Student Assignment Cover Sheet

NAME:

Adriane Almeida

STUDENT NO:

MODULE:

13202354

HNUT40100 - Food and Regulatory Affairs

ASSIGNMENT: Assignment 2 Novel Food

e-TUTOR:

Dr. Marianne Walsh

PLAGIARISM STATEMENT
I declare that this is all my own work and does not contain unreferenced material copied from
any other source. I have read the Universitys policy on plagiarism and understand the
definition
of
plagiarism
as
given
http://www.ucd.ie/registry/academicsecretariat/docs/plagiarism_po.pdf.
If it is shown that
material has been plagiarised, or I have otherwise attempted to obtain an unfair advantage for
myself and others, I understand that I may face sanctions in accordance with the policies and
procedures of the University. A mark of zero may be awarded and the reason for that mark will
be recorded. I give my approval for my work to be checked by electronic means
Signed: Adriane Almeida

Date: 8th December 2014

PHYTOSTEROLS FOR USE AS A NOVEL INGREDIENT IN FRUIT SMOOTHIES

Product Description
In accordance with the regulation (EC) No 258/97 concerned with novel food and food
ingredients, Delta Foods Ltda. issues a dossier to apply for an approval to use phytosterols in
fruit smoothies as a novel ingredient.
In conformity with the EU legislation, a novel food is a food product or ingredient that
was not available for consumption in the EU market before May 15 of 1997, when the current
novel food legislation was created (Regulation EC No. 258/97). This interpretation also
comprises food processes that will lead to the production of a food with high nutritional value
and with particular compositional structure. Though, this legislation does not include food
additives, extraction solvents and flavorings as novel foods or ingredients.
One of the characteristics of a novel food is that it cannot show any risk to consumers
health, it cannot fool the consumer into believe that the novel product has the same nutritional
value as a known product when it does not.
In the present project, the novel product proposed is a smoothie called VIVA Fruit
Smoothie 4U made of a combination of strawberries, raspberries, blackberries and cranberries
along with a novel ingredient, a plant sterol with known healthy properties.
A smoothie, which name refers to the smooth consistence of the solution, is a thick
beverage made with blended fresh fruits and/or vegetables that can have additional ingredients
such as crushed ice, syrups, chocolate or natural products that are claimed to have health
benefits such as grains and seeds. The production of smoothies is normally geared to a healthconscious public due to its low caloric properties and high nutritional value. As the whole fruit is
blended, the fibers, vitamins and minerals presents in the fruits or vegetables will be available in
the smoothie.
Berries are full of benefits for our health. They have elevated levels of phytochemicals,
natural nutrients that helps to protect our body cells against damage. They are also full of fibers
which give you a sense of fullness, helping people who are trying to lose weight to achieve their
objectives more quickly. This type of fruit is also known for being effective as an antioxidant,
helping to protect our body against free radicals and inflammations. A study carried out by the
American Chemical Society says that a chemical compound known as polyphenolics present in
berries could help in the prevention of cognitive diseases such as Alzheimers. Its antioxidant
effect can help to retard the aging effects on the brain, which leads to changes that are
responsible for the cognitive decline related to Alzheimers disease.

Another research issued by the Neurology journal showed that people who eat an average
of two portions of berries per week decrease its probability of having Parkinsons disease in
25%. The researched also brought into light the benefits of the high abundance of flavonoids in
berries. The high intake of these metabolites is proved to reduce the risk of Parkinsons in men
by 40%. The benefits of fruits are higher when eaten fresh and plain but as the whole fruit are
used in smoothies, all the vitamins and metabolites are maintained, giving the consumers all the
benefits the fruit has to offer.
Also, berries are rich in fiber and water, making us to feel sated by eating less. It can be a
helpful ingredient for those who are planning a diet. They are sweet fruits but the type of sweet
that can be consumed by diabetic people without any concern because of their fiber property.
Strawberries also contain vitamin K, potassium and magnesium, helping to promote bone and
eye health. Strawberries are particularly rich in Vitamin C, having more of this nutrient than
oranges, and in folic acid. The presence of anthocyanins helps in the burning of storage fat. It
also improves short term memory and lower blood levels, easing the occurrence of
inflammations. Besides, studies had shown that the consumption of strawberries helps to
prevent oesophageal cancer.
Meanwhile, cranberries are the type of berry most effective in promoting urinary tract
health. This fruit is powerful against urinary tract infections because it prevents the Escherichia
coli to grow in the urinary tract. At the same time, cranberries can act as natural probiotic,
supplying healthy bacteria to grow in the gastrointestinal tract.
All types of berries provide health benefits. The best way to take full advantage of these
benefits is to eat more than one type of berries each day. That is why the mixed berries
smoothie is so rich in nutrients and should be part of a daily diet.

Composition of Novel Ingredient

The European Commission establishes specifications for the addition of phytosterols in
food products. The composition of plant sterols were identified with GC-FID method.
< 80 % -sitosterol
< 35 % -sitostanol
< 40 % campesterol
< 15 % campestanol
< 30 % stigmasterol
< 3 % brassicasterol

< 3 % other sterols/stanols

Data extracted from Official Journal of the European Union (2004/845/EC).

Ingredients
As the phytosterol will be added in extract form and due to its insolubility rate, a portion
of greek style yogurt and low fat milk are proposed to be added in the product to act as an
emulsifier.
The ingredients to be used in the production of the smoothie are listed below:

Strawberry
Raspberry
Blackberry
Cranberry
Greek style yogurt
Low fat milk
Honey

Production
The process used to produce milk and yogurt products with the addition of phytosterols
is the same used in conventional milk and yogurt drinks. No special controls or storage
instructions are necessary.
Quantity of ingredients

75g of fresh strawberries

75g of fresh blackberries
75g of fresh raspberries
75g of fresh cranberries
250ml of low fat milk
250g of Greek style yogurt
1 tbsp of honey
Plant phytosterol extract

The production of smoothies is quite simple but to prepare this new recipe the steps
mentioned next should be followed.

Step One:
Firstly, the ingredients should be prepared. As we are using fresh fruits they have to be
well washed and the strawberries of bigger size must be cut into smaller, reasonable sizes. The
size will depend on the blender used.
Step Two:
The liquid ingredients, the low fat milk and the strawberry yogurt, will be put in the
blender first. Then, the fruits are added.
Step Three:
Then you blend it until it acquires the consistence desired, smoothie and thick.
Step Four:
Add in the honey and the phytosterol ingredient and blend them thoroughly.
Step Five:
Pack it and refrigerate.

Composition of Novel Food

Blackberries Raw (100g)
Energy

25kcal/104kJ

Protein

0.9

Carbohydrate

5.1

Of

5.1

which

sugars
Fat
Of
saturates
Fibre
Sodium

0.2
which

Trace
2.1
3mg

Raspberries Raw (100g)

Energy

25kcal/109K
J

Protein

1.4

Carbohydrate

4.6

Of which sugars

4.6

Fat

0.3

Of which saturates

0.1

Fibre

2.5

Sodium

3mg

Strawberries Raw (100g)

Energy

27kcal/113kJ

Protein

0.8

Carbohydrate

6.0

Of

6.0

which

sugars
Fat
Of

0.1
which

saturates
Fibre

Trace
1.1

Sodium

6mg

Cranberries Raw (100g)

Energy
46kcal/193kJ
Protein
0
Carbohydrates
12
Of
which
4
sugars
Fat
Of
saturates
Fibre
Sodium

which

0
0
5
2mg

Low fat milk (250mL)

Calories

130Kcal

Fat

5g

Of

which

saturated
And trans
Cholesterol

3g
0.1g
20mg

Sodium

115mg

Carbohydrate

12g

Fibre

0g

Protein

9g

Efficacy of Novel Ingredient

Phytosterols, which are sub classified in sterols and stanols, have similar function and
composition as cholesterol though the first is found in plants while the latter is found in animals.
Plant sterols are abundantly in vegetable oils and their sub products, whole grains, seeds,
legumes, some fruits and all type of nuts. More than 40 different types of phytosterols had been
discovered in the past years but the three more available ones are campesterol, beta-sitosterol
and stigmasterol.
The cholesterol present in animal origin food is known for increasing the risk of
atherosclerosis and cardiovascular diseases. On the other hand, phytosterols have been the
subjective of various studies for its cholesterol lowing effect by lowering the rate of cholesterol
absorption.
A healthy diet containing moderate amounts of phytosterol (459mg/day) can favorably
lower cholesterol levels.

Labelling
The labeling of food products in Ireland is controlled under the legislation Directive
2000/13/EC, as well as advertising and presentation of foods, as it is detailed by an
amendment. Such legislation was rearranged to be used in Ireland system of law by the
European Communities under the regulation 2002 (S.I. No. 483 of 2002).
There are a few mandatory labeling prerequisites for pre packed foodstuff. Every food

product must have in its package the following information attached:

The name of the product under which it is going to be sold;

A list of the ingredients;

Quantity of each ingredient;
Net quantity;
The best before date;
Instructions in case of specific storage instructions and/or conditions of use;
Name and address of manufacturer within EU;
Usage instructions when it is necessary;
Alcohol percentage for drinks with more than 1.2% of alcohol in its composition.

About the shelf-life of this smoothie, it will be referenced as best before date on the label.
Shelf-life of a product refers to the time period that the food will still be in acceptable conditions
of use. In other words, when all the nutrients and properties are still available in the food, such
as appearance, taste, aroma and it does not present any biological, physical or chemical
change that can present risk to consumer health. Products can be labeled with best before
date or use by date. Best before date is typically used in processed products such as canned,
frozen or dried food that maintain its properties for a longer period of time. For foodstuff that has
a higher perishable rate such as food made with fresh ingredients or ready to eat products
such as smoothies and that therefore are more likely to present microbiological changes that
can be dangerous to human health, the use by date is more appropriated. It implies that the
product is safe for consumption until the date established, after that, the food is considered
unsafe. To find out what is the appropriate use by date of the smoothie laboratory tests should
be conducted. Laboratory based testes are critical to decide what is the product shelf-life in a
safe rate.
According to the Directive 2003/89/EC, an amendment of the Directive 2000/13/EC, all the
ingredients that compose the food product must be present in the label section. Although, there
are a few exceptions to this requirement as described below:

When the ingredient in question is described under the Community legislation and the same
ingredient represents a value under 2% of the final product. Additives are not considered an

exception and must be labeled.

Ingredients that are composed by a mix of spices and herbs and that count for less than 2% of

the total product.

Some ingredients are not required by the Community legislation to be present in the label.
Still, all ingredients used in the production process and that are present in the product that
will be available for consumers must be listed on the label, even if the ingredient was altered
during the process.

Also, nutritional information is not always required to be put in the product label. It will
only be demanded when the product has a nutrition claim such as the availability of high fiber
content or low fat content. The Directive 90/496/EC dictated the requirements necessary to be
present in the nutritional information of a food product. Such information can be classified in two
groups:

Group 1: here the nutritional information will consist on energy (Kcal/kJ), carbohydrate, protein

and fat.
Group 2: gives information about energy (kcal/kJ), fat (saturates) protein, carbohydrates (sugar),
fiber and sodium.
Any other nutritional information can also be provided in respect of the amount of starch,
cholesterol, vitamins and minerals, polyols, monounsaturated and polyunsaturated, unless a
nutritional claim about any of these components had been made then the information should be
placed in the nutritional table.
Labeling instructions for the novel product:

Name: VIVA Fruit Smoothie 4U

Made with fresh ingredients
Special Instructions:
You have acquired a fresh product that must be kept in temperature range of 0-5 before and

after opening. After opened, consume within 2 days.

Shake it before drink.
Origin:
Produced in Ireland
Allergens:
Contains milk
Contain nuts

Health Claims
A claim was submitted to the European Foods Safety Authority (EFSA) to evaluate the
effect of phytosterols in reducing the concentration of blood cholesterol and therefore reducing
the risk of coronary diseases. The EFSA panel concluded that the consumption of phytosterols
can in fact reduce blood cholesterol in human by an average of 7-10% when a consuming foods
containing sterols/stanols with more than 0.8g every day on a balanced diet. Researches
showed that after consuming phytosterols on a daily base for 2 or 3 weeks the lowering
cholesterol effects can already be seen. Also, further studies showed that long-term effects can
also be achieved by the use of the nutrient. After EFSA consider all the pertinent data the health

claim saying that plant sterols have a lowering cholesterol effect on blood and that it can indeed
reduce the occurrence of heart diseases was made.
Another claim about the health effects of phytosterols was approved by the EFSA.
According to this claim, the use of plant sterols and stanols can help in the maintance of protate
size and kidney health and also can normalize urination in male population. The Panel analyzed
the data and considered the use of phytosterols effective in the maintenance of a normal size
prostrate and regular urination.
The Regulation 1924/2006/EC of nutrition and health claim covers all type of foods
comprising foods with specific nutritional properties, bottled water and food supplements. It is
used in the commercial segment for nutritional and health claims presented in labels and
advertising of foodstuff. It is also applied in mass catered places such as restaurants, schools
and hospital canteens.

Relevant Legislation
The Legislation No. 97/618/EC rules the specifications for novel food or novel ingredients.
Food when not pure, is normally a complex combination of macro and micro components that
together gives us nourish and energy necessary to maintain the well-being and health of
humans. These products are traditionally considered natural sources of nutrients. They are
regarded as helpful and necessary nutriments that have undoubtedly safety and enriched
nutritional value.
Due to this concept about food, the food safety regulations have been focused its
attention on substances that are used during food processing but that are removed from the
product before its packaging or components that are added to the food while its being
processed but that does not change the total amount of constituents in the food or its nutritional
value, on food additives and on contaminants, being it natural or industrially originated.
Therefore, no nutritional or toxicological tests have yet been conducted with food products,
aside from exceptional cases where strong toxic consequences have been denounced in
humans or even in cases where studies using animals showed that some raw food material had
negative effects. This is not meant to say that nutritional assessment of novel foods has not
being practiced but to emphasize that nutritional evaluations are not considered a base for food
safety evaluations.
A huge number of foods are acknowledged to be composed by toxic substances, such as
mutagens and carcinogens. Various chronic diseases have their contaminant origin in food
products. Whereas it is admitted that some negative effects of diets on peoples health are
linked to the amount of nutrients intake.

The determination of all the benefits of food products and food ingredients is a hard task.
Typical toxicological tests cannot be used to evaluate food. The reason is due to the presence
of singular adversities in food products that are not found when evaluating food contaminants or
additives both in vitro and in vivo. To simplify, the example of the quantity of food to be used in
an animal diet for feeding analysis without disturbing its nutritional balance turns the application
of traditional safety elements inappropriate for hazard evaluation and administration for products
intended to be used as food ingredient.
The regulation 258/97 sets about the placing of novel food or ingredients on the European
market while at the same time concerns about the position in which the novel product will be
placed in a market where this product has not been commercialized before. Such food products

are classified in categories as follow:

Food products or ingredients that presents a new or modified molecular composition that have

not been used before;

Food products or ingredients made of or with microorganisms, fungus or algae;
Food products or ingredients made of or with plant or animals isolated components. Exceptions

apply for foods that have been produced by traditional breeding and that are known to be safe;
Food products or ingredients that are intended to be produced using a process not yet known
when the process implies in considerable changes in the composition of the food or ingredient
that may affect the nutritional performance of the same.
Analysis of Composition
Analysis of the composition of a product is a key element of the process of approving a
novel food. It is crucially important to provide enough data of the composition of the new
product. Also, it will be used as pre requisite when the nutritional and toxicological evaluations
take place. Old methods of evaluation had to be standardized and regulated to make sure that
the data analyzed would be consistent. The assessments performed and the data collected
should be used under scientific principles, being created specially according to the nature of the
novel food. Researches should be focused mainly to identify the composition of crucial macro
and micro nutrients as well as toxic and anti-nutritional substances that might be present in the
product.
Intake of the novel food
The food consumption pattern can show differences once a novel food is incorporated in a
diet, even more when the novel food has a novel ingredient in its composition, and thus
influencing the nutritional state of a person. As it is hard to predict how a novel food will affect

the consumers life, a supervision programme should be used to follow the marketing of the
novel food and gather information about the changes occurred in the nutritional status of
consumers as well as replacement of other food products for the new product available. If the
researches show that changes in critical factors, such as the lack of important nutrients, that
might be associated with the consumption of the novel product and regarded to its composition,
then a re-evaluation of the novel food should be required.
Effects of Novel Food in Human Nutrition
The evaluation of the novel food must take in consideration the nutritional effects of the
novel food both when a normal intake is consumed and at maximum levels of intake. The
assessment would be performed by estimating relevant values from important literature,
analysis of the components, and if necessary information from analysis conducted in animals. If
the new product is aimed to be part of a daily diet, assuming a consumption of a considerable
amount per day, then human nutritional evaluations should be performed. If the product will be
available for all groups of consumers such as infants, pregnant, children, lactating woman,
elderly and people with chronic diseases such as diabetes, then analysis considering
physiological features should be the focus.
Data about the effects of long term and short term consumption of the novel food should
be provided. Such information should be acquired by nutritional analysis and post-market
surveillance.
Allergen Information
The possibility that the ingredients present in the novel product might lead to allergic
reactions need to be considered and explored. The assessment of allergenic potential of a food
product is normally conducted by considering how individuals normally react to a traditional food
similar to the novel ingredient. Ethical characteristics should also be considered. There are
various factors that can help to indicate if the product is potentially allergenic or not, such as
heat and pH sensitivity, digestibility of proteases, molecular weight, etc. Furthermore, evidences
can be found in pre-marketing surveillances results and workers sensitizations.

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