European Regulation On Novel
Foods & Novel Food
Ingredient.

1

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EU Regulations on Novel Foods

• As of 1 January 2018, the new Regulation (EU) 2015/2283
on novel foods (the new Regulation) is applicable.

• It repeals and replaces Regulation (EC) No 258/97
and Regulation (EC) No 1852/2001 which were in force until
31 December 2017.

• The new Regulation improves conditions so that food
businesses can easily bring new and innovative foods to the
EU market, while maintaining a high level of food safety for
European consumers

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Main features and improvements of
the new Regulation

1.Expanded categories of Novel Foods: The Novel Food
definition describes the various situations of foods
originating from plants, animals, microorganisms, cell
cultures, minerals, etc., specific categories of foods (insects,
vitamins, minerals, food supplements, etc.), foods resulting
from production processes and practices, and state of the art
technologies (e.g. intentionally modified or new molecular
structure, nanomaterials), which were not produced or used
before 1997 and thus may be considered to be as novel foods.

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Main features and improvements of
the new Regulation

2.Generic authorisations of Novel Foods: Under the new
Regulation, all authorisations (new and old) are generic as
opposed to the applicant-specific, restricted novel food
authorisations under the old Novel Food regime. This means
that any food business operator can place an authorised Novel
Food on the European Union market, provided the authorised
conditions of use, labelling requirements, and specifications
are respected.

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Main features and improvements of
the new Regulation

3.Establishment of a Union list of authorised Novel
Foods: This is a positive list containing all authorised novel
foods. Novel Foods which will be authorised in the future will
be added to the Union list by means of Commission
Implementing Regulations. Once a novel food is added to the
Union list, then it is automatically considered as being
authorised and it can be placed in the European Union market.
4.A simplified, centralised authorisation procedure manged
by the European Commission using an online application
submission system

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Main features and improvements of
the new Regulation

5.Centralised, safety evaluation of the Novel Foods will be
carried out by the European Food Safety Authority (EFSA).
The European Commission consults EFSA on the
applications and bases its authorisation decisions on the
outcome of the EFSA’s evaluation.
6.Efficiency and transparency will be improved by
establishing deadlines for the safety evaluation and
authorisation procedure, thus reducing the overall time spent
on approvals.

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Main features and improvements of
the new Regulation

7.A faster and structured notification system for traditional foods from third
countries on the basis of a history of safe food use. To facilitate the marketing of
traditional foods from countries outside the EU, which are considered novel foods in
the EU, the new Regulation introduces a simplified assessment procedure for foods
new to the EU. If the safety of the traditional food in question can be established on
the basis of evidence of a history of consumption in the third country, and there are no
safety concerns raised by the EU countries or EFSA, the traditional food will be
allowed to be placed on the European Union market.
8.Promotion of innovation by granting an individual authorisation for five years
based on protected data. Data protection provisions are included in the new
Regulation. That means that an applicant may be granted an individual authorisation
for placing on the market of a novel food. This is based on newly developed scientific
evidence and proprietary data and is limited in time to 5 years.

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DEFINITION OF NOVEL FOOD
As per Article 3, paragraph 2 of Regulation (EU) 2015/2283:
(a)‘Novel food’ means any food that was not used for human consumption to a significant
degree within the Union before 15 May 1997 and that falls under at least one of the following
categories:
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;

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Definition
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, microorganisms, 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, 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 as referred to in point (a) (vii) of this paragraph; or–they contain or consist of
engineered nanomaterials;
x) food used exclusively in food supplements within the Union before 15 May 1997,

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2 What are Novel Foods?

Food that has not been consumed to any significant
degree in EU before May 1997.

Novel food can be newly developed or innovative
food.

Produced using new technologies and production
process.

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3
Cont.…

Novel foods include new sources of Vitamin
K(menaquinone).

Agricultural products from third countries like
Chia seeds(Sabja)

Food derived from new production processes(UV
treated food (milk, bread and mushrooms)

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4 Principles under novel foods and
ingredients.
Safe for consumers

Properly labeled as not to mislead consumers

Novel food is intended to replace another food, it
should not lead to any disadvantages.

Pre market authorization should be done in case of
novel foods and ingredients.

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5 Are insects covered by the new
novel food ingredient?

Insects fall within the Novel food ingredient.
Parts of insects (such as legs ,wings,head,etc)as well

as whole insects
Whereas nanomaterials with one or more dimensions

of 100 nm are included in novel foods.
They include structures, aggregates and agglomerates.

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6
Who holds primary
responsibility for determining
the novel food status of a food?

European Food Safety Authority (EFSA) conducts a
scientific risk assessment for the novel food application.

An e-submission system has been developed to facilitate
novel foods application.

Economic operators in Europe are responsible for
determining whether the food intend to place in Europe
market is novel.

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7
Conditions for Authorisation.

It should not present a risk to public health.

It should not be nutritionally disadvantageous
when replaced with similar food.

It must undergo a scientific assessment prior to
authorization to ensure its safety.

Its designation as food and specific labelling
requirements and post market monitoring
requirements.

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8
Some examples of novel foods
Milk products including milk based fruit drinks.

Yoghurt type products and cheese type products
with added Phytosterols.

Coagulated potato proteins and hydrolysates

Oil rich in DHA(Decosahexaenoic acid).

Pasteurized fruit based preparations.

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9 Contd…
Flavonoids from Glycyrrhiza glabra

Lycopene from tomatoes

N-Acetyl-D-neuraminic acid

Chitosan extract from fungi(Aspergillus niger).

Coriander seed oil from Coriandrum sativum.

Chitin glucan from Aspergillus Niger.

Arachidonic acid rich oil from the fungus Mortierella alpina.

Guar gum.

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10
Role of novel food in food sector.

Aims to help innovators and economic operator to
develop EU market.

Helps In maintaining high level of consumer
safety.

Helps to create new job and growth opportunities
and strengthen the competitiveness of the european
union food industry.

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Food Labelling Information System
(FLIS)

Nutrition and Health Claims –
Union rules on nutrition and health claims have been established
by Regulation (EC) No 1924/2006
nutrition claims (such as “low fat”, “high fibre”) and to health
claims (such as “Vitamin D is needed for the normal growth and
development of bone in children”)

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11 References

Europa.eu

European Food Safety Authority.

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12

THANK YOU

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