Published at EU Food Law on Feb 28, 2017 Source: Eurofoodlaw.com: http://www.eurofoodlaw.com/food-technology/analysis-will-personalised-nutrition-replace-the-one-size-fits-all-approach--1.htm
Personalised nutrition promises the delivery of a diet based on a person's genetic makeup. But legal constraints may jeopardise the success of this service, as Katia Merten-Lentz of international law firm Keller & Heckman writes
The concept of personalised nutrition can be defined as a particular kind of personalised dietary advice based on a person's genetic makeup. The personalised nutrition approach is based on the idea that by "individualising" advice and support, each of us can, and will be motivated to, make the dietary changes necessary for our individual needs.
Instead of providing generic, one-size-fits-all, advice such as "eat at least five portions of fruits and vegetables daily", a personalised nutrition approach uses information to derive specific advice and support relevant for the individual. In other words, “show me your genes, and I will tell you your diet”.
In personalised nutrition services, manufacturers of nutritional products play a key role in order to provide people with the precise molecules they need, especially to address long-term diseases - like obesity and diabetes - in a more effective way. However, legal constraints may jeopardise the success of this very innovative healthcare service.
Investments in Personalised Nutrition The scientific community has only recently provided the scientific expertise which is making Personalised Nutrition services possible. Nutrigenomics for example, is a relatively young scientific field (2012), and it is surrounded by considerable uncertainty regarding its actual deliverables for health improvement.
At this moment, the private sector is investing more and more in personalised nutrition, especially in terms of food and technological innovations. In the US for instance, Campbell Soup recently invested $32 million in a new nutrition-focused startup called Habit that uses data from an at-home test kit; whilst another large company like Tool Box Genomics has just entered the market and secured seed round funding and will soon complete its beta testing.
In Europe, Katana, a €1.2 million investment fund, is calling for Europe’s brightest entrepreneurs to pitch their ideas and win funding for agri-food innovation, from functional foods to tech solutions for sustainable sourcing. However, personalised nutrition services may involve legal barriers which should not be underestimated.
Main EU regulatory barriers
Novel food Certain European companies are already providing food formulators capable of managing blood glucose in people with diabetes. No doubt that in the nearby future, the private sector will try to address a much broader range of diseases by seeking new molecules or new production processes. In this regard, one of the main legal obstacles may be the recently reviewed EU novel food regulation that will apply from the 1 January 2018 onwards.
This legislation has a broad scope, covering “any food that was not used for human consumption to a significant degree within the EU before 15 May 1997, irrespective of the dates of accession of Member States to the Union”.
Stakeholders investing in personalised nutrition services and food innovation should be aware of the rules and procedures related to novel foods and have to pay attention to the precise legislation applicable to their situation.
Data protection Personalised nutrition advice based on a person's genetic makeup does not only involve EU food regulatory barriers. Personalised nutrition companies stocking and processing genetic data will certainly also have to deal with data protection issues.
Genetic data are “sensitive data” which benefit from a special status under the EU data protection regulation, which will come into force in May 2018.
Under the current legislation, it is up to Member States to decide the requirements for the processing of sensitive data.
Conversely, under the new data protection regulation, data controllers will not need to obtain an authorisation by national authorities, but they will have to meet more stringent security requirements and obligations, which can be seen as a regulatory barrier for companies, but also as a safeguard for consumers from possible abuses.
What’s next? Personalised nutrition success will depend on a wide variety of different factors, all very hard to predict at this stage. First, it will primarily depend on the EU and national institutions’ willingness to find an adequate legal framework for Personalized Nutrition.
Second, its success will also depend on its effectiveness and costs in the upcoming years. Positive outcomes will surely trigger “a domino effect” that will make more and more consumers curious about this new type of healthcare/dietary services, and EU and national institutions more willing to cut down their regulatory barriers. For those investing in Personalized Nutrition services today, it is key to be aware of the regulatory framework addressing their specific situation and if possible to lobby for one providing more clarification.