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Frequently asked questions of Benecol®
Questions and Answers by the Benecol® staff
Clinical
How does Benecol® work?
Answer:
The Benecol® ingredient works by inhibiting the absorption
of cholesterol from the digestive tract into the bloodstream.
The cholesterol-lowering effect of the Benecol® ingredient
can be seen within 1-2 weeks after introducing the
recommended dose of Benecol® food products into your diet.
3
How much does Benecol® affect levels of LDL
cholesterol?
Answer:
Over 40 studies have been published to date in scientific
journals, such as the New England Journal of Medicine and
Circulation, documenting the excellent efficacy and
safety profile of the Benecol® ingredient. These studies
show that Benecol® reduces LDL or ‘bad’ cholesterol levels
by up to 15%, but has no effect on levels of ‘good’ HDL
cholesterol.
4
For whom is Benecol® intended?
Answer:
Benecol® products are recommended for everyone with
elevated cholesterol levels. Pregnant women,
lactating women, and children under 5 have special dietary
needs, however, and should consult their doctor before
using any products designed to help manage cholesterol
levels.
5
How will I know that Benecol® is working?
Answer:
Benecol® starts to work within 1-2 weeks after introducing the
recommended daily dosage into your diet. Regular cholesterol tests will
show how Benecol® is working.
6
What happens if I eat less than the recommended daily dosage
of Benecol® ?
Answer:
Your blood cholesterol level will still go down, but the
dosage will not be as effective. Missing one or two days will
not have any real effect, but you should remember that
Benecol® can only prevent the absorption of excess
cholesterol when consumed on a regular basis and in
connection with meals.
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What happens if I eat more than the recommended daily dosage
of Benecol® ?
Answer:
An excess amount of Benecol® will not harm you in any
way, since it will not be absorbed. The excess will simply be
excreted by natural means.
8
What happens if I stop eating Benecol® ?
Answer:
Your cholesterol levels will return to their previous levels.
9
Can my cholesterol drop too much by eating Benecol® products?
Answer:
No. Benecol® will not reduce your cholesterol too much,
because your body will produce a sufficient amount of cholesterol for its
needs.
10
Does Benecol® affect blood vitamin levels?
Answer:
No, Benecol® products do not have an effect on blood
vitamin levels. The only reductions were noted in carotenoid levels.
However, an adequate consumption of fruit and vegetables,
together with plant stanol-enriched products, will sufficiently maintain your
normal carotenoid level.
11
When and how should I use Benecol® ?
Answer:
For the best results, Benecol® foods should be consumed with
meals. Benecol® foods are recommended as part of a healthy diet
and lifestyle every day.
12
What is the difference between endogenous cholesterol
production and food-originated cholesterol?
Answer:
The molecules are similar. Chemically, there's no difference.
Benecol® reduces the absorption of both.
13
Can children and pregnant women use Benecol® ?
Answer:
Children younger than 5 years of age do not normally need Benecol® .
Pregnant women are advised to consult their doctor. As plant stanols are
largely not absorbed by the body, Benecol® is very safe, and its effect and
safety have been tested on children from the age of 5 upward with excellent
results.
14
It is acknowledged that our body needs lipids (fat) for certain functions,
but does the use of plant stanol impair the metabolism in our body?
Answer:
Benecol® only reduces the absorption of cholesterol. Our body synthesizes
the amount of cholesterol that it needs.
15
It is commonly understood that Benecol® inhibits the absorption of fat. What
about the cholesterol that has already accumulated in our body, and in
particular, in our arteries? Clinical studies have proven its cholesterol-lowering
effect, but what is the mechanism in Benecol® that reduces accumulated
cholesterol?
Answer:
Animal studies have shown that Benecol® reduces the accumulation of
cholesterol within the vascular walls. The hypothetical mechanism is such
that when the amount of cholesterol circulating in the blood is reduced,
the accumulated cholesterol is gradually removed by the HDL. So far, there are
no human studies on this issue.
16
Are there any clinical studies on genetically high cholesterol
levels which are not merely the result of an unhealthy diet?
Answer:
Yes, there are several studies on persons with familial
hypercholesterolemia. These studies have shown that Benecol® also reduces
cholesterol in such cases.
17
Why should I use Benecol® to lower my cholesterol when I can
simply use tablets whose efficiency has been proven?
Answer:
More than 40 scientific clinical trials have proven the cholesterol-lowering effect of
Benecol® . Thus, the efficacy of Benecol® is well-proven and acknowledged by the
scientific community worldwide. Benecol® lowers LDL cholesterol by up to 15 %. The
products should be used when the cholesterol level has started to rise and when this
kind of reduction is preferable. If a person requires a dramatic cholesterol reduction,
Benecol® products can be used together with medication to improve the results. The
cholesterol-lowering mechanism of Benecol® is different than the mechanism of
common cholesterol-lowering drugs. Therefore, the use of Benecol® adds to the
positive effects of drug therapeutics that reduce harmful cholesterol. Another benefit of
Benecol® products is that they don’t have any side effects since Benecol® is a food –
not a drug. As a marketing issue, the entire Benecol® concept is very different from that
for drugs. Benecol® is an easy lifestyle change that attracts consumers who want to
take care of their own health, and who believe in preventive tools for maintaining their
good health.
18
Can I take Benecol® with cholesterol-lowering medication?
Answer:
People with cholesterol medication should discuss their individual
needs with their doctor to find the optimum solution. Many people with
cholesterol medication will benefit from using Benecol® products in
combination with their medication.
19
Can Raisio Life Sciences arrange double-blind placebo studies?
Answer:
Raisio’s R&D department is conducting the basic research on the Benecol®
ingredient, and there are clinical studies going on all the time.
If one of our partners would like to do a clinical study using local Benecol®
products, Raisio can provide the study protocol and help in the planning. The
partner commits to taking care of the practical arrangements. All clinical
studies should be approved by Raisio.
20
Why do sterols lose their efficacy after a certain period of time?
Answer:
It is hypothesized that long-term consumption of sterols reduces bile
acid formation and thereby leads to a partial loss in efficacy.
21
What happens to the cholesterol that is not absorbed?
Answer:
It is excreted naturally from the body.
22
Can Benecol® inhibit the cholesterol which is produced by our
own body?
Answer:
Yes, it can.
23
Does Benecol® have any side effects?
Answer:
No. As plant stanols are largely not absorbed by the body, Benecol® does
not enter the bloodstream. As a result, no side effects have been reported
in the numerous clinical studies that have been carried out on the
ingredient.
24
What procedure should be used in testing the efficacy of
Benecol® ?
Answer:
Double-blind, randomized and controlled clinical trials are the
recommended procedures. Raisio provides the protocol and
must preapprove the study.
25
Benecol® reduces the cholesterol level by 10% after 2 weeks of use. Is
this the maximum reduction even after long-term consumption?
Answer:
Yes, the maximal effect can be reached already after 1-2-weeks of
using Benecol® .
26
Is Benecol® beneficial for vegetarians as well?
How does it work?
Answer:
Yes, Benecol® is also beneficial for vegetarians, because, in such cases, it
reduces the absorption of endogenously-derived cholesterol.
27
If our customer has a lot of fatty acid in his/her liver, can
Benecol® reduce this build-up?
Answer:
No, Benecol® only reduces the amount of cholesterol.
28
Why does Benecol® lower LDL cholesterol but not HDL
cholesterol?
Answer:
The serum level of LDL cholesterol is sensitive to dietary changes, whereas the
level of HDL cholesterol is strongly determined by genetics and is minimally affected by
dietary factors. Increased physical activity may increase serum levels of
HDL cholesterol in a beneficial manner.
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Technological
Is there any difference in the shelf life of Benecol® Classic,
Powder and Liquid?
Answer:
Shelf life below + 10°C
Benecol® Classic 12 months
Benecol® Liquid 6 months
Benecol® Powder 9 months
31
When Benecol® is delivered by air freight, does it need to be
refrigerated during transport?
Answer:
No, it does not.
32
Will the maximum shelf life of Benecol® Classic be extended if it
is kept frozen?
Answer:
The shelf life of Benecol® Classic could be extended to 18 months if it is kept
frozen.
33
What is the method used to measure the Benecol® content in the
finished product?
Answer:
The stanol content in a Benecol® product is analysed using gas
chromatography.
34
What is the test method for stanol ester?
Answer:
The amount of stanol can be analysed using gas chromatography. The stanol
ester content is calculated from the amount of stanols.
35
What is the energy content of Benecol® Classic, Liquid and
Powder? Is it the same as in normal fats ~ 9 kcal/g?
Answer:
Energy contents
Benecol® Classic
Benecol® Liquid
Benecol® Powder
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3.6 kcal/g
3.6 kcal/g
4.8 kcal/g (estimated)
Are the fatty acids in Benecol® trans-fatty acids or cis-fatty acids?
Answer:
Fatty acids come from vegetable oils and the composition is derived from
the oil. Vegetable oils usually contain less than 1% of trans-fatty
acids. For example, Benecol® Classic, in which stanols are esterified
with rapeseed oil, have the same fatty acid composition as rapeseed oil.
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What is the proper dosage of Benecol® Liquid?
Answer:
The recommended daily dose of Benecol® Liquid is 3.4 g, which contains 2 g
of stanols.
38
Is Benecol® Powder soluble in water and oil?
Answer:
Benecol® Powder is soluble in hot (> 50 °C) water.
39
At what temperature is Benecol® Powder no longer
homogeneous?
Answer:
Benecol® Powder is soluble in hot (> 50 °C) water.
40
What is the shelf life of Benecol® products?
Answer:
• Benecol® foods have the same shelf life as any food containing fats or
oils
• An off-flavor might be a sign of extended storage (oxidation)
• Oxidation does not decrease the cholesterol-lowering effect, but may
affect the taste of the product
41
What kind of packaging do Benecol® products need? Is airtight
packaging required?
Answer:
Benecol® food can be packed in the same way as the parent food without
Benecol® . Only fat-free and long-shelf-life products, like cereals, may need
another type of packaging.
42
If the product’s shelf life is one year, what happens to the
Benecol® ingredient after that period?
Answer:
As with any other vegetable fat, the Benecol® ingredient oxidises and may
result in an off-flavor. The length of the shelf life depends on the particular
application and should be considered on an individual basis. A storage period
of one year will have no effect on the cholesterol-lowering property.
43
In what circumstances does the Benecol® ingredient lose its
cholesterol-lowering effect in food and beverages?
Answer:
When a food or beverage (not Benecol® itself) is spoiled either
microbiologically or in some other way that renders the product inedible.
Stanol, the cholesterol-lowering part of molecule, is very stable.
44
Can Benecol® be incorporated in canned processed foods? Will
it have any effect on the stability of Benecol® ?
Answer:
There should be no problems associated with the addition of Benecol® in
canned foods. The canning process will not change the stability of Benecol® .
Each application will still require further development and should be tested
independently.
45
Can we use Benecol® Liquid in soft gel products?
Answer:
Benecol® Liquid is suitable for soft gels. The maximum efficacy is
obtained with a daily dose of 3.4 g, or 4-5 capsules.
46
Deep-frying with Benecol® may cause dosage problems – what
is the solution for such problems?
Answer:
The development of a deep-fried product requires a lot of
experience and process repetition. During the development
phase, the stanol content of a product needs to be analyzed through repetitive
trials.
47
As regards the milk powder application or powder drink application/
tablet, what is their solubility in water? Is the dosage the same? Is
Benecol® hygroscopic?
Answer:
Milk powder or drink powder containing Benecol® is soluble in hot
water in just the same way as the parent powder without Benecol® .
The dosage of Benecol® Powder is approximately 5 g / serving.
Neither Benecol® Classic or Benecol® Liquid are hygroscopic. Benecol®
Powder is hygroscopic.
48
How can the separation of the stanol ester to the surface of a fruit juice
or soft drink product be reduced?
Answer:
Benecol® should be added to food products through the process of
homogenisation. There are some starting parameters we might recommend,
but since process equipment and process lines are different, the exact
parameters will need to be gained through on-site trials.
49
What is the stability of Benecol® in fruit juice or soft drinks if
soda or CO2 is added?
Answer:
Adding Benecol® to soft drinks containing soda or CO2 is very
challenging. One example of this kind of product is RhönSprudel’s
Benecol® Wellness drink.
Fruit juice drinks are recommended.
50
Does soda or CO2 change the structure of Benecol® ?
Answer:
Benecol® is typically emulsified in foods. Soda or CO2 breaks down the
emulsion and the stability of the product is decreased. The structure of the
Benecol® ingredient itself is not affected by soda or CO2 .
51
What happens to the dosage of Benecol® if we mix it with other
ingredients such as polycosanol, oat bran, β-glucan or maltoglucose?
Answer:
The daily dose of Benecol® is not affected by other ingredients. Other
ingredients, like oat bran or β-glucan, together with Benecol® may
cause a food to become too viscous and, therefore, the amount of these
compounds should be lowered in any recipe.
52
Does the addition of Benecol® to liquid foods result in a thick,
fatty texture?
Answer:
Benecol® typically creates a smooth and slightly creamy texture.
53
Is the use of emulsifiers required during the manufacturing
process when mixing Benecol® in fruit juices (e.g. orange juice)?
Answer:
Emulsifiers and/or stabilisers help to create a stable product. All
ingredients are generally listed on the label, but regulations may
differ from country to country.
54
If we decide to use an emulsifier, what is the best option for e.g.
orange juice production and yoghurt drinks?
Answer:
The best emulsifiers for juice are e.g. citric acid ester from mono- and
diglycerides and, for yoghurt, additional mono- and diglycerides are
used.
55
How do you measure the fat content of products with Benecol® ? The customers always
worry that Benecol® will affect the fat content in finished products, such as juices and fatfree milk. Normally, juice does not contain fat and it doesn’t look very encouraging if the fat
content is shown in the nutrition facts on Benecol® juice.
Answer:
For labelling (nutrition facts) purposes, the fatty acids of Benecol should be
labelled as fats. The stanol content of the product should be analysed but is
not included in the fat content on the label. The regulations may differ from
country to country and should be taken into consideration.
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Production
Can you explain the processes used to make stanol ester and why it is
more expensive then pure sterols on the market?
Answer:
Both sterol ester and stanol ester are manufactured using esterfication,
a fact which increases their price when compared to pure sterols.
Esterfication makes sterols and stanols fat soluble.
When producing stanol ester, there is an additional refining process:
saturation, where sterols are coverted into stanols. No saturation process is
used in the production of sterol esters.
58
Where does the Benecol® ingredient come from?
Answer:
Small amounts of stanols occur naturally in corn, wheat,
rye and other plants, and are known to reduce cholesterol
over time with continued use. Combining stanols with
vegetable oil extracts creates plant stanol ester, which is an
ideal ingredient in a wide variety of food products.
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Non-GMO & PCR negative certification. If we are using wood sterols,
why does it cost more to get a Non-GMO certificate?
Answer:
Wood sterols are more expensive than vegetable sterols.
Wood sterols have IP certification as a non-GMO, whereas vegetable sterols
have PCR negative certification.
60
Are the raw materials (plant stanols) always available for making
Benecol® ?
Answer:
Yes, they are, according to the current estimated demand.
61
Is Raisio ISO certified?
Answer:
Yes, we are.
We have received ISO-9001 certificates, and our activities and
processes are reviewed annually by an external auditor in order
to retain the certification.
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Sales & Marketing
What is Benecol® ?
Answer:
Benecol® is the brand name of Raisio Life Sciences’
cholesterol-lowering ingredient, and the line of functional
foods that various manufacturers produce using the ingredient. The
name Benecol® combines two concepts: bene, meaning
‘good’, and col, from ‘cholesterol’.
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How long has Benecol® been available?
Answer:
Benecol® has been on the market since it was first launched in Finland in
1995 – and it is now available in a number of European and South American
countries, as well as in the US.
65
What kind of help does Benecol® Marketing provide for a
product launch?
Answer:
The Benecol® marketing team provides assistance and examples for creating marketing
materials such as brochures, web-pages, TV-commercials etc. We can also help in
finding speakers for seminars etc.
All interested parties are welcome to join the global network of Benecol® partners. New
partners have access to existing Benecol® materials, examples of successful marketing
cases, market reports and contact details for all other partners in the Benecol® extranet.
We help new partners in creating the Benecol® brand identity and positioning the new
Benecol® products.
The role of the Benecol® marketing team is to give support and share ideas with the new
partner. The practical marketing activities and arrangements are done by the local
partner.
66
Have you had any problems with different customers in the same country which
are competitors and have Benecol® products in different areas? (ex. a dairy
product and a beverage product made by two different major customers)?
Answer:
No, we always licence category-specific rights to the products. Thus,
both companies in the above case would benefit from the Benecol®
marketing campaigns of one another.
Sometimes, the companies are so jeaolous about their marketing
investments, that they want to have a so-called first right of negotiation whenever
new applications are being considered within their geographical area.
Such cases are considered on an individual basis. However, we have already noticed
that new product forms do not generally jeopardize the market. Usually, the
efforts of the new marketer increase the sales of all Benecol® products.
67
What is the price difference of different Benecol® types?
Answer:
Liquid and powder forms are initially somewhat more expensive than
the classic. This is due to more expensive raw materials and
investments in the production technology. The price difference is
roughly € 4 per kilo depending on the volume, but each case is different.
68
As regards the Benecol® ingredient, is there a different price
policy depending on the country or product application?
Answer:
Not really. The pricing is always volume-dependent and may be discounted
according to volume in order to encourage partners to sell
more end products enriched with Benecol® .
69
How do you block the migration of finished products from
market to market?
Answer:
Through licensing and supply agreements which specify the
geographical rights of each product.
70
We have two customers who are interested in Benecol® . They are both large
companies in our country and both want to make a product with Benecol® .
Which company should we choose? Can we use a non-exclusive arrangement
even though the companies are competitors in the same market?
Answer:
The Benecol® sales department will help you to choose the best partner. Each
of them would probably like to have an exclusive agreement since they are
investing in the market. However, if they are happy with the non-exclusive
arrangement, that might be considered. The above is usually the case only if
the end product application is exactly the same. In case the applications are
different, say one is a dairy product and the other is a soup product, there is
no conflict of interest, and we can work with both of them on an exclusive
basis.
71
Who will register Benecol® with the government food bureau?
1) RLS Benecol®
2) Partner/customer
3) Organisation/agent
Answer:
This varies from country to country and depends on national legislation. The
ingredient should be registered by Raisio Life Sciences Benecol® whenever
possible with the agent/partner being the second choice. The Benecol®
partner/customer often needs to also register their own end product.
72
Who are Benecol® ’s competitors?
Answer:
Sterol-enriched consumer products:
- Unilever (pro.activ), Danone (Danacol), Nestle (Nesvita Pro-Heart),
MinuteMaid (Heartwise)
- Supplements and medication (statins)
Sterol ingredients:
- Gognis, Cargill, Forbes Medi-Tech / Phyto Source, ADM, Degussa
73
What are the advantages Benecol® has over competitive
products?
Answer:
The advantages compared to sterols:
- Benecol® has proven long-term cholesterol-lowering efficacy
- Benecol® is minimally absorbed
- The Benecol® brand is already known in many countries
- None of our competitors can offer a brand network in which experiences are shared
The advantages compared to other functional foods:
- The cholesterol-lowering efficacy of Benecol® can clearly be measured and is acknowledged
by authorities and scientists worldwide.
- High cholesterol is a major risk factor for coronary heart disease, which is a growing problem
all over the world. Therefore, there is a strong need for these kinds of products.
- Health is one of the main consumer trends.
- Convenience is one of the main consumer trends.
74
What products compete with Benecol® ?
Answer:
Sterol esters and free sterols.
75
Legal
When, how and what is the proper way to present the agreement
issue to possible Benecol® partners?
Answer:
An agreement should not be presented to possible customers at the
early stage of discussions (when introducing Benecol® ), but only
when they express a true interest in actual co-operation. Then, the first stage
is to present a confidentiality agreement and to introduce the main points of
the license/supply agreement. The second stage is to draft the main
agreement. All agreement-related issues shall be introduced in close
co-operation with the Raisio team, which shall also lead the agreement
negotiations.
77
Can you give an example of an agreement draft between
Benecol® and a customer?
Answer:
Although Raisio has standard types of agreements that are used in the Benecol®
business, agreements are always prepared with consideration for the
differences of each case. For example, certain main points of the
agreement shall be agreed on by the customer and Raisio
before drafting the final agreement. Thereby, we avoid a situation where the
customer receives an unsuitable version. The agreement itself is quite a standard
license and supply agreement with approximately 20 pages + about 10 pages of
appendices.
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