Regulatory and Legislative Framework for Novel Foods

Abstract

The paper discusses how novel foods are regulated in the EU, US, and elsewhere. It reviews some of the reasons novel foods might be regulated and how such regulatory goals can be accomplished. Regulation of novel foods is the policy maker’s reaction to the unknown, although what is novel today may not be novel tomorrow. Indeed, the novel food industry has grown immensely over the past decade due to the need to feed a growing world population while using less land, water, and other limited natural resources. Ultimately, policy makers have the difficult task of balancing adequate government oversight over novel foods without stifling innovation and creativity.

Full text

WORKING PAPER SERIES
Chair for Food Law
Regulatory and Legislative Framework
for Novel Foods
Jessica Vapnek
Kai P. Purnhagen
Ben Hillel
16.09.2020
final version forthcoming in:
Shivani Pathania and Brijesh Tiwari (eds.), Food
formulation: Novel Ingredients and processing
techniques (Wiley)

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Chair for Food Law

WORKING PAPER 03/2020
Regulatory and Legislative Framework
for Novel Foods
Jessica Vapnek
Kai P. Purnhagen
Ben Hillel
Suggested citation:
Jessica Vapnek, Kai Purnhagen and Ben Hillel, Regulatory and Legislative
Framework for Novel Foods, Bayreuth Working Paper Series Food Law
03/2020, p. number.

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publisher.
© 2020 Jessica Vapnek, Kai P. Purnhagen and Ben Hillel
Contact: University of Bayreuth | Chair for Food Law / Campus Kulmbach |
Fritz-Hornschuch-Straße 13 | 95326 Kulmbach | Germany
foodlaw@uni-bayreuth.de
Chair for Food Law

Working Paper 03/2020 Regulatory and Legislative Framework for Novel Foods
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Chair for Food Law
Regulatory and Legislative Framework
for Novel Foods
Jessica Vapnek
Kai P. Purnhagen
Ben Hillel
Table of contents:
Abstract .................................................................................................... 3
Introduction............................................................................................... 4
What Is a Novel Food? ................................................................................ 4
Overview of Regulatory Frameworks for Novel Foods ...................................... 5
Why Regulate Novel Foods? ...................................................................... 5
How Are Novel Foods Regulated? ............................................................... 6
How Novel Foods Came To Be Regulated Internationally ............................... 6
How Novel Foods Are Regulated in the European Union ................................ 7
How Novel Foods Are Regulated in the United States ................................. 10
How Novel Foods Are Regulated in Other Jurisdictions ................................ 12
Specific Regulatory Issues ......................................................................... 14
Regulatory Issues Connected to Food Formulation ..................................... 14
Regulatory Issues Connected to Food Formulation for Special Populations .... 15
Regulatory Issues Connected to Genetically Modified Food .......................... 15

2
Regulatory Issues Connected to Food Containing Nanomaterials .................. 17
Regulatory Issues Connected to 3D Printed Food Products .......................... 17
Regulatory Issues Connected to Food Made from Insects ............................ 18
Other Legal Issues ................................................................................. 18
Intellectual Property Law ..................................................................... 18
Tort Law ............................................................................................ 19
Marketing Law .................................................................................... 20
Criminal Law ...................................................................................... 20
Conclusion ............................................................................................... 21

Working Paper 03/2020 Regulatory and Legislative Framework for Novel Foods
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Abstract
The paper discusses how novel foods are regulated in the EU, US, and elsewhere.
It reviews some of the reasons novel foods might be regulated and how such
regulatory goals can be accomplished. Regulation of novel foods is the policy
maker’s reaction to the unknown, although what is novel today may not be novel
tomorrow. Indeed, the novel food industry has grown immensely over the past
decade due to the need to feed a growing world population while using less land,
water, and other limited natural resources. Ultimately, policy makers have the
difficult task of balancing adequate government oversight over novel foods without
stifling innovation and creativity.
Keywords: Novel Foods, European Union Law, Law in the United States of America,
Comparative Law

Working Paper 03/2020 Jessica Vapnek, Kai P. Purnhagen and Ben Hillel
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Introduction
Scientific advances have made it possible to produce foods from unconventional
sources or through new techniques. At the same time, globalization and integrated
value chains have facilitated the movement of foods and food ingredients from
regions where they have been in use for decades or longer to other regions where
they are unknown – and therefore perceived as “novel.” Earlier chapters of this
book provided an overview of novel food ingredients and processing techniques.
They also explored the use of novel food ingredients in the formulation of novel
and health-promoting food products. With more and more of these foods and food
ingredients circulating in the market, interest in regulation is increasing.
The purpose of this paper is to review how novel foods are currently regulated in
the European Union (EU), United States (US), and elsewhere. We briefly review
what novel foods are – and in later sections we look at special categories of foods
such as foods derived from insects, 3D printed food, and food formulated for
special population segments – and why they are regulated. We then discuss the
various types of regulation of novel foods – primarily official review and approval
(or rejection) of the introduction of these types of foods on the market, but also
intellectual property law, marketing law, tort law, and criminal law.
This paper provides an overall picture of what public and private entities should
take into account when regulating or trading in novel foods.
What Is a Novel Food?
In most jurisdictions, new foods and ingredients introduced into the stream of
commerce are generally referred to as “novel foods.” In some ways it is a circular
effort to define a novel food because the definition varies depending on what the
applicable legislation says it is. In turn, whether a food is “novel” according to
legislation may depend on geographic, temporal, or cultural variables, i.e.,
whether it is unfamiliar to a specific region, time period, or culture. The definition
of a novel food may also differ depending on the purpose for which the food is
being regulated. For example, one piece of legislation might define a novel food
for purposes of protecting public health, while another piece of legislation may
propose a different definition for another purpose, such as securing intellectual
property rights.
Some examples of what might be considered novel foods are newly developed and
innovative foods, foods produced using new technologies and production
processes, or foods traditionally eaten outside of a geographical region.
1
More than
30 years ago, the International Programme on Chemical Safety (IPCS), a joint UN
body with representation from the World Health Organization, the International
Labour Organization, and the United Nations Environment Programme, defined a
novel food as “a food or food ingredient produced from raw materials not normally
used for human consumption or food that is severely modified by the introduction
of new processes not previously used in the production of food.”
2
In the EU, the
Novel Food Regulation (NFR),
3
which in its current form came into force on January
1, 2018, defines novel foods as foods that have not been used for human
consumption to a significant degree within the EU before May 15, 1997 and that
fall within one of ten enumerated categories.
4
The European Commission provides
the following specific examples:

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Examples of Novel Food include new sources of vitamin K (menaquinone) or
extracts from existing food (Antarctic Krill oil rich in phospholipids from
Euphausia superba), agricultural products from third countries (chia seeds,
noni fruit juice), or food derived from new production processes (UV-treated
food (milk, bread, mushrooms and yeast)).
5
In the US, the Food and Drug Administration (FDA), which serves as the primary
food regulatory agency, has no formal definition and in fact does not recognize
“novel foods” as a category of food. Instead, any new food (no matter its
technological, temporal, or geographical origin) is regulated like any other food.
Instead, a new substance or new food ingredient is regulated through the food
additive process, unless it meets an exception under the Federal Food, Drug, and
Cosmetic Act
6
or is considered Generally Recognized as Safe.
7
We examine the regulatory frameworks for new or novel foods in greater detail in
the next section.
Overview of Regulatory Frameworks for Novel Foods
Why Regulate Novel Foods?
There are many reasons to regulate novel foods. At the most fundamental level,
regulation of novel foods represents how society has chosen to deal with the
unknown consequences of new technologies and materials. This decision-making
process is implicated not only with respect to novel foods but also to all novel
techniques and materials on the market. Scholars call this “regulating the
unknown.”
8
Policy makers weighing and choosing regulatory approaches must find
a balance between, for example, protection and innovation, between financing of
research and reaping of societal benefits, and between societal acceptance and
necessary government interference. Depending on the culture and legal system,
the balances may shift, and one factor may be privileged over others. In Ulrich
Beck’s work, which has guided EU regulation,
9
technologies create risks that trigger
regulation.
10
Commentators in the economic arena have noted that this approach
focuses on maintaining the status quo,
11
and critics charge that it therefore limits
flexibility and stifles innovation. But at the least, regulation of technologies should
preserve society’s ability to understand potential future uses of the technology to
evaluate whether risks are worth taking to reap potential future benefits.
12
Whatever the locale or justification, regulation in this context generally consists of
testing, data, and scientific evaluation of potential adverse effects on health,
safety, and the environment.
The problem arises when data on potential hazards is non-existent or inconclusive.
Whereas the United States’ regulatory approach requires scientific proof of harm,
Europe requires regulators to take action when, after assessment of available
information, a possibility of harmful effects on health is identified but scientific
uncertainty persists:
13
this is known as the precautionary principle, which applies
under the General Food Law (GFL) (the preeminent EU Regulation on food)
14
and
hence to novel foods.
15
Although this definition is widely shared, it is important to
note that that the exact wording and application of the precautionary principle in
EU law depend on the legal sector and/or type of good it applies to.
The European Commission describes the principle’s justification as follows:
“decision-makers are constantly faced with the dilemma of balancing the freedom

Working Paper 03/2020 Jessica Vapnek, Kai P. Purnhagen and Ben Hillel
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and rights of individuals, industry and organisations with the need to reduce the
risk of adverse effects to the environment, human, animal or plant health.”
16
Equally, policy makers are divided over how to weigh and evaluate the relative
importance of types of adverse effects: should one prioritize conservation,
innovation, or consumer health? These are political decisions which regulations
cannot solve, but rather are left to the political realm. At least within the EU, the
precautionary principle is the only tool available to regulate decisions under
circumstances of uncertainty, and policy makers have determined that the
precautionary principle applies to novel foods.
17
How Are Novel Foods Regulated?
Novel food regulation can be categorized in a variety of ways to facilitate
understanding. The first division is between content-related vs. information-
related measures. Content-related measures, in this context, consist of measures
such as approval procedures, where responsible authorities examine the type of
food before approving or rejecting an application to commercialize it or before
banning certain types of foods. Information-related measures, by contrast, are
measures where regulators control information about the food through labelling or
through information released to consumers to affect consumer choice.
Regulation of novel foods can also be categorized based on the phase of market
introduction of the product. Here, measures can be conceptually divided into those
regulating market access (e.g., pre-market measures such as approvals) and
those regulating products already on the market (e.g., post-market measures such
as liability).
Regulation can also be grouped into measures that are process-related (i.e.,
regulating the technique used to produce the food) and those that are product-
related (i.e., regulating different features of the product). Which of these might be
given more or less attention or weight in the regulation of novel foods at a
particular time depends on the jurisdiction. It is worth noting, however, that most
novel food regulations apply a product-related approach, which experts consider
the favoured strategy in the face of uncertainty.
18
With this type of regulatory
framework, whether a food is subject to special regulation as a “novel food” mainly
depends on evaluation of the “nutritional composition, presence of known toxins
or anti-nutrients, and allergenicity of proteins as well as . . . the potential
nutritional impact of introducing the novel food into the human diet.”
19
It is important to underline here that although some technology-related regulation
exists, in some respects this is just another type of product-related measure. For
instance, the EU applies the novel food regulatory regime to foods containing
engineered nanomaterials, but in fact it is not the technique that is being
regulated, but rather the risks stemming from the use of the technique.
Regardless of how one conceives of the regulation of novel foods, in all jurisdictions
that regulate them we find most of these categories in use.
How Novel Foods Came To Be Regulated Internationally
More than 30 years ago, the IPCS developed guidelines for the safety assessment
of novel foods. The IPCS defined a novel food as “a food or food ingredient
produced from raw materials not normally used for human consumption or food

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that is severely modified by the introduction of new processes not previously used
in the production of food.”
20
The definition applied to foods intended for direct
consumption or for consumption after some alterations to make the product more
acceptable.
The IPCS was particularly concerned about circumstances where novel foods are
intended to replace a significant portion of traditional food in the diet, because of
the likely nutritional impact. For this reason, in addition to recommending animal
and human tests, the IPCS proposed examining the effect of the introduction of
the new substance on the nutrient composition of the diet as a whole. It
recommended particular care where the food is intended for groups such as
“children, the elderly, and ‘captive populations’, e.g., hospital patients and school
children.”
21
As we saw in earlier chapters of this text, complete chemical identification of novel
foods may not be feasible, but it is important that the regulatory system ensure
microbiological purity and that levels of potentially hazardous contaminants are
kept to a minimum. The IPCS pointed out that if the novel food is intended to be
an alternative significant supply of protein, tests on its protein quality will be
necessary.
22
Other studies should analyse: (a) the availability of vitamins and
minerals in the novel food in comparison with the food it would replace; and (b)
any interaction the novel food might have with other items of the diet that would
reduce the whole diet’s nutritional value. IPCS also recommended testing for
allergenicity.
23
Currently, the Joint FAO/WHO Committee on Food Additives (JECFA), a scientific
advisory body, evaluates the safety of food additives for purposes of advising the
Codex Alimentarius Commission, which is the reference body for international food
standards under the World Trade Organization (WTO)
24
that produces standards
to guide national legislators. Although JECFA’s safety determinations are not
binding at national level (i.e., at the moment a particular jurisdiction is deciding
whether to approve a particular new food additive), its recommendations are
broadly accepted and so are likely to be taken into consideration.
25
How Novel Foods Are Regulated in the European Union
Before looking specifically at the regulation of novel foods in the EU, it may be
useful to review the complex institutional and legislative framework underpinning
the regulation of food within the Union.
26
Legislation issued at EU level in the form
of a Regulation, such as the NFR, is paramount and directly applicable in member
states, without any need for national adoption or enactment. Member state
legislation that conflicts with an EU-level Regulation is invalidated in case of
conflict, much as federal law pre-empts state law in the US. Since most food laws
in the EU are in the form of Regulations, they are directly applicable to EU
institutions, all member state authorities, and all persons within the EU.
Enforcement responsibility rests with food business operators, although member
states are also obligated to establish appropriate enforcement mechanisms.
27
The
European Commission in turn carries out regular audits to identify and minimize
variations among these member state controls.
The European Commission’s integrated approach to food safety is set out in the
White Paper on Food Safety,
28
now almost 20 years old, which has become binding

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8
law through the GFL. The regulatory system covers all stages “from farm to fork,”
starting with feed production and primary production and continuing through food
processing, storage, transport, and sale. The GFL sets out an overarching
framework for the development of food legislation and regulation at EU and
member state levels. It establishes the “general principles, requirements, and
procedures that underpin decision making in matters of food and feed safety.”
29
As noted, since the GFL is a Regulation, it is directly applicable and does not need
to be transposed into member state legislation.
In the EU, pre-emption occurs only where EU law regulates the precise topic at
issue. To take a simple example, if member state law says that strawberries must
be green but EU law states that they must be red, then EU law pre-empts all
national laws with regard to strawberries (but not to apples). What distinguishes
the GFL from most EU law is that it applies a horizontal (systemic) approach,
meaning that it covers not only legislation but all types of action by member states,
businesses, and other private parties active on the internal EU market. If the GFL
said that all fruits must have their natural colour, this would cover all laws,
regulations, rules, and practices in a member state regarding strawberries, apples,
and all other fruits – no matter the form of the rule or business practice in the
member state. The GFL also introduces a science-based approach, meaning that
no decision on foods can be made without scientific evidence being available.
30
Within the EU, the enactment of the NFR has provided the region with a
comprehensive novel food definition and regulatory framework, which was
substantially revised as of January 1, 2018. Under the NFR, novel foods are foods
that have not been used for human consumption to a significant degree within the
EU before May 15, 1997 and that fall within one of ten enumerated categories:
1. food with a new or intentionally modified molecular structure;
2. food consisting of, isolated from, or produced from microorganisms,
fungi, or algae;
3. food consisting of, isolated from, or produced from material of mineral
origin;
4. food consisting of, isolated from, or produced from plants or their parts
obtained by non-traditional propagating practices if significant changes
in the composition or structure of the food affect its nutritional value,
metabolism, or level of undesirable substances;
5. food consisting of, isolated from, or produced from animals or their parts
obtained by non-traditional breeding techniques;
6. food consisting of, isolated from, or produced from cell culture or tissue
culture derived from animals, plants, microorganisms, fungi, or algae;
7. food resulting from a new production process if significant changes in the
composition or structure of the food affect its nutritional value,
metabolism, or level of undesirable substances;
8. food consisting of engineered nanomaterials;

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9. vitamins and minerals and other substances used in accordance with
Food Supplements Directive 2002/46/EC obtained by a new food
production process or containing engineered nanomaterials;
10. food used exclusively in food supplements within the EU before May 15,
1997, intended to be used in foods other than food supplements.
31
The NFR’s regulation of novel foods attempts a maximum harmonization
approach,
32
so that EU law provides both floor and ceiling for member state
regulation. What this means in practice is that member states, in general, cannot
introduce higher protection measures in their national legislation than the EU
standards. If, for example, EU member states would like to add additional labelling
requirements for novel foods which are not foreseen in the NFR or accompanying
EU texts, this would be against EU law. However, EU law provides some options to
deviate from this strict regime if new scientific evidence comes to light.
33
In such
circumstances, the member state has to notify the Commission, which decides
whether the proposed member state measure is justified.
34
This accords with WTO
rules, in that international standards are a floor, and member states may enact
more rigorous standards so long as they are based on science and do not violate
other WTO principles.
35
The NFR applies to novel foods placed on the market within the EU.
36
Some foods,
however, including those made with genetically modified organisms (GMOs), food
enzymes, food additives, food flavourings, and extraction solvents, are covered by
other legislative measures and hence fall outside the scope of the NFR.
37
For
example, if a food has been in continual use in a non-EU country, it is not
considered “novel” if its safety has been confirmed with compositional data:
continual use is defined here as use for at least 25 years in the customary diet of
a significant number of people residing within in at least one non-EU country.
38
If
these criteria are not met, non-EU or “third-country foods” are considered
“novel.”
39
Third-country foods are also considered novel if the food belongs to one
of the categories that are excepted from the NFR, set out above.
40
The burden of
establishing whether a foodstuff is “novel” lies with the food business operator that
intends to place the food on the EU market,
41
although member states and the
Commission have a duty to assist food business operators in making that
assessment.
42
Novel foods may only be placed on the market within the EU if they are authorized
via inclusion on a publicly available list established by the Commission.
43
Article 10
of the NFR lists some generic requirements that must appear in all authorization
applications, including:
1. the name and address of the applicant;
2. the name and description of the novel food;
3. the description of the production process(es);
4. the detailed composition of the novel food;
5. scientific evidence demonstrating that the novel food does not pose
a safety risk to human health;

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6. the analysis method(s) applied, where applicable;
7. a proposal for the conditions of intended use and for specific labelling
requirements which do not mislead the consumer, or a verifiable
justification why those elements are not necessary.
44
In assessing the safety of a novel food under the NFR, the EU Commission may
grant authorization only where:
1. the food does not pose any risk to human health on the basis of
scientific evidence;
45
2. the food’s intended use does not mislead the consumer, especially
when the food is intended to replace another food and there is a
significant change in the nutritional value;
46
3. where the food is intended to replace another food, it does not differ
from that food such that its normal consumption would be
nutritionally disadvantageous for the consumer.
47
How Novel Foods Are Regulated in the United States
As we did for the EU, in this section we briefly review the legislative framework for
food in the US. The US system consists of federal law, which applies throughout
the country and exists concurrently with the individual regulatory frameworks of
the 50 states. Local legislatures (such as counties and cities) may also regulate
aspects of food within their jurisdictions. Both state and local legislatures are free
to regulate food so long as their regulation does not contradict federal law.
However, certain topics are relegated to the federal government’s purview
exclusively, such as import, export, and interstate commerce.
48
In the US, federal law is often, but not always, considered supreme to state law.
Federal law operates within the federal government’s constitutionally established
bounds. In contrast, state law often concerns intrastate matters that fall outside
of these boundaries or are not covered by federal law. State law can fill in the gaps
that federal law, sometimes purposely, leaves behind for states to legislate. All US
states have passed laws regulating foods and other products.
The Pure Food and Drug Act (PFDA), enacted in 1906, was the first federal law to
regulate food in the United States; the Meat Inspection Act was passed the same
year.
49
Both laws were adopted to respond to burgeoning public attention to food
hygiene and safety issues. The PFDA hewed closely to the model of the state-level
laws that had proliferated in the latter half of the 19th century, in that it mandated
accurate product labelling, outlawed interstate trade in “adulterated” and
“misbranded” foods, and required producers to indicate on food labels the presence
of mixtures or impurities.
50
Congress later passed the 1938 Food, Drug, and
Cosmetics Act (FDCA) to expand federal regulatory authority over drugs while also
more generally strengthening the powers of the FDA.
51
Another piece of federal
legislation, the Nutrition Labeling and Education Act enacted by Congress in 1990,
required all packaged foods to contain standardized information on nutrition and
on serving sizes.
52
Four years later, the Dietary Supplement Health and Education
Act classified dietary supplements as foods rather than drugs.
53
In more recent
years, Congress reformed major food safety laws via the 2011 Food Safety

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Modernization Act; this overhaul shifted the FDA’s focus from reacting to food
safety issues to preventing foodborne illnesses through expanded regulatory
authority.
54
The US does not specifically define or regulate novel foods; instead, they are
regulated as food, regardless of their technological, temporal, or geographical
origin. If not a food, a new substance would be regulated as a direct food additive
or food contact substance, depending on its intended use. The FDA considers any
new food ingredient either a food additive (requiring a pre-market approval by the
FDA) or Generally Recognized as Safe (GRAS) for specific uses (as classified by a
panel of experts and determined independently from the FDA).
55
The FDCA defines “food additive” as any substance that is intentionally added to
food as a consumable component or will affect the characteristic of the final end
product, unless it falls under a listed exception (such as a colour additive, new
animal drug, pesticide chemical, or dietary supplement) or is considered a GRAS
substance.
56
Food additives are considered unsafe until the manufacturer can
prove in a Food Additive Petition (FAP) that the ingredient is food-grade pure and
meets food safety regulations.
57
The FDA will review the scientific data and
information submitted in the FAP to ensure it is “safe,” which is defined as a
reasonable certainty of no harm to consumers.
58
After the FDA approves the FAP,
the substance may enter interstate commerce.
59
Most companies opt to list new food ingredients as GRAS where possible, to avoid
the tedious FAP pre-market approval process.
60
The key difference between the
GRAS and food additive classification process is who reviews the scientific data and
information to make the final decision. As indicated above, the FDA approves food
additive safety based on privately held data and information about the substance
that the producer compiled in the FAP.
61
By contrast, a company relies on the
opinion of “experts qualified by scientific training and experience to evaluate . . .
safety” in making its own (not the FDA’s) determination that a substance’s use is
GRAS.
62
This self-determination still requires both technical evidence of safety and
a basis to conclude that this evidence is generally known and accepted.
There is no requirement for the FDA to corroborate the company’s findings before
the self-determined GRAS substance is released on the market; instead, the
company may voluntarily submit a notification of its determination to the FDA for
review before putting it on the market.
63
The notification includes a detailed
description of the substance, the conditions of use, and the basis of the
determination.
64
A “no questions” response from FDA does not mean that the FDA
has approved the substance; as noted, in the GRAS process the FDA relies on the
determination made by the company submitting the substance for approval.
In the US, companies have already taken advantage of the GRAS pathway to get
their vegetarian food products, which contain new food ingredients, to market
quickly. For example, the FDA examined extensive test data about the Impossible
Burger’s key ingredient, a protein called “soy leghaemoglobin,” before affirming
its GRAS status.
65
Approval for this protein was key to its success because it carries
heme and makes the vegetarian patty “bleed” like real meat.
66

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Alternatively, a substance can be classified as GRAS if it has been used in food
before 1958 and has been commonly ingested by a significant number of
consumers; however, this route is rarely utilized today.
67
How Novel Foods Are Regulated in Other Jurisdictions
Governments make different choices on how to design, enact, and enforce novel
food regulation within their borders. In Australia and New Zealand, the
establishment of a new, joint regulatory body has led to the creation of a new set
of food standards that apply in both countries. In Brazil, the country’s own
regulation exists alongside concurrent regulation across almost all of South
America, through Mercosur, the South American Common Market. Novel foods are
specifically defined and regulated in several countries including Australia/New
Zealand, Brazil, Canada, and China; we look at each of these in turn.
Australia/New Zealand
By agreement in July 1996, Australia and New Zealand authorized the bilateral
agency “Food Standards Australia New Zealand” (FSANZ) to establish and maintain
food standards that apply in both countries.
68
The two countries have also
harmonized labelling and compositional standards under the Australia New
Zealand Food Standard Code (the Code).
69
Within Australia, enforcing compliance
with the Code with respect to all foods is the responsibility of State/Territory Health
Departments,
70
while for imported foods, enforcement is the responsibility of the
Australian Quarantine Inspection Service.
71
The Code regulates all aspects of food including labelling, food additives,
processing aids, nutritive substances, contaminants, approval of new foods (novel
foods, genetically modified foods, and irradiated foods), and composition of
standardized and special purpose foods, among others.
72
Other standards that are
not part of the joint food standards setting system cover food safety, agricultural
compounds, veterinary medicines, and primary food production and processing.
73
Food ingredients are not defined under the Australia New Zealand food
regulations;
74
ingredients are generally considered to be either foods or substances
added to food.
75
FSANZ defines a novel food as a non-traditional food with no
history of safe use where the food requires an assessment of the public health and
safety considerations with regard to:
1. the potential for adverse effects on humans;
2. the composition or structure of the food;
3. the process by which the food has been prepared;
4. the source from which it is derived;
5. patterns and levels of consumption of the food; or
6. any other relevant matters.
76
Non-traditional food is defined as:
1. a food that does not have a history of human consumption in
Australia/New Zealand;

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2. a substance derived from a food where that substance does not have a
history of human consumption in Australia/New Zealand other than as a
component of that food;
3. any other substance, where that substance, or the source from which it
is derived, does not have a history of human consumption as a food in
Australia/New Zealand.
77
An application to vary the Code is required to approve the use of a nutritive
substance or to change the permissions for a currently used nutritive substance.
78
Brazil
The main authority within Brazil for food regulation and safety assessment is the
Ministry of Health (Ministrio da Saude) through its autonomous regulatory
agency, Agencia Nacional de Vigilancia Sanitria (ANVISA – National Agency of
Sanitary Surveillance).
79
ANVISA’s function is to evaluate the safety of use of food
additives and ingredients in foods. Specific working groups within ANVISA work on
the approval of novel foods and novel food ingredients with functional health
claims.
80
Novel foods and ingredients require a pre-market approval by ANVISA:
81
pre-market approvals are valid for five years from the date of their publication in
the Brazilian Official Gazette and may be renewed.
82
The following foods must be registered in the category of novel food, even if they
do not bear functional and/or health claims:
83
1. foods with no history of use in the country;
2. foods containing novel ingredients;
3. foods containing substances already consumed that may be added or
used at levels much higher than those currently observed in the foods
that constitute part of a regular diet; and
4. food offered in the form of capsules, pills, tablets, and the like.
Brazil is a member of the Southern Common Market, Mercosur, whose other
members are Argentina, Paraguay, Uruguay, and Venezuela. Like the other
member countries,
84
Brazil is gradually replacing many of its food standards with
official Mercosur standards as they are developed. Mercosur standards are
influenced by the EU, the Codex Alimentarius, and the FDA.
85
Mercosur does not
have a definition of novel foods, although such foods are recognized in practice.
86
Canada
In Canada, the Health Canada Food Directorate is responsible for establishing
policies, setting standards, and providing advice and information on the safety and
nutritional value of food.
87
It is also responsible for promoting the nutritional health
and well-being of Canadians by defining, promoting, and implementing evidence-
based nutrition policies and standards.
88
In addition, it administers the provisions
of the Food and Drugs Act (1920) that relate to public health, safety, and
nutrition.
89
The Canadian Food Inspection Agency is responsible for enforcing the
food safety and nutritional quality standards established by Health Canada.
90

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Health Canada defines a novel food as:
1. a substance, including a microorganism, that does not have a history of
safe use as a food;
2. a food that has been manufactured, prepared, preserved, or packaged
by a process that has not been previously applied to that food and causes
the food to undergo a major change; and
3. a food that is derived from a plant, animal, or microorganism that has
been genetically modified.
91
Pre-market application is required for a new substance, for an extension of the use
of a permitted food additive, for permission to change the maximum level of a
permitted food additive, or for authorization to add a new organism to the list of
permitted sources of enzymes used as a food additive.
92
China
In China, the Ministry of Health (MOH) is responsible for drafting health laws,
regulations, policies, and standards.
93
It also supervises enforcement of these
standards, unlike many other countries that assign enforcement authority to a
different entity.
94
Novel foods are referred to as new resource foods, which are defined as raw food
materials or food ingredients that do not have a significant history of consumption
in the country.
95
Chinese legislation under the MOH defines a new food additive as
an additive that is not included in the national food safety standards, not included
in the public announcement of permitted use issued by the MOH, and whose scope
of use or dosage is increased.
96
Pre-market application is required for new food
additives.
97
Specific Regulatory Issues
Regulatory Issues Connected to Food Formulation
A food that results from a process not used for food production in the EU before
May 15, 1997 but that gives rise to significant changes in the composition or
structure of a food (affecting its nutritional value, metabolism, or level of
undesirable substances) is considered a “novel food” under the NFR. The same
applies if vitamins, minerals, and other substances are used in the production
process and the process was not used for food production within the EU before
May 15, 1997.
As discussed in the next section, more specific regulations apply if the novel food
is being prepared for specifically defined vulnerable groups such as infants. In such
circumstances, the rules of Regulation (EU) No 609/2013 on food intended for
infants and young children, food for special medical purposes, and total diet
replacement for weight control apply in addition to the rules of the NFR.
98
In the US, federal agencies regulate food produced through unconventional
methods within existing legal frameworks. Accordingly, the FDA focuses on the
characteristics of the food product rather than the method by which the food is
produced or developed.
99
It justifies this approach by reference to the agency’s
dual purpose: protecting the public’s health by assuring the safety of food that

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enters the US market, while also fostering innovation and technological advances
in the food sector.
100
Anticipating a boom in the application of the genomic editing technology called
clustered regularly interspaced short palindromic repeats, also known as CRISPR-
cas9 (CRISPR), the FDA released a draft guidance document in 2017. In it, the
FDA proposes to expand the definition of “new animal drug” to include animals
altered or developed through genome editing and genetic engineering (GE)
technologies.
101
The agency justifies the expansion on the basis that altering an
animal’s genome to affect its bodily structure or function or to cure, treat, or
prevent disease in the animal falls within the FDCA’s definition of drug.
102
In
addition to CRISPR, the guidance document also identifies rDNA as a new animal
drug, even though rDNA has been widely used in plants to create GMOs. The
Guidance Document clarifies that the genetically modified animal is not a drug, but
rather the genome editing technology is a new animal drug (NAD).
103
Similar to
food additives, NADs are subject to an expensive and time-consuming pre-market
review process.
104
The FDA anticipates releasing a final guidance document by the
end of 2020.
105
Regulatory Issues Connected to Food Formulation for Special Populations
In the EU, Regulation (EU) No 609/2013 on food intended for infants and young
children, food for special medical purposes, and total diet replacement for weight
control (Food for Specific Groups (FSG))
106
stipulates a special regime for
formulation of food for specific populations. According to FSG Recital 23, the rules
in the FSG complement the rules of the NFR in the sense that no novel food shall
be added to food covered by the FSG unless such substances fulfil the FSG’s
conditions for being placed on the market.
Where a food promises health benefits or nutritional benefits and the food business
operator makes use of these benefits in its marketing communication, the EU’s
special regime of health claims applies. In this regard, Regulation (EC) No
1924/2006 on nutrition and health claims made on foods (NHCR)
107
introduces EU-
wide quality requirements, which apply in addition to the novel foods regime.
According to the NHCR, health and nutrition claims concerning foods need to be
based on scientific evidence
108
and not be “false, ambiguous or misleading.”
109
In
addition, the NHCR introduces an authorization procedure for health claims.
110
Certain uses of health claims are also prohibited without exception, such as those
that “make reference to the rate or amount of weight loss.”
111
The EU Register of
Nutrition and Health Claims lists all permitted nutrition claims and all authorized
and non-authorized health claims.
Regulatory Issues Connected to Genetically Modified Food
In the EU, genetically modified foods are not subject to the novel foods regime.
112
Rather, a special regulatory regime requires authorization and traceability of GMOs
before they are released into the environment, introduced into the market, or used
in food for human beings or animal feed.
113
Furthermore, EU law foresees certain
liability requirements for damage caused by GMOs.
114
In addition, specific labelling requirements exist for (authorized) GMOs. Regulation
(EC) No 1829/2003 (GMO Labelling Regulation) concerns labelling of foods which
contain or consist of GMOs or are produced from or contain ingredients produced

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from GMOs.
115
Article 13(1)(a) of this Regulation introduces an EU-wide labelling
requirement, according to which each food containing or produced from GMOs
must bear a label with mandatory information attached to it, indicating that the
food or the respective ingredient contains GMOs. Article 12(2), however, exempts
all “foods containing material which contains, consists of or is produced from GMOs
in a proportion no higher than 0.9 per cent of the food ingredients considered
individually or food consisting of a single ingredient, provided that this presence is
adventitious or technically unavoidable.”
116
It is also important to note that GMOs
obtained by mutagenesis are not considered to be part of the special GMO
regulation in the EU, with the exception of techniques developed after 2001 such
as CRISPR.
117
In the US during the 1970s and 80s, there was increased application of innovative
biotechnology in formulation of food products, specifically GMOs. The White House
investigated how to regulate biotechnology products and who should be
responsible for the review of their safety and for enforcement.
118
After 18 months
of public comments, the White House finalized a federal policy entitled the
Coordinated Framework for the Regulation of Biotechnology (Coordinated
Framework) in 1986.
119
The Coordinated Framework outlines three basic
regulatory principles.
120
First, agencies should focus on the end products, not the
process used to create GE
121
food.
122
Second, GMOs are low risk and no more
dangerous or risky than traditionally produced food.
123
Third, existing federal
statutes are sufficient to ensure that GMOs and their by-products meet the same
safety standards as their conventional counterparts; thus, GMOs do not require
pre-market approval.
124
The Coordinated Framework tasks the Environmental
Protection Agency, United States Department of Agriculture, and the FDA with
enforcing biotechnology regulations according to the three principles just listed.
125
Under the Coordinated Framework, human and animal food derived from GE plants
is held to the same food safety and labelling standards as all FDA-regulated food.
126
The White House issued two updates to the Coordinated Framework, in 1992 and
2017. Both continued to emphasize a “product-focused, not process-focused”
regulatory approach to GMOs.
127
Accordingly, the Coordinated Framework
continues to provide that GMOs should not be subject to excessive oversight
compared to their non-modified counterparts, unless the risk posed by the GE
product is unreasonable: this occurs when the amount of risk reduced by
regulatory oversight exceeds the cost of regulation.
128
As set out in the Coordinated Framework, GE plants are regulated under the
relevant agency’s existing framework, but additional regulatory programs have
been enacted to ensure GE food safety.
129
For example, while the FDA operates
under the assumption that GE plants are not materially different from their
conventional counterparts, the agency established a voluntary premarket Plant
Biotechnology Consultation Program. To date, all GE plant developers have
voluntarily participated in the Consultation Program and waited for final FDA
approval before selling their products.
130
The FDA evaluates factors such as
whether the GE plant is as nutritious as its conventional counterpart and whether
the genetic alteration may contain a new toxin or allergen.
131
After reviewing the
sponsor’s data, the agency issues a letter of its findings to the developer and
publishes the consultation package online for the public.
132
As noted earlier, the

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FDA does not impose special GE labelling requirements.
133
The FDA treats GE
products as GRAS, but GE developers must demonstrate that the modified crops
are substantially equivalent to their non-modified version and are safe before
placing them in interstate commerce.
134
Regulatory Issues Connected to Food Containing Nanomaterials
In the EU, foods containing engineered nanomaterials are considered “novel
foods.”
135
“‘[E]ngineered nanomaterial’ means any intentionally produced material
that has one or more dimensions of the order of 100 [nanometers] (nm) or less or
that is composed of discrete functional parts, either internally or at the surface,
many of which have one or more dimensions of the order of 100 nm or less,
including structures, agglomerates or aggregates, which may have a size above
the order of 100 nm but retain properties that are characteristic of the nanoscale.
Properties that are characteristic of the nanoscale include:
(i) those related to the large specific surface area of the materials
considered; and/or
(ii) specific physico-chemical properties that are different from those of
the non-nanoform of the same material.”
136
If a food contains such nanomaterials, the entire legal regime of the NFR applies.
Nanomaterials, or “nanoparticles” are already present in many foods, both natural
and processed. Some nanoparticles are specifically designed for incorporation into
foods as a delivery system.
137
In the US, engineered nanomaterials are considered
food additives and must go through the FAP pre-market approval process before
entering the market. The FDA declared as policy in its guidance document that
food ingredients created through nanotechnology and foods containing engineered
nanomaterials are not eligible for GRAS status, although this guidance is not
binding.
138
Regulatory Issues Connected to 3D Printed Food Products
3D printing in the area of foods is still at an early stage. Potential applications
include the production of food with special nutritional and dietary needs (for
example for people suffering from illnesses) or substitution of food materials. In
the EU there is no specific legal framework for the application of 3D printing
techniques for foods. Therefore, in the absence of specific legislation, the
applicable regulatory framework will depend on the product. It is unlikely that 3D
foods will mimic foods which have been in circulation in the EU before May 15,
1997 and alter some of their structure, and so they are likely to fall under the
regulatory scrutiny of the NFR. And if the additional prerequisites of the NFR are
met, i.e. the 3D printing is conducted such that it falls within the NFR’s initial list,
139
most of these 3D foods would qualify as “novel” and hence require authorization
in the EU. If, as expected, they are designed for specific groups, the rules of the
FSG would also apply, as described above. Here, a regulatory obstacle with 3D
printing is very likely to arise under FSG Article 4(2), which only allows such
personalized foods to be sold prepacked in retail markets.
Although the US FDA has released a final guidance document for industry on 3D-
printed medical devices, there is no similar policy in place for 3D printed food.
140
The two main outstanding questions regarding 3D-printed food are whether it

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should be considered “imitation” food and be labelled as such, and whether 3D-
printed foods will lead to economic adulteration or “food fraud.”
141
An example
would be the sale of 3D-printed food without proper labelling.
142
Regulatory Issues Connected to Food Made from Insects
In the EU, foods made from insects are generally defined as novel foods. According
to NFR Recital 8, if insects or their parts are used as food, they are also considered
novel: this was subject to debate before the NFR came into force. Since the term
“insects” has not been defined in the NFR, it is unclear how it might apply. Some
possible questions are whether it would cover only the insects themselves, or also
processed insects or their products. Since insect food is a business of particular
interest for start-ups, the compliance risks with the NFR can serve as a barrier to
innovation for these companies.
In the US, there is no official FDA regulation or guidance document that prohibits
or approves using insects as human food,
143
and novelty foods such as chocolate-
covered ants have been on the market for years. The FDCA forbids the adulteration
of food in interstate commerce, with adulteration defined as containing “filthy . . .
substances, or if it is otherwise unfit for food.”
144
Courts have affirmed the FDA’s
interpretation of “filthy” to include the unintentional addition of insects and insect
parts,
145
but this would not apply to insects intentionally added to food.
Recognizing the unavoidable presence of insects in certain food products, the FDA
permits a certain amount of negligible insects in a food before it is deemed
adulterated.
146
Again, where insects are the main feature of the food and are in
more than negligible quantities, it is unlikely that the FDCA’s prohibitions would
apply.
To date, the FDA has given little attention to insects as an intentional component
of food.
147
Many American consumers have a generally negative view of consuming
insects, but there are a growing number of companies seeking to promote insects
as an alternative form of protein.
148
Until specific guidelines appear regarding the
use of insects, companies may find it risky to invest in this type of food.
149
It is
also worth noting that companies that seek to sell insect-based human food in the
interstate market will likely need to go through the pre-market food additive
approval process.
150
Other Legal Issues
To this point, this chapter has addressed and discussed regulation of novel foods
– but only regulation in the sense of regulatory approval. Other regulatory (in the
sense of legal and legislative) issues are implicated with respect to novel foods.
For this reason, the remainder of this chapter turns more broadly to the
constellation of other legal issues implicated by novel foods. In particular, we
examine how producers of novel foods may run afoul of legal requirements in
different regulatory areas.
Intellectual Property Law
We saw in earlier chapters that scientists have become ever more creative in
devising new food ingredients and processes. The question is at what point an
inventor would seek intellectual property protection for a novel food.

Working Paper 03/2020 Regulatory and Legislative Framework for Novel Foods
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Note first that “novelty” for the purposes of patent law generally concerns prior art
(e.g., whether the claimed invention has already been patented, described, in
public use, on sale, or otherwise available to the public) rather than a history of
consumption, which is key to the definition of novel foods.
151
Another feature of
intellectual property law is that novelty alone does not make a product patentable.
There is also a requirement of non-obviousness of the purported invention.
152
This
means that a claimed invention is only patentable if, prior to the effective filing
date, it would not have been obvious to a person having ordinary skill in the art to
which the claimed invention pertains.
153
In terms of novel foods, this could mean
that a food that merely substitutes one ingredient for another might not be
considered patentable due to obviousness.
Alternatively, companies may seek to protect their investment by applying for
patents on the technology that makes the novel food product possible. For
example, as mentioned earlier, the US Patent Office has granted patents to the
company Impossible Foods, Inc. for its technology which uses the key ingredient,
soy leghaemoglobin, to make its plant-based Impossible Burger bleed like real
meat.
154
In the US and in the EU, the issues of intellectual property rights and GMOs are
deeply intertwined. As members of the WTO, countries must comply with Trade-
Related Aspects of Intellectual Property Rights (TRIPS) Article 27, “Patentable
Subject Matter.” TRIPS provides that “patents shall be available for any inventions,
whether products or processes, in all fields of technology,” although member
countries may exempt plants and animals from patentability.
155
Both the US and
the EU have afforded patent protection for genetically modified plants and
animals.
156
For example, in Diamond v. Chakrabarty, the US Supreme Court held
that “anything under the sun made by man,” such as genetically engineered
microorganisms, are patentable subject matters.
157
Tort Law
Legal issues can also arise in the tort area. The seller of an unregulated food found
harmful to consumers could be subject to a wide variety of potential litigation. In
the EU, liability under tort law varies widely, as national tort law systems are
generally not harmonized. One exception is the area of product liability, which
according to Article 21 of the GFL also applies to foodstuffs. A comparable liability
regime applies in the US, where a claim can be made under tortious product
liability if the seller of a substance is found to have sold a product that caused the
plaintiff injury due to its defective or unsafe nature.
158
In such a case, the seller
could be liable for damages.
In addition, where a harm results from a substance which misleads the consumer,
a cause of action might potentially be filed under the contract and consumer law-
based principle of an implied warranty of fitness for a particular purpose, which is
outlined in § 2-315 of the Uniform Commercial Code (UCC).
159
Under this claim,
where a seller has reason to know any particular purpose for which the goods being
furnished are required, and the buyer justifiably relies upon the seller’s knowledge,
skill, or judgment to furnish goods suitable for a particular purpose, the seller may
be held liable if the goods do not fulfil that purpose.

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Marketing Law
In the EU, the Food Information Regulation (FIR)
160
covers most food marketing
and outlines a number of fair information practices.
161
The basic principles are that
food information must be accurate, clear, and easy for consumers to understand.
Specifically, food information must not be misleading:
 as to the characteristics of the food and, in particular, as to its nature,
identity, properties, composition, quantity, durability, country of origin
or place of provenance, method of manufacture or production;
 by attributing to the food effects or properties which it does not possess;
 by suggesting that the food possesses special characteristics (when in
fact all similar foods possess such characteristics), in particular by
specifically emphasising the presence or absence of certain ingredients
and/or nutrients;
 by suggesting, via the appearance, the description, or pictorial
representations, the presence of a particular food or an ingredient when
in reality a component naturally present or an ingredient normally used
in that food has been substituted with a different component or
ingredient.
Food information may not attribute to any food the property of preventing,
treating, or curing a human disease, or refer to such properties. The prohibitions
extend to advertising and the general presentation of foods, regarding their shape,
appearance, or packaging; the packaging materials used; the way in which they
are arranged; and the setting in which they are displayed. The FIR does not
distinguish between foods and “novel foods,” and so all foods are treated the same,
with no special requirements for marketing novel foods to consumers.
Criminal Law
Gene-editing technology, such as rDNA and CRISPR, holds great potential to
revolutionize the food supply. Many laboratories are exploring the use of these
technologies for the benefit of humankind, such as by formulating transgenic
goat’s milk to combat juvenile diarrhoea in developing countries.
162
However, just
as food can be bioengineered to enhance or insert desirable characteristics, it could
potentially be bioengineered for nefarious purposes. A bad actor could potentially
target a nation’s food supply chain to inflict serious damage on thousands of
people.
In the EU, comparable to tort law, criminal law is generally a matter for individual
member states. Hence, it would depend on the specific national legal system
whether an act or an omission relating to novel food would be subject to criminal
charges.
In the US, FDCA Chapter III explicitly prohibits certain actions and outlines
potential civil and criminal liability.
163
For example, it prohibits introducing
adulterated or misbranded food into the market,
164
and corporate officers have
been found guilty of knowingly introducing adulterated food into interstate
commerce.
165
Since criminal liability attached even where those corporate officers

Working Paper 03/2020 Regulatory and Legislative Framework for Novel Foods
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did not intentionally set out to create contaminated products, it is clear that
criminal liability would also apply in the case of an intentional act.
Conclusion
This chapter discussed how novel foods are regulated within the EU, US, and
elsewhere. We reviewed some of the reasons novel foods might be regulated and
how such regulatory goals can be accomplished. Regulation of novel foods is the
policy maker’s reaction to the unknown, although what is novel today may not be
novel tomorrow. Indeed, the novel food industry has grown immensely over the
past decade due to the need to feed a growing world population while using less
land, water, and other limited natural resources. Ultimately, policy makers have
the difficult task of balancing adequate government oversight over novel foods
without stifling innovation and creativity.
1
European Commission, What is Novel Food?
https://ec.europa.eu/food/safety/novel_food_en (accessed 28 March 2020).
2
World Health Organization (1987). International Programme on Chemical Safety
[hereinafter IPCS], Environmental Health Criteria 70, Principles for the Safety
Assessment of Food Additives and Contaminants in Food.
http://www.inchem.org/documents/ehc/ehc/ehc70.htm#SubSectionNumber:6.2.4
(accessed 28 March 2020).
3
Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25
November 2015 on novel foods [hereinafter NFR] Article 3(2)(a), amending Regulation
(EU) No 1169/2011 of the European Parliament and of the Council and repealing
Regulation (EC) No 258/97 of the European Parliament and of the Council and
Commission Regulation (EC) No 1852/2001 (text with EEA relevance), OJ L 327,
11.12.2015, p. 1-22.
4
See infra text at n. 32.
5
See infra text at n. 32.
6
Food, Drug, and Cosmetic Act 1938, 21 U.S.C. s 301 et seq.
7
Magnuson, B., Munro, I., Abbot, P. et al. (2013). Review of the Regulation and Safety
Assessment of Food Substances in Various Countries and Jurisdictions. Food Additives &
Contaminants. Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment 30 (7):
1189. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3725665/ (accessed 28 March
2020).
8
See, e.g., Finck, M. (2018). Blockchains: Regulating the Unknown, German Law Journal
19: 665. (blockchain technology); Åm, H. (2011). Regulating the Unknown: Governing
Nanotechnologies by a Logic of Pre-emption, p.11 (“nanotechnology brings to the fore
the difficulties of regulatory policymaking under conditions of uncertainty”). Dissertation.
University of Vienna.
https://www.researchgate.net/profile/Heidrun_Am/publication/265276233_Regulating_th
e_Unknown_Governing_Nanotechnologies_by_a_Logic_of_Pre-
emption/links/544fbe230cf24e8f7374a53a/Regulating-the-Unknown-Governing-
Nanotechnologies-by-a-Logic-of-Pre-emption.pdf (accessed 28 March 2020).
9
Opinion of AG Bobek delivered on 30 March 2017, Case C-111/16, Criminal proceedings
against Giorgio Fidenato and Others, ECLI identifier: ECLI:EU:C:2017:248, para. 31
(stipulating that Ulrich Beck’s work guided EU regulation).
10
Beck, U. (1992). Risk Society: Towards a New Modernity. London: Sage. But see
Bergkamp, L. (2016) The concept of risk society as a model for risk regulation – its
hidden and not so hidden ambitions, side effects, and risks. Journal of Risk Research 20
(10) (criticizing the risk society approach, inter alia because it politicizes science and
taints risk management decision-making).
11
In economic terms this is called the existence value. See Dana, D. (2004). Existence
Value and Federal Preservation Regulation. Harvard Environmental Law Review 28: 345.

Working Paper 03/2020 Jessica Vapnek, Kai P. Purnhagen and Ben Hillel
22
12
Cicchetti, C., Wilde, L. (1992). Uniqueness, Irreversibility, and the Theory of Nonuse
Values, American Journal of Agricultural Economics. 1121-1122.
13
General Food Law [hereinafter GFL], 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, Art. 7(1).
14
GFL Arts. 1(3) and 4(1).
15
Id.
16
Commission of the European Communities (2000). Communication from the
Commission on the precautionary principle, Document 52000DC0001, COM/2000/0001
final. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex:52000DC0001
(accessed 28 March 2020).
17
NFR Recital 20.
18
See, e.g., Finck, supra note 8, at 682-90. As one researcher pointed out, “Uncertainty
poses particular problems for governments, as decision-making is highly politicised when
no recourse to ‘facts’ is possible when faced with new technologies.” Åm, supra note 8, at
15. But see Cicchetti & Wilde, supra note 12 (an early example of the increasing
literature in law and economics on the valuation of uncertainty, which can be used in
assisting such decisions).
19
Magnuson, et al., supra note 7, at 1202.
20
IPCS, supra note 2.
21
Id.
22
Id.
23
Id.
24
FAO, About Codex Alimentarius, http://www.fao.org/fao-who-
codexalimentarius/about-codex/en/#c453333 (accessed 28 March 2020). On the
relationship between Codex standards and WTO law, see Dominique, S., Purnhagen, K.
(2016). Reversed Harmonization or Horizontalization of EU Standards? Wisconsin
International Law Journal. 34: 102-104.
25
Magnuson, et al., supra note 7, at 1148.
26
For more background, see Vos, E., Wendler, F. (2007). Food safety regulation in
Europe. A comparative institutional analysis. In: Food Safety Regulation in Europe: A
Comparative Institutional Analysis (ed. E. Vos and F. Wendler), 74. Antwerp: Intersentia;
Faure, M. (2018). The Economics of Harmonization of Food Law in the EU. In: Regulating
and Managing Food Safety in the EU (ed. Bremmers and K. Purnhagen), 283. New York:
Springer.
27
GFL Art. 17.
28
Commission of the European Communities (1999). White Paper on Food Safety.
29
European Commission. General Food Law.
https://ec.europa.eu/food/safety/general_food_law_en (accessed 28 March 2020).
30
There are exceptions when the precautionary principle applies. See GFL Art. 7.
31
NFR Art. 3 II (a).
32
Id. Recital 42.
33
Treaty on Functioning of the European Union Art. 114 (5).
34
Id. Art. 114 (5, 6).
35
World Trade Organization. Understanding the WTO: The Agreements, Standards and
Safety. https://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm4_e.htm (accessed
28 March 2020).
36
NFR Art. 2 I.
37
Id. Art. 2 II.
38
Id. Art. 3 II (b).
39
Id. Art. 3 II (c).
40
See supra text at n. 31.
41
Id. Art. 4 (1).
42
Id. Art. 4 (2, 3).
43
Id. Art. 6 (2).
44
Id. Art. 10.
45
Id. Art. 7 (a).

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46
Id. Art. 7 (b).
47
Id. Art. 7 (c).
48
FDA Center for Food Safety and Applied Nutrition (2018). Frequently Asked Questions
About GRAS for Substances Intended for Use in Human or Animal Food: Guidance for
Industry. https://www.fda.gov/media/101042/download (accessed 28 March 2020).
49
Mark T. Law. History of Food and Drug Regulation in the United States.
http://eh.net/encyclopedia/history-of-food-and-drug-regulation-in-the-united-states/
(accessed 28 March 2020).
50
Id.
51
Id.
52
Id.
53
Id.
54
See Strauss, D. (2011). An Analysis of the FDA Food Safety Modernization Act:
Protection for Consumers and Boon for Business. Food & Drug Law Journal 66: 354-355.
55
Intertek. Novel Food & Food Additive Services.
http://www.intertek.com/food/consulting/novel-foods (accessed 28 March 2020).
56
21 U.S.C. s 321(s); see also International Food Information Council and U.S. Food and
Drug Administration (2010). Overview of Food Ingredients, Additives & Colors.
https://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm0
94211.htm (accessed 28 March 2020).
57
Merrill, R., Francer, J. (2000). Organizing Federal Food Safety Regulation. Seton Hall
Law Review 31: 96.; FDA. Determining the Regulatory Status of a Food Ingredient.
https://www.fda.gov/food/ingredientspackaginglabeling/foodadditivesingredients/ucm22
8269.htm (accessed 28 March 2020).
58
FDA (2016). FAQs About GRAS for Substances Intended for Use in Human or Animal
Food: Guidance for Industry.
https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulator
yInformation/UCM525233.pdf (accessed 28 March 2020); 21 C.F.R. § 170.3(i).
59
See 21 U.S.C. s 170.20(a) (establishing general principles for Food Additive Petition
pre-market approvals); 21 U.S.C. s 171.1.
60
See Kelly Damewood, Food Safety News (2014). The GRAS Process: How Companies
Legally Add Ingredients to Food. https://www.foodsafetynews.com/2014/01/the-gras-
process-how-companies-legally-add-ingredients-to-food/ (accessed 28 March 2020).
61
FDA, supra note 58.
62
21 U.S.C. s 321(s); FDA (2005-2006). How US FDA’s GRAS Notification Program
Works. https://www.fda.gov/food/ingredientspackaginglabeling/gras/ucm083022.htm
(accessed 28 March 2020).
63
Substances Generally Recognized as Safe, 81 Fed. Reg. 54960 (Aug. 17, 2016). See
also 21 C.F.R. s 170 subpart E; FDA (2016). About the GRAS Notification Program
https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/ucm2006851.htm
(accessed 28 March 2020).
64
Damewood, supra note 60.
65
Business Wire (2018). Impossible Foods Receives No-Questions Letter From US Food
and Drug Administration.
https://www.businesswire.com/news/home/20180723005786/en/Impossible-Foods-
Receives-No-Questions-Letter-Food-Drug (accessed 28 March 2020).
66
Id.
67
Damewood, supra note 60. See also 21 C.F.R. s 170.30(c), 170.3(f).
68
Magnuson, et al., supra note 7, at 1150.
69
Id.
70
Id. at 1155.
71
Id.
72
Id. See also FSANZ 2011, http://www.foodstandards.gov.au (accessed 28 March
2020).
73
Magnuson, et al., supra note 7, at 1150.
74
Id. at 1156.
75
Id.
76
Id.

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77
Id.
78
Id. at 1157.
79
For more information, see Ministry of Health, www.saude.gov.br (accessed 28 March
2020); see also National Agency of Sanitary Surveillance website, portal.anvisa.gov.br
(accessed 28 March 2020).
80
Magnuson, et al., supra note 7, at 1161.
81
See Annex II of Resolution RDC 240/2018. See also
http://portal.anvisa.gov.br/en/food (accessed 28 March 2020).
82
Id.
83
Magnuson, et al., supra note 7, at 1161.
84
Id at 1192.
85
Id. at 1161.
86
Id. at 1152.
87
Id. at 1164; see also Government of Canada (2019). Food and Nutrition
https://www.canada.ca/en/health-canada/services/food-nutrition.html (accessed 28
March 2020).
88
Magnuson, et al., supra note 7, at 1164.
89
Id.
90
Id.; see also Government of Canada, Canadian Food Inspection Agency (2018). About
the CFIA. http://www.inspection.gc.ca/about-the-
cfia/eng/1299008020759/1299008778654 (accessed 28 March 2020).
91
Magnuson, et al., supra note 7, at 1199.
92
Id. at 1198.
93
Id. at 1170.
94
Id.
95
Id. at 1199.
96
Id. at 1198.
97
Id. at 1199.
98
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 and repealing Council Directive 92/52/EEC,
Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive
2009/39/EC of the European Parliament and of the Council and Commission Regulations
(EC) No 41/2009 and (EC) No 953/2009 Text with EEA relevance, OJ L 181, 29.6.2013,
pp. 35-56.
99
FDA (1992). Statement of Policy: Foods Derived From New Plant Varieties, 57 Fed.
Reg. 22984.
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformatio
n/Biotechnology/ucm096095.htm (accessed 28 March 2020).
100
FDA (2018). What Does FDA Do? https://www.fda.gov/about-fda/fda-basics/what-
does-fda-do (accessed 28 March 2020); FDA (2018). Press Release, Statement from FDA
Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram on
emerging food innovation, “cultured” food products.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610869.htm
(accessed 28 March 2020).
101
Regulation of Intentionally Altered Genomic DNA in Animals: Notice of Availability of
Draft Guidance for Industry #187 (“Notice of Availability: GFI #187”), 82 Fed. Reg.
6561, 6563 (Jan. 19, 2017).
102
Id.; 21 U.S.C. s 321(g).
103
FDA (2017). Q&A on FDA Regulation of Intentionally Altered Genomic DNA in Animals.
https://www.fda.gov/animal-veterinary/animals-intentional-genomic-alterations/qa-fda-
regulation-intentionally-altered-genomic-dna-animals (accessed 28 March 2020).
104
FDA (2019). New Animal Drug Applications. https://www.fda.gov/animal-
veterinary/development-approval-process/new-animal-drug-applications (accessed 28
March 2020).
105
FDA (2019). Guidances Under Development for 2019. https://wayback.archive-
it.org/7993/20190422162610/https://www.fda.gov/AnimalVeterinary/GuidanceComplian
ceEnforcement/GuidanceforIndustry/ucm042451.htm (accessed 28 March 2020).

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106
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 and repealing Council Directive
92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and
2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and
Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 Text with EEA
relevance, OJ L 181, 29.6.2013, pp. 35–56.
107
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, p.
9), last amended by Commission Regulation (EU) No 1047/2012 of 8 November 2012 L
31036 9.11.2012 [hereinafter NHCR].
108
Id. Art. 6 I.
109
Id. Art. 3(a).
110
Id. Art. 10.
111
Id. Art. 12(b).
112
NFR Art. 2(2)(a).
113
See Purnhagen, K. (2019). How to manage the Union’s diversity: The regulation of
New Plant Breeding Technologies in Confederation paysanne and Others, Common Mkt.
L. Rev. 56 (5): 1379-1396.
114
Article 18(3)(b) Directive 2004/35/EC on Environmental liability with regard to the
prevention and remedying of environmental damage, OJ 2004, L 143/56.
115
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22
September 2003 on genetically modified food and feed (Text with EEA relevance), OJ L
268, 18.10.2003, pp. 1-23.
116
NFR Art. 12(2).
117
See Purnhagen, K., Kok, E., Kleter, G. et al. (2018). EU Court casts new plant
breeding techniques into regulatory limbo. Nature Biotechnology 36 (9): 799-800.
118
The National Academies of Science, Engineering, and Medicine et al. (2017). Preparing
for Future Products of Biotechnology. National Academies Press.
https://www.ncbi.nlm.nih.gov/books/NBK442204/ (accessed 28 March 2020).
119
Id.
120
Coordinated Framework for the Regulation of Biotechnology, 51 Fed. Reg. 23302
(June 26, 1986) [hereinafter Coordinated Framework].
121
Organisms modified through recombinant DNA (rDNA) technology are known as
genetically modified (GM), genetically modified organism (GMO), or GE, but the FDA
prefers referencing the rDNA technology as “genetic engineering.” FDA (2018). Questions
& Answers on Food from Genetically Engineered Plants. https://wayback.archive-
it.org/7993/20180908125544/https://www.fda.gov/Food/IngredientsPackagingLabeling/
GEPlants/ucm346030.htm (accessed 28 March 2020).
122
Id.
123
Id.
124
Marden, E. (2003). Risk and Regulation: US Regulatory Policy on Genetically Modified
Food and Agriculture. Boston College Law Review 44: 734, 747; Coordinated Framework,
supra note 120.
125
Marden, supra note 124, at 739.
126
FDA (2018). How FDA Regulates Food from Genetically Engineered Plants.
https://www.fda.gov/food/food-new-plant-varieties/how-fda-regulates-food-genetically-
engineered-plants (accessed 28 March 2020).
127
Exercise of Federal Oversight Within Scope of Statutory Authority: Planned
Introductions of Biotechnology Products into the Environment, 57 Fed. Reg. 6753 (Feb.
27, 1992) [hereinafter1992 Coordinated Framework Update]; Executive Office of the
President (2017). Modernizing the Regulatory System for Biotechnology Products: Final
Version of the 2017 Update to the Coordinated Framework for the Regulation of
Biotechnology.
https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/2017_coordina
ted_framework_update.pdf [hereinafter 2017 Coordinated Framework Update] (accessed
28 March 2020).
128
1992 Coordinated Framework Update, supra note 127.

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129
Coordinated Framework, supra note 120.
130
Id.
131
Id.
132
Id.
133
FDA (2018). Labeling of Foods Derived From Genetically Engineered Plants.
https://wayback.archive-it.org/7993/20190917033156/https://www.fda.gov/food/food-
new-plant-varieties/labeling-foods-derived-genetically-engineered-plants (accessed 28
March 2020).
134
Consumer Reports (2001). Comment Letter from Consumers Union to FDA Regarding
Docket No 00N-1396, Premarket Notice Concerning Bioengineered Foods.
https://advocacy.consumerreports.org/press_release/cus-comments-on-premarket-
notice-concerning-bioengineered-foods/ (accessed 28 March 2020).
135
NFR Art. 3(2)(a)(viii).
136
Id. Art. 3(2)(f).
137
Takhistova, K. (2009). Note, Food Nanotechnology – In Search of a Regulatory
Framework. Rutgers Computer & Technology Law Journal 35: 261.
138
Use of Nanomaterials in Food for Animals: Guidance for Industry #220, 80 Fed. Reg.
46587 (August 5, 2015).
139
See supra text at n. 31.
140
See Technical Considerations for Additive Manufactured Medical Devices, Final
Guidance for Industry, 82 Fed. Reg. 57462 (Dec. 5, 2017).
141
Id.
142
Id.
143
Boyd, M. (2017). Cricket Soup: A Critical Examination of the Regulation of Insects as
Food. Yale Law & Policy Review 36: 66.
144
21 U.S.C. s 342 (emphasis added).
145
Boyd, supra note 143, at 40-41.
146
Id. at 43; 21 C.F.R. s 110.110(a).
147
Boyd, supra note 143, at 20.
148
Id. at 21.
149
Id. at 37.
150
Id. at 44-45 (discussing a federal case in which the FDA sought to enforce its
regulation of intentionally added insects to animal-feed grain as a food additive).
151
See, e.g., 35 U.S.C. s 102 (US statute setting out rules for patentability).
152
Legal Information Institute. 35 U.S.C. §103; Conditions for patentability; non-obvious
subject matter. https://www.law.cornell.edu/uscode/text/35/103 (accessed 28 March
2020).
153
See, e.g., 35 U.S.C. s 103 (US statute setting out the rules for non-obviousness).
154
US Patent # 9,700,067, Justia https://patents.justia.com/patent/9700067 (accessed
28 March 2020).
155
Torrance, A. (2007). Intellectual Property as the Third Dimension of GMO Regulation,
Genetically Modified Organisms: Philosophy, Science, and Policy Symposium, Kansas
Journal of Law & Public Policy (16): 279.
156
Id. at 280.
157
Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).
158
Legal Information Institute. Products Liability.
https://www.law.cornell.edu/wex/products_liability (accessed 28 March 2020).
159
The Uniform Commercial Code (UCC) is not a federal law but rather a model
commercial code for the states, governing commercial transactions to facilitate interstate
commerce.
160
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, amending Regulations
(EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the
Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC,
Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and
of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission
Regulation (EC) No 608/2004 Text with EEA relevance, OJ L 304, 22.11.2011, p. 18–63.
161
FIR Art. 7.

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162
Cooper, C., Klobas, L., Maga, E. et al. (2013). Consuming Transgenic Goats’ Milk
Containing the Antimicrobial Protein Lysozyme Helps Resolve Diarrhea in Young Pigs. 8
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(accessed 28 March 2020).
163
21 U.S.C. s 331 et seq.
164
Id. s 331(a).
165
Department of Justice (2015). Department of Justice, Former Peanut Company
President Receives Largest Criminal Sentence in Food Safety Case; Two Others also
Sentenced for Their Roles in Salmonella-Tainted Peanut Product Outbreak.
https://www.justice.gov/opa/pr/former-peanut-company-president-receives-largest-
criminal-sentence-food-safety-case-two (28 March 2020).