Student Assignment Cover Sheet

NAME: Adriane Almeida

STUDENT NO: 13202354

MODULE: 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 University’s 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: 8 th 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, Δ 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 health-

conscious 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 Alzheimer’s. 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 Alzheimer’s 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 Parkinson’s

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

Parkinson’s 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 % β-sitosterol

< 35 % β-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 which

sugars

5.1

Fat 0.2

Of which

saturates

Trace

Fibre 2.1

Sodium 3mg

Raspberries Raw (100g)

Energy 25kcal/

109KJ

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 which

sugars

6.0

Fat 0.1

Of which

saturates

Trace

Fibre 1.1

Sodium 6mg

Cranberries Raw (100g)

Energy 46kcal/193kJ

Protein 0

Carbohydrates 12

Of which

sugars

4

Fat 0

Of which

saturates

0

Fibre 5

Sodium 2mg

Low fat milk (250mL)

Calories 130Kcal

Fat 5g

Of which

saturated

And trans

3g

0.1g

Cholesterol 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 people’s 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 consumer’s 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 worker’s sensitizations.

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