ArticlePDF Available

Personalised Nutrition: The EU's Fragmented Legal Landscape and the Overlooked Implications of EU Food Law

September 2020
European Journal of Risk Regulation

DOI:10.1017/err.2020.79

License
CC BY 4.0

Authors:

Sabrina Röttger-Wirtz

Maastricht University

Alie de Boer

Maastricht University

Personalised nutrition, the tailoring of nutrition products, services or advice to individual characteristics such as genetics, phenotype, nutritional intake and/or exercise routine, is increasingly attracting the interest of industry, consumers and researchers. This article provides an overview of the current European Union (EU) regulatory framework as applying to personalised nutrition and draws attention to the important role of EU food law in the regulation of this innovative approach to nutrition. It is argued that personalised nutrition challenges the regulatory borderline between health and lifestyle products or services and, furthermore, also pushes the boundaries of current food safety and health claims legislation. (Open Access via: https://doi.org/10.1017/err.2020.79)

Personalised nutrition activities and regulatory frameworks applicable to these activities.

…

Figures - available via license: Creative Commons Attribution 4.0 International

Content may be subject to copyright.

Available via license: CC BY 4.0

Content may be subject to copyright.

Personalised Nutrition: The EU’s Fragmented

Legal Landscape and the Overlooked

Implications of EU Food Law

Sabrina RÖTTGER-WIRTZ*and Alie DE BOER**

Personalised nutrition, the tailoring of nutrition products, services or advice to individual

characteristics such as genetics, phenotype, nutritional intake and/or exercise routine, is

increasingly attracting the interest of industry, consumers and researchers. This article

provides an overview of the current European Union (EU) regulatory framework as applying

to personalised nutrition and draws attentiontotheimportantroleofEUfoodlawinthe

regulation of this innovative approach to nutrition. It is argued that personalised nutrition

challenges the regulatory borderline between health and lifestyle products or services and,

furthermore, also pushes the boundaries of current food safety and health claims legislation.

I. I

NTRODUCTION

The personalisation of health is a game changer in the health sector at large. Amidst this

trend, “personalised nutrition”became a buzzword, both for individual consumers and

for the industry. The number of offers for personalised nutrition advice and products are

ever-increasing, from a personalised nutrition programme developed on the basis of

continuous glucose monitoring and tracking of eating habits,1to personalised muesli

that is mixed based on an at-home blood and/or DNA test.2Where, historically,

nutrition was mainly used to prevent hunger, people today are increasingly interested

in using foods to stay healthy, or even to prevent diseases.3From the scientific

perspective, variations in responses to nutrition were already a topic of interest in the

1950s, but advancements in scientific methods such as the possibility of human

whole-genome sequencing since 2001 have made large contributions to the fields of

*Assistant Professor of EU Law, Maastricht University, The Netherlands; email: s.roettger-wirtz@

maastrichtuniversity.nl. This research has benefitted from the Fundamental Research Grant for Early Career

Scholars awarded by “Maastricht, Working on Europe”, a joint project of the City of Maastricht, Province of

Limburg and Maastricht University, to Sabrina Röttger-Wirtz and Alie de Boer.

** Assistant Professor Food Claims Centre Venlo, Maastricht University, The Netherlands; email: a.deboer@

maastrichtuniversity.nl.

European Journal of Risk Regulation (2020), page 1 of 24 doi:10.1017/err.2020.79

of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-

use, distribution, and reproduction in any medium, provided the original work is properly cited.

1<https://www.theclearhealthprogram.com/clear-nutrition-program>(last accessed 8 June 2020).

2<https://www.mymuesli.com/neuheit/personalised-nutrition/mymicro-vital>(last accessed 8 June 2020).

3N Georgiou, J Garssen and R Witkamp, “Pharma–nutrition interface: The gap is narrowing”(2011) 651 European

Journal of Pharmacology 1, p 2; B Bigliardi and F Galati, “Innovation trends in the food industry: The case of functional

foods”(2013) 31 Trends in Food Science & Technology 118, p 118.

Downloaded from https://www.cambridge.org/core. IP address: 38.145.99.193, on 17 Nov 2020 at 02:19:17, subject to the Cambridge Core terms of use, available at https://www.cambridge.org/core/terms. https://doi.org/10.1017/err.2020.79

nutrigenetics (how the genotype –the DNA sequence –affects an individual’s response to

foods) and nutrigenomics (what the effect of food is on gene expression), and thereby

enhanced the development of personalised nutrition.4

Today, dietary advice is very general and targets the full population: it gives one-size-

fits-all advices to address risk factors in the development of chronic diseases, including

obesity and diabetes type II,5with limited impact so far.6Personalising such strategies

has been suggested as more effective for changing behaviour.7Therefore, scientists

concentrate on the development of methods to analyse inter-individual differences

between people in their response to food products and how this can be translated into

nutrition advice.8In this regard, the personalisation of nutrition indicates a move away

from dietary advice for the general public to more tailored products and services that

are offered for groups of people or individuals to meet their nutritional needs.9

Therefore, personalised nutrition is not only gaining traction in the more lifestyle- and

wellness-orientated food industry, but in a public health context personalised nutrition is

presented as a promising contributor to alleviating non-communicable diseases.10

Currently, personalised nutrition is something that is available to a narrow group of

highly motivated and financially affluent consumers11 or those who engage in

personalised nutrition approaches due to certain specific circumstances like a career

in professional sports. Nevertheless, since personalised nutrition could succeed in

providing significant and sustainable changes to health, it is argued that it is very

desirable to make it accessible to the population at large,12 especially for low-income

citizens, as the burden of a developing a disease is the highest on them.13

The scientific progress in health and nutrition and the way in which it is translated into

services and goods also entails challenges from a legal and regulatory perspective.

However, so far, research into the regulatory framework for personalised nutrition has

mainly focused on data protection and medical testing devices, as well as the regulation

4BdeRoos,“Personalised nutrition: ready for practice?”(2012) 72(1) Proceedings of the Nutrition Society 48; R Fallaize

et al, “An insight into the public acceptance of nutrigenomic-based personalised nutrition”(2013) 26 Nutrition Research

Reviews 39; L Ferguson et al, “Guide and Position of the International Society of Nutrigenetics/Nutrigenomics on

Personalised Nutrition: Part 1 –Fields of Precision Nutrition”(2016) 9(1) Journal of Nutrigenetics and Nutrigenomics 12.

5M Ordovas, LR Ferguson, E Shyong Tai and JC Mathers, “Personalised nutrition and health”(2018) BMJ 361, p 1;

D Kromhout, CJK Spaaij, J de Goede and RM Weggemans, “The 2015 Dutch food-based dietary guidelines”(2016) 70

European Journal of Clinical Nutrition 869.

6L Snyder, “Health Communication Campaigns and Their Impact on Behavior”(2007) 39(2) Journal of Nutrition

Education and Behavior 32.

7Ordovas et al, supra, note 5, pp 1, 4.

8European Food Safety Authority, “Scanning the Food Safety Environment –EFSA’s Strategic Environmental

Scan Report”(2019) <https://www.efsa.europa.eu/sites/default/files/EFSA_Environmental_Scan_Report_2019.pdf>

(last accessed 8 June 2020).

9Ordovas et al, supra, note 5; J Toro-Martin et al, “Precision Nutrition: A Review of Personalized Nutritional

Approaches for the Prevention and Management of Metabolic Syndrome”(2017) 9 Nutrients 913; Food4Me

project, “Personalised nutrition: paving a way to better population health –A White Paper from the Food4Me

project”(2015) <https://www.researchgate.net/publication/317012773_White_paper_on_personalised_nutrition_

-_paving_a_way_to_better_population_health>(last accessed 8 June 2020).

10 JMathers,“Paving the way to better population health through personalised nutrition”(2019) 17 EFSA Journal 1, p 7.

11 S Adams et al, “Perspective: Guiding principles for the implementation of personalized nutrition approaches that

benefit health and function”(2020) 11 Advances in Nutrition 25, p 4.

12 ibid.

13 ibid,p7.

2European Journal of Risk Regulation Vol. 00:00

of personalised nutrition services.14 After defining the phenomenon of personalised

nutrition (Section II), this article will also provide an overview of the most important

legal requirements in these areas (Sections III and VI) by addressing the basic

requirements of consumer protection on health and lifestyle advice and the legal

requirements for gathering data and information on consumers or patients. However,

the role of food law in the regulation of personalised nutrition has only been addressed

to a limited extent.15 Where the advancements in personalised nutrition will also lead to

the production and marketing of personalised foods, European Union (EU) food law

and its requirements regarding health protection and consumer information creates

significant legal boundaries (Section V), which so far have not been intensively studied.

The aim of this article is, therefore, to provide a comprehensive overview of the current

regulatory framework established by EU law as it can be applied to personalised nutrition

and to provide novel insights into to the important role of EU food law in the regulation of

this innovative approach to nutrition. It will be demonstrated that the current legal

framework is very fragmented, which is also attributable to the multifaceted nature

of the phenomenon: various stages of the development and marketing of products

have to comply with a range of legal requirements that will be addressed in detail.

Furthermore, within personalised nutrition, the borderlines between health and

lifestyle and the corresponding regulatory frameworks fade. Generally, whereas a

lifestyle offering would aim at maintaining or optimising the status quo of the well-

being of the person concerned, it becomes a health offering where it is meant to

alleviate or prevent illness. With personalised nutrition, as this paper will show, the legal

status of a personalised offering is dependent on the type of information collected as

well as the combination and use of this information and, additionally, the aim and claim

raised by the product or service. Therefore, it will be argued that, within this already

fragmented regulatory framework, the fact that personalised nutrition is in-between

health and lifestyle gives rise to several challenges for the application of the existing

legislation in the areas concerned and leads to uncertainty concerning the applicable set

of rules. Where these rules aim to facilitate innovation in the area but also ensure health

and consumer protection, personalised nutrition is blurring the borderline between the

highly regulated medicines sector and less regulated wellness and lifestyle products and

services. Moreover, personalised food products push at the boundaries of the existing

framework for food safety and permitted health claims.

II. P

ERSONALISED NUTRITION

A DEFINITION

Although personalised nutrition is still a relatively young phenomenon, what is already

clear is that its exact contents can be multifaceted, ranging from testing services and

14 Food4Me project, supra, note 9; J Ahlgren et al, “Consumers on the Internet: ethical and legal aspects of

commercialization of personalized nutrition”(2013) 8 Genes & Nutrition 349; D Castle and N Reis, “Ethical, legal

and social issues in nutrigenomics: The challenges of regulating service delivery and building health professional

capacity”(2007) 662 Mutation Research 138; P Reilly and R DeBusk, “Ethical and legal issues in nutritional

genomics”(2008) 108 Journal of the American Dietetic Association 36.

15 A notable exception is C Ballke and A Meisterernst, “Nutrigenomics –A New Trend from a Legal Perspective”

(2014) 7 European Food & Feed Law Review 14.

2020 Personalised Nutrition 3

nutrition advice to the personalisation of different kinds of food, with varying “levels”of

personalisation from mere questionnaires to personalisation of advice and products via

gene and/or blood tests.16 What unites these various offerings is the core thinking that

personalised nutrition is more effective than general nutrition advice and that

individuals are shown to respond differently to dietary advice.17 Differences that are

experienced by individuals can, for example, be related to the individual genetic

variation that affects their ability to absorb, distribute, metabolise or excrete a

compound (kinetics).18

Generally, three layers of information can be used to increase understanding of

individual responses to food ingredients, foods and the overall diet: (1) demographic

and lifestyle-related information, such as age and frequency of food consumption;

(2) phenotypic information,19 such as body mass index (BMI) and cholesterol levels,

all of which are observable characteristics that are the expressed result of how

the genetic make-up (DNA) interacts with environmental factors (eg diet); and

(3) information based on an individual’s genotype (the DNA structure in itself),20

including the genetic predisposition for certain diseases or the (in)capacity to absorb

or metabolise a specific nutrient. These three information layers originate from data

gathered through different more or less invasive methods: data describing food intake

and eating habits via (online) questionnaires, activity tracking via wearables,

phenotypic data (gender, weight, etc.), measures of blood pressure, sampling of blood

or urine such as blood glucose levels or genetic data, which are usually collected

through buccal swabs.21

The first type of information, demographics and lifestyle, can be used to provide

stratified or tailored advice to specific subgroups of the population. Stratified, tailored

or targeted nutrition describes the aim of grouping people together based on their

personal information.22 And even though this first layer of information could already

be used to provide more individualised dietary information, the second level of

individualisation –“individualised”or “personalised”nutrition –mainly refers to the

use of phenotypic data. The third level of individualisation –“genotype-directed”

nutrition –focuses on using the genotypic data of an individual as the basis for their

personalised nutrition plan.23 These three levels of individualisation can all be used

separately to develop personalised nutrition products and services.24 Interestingly, the

potential for integrating data from different sources has resulted in the trend to focus

16 Ordovas et al, supra, note 5, p 1; Toro-Martin et al, supra, note 9.

17 Fallaize et al, supra, note 4; J Hesketh, I Wybranska, Y Dommels, M King, R Elliott, C Pico and J Keijer, “Nutrient–

gene interactions in benefit–risk analysis”(2006) British Journal of Nutrition 95.

18 Ferguson et al, supra, note 4, p 15.

19 MJ Gibney and MC Walsh, “The future direction of personalised nutrition: my diet, my phenotype, my genes”

(2013) 72 Proceedings of the Nutrition Society 219, p 221.

20 Ferguson et al, supra, note 4.

21 Food4Me project, supra, note 9, p 22; Adams et al, supra, note 11; H Forster, MC Walsh, MJ Gibney, L Brennan

and ER Gibney, “Personalised nutrition: the role of new dietary assessment methods”(2016) 75 Proceedings of the

Nutrition Society 96.

22 Ordovas et al, supra, note 5, p 1; Toro-Martin et al, supra, note 9.

23 Ferguson et al, supra, note 4; Toro-Martin et al, supra, note 9.

24 Food4Me project, supra, note 9, pp 3, 58.

4European Journal of Risk Regulation Vol. 00:00

on combining data obtained through all three of these layers.25 The addition of genotypic

data to the information obtained through analysing demographics, lifestyle, food

behaviour, (deep) phenotyping and metabolomics is now known as “precision

nutrition”.26 It is the combination and blending of the obtained insights and the

symbiosis that this creates that provide more insights into individual nutrition benefits.

These levels of individualisation can be marketed to consumers in various forms.

The umbrella term “personalised nutrition”can be used to refer to products, services

and advice.27 In this definition, personalised nutrition “products”refer to food

products that can be or are already personalised by or for consumers based on

specific individual data. “Service”concerns the gathering and analysis of personal

data to obtain information that allows for the individualisation of the diet. The most

common example of such a service is carrying out a genetic test; however, it may

also include other or additional sources of personal data, such as a questionnaire-

based analysis of dietary habits. Even though personalised nutrition advice can be

addressed separately,28 the line between service and advice is not clear cut. “Advice”

is generally considered to entail the advice given after providing some type of

information (based on the service) and how to optimise the diet based on the analysed

results.29 Both “service”and “advice”can therefore be grouped together to relate

to all steps in offering, identifying, processing and advising upon the obtained

information.30 Finally, at least certain personalised nutrition products, in their

development and production, will be based on or combined with prior services and

advice, as described above.

Therefore, to provide a working definition, personalised nutrition encompasses

products, services and/or advice (or a combination of these) that offer the

personalisation of individuals’nutrition based on their needs and preferences, using

demographic and lifestyle-related phenotypic and/or genotypic information.

III. T

HE FRAGMENTED REGULATION OF PERSONALISED NUTRITION

Having described the multifaceted definition of what constitutes personalised nutrition in

Section II, it is not surprising that the phenomenon raises various legal and regulatory

concerns. Personalised nutrition entails risks for consumers that go beyond the

traditional general nutrition advice: personalisation per se requires data, including

very sensitive health data, that deserve adequate protection; these data might be

collected through at-home tests without professional supervision; consumers might be

more likely to believe false, not scientifically substantiated claims if the advice

and products are personalised. Subsequently, the question arises as to whether

25 Ordovas et al, supra, note 5; Food4Me project, supra, note 9; Mathers, supra, note 10, p 6; Adams et al,

supra, note 11.

26 Ferguson et al, supra, note 4; Ordovas et al, supra, note 5, p 1; Toro-Martin et al, supra, note 9; Adams et al, supra,

note 11, p 3.

27 Ordovas et al, supra, note 5, p 1; Adams et al, supra, note 11.

28 ibid.

29 ibid.

30 Toro-Martin et al, supra, note 9; Adams et al, supra, note 11.

2020 Personalised Nutrition 5

personalised nutrition products are safe when consumed by someone to whom they were

not targeted.

In general, the EU’s regulatory approach to new technologies is risk-based and follows

the precautionary principle, which implies that it focuses on trying to identify the risks

that a technology entails for humans or the environment and subsequently puts into place

procedures to assess and manage the respective risks.31 Currently, at the EU level,

personalised nutrition and the risks it entails are not regulated in a sui generis form

such as a specific Regulation or Directive. This seems to also hold true for the

legislation of the Member States.32 The European Commission in 2016 conducted a

workshop on “smart personalised nutrition”(SPN) and concluded that it is necessary

to “establish a legal and ethical framework for SPN and promote its international

harmonization. This should encompass data sharing frameworks, privacy laws,

information law and food legislation”.33

Nevertheless, the absence of a specific regulatory framework does not mean that the

phenomenon is unregulated. On the contrary, personalised nutrition falls within the scope

of various existing legal instruments, the application of which will differ with regard to

the type of personalised nutrition product, service or advice in question. The application

of existing legislation to emerging technologies, or “recombinant regulation”,34 as Ellen

Stokes calls it, is not a rare occurrence in risk regulation and the approach to new

technologies in the EU.35 This does not necessarily require the adoption of new

legislation.36 For example, in the regulation of nanotechnologies, the “incremental

approach”was chosen, where the existing legislation was reviewed and adapted

where this was deemed necessary.37

Although in the context of personalised nutrition no formal process has been carried

out to assess the applicability and effectiveness of the various existing legal provisions in

place, it is clear that many of the risks identified with regard to personalised nutrition fall

within the remit of existing legislation. With regard to personalised nutrition, next to the

EU law applying to the provision of personalised nutrition services and general consumer

protection measures, the risks associated with the gathering of personalised nutrition data

and the development of food products are also subject to existing EU law (Table 1).

This means that companies interested in developing personalised nutrition services or

products are faced with a multitude of legal requirements arising from various legal

sources. For companies developing a product, it is essential to know which legal

framework will apply to them, because the regulatory requirements and, therefore, the

31 See further: M Cremona, “Introduction”in M Cremona (ed.), New Technologies and EU Law (Oxford, Oxford

University Press 2017) pp 1–6.

32 Food4Me project, supra, note 9, p 72.

33 <https://ec.europa.eu/research/bioeconomy/pdf/spn_quo_vadis_final.pdf>(last accessed 8 June 2020).

34 E Stokes, “Recombinant Regulation: EU Executive Power and Expertise in Responding to Synthetic Biology”in

M Weimer and A de Ruijter, Regulating Risks in the European Union: The Co-production of Expert and Executive

Power (Oxford, Oxford University Press 2017), pp 59–79.

35 M Kolacz and A Quintavalla, “Law in the Face of Disruptive Technology, An Introduction”(2019) 10 European

Journal of Risk Regulation 1; Cremona, supra, note 31.

36 Kolacz and Quintavalla, supra, note 35.

37 GvanCalster,“Simply Swallow –The Application of Nanotechnologies in European Food Law”(2009)

4 European Food & Feed Law Review 167; T Ehnert, “The Legitimacy of New Risk Governance –A Critical View

in Light of the EU’s Approach to Nanotechnologies in Food”(2015) 21 European Law Journal 44.

6European Journal of Risk Regulation Vol. 00:00

hurdles of proving the safety and the efficacy of the product are diverging. Especially in

precision nutrition, development costs are expected to be high,38 and it will be essential

for companies to understand the regulatory requirements and the costs that they give rise

to early in the research and development process.39 From a consumer protection

perspective, it is important to understand the regulatory mechanisms in place and to

question how the existing legislation ensures the safety of the products and prevents

misleading claims.

IV. P

ERSONALISED NUTRITION

BLURRING THE BORDERLINE BETWEEN

HEALTH AND LIFESTYLE IN THE EXISTING REGULATORY FRAMEWORK

As discussed in the previous section, personalised nutrition is subject to various

pre-existing regulatory measures. In this section, we will provide an overview and

analysis of the application of EU law to personalised nutrition in more detail. We will

examine the legislation that is applicable to gathering data for the personalisation of

nutrition, the provision of nutrition advice and services on the internal market and the

marketing of personalised nutrition. What will become evident in the analysis is that

personalised nutrition can be categorised between healthcare and lifestyle-related

products and services,40 which affects the question as to which legal framework will

be applicable.

Table 1. Personalised nutrition activities and regulatory frameworks applicable to these activities.

Activity European Union regulatory framework applicable

Collecting data Data Protection (especially GDPR)/Privacy

Medical Devices Regulation/IVDD Regulation

Providing advice and/or offering

a personalised nutrition service

Free Movement of Services/Services Directive

Patients’Rights Directive

Marketing Unfair Commercial Practices Directive

Consumer Rights Directive

E-Commerce Directive

Food product development

and sale

Food Law (especially General Food Law; FIC Regulation;

Nutrition and Health Claims Regulation)

FIC =Food Information to Consumers; GDPR =General Data Protection Regulation; IVDD =In Vitro Diagnostic

Medical Device.

38 Ordovas et al, supra, note 5, p 4.

39 SBröring,“The role of open innovation in the industry convergence between foods and pharmaceuticals”in

M Martinez (ed.), Open Innovation in the Food and Beverage Industry (Cambridge, Cambridge University Press

2013), pp 39–62, 50f.

40 F Lucivero and B Prainsack, “The lifestylisation of healthcare? ‘Consumer genomics’and mobile health as

technologies for healthy lifestyle”(2015) 4 Applied & Translational Genomics 44; Food4Me project, supra, note 9,

p 89; Ahlgren et al, supra, note 14, p 352f.

2020 Personalised Nutrition 7

1. Gathering data: data protection and privacy

The whole premise of personalised nutrition –the personification of nutrition advice,

services and products –depends on obtaining information about individuals. The

ever-increasing ability to process data is a catalyst for the personalisation of nutrition,

and it is very likely that online tools (such as apps)41 will play a big role in this

developments in collecting information and in providing services to consumers.42 The

legal and ethical questions of data protection and privacy in the context of

personalised nutrition are extensive, which is why this section only provides an

overview.43

In the EU, the rights to privacy and data protection are fundamental rights: Article 7 of

the Charter of Fundamental Rights of the European Union grants the right to respect for

private and family life, while Article 8(1) of the Charter and Article 16(1) of the Treaty on

the Functioning of the European Union (TFEU) provide the correlated right to the

protection of personal data. Concrete norms on how to handle data can be found in

the General Data Protection Regulation (GDPR),44 which applies when personal data

are processed, which includes collecting, storing, disseminating and combining data.45

Information constitutes personal data if it relates to an identified or identifiable natural

person,46 which in times of Big Data and technological processes becomes an

increasingly broad category, as it becomes more and more likely that, through a

combination of available data, certain information can be traced back to an

individual.47 Personalised nutrition depends on the processing of personal data:

obviously, the name of a person is personal data, but also information such as height

and weight can be personal data if they can lead to identifying a person (eg when

combined with other data). It is also important to stress that DNA can constitute

personal data in itself (person X has this DNA), while it may also establish a link

between another piece of information and the individual, as the individual DNA is

specific to an individual and may be used to identify the person.48 In addition, for

human tissue samples, it has been made clear that extracting information from such

samples constitutes the collection of personal data.49

Where personal data are processed in the context of personalised nutrition, several

protection mechanisms apply. The GDPR in Article 5 lays down several key

principles applying to the processing of personal data, such as lawfulness, fairness

41 This can then fall under “mobile health”(mHealth). See further: European Commission, Green Paper on mobile

Health (“mHealth”), COM(2014) 219 final, Brussels, 10.4.2014.

42 Food4Me project, supra, note 9, p 79.

43 See further: Ahlgren et al, supra, note 14; Castle and Reis, supra, note 14.

44 Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on

the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), OJ 2016 L 119,

pp 1–88 (hereafter GDPR).

45 Art 4(2) GDPR.

46 Art 4(1) and Recital 26 GDPR.

47 For a detailed discussion, see N Purtova, “Health data for common good: Defining the boundaries and social

dilemmas of data commons”in S Adams, N Purtova and R Leenes (eds), Under Observation: The Interplay

between eHealth and Surveillance (New York, Springer International 2016) pp 177–210.

48 Art 29 Working Party, Letter to the European Commission, Annex, 5 February 2015.

49 ibid.

8European Journal of Risk Regulation Vol. 00:00

and transparency, purpose limitation and data minimisation. The lawfulness in terms of

the grounds of the processing can be based on freely given, informed, specific and

unambiguous consent, or on several other grounds, to be found in Article 6 of the

GDPR.50 Next to the responsibility that the GDPR assigns to companies that control

the data in accordance with these principles, the GDPR also gives rights to the data

subject (the person who’s data are processed), including rights of information, access,

rectification, erasure, object, data portability and a protection against certain types of

automated decision-making.51 The GDPR in Chapter IV also places several other

obligations on companies that would process personal data in the context of offering

personalised nutrition.

The personalisation of nutrition products, advice and services will not only require the

processing of personal data, but might also presuppose the processing of data concerning

the health of a person. Such data are sensitive data and subject to the even stricter

protection of Article 9 of the GDPR. According to Article 4(15) of the GDPR, data

concerning health are defined as: “personal data related to the physical or mental

health of a natural person, including the provision of health care services, which

reveal information about his or her health status”. This applies to data which “reveal

information relating to the past, current or future physical or mental health status of

the data subject”,52 and Recital 35 explicitly mentions “information derived from the

testing or examination of a body part or bodily substance, including from genetic data

and biological samples ::: and any information on, for example, a disease, disability,

disease risk :::”.53

This type of data, as well as genetic data and biometric data,54 cannot be processed

unless this is authorised under the conditions of Article 9(2). Article 9(2) then lists

several circumstances under which such processing is allowed, the most important in

the context of personalised nutrition being explicit consent (Article 9(2)(a)) and the

processing for purposes of preventative or occupational medicine, carried out by a

professional subject to the obligations of profession secrecy (Article 9(2)(h) and 9(3)).

Notably, the necessity for the performance of a contract is not an acceptable

exception in the processing of health data. The GDPR does not further specify which

additional requirements apply to explicit consent as opposed to regular consent,

which has to be “freely given, specific, informed and unambiguous”,asdefinedin

Article 4(11) GCPR. Guidelines by the Article 29 Working Party indicate that

“explicit”isreferringtothewayinwhichconsentisgiven,inthesensethatitmust

be an express statement of consent, preferably in writing and potentially even signed

or via two-staged verification in the digital context.55

50 The definition of consent is to be found in Art 4(11) GDPR.

51 Arts 12–23 GDPR.

52 Recital 35 GDPR.

53 ibid.

54 The definitions of genetic and biometric data are to be found in Arts 4(13) and (14) GDPR.

55 Art 29 Working Party, Guidelines on consent under Regulation 2016/679, As last Revised and Adopted on 10 April

2018, WP259 rev.01, pp 18–20.

2020 Personalised Nutrition 9

Ultimately, the borderline between personal data and health data is fluid:56 data about

the health status of a person as generated in a professional medical context are clearly

health data and so are especially protected.57 However, information that pertains to a

scientifically proven risk indicator (eg high blood pressure or obesity) also constitutes

health data.58 Furthermore, data such as the tracking of the sport activities of a person

or dietary information are not in themselves health data, although they can become

health data where they are combined with other information and conclusions can be

drawn on the person’s health status.59 This means that in the processing of data in

the context of personalised nutrition offerings, the extent of data protection –and the

corresponding rights and duties –depend not only on the nature of the data processed,

but also on the question of how they are combined. It does not matter whether, for

example, an app is marketed more as a lifestyle app than making explicit health benefit

claims –it still might process health data. For the consumer, it might not always be

obvious that they are volunteering sensitive health data, especially if the nutrition advice

is offered outside of the medical context. Moreover, the understanding of the risks

attached to sharing these data might not be entirely clear to them.60

2. Collecting data: medical devices and the regulation of genetic testing

Offering personalised nutrition can require the use of devices, such as the tools used to

collect samples for blood or buccal cell swabs. Some of the equipment and technology

used in the personalisation of nutrition will qualify as medical devices and, therefore, will

be subject to EU law. In this regard, “medical device”refers to a broad range of products

such as instruments, appliances or software, which are produced with the intention of

medicinal use, thus for the purpose of diagnosis, prevention, monitoring, treatment or

alleviation of disease.61 The additional category of in vitro diagnostic devices, which

are devices such as test kits, intended for the collection and examination of specimens

(including tissue and blood) taken from the human body to examine the physiological

state of someone or to monitor therapeutic treatment, is subject to a separate piece of

legislation with specific requirements.62

Therefore, the manufacturing and marketing of medical devices is subject to EU

harmonisation.63 However, the legislation itself is limited to establishing essential

56 For a detailed discussion of the difficulty in defining a borderline, see Purtova, supra, note 47.

57 Art 29 Working Party, supra, note 55.

58 ibid.

59 ibid.

60 For a more comprehensive analysis of how, especially with regard to devices from the Internet of Things (eg smart

watches), the creation of personalised data sets and offering of personalised services are in conflict with user privacy, see

S Wachter, “Normative challenges of identification in the Internet of Things: Privacy, profiling, discrimination, and the

GDPR”(2018) 34(4) Computer Law & Security Review 436.

61 Art 1(2)(a), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169, 12.7.1993,

pp 1–43.

62 Art 1, Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic

medical devices, OJ L 331, 7.12.1998, pp 1–37.

63 For an introduction to medical device regulation, see N Chowdhury, European Regulation of Medical Devices and

Pharmaceuticals –Regulatee Expectations of Legal Certainty (Berlin, Springer 2014); C Altenstetter and G Permanand,

“EU Regulation of Medical Devices and Pharmaceuticals in Comparative Perspective”(2007) 24 Review of Policy

Research 390.

10 European Journal of Risk Regulation Vol. 00:00

requirements regarding the safety and performance of the devices, containing minimum

requirements concerning the reduction of risks to patients and the efficiency of the

products. In order to demonstrate that a medical device conforms with these essential

requirements, it will have to fulfil the technical specifications that are adopted in the

form of harmonised standards by private standardisation bodies. Their compliance

will be assessed by so-called notified bodies. Manufacturers must apply for

assessment with a notified body in order to obtain certification, while some low-risk

products can even be self-certified. A product that has shown compliance with the

standards –and therefore the essential requirements in the legislation –will be

certified, can bear the CE mark and subsequently can be sold in the EU.

As personalised nutrition services will often be offered outside of the classical

healthcare setting, the defining question for the qualification of a piece of equipment

or a technology as a medical device will be whether the personalisation of nutrition in

a general or specific case would qualify as a medical purpose or would be seen as

lifestyle related. This is especially difficult to determine with regard to software such

as apps or algorithms to support dietary advice, which can constitute medical devices,

but this depends very much on its intended use. A similar problem in the distinction

between health and lifestyle is also present with regard to genetic testing kits.64

Nevertheless, this characterisation problem is partially addressed by a recent revision

of the medical device legislation. Currently, the EU is in a transition phase between

the three previous Medical Device Directives,65 which have been replaced in April

2017 by two new Regulations.66 The two new Regulations were meant to apply after

a transition period in May 2020 (medical devices) and May 2022 (in vitro diagnostic

devices); however, this has now been delayed by a year due to the COVID-19

crisis.67 The new Medical Device Regulation includes the prediction of diseases as a

medical purpose and therefore means that the tools used in personalised nutrition

services will be covered by the legislation if they are used to predict the disease

predisposition of a person.68 Moreover, the new In Vitro Diagnostic Medical Device

(IVDD) Regulation also includes devices aimed at “providing information :::

concerning the predisposition to a medical condition or a disease”69 in its definition.

The IVDD Regulation also specifically addresses genetic testing in Article 4 and

requires the informed consent of the person being tested. Thus, under the new

64 See further: Food4Me project, supra, note 9, p 82ff. For an overview of the developments in direct-to-consumer

genetic testing, see A Phillips, “Only a click away –DTC genetics for ancestry, health, love ::: and more: A view of the

business and regulatory landscape”(2016) 8 Applied & Translational Genomics 16.

65 Council Directive 93/42/EEC; Directive 98/79/EC; Council Directive 90/385/EEC of 20 June 1990 on the

approximation of the laws of the Member States relating to active implantable medical devices, OJ L 189,

20.7.1990, pp 17–36.

66 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices,

amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing

Council Directives 90/385/EEC and 93/42/EEC; OJ L 117, 5.5.2017, pp 1–175; Regulation (EU) 2017/746 of the

European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing

Directive 98/79/EC and Commission Decision 2010/227/EU, OJ L 117, 5.5.2017, pp 176–332.

67 Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation

(EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions, OJ L 130, 24.4.2020,

pp 18–22.

68 Art 2(1), Regulation (EU) 2017/745.

69 Art 1(2)(c), Regulation (EU) 2017/746.

2020 Personalised Nutrition 11

legislation, tests that are performed outside of the classical health setting but are aimed at

providing information on disease predisposition also qualify as (in vitro) medical devices

and will have to be manufactured and marketed in accordance with the applicable

Regulation.

While the medical devices used in genetic testing are regulated at the EU level, this

does not hold true for the different methods in which genetic testing can be offered or

by whom it is offered. Questions relating to medical supervision or informed consent

are subject to national legislation and are hardly harmonised at the EU level.70

Traditionally, genetic testing took place in a medical or clinical setting for health-

related reasons, whereas with personalised nutrition genetic testing is not restricted to

a clinical setting, but also includes a lifestyle-related offer that commercial parties

directly market to interested consumer. Member States are free to restrict and regulate

direct-to-consumer genetic testing and have done so in very diverging ways.71

Generally, we can distinguish between whether or not a country prohibits genetic

testing outside of medical supervision and whether or not (professional) counselling

is required, and there is variation in the rules concerning informed consent. Some

countries, such as France and Germany, restrict genetic testing for health purposes to

the medical supervised used, which essentially constitutes a prohibition of direct-

to-consumer testing.72

3. Offering advice and services on the internal market

EU law also affects who can offer personalised nutrition services, such as carrying out

tests regarding nutrition deficits, gene tests or the provision of nutrition advice and under

which conditions. Thus, on a case-by-case basis, depending on the nature of the service

and the professional providing it, either the Services Directive73 or the Patients’Rights

Directive74 will be applicable, but only where the service is provided cross-border, as

otherwise the national legislation will govern the provision of the service. The main

importance of EU law in this regard is that it simplifies offering personalised nutrition

services outside of the Member State where the service provider is established by

guaranteeing the freedom to provide services.75 This is further specified in the

Services Directive, which minimises administrative burdens on service providers.

From a consumer protection perspective, the Directive is relevant because it entails

certain rights for the recipient of a service, minimum information to be provided to

the customer and rules on professional liability.76

70 L Kalokairinou et al, “Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory

landscape”(2018) 9 Journal of Community Genetics 117.

71 ibid.

72 ibid; Ballke and Meisterernst, supra, note 15, p 18.

73 Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the

internal market, OJ L 376, 27.12.2006, pp 36–68.

74 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of

patients’rights in cross-border healthcare, OJ L 88, 4.4.2011, pp 45–65.

75 Arts 56–62 Treaty on the Functioning of the European Union (TFEU), Consolidated Version, OJ C 326,

26.10.2012, pp 47–390.

76 Arts 19–23 Directive 2006/123/EC.

12 European Journal of Risk Regulation Vol. 00:00

However, personalised nutrition can, under certain circumstances, fall outside the

Services Directive and into the remit of the Patients’Rights Directive which applies

to cross-border healthcare.77 According to Article 3(a) of the Patients’Rights

Directive, healthcare is defined as “health services provided by health professionals to

patients to assess, maintain or restore their state of health, including the prescription,

dispensation and provision of medicinal products and medical devices”. Therefore,

depending on who is involved in the provision of personalised nutrition services, this

might qualify as healthcare. In this regard, doctors and nurses fall under the definition

of health professionals as regulated professions in the healthcare sector.78 Notably,

many countries have regulated the profession of dieticians, which means that the title

can only by carried and the respective tasks can only be executed by persons who

have obtained the required professional qualification.79 In Germany, for example,

a“Diätassitent(in)”is someone who “(a)dministers dietary and nutritional therapies as

prescribed by or upon prescription of a medical practitioner; helps prevent and treat

medical conditions; offers nutritional advice to patients and runs courses on nutrition;

accepts full responsibility for his/her work”.80 Thus, providers of personalised

nutrition services will have to carefully examine whether they can offer their

specific service in a Member State that might regulate dietary advice. The Patients’

Rights Directive mostly concerns questions of facilitating cross-border healthcare and

regulating its reimbursement; for consumers/patients, it is mainly relevant due to

the minimum information it requires to be provided in order to enable informed

decision-making.81

4. Marketing: contracts and advertising

Finally, EU law also places limits and conditions on the marketing of personalised

nutrition services and products and grants certain consumer protection rights. First of

all, Directive 2005/29/EC on unfair business-to-consumer commercial practices,

the enforcement of which currently has been strengthened, prohibits misleading

commercial practices, including deceiving information.82 As argued by Ballke and

Meisterernst, if a personalised nutrition product or service offered would, for

example, fall short of providing the state-of-the-art genetic analysis concerning

predisposition for certain diseases that the consumer would legitimately expect

77 For a more detailed analysis on the implications of either the Services Directive or the Patients’Rights Directive

applying, see Food4Me project, supra, note 9, pp 73–77.

78 Art 3(f) Directive 2011/24/EU.

79 The European Commission has created a database on regulated professions, which provides an overview of

which Member States regulate the profession of dieticians and which rules apply: <https://ec.europa.eu/growth/

tools-databases/regprof/index.cfm?action=profession&id_profession=1380&from=regprof&id_regprof=919>(last

accessed 3 August 2020).

80 Diätassistentengesetz vom 8. März 1994 (BGBl. I S. 446). The translation is derived from <https://ec.europa.eu/

growth/tools-databases/regprof/index.cfm?action=regprof&id_regprof=919&id_profession=1380&tab=countries&quid=2

&mode=asc&pagenum=1>(last accessed 3 June 2020).

81 Art 4(2)(b), Directive 2011/24/EU.

82 Arts 6 and 7, Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning

unfair business-to-consumer commercial practices in the internal market, OJ L 149, 11.6.2005, pp 22–39.

2020 Personalised Nutrition 13

through the information provided about the product, this would be a misleading

practice.83 In such cases, the Directive grants rights to proportionate and effective

remedies, which might be in the form of damages, but the exact nature of this is

dependent on national law.84

Additionally, Directive 2011/83/EU on consumer rights harmonises the protection of

consumers in contacts between them and traders, including distance sales contracts but

excluding contracts for healthcare.85 It provides for minimum information that needs to

be given to the consumer before the conclusion of a contract and grants a 14-day

withdrawal right for distance contracts.86 In case a personalised nutrition product or

service is offered via the Internet, the E-Commerce Directive 2000/31/EC applies as

lex specialis, requiring for certain information to be provided and regulating

contractual matters.87 Article 8 of the Directive particularly specifies that services

provided by members of regulated professions need to be performed in accordance

with the applicable regulations for this profession.

V. T

HE MISSING PIECE

DEVELOPING AND SELLING A FOOD

PRODUCT

–

SAFETY AND CONSUMER PROTECTION

The discussion of personalised nutrition in the literature often focuses on the technical

and technological regulation discussed in Section IV; however, it fails to address the

regulation of personalised nutrition products: foods that are personalised by or for the

consumer, such as the muesli mentioned in Section I. As will be discussed in this

section, the development of such products challenges the existing legal framework for

foods, which is aimed at ensuring a balance between internal market values, including

the free movement of goods, while guaranteeing a high level of human health and

maintaining consumer protection against misleading practices.88 First, personalised

foods blur the borderline between foods and medicinal products. Second, as will be

argued in this section, while the scientific progress allows for personalisation of

nutrition products and services, the legal framework is focused on general safety

protection, ensuring that only food products that are proven to be safe and have

health benefits for the general population are allowed. Therefore, personalised

nutrition is pushing at the boundaries of EU food law and the norms established for

the science-based decision-making in the field.

83 Ballke and Meisterernst, supra, note 15, p 18.

84 Art 11, Directive 2005/29/EC.

85 Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights; OJ L

304, 22.11.2011, pp 64–88.

86 Arts 5–16, Directive 2011/83/EU.

87 Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of

information society services, in particular electronic commerce, in the Internal Market, OJ L 178, 17.7.2000, pp 1–16.

88 Art 1(1), Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying

down the general principles and requirements of food law, establishing the European Food Safety Authority and laying

down procedures in matters of food safety OJ L 31, 1.2.2002, pp 1–24 (hereafter General Food Law, GFL).

14 European Journal of Risk Regulation Vol. 00:00

1. Blurring the food–medicine borderline

From a regulatory perspective, foods and medicines are two strictly separate categories of

products, with diverging legal frameworks and requirements. Article 2 of the General

Food Law (GFL) contains a very broad definition of food encompassing “any

substance or product, whether processed, partially processed or unprocessed, intended

to be, or reasonably expected to be ingested by humans”. This has to be opposed

with cases in which the (claimed) effect on health is so prominent that it would fulfil

the definition of a medicinal product. Article 1(2) of Directive 2001/83/EC defines

medicinal products as any substance or combination of substances that either is

“presented as having properties for treating or preventing disease in human beings”or

that “may be used in or administered to human beings either with a view to restoring,

correcting or modifying physiological functions by exerting a pharmacological,

immunological or metabolic action, or to making a medical diagnosis”. Thus, the

qualification as medicinal product either follows from the presentation of the product

or from its function. The Directive also clarifies that, in cases where it is unclear

whether a product might be qualified as a medicinal product or as another regulated

product (eg a food product), then the application of the pharmaceutical legislation

takes precedence.89 This hierarchy of regulatory frameworks is also confirmed in the

GFL, which in Article 2(d) excludes the application of the GFL to medicinal products.

In simpler terms, food can play a role in maintaining and possibly also improvinghealth,

whereas a product is a pharmaceutical where it is (claimed to be) used to prevent, treat or

cure a disease.90 However, some personalised nutrition products will be difficult to

characterise as either food or medicinal product. Where personalised nutrition products

are aimed at preventing someone from developing a disease to which that person is

genetically predisposed or where it is targeted at remedying someone’s serious nutrient

deficiency, this borderline is difficult to determine. Generally, it has been argued that

foods and nutrition can play a preventative role and provide their benefits only over a

certain amount of time, whereas pharmaceuticals provide an immediate effect.91

However, certain foods also have immediate effects (eg polysterol-enriched foods

reducing blood cholesterol levels).92 Today, the scientific and technological advances in

phenotyping and genomics as used in personalised nutrition are further blurring the

borderline between food and medicinal products.93

Moreover, the qualification of the product as one or the other has regulatory

consequences and, once a product crosses the fine borderline from foodstuff to a

medicinal product, it is subject to an even heavier regulatory burden and has to obtain

a marketing authorisation before it can be sold.94 When the presentation or function

89 Art 2(2), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the

Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, pp 67–128.

90 Georgiou et al, supra, note 3, p 2.

91 Bröring, supra, note 39, p 50.

92 ibid.

93 ibid, p 49.

94 For an overview of EU pharmaceutical regulation, see E Jackson, Law and the Regulation of Medicines (Oxford,

Oxford University Press 2012); S Shorthose, Guide to European Pharmaceutical Regulatory Law (Alphen aan den Rijn,

Wolters Kluwer 2013); M Manely and M Vickers (eds), Navigating European Pharmaceutical Law (Oxford, Oxford

University Press 2015).

2020 Personalised Nutrition 15

of the personalised food does not make it a medicinal product, it remains a food for the

purposes of EU law, which does not imply that it is not regulated. On the contrary, the

GFL and other more specific secondary legislation also impose several obligations that

have to be honoured at every stage of food production and processing, as well as during

its distribution.95

2. Pushing the boundaries: safety –for whom?

First and foremost, like any other food, personalised nutrition products must not be

injurious to health and not be unfit for human consumption (eg through decay),

according to Article 14 of the GFL.96 While food safety is generally concerned with

the safety of food for the general population,97 how does it address a situation where

a personalised nutrition product is beneficial for a person or groups of persons, while

potentially unsafe for the public at large?

In case a product is created to serve the nutritional needs of a certain individual or group

of individuals, it might be possible that its consumption by the average consumer would

have negative effects on health. This is exemplified by plant sterols, which are added to

products such as margarine and can claim to lower cholesterol, which reduces a risk factor

in the development of coronary heart disease.98 However, at the same time, consumption

can also lead to an increase in plasma concentrations of phytosterols (for which the

consequences on cardiovascular risk are unknown) and a reduction in plasma

concentrations of β-carotene (which is likely to increase cardiovascular risk).99 In this

case, the EU introduced a mandatory warning label stating that the product is not

intended for people that do not need to control their blood cholesterol level.100

In particular, pregnant and breastfeeding women and children are recommended not

to consume food fortified with phytosterols.101

When examining whether the GFL would cover a situation where a personalised

nutrition product would be harmful if consumed by someone other than the intended

consumer, it should be considered that the GFL does not require a food to be safe,

but rather requires is not to be unsafe.102 Generally, European food law operates on

the presumption that food is safe and that, by controlling hazards in the supply chain

95 Art 1(3) General Food Law.

96 Art 14 General Food Law.

97 Art 14 of the General Food Law refers to health and human consumption in a general way, while only Art 14(4)(c)

addresses the case of marketing a food to specific consumer groups.

98 European Food Safety Authority, “Scientific Opinion on the substantiation of a health claim related to 3 g/day plant

sterols/stanols and lowering blood LDL-cholesterol and reduced risk of (coronary) heart disease pursuant to Article 19 of

Regulation (EC) No 1924/2006”(2012) 10 EFSA Journal 2693.

99 See information provided by the French Agency for Food, Environmental and Occupational Health & Safety

(ANSES): <https://www.anses.fr/en/content/foods-fortified-phytosterols-and-prevention-cardiovascular-disease>

(last accessed 8 June 2020).

100 Commission Regulation (EU) No 718/2013 of 25 July 2013 amending Regulation (EC) No 608/2004 concerning

the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol

esters. Text with EEA relevance, OJ L 201, 26.7.2013, pp 49–50.

101 ANSES, supra, note 99.

102 A Meisterernst, Lebensmittelrecht (Munich, Beck C. H. 2019), p 26.

16 European Journal of Risk Regulation Vol. 00:00

(through food safety management systems), risks are minimised.103 This changes where a

food business operator realises or has reason to believe that food is unsafe (Article 19(1)

GFL). Moreover, for specific foods where the legislator has deemed the presumption of

safety not to exist, such as novel foods where no history of consumption would vouch for

their safety, the food business operator will have to prove the safety of the food.104

Therefore, certain studies need to be conducted (eg sub-chronic toxicity studies) or

specific end points need to be reported to show that such foods are safe for the

general population.105

What is essential when assessing the (un)safety of food are the conditions of use that

are normally to be expected.106 A personalised food that is specifically made for one

person could therefore presumably be expected to be consumed by this person or a

group of consumers sharing specific similarities and no one else. Where a food is

intended for a certain category of consumers, the health sensitivities of this specific

consumer segment, such as infants or elderly people, need to be taken into

account.107 However, when such a product would be sold in a normal supermarket, it

could be expected that someone else would buy it (much like in the fortified

margarine example above). Where a product is harmful to a group of people with

health sensitivities that it was not marketed for, it is not automatically injurious in the

sense of Article 14.108

Finally, the information provided to consumers is also taken into account in

determining the potential unsafety of food (Article 14(3)(b)). Overall, if a

personalised nutrition product is accessible to the public at large, for products that

have known unwanted side effects in the general population or any non-target group,

additional information on the packaging is probably necessary. For specific sensitive

groups of the population (eg those suffering from allergies), this additional

information is already provided: foods that contain one of the fourteen specified

allergens or that could be contaminated with such allergen need to carry a warning on

their label or the related information on the food.109 In addition, other specific food

legislation recognises the need to inform vulnerable groups about risk (as exemplified

103 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls

and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare,

plant health and plant protection products, OJ L 95, 7.4.2017, pp 1–142.

104 Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods,

OJ L 327, 11.12.2015, pp 1–22.

105 An example of such required studies is the repeated-dose 90-day oral toxicity study, which is required in the

scientific dossiers of genetically modified foods and crops, but is also highly suggested in guidance documents for

other foods for which sub-chronic toxicity needs to be established, including Regulation (EU) No 2015/2283.

106 This also means that cases of misuse and excessive consumption are not covered. Meisterernst, supra, note 102,

p 138.

107 Art 14(4)(c), General Food Law.

108 Standing Committee on the Food Chain and Animal Health, Guidance on the implementation of Articles 11, 12,

14, 17, 18, 19, and 20 of Regulation 178/2002, p 9, via <https://ec.europa.eu/food/sites/food/files/safety/docs/

gfl_req_guidance_rev_8_en.pdf>(last accessed 8 June 2020).

109 The Food Information to Consumers Regulation lists allergens as mandatory particulars to be inserted on the food

label: Art 9(1)(c), Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on

the provision of food information to consumers, OJ L 304, 22.11.2011, pp 18–63 (hereafter FIC Regulation).

2020 Personalised Nutrition 17

for non-intended consumer segments for fortified margarine), although not classifying

such foods as unsafe.110

In summary, although personalised nutrition pushes at the boundaries of the rules

regarding food safety, personalised nutrition does not seem to raise safety risks that

would be so new that they are either not adequately addressed in the current legal

framework or could not already be contained within existing risk mitigation measures

such as adequate labelling.

3. Pushing the boundaries: claims made on personalised nutrition

In addition to food safety, EU food law also aims to protect consumers against false

claims, such as unsubstantiated statements about the health effects of a food product.

In this regard, most important in the context of the debate surrounding personalised

nutrition –the sometimes unproven claims made111 –is the obligation that the

labelling, advertising and presentation, including packaging and information

provided, shall not be misleading.112

This is further specified in the Food Information to Consumers (FIC) Regulation,

which covers any information that is provided to the final consumer concerning a

food, including the label and packaging, but also any other accompanying material,

advertising and technological tools (eg QR codes, apps or websites).113 The

Regulation not only prohibits information that is misleading to consumers concerning

the characteristics of the food, such as its composition or the quantity of the product,

but also entails prohibitions on “attributing to the food effects or properties which it

does not possess”, and most importantly in the area of personalised nutrition, it

prohibits any information that will “attribute to any food the property of preventing,

treating or curing a human disease, nor refer to such properties”.114 This provision

reinforces the food–medicine borderline, and, as explained by Ballke and

Meisterernst, will significantly limit the marketing options, especially in areas such as

personalised nutrition products based on nutrigenomics, which are (allegedly) meant

to prevent diseases to which the person in question is genetically predisposed.115

The only viable route to making a health-related statement on food is through

a so-called health claim, which has to comply with the requirements of the Nutrition

110 An example is the Nutrition and Health Claims Regulation (Regulation (EC) No 1924/2006 of the European

Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods, OJ L 404,

30.12.2006, pp 9–25, hereafter NHCR). The NHCR focuses on the health benefits of foods; however, it does

stipulate the need to inform vulnerable groups for whom the food is not intended about potential risks on the labels

of such products (Art 10(2)(c) NHCR and Art 6(c) Commission Regulation (EC) No 353/2008 of 18 April 2008

establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of

Regulation (EC) No 1924/2006 of the European Parliament and of the Council, OJ L 109, 19.4.2008, pp 11–16).

In addition, when the excess consumption of a product that bears a health claim could lead to health risks, a

warning needs to be included on the label or in the food’s presentation and advertising (Art 10(2)(d) NHCR;

Regulation 353/2008 Art 6(d,e)).

111 Ordovas et al, supra, note 5, p 5.

112 Art 16, General Food Law.

113 Art 2(2), FIC Regulation.

114 Art 7, FIC Regulation.

115 Ballke and Meisterernst, supra, note 15, p 19.

18 European Journal of Risk Regulation Vol. 00:00

and Health Claims Regulation.116 This Regulation was introduced in the early 2000s in

the wake of the rising trend of functional foods (ie foods that have a positive effect on one

or more body functions beyond nutritional effects) to harmonise national regulation and

to ensure that consumers are protected against false claims and given sufficient

information to make an informed choice.117 The use of health claims is prohibited

unless it concerns an authorised claim and conforms to the additional requirements of

the Regulation.

The Regulation distinguishes between nutrition claims (beneficial nutritional

properties given a food’s energy and calorific value or the quantity, presence or

absence of nutrients)118 and health claims (which either explicitly or implicitly link a

food/food category/one of the food’s constituents with health effects).119 An example

of a nutrition claim is “fat-free”, whereas a health claim would be “includes vitamin

C, which supports your immune system”. Any of these claims will only be acceptable

where the nutritionally or physiologically positive effect has been proven by

generally accepted scientific evidence; where the nutrient or substance in question is

actually present (or absent) in the final food in a quantity that allows for the

beneficial effect; where the nutrient or substance is contained in a form that is

bioavailable; and where it can be reasonably expected for a consumer to actually

ingest enough of the food to generate the positive effects.120

For most personalised foods, health claims would be the most commercially interesting

statement to make, as personalised nutrition is aimed at maintaining or improving the

health of an individual.121 The legislation makes a distinction between different types

of health claims, which either are function claims (Article 13), disease risk reduction

claims (Article 14(1)) or children’s development claims (Article 14(1)). Any

information to final consumers referring to the impact of a nutrient or substance

contained in the food on (1) growth, development and functions of the human body;

(2) any psychological as well as behavioural functions; or (3) losing or controlling

bodyweight or hunger reduction/suppression, as well as reductions of energy (in the

sense of caloric value), will constitute function claims under Article 13. These claims

can only be used where they are contained in the list of authorised health claims,122

while the inclusion of additional claims has to be applied for on the basis of newly

generated scientific evidence (Article 13(5)).

Disease risk reduction claims (Article 14(1)) are claims that explicitly or implicitly

attribute the significant reduction of a risk factor for the development of a human

disease to consuming a food (ingredient).123 Especially with regard to these disease

116 NHCR, supra, note 110.

117 See further: H Verhagen et al, “Status of nutrition and health claims in Europe”(2010) 501 Archives of

Biochemistry and Biophysics 6.

118 Art 2(2)(4), NHCR.

119 Art 2(2)(5), NHCR.

120 Art 5, NHCR.

121 Adams et al, supra, note 11; Ordovas et al, supra, note 5, p 1.

122 Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on

foods, other than those referring to the reduction of disease risk and to children’s development and health, OJ L 136,

25.5.2012, pp 1–40.

123 Art 2(2)(6), NHCR.

2020 Personalised Nutrition 19

risk reduction claims, one has to again refer to the borderline with medicinal products:

since most diseases are multifactorial –they are likely to be caused by a combination of

factors –a food or functional ingredient can only claim to positively affect one risk factor

in disease development. The positive effect on this risk factor for the development or

progress of the disease can then be connected to the reduced risk of developing the

disease itself. Thus, coming back to the plant sterol example, the claim may not be

that “plant sterols prevent heart disease”,butthat“plant sterols have been shown to

lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of

coronary heart disease”.124 If the consumption of the food (ingredient) would be

immediately suggested to reduce the risk of disease (without clearly stipulating the

single risk factor affected by the food), the product would be seen as a medicinal

product by presentation. Related to this food–medicine borderline is the requirement

for any disease risk reduction claim to be accompanied by a statement that clarifies

whether a disease is always multifactorial and whether changing one of these factors

can but does not necessarily have a beneficial effect.125

The use of a nutrition or health claim is only possible in a specifically delimited setting,

providing that a health claim cannot be “false, ambiguous or misleading”,butalso

comparative statements about other foods cannot be made in a way that makes

consumers question the safety or nutritional value of the other foods.126 In addition to

the requirements stated above, for health claims specifically, it is prohibited to imply

that not consuming the food in question would negatively affect health, to indicate an

amount or rate of weight loss and, finally, to make claims referring to statements of

individual doctors or other health professionals.127 Further requirements include that

the following need to be included on the label: a statement on the importance of a

varied and balanced diet; how much of and in which way the food in question needs

to be consumed in order to achieve the effects claimed; if applicable, information on

who should not consume the food; and, finally, a statement on potential health

risks.128 Any reference to the benefits of the product to health in general (eg “good

for you”or “healthy”) or health-related well-being can only be made where they are

accompanied by a health claim included in the list.129

Thus, with regard to personalised food, the remit to make claims on positive health

effects is severely limited. Overstepping these limits would mean that the claims

made would be illegal, or might even push the product over the borderline, such that

it would then need to be regulated as a medicinal product. Moreover, whereas

personalised foods can already make use of currently authorised health claims, and an

authorisation request can be submitted under Article 13(5) or Article 14(1)(a) for

specific nutrients that affect bodily functions or a risk factor for disease in the general

124 Commission Regulation (EU) No 384/2010 of 5 May 2010 on the authorisation and refusal of authorisation of

certain health claims made on foods and referring to the reduction of disease risk and to children’s development and

health, OJ L 113, 6.5.2010, pp 6–10.

125 Art 14(2), NHCR.

126 Arts 3(a) and 3(b), NHCR and Art 9, NHCR.

127 Art 12, NHCR.

128 Art 10, NHCR.

129 Art 10(3), NHCR.

20 European Journal of Risk Regulation Vol. 00:00

population, some questions with regard to the approval of health claims

remain, specifically related to single effects highlighted in claims, the use of genetic

predisposition as risk factor for disease development and target groups for claims.

Firstly, personalised nutrition focuses on developing foods that are tailored towards

positively affecting a group of consumers or an individual based on their personal

needs, which are therefore expected to not just affect one but rather multiple

biomarkers. However, health claims can only address one relationship between a

single nutrient and a single effect currently.130 Whereas personalised nutrition should

make use of a combination of different insights (eg into genetic, phenotypic, clinical

and dietary information),131 it can thus be questioned whether such information can

be transferred to consumers within one health claim.

Health claims can address how an ingredient can positively affect a bodily function or

how it can reduce a single risk factor in the development of a disease. To substantiate the

effect of a personalised nutrition product on a bodily function under an Article 13(5)

claim, scientific evidence should be generated regarding how an ingredient would

affect genes in such a way that normal functions are maintained or supported.132 For

disease risk reduction claims (Article 14(1)) on personalised nutrition, the effect of a

nutrient on the genetic predisposition for a disease would need to be accepted as a

risk factor for disease development. Other currently authorised disease risk reduction

claims focus on the role of a nutrient in affecting the nutritional status of an

individual (eg bone mineral density) or blood plasma levels of nutrients (lowering

low-density lipoprotein cholesterol), both of which are seen as risk factors in the

development of a specific disease. No claim has yet been submitted that suggests that

a nutrient can affect the genetic predisposition to the development of a specific

disease, and thus it is unknown whether this will fall within the remit of disease risk

reduction claims or again will be interpreted as a medicinal claim. However, as has

been put forward by Ballke and Meisterernst, communicating the health benefits of a

product based on this nutrigenomic information seems to be essential for the success

of such personalised products.133

Furthermore, personalised products are meant to be for specific individuals (or groups

of individuals with similar traits) that would benefit from a product. Importantly, for

any food, it is prohibited to explicitly state or in some form imply that sufficient

nutrients cannot be derived from a balanced and varied diet, unless it concerns

nutrients that have been identified as lacking (eg in a specific region) in the context

of the Regulation.134 Meisterernst, however, describes that this prohibition refers

to the required quantities of nutrients in a balanced and varied diet in general, but that

130 Art 2, Commission Regulation 353/2008.

131 K Grimaldi et al, “Proposed guidelines to evaluate scientific validity and evidence for genotype-based dietary

advice”(2017) 12(35) Genes & Nutrition 1, pp 2–3.

132 For further analysis, see I Pravst et al, “Recommendations for successful substantiation of new health claims in the

European Union”(2018) 71 Trends in Food Science & Technology 259; A de Boer, E Vos and A Bast, “Implementation

of the nutrition and health claim regulation –The case of antioxidants”(2014) 68 Regulatory Toxicology and

Pharmacology 475.

133 Ballke and Meisterernst, supra, note 15, p 18.

134 Art 3(2)(d), NHCR.

2020 Personalised Nutrition 21

claims of nutritional deficiency or “extra needs”may be permissible in special

situations.135 This would open the door for such claims in the context of personalised

nutrition for people in specific situations such as sportspeople or pregnant women.

This relates to the use of target groups for claims: when the described health

benefit is not necessarily beneficial for the general population but merely addresses

a specific subgroup, this needs to be specified in the conditions of use of a

proposed claim.136 The Member State to whom the authorisation request is

submitted is responsible for reviewing whether a certain subgroup of the

population can be seen as a target population for a claim.137 However, neither in

the Nutrition and Health Claims Regulation nor in any other legislative documents

are specifications provided for when a certain subpopulation would be admissible

as a target group for a claim.

When in a claim’s conditions of use a target group is specified, it affects the assessment

of its scientific substantiation. In those cases where the health effect is deemed relevant

for a specific target population based on age, sex, lifestyle or physiological conditions, the

scientific evidence for the claim must be gathered by studying the proposed health effect

in individuals who are representative of this subpopulation.138 Only when health effects

are reported in the subpopulation or when the results can be extrapolated to this

subpopulation can the findings be used to support a proposed claim.139 The European

Food Safety Authority’s (EFSA) guidance seems to imply that a subgroup can

be based on different characteristics or traits. Various references to subgroups relate

to demographics (including age), lifestyle characteristics (being an athlete) and

sometimes phenotypic traits (suffering from mild to moderate hypercholesterolaemia).

Nonetheless, there is no indication of whether (and when) individual differences such

as genotypic traits would be accepted as the basis for a subgroup by the risk manager.

Claims that are even more personalised –purely individual health claims –do not

seem to be foreseen by the current regulation at all.

In addition to the Nutrition and Health Claims Regulation, Regulation 609/2013

provides the opportunity to target food products to special groups, regulating foods

intended for infants and young children, foods for special medical purposes and

products for weight reduction that can replace the full diet.140 However, this is limited

to food products that are used in the dietary management of medical conditions, when

individuals due to their condition cannot meet their nutritional requirements by

135 A Meisterernst, Health & Nutrition Claims (Berlin, Lexxion 2010) p 69.

136 Art 6(a), Commission Regulation 353/2008.

137 Art 7(a), Commission Regulation 353/2008; European Food Safety Authority, “General scientific guidance for

stakeholders on health claim applications”(2016) 14 EFSA Journal 4367, p 8.

138 European Food Safety Authority, supra, note 137, pp 7, 15.

139 ibid, p 18.

140 Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for

infants and young children, food for special medical purposes, and total diet replacement for weight control, OJ L 181,

29.6.2013, pp 35–56. For foods for infants and young children, more detailed compositional and labelling requirements

are laid down in Commission Delegated Regulation (EU) 2016/127 (OJ L 25, 2.2.2016, pp 1 –29). Such requirements are

also defined for foods for special medical groups, which can be found in Commission Delegated Regulation (EU) 2016/

128 (OJ L 25, 2.2.2016, pp 30–43).

22 European Journal of Risk Regulation Vol. 00:00

consuming normal foods.141 However, no nutrition and health claims can be made

regarding foods for special medical purposes,142 and the product must be used under

medical supervision.143 Even though such products may be of interest for specific

patient groups, the use of this Regulation for personalised nutrition is limited, as it is

unlikely that a group of healthy people who share common phenotypic or genotypic

traits will be treated as a relevant target group for foods for special medical purposes.

Sportspeople and diabetics have expressly been described as not relevant to being

defined as specific target groups for food categories,144 and thus they are excluded

from the scope of this Regulation.

The Nutrition and Health Claims Regulation therefore places strict conditions on the

communication of the health benefits of foods. While personalised foods could use health

claims relating to single nutrients targeting larger subgroups of the population, it can be

questioned to what extent the actual health benefits of a fully personalised product can be

communicated to individual consumers. In this regard, further regulatory and scientific

clarification is required regarding the possibility of communicating effects on multiple

biomarkers and genetic predisposition to diseases. Moreover, uncertainty persists

concerning the definition of potential target groups.

VI. C

ONCLUSION

Personalised nutrition is a multifaceted phenomenon that encompasses testing services,

nutrition advice as well as the personalisation of different kinds of food, and sometimes

even a combination of all of these components. Moreover, the personalisation can follow

varying “levels”of individualisation, using demographic and lifestyle-related phenotypic

and/or genotypic information. The broad definition of personalised nutrition and the fact

that a wide range of activities and products come into play in personalised nutrition have

resulted in quite fragmented legislation. Many legal requirements address the separate

aspects that fall within the remit of personalised nutrition: consumer protection on

health and lifestyle advice is dealt with in distinct legal acts, and the gathering and

handling of data and information on consumers (and patients) is regulated by separate

Regulations and Directives. In the dimension of personalised nutrition advice and

services (and the data and information required for them), the boundaries between

health and lifestyle start to blur. This leads to uncertainty for those working in the

field, for whom it might not necessarily be clear which rules and regulations to follow.

141 According to Art 9 of Regulation 2016/128, national competent authorities of Member States need to be notified of

the placement on the market of such foods for special medical purposes. This notification needs to contain generally

accepted scientific data to support that the product is not just safe, but can also effectively meet the nutritional

requirements of these patients (Art 2(2)).

142 Art 7, Regulation (EU) No 609/2013.

143 Art 5(2)(a), Regulation (EU) No 609/2013.

144 Recitals 32 and 33, Regulation (EU) No 609/2013 of the European Parliament and of the Counc il of 12 June 2013

on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight

control, OJ L 181, 29.6.2013, pp 35–56; European Commission, Report on food intended for sportspeople, 15.6.2016

COM(2016) 402 final. This seems to be in line with the trend of simplifying the previously scattered legal framework for

food categories targeting small subgroups of the population.

2020 Personalised Nutrition 23

Many legal requirements address the separate aspects that fall within the remit of

personalised nutrition. Nevertheless, the boundaries between health and lifestyle

products and services are not always clear, which challenges the rigid legal division

between a highly and a less regulated area. This leads to uncertainty for those

working in the field, for whom it is not necessarily clear which rules and regulations

to follow. In the gathering of data needed for personalised nutrition, the GDPR

applies and introduces a special regime for health data, which are deemed to be

sensitive data. Nevertheless, producers, service providers and also consumers might

not be as vigilant as in a more lifestyle-related context than a clearly medical one.

Moreover, with the increase in personal data being shared, processed and combined,

more and more information allows for the drawing of conclusions about a person’s

health status, therefore constituting health data. In addition, for the medical

devices used to gather information, even if they are extensively regulated, their

characterisation as medical devices hinges on an intended medical use, which creates

a grey area for devices used in personalised nutrition.

When analysing the product level of personalised nutrition, it is the borderline between

food and medicine that is blurring. Our food law analysis shows that it is not always clear

cut when certain nutrigenomic or nutrigenetic effects should be considered to be health

optimising or health maintaining, or rather be defined as preventing diseases. The latter

would lead a product to be regulated as medicinal product by presentation, instead of

falling under food law. It is especially this difficulty that deserves the attention of those

working on the development of personalised nutrition. And even though the safety of

products could be of concern for specific non-target groups of personalised foods, the

information requirements currently established in EU food law should be able to ensure

that “health-sensitive”and vulnerable consumers are sufficiently informed. Information

is also key when ensuring that the communicated health benefits are sufficiently

targeted to those groups that have been proven to benefit from consuming the product,

but the risk of misleading health claims is greatly reduced by the claims regulation

already in place. However, our analysis also reveals that although the regulatory

framework itself sets clear delimitations concerning the efficacy of personalised

nutrition and the potential use of health claims for such products, the approach to the

underlying scientific evidence required to obtain health claims needs to be developed

further and adjusted to the unique challenges of personalised nutrition.

24 European Journal of Risk Regulation Vol. 00:00

Stance4Health Nutritional APP: A Path to Personalized Smart Nutrition

Article

Full-text available

Jan 2023

Access to good nutritional health is one of the principal objectives of current society. Several e-services offer dietary advice. However, multifactorial and more individualized nutritional recommendations should be developed to recommend healthy menus according to the specific user’s needs. In this article, we present and validate a personalized nutrition system based on an application (APP) for smart devices with the capacity to offer an adaptable menu to the user. The APP was developed following a structured recommendation generation scheme, where the characteristics of the menus of 20 users were evaluated. Specific menus were generated for each user based on their preferences and nutritional requirements. These menus were evaluated by comparing their nutritional content versus the nutrient composition retrieved from dietary records. The generated menus showed great similarity to those obtained from the user dietary records. Furthermore, the generated menus showed less variability in micronutrient amounts and higher concentrations than the menus from the user records. The macronutrient deviations were also corrected in the generated menus, offering a better adaptation to the users. The presented system is a good tool for the generation of menus that are adapted to the user characteristics and a starting point to nutritional interventions.

Stance4Health nutritional APP: A Path to Personalized Smart Nutrition

Preprint

Full-text available

Dec 2022

Access to good nutritional health is one of the principal objectives of current society. Several e-services offer dietary advice. However, multifactorial and more individualized nutritional recommendations should be developed to recommend healthy menus according to the specific user's needs. In this article we present and validate a personalized nutrition system based on an application (APP) for smart devices with the capacity to offer an adaptable menu to the user. The APP was developed following a structured recommendation generation scheme, where the characteristics of the menus of 20 users were evaluated. Specific menus were generated for each user based on their preferences and nutritional requirements. These menus were evaluated by comparing their nutritional content versus the nutrient composition retrieved from dietary records. The generated menus showed great similarity to those obtained from the user dietary records. Furthermore, the generated menus showed less variability in micronutrient amounts and higher concentrations than the menus from the user records. The macronutrient deviations were also corrected in the generated menus, offering a better adaptation to the users. The presented system is a good tool for the generation of menus that are adapted to the user characteristics and a starting point to nutritional interventions.

Nutrigenomics: Tailoring Nutrition Based on Genes

Article

Full-text available

Jan 2025

Mary Christine Wheatley

This review explores the emerging field of nutrigenomics, which integrates genomics and nutrition to tailor dietary recommendations based on individual genetic profiles. Nutrigenomics promises to revolutionize personalized nu trition by providing insights into how genetic variations influence dietary responses and predispositions to various diseases. This review also explores the scientific foundations of nutrigenomics, including gene–nutrient interactions and the technological advances that facilitate personalized dietary strategies. It also examines the practical applications in disease prevention, particularly focusing on conditions such as diabetes, obesity, and cardiovascular diseases. Furthermore, the review addresses the ethical, legal, and social implications of applying genetic information to nutrition, highlighting the challenges and potential for socioeconomic disparities in access to nutrigenomic services. By offering a comprehensive overview of both the transformative potential and the complexities of nutrigenomics, this review underscores its significance in advancing personalized healthcare and preventive medicine.

Precision nutrition: Is tailor‑made dietary intervention a reality yet? (Review)

Article

Full-text available

Mar 2025

Precision nutrition (PN) is an emerging field of science recognizing the variability in how individuals respond to different nutrients, driven by their unique biological makeup. The central aim of PN is to tailor dietary interventions to improve individual health, prevent disease and manage existing health conditions based on specific biological characteristics. The present review aimed to provide an overview of available multi-omics platforms that can be applied to extracting data from biological materials in the context of PN. Additionally, it proposed an updated pipeline for handling and integrating these data. A comprehensive search of academic publications was conducted across multiple databases, focusing on recent advances in PN, including its challenges and opportunities. Following this preparatory step, a data handling protocol for different omics layers was compiled to develop an up-to-date multi-omics pipeline applicable to PN. The successful implementation of PN requires a systems-level understanding of human physiological networks, their plasticity, variations in response to dietary exposures and the ability to classify population subgroups based on their nutritional needs. The realization of PN may currently seem distant due to several limitations such as the lack of ongoing large-scale epidemiological studies, challenges in database curation, the high cost of omics analysis and ethical concerns. A key advancement to this field would be the development of next-generation biomarkers connecting nutrition to chronic diseases. These biomarkers would help classify individuals at risk of diet-related conditions and quantify the dose-response relationships between individuals or groups of interacting nutrients and the onset and progression of diseases.

A health technology assessment of personalized nutrition interventions using the EUnetHTA HTA Core Model

Article

Full-text available

Mar 2024
INT J TECHNOL ASSESS

Objectives Poor nutrition links to chronic diseases, emphasizing the need for optimized diets. The EU-funded project PREVENTOMICS, introduced personalized nutrition to address this. This study aims to perform a health technology assessment (HTA) comparing personalized nutrition interventions developed through this project, with non-personalized nutrition interventions (control) for people with normal weight, overweight, or obesity. The goal is to support decisions about further development and implementation of personalized nutrition. Methods The PREVENTOMICS interventions were evaluated using the European Network for HTA Core Model, which includes a methodological framework that encompasses different domains for value assessment. Information was gathered via [1] different statistical analyses and modeling studies, [2] questions asked of project partners and, [3] other (un)published materials. Results Clinical trials of PREVENTOMICS interventions demonstrated different body mass index changes compared to control; differences ranged from −0.80 to 0.20 kg/m ² . Long-term outcome predictions showed generally improved health outcomes for the interventions; some appeared cost-effective (e.g., interventions in UK). Ethical concerns around health inequality and the lack of specific legal regulations for personalized nutrition interventions were identified. Choice modeling studies indicated openness to personalized nutrition interventions; decisions were primarily affected by intervention’s price. Conclusions PREVENTOMICS clinical trials have shown promising effectiveness with no major safety concerns, although uncertainties about effectiveness exist due to small samples (n=60–264) and short follow-ups (10–16 weeks). Larger, longer trials are needed for robust evidence before implementation could be considered. Among other considerations, developers should explore financing options and collaborate with policymakers to prevent exclusion of specific groups due to information shortages.

Cow’s Milk: A Benefit for Human Health? Omics Tools and Precision Nutrition for Lactose Intolerance Management

Article

Full-text available

Jan 2024

Cow’s milk (CM) is a healthy food consumed worldwide by individuals of all ages. Unfortunately, “lactase-deficient” individuals cannot digest milk’s main carbohydrate, lactose, depriving themselves of highly beneficial milk proteins like casein, lactoalbumin, and lactoglobulin due to lactose intolerance (LI), while other individuals develop allergies specifically against these proteins (CMPA). The management of these conditions differs, and an inappropriate diagnosis or treatment may have significant implications for the patients, especially if they are infants or very young children, resulting in unnecessary dietary restrictions or avoidable adverse reactions. Omics technologies play a pivotal role in elucidating the intricate interactions between nutrients and the human body, spanning from genetic factors to the microbiota profile and metabolites. This comprehensive approach enables the precise delineation and identification of distinct cohorts of individuals with specific dietary requirements, so that tailored nutrition strategies can be developed. This is what is called personalized nutrition or precision nutrition (PN), the area of nutrition that focuses on the effects of nutrients on the genome, proteome, and metabolome, promoting well-being and health, preventing diseases, reducing chronic disease incidence, and increasing life expectancy. Here, we report the opinion of the scientific community proposing to replace the “one size fits all” approach with tailor-made nutrition programs, designed by integrating nutrigenomic data together with clinical parameters and microbiota profiles, taking into account the individual lactose tolerance threshold and needs in terms of specific nutrients intake. This customized approach could help LI patients to improve their quality of life, overcoming depression or anxiety often resulting from the individual perception of this condition as different from a normal state.

Cow’s Milk: A Benefit for Human Health? Omics Tools and Precision Nutrition for Lactose Intolerance Management

Preprint

Full-text available

Dec 2023

Cow’s Milk (CM) is a healthy food consumed worldwide by individuals of all ages. Unfortunately, 'lactase deficient' individuals cannot digest milk's carbohydrate lactose depriving themselves of highly beneficial milk proteins like casein, lactoalbumin and lactoglobulin, due to lactose intolerance (LI), while other individuals develop cow milk allergy specifically against these proteins (CMPA). The management of these conditions is distinctly different and an inappropriate diagnosis or treatment may have significant implications for the patients, especially if they are infants or very young children, resulting in unnecessary dietary restriction or avoidable adverse reactions. Omics technologies play a pivotal role in elucidating the intricate interactions between nutrients and the human body, spanning from genetic factors to the microbiota profile and metabolites. This comprehensive approach enables the precise delineation and identification of distinct cohorts of individuals with specific dietary requirements, so that tailored nutrition strategies can be developed. This is what is called personalized nutrition or precision nutrition (PN), the area of nutrition that focuses on the effects of the nutrients over the genome, proteome and metabolome, promoting well-being and health, preventing diseases, reducing chronic disease incidence, and so increasing life expectancy. Here, we report the scientific community opinion proposing to replace the approach “one size fits all” with tailor-made nutrition programs, designed by integrating nutrigenomic data together with clinical parameters and microbiota profiles, taking into account the individual lactose tolerance threshold and needs in terms of specific nutrients intake. This customized approach could help LI patients to improve their quality of life, overcoming depression or anxiety, often resulting from the individual perception of this condition as different from a normal state.

17. Nutrition and health

Chapter

Full-text available

Oct 2022

Alie de Boer

Putting It Together: Diet, Genetics, Microbiome, and Health

Chapter

Jul 2024

This chapter thoroughly examines the interrelationships among nutrition, genetics, and the microbiome, clarifying their collective influence on human health and the defense against chronic illnesses. This text delves into the crucial significance of diet in regulating physiological processes, including metabolic pathways, hormonal equilibrium, and immune system effectiveness. This study focuses on the burgeoning discipline of nutrigenomics, which underscores the impact of dietary components on gene expression and their potential to alleviate hereditary predispositions to different health disorders. Furthermore, the chapter explores the substantial impact of the microbiome on human health, which is mediated by dietary and genetic connections. The chapter concludes by proposing personalized dietary strategies that take into account an individual's genetic composition and microbial profiles. This approach offers a potential avenue for achieving optimal health and preventing diseases by leveraging the complex interplay between diet, genetics, and interactions within the microbiome.

Personalized nutrition: from science to consumer

Chapter

Jan 2023

Commission Regulation 353

Jan 2008

Art 6(a), Commission Regulation 353/2008.

General scientific guidance for stakeholders on health claim applications

Jan 2016
14

Art 7(a), Commission Regulation 353/2008; European Food Safety Authority, "General scientific guidance for stakeholders on health claim applications" (2016) 14 EFSA Journal 4367, p 8.

For foods for infants and young children, more detailed compositional and labelling requirements are laid down in Commission Delegated

Jun 2013
30-43

Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control, OJ L 181, 29.6.2013, pp 35-56. For foods for infants and young children, more detailed compositional and labelling requirements are laid down in Commission Delegated Regulation (EU) 2016/127 (OJ L 25, 2.2.2016, pp 1-29). Such requirements are also defined for foods for special medical groups, which can be found in Commission Delegated Regulation (EU) 2016/ 128 (OJ L 25, 2.2.2016, pp 30-43).

Personalised Nutrition: The EU's Fragmented Legal Landscape and the Overlooked Implications of EU Food Law

Abstract and Figures

Recommended publications

Fifteen Years of Regulating Nutrition and Health Claims in Europe: The Past, the Present and the Fut...

EU Food Law and the WTO: Trade, Science and Politics: Liber Amicorum in Honour of Peter Van den Boss...

The barriers and drivers of a safe market introduction of cultured meat: A qualitative study

Transparency and consumer trust in scientific assessments under European food law