14 Novel Protein Sources: An

Overview of Food Regulations

Malik Altaf Hussain
Food Safety Unit, The Victorian Department of Health, Melbourne,
Australia

CONTENTS
14.1 Introduction.........................................................................................................................407
14.2 Regulatory Framework....................................................................................................... 408
14.2.1 Novel Food Regulation ........................................................................................408
14.2.2 Food Safety Regulation........................................................................................413
14.2.3 Other Regulations.................................................................................................418
14.3 Regulatory Examples of Specific Novel Protein Sources................................................. 419
14.3.1 Insects ................................................................................................................... 419
14.3.2 Microalgae ............................................................................................................421
14.3.3 Seaweed ................................................................................................................421
14.3.4 Duckweed .............................................................................................................422
14.3.5 Rapeseed ...............................................................................................................422
14.3.6 Single Cell Protein ............................................................................................... 423
14.3.7 Cultured Meats .....................................................................................................423
14.4 Need for Harmonized Global Regulations of Novel
Protein Sources................................................................................................................... 423
14.5 Conclusion ..........................................................................................................................424
Acknowledgement and Declaration .............................................................................................. 424
References...................................................................................................................................... 424

14.1 INTRODUCTION
Food laws and standards are key elements of any legal framework to ensure safe food production
and supply to consumers. Generally, a set of complex food laws and regulations is used to regulate
the production, trade, and handling of foods. These legislations cover the regulation of food
control, food safety and relevant aspects of food trade (van der Spiegel et al., 2013; Lähteenmäki-
Uutela & Grmelová, 2016; de Boer & Bast, 2018). In recent years, many countries have reviewed
their existing food laws to develop modern and effective national food laws and regulations. These
food laws generally regard international agreements such as the World Trade Organization (WTO)
and Codex Alimentarius standards (Kuik, 2004). The most essential and challenging part of a food
regulatory system is to implement food laws and regulations effectively. Countries also face
challenges of updating their food laws to meet the pace of rapid growth and innovation taking
place at the commercial level (Marinangeli et al., 2017).
Many countries have general legal requirements for the introduction of new foods or ingredients
in the market. For example, food business operators that wish to introduce a novel food protein
product into the European market should comply with the requirements established in EU and
national laws. The novel products, including new protein sources, would need to meet the general
legal requirements to be considered as food. This would include novel food regulations, food safety

DOI: 10.1201/9780429299834-14 407

408 Alternative Proteins

legislation, labelling requirements and other specific legislation that may apply to new protein
sources. Under EU regulations, any food that was not consumed ‘significantly’ prior to May 1997
is considered to be a novel food (European Parliament and the Council, 1997). These regulations
are applied to all new foods, food from new sources, new substances used in food, and new
technologies for producing food. Similarly, several regulatory agencies include a definition of
novel food in their regulations (Table 14.1).
A new protein source can be considered as a novel food or ingredient if it is a newly developed
and innovative protein, a protein produced using new technologies and production processes, or
foods traditionally eaten outside of a geographical region (https://ec.europa.eu/food/safety/novel_
food_en). Cultured meat is an example of a protein produced using new technologies by growing
cell lines in artificial media in a laboratory or in vitro condition. Cultured meat is a novel food as
compared to the production of animals on farm and obtaining meat post-slaughter. There are many
reasons to regulate novel protein sources. One of the most important is to manage any potential
risks and unknown consequences of new technologies and materials developed to produce food for
human consumption (Vapnek et al., 2020). Regulations of novel proteins can be categorized into
two major phases that include regulating market access (e.g., regulatory requirements for pre-
market assessment and approvals) and regulating the products after approval in the market (e.g.,
labelling requirements).
This chapter provides an overview of regulatory frameworks that are in force to assess and
regulate novel proteins in different parts of the world. Novel food regulations in Australia/New
Zealand, Canada, and the European Union are discussed in more detail, as they are more developed.
The legislation in all three regions differentiates the traditional protein foods and the novel protein
foods because the novel protein foods need to go through a pre-market assessment process. Examples
of some specific regulatory requirements for selected novel protein sources are also outlined.

14.2 REGULATORY FRAMEWORK

Current approval processes of novel and alternative protein sources are lacking a universal and
harmonized regulatory framework. Several countries with well-established food regulatory sys-
tems have developed regulations for novel foods, food safety, and labelling that may apply to a
novel protein source. Regulatory approval assessment is generally conducted by a regulatory or
standard-setting agency.

14.2.1 NOVEL FOOD REGULATION

In most countries, novel protein sources are regulated under novel food regulations. However,
there is no universally accepted definition of novel food. The description of a novel food or
ingredient in the novel food regulations does vary from country to country. The requirement of a
pre-market safety assessment for novel foods is a common element of these regulations. Table 14.1
provides an overview of novel food definitions adopted by some selected countries. The EU and
Australia/New Zealand novel food legislation considers food with no documented history of food
use in the definition of novel foods. Australia/New Zealand use the specific term ‘non-traditional
food’ to describe novel food. The definition of ‘novel food’ in legislation creates some common
understanding, but there is still room for interpretation that can cause confusion and uncertainty in
many cases. Therefore, a need exists to develop a more precise definition to diminish any grey
areas and create certainty in the novel food assessment process. Novel food assessment applica-
tions are handled by national agencies in Australia/New Zealand and Canada. In the EU, handling
and processing of novel food applications is now centralized, and it has been assessed by the
European Food Safety Authority (EFSA) since 2018.
In Australia and New Zealand, novel foods are regulated by Standard 1.5.1 – Novel Foods of
the Australia New Zealand Food Standards Code (Australian Government, 2017a). Standard 1.5.1
Novel Protein Sources and Regulations 409

TABLE 14.1
Definitions of ‘Novel Food’ by different regulatory agencies in the world
Country/ Novel Food Definition and Description Source
Region

Australia/New In Australia and New Zealand novel foods are regulated by ( Australian Government, 2017a;
Zealand Standard 1.5.1 – Novel Foods of the Australia New Zealand FSANZ, 2010)
Food Standards Code. Standard 1.5.1 introduced in
December 1999 defines non-traditional food and novel food
as follows:
• non-traditional food means a food which does not have a
history of significant human consumption by the broad
community in Australia or New Zealand.
• novel food means a non-traditional food for which there is
insufficient knowledge in the broad community to enable
safe use in the form or context in which it is presented,
taking into account –
a. the composition or structure of the product; or
b. levels of undesirable substances in the product; or
c. known potential for adverse effects in humans; or
d. traditional preparation and cooking methods; or
e. patterns and levels of consumption of the product.
(Australia New Zealand Food Standards Code, Standard
1.5.1, 'Novel Foods')
Canada The Canadian Food and Drug Regulations (Health Canada ( Department of Justice Canada, 2010)
1999) states that 'novel food' means:
a. a substance, including a microorganism, that does not
have a history of safe use as a food;
b. 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
c. a food that is derived from a plant, animal or
microorganism that has been genetically modified such
that
• the plant, animal or microorganism exhibits
characteristics that were not previously observed in
that plant, animal or microorganism,
• the plant, animal or microorganism no longer exhibits
characteristics that were previously observed in that
plant, animal or microorganism, or
• one or more characteristics of the plant, animal or
microorganism no longer fall within the anticipated
range for that plant, animal or microorganism.
(Consolidated Regulations of Canada, chapter 870, Food and
Drugs Act, Food and Drug Regulations, Part B, ‘Foods’,
Division 28, ‘Novel Foods’)
EU The EU Regulations define ‘novel food’ as any food that was ( European Parliament and the
not used for human consumption to a significant degree Council, 1997)
within the Union before 15 May 1997, irrespective of the
dates of accession of Member States to the Union, and that
falls under at least one of the following categories:
(Continued)
410 Alternative Proteins

TABLE 14.1 (Continued)

Definitions of ‘Novel Food’ by different regulatory agencies in the world
Country/ Novel Food Definition and Description Source
Region

i. food with a new or intentionally modified molecular

structure, where that structure was not used as, or in, a
food within the Union before 15 May 1997;
ii. food consisting of, isolated from or produced from
microorganisms, fungi or algae;
iii. food consisting of, isolated from or produced from
material of mineral origin;
iv. food consisting of, isolated from or produced from
plants or their parts, except when the food has a history
of safe food use within the Union and is consisting of,
isolated from or produced from a plant or a variety of the
same species obtained by: - traditional propagating
practices which have been used for food production
within the Union before 15 May 1997; or - non-
traditional propagating practices which have not been
used for food production within the Union before 15
May 1997, where those practices do not give rise to
significant changes in the composition or structure of the
food affecting its nutritional value, metabolism or level
of undesirable substances;
v. food consisting of, isolated from or produced from
animals or their parts, except for animals obtained by
traditional breeding practices which have been used for
food production within the Union before 15 May 1997
and the food from those animals has a history of safe
food use within the Union;
vi. food consisting of, isolated from or produced from cell
culture or tissue culture derived from animals, plants,
micro-organisms, fungi or algae;
vii. food resulting from a production process not used for
food production within the Union before 15 May 1997,
which gives rise to significant changes in the
composition or structure of a food, affecting its
nutritional value, metabolism or level of undesirable
substances;
viii. food consisting of engineered nanomaterials
ix. vitamins, minerals and other substances used in
accordance with Directive 2002/46/EC, Regulation (EC)
No 1925/2006 or Regulation (EU) No 609/2013, where:
- a production process not used for food production
within the Union before 15 May 1997 has been applied
(The Regulation (EU) 2015/2283 Regulation (EC) No
258/97)
Singapore SFA considers novel foods to be foods and food ingredients (SFA, 2020a)
that do not have a history of safe use. A history of safe use is
defined as substances that have been consumed as an
ongoing part of the diet by a significant human population,
for a period of at least 20 years and without reported adverse
human health effects. Food and food ingredients which are
Novel Protein Sources and Regulations 411

TABLE 14.1 (Continued)

Definitions of ‘Novel Food’ by different regulatory agencies in the world
Country/ Novel Food Definition and Description Source
Region

shown to have history of safe use will not be considered to

be novel foods. Novel foods may also include compounds
that are chemically identical to naturally occurring
substances, but produced through advances in technology.
UK Novel foods are foods which have not been widely consumed (FSA, 2020)
by people in the UK or European Union (EU) before May
1997. This means that the foods don’t have a ‘history of
consumption’. Examples of novel foods include:
• new foods, for example, phytosterols and phytostanols
used in cholesterol reducing spreads
• traditional foods eaten elsewhere in the world, for
example, chia seeds, baobab
• foods produced from new processes, for example, bread
treated with ultraviolet light to increase the level of
vitamin D present
USA Not generally recognized as safe, including food substances ( Food and Drug Administration U.S.,
that were not used as food in the USA before January 1, 2004; Food and Drug Administration
1958; and/or foods for which no recognition of safety based U.S., 2009)
on scientific procedures exists yet. This also includes
processes and breeding/selection applied to GRAS
substances so that the characteristics (e.g., composition,
levels of toxicants) are changed, such as extracts, isolates,
distillates, and reaction products of GRAS substances, as
well as synthetic analogues of GRAS substances of
biological origin(Federal Food Drug and Cosmetic Act,
Chapter II (Definitions), Section 201(s), and Chapter IV
(Food), Section 409 (Unsafe Food Additives), Implementing
regulations: Code of Federal Regulations, Title 21 (Food
and Drugs), Subchapter B (Food for Human Consumption),
Part 170 (Food Additives), Sections 170.3 (Definitions) and
170.30 [‘Eligibility for classification as generally recognized
as safe (GRAS)’].

does not clearly state whether it applies retrospectively. Therefore, a product that was on the
market in Australia and/or New Zealand prior to the introduction of the Standard could possibly be
considered as ‘non-traditional’ (Knudsen et al., 2005). Food Standards Australia New Zealand
(FSANZ) describes novel foods as non-traditional foods that require an assessment to establish
their safety before they are added to the food supply chains in Australia and New Zealand. Food
businesses or companies interested in selling a novel food or a novel food ingredient must apply to
FSANZ for a pre-market safety assessment and request that the Standard be amended to include a
new protein source in the permitted novel foods list (Australian Government, 2017b). Currently,
there are two documents developed by the FSANZ to assist in interpreting the Standard as follows:

1. ‘Format for applying to amend the Code – Novel Foods’ which has a template that can be
used when making an application for permission to use a novel food (FSANZ, 2017).
412 Alternative Proteins

2. ‘Guidelines to assist in applying to amend the Australia New Zealand Food Standards Code –
Novel Foods’ which provides details of the operation of the standard, descriptions of the likely
categories of novel foods, a decision tree for determining the novelty of food, data require-
ments for the assessment of novel foods and a record of views formed in response to inquiries
with respect to novelty (FSANZ, 2004).

FSANZ has set up the Advisory Committee on Novel Foods (the ACNF) that represents Australian
state and territory jurisdictions and the New Zealand Ministry for Primary Industries (Source: https://
www.foodstandards.gov.au/industry/novel/novelcommittee/Pages/default.aspx). Food businesses or
companies can send inquiries to the ACNF for an opinion as to whether a food is considered novel or
not. The ACNF members consider the information provided by an enquirer to make an assessment as
to whether a particular food meets the definition of ‘non-traditional food’ in the Standard and needs a
safety assessment. Then ACNF makes a recommendation about the novelty status of the food in
question, and it publishes ‘Novel food – Record of views formed in response to inquiries’ on the
FSANZ website along with necessary information (FSANZ, 2021). The ACNF recommendations are
neither legal advice nor have any legal binding, but views of the Committee members to advise
enquirers whether they should submit an application seeking to amend the Standard.
The Canadian Novel Food Regulations have a two-step assessment process – first, the de-
termination that something is novel and second, the requirement of a food safety assessment. A
pre-market notification of novel foods to Health Canada is a mandatory part of the assessment
process. Health Canada describes several groups of foods, including products that do not have a
history of safe use as a food, foods resulting from a process not previously used for food, or foods
that have been modified by genetic manipulation (also known as genetically modified foods, GM
foods, genetically engineered foods or biotechnology-derived foods) as novel foods. The Food
Directorate maintains an updated list of novel foods, including genetically modified (GM) foods,
where information on safety assessment and findings that supports it to be safe for human con-
sumption, are made publicly available (Health Canada, 2021). There are 226 entries in the list that
was updated on 23 April 2021.
The first EU Novel Food Regulation (EC No 258/97) was adopted in 1997 and came into force
on 15 May 1997 to protect public health. In the regulation novel food is defined as ‘food that had
not been consumed to a significant degree by humans in the EU before 15 May 1997’. The original
EU Novel Food legislation focused mainly on genetically modified organisms; however, this part
was detached from the Novel Food Regulation to introduce the new EC regulation (No. 1829/
2003) on genetically modified food and feed in 2003. The remaining part of the Novel Food
Regulation (EC No. 258/97) was revised as the Novel Food Regulation (EC No 1852/2001) and
remained in force until 31 December 2017. On 1 of January 2018, it was replaced with the new
Regulation (EU) 2015/2283 on novel food that is applicable now. The new regulation is developed
to promote food innovation by the industry by safeguarding food for consumers in the EU market.
The novel food assessment situation in the UK is interesting and has continued to change with
the regional geographic alliance. The legislation changes can be categorized into three periods:

1. In the pre-EU era, the UK reconstituted the Advisory Committee on Irradiated and Novel
Foods as the Advisory Committee on Novel Foods and Processes (ACNFP) in 1988. The
ACNFP was established as an independent body of experts to advise the central authorities
on any matters relating to novel foods and novel food processes (ACNFP, 2003; 2004).
2. As part of the EU, the UK accepted the assessment of novel foods under the regulations of
the European Union.
3. Now in the Post-EU era, the novel foods need to be authorized before they can be placed on
the market in the UK. The UK retained the EU law on novel foods, Regulation (EU) 2017/
2468. Now the UK has developed two authorization routes under the retained EU law on
novel food using a traditional food notification or full application.
Novel Protein Sources and Regulations 413

The EFSA guidance remains relevant to the development of dossiers for the authorization pro-
cesses in the UK. However, a new application for authorization of a novel food should use a
regulated products application service (FSA, 2020). A list of all authorized novel foods that can be
sold in accordance with the conditions and protection set out is available online (https://
www.legislation.gov.uk/eur/2017/2470/annex/2017-12-20).
In the USA, novels foods are not considered as an individual group of food products. Therefore,
there are no specific regulations in place for novel foods. There are two main entry routes for
novels foods into the US market. A novel ingredient or substance (food additive) needs pre-market
approval by the US Food and Drug Administration (FDA) before it can be added to food or used as
food unless its use is generally recognized as safe (GRAS) by qualified experts. A novel ingredient
or substance can be sold in the market if it is a prior sanctioned substance (food additive) that the
FDA or the US Department of Agriculture (USDA) determined safe for use in food before 1958
(Food and Drug Administration U.S., 2010). FDA has published partial lists of GRAS-approved
ingredients including microorganisms and microbial-derived ingredients and enzyme preparations
used in food (Food and Drug Administration U.S., 2019a).
In Singapore, new protein sources are assessed by the Singapore Food Agency (SFA) under the
novel food regulation. SFA requires food traders who intend to use and/or sell novel foods in its
market to submit an application for approval. In 2019, SFA introduced the novel food regulatory
framework to require food companies to seek pre-market allowance for novel foods such as al-
ternative protein products (Singapore Food Agency, 2019). The pre-market safety assessment is
required for novel protein sources that do not have a history of being consumed as food.
In China, novel foods and ingredients are regulated according to the Administrative Measures
for Safety Review of New Food Materials (2013). In Chinese regulations, novel foods are defined
as animal, plant, or micro-organisms or substances derived from these sources, food substances
with structural changes, or newly developed food materials. The National Health and Family
Planning Commission (NHFPC) conducts pre-market approval of novel food materials to be sold
in China. In Japan, regulatory requirements are specific to the nature of the new food ingredient.
For example, the Ministry of Health, Labour and Welfare (MHLW) does not require a pre-market
assessment and authorization for the new food ingredients to be used as food. However, the new
food must be compliant with the Food Sanitation Act (Act No. 233, 1947). When the new food
ingredient is used as a food additive, then a pre-market assessment and authorization is required
prior to entry into the Japanese market.

14.2.2 FOOD SAFETY REGULATION

The scientific guidelines for performing risk assessments of novel foods are in general poorly
harmonized and are still at the development stage. More attention is paid to these foods as more
experience about testing methodology is obtained. Therefore, it would be very helpful to develop a
common understanding of how such a safety assessment could be carried out based on present-day
knowledge. Table 14.2 provides details of the information required to conduct food safety as-
sessments for novel food, such as a new protein source, by selected regulatory agencies.
In Australia and New Zealand, all non-traditional and novel foods go through a pre-market
safety assessment as part of the assessment of an application by FSANZ to amend Standard 1.5.1.
A risk-based assessment approach is used to make an assessment of the level of knowledge and
scientific data about the safe use of non-traditional food in the broad community of Australia and
New Zealand. The assessment process is designed to evaluate the public health and safety of a
novel food or novel food ingredient and its potential adverse impact on consumers. A range of
biological, chemical, toxicological, and nutritional issues related to a novel food are considered to
ensure the safety of novel foods before permitting their sale in Australia and New Zealand. The
essential information required to make an application to seek permission for the sale of a novel
protein source in the Australia New Zealand Food Standards Code (the Code) is available in the
414 Alternative Proteins

TABLE 14.2
Information required to conduct food safety assessment for novel food approvals by
different agencies around the world
Country/Region Safety Assessment Process Source

Australia/New FSANZ considers following factors in a safety assessment of (Food Standards Australia New
Zealand novel foods: Zealand, 2019)
a. the history of use as a food in other countries
b. the composition of the novel food, particularly the levels of
anti-nutrients and naturally occurring toxins
c. the method of preparation and specifications of a novel food
ingredient
d. potential for allergenicity of the novel food
e. metabolism/toxicokinetic studies on the novel food ingredient
f. animal toxicity studies on the novel food ingredient
g. human toleration studies on the novel food ingredient
Canada Information sufficient to establish that a novel food is safe for (Health Canada, 2006)
consumption are required, Health Canada recommends the
safety assessment data packages according to the following
headings, as applicable:
a. History of use
b. Dietary exposure
c. Detail of novel process
d. History of organism(s)
e. Characterization of derived line/strain
f. Genetic modification considerations
g. Nutritional considerations
h. Toxicology considerations
i. Allergenicity considerations
j. Chemical considerations
k. Microbiological considerations
EU Since the new EU regulation on novel food came into effect in (EFSA, 2018)
January 2018, the process for scientific risk assessment of a
novel food application has been centralized. EFSA performs
risk assessments on the safety of a novel food upon request by
the European Commission. EFSA carries out its safety
assessment based on dossiers provided by applicants. Dossiers
need to contain data on the compositional, nutritional,
toxicological and allergenic properties of the novel food as well
as information on respective production processes, and the
proposed uses and use levels. Substances that do not have a
history of safe use will be considered to be novel foods.
Singapore SFA takes into consideration the following information: (SFA, 2020a)
i. the length of consumption/use of the ingredient (i.e., how
many years the ingredient has been consumed as food or
used in food).
ii. extent of use of the ingredient (i.e., whether the ingredient is
consumed or used by the general population, sub-population,
certain tribes, etc).
iii. quantity (i.e., the level of the ingredient consumed as food or
used in food).
Novel Protein Sources and Regulations 415

TABLE 14.2 (Continued)

Information required to conduct food safety assessment for novel food approvals by
different agencies around the world
Country/Region Safety Assessment Process Source

iv. purpose/context of use (i.e., whether the ingredient is used

for ceremonial purposes such as weddings, during
famines, etc).
v. evidence demonstrating lack of adverse effects to human
health attributed to the substance during the specific period of
use as food.
Singapore Food Agency uses following safety assessment
criteria for novel foods food ingredients in general:
i. Information on the identity and purity of the novel food,
including, percentages of major components and impurities
present.
ii. Information on the novel food's manufacturing process, and
inputs used.
iii. Intended use and proposed use levels in food. Novel foods
which are intended for consumption by specific population
groups should be indicated.
iv. Toxicity studies (in-vitro and in-vivo), where relevant. This
includes acute, short-term and long-term toxicity studies,
carcinogenicity studies, reproductive toxicity studies,
developmental toxicity studies and genotoxicity studies.
v. Metabolism or toxicokinetics studies, where relevant. These
include absorption, distribution, metabolism and excretion
(ADME) studies.
vi. Any safety assessment reports conducted by food safety
authorities in major developed countries (Australia, Canada,
New Zealand, Japan, the European Union and the USA)
In general, studies referenced in safety assessments should be
published in reputable scientific journals. Unpublished studies
may be considered if they have been conducted according to
Good Laboratory Practice and other relevant guidelines
established internationally (such as OECD guidelines).
Safety assessments that have been conducted in accordance to
the following reference documents published by the US FDA,
European Food Safety Authority (EFSA), and FAO/WHO,
would be accepted for review.
• US FDA Guidance for Industry and Other Stakeholders
Toxicological Principles for the Safety Assessment of Food
Ingredients, Redbook 2000
• EFSA Guidance for submission for food additive evaluations
• FAO/WHO Environmental Health Criteria 240 - Principles
and Methods for the Risk Assessment of Chemicals in Food
UK Food Standards Agency requires specific information to assess (FSA, 2020)
the food safety of the novel food:
a. identity of the novel food
b. production process
c. compositional data
d. specifications
(Continued)
416 Alternative Proteins

TABLE 14.2 (Continued)

Information required to conduct food safety assessment for novel food approvals by
different agencies around the world
Country/Region Safety Assessment Process Source

e. the history of use of the novel food and/or of its source

f. proposed uses and use levels and anticipated intake
g. absorption, distribution, metabolism and excretion
h. nutritional information
i. toxicological information and allergenicity
USA The information critical in determining the safety of a GRAS (Food and Drug Administration
substance and must be publicly available: U.S., 2016b)
• Description of the GRAS substance
• Production process
• Historical use, regulatory status, and consumer
• Intended effect
• Analytical methodology
• Review of safety data
• Safety assessment and GRAS determination
The following information for the food additive is required for a (FDA, 2019)
safety assessment:
• identity and composition,
• proposed use,
• use level,
• data establishing the intended effect,
• quantitative detection method(s) in the intended food,
• estimated exposure from the proposed use (in food, drugs,
cosmetics, or devices, as appropriate),
• full reports of all safety studies,
• proposed tolerances (if needed),
• environmental information (as required by the National
Environmental Policy Act (NEPA), as revised (62 FR 40570;
29 July 1997))
• Consistent information should be presented throughout all
sections of the petition, including those pertaining to,
• chemistry,
• toxicology,
• environmental science, and any other pertinent studies (e.g.,
microbiology)

Application Handbook (Food Standards Australia New Zealand, 2019). There are several cate-
gories of novel foods, and FSANZ requires applicants to provide information on the safety of the
novel food (Table 14.2). The information and data required depend on the nature of the novel foods
that need to be assessed.
In Canada, novel foods, novel fibres, and food additives must undergo pre-market safety as-
sessments before they can be sold in the market. Novel food safety assessments are conducted by
the Food Directorate, Health Products and Food Branch of Health Canada, and a set of regulatory
requirements has been developed for this purpose (Table 14.2). As previously described, novel
Novel Protein Sources and Regulations 417

foods are products that do not have a history of safe use as a food, foods resulting from a process
not previously used for food, or foods that have been modified by genetic manipulation (also
known as genetically modified foods, GM foods, genetically engineered foods or biotechnology-
derived foods). The Guidelines for the safety assessment of novel foods that were updated in 2006,
were originally produced in 1994 to address the safety of GMO and novel processing technologies
(Health Canada, 1994; 2006). These Guidelines help the applicant to prepare a novel food sub-
mission and to ensure that sufficient information is available for a safety assessment.
The European Novel Food Regulation has established a system for pre-market approval of
novel foods, and the legislation aims to protect public health and safety. Before placing a novel
food on the European Union market, the applicant must submit an online application for food
safety assessment and authorization. The first Novel Food Regulation of the European Parliament
and the Council, Regulation (EC) No 258/97 was adopted in 1997. Until 2018, the applications
were assessed by the competent authority of the member state where the product is first to be
placed on the market and a copy was sent to the European Commission. The new EU regulation on
novel food came into effect in January 2018, which meant that the scientific risk assessment of a
novel food application had been centralized. Now it is EFSA’s responsibility to perform risk
assessments on the safety of a novel food upon request by the European Commission (Ververis
et al., 2020). The application must fulfill the requirements set in Article 10 of the Novel Food
Regulation. The EU Commission’s Implementing Regulation (EU) 2017/2469 has details of ad-
ministrative and scientific requirements for applications. Since 2018, EFSA has published several
risk assessments of different novel foods (Source: https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2
903/sp.efsa.2018.EN-1381). These documents contain useful information, checklists, and tables for
presenting the scientific data required for food safety assessments and authorizations (Table 14.2).
The European Commission, through the Regulation (EU) 2017/2470, maintains an online list of all
authorized novel foods, called the Novel Food Catalogue.
For new microorganisms, EFSA conducts assessments to determine the safety status. The EFSA
grants a microorganism qualified presumption of safety (QPS) status if the safety assessment
concludes that a group of microorganisms does not raise safety concerns. The qualified pre-
sumption of safety (QPS) status is based on reasonable evidence (https://www.efsa.europa.eu/en/
topics/topic/qualified-presumption-safety-qps). If the QPS status indicates that the biological
agents require a safety risk assessment, then that group must undergo a full safety assessment. A
list of all notifications received by EFSA since 2007 for inclusion in the QPS list is available
(https://zenodo.org/record/4428353#.YIuFwSXivIU), and the next scientific opinion updating the
QPS list is planned for December 2022. An application for market authorization of a regulated
product that requires a safety assessment needs to be submitted to EFSA for a QPS assessment. A
microorganism must meet the following criteria to have a QPS status:

• Its taxonomic identity must be well defined.

• The available body of knowledge must be sufficient to establish its safety.
• A lack of pathogenic properties must be established and substantiated.
• Its intended use must be clearly described.

In the UK, the ACNFP undertook risk assessments of various types of novel foods, such as quorn,
lupins, quinoa and passion fruit seed oil, and examples of these novel food risk assessments can be
found in the annual reports (ACNFP, 2003; 2004). Current advice by FSA is to follow EFSA
guidance on the preparation of dossiers and to present an application for safety assessment and
authorization of a novel food (FSA, 2020). FSA requires specific information for the risk as-
sessment element to the novel food (Table 14.2).
In the USA, any new food ingredient is assessed at two different levels, either as a food additive
or as being Generally Recognized as Safe (GRAS). For a food additive, a pre-market approval for
418 Alternative Proteins

specific uses is required by the FDA. GRAS approval for specific uses is granted by the consensus
of a panel of qualified experts. GRAS status is determined by the history of safe use in food prior to
1958 or using a scientific procedure. The GRAS procedure is a notification procedure that assesses
a new food ingredient or product using scientific data and evidence, such as (un)published studies
and information (Food and Drug Administration U.S., 2010). Alternatively, a substantial history of
consumption for food use by a significant number of consumers is required to make a GRAS
assessment (Food and Drug Administration U.S., 2010). A comprehensive set of scientific data,
information on the consumption, microbiological safety, pharmacological activities, methods, or
principles should be provided to qualified experts to determine that the substance is not harmful
(Food and Drug Administration U.S., 2016a).
If a substance is not GRAS or has a prior sanction as substance, then it is considered a food
additive and requires a safety assessment. For a mandatory safety assessment of a food additive by
the FDA, comprehensive toxicological testing, genetic toxicity, acute oral toxicity, short-term
toxicity, (sub)chronic toxicity, and reproduction and developmental toxicity are required (Food and
Drug Administration U.S., 2019b). The approach to the safety assessment of food additives is
compiled in a publication entitled Toxicological Principles for the Safety Assessment of Direct
Food Additives and Color Additives Used in Food, commonly known as ‘the Redbook’ originally
published in 1982 and revised in 2000 (Food and Drug Administration U.S., 1982; 2007).
In Singapore, the novel food regulatory framework requires food companies to conduct and
submit safety assessments of the novel foods including new protein sources to address potential
food safety risks (SFA, 2020a). Provision of detailed information on raw material and ingredients,
processes, food safety risks including toxicity, allergenicity, the safety of its production method,
and dietary exposure, as well as their preventive control is mandatory. These safety assessments
are rigorously reviewed by a Novel Food Safety Expert Working Group established by SFA. The
expert group provides scientific advice on the food safety status of a novel protein. Recently, SFA
reviewed the safety assessment of Eat Just, Inc.’s cultured chicken and allowed its sale in
Singapore as a novel food and alternative protein product (SFA, 2020b).

14.2.3 OTHER REGULATIONS

A range of other regulations such as Food Labelling, Food Hygiene, Food Safety Management, and
others could be applicable to novel foods including new protein sources once approved to be sold.
These regulations are dependent on the type of novel food or ingredients and legislative re-
quirements of the authorizing agency.
Consumers have the right to know what they are eating and where a particular food came
from. Information regarding the species, origin, safety concerns, and any known allergens are
also important for consumers to make informed decisions on whether to consume a food or not.
Food labelling regulations are set up in different countries to ensure that food manufacturers are
providing the required information to their customers. Generally, approval of a novel protein
source also includes labelling requirements such as origin labelling, health and nutrition claims,
and allergen declarations. The labelling regulations and rules vary from country to country and
for different types of food, and the information on labelling requirements is generally described
in the Food Act.
In Canada, new regulations on food allergen labelling came into force on 4 August 2012. The
food allergens labelling requirements are applied to all pre-packaged foods sold in Canada
(Agriculture and Agri-Food Canada, 2021). Food labels must declare specific priority food al-
lergens, gluten sources, and added sulphites either in the list of ingredients or immediately fol-
lowing the list of ingredients. Mustard is a new priority allergen. Many foods or proteins derived
from foods are included in the priority food allergens. Peanuts, tree nuts (almonds, brazil nuts,
Novel Protein Sources and Regulations 419

cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, walnuts), sesame seeds, milk,
eggs, seafood (fish, crustaceans and shellfish), soybeans, wheat (including kamut, spelt and triti-
cale) and mustard seeds are included in the priority food allergens.
An example of food labelling requirements has been set up by Singapore for alternative protein
products as part of the approval for cultured meat. Food establishments are required to clearly
communicate on the true nature of food. The misrepresentation of cultured meat as conventionally
produced meat to consumers is not allowed. Food companies that sell pre-packaged alternative
protein products in Singapore must label the product packaging with qualifying terms such as
‘mock’, ‘cultured’ or ‘plant-based’ to indicate their true nature. A qualifying labelling term for
products made of surimi fish paste is ‘imitation crabmeat’. The labelling of alternative meat
products as meat is not allowed. This is important so that consumers can decide whether to buy
alternative protein products.
The EU Food Hygiene Regulations (Regulation (EC) 852/2003 and (EC) 853/2004) contain
general rules on hygiene applied to manufacturers of the foodstuffs including those involved in
primary production. According to the Food Hygiene regulations, the food business operator is
obliged to notify the competent authorities of its existence (art. 6, 852/2004). For the handling of
certain animal-origin products, the food business operator should be approved before the start of
operations (art. 4, 853/2004). Similar food hygiene requirements are also set by countries.

14.3 REGULATORY EXAMPLES OF SPECIFIC NOVEL PROTEIN SOURCES

This section covers regulatory approvals and key requirements for novel protein sources by pro-
viding some examples from the countries, such as Australia/New Zealand, Canada, Singapore, the
UK, and the USA, as well as the EU. More detailed and updated information can be obtained from
the regulatory agency’s website of the relevant country or region. Table 14.3 lists selected ex-
amples of novel protein sources that were assessed for regulatory approvals by different agencies.

14.3.1 INSECTS
The lack of regulations for production, processing, and sale of edible insects in developing
countries where entomophagy is traditionally practiced (Dobermann et al., 2017) generally leads to
no barriers imposed to their utilization. However, western countries face a different situation,
where regulatory approvals are required to introduce a new food source such as edible insects or
their products. For example, the EU legislation requires that all insect-based foods meant for
human consumption be regarded as novel foods. Novel foods are mainly considered those that do
not have a history of consumption by humans in the country/region in question. Therefore, au-
thorization is required to sell edible insects and their products under the Novel Food Regulation
(EU) 2015/2283.
If approved, then the general requirements of the food legislation and controls are applied to
insect production. For instance, food business operators need to meet the legislative requirements
under the Food Act. They are also responsible for implementing process controls, maintaining the
microbiological quality, determining the shelf life of the products as well as the safety of their final
products. Animal welfare, hygiene practices and the labeling information provided to the customer
need to be taken into account (Evira, 2018). According to Merten-Lentz and Commandeur (2018),
none of the edible insects were included in the EU novel food list until November 2018. At this
stage, more than 20 applications for authorization of edible insects as novel foods have been
assessed by the European Commission.
Edible insects such as Acheta domesticus, Aegiale hesperiaris, Alphitobius diaperinus (larvae),
Apis mellifera (male pupae), Gryllodes sigillatus, Hermetia illucens (larvae), Liometopum api-
culatum (larvae and pupae), Liometopum occidentale (larvae and pupae), Locusta migratoria,
420 Alternative Proteins

TABLE 14.3
Examples of novel protein assessment and decision by different agencies around the world
Product/Ingredient The Decision Issues/Comments References
Authority

Rapeseed protein FSANZ Permitted FSANZ has permitted the use of (FSANZ, 2020)
isolate rapeseed protein isolate as a novel
food, subject to specified conditions
of use. The approved draft variation
to the Code has a commencement
date of 30 June 2021.
Rapeseed powder EFSA Authorized The Panel considers that the rapeseed (EFSA NDA Panel,
powder from Brassica rapa L. and 2020a)
Brassica napus L., is safe at the
proposed conditions of use.
(Regulation (EU) 2015/2283)
Dried yellow EFSA Authorized The Panel concludes that the dried (EFSA NDA
mealworm yellow mealworm is safe under the Panel, 2021)
(Tenebrio molitor proposed uses and use levels.
larva) (Regulation (EU) 2015/2283)
Freeze-dried alga Health Notified Health Canada assessed and (Health Canada, 2017)
Canada determined that the proposed use of
freeze-dried Tetraselmis chui strain 8/
6 does not pose a risk to consumers.
Therefore, Health Canada has no
objection to the sale of this product
for human food use in Canada.
Lemna protein or US FDA GRAS Pursuant to the regulatory and (Food and Drug
water lentil protein Approved scientific procedures established by Administration
(Duckweed) the regulation at 21 C.F.R.§ 170.225 U.S., 2017)
(c)(5), the intended use of Parabel's
LENTEIN Complete and Degreened
LENTEIN™ Complete are exempt
from premarket approval
requirements of the United States
Federal Food, Drug and Cosmetic
Act. It is determined that such use
is GRAS.
Yarrowia lipolytica EFSA Approved (EFSA NDA
yeast biomass Panel, 2019)
(Single cell protein)
Cultured chicken SFA Allowed (SFA, 2020)
nuggets

Schistocerca gregaria and Tenebrio molitor (larvae) are being considered in the applications. After
EFSA safety assessment that was planned to be completed in 2020, the European Commission will
finalize the decision about the authorization. The EU allowed countries to make individual deci-
sions on edible insects until 2020, the time when EFSA’s assessments on edible insect applications
are expected to become available. In January 2021, EFSA published its first scientific opinion on
Novel Protein Sources and Regulations 421

an insect-derived food, ‘Safety of dried yellow mealworm (Tenebrio molitor larva) as a novel food
pursuant to Regulation (EU) 2015/2283’, and it concluded that there were no safety concerns
(EFSA, 2021). The EFSA’s endorsements of whole or ground mealworms, lesser mealworms,
locusts, crickets, and grasshoppers for human consumption are expected to be released in 2021.
Although edible insect authorizations are pending, some EU countries, including Finland,
Denmark, and the United Kingdom, have granted temporary market access to insect foods. The
market access is given using the former Novel Food Regulation (EU) 258/97 that had some room for
interpretations for animals that are consumed in whole and not slaughtered. In 2018, the Finnish
Food Authority (Evira) published guidelines for the food industry in relation to the farming, sales,
and preparation of insects for consumption (Evira, 2018). It is the responsibility of insect farmers,
manufacturers and sellers to be responsible to ensure that insect-based products are safe for con-
sumers. The guide only applies to farmed insects intended for sale as a whole for human con-
sumption. Wild insects are not permitted to be sold, marketed or presented as food.
In the USA, there is no specific regulation for edible insects. However, edible insects fit the
definition of food as described under US Code Title 21, Subchapter II: Definitions, which therefore
fall under current legislation. The legislative requirements include the requirement that they must
be wholesome, labeled appropriately to declare origin, species and allergen content, toxin-free, and
produced under sanitary conditions.

14.3.2 MICROALGAE
The regulatory bar for marine microalgae to enter the food supply chain is relatively high, and it follows
a lengthy process. The existing regulations (such as GRAS, New Dietary Ingredient Notification, Novel
Food) generally take from a few months to years to grant approval, and the process involves many
complex regulatory challenges. For example, at present, some algae have received approval for their oil,
however, the protein from the same algae is not approved. Similarly, some algae are known to be
toxigenic, producing neurotoxins. Therefore, any microalgae strain that is selected for the production of
food proteins must be non-toxic. In the USA, FDA has five algae included in the GRAS list. In the EU,
foods consisting of or derived from algae are considered under the Novel Food Regulation (EU) 2015/
2283. Therefore, an application should be filed for authorization to introduce novel algae or the product
in the market. There is a need for a fast-track regulatory approval process, simpler evaluation criteria for
photosynthetic algae, and guidelines for research and development.
Health Canada approved the sale of freeze-dried algae, Tetraselmis chui strain 8/6, as a novel
food ingredient in 2017 (Health Canada, 2017). The freeze-dried algae were assessed to be used as
a condiment to give flavour to different foods. The assessment was done according to the
Guidelines for the Safety Assessment of Novel Foods (Health Canada, 2006) for the safety of the
organism, the manufacturing process, the nutritional composition of the final food product, and
what the potential is for this product to present a toxic or allergenic concern. The assessment
determined that the proposed use of freeze-dried Tetraselmis chui strain 8/6 does not pose a risk to
consumers, therefore it can be sold for human consumption in Canada.

14.3.3 SEAWEED
Seaweeds are macroalgae, and a vast variety of macroalgae species has the potential to be used as raw
material for food. Until now, there is no report suggesting marine macroalgae species are harmful to
human health. In the EU, all edible macroalgae species are not authorized as food or food supplements
but the consumption history of these species is the most important factor that affects their regulatory
status. Proteins isolated from macroalgae need authorization, and they are regulated by the Novel Food
Regulation (EU) 2015/2283. The European Commission’s Novel Food Catalogue lists the status of
422 Alternative Proteins

certain varieties of seaweed to be considered as a novel or not. For instance, according to this catalogue,
the brown seaweed Fucus vesiculosus is not a novel food whereas the red seaweed Rhodymenia palmata
L (P. palmata) is a novel food because only brown seaweed has a history of use as a food supplement.
There were 22 seaweed species listed in the Novel Food Catalogue until the end of 2020 (https://
ec.europa.eu/food/safety/novel_food/catalogue_en). When seaweeds are used for human consumption,
then MRLs for residues of plant protection products apply. Commission Regulation (EC) No. 1881/2006
sets a maximum limit of 3.0 mg/kg for cadmium in food supplements consisting exclusively or mainly
of dried seaweed or of products derived from seaweed.

14.3.4 DUCKWEED
In the EU, common duckweed (Lemna minor) was considered to be a novel food when an
application was filed under the Novel Food Regulation (Novel Food Catalogue). Similarly, the
novel foods regulation will be applied to other subspecies of duckweed and require authorization
prior to marketing as a food. Duckweed is likely to belong to the product group ‘fish, fish
products, shellfish, molluscs, and other marine and freshwater food products’ in Annex I of
pesticide residue Regulation (EC) 396/2005. No MRLs for the residues of plant production
products have been set for duckweed. Duckweed protein products from the Lemnaceae poly-
genus, including Wolffia, Lemna, Landoltia, and Spirodella were evaluated for safety (Food and
Drug Administration U.S., 2017). The products are produced by Parabel and identified as
Parabel’s LENTEIN Complete and Parabel’s degreened version of LENTEIN Complete
(LENTEINTM Lean) have been determined to be GRAS based on scientific procedures Pursuant
to 21CFR 170.30 (a). Therefore, these products are exempted from pre-market approval re-
quirements of the United States Federal Food, Drug and Cosmetic Act.

14.3.5 RAPESEED
Historically, rapeseed or canola is processed for oil production which is then used as food.
Therefore, the oil of rapeseed is not a novel food. In the EU, rapeseed is included in Annex I of
Regulation (EC) 396/2005. However, the by-product from rapeseed processing has been used in
animal feed but not consumed as human food. The novel foods Regulation (EU) 2015/2283
applies to the proteins derived from rapeseed seeds. Recently, the EFSA assessed the author-
ization application to place rapeseed powder on the EU market. The scientific opinion on the
safety of rapeseed powder from Brassica rapa L. and Brassica napus L. as a novel food (NF)
pursuant to Regulation (EU) 2015/2283 was published in 2020 (EFSA NDA Panel, 2020a). The
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) considered the rapeseed
powder from Brassica rapa L. and Brassica napus L. to be safe in the proposed conditions of
use. The approved rapeseed powder as a novel protein source is produced using the seeds of
non‐genetically modified double low (00) cultivars. The Brassica varieties have a low erucic
acid content and reduced content of glucosinolates.
Food Standards Australia New Zealand (FSANZ) also assessed an application to amend the
Australia New Zealand Food Standards Code (the Code) to permit the use of rapeseed protein
isolate as a novel food and approved it in 2020 (FSANZ, 2020). This approval is for rapeseed
protein isolate sourced from Brassica species that are naturally low in the anti-nutritional factors
erucic acid and glucosinolates. FSANZ also outlined regulatory requirements and risk management
measures to minimize the identified risks with the consumption of rapeseed protein isolate. The
identified risks include the potential for microbiological contamination, the potential for allergic
reaction in consumers with mustard allergy, and the need to ensure that levels of substances such as
phytates and certain metal contaminants are retained as low as reasonably achievable.
Novel Protein Sources and Regulations 423

14.3.6 SINGLE CELL PROTEIN

In the EU, the novel food regulations apply to the SCP product if the producer strain is not on the QPS
list. EFSA has already published several scientific opinions on food safety assessments of SCP products.
For example, the EFSA NDA Panel favourably assessed the safety of Yarrowia lipolytica yeast biomass
as a novel food (EFSA NDA Panel EFSA Panel on Nutrition, Novel Foods and Food Allergens et al.,
2019). The yeast, Y. lipolytica, is widespread in nature and naturally present in foods high in fat and
protein such as cured meat, dairy products, and various types of cheese. There is no history of Y.
lipolytica biomass consumption, so it is considered a novel food. The biomass of heat‐killed Y. lipolytica
yeast was authorized for placement on the market as a food supplement, excluding food supplements for
infants and young children, in 2019 (Commission Implementing Regulation (EU) 2019/7666). In an-
other application, the EFSA NDA Panel assessed the selenium‐enriched biomass of Y. lipolytica as a
novel food (NF) pursuant to Regulation (EU) 2015/2283 and published a scientific opinion in 2020
(EFSA NDA Panel, 2020). The selenium‐enriched biomass of the yeast Y. lipolytica falls under category
(ii), i.e., food consisting of, isolated from or produced from microorganisms, fungi or algae, according to
the Article 3(2)(a) of Regulation (EU) No. 2015/2283.

14.3.7 CULTURED MEATS

Cultured meat is meat produced by cell culture of animal cells in vitro. The Singapore Food Agency
(SFA) approved the world’s first cultured chicken produced by Eat Just, Inc. in December 2020. The
SFA reviewed the Eat Just’s cultured chicken using the ‘novel food’ petition against the requirements for
the safety assessment of novel foods (SFA, 2020a). This is seen as the beginning of the global regulatory
approval process to clear the entry of cultured meats and their products in the food supply chain. Food
traders and establishments selling alternative protein products such as cultured meats must label the
products with qualifying terms such as ‘mock’ or ‘cultured’ to indicate the true nature of the product.
This approval has initiated a legislative discussion in many countries to develop a regulatory
framework specifically for cultured meat and cell-based products. For example, a formal agree-
ment to regulate cell-cultured food products from cell lines of livestock and poultry was announced
in 2019 by the US FDA (Food and Drug Administration U.S., 2019c). In the EU, novel foods
Regulation (EU) 2015/2283 needs an application to authorize cultured meats or cell-based products
filed to the EFSA for a scientific assessment. In China, a possible route to obtain approval for
cultured meat is through a petition process for approving ‘new food ingredients’. According to
FSANZ, the Food Regulation System in Australia and New Zealand is equipped to deal with new
types of foods including foods produced by new technologies such as cell-based meats (https://
www.foodstandards.gov.au/consumer/generalissues/Pages/Cell-based-meat.aspx).

14.4 NEED FOR HARMONIZED GLOBAL REGULATIONS OF NOVEL

PROTEIN SOURCES
As discussed in previous sections, foods or food ingredients that do not have a history of use within a
country are typically considered as ‘novel foods’ or ‘new food additives’. A pre-market authorization
or approval is necessary to assess the safety of novel food for human consumption. There are no
harmonized international guidelines to conduct these safety assessments. Many different regulations
and pre-market assessment requirements for novel food/ingredient approvals exist in different
countries. Therefore, good planning and a solid strategy are needed to deal with the complexities in
obtaining approvals for novel proteins and the ever-evolving global regulatory landscape.
Efforts are made to adopt a harmonized assessment approach in some parts of the world. For
example, the EU has centralized the assessment process to be carried out by EFSA to ensure the
harmonized scientific assessment of novel foods. The EFSA assesses the novel food that may pose
424 Alternative Proteins

a safety risk to human health and provides its opinion to assist the authorization process for EU
markets. There is an agreed procedure for authorizing a novel food and updating the European
Union’s list of authorized novel foods. This could be a model to develop a globally harmonized
system to set the regulatory and safety assessment requirements for novel foods and additives,
including novel protein sources. This would be useful for food innovation processes and com-
panies to gain approval in multiple markets efficiently and effectively.

14.5 CONCLUSION
Novel protein products are generally required to go through a pre-market safety assessment and
approval process prior to placing them in a market. Regulatory agencies in each country or region
have developed their own regulatory framework. Most of the countries and regions, including
Australia/New Zealand, Canada, the EU, and Singapore use Novel Food legislation to deal with
foods with no documented history of food use. The USA uses either GRAS status or a pre-approval
process for food additives to enter the market. The novel proteins approval applications are
handled by central authorities, for example in Canada it falls within the responsibility of Health
Canada, and FSANZ is an authorized agency in Australia/New Zealand. Once approved, a new
protein or product must meet the regulatory requirements (such as hygiene regulations, labelling
regulations, MRLs, and food safety management) outlined in the Food Act of the particular country
or region. Globally, the safety assessment of novel proteins is not harmonized, and international
guidelines as to how such assessments should be performed are lacking.

ACKNOWLEDGEMENT AND DECLARATION

The author declares no conflict of interest. The views and opinions expressed in this chapter are the
author’s own and do not reflect the position of the Victorian Department of Health.

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