ISCAGUARD ® Preservatives for Personal Care - ISCA UK Ltd
ISCAGUARD ® Preservatives for Personal Care - ISCA UK Ltd
ISCAGUARD ® Preservatives for Personal Care - ISCA UK Ltd
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Iscaguard <strong>®</strong><br />
Preserving Making chemistry the work tradition<br />
<strong>for</strong> you<br />
<strong>Preservatives</strong><br />
<strong>for</strong> <strong>Personal</strong> <strong>Care</strong>
<strong>ISCA</strong> was established in 1998 with the aim of<br />
supplying high quality speciality chemicals<br />
across a broad spectrum of industry.<br />
Our commitment to provide expert technical<br />
support and product innovation, coupled with<br />
a professional, flexible and friendly approach<br />
to customer service, has seen <strong>ISCA</strong> quickly<br />
establish itself as a leading manufacturer<br />
and supplier in a number of fields.<br />
In 2005 <strong>ISCA</strong> entered into preservatives <strong>for</strong> the<br />
personal care market.<br />
Our product range encompasses both individual<br />
preservatives and broad-spectrum preservative<br />
blends in order to provide the choices required<br />
by the customer and to satisfy the<br />
requirements of the most demanding<br />
applications.<br />
Based in Newport, South Wales, we have<br />
extensive warehouse facilities throughout the<br />
<strong>UK</strong> and Europe enabling us to offer prompt<br />
deliveries from stock, as well as a full export<br />
service to overseas customers. From our<br />
purpose-built laboratories, our experienced<br />
technical team offers a full support service,<br />
providing <strong>for</strong>mulatory advice, product<br />
development, raw material evaluation and<br />
end-use application testing, together with<br />
microbiological services from basic challenge<br />
testing to complete plant audits.<br />
<strong>ISCA</strong> can offer the benefits of over 30 years’<br />
cumulative experience and expertise in<br />
preservatives <strong>for</strong> personal care products. We<br />
have an ongoing programme of new product<br />
development that includes adding new<br />
preservatives to our range and developing<br />
new, more effective preservative blends.<br />
At <strong>ISCA</strong> we welcome the opportunity to work<br />
closely with customers to solve preservation<br />
problems, either using existing products, or<br />
with specially designed blends.<br />
This brochure gives a brief summary of some<br />
of the individual preservatives and preservative<br />
blends currently available from <strong>ISCA</strong>. However,<br />
such is the fast-moving nature of the <strong>Personal</strong><br />
<strong>Care</strong> Industry, any brochure can quickly<br />
become out of date, at least in part. For this<br />
reason we recommend that customers also<br />
check out our web site at www.iscauk.com<br />
<strong>for</strong> further in<strong>for</strong>mation and news of<br />
new products.
<strong>Preservatives</strong> available<br />
from <strong>ISCA</strong><br />
Today, perhaps more than ever be<strong>for</strong>e, the safety of the<br />
consumer has to be one of the most important concerns<br />
when developing personal care products. For this reason<br />
alone it is essential that cosmetics and toiletries are<br />
protected from the unsightly and potentially hazardous<br />
effects of microbial spoilage.<br />
This is why <strong>ISCA</strong> offers a range of preservation solutions<br />
based on tried and tested individual actives and<br />
preservative blends.<br />
This range includes:<br />
• Parabens and their sodium salts<br />
• 2-phenoxy ethanol<br />
• Benzyl alcohol<br />
• Imidazolidinyl and diazolidinyl urea<br />
• Dimethyl dimethylol hydantoin (DMDMH)<br />
• Chloromethyl/methyl isothiazolinone<br />
• Liquid blends developed to optimise the<br />
complementary properties of the individual actives.<br />
Parabens and their<br />
sodium salts<br />
The antimicrobial efficacy of the esters of 4-hydroxy<br />
benzoic acid was first discovered and patented in the<br />
1920’s. Since that time they have become the most<br />
frequently used, and, it is widely believed, safest<br />
preservatives <strong>for</strong> personal care products.<br />
The parabens are also available as their sodium salts,<br />
which have the benefit of increased solubility in cold<br />
water.<br />
The list of benefits of the parabens includes;<br />
• Broad spectrum of activity against bacteria and fungi<br />
• Low order of toxicity<br />
• Effectiveness at low concentrations<br />
• Stability over a wide pH range<br />
• Biodegradability at environmental concentrations<br />
• Global acceptance in personal care <strong>for</strong>mulations<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends 2<br />
The paraben range available from <strong>ISCA</strong> is<br />
highlighted below:<br />
Iscaguard <strong>®</strong><br />
M - methyl paraben<br />
Iscaguard <strong>®</strong><br />
E - ethyl paraben<br />
Iscaguard <strong>®</strong><br />
P - propyl paraben<br />
Iscaguard <strong>®</strong><br />
B - butyl paraben<br />
Iscaguard <strong>®</strong><br />
MS - sodium methyl paraben<br />
Iscaguard <strong>®</strong><br />
ES - sodium ethyl paraben<br />
PS - sodium propyl paraben<br />
Iscaguard <strong>®</strong><br />
Regulatory Status<br />
Paraben esters and their sodium salts are permitted <strong>for</strong><br />
use in personal care <strong>for</strong>mulations in the US, Europe (total<br />
paraben concentration maximum 0.8%) and Japan (total<br />
paraben concentration maximum 1.0%).<br />
Using paraben esters<br />
Paraben esters may be added at any time during the<br />
manufacturing process but it may be preferable to add<br />
prior to any heating stage in order to facilitate good<br />
mixing. They are more easily incorporated if pre-dissolved<br />
in a solvent, such as propylene glycol. The sodium salts<br />
can be added directly to cold aqueous mixes, but it is<br />
important to subsequently adjust the pH, where<br />
appropriate, as they exhibit a high pH.<br />
Table 1<br />
Solubility of paraben esters (% w/w @ 25°C)<br />
Solvent M E P B MS ES PS<br />
Water 0.25 0.11 0.04 0.02 33 50 50<br />
Propylene glycol 26 20 29 49 ND ND ND<br />
Ethanol<br />
ND = no data<br />
32 41 50 68 ND ND ND<br />
Table 2<br />
Antimicrobial activity of paraben esters<br />
Microorganism Minimum inhibitory concentration (%)<br />
M E P B MS ES PS<br />
Pseudomonas aeruginosa 0.20 0.12 0.08 0.015 0.25 0.13 0.09<br />
Escherichia coli 0.12 0.08 0.045 0.015 0.17 0.09 0.05<br />
Proteus vulgaris 0.20 0.075 0.045 0.01 0.24 0.09 0.55<br />
Staphylococcus aureus 0.16 0.12 0.045 0.015 0.20 0.14 0.05<br />
Enterococcus faecium 0.15 0.10 0.06 0.015 0.20 0.10 0.06<br />
Bacillus cereus 0.13 0.075 0.045 0.01 0.17 0.085 0.035<br />
Candida albicans 0.10 0.06 0.025 0.015 0.14 0.075 0.035<br />
Saccharomyces cerevisiae 0.08 0.045 0.025 0.015 0.11 0.05 0.025<br />
Aspergillus niger 0.085 0.045 0.035 0.025 0.10 0.055 0.04
3<br />
Iscaguard <strong>®</strong><br />
PE<br />
Iscaguard <strong>®</strong><br />
PE, 2-phenoxy ethanol is a versatile and<br />
widely used preservative <strong>for</strong> personal care products.<br />
Often used in conjunction with parabens, it has good<br />
activity against gram-positive and gram-negative bacteria<br />
and is particularly effective against troublesome<br />
Pseudomonas species.<br />
Iscaguard <strong>®</strong><br />
PE is active over a pH range of 3.0 to 8.5 and<br />
is compatible with most personal care ingredients. Typical<br />
use levels <strong>for</strong> Iscaguard <strong>®</strong><br />
PE range from 0.4% to 1.0%.<br />
Regulatory Status<br />
Iscaguard <strong>®</strong><br />
PE is permitted <strong>for</strong> use in personal care<br />
products in the US, Europe (up to a maximum of 1.0%)<br />
and Japan (up to a maximum of 3.0%).<br />
Using Iscaguard <strong>®</strong><br />
PE<br />
Iscaguard <strong>®</strong><br />
PE is soluble in water to approximately 2.4%,<br />
significantly higher than typical use concentrations, but<br />
warming to 40ºC may be required to speed dissolution in<br />
<strong>for</strong>mulations with a very high water content.<br />
Table 3<br />
Solubility of Iscaguard <strong>®</strong><br />
PE (% w/w @ 25°C)<br />
Water Approx. 2.4%<br />
Propylene glycol Miscible<br />
Butylene glycol Miscible<br />
Table 4<br />
Antimicrobial activity of Iscaguard <strong>®</strong><br />
PE<br />
Micro-organism Minimum inhibitory<br />
concentration (%)<br />
Pseudomonas aeruginosa 0.55<br />
Escherichia coli 0.55<br />
Proteus vulgaris 0.55<br />
Staphylococcus aureus 0.70<br />
Bacillus cereus 0.65<br />
Enterococcus faecium 0.90<br />
Candida albicans 0.45<br />
Saccharomyces cerevisiae 0.37<br />
Aspergillus niger 0.30<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends<br />
Iscaguard <strong>®</strong><br />
BA<br />
Iscaguard <strong>®</strong><br />
BA, benzyl alcohol, has broad-spectrum<br />
activity against bacteria and fungi and is also particularly<br />
effective against troublesome gram-negative<br />
Pseudomonas species.<br />
Like Iscaguard <strong>®</strong><br />
PE, Iscaguard <strong>®</strong><br />
BA is effective over a<br />
pH range of 3.0 – 8.5 and is compatible with most<br />
ingredients found in personal care <strong>for</strong>mulations.<br />
Typical use concentrations <strong>for</strong> Iscaguard <strong>®</strong><br />
BA range<br />
from 0.4% to 1.0%.<br />
Regulatory Status<br />
Iscaguard <strong>®</strong><br />
BA is permitted in personal care products in<br />
the US, Europe (up to a maximum of 1.0%), and Japan<br />
(up to a maximum of 3.0%).<br />
Using Iscaguard <strong>®</strong><br />
BA<br />
Iscaguard <strong>®</strong><br />
BA is soluble to approximately 4.0% but, like<br />
Iscaguard <strong>®</strong><br />
PE, warming up to 40ºC may be useful in order<br />
to speed up the dissolution in <strong>for</strong>mulations with a high<br />
water content.<br />
Table 5<br />
Solubility of Iscaguard <strong>®</strong><br />
BA (% w/w @ 25°C)<br />
Water Approx. 4%<br />
Propylene glycol Miscible<br />
Butylene glycol Miscible<br />
Table 6<br />
Antimicrobial activity of Iscaguard <strong>®</strong><br />
BA<br />
Micro-organism Minimum inhibitory<br />
concentration (%)<br />
Pseudomonas aeruginosa 0.35<br />
Escherichia coli 0.55<br />
Proteus vulgaris 0.65<br />
Staphylococcus aureus 0.65<br />
Bacillus cereus 0.75<br />
Enterococcus faecium 0.95<br />
Candida albicans 0.50<br />
Saccharomyces cerevisiae 0.37<br />
Aspergillus niger 0.32
Iscaguard <strong>®</strong><br />
Iscaguard <strong>®</strong><br />
IU and<br />
DU<br />
Iscaguard <strong>®</strong><br />
IU, imidazolidinyl urea and Iscaguard <strong>®</strong><br />
DU,<br />
diazolidinyl urea, are both fine white, virtually odourless<br />
powders with excellent activity against gram-negative<br />
and gram-positive bacteria.<br />
Both are extremely soluble in water and do not usually<br />
require heating to dissolve. Neither product should be<br />
exposed to temperatures greater than 40ºC and should be<br />
added during the cooling stage of hot processes.<br />
Regulatory Status<br />
Iscaguard <strong>®</strong><br />
DU is permitted in the US (maximum 0.5%)<br />
and Europe (maximum 0.5%) but it is not permitted in Japan.<br />
Iscaguard <strong>®</strong><br />
IU is permitted in the US (maximum 0.5%)<br />
and Europe (maximum 0.5%). It is permitted in Japan <strong>for</strong><br />
use in rinse-off products only up to a maximum of 0.3%.<br />
Table 7<br />
Solubility of Iscaguard <strong>®</strong><br />
DU (% w/w @ 25°C)<br />
Water 70%<br />
Propylene glycol 40%<br />
Butylene glycol 0.25%<br />
Table 8<br />
Antimicrobial activity of Iscaguard <strong>®</strong><br />
DU<br />
Microorganism Minimum inhibitory<br />
concentration (%)<br />
Pseudomonas aeruginosa 0.10<br />
Escherichia coli 0.12<br />
Proteus vulgaris 0.13<br />
Staphylococcus aureus 0.08<br />
Bacillus cereus 0.10<br />
Enterococcus faecium 0.11<br />
Candida albicans 0.70<br />
Saccharomyces cerevisiae 0.20<br />
Aspergillus niger 0.30<br />
Table 9<br />
Solubility of Iscaguard <strong>®</strong><br />
IU (% w/w @ 25°C)<br />
Water 65%<br />
Glycerine 48%<br />
Mineral oil < 0.01%<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends 4<br />
Table 10<br />
Antimicrobial activity of Iscaguard <strong>®</strong><br />
IU<br />
Microorganism Minimum inhibitory<br />
concentration(%)<br />
Pseudomonas aeruginosa 0.10<br />
Escherichia coli 0.13<br />
Proteus vulgaris 0.13<br />
Staphylococcus aureus 0.10<br />
Bacillus cereus 0.10<br />
Enterococcus faecium 0.10<br />
Iscaguard <strong>®</strong><br />
DMD<br />
Iscaguard <strong>®</strong><br />
DMD is a 55% solution of dimethyl dimethylol<br />
hydantoin(DMDMH) in water. It has excellent<br />
broad-spectrum activity and is effective at low use<br />
concentrations, from 0.15-0.4%.<br />
Using Iscaguard <strong>®</strong><br />
DMD<br />
Iscaguard <strong>®</strong><br />
DMD has excellent solubility in water and<br />
should be added during the cooling stage of hot<br />
processes.<br />
Regulatory Status<br />
Iscaguard <strong>®</strong><br />
DMD is approved <strong>for</strong> use in the US, Europe (up<br />
to a maximum of 0.6%) and Japan <strong>for</strong> rinse-off products<br />
only, up to a maximum concentration of 0.3%.<br />
Table 11<br />
Antimicrobial activity of Iscaguard <strong>®</strong><br />
DMD<br />
Microorganism Minimum inhibitory<br />
concentration(%)<br />
Pseudomonas aeruginosa 0.05<br />
Staphylococcus aureus 0.025<br />
Candida albicans 0.1<br />
Aspergillus niger 0.15<br />
Iscaguard <strong>®</strong><br />
CMI<br />
Iscaguard <strong>®</strong><br />
CMI is a 1.5% solution of a blend of<br />
chloromethyl and methyl isothiazolinone in a strictly<br />
controlled ratio of 3:1. The mixture is stabilised with<br />
magnesium chloride and magnesium nitrate.<br />
Using Iscaguard CMI <strong>®</strong><br />
On a weight/weight basis, this isothiazolinone blend is<br />
probably the most effective broad-spectrum preservative<br />
available <strong>for</strong> personal care products and it is particularly<br />
useful in detergent-based products, such as shower gels,<br />
bath foams and shampoos.
5<br />
It can be used over a wide pH range, from 3.0 or lower,<br />
up to 8.0 and should be added during the cooling stage<br />
of any hot process.<br />
Regulatory Status<br />
Iscaguard <strong>®</strong><br />
CMI is approved <strong>for</strong> use in the US (up to a<br />
maximum of 0.1% in rinse-off products and 0.05% in<br />
leave-on products) Europe (up to a maximum of 0.1%)<br />
and Japan (up to a maximum of 0.1% in rinse-off<br />
products only).<br />
Table 12<br />
Antimicrobial activity of Iscaguard <strong>®</strong><br />
CMI<br />
Microorganism Minimum inhibitory<br />
concentration(%)<br />
Pseudomonas aeruginosa 0.03<br />
Staphylococcus aureus 0.02<br />
Candida albicans 0.03<br />
Aspergillus niger 0.06<br />
Liquid blends developed to<br />
optimise the complementary<br />
properties of the individual<br />
actives<br />
Although successful preservation can be achieved by<br />
using single-component preservatives, we at <strong>ISCA</strong> believe<br />
that it can often be achieved more effectively and more<br />
safely, through the use carefully designed preservative<br />
blends.<br />
Why Blends?<br />
An ideal preservative system must be:<br />
• Effective (i.e. have a broad spectrum of activity)<br />
• Safe to use<br />
• Safe at use levels<br />
• Stable in the product<br />
• Compatible with the product and packaging<br />
It is rare to find a single preservative that meets all of the<br />
above requirements. Most preservatives have their plus<br />
points, but they usually also have some negatives<br />
associated with their use. However, if we stop thinking<br />
about “The Preservative”, and start thinking about “The<br />
Preservation System”, we can minimise the negatives<br />
and accentuate the positives.<br />
One further consideration is that of time. Preserving a<br />
<strong>for</strong>mulation using separate components can be time<br />
consuming. If the product fails the microbial challenge<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends<br />
test, the next stage of development can involve adding<br />
an extra component to combat the organisms that caused<br />
the initial failure. The revised preservative system may<br />
also fail the challenge test, resulting in still more<br />
preservative being added. This unfocussed strategy can<br />
result in too many preservatives at too high a<br />
concentration, and a significant delay <strong>for</strong> the product<br />
launch with all the associated cost implications.<br />
The process may be simplified by testing a broadspectrum<br />
preservative blend over a range of<br />
concentrations. This strategy, if correctly employed, can<br />
usually result in a challenge test pass at the first attempt,<br />
and at a concentration reasonably close to the optimum<br />
<strong>for</strong> that particular <strong>for</strong>mulation. Closer optimisation can be<br />
achieved by testing two or more different blends.<br />
For all these reasons, <strong>ISCA</strong> offers a range of preservative<br />
blends with all the advantages we can put in there.<br />
These products have been carefully developed to give a<br />
combination of preservatives in which the ratio of<br />
components is closest to the optimum activity <strong>for</strong> as<br />
many different <strong>for</strong>mulations as possible.<br />
An example of a<br />
preservation strategy<br />
Better optimisation of the preservative system in a<br />
product may be achieved by testing many different<br />
preservatives, or preservative blends, over a broad range<br />
of concentrations. It is often difficult, however, to justify<br />
submission of more than 5 or 6 different options <strong>for</strong><br />
challenge testing. On this basis, a general example of a<br />
possible preservation strategy is given below:<br />
Submit samples containing the following preservative<br />
blends:<br />
Iscaguard <strong>®</strong><br />
Iscaguard <strong>®</strong><br />
MPB @ 0.3, 0.6 and 1.0%<br />
PBA @ 0.3 and 0.6%<br />
The results will indicate which of the blends is the more<br />
effective in the product under test. Iscaguard <strong>®</strong><br />
MPB is<br />
included at 1.0% to try to ensure that at least one<br />
preservative treatment passes the challenge test, even if<br />
the lower concentrations fail. This strategy makes it more<br />
likely that the product can be launched without delay<br />
and, if the highest concentration is the only successful<br />
one, lower concentrations (in this example, 0.7, 0.8 and<br />
0.9%) could be tested after launch to establish whether a<br />
reduction in the preservative concentration is possible.
Iscaguard <strong>®</strong><br />
Iscaguard <strong>®</strong><br />
DPE<br />
Iscaguard <strong>®</strong><br />
DPE is a blend of phenoxyethanol and<br />
methyldibromo glutaronitrile giving the advantages of<br />
broad-spectrum antimicrobial protection and the ease of<br />
liquid handling.<br />
Iscaguard <strong>®</strong><br />
DPE is effective at 0.1 – 0.3% in many<br />
<strong>for</strong>mulation types, and is compatible with proteins and<br />
anionic, cationic and nonionic emulsifiers.<br />
Iscaguard <strong>®</strong><br />
DPE is <strong>for</strong>maldehyde-free and retains its<br />
activity over the range pH 4.0 – 8.0.<br />
Regulatory status<br />
Iscaguard <strong>®</strong><br />
DPE is permitted <strong>for</strong> use in rinse-off products<br />
in the European Union (maximum 0.125%) and the USA<br />
(maximum 0.125%). Iscaguard <strong>®</strong><br />
DPE is not permitted <strong>for</strong><br />
use in Japan.<br />
INCI name: phenoxyethanol, methyldibromo glutaronitrile.<br />
Using Iscaguard <strong>®</strong><br />
DPE<br />
Iscaguard <strong>®</strong><br />
DPE is soluble in water to approximately 0.4%,<br />
but it is advisable to pre-dissolve the product in one of<br />
the non-aqueous <strong>for</strong>mulation components prior to<br />
addition. This will avoid the need to heat Iscaguard <strong>®</strong><br />
DPE,<br />
as the product should not be exposed to temperatures<br />
above 40°C <strong>for</strong> prolonged periods.<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends 6<br />
Preservative Blends<br />
Iscaguard <strong>®</strong><br />
DPE may discolour on exposure to UV light and<br />
should be stored in the original container.<br />
Table 13<br />
Solubility of Iscaguard <strong>®</strong><br />
DPE (% w/w @ 25°C)<br />
Water Approx. 0.4%<br />
Propylene glycol Miscible<br />
Butylene glycol Miscible<br />
Table 14<br />
Antimicrobial activity of Iscaguard <strong>®</strong><br />
DPE<br />
Microorganism Minimum inhibitory<br />
concentration (%)<br />
Pseudomonas aeruginosa 0.07<br />
Escherichia coli 0.025<br />
Proteus vulgaris 0.02<br />
Staphylococcus aureus 0.02<br />
Bacillus cereus 0.02<br />
Enterococcus faecium 0.025<br />
Candida albicans 0.0125<br />
Saccharomyces cerevisiae 0.01<br />
Aspergillus niger 0.035
7<br />
Iscaguard <strong>®</strong><br />
DPM<br />
Iscaguard <strong>®</strong><br />
DPM is a blend of diazolidinyl urea,<br />
methylparaben and propylparaben in propylene glycol<br />
giving the advantages of broad-spectrum antimicrobial<br />
protection and the ease of liquid handling.<br />
Iscaguard <strong>®</strong><br />
DPM is effective at 0.3 – 1.0% in many<br />
<strong>for</strong>mulation types, and is compatible with proteins and<br />
anionic, cationic and nonionic emulsifiers. It is an ideal<br />
preservative in both rinse-off and leave-on products and<br />
is particularly suitable <strong>for</strong> emulsions with a low (25%) oil phase.<br />
Iscaguard <strong>®</strong><br />
DPM2 retains its activity over the range pH 3.0 – 7.0.<br />
Regulatory Status<br />
Iscaguard <strong>®</strong><br />
DPM2 is permitted <strong>for</strong> use in personal care<br />
products in the European Union (maximum 2.50%) and<br />
the USA (maximum 2.50%). Iscaguard<strong>®</strong> DPM2 is not<br />
permitted <strong>for</strong> use in Japan.<br />
INCI name: propylene glycol, diazolidinyl urea,<br />
methylparaben, propylparaben.<br />
Using Iscaguard <strong>®</strong><br />
DPM2<br />
Iscaguard <strong>®</strong><br />
DPM2 is soluble in water to approximately<br />
0.5% and is readily incorporated into most product types.<br />
In hot emulsification processes it is advisable to add the<br />
product during the cooling stage as it should not be<br />
exposed to temperatures above 60°C <strong>for</strong> prolonged<br />
periods.<br />
Table 17<br />
Solubility of Iscaguard <strong>®</strong><br />
DPM2 (% w/w @ 25°C)<br />
Water Approx. 0.5%<br />
Propylene glycol Miscible<br />
Butylene glycol Approx. 5.0%<br />
Table 18<br />
Antimicrobial activity of Iscaguard <strong>®</strong><br />
DPM2<br />
Microorganism Minimum inhibitory<br />
concentration (%)<br />
Pseudomonas aeruginosa 0.25<br />
Escherichia coli 0.20<br />
Proteus vulgaris 0.25<br />
Staphylococcus aureus 0.20<br />
Bacillus cereus 0.30<br />
Enterococcus faecium 0.25<br />
Candida albicans 0.40<br />
Saccharomyces cerevisiae 0.25<br />
Aspergillus niger 0.40
Iscaguard <strong>®</strong><br />
FPX<br />
Iscaguard <strong>®</strong><br />
FPX is an optimised blend of paraben esters in<br />
phenoxyethanol giving the advantages of broad-spectrum<br />
activity and ease of liquid handling.<br />
Iscaguard <strong>®</strong><br />
FPX is compatible with most personal care<br />
ingredients and the presence of phenoxyethanol reduces,<br />
or overcomes the inactivation of parabens exhibited by<br />
some nonionic emulsifiers when parabens are used alone.<br />
In <strong>for</strong>mulations with a high protein content, it may be<br />
necessary to use a higher concentration of Iscaguard <strong>®</strong><br />
FPX<br />
compared with a similar <strong>for</strong>mulation with no protein present.<br />
At typical use concentrations of 0.3 – 1.0%,<br />
Iscaguard <strong>®</strong><br />
FPX is non-irritant to skin, eyes and mucous<br />
membranes.<br />
Iscaguard <strong>®</strong><br />
FPX has application in all categories of<br />
personal care products and retains its activity over the<br />
range pH 3 – 8.<br />
Regulatory Status<br />
Iscaguard <strong>®</strong><br />
FPX is permitted <strong>for</strong> use in personal care<br />
products in the European Union (maximum 1.39%),<br />
the USA (safe as used) and Japan (maximum 1.39%).<br />
INCI name: phenoxyethanol, methylparaben,<br />
ethylparaben, butylparaben, propylparaben,<br />
isobutylparaben.<br />
Using Iscaguard <strong>®</strong><br />
FPX<br />
Iscaguard <strong>®</strong><br />
FPX is soluble in water to approximately 0.5%,<br />
but may be incorporated at higher concentrations into<br />
<strong>for</strong>mulations containing surfactants, oils and waxes.<br />
Prolonged heating at elevated temperatures is not<br />
recommended, but Iscaguard <strong>®</strong><br />
FPX may be added<br />
immediately after emulsification in hot processes.<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends 8<br />
Table 19<br />
Solubility of Iscaguard <strong>®</strong><br />
FPX (% w/w @ 25°C)<br />
Water Approx. 0.5%<br />
Propylene glycol Miscible<br />
Butylene glycol Miscible<br />
Isopropyl myristate Miscible<br />
Table 20<br />
Antimicrobial activity of Iscaguard <strong>®</strong><br />
FPX<br />
Microorganism Minimum inhibitory<br />
concentration (%)<br />
Pseudomonas aeruginosa 0.32<br />
Escherichia coli 0.24<br />
Proteus vulgaris 0.24<br />
Staphylococcus aureus 0.21<br />
Bacillus cereus 0.21<br />
Enterococcus faecium 0.21<br />
Candida albicans 0.12<br />
Saccharomyces cerevisiae 0.11<br />
Aspergillus niger 0.13
9<br />
Iscaguard <strong>®</strong><br />
LIN<br />
Iscaguard <strong>®</strong><br />
LIN is a strongly synergistic blend of<br />
methyldibromo glutaronitrile, bronopol, phenoxyethanol,<br />
butylparaben and isobutylparaben giving the advantages<br />
of broad-spectrum antimicrobial protection and ease of<br />
liquid handling.<br />
The synergistic activity of Iscaguard <strong>®</strong><br />
LIN allows very low<br />
use concentrations (typically between 0.03 – 0.15%). This<br />
activity is similar to that of isothiazolinone-based<br />
preservatives.<br />
The low concentrations required of Iscaguard <strong>®</strong><br />
LIN<br />
enhance the safety profile of the product, as much lower<br />
concentrations of the individual components are present<br />
in the final product compared to normal usage. When<br />
using Iscaguard <strong>®</strong><br />
LIN, the concentration of bronopol, <strong>for</strong><br />
example, is reduced by a factor of between 5 – 12.<br />
This substantial reduction in bronopol concentrations has<br />
critical implications <strong>for</strong> nitrosamine <strong>for</strong>mation in products<br />
containing amines. At normal bronopol use concentrations<br />
(200 – 400ppm), there is an increase in the potential <strong>for</strong><br />
nitrosamine <strong>for</strong>mation when amines are present.<br />
Evidence suggests, however, that nitrosamine <strong>for</strong>mation<br />
is not detectable in <strong>for</strong>mulations containing both<br />
Iscaguard <strong>®</strong><br />
LIN and amines such as triethanolamine and<br />
stearamidopropyl dimethylamine, even after prolonged<br />
storage. Iscaguard <strong>®</strong><br />
LIN may, there<strong>for</strong>e, be used in<br />
amine-based <strong>for</strong>mulations, although testing to confirm<br />
the absence of nitrosamines is strongly recommended.<br />
Iscaguard <strong>®</strong><br />
LIN is effective over the range pH 3.0 – 7.5 and<br />
is non-irritating to eyes, skin and mucous membranes at<br />
the recommended use concentrations.<br />
Iscaguard <strong>®</strong><br />
LIN retains its activity in the presence of<br />
proteins and nonionic emulsifiers.<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends<br />
Regulatory Status<br />
Iscaguard <strong>®</strong><br />
LIN is permitted <strong>for</strong> use in rinse-off products in<br />
the European Union (maximum 0.77%) and the USA<br />
(maximum 0.77%). Iscaguard <strong>®</strong><br />
LIN is not permitted <strong>for</strong><br />
use in Japan.<br />
INCI name: phenoxyethanol, methyldibromo glutaronitrile,<br />
2-bromo-2-nitropropane-1,3-diol, butylparaben,<br />
isobutylparaben.<br />
Using Iscaguard <strong>®</strong><br />
LIN<br />
Iscaguard <strong>®</strong><br />
LIN is soluble in water to approximately<br />
0.4% – significantly greater than the typical use<br />
concentrations – but it is preferable to pre-dissolve the<br />
product in a non-aqueous component prior to addition.<br />
This avoids the need to heat Iscaguard <strong>®</strong><br />
LIN, as the<br />
product should not be exposed to temperatures above<br />
40°C <strong>for</strong> prolonged periods.<br />
Iscaguard <strong>®</strong><br />
LIN may discolour on exposure to UV light and<br />
should be stored in the original container.<br />
Table 21<br />
Solubility of Iscaguard <strong>®</strong><br />
LIN (% w/w @ 25°C)<br />
Water Approx. 0.4%<br />
Propylene glycol Miscible<br />
Butylene glycol Miscible<br />
Table 22<br />
Antimicrobial activity of Iscaguard <strong>®</strong><br />
LIN<br />
Microorganism Minimum inhibitory<br />
concentration (%)<br />
Pseudomonas aeruginosa 0.035<br />
Escherichia coli 0.025<br />
Proteus vulgaris 0.0175<br />
Staphylococcus aureus 0.03<br />
Bacillus cereus 0.0275<br />
Enterococcus faecium 0.035<br />
Candida albicans 0.0125<br />
Saccharomyces cerevisiae 0.0125<br />
Aspergillus niger 0.04
Iscaguard <strong>®</strong><br />
IPT<br />
Iscaguard <strong>®</strong><br />
IPT is a blend of phenoxyethanol and<br />
iodopropynyl butylcarbamate giving the advantages of<br />
broad-spectrum antimicrobial protection and the ease of<br />
liquid handling.<br />
Iscaguard <strong>®</strong><br />
IPT is effective at 0.6 – 1.0% in many<br />
<strong>for</strong>mulation types, and is compatible with proteins and<br />
anionic, cationic and non-ionic emulsifiers. The product<br />
should not be used in applications where direct contact<br />
with mucous membranes in intended.<br />
Iscaguard <strong>®</strong><br />
IPT is <strong>for</strong>maldehyde-free and retains its activity<br />
over the pH range 4.0 – 8.0.<br />
Regulatory Status<br />
Iscaguard <strong>®</strong><br />
IPT is permitted <strong>for</strong> use in personal care<br />
products in the European Union and the USA<br />
(maximum 1.0%), but may not be used in products<br />
intended to come into direct contact with mucous<br />
membranes. It is not currently permitted in Japan.<br />
INCI name: phenoxyethanol, iodopropynyl butylcarbamate<br />
Using Iscaguard <strong>®</strong><br />
IPT<br />
Iscaguard <strong>®</strong><br />
IPT is soluble in water to approximately 0.4%,<br />
but may require gentle heating (35 - 40°C) to dissolve<br />
completely. It is advisable to pre-dissolve the product in<br />
one of the non-aqueous <strong>for</strong>mulation components prior to<br />
addition unless the manufacturing process already<br />
requires heating.<br />
Iscaguard <strong>®</strong><br />
IPT may discolour on exposure to UV light and<br />
should be stored in the original container.<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends 10<br />
Table 23<br />
Solubility of Iscaguard <strong>®</strong><br />
IPT (% w/w @ 25°C)<br />
Water Approx. 0.4%<br />
Propylene glycol Miscible<br />
Butylene glycol Miscible<br />
Table 24<br />
Antimicrobial activity of Iscaguard <strong>®</strong><br />
IPT<br />
Microorganism Minimum inhibitory<br />
concentration (%)<br />
Pseudomonas aeruginosa 0.45<br />
Escherichia coli 0.35<br />
Proteus vulgaris 0.40<br />
Staphylococcus aureus 0.40<br />
Bacillus cereus 0.40<br />
Enterococcus faecium 0.50<br />
Candida albicans 0.05<br />
Saccharomyces cerevisiae 0.01<br />
Aspergillus niger 0.005
11<br />
Iscaguard <strong>®</strong><br />
MPB<br />
Iscaguard <strong>®</strong><br />
MPB is an optimised blend of methylparaben,<br />
propylparaben and bronopol in phenoxyethanol giving<br />
the advantages of broad-spectrum antimicrobial<br />
protection and ease of liquid handling.<br />
At typical use concentrations of 0.3 – 0.8%,<br />
Iscaguard <strong>®</strong><br />
MPB exhibits excellent preservative efficacy,<br />
and is non-irritating to eyes, skin or mucous membranes.<br />
Iscaguard <strong>®</strong><br />
MPB is highly effective in a broad range of<br />
<strong>for</strong>mulation types, but is particularly successful in sun care<br />
products (based both on UV absorbers and inorganic<br />
sunscreen agents), and in moist tissue wipes. Both of<br />
these product types are usually very difficult to preserve.<br />
Iscaguard <strong>®</strong><br />
MPB is compatible with most types of personal<br />
care ingredients and its use is strongly recommended in<br />
nonionic systems where parabens alone show reduced<br />
activity. Tests have shown that Iscaguard <strong>®</strong><br />
MPB<br />
significantly reduces and often completely eliminates the<br />
paraben inactivation effect exhibited by some nonionic<br />
emulsifiers. More details are available on request.<br />
Regulatory Status<br />
Iscaguard <strong>®</strong><br />
MPB is permitted <strong>for</strong> use in personal care<br />
products in the European Union (maximum 1.33%) and<br />
the USA (safe as used). The product is not permitted in<br />
Japan.<br />
INCI name: phenoxyethanol, methylparaben,<br />
propylparaben, 2-bromo-2-nitropropane-1,3-diol.<br />
Using Iscaguard <strong>®</strong><br />
MPB<br />
Iscaguard <strong>®</strong><br />
MPB is soluble in water to approximately<br />
0.5%. Heating to 40°C may be required, however, in<br />
order to dissolve the product more rapidly in aqueous<br />
solutions. Alternatively, Iscaguard <strong>®</strong><br />
MPB may be<br />
pre-dissolved in one of the other <strong>for</strong>mulation<br />
components, e.g. surfactant or organic solvent.<br />
Iscaguard <strong>®</strong><br />
MPB should be added during the cooling stage<br />
(below 40°C, where possible) of hot processes to avoid<br />
preservative loss.<br />
Amines have the potential to <strong>for</strong>m nitrosamines in<br />
products, and the presence of bronopol may increase this<br />
potential. It is recommended that Iscaguard <strong>®</strong><br />
MPB is not<br />
used in <strong>for</strong>mulations containing amines.<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends<br />
Table 25<br />
Solubility of Iscaguard <strong>®</strong><br />
MPB (% w/w @ 25°C)<br />
Water Approx. 0.5%<br />
Propylene glycol Miscible<br />
Butylene glycol Miscible<br />
Glycerine 10%<br />
Table 26<br />
Antimicrobial activity of Iscaguard <strong>®</strong><br />
MPB<br />
Microorganism Minimum inhibitory<br />
concentration (%)<br />
Pseudomonas aeruginosa 0.07<br />
Escherichia coli 0.07<br />
Proteus vulgaris 0.07<br />
Staphylococcus aureus 0.09<br />
Enterococcus faecium 0.09<br />
Bacillus cereus 0.08<br />
Candida albicans 0.175<br />
Saccharomyces cerevisiae 0.14<br />
Aspergillus niger 0.175
Iscaguard <strong>®</strong><br />
PBA<br />
Iscaguard <strong>®</strong><br />
PBA is an optimised combination of<br />
methylparaben and propylparaben in benzyl alcohol<br />
giving the advantages of broad-spectrum antimicrobial<br />
protection and the ease of liquid handling.<br />
Iscaguard <strong>®</strong><br />
PBA retains its activity in the presence of most<br />
cosmetic ingredients, and the use of benzyl alcohol<br />
eliminates / reduces the paraben inactivation observed<br />
with the use of some nonionic emulsifiers. (Contact <strong>ISCA</strong><br />
<strong>for</strong> more details.)<br />
Iscaguard <strong>®</strong><br />
PBA retains its activity and is stable over the<br />
pH range 4 - 8. It is also stable to UV light.<br />
Iscaguard <strong>®</strong><br />
PBA is typically used at concentrations of<br />
0.3 – 0.8%. In systems that are difficult to preserve,<br />
slightly higher concentrations may be required.<br />
Iscaguard <strong>®</strong><br />
PBA is non-irritating to skin, eyes or mucous<br />
membranes at permitted use concentrations and may be<br />
used in a wide variety of <strong>for</strong>mulation types, but has been<br />
demonstrated to be particularly effective in sun care<br />
products and moist tissue wipes.<br />
Regulatory Status<br />
Iscaguard <strong>®</strong><br />
PBA is permitted <strong>for</strong> use in personal care<br />
products in the European Union (maximum 1.37%), the<br />
USA (safe as used) and Japan (maximum 3.7%). There is<br />
no limit applied to the use of benzyl alcohol in Japan,<br />
however, it is recommended that the use concentration<br />
does not exceed 1.37%.<br />
INCI name: benzyl alcohol, methylparaben,<br />
propylparaben.<br />
Using Iscaguard <strong>®</strong><br />
PBA<br />
Iscaguard <strong>®</strong><br />
PBA is soluble in water to approximately 0.5%.<br />
Heating to 40°C may be required, however, in order to<br />
dissolve the product more rapidly in aqueous solutions.<br />
Alternatively, Iscaguard <strong>®</strong><br />
PBA may be pre-dissolved in one<br />
of the other <strong>for</strong>mulation components, e.g. surfactant or<br />
organic solvent.<br />
Iscaguard <strong>®</strong><br />
PBA should be added during the cooling stage<br />
(below 40°C, where possible) of hot processes in order to<br />
minimise loss of benzyl alcohol.<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends 12<br />
Table 27<br />
Solubility of Iscaguard <strong>®</strong><br />
PBA (% w/w @ 25°C)<br />
Water Approx. 0.5%<br />
Propylene glycol Miscible<br />
Butylene glycol Miscible<br />
Phenoxyethanol Miscible<br />
Table 28<br />
Antimicrobial activity of Iscaguard <strong>®</strong><br />
PBA<br />
Microorganism Minimum inhibitory<br />
concentration (%)<br />
Pseudomonas aeruginosa 0.30<br />
Escherichia coli 0.20<br />
Proteus vulgaris 0.25<br />
Staphylococcus aureus 0.20<br />
Enterococcus faecium 0.25<br />
Bacillus cereus 0.15<br />
Candida albicans 0.15<br />
Saccharomyces cerevisiae 0.19<br />
Aspergillus niger 0.15
13<br />
Iscaguard <strong>®</strong><br />
PPM<br />
Iscaguard <strong>®</strong><br />
PPM is an optimised blend of methylparaben<br />
and propylparaben in phenoxyethanol giving the<br />
advantages of broad-spectrum activity and ease of liquid<br />
handling.<br />
Iscaguard <strong>®</strong><br />
PPM is compatible with most personal care<br />
ingredients and the presence of phenoxyethanol reduces,<br />
or overcomes the inactivation of parabens exhibited by<br />
some nonionic emulsifiers when parabens are used<br />
alone. In <strong>for</strong>mulations with a high protein content,<br />
it may be necessary to use a higher concentration of<br />
Iscaguard <strong>®</strong><br />
PPM compared with a similar <strong>for</strong>mulation<br />
with no protein present.<br />
At typical use concentrations of 0.3 – 1.0%,<br />
Iscaguard <strong>®</strong><br />
PPM is non-irritant to skin, eyes and mucous<br />
membranes.<br />
Iscaguard <strong>®</strong><br />
PPM has application in all categories of<br />
personal care products and retains its activity over the<br />
range pH 3 – 8.<br />
Regulatory Status<br />
Iscaguard <strong>®</strong><br />
PPM is permitted <strong>for</strong> use in personal care<br />
products in the European Union (maximum 1.39%),<br />
the USA (safe as used) and Japan (maximum 1.39%).<br />
INCI name: phenoxyethanol, methylparaben,<br />
propylparaben.<br />
Using Iscaguard <strong>®</strong><br />
PPM<br />
Iscaguard <strong>®</strong><br />
PPM is soluble in water at approximately<br />
0.5%, but may be incorporated at higher concentrations<br />
into <strong>for</strong>mulations containing surfactants, oils and waxes.<br />
Prolonged heating at elevated temperatures is not<br />
recommended, but Iscaguard <strong>®</strong><br />
PPM may be added<br />
immediately after emulsification in hot processes.<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends<br />
Table 29<br />
Solubility of Iscaguard <strong>®</strong><br />
PPM (% w/w @ 25°C)<br />
Water Approx. 0.5%<br />
Propylene glycol Miscible<br />
Butylene glycol Miscible<br />
Isopropyl myristate Miscible<br />
Table 30<br />
Antimicrobial activity of Iscaguard <strong>®</strong><br />
PPM<br />
Microorganism Minimum inhibitory<br />
concentration (%)<br />
Pseudomonas aeruginosa 0.35<br />
Escherichia coli 0.26<br />
Proteus vulgaris 0.27<br />
Staphylococcus aureus 0.29<br />
Bacillus cereus 0.22<br />
Enterococcus faecium 0.32<br />
Candida albicans 0.16<br />
Saccharomyces cerevisiae 0.12<br />
Aspergillus niger 0.15
Aquaguard <strong>®</strong><br />
9093<br />
Aquaguard 9093 is the latest environmentally friendly<br />
preservative from <strong>ISCA</strong> <strong>UK</strong>. It is suitable <strong>for</strong> both leave on<br />
and wash off products. Aquaguard 9093 is based on an<br />
aqueous dispersion of organic acids, and exhibits a broad<br />
spectrum anti microbial activity. The product is supplied<br />
as an easy to use, readily dispersible liquid which is<br />
alcohol and solvent free.<br />
Aquaguard 9093 is designed <strong>for</strong> use in skin friendly<br />
<strong>for</strong>mulations with pH values up to 6.5. It offers protection<br />
against bacteria, yeast mould and fungi and also offers<br />
protection at the interface in containers.<br />
Regulatory Status<br />
Aquaguard 9093 is permitted <strong>for</strong> use in personal care<br />
products within the European Union (maximum 1.5%)<br />
and the USA and Japan (safe as used).<br />
INCI name: Sodium benzoate & Sodium dehydroacetate.<br />
Using Aquaguard 9093<br />
Aquaguard 9093 is completely soluble in water. For<br />
effective per<strong>for</strong>mance a 48 hour contact period is<br />
necessary to kill any micro-organisms caused from<br />
contamination. Good production hygiene is advisable and<br />
the use of raw materials with a low level of<br />
contamination is essential. Aquaguard 9093 may be used<br />
in a wide range of personal care applications including<br />
cosmetics, toiletries, wet-wipes and suncare products.<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends 14<br />
Use Concentrations<br />
Leave On 0.2 – 1.00%<br />
Rinse Off 0.2 – 1.00%<br />
<strong>ISCA</strong> <strong>UK</strong> highly recommends that the dose level is<br />
determined by incorporation into the end product.<br />
<strong>ISCA</strong> <strong>UK</strong> offers a challenge testing service to determine<br />
the suitability of its products in the intended end use<br />
application.<br />
Table 31<br />
Antimicrobial activity of Aquaguard 9093<br />
Microorganism Minimum inhibitory<br />
concentration(%)<br />
Pseudomonas aeruginosa 0.44<br />
Escherichia coli 0.40<br />
Proteus vulgaris 0.24<br />
Staphylococcus aureus 0.24<br />
Bacillus cereus 0.22<br />
Enterococcus faecium 0.22<br />
Candida albicans 0.17<br />
Saccharomyces cerevisiae 0.15<br />
Aspergillus niger 0.17
15<br />
Iscaguard <strong>®</strong><br />
BIB<br />
Iscaguard <strong>®</strong><br />
BIB is a blend of 2-bromo-2-nitropropane-1,<br />
3-diol (bronopol) and iodopropynyl butyl carbamate<br />
(IPBC) in Benzyl alcohol, giving the advantages of<br />
broad-spectrum anti-microbial protection and the ease of<br />
liquid handling.<br />
Iscaguard <strong>®</strong><br />
BIB retains its activity and is stable over<br />
a pH range of 4.5 – 8.5.<br />
Using Iscaguard <strong>®</strong><br />
BIB<br />
Iscaguard <strong>®</strong><br />
BIB is soluble up to approximately 2.5% in<br />
water, but warming up to 40ºC may help speed its<br />
dissolution. It is recommended that it is added during<br />
the cooling stage of hot processes. Iscaguard <strong>®</strong><br />
BIB is<br />
typically used 0.05 – 0.3%.<br />
Regulatory status<br />
Iscaguard <strong>®</strong><br />
BIB is approved <strong>for</strong> use in Europe at up to<br />
0.61% but should not be used in oral hygiene and<br />
lipcare products. It is considered safe as used in the US.<br />
Iscaguard <strong>®</strong><br />
BIB is not permitted in Japan.<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends<br />
Table 32<br />
Antimicrobial activity of Iscaguard <strong>®</strong><br />
BIB<br />
Microorganism Minimum inhibitory<br />
concentration(%)<br />
Pseudomonas aeruginosa 0.005<br />
Staphylococcus aureus 0.021<br />
Candida albicans 0.001<br />
Aspergillus niger 0.021
Iscaguard<strong>®</strong><br />
Iscaguard <strong>®</strong> BOA is a brand new environmentally friendly<br />
preservative suitable <strong>for</strong> leave on and wash off products.<br />
It is based on benzyl alcohol with a synergistic blend of<br />
organic acids. It has advantages of being broad spectrum<br />
and comes in the <strong>for</strong>m of an easy dispersible liquid.<br />
Iscaguard <strong>®</strong> BOA is designed <strong>for</strong> use in skin friendly<br />
<strong>for</strong>mulations with pH values up to 6.5. It offers protection<br />
against bacteria, yeasts mould and fungi and also offers<br />
protection at the interface in containers.<br />
Regulatory Status<br />
Iscaguard <strong>®</strong> BOA is permitted <strong>for</strong> use in personal care<br />
products within the European Union (maximum 1.5%)<br />
and the USA and Japan (safe as used)<br />
INCI name: Benzyl Alcohol, Dehydro Acetic Acid, Sorbic<br />
Acid and Benzoic Acid<br />
Using Iscaguard <strong>®</strong> BOA<br />
Iscaguard <strong>®</strong> BOA is soluble in water to approximately 1%<br />
however heating to 40°C maybe required <strong>for</strong> dispersion<br />
into some aqueous solutions. For effective per<strong>for</strong>mance it<br />
is advisable a 48 hour contact period is necessary to kill<br />
any micro-organisms caused from contamination. Good<br />
production hygiene is advisable and also raw materials<br />
with a low level of contamination are essential.<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends 16<br />
BOA<br />
Use Concentrations<br />
Leave On 0.2 – 1.00%<br />
Rinse Off 0.2 – 1.00%<br />
<strong>ISCA</strong> <strong>UK</strong> Limited highly recommends the usage<br />
concentration should always be determined by<br />
incorporation into the end product. <strong>ISCA</strong> <strong>UK</strong> LIMITED<br />
offers a free challenge testing service to determine<br />
suitability of its products.<br />
Table 33<br />
Antimicrobial activity of Iscaguard <strong>®</strong> BOA<br />
Microorganism Minimum inhibitory<br />
concentration(%)<br />
Pseudomonas aeruginosa 0.25<br />
Escherichia coli 0.06<br />
Proteus vulgaris 0.24<br />
Staphylococcus aureus 0.21<br />
Bacillus cereus 0.21<br />
Enterococcus faecium 0.21<br />
Candida albicans 0.13<br />
Saccharomyces cerevisiae 0.11<br />
Aspergillus niger 0.13
17<br />
Iscaguard<strong>®</strong><br />
Iscaguard <strong>®</strong> POA is a paraben free, environmentally friendly<br />
preservative suitable <strong>for</strong> leave on and wash off products. It<br />
is based on Phenoxyethanol with a synergistic blend of<br />
organic acids. It has advantages of being broad spectrum<br />
and comes in the <strong>for</strong>m of an easy dispersible liquid.<br />
Iscaguard <strong>®</strong> POA is designed <strong>for</strong> use in skin friendly<br />
<strong>for</strong>mulations with pH values up to 6.5. It offers protection<br />
against bacteria, yeasts mould and fungi and also offers<br />
protection at the interface in containers.<br />
Regulatory Status<br />
Iscaguard <strong>®</strong> POA is permitted <strong>for</strong> use in personal care<br />
products within the European Union (maximum 1.5%)<br />
and the USA and Japan (safe as used)<br />
INCI name: Phenoxyethanol, Dehydro Acetic Acid, Sorbic<br />
Acid and Benzoic Acid<br />
Using Iscaguard <strong>®</strong> POA<br />
Iscaguard <strong>®</strong> POA is soluble in water to approximately 1%<br />
however heating to 40°C maybe required <strong>for</strong> dispersion<br />
into some aqueous solutions. For effective per<strong>for</strong>mance it<br />
is advisable a 48 hour contact period is necessary to kill<br />
any micro-organisms cause from contamination. Good<br />
production hygiene is advisable and also raw materials<br />
with a low level of contamination are essential.<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends<br />
POA<br />
Use Concentrations<br />
Leave On 0.2 – 1.00%<br />
Rinse Off 0.2 – 1.00%<br />
<strong>ISCA</strong> <strong>UK</strong> Limited highly recommends the usage<br />
concentration should always be determined by<br />
incorporation into the end product. <strong>ISCA</strong> <strong>UK</strong> LIMITED<br />
offers a free challenge testing service to determine<br />
suitability of its products.<br />
Table 34<br />
Antimicrobial activity of Iscaguard <strong>®</strong> POA<br />
Microorganism Minimum inhibitory<br />
concentration(%)<br />
Pseudomonas aeruginosa 0.35<br />
Escherichia coli 0.16<br />
Proteus vulgaris 0.26<br />
Staphylococcus aureus 0.12<br />
Bacillus cereus 0.22<br />
Enterococcus faecium 0.21<br />
Candida albicans 0.16<br />
Saccharomyces cerevisiae 0.12<br />
Aspergillus niger 0.15
Iscaguard<strong>®</strong><br />
Iscaguard <strong>®</strong> PFA is a “preservative free additive” with a<br />
synergistic combination of multifunctional cosmetic raw<br />
materials with broad-spectrum antimicrobial protection.<br />
Iscaguard <strong>®</strong> PFA may be classed as a “preservative free<br />
system”. This system represent an alternative to<br />
traditional cosmetic preservatives allowing<br />
self-preserving <strong>for</strong>mulations thereby reducing irritant<br />
and sensitizing potentials.<br />
Iscaguard <strong>®</strong> PFA is stable and active over a pH range of<br />
4 to 8. Typical use levels <strong>for</strong> Iscaguard <strong>®</strong> PFA range from<br />
0.5% to 1.5%. It is synergistic in combination with<br />
chelating agents.<br />
Regulatory Status<br />
Iscaguard <strong>®</strong> PFA is permitted worldwide <strong>for</strong> use in both<br />
leave-on and rinse-off personal care products.<br />
EU – allowed without restriction in all products<br />
(not listed on Annex VI)<br />
USA – allowed without restriction in all products<br />
Japan – allowed without restrictions in all products<br />
Phenethyl alcohol is judged safe <strong>for</strong> use in cosmetics<br />
to 1.0%. Based on the CIR review <strong>for</strong> phenethyl alcohol<br />
and the good toxicity assessment <strong>for</strong> caprylyl glycol<br />
Iscaguard <strong>®</strong> PFA should be safe in cosmetics up to 1.8%<br />
INCI name: phenethyl alcohol and caprylyl glycol<br />
Using Iscaguard <strong>®</strong> PFA<br />
Iscaguard <strong>®</strong> PFA is particularly suitable <strong>for</strong> emulsions,<br />
oil and surfactant based <strong>for</strong>mulations and may be used<br />
in aqueous <strong>for</strong>mulations upto its solubility limit i.e. 0.6%.<br />
Iscaguard <strong>®</strong> PFA can be added to <strong>for</strong>mulation at<br />
temperatures up to 80ºC, prolonged heating at elevated<br />
temperatures is not recommended.<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends 18<br />
PFA<br />
Physical/Chemical Characteristics<br />
Caprylyl glycol 35 – 45%<br />
Phenethyl alcohol 55 – 65%<br />
Appearance Clear colorless liquid<br />
Odor Mild rose-like odor<br />
Density 0.98 g/ml<br />
pH (0.5% in water) 4.6<br />
Table 35<br />
Solubility of Iscaguard <strong>®</strong> PFA (% w/w @ 25ºC)<br />
Water 0.6%<br />
Ethanol >50%<br />
Propylene glycol >50%<br />
Butylene glycol >50%<br />
Table 36<br />
Antimicrobial activity of Iscaguard <strong>®</strong> PFA<br />
Microorganism Minimum inhibitory<br />
concentration(%)<br />
Pseudomonas aeruginosa 0.10 - 0.30<br />
Escherichia coli<br />
Proteus vulgaris<br />
0.10 – 0.20<br />
Staphylococcus aureus 0.175 – 0.2<br />
Bacillus subtilis 0.20<br />
Enterococcus hirae 0.20<br />
Candida albicans 0.175 – 0.25<br />
Saccharomyces cerevisiae 0.10<br />
Aspergillus niger 0.175
19<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends<br />
Iscaguard + SAP<br />
The preservation of cosmetic products is becoming ever<br />
more customer driven partially due to a wider knowledge<br />
base and partially due to bad press of chemical based<br />
preservatives. Combined with this regulatory standards<br />
governing personal care products are becoming more<br />
stringent. In the last thirty years we have seen several<br />
groups of chemical products either removed through<br />
legislation or becoming unpopular. Isca <strong>UK</strong> <strong>Ltd</strong> has worked<br />
on a solution whereby customers are able to purchase<br />
products that whilst they are not preservative chemicals<br />
as listed in Annex VI of the Biocidal Products Directive,<br />
they do inherently have anti-microbial properties.<br />
Iscaguard + SAP is enriched with L(+) amino acids<br />
physiologically valuable substances which contribute<br />
considerably to antimicrobial effects.<br />
Iscaguard + SAP is a 100% natural preservative containing<br />
Ecocert certified ingredients. It is a synergistic blend of<br />
propandiol with Salix alba extract. The renewablysourced<br />
propanediol made using a unique process is more<br />
sustainable compared to petroleum-based 1,3-PDO and<br />
PG. Benefits include its high purity, lack of skin irritation<br />
or sensitization, improved humectancy, excellent<br />
aesthetics and environmentally sustainable nature.<br />
Iscaguard + SAP is based on compounds that occur in<br />
nature and have natural anti-microbial properties.<br />
Typical use levels <strong>for</strong> Iscaguard + SAP range from<br />
0.125% to 1.0%<br />
Using Iscaguard + SAP<br />
Iscaguard + SAP is soluble in water to approximately<br />
0.35%, the preferred method of use is to pre dissolve into<br />
the non-aqueous phase prior to addition. This negates the<br />
need to heat Iscaguard + SAP.<br />
INCI name: Propandiol & Salix alba.<br />
Regulatory Status<br />
Not Regulated<br />
Antimicrobial activity of Iscaguard + SAP<br />
Microorganism Minimum inhibitory<br />
concentration(%)<br />
Pseudomonas aeruginosa ≤ 0.125<br />
Escherichia coli ≤ 0.125<br />
Staphylococcus aureus ≤ 0.125<br />
Candida albicans 0.5<br />
Aspergillus niger 0.5
Iscaguard MIT<br />
Iscaguard is a safe, broad spectrum bactericide <strong>for</strong> the<br />
preservation of leave-on and rinse-off products.<br />
Iscaguard MIT is a particularly suitable as replacement <strong>for</strong><br />
<strong>for</strong>maldehyde donors in leave-on applications such as<br />
skin care <strong>for</strong>mulations and sun care <strong>for</strong>mulations, Zinc<br />
pyrithione-based antidandruff shampoos, high pH<br />
surfactant systems and high pH liquid cleaners.<br />
Iscaguard MIT provides <strong>for</strong>mulators with a non<br />
<strong>for</strong>maldehyde-releasing bactericidal solution which is<br />
effective at very low use levels. Iscaguard MIT is also<br />
compatible with existing fungicides like parabens and is<br />
more stable in difficult to preserve high pH <strong>for</strong>mulations.<br />
INCI Name: Methylisothiazolinone<br />
Regulatory Status<br />
Isacaguard MIT is supported by extensive toxicology<br />
studies and global regulatory dossiers and is expected<br />
to have global approvals <strong>for</strong> use in cosmetics at the<br />
time of printing.<br />
Using Iscaguard MIT<br />
Iscaguard MIT preservative should be added as the last<br />
ingredient and at the lowest temperature (≤ 45°C if<br />
possible). Since the components of personal care<br />
<strong>for</strong>mulations vary considerably and may impact on the<br />
effect of preservatives, we urge each manufacturer to<br />
confirm the efficacy and stability of Iscaguard MIT in use.<br />
The recommended use level is 0.05% - 0.1% (48 - 95<br />
ppm of active ingredient) as supplied. At low<br />
contamination risk and low detergent or protein content;<br />
0.01-0.05%<br />
At medium contamination risk, medium detergent or<br />
protein content; 0.05 - 0.1%<br />
<strong>ISCA</strong> Iscaguard <strong>®</strong><br />
Preservative Blends 20<br />
Solubility of Iscaguard MIT (%w/w @ 25ºc)<br />
Water Miscible<br />
Propylene Glycol Miscible<br />
Butylene Glycol Miscible<br />
Antimicrobial activity of Iscaguard MIT<br />
Microorganism Minimum inhibitory<br />
concentration(%)<br />
Pseudomonas aeruginosa 0.04<br />
Escherichia coli 0.04<br />
Proteus vulgaris 0.02<br />
Staphylococcus aureus 0.03<br />
Bacillus cereus 0.02<br />
Enterococcus faecium 0.04<br />
Candida albicans 0.32<br />
Saccharomyces cerevisiae 0.35<br />
Aspergillus niger 0.16<br />
The MIC-values have been determined in dilution assays:<br />
Bacteria: 24-48 h at 37ºC<br />
Yeast/Fungi: 48-72 h at 28ºC
Preserving Making chemistry the work tradition <strong>for</strong> you<br />
<strong>ISCA</strong> <strong>UK</strong> <strong>Ltd</strong><br />
Nine Mile Point Industrial Estate<br />
Cross Keys, Newport NP11 7HZ<br />
Wales, <strong>UK</strong><br />
Tel: +44(0)1495 200747<br />
Fax: +44(0)1495 200757<br />
E-mail: enquiries@iscauk.com<br />
www.iscauk.com<br />
Technical Service<br />
<strong>ISCA</strong> support their product range with a telephone<br />
advisory service and in-house microbiological testing<br />
facilities. Please contact any member of our team <strong>for</strong><br />
further details.<br />
Disclaimer<br />
Whilst the in<strong>for</strong>mation contained herein is accurate to the<br />
best of our knowledge, no warranty is either expressed or<br />
implied. It is the responsibility of the individual to ensure<br />
that their products will remain preserved over the<br />
anticipated shelf life.<br />
United Registrar of Systems Cert No.11860