrong?
Health and nutrition claims need a personalised nutrition update
Any food products that are attached to a personalised nutrition offer can only claim to maintain and optimize health, not to prevent, treat, or cure disease. For personalised nutrition food products to be legally placed on the market in the EU, they must comply with all provisions made about foods and ingredients. The primary objective of these is to ensure food safety.
European food law also strictly regulates the claims that can be made about the properties of food. There are two types of claims: nutrition claims and health claims. Nutrition claims refer to the nutrient content of the food while health claims mean any claim that links the consumption of food to a beneficial health effect. Only authorized claims from the EU register of nutrition and health claims may be used. All claims on that list have been studied and proven in clinical research.
Health claims generally assume that the health benefit is applicable for the average population or a large subpopulation (like children). In contrast, Personalised Nutrition focuses on one specific individual or a smaller group of individuals who share specific characteristics. The “generic” health claims may be applied to personalised foods, but no claims about further personalised benefits can be made. This makes it very difficult to communicate the benefits of personalised products. However, with new evidence, it is possible that claim applications linking a nutrient to a genetically predisposed risk factor or phenotypic characteristic will be filed in the future. Another possibility is mass-personalisation through a grouping of consumers into one genotype group, for example.
As the demand for personalised nutrition is growing, it is necessary to have an evidence based solid legal foundation. Combined with research, it is possible to make existing offers safer and better, while laying the path for many to come. It may take some time and analytical thinking to determine the right framework for every aspect of personalised nutrition concepts. EU innovation programmes such as Food 2030 and Horizon Europe have recognized Personalised Nutrition as a powerful tool to combat obesity and noncommunicable diseases, improve public health and empower people with knowledge to take their health in their own hands. These initiatives support research and strive to connect stakeholders, policymakers, and innovators to make our food system fit for the future.
This guest article was written by Nutrition Expert Anja Bronnert. At Maastricht University she met food law researchers Sabrina Röttger-Wirtz, Assistant Professor of EU Law and Alie de Boer, Assistant Professor Food Claims Centre Venlo, who recently published the article "Personalised Nutrition: The EU’s Fragmented Legal Landscape and the Overlooked Implications of EU Food Law". The publication and Anjas work in this field inspired her for this article.
BTW.: This quarter we’ll be focusing on the topic of ‘Personalised Nutrition’ - which is in the second place within the top 10 nutrition trends. Are you an expert in this field or want to share anything we should not forget about when focussing on this topic? Get in touch: email@example.com.