Probiotic drops for

infants & young children

Probio-Tec®… when science matters 1

Why probiotic drops for
infants & young children?

In the first years of life a child’s gastrointestinal tract is colonized by a large
number of bacteria resulting in a highly complex microbiota

The microbiota plays a role in the functioning of the gastrointestinal and the
immune system

Bifidobacteria are considered to be of special importance, as it is one of the first

species colonizing the infant gut

Clinical documentation on BB-12® has shown an effect on:

an effect on the bifidobacteria content in the stools*

to have an impact on gastrointestinal health/diarrhea**

to have an impact on immune function***

* Ref.: Langhendries et al. 1995 **ref.: Chouraqui et al. 2004 *** ref.: Taipale et al. 2010

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 Gastrointestinal colonization
Bacteriodes, Streptococcus

Bifidobacteria

E. Coli, Enterococci

Lactobacilli

Clostridia

Adapted from:
Mitsuoka, T. Bifidobacteria and their role in human health.
Journal of Industrial Microbiology, 1990;6:263-268

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Product specifications

Composition
Taste

1 Billion Bifidobacterium BB-12® end
Neutral
shelf life per daily dose

Intake & dose

Sunflower oil, DL-α-tocopherol
(vitamin E) and citric acid
To use, shake well, hold in an angle
of 150°(see picture above) and

Dosage form administer 6 drops of oil onto a spoon

Liquid formulation with probiotics in or into milk/food once a day, for a
oil, delivered in a 10 ml glass bottle daily dose of 1B CFU

Content in bottle is 8 g
Period of intake depends on

indication and need

Packaging

One bottle contains enough liquid for

Amber glass bottle, an horizontal 21 days of use
plastic dropper and a plastic lid

Neutral bottle and ink print in bottom
available as from beginning of 2014

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Target group

Healthy infants & young children

 Infants 0-12 months of age

 Young children from 1-3 years

 Mothers :
 wanting healthy tummies in healthy infants & young children
 wanting to support a healthy microbiota in their children

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Potential consumer positioning

Healthy tummies in healthy infants & young children

- trustworthy effect and safety

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Chr. Hansen Product
Unique Selling Points Unique Selling Points

Documented Effect
Documented efficacy in 3 areas

Documented stability in final consumer pack

BB-12® is tested in numerous clinical trials from newborn preterm

Documented Stability infants to elderly in doses up to 100 billion CFU/day, with no
reported side effects

Limits of contaminants and the monitoring program of the raw

Proven Safety materials are the same as for Infant formulae, even though the
product officially is regulated as dietary supplement

Unique formulation - no SiO2

Multiple Applications

No refrigeration needed - benefit for industry and consumer

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Other product advantages

Unique formulation

Few ingredients used to ensure a clean and simple product

No use of the anti-caking agent SiO2 which is present in most competitor products to ease
powder re-suspension

No refrigeration needed

Sell-in to pharmacies easier, as no refrigeration needed

Benefit through entire value chain

Consumer convenience during storage and usage

Documented effect

Documented efficacy of BB-12® in clinical studies on a healthy microbiota*,
gastrointestinal health/diarrhea** & immune function***

Documented stability in final consumer pack

* Ref.: Langhendries et al. 1995 ** ref.: Chouraqui et al. 2004 *** ref.: Taipale et al. 2010

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Other product advantages –
Optimal safety considerations

Chr. Hansen Probiotic Drops have optimal product safety, both in terms of production method and
product control

From a regulatory point of view, the product is considered a dietary supplement

However, final product release is done according to Chr. Hansen’s own “Infant dietary standard”,
observing even stricter criteria than set by the Authorities

HACCP evaluation from raw material to final product

Stricter limits of contaminants than for dietary supplements (heavy metals, pesticides, dioxins)

The monitoring program of raw materials is the same as for Infant formulae

Stricter analytical program for microbiology has been implemented

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Other product advantages –
Optimal safety considerations
Comparison of microbiological specifications for
“dietary supplement” and “probiotic drops for infants & children”

Microbiological purity level

Parameter Dietary supplement Probiotic drops

Total viable aerobic count (cfu/g) ≤ 2000 ≤ 2000

Total mould & yeast (cfu/g) ≤ 200 ≤ 100
E. coli Absent/g Part of Enterobacteriaceae test
Enterobacteriaceae - Absent in 10 x 10 g
Salmonella - Absent in 10 x 10 g
Cronobacter spp. (E. sakazakii) - Absent in 10 x 10 g
Staphylococcus aureus (cfu/g) - < 10
Bacillus cereus (cfu/g) - < 100
Listeria monocytogenes - Absent in 10 x 10 g

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Other product advantages –
Optimal safety considerations

Chr. Hansen Probiotic Drops have optimal product safety, also in choice of strain

The BB-12® strain is tested in numerous clinical trials from newborn preterm infants to elderly in doses up
to 100 billion CFU/day, with no reported side effects

BB-12® is furthermore GRAS (Generally Recognized As Safe) notified by FDA and approved by the Danish
Veterinary and Food Administration for use in infant formulae (2009) and for use in food supplements
(2006)

BB-12® has been tested in clinical trials in pregnant and lactating women without any safety issues
reported

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 Overview of references on BB-12®
- Supporting Gastrointestinal Health in infants & young children
Health Indication Results Reference
Microbiota Bifidobacteria count similar to breastfed, and Langhendries et al. 1995
higher than given an infant formula without
Bifidobacteria

Stool characteristics Softer stools Vlieger et al. 2009

Increased frequency
Infections Fewer diarrhea days Chouraqui et al. 2004
Lower probability of getting diarrhea
Fewer episodes of diarrhea. Less shedding of Saavedra et al.1994
rotavirus

Colic Reduced frequency of colic/irritability Saavedra et al. 2004

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 Bifidobacterium BB-12®
- Supporting Immune Function in infants & young children
Health Indication Results Reference
Infections Reduced respiratory infections Taipale et al. 2010

Reduced ear infections Rautava et al. 2009

Reduced recurrent respiratory infections
Immune markers Increases anti-polivirus-specific IgA Holscher et al. 2010
Increased fecal sIgA in cesarean-born infants

Increased cow’s milk specific IgA Fukushima et. al. 1997

Antibiotic use Reduced antibiotic use Rautava et al. 2009

Saavedra et al 2004
Eczema Reduced symptoms Isolauri et al. 2000

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Product specifications

Aim for product stability is 2 years
Stability of BB-12® drops documented
shelf life at room temperature at 12 months on lab batch

This means no refrigeration at

pharmacy or at home

To be stored at room temperature

after opening as well

In-use test during 4 weeks shows good

stability

Commercial production also in
stability

6 months data available with same
results as lab batch

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Tests performed

Stability tests to confirm CFU and shelf life

Both storage and in-use test, investigating survival of strains during use

Contaminant test to ensure that no harmful bacteria will grow in the oil if contaminated during
use (e.g. child licks dropper)

Oxidation test to ensure that no harmful oxidation products are formed from the oil

Re-suspension test ensuring the ability of re-suspend the product after sedimentation

Extensive analysis program upon product release to ensure product quality suitable for infants

Raw materials chosen specifically to suit user segment

Test of different droppers (internal end external)

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Documentation of in-use survival of BB-12®

Aim to test how BB-12® survives during
daily use of the product for 4 weeks

Bottle shaken to re-suspend probiotics

and then opened
 Kept open for 15 minutes per day at room
temperature to mimic actual use

CFU tested after opening compared to

starting CFU

Results
 Good survival of BB-12® during 4 weeks
of use
 CFU count stable during the in-use
period

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Oxidation tests performed

Oxidation tests on BB-12® version was
performed in order to evaluate if oil
oxidizes during usage (in-use test)
Stored without lid
No tocopherol
added

Results very positive, as we see hardly any
oxidation products from the oil

Only case showing oxidation is product

without DL-α-tocopherol (vitamin E) stored
for 6 months without lid above 30ºC / 75%
RH

This underlines the choice of adding DL-α-

tocopherol (vitamin E) for optimal product
quality

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Re-suspension tests performed

In a clean product without SiO2, probiotics will sediment in the oil

Maximum amount of bottle fill has been tested and evaluated to ensure re-
suspension properties

Maximum ratio between probiotics and oil has been tested and evaluated

Top high inclusion of powder in oil will cause difficulties in re-suspension

Centrifugation has been used as artificial gravity – to mimic gravity for days or
months within minutes

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Recommended daily probiotic drop dose
– risk assessment

6 drops recommended per day, corresponding to 1 Billion BB-12®

A risk assessment of the product has been conducted with respect to

higher supplementation than the recommended 6 drops dose. No risk to
health has been identified

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Packaging details

10 ml amber glass bottles

Art. 484 Tropfflaschen DIN 18 braun rund 10ml

Horizontal dropper

Art. 202 Horizontal Sensoplast dropper, UNI 1, LDPE

Plastic Cap

Art. 414, Cap DIN 18 white, HDPE for UNI 1 dropper.

Label (30x60 mm), box and leaflet available

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Executive summary

Probiotic drops is a well-established and acknowledged market, with
high awareness among healthcare professionals

Chr. Hansen’s infant product has trustworthy effect and safety

Good clinical documentation and stability data

A unique and “clean” formulation without the anti-caking agent SiO2

No refrigeration needed – a benefit throughout the whole value chain

Final product release done according to Chr. Hansen’s own “Infant

dietary standard”, observing even stricter criteria than set by the
Authorities

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