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OVERVIEW
fast and
or your
Cosmetic
price-
Challenge
of the
like the
evaluates
cosmetics
and personal care products. Preservatives are anitmicrobial ingredients that are added to
product formulations to help maintain the safety of the product by inhibiting the growth and
reducing the amount of microbial contaminants. The USP <51> challenge test for cosmetics
utilizes 5 microorganisms, 3 bacteria and 2 fungi, for challenge testing. Each of the
microorganisms are known strains of pathogenic microorganisms. The first time a product is
challenge tested for antimicrobial effectiveness under the USP <51> method, a neutralization
and recovery validation is required to ensure that the microorganisms are able to be recovered
from the product if they are present.
The product is evaluated using the USP <61> - Microbial Enumerations Test for the
presence of pathogens after manufacturing.
The product is separated out into 5 containers, each being challenged with one of the
5 method-specified microorganisms (S. aureus, E. coli, P. aeruginosa, C. albicans,
and A. brasiliensis) at fairly high concentrations.
A separate aliquot of the product is diluted along with a control substance, to be used
in the neutralization and recovery validation
The product is held at room temperature for a period of no less than 28 days.
The product is evaluated at specific intervals within the 28 day period that depend on
the category of the product specified by the method. Click here for USP <51> product
categories.
Test sample colonies are counted at each specified interval to determine the amount of
microorganisms remaining.
The effectiveness of the preservative system is determined based on the USP <51>
passing criteria.
It is important to determine if the preservative chosen for a product is compatible with the
formulation soon after manufacture. It may also be helpful to challenge test again within 2-3
months of manufacture or as appropriate to the intended shelf-life as part of your stability
testing regimen. It is also necessary to re-evaluate preservative effectiveness in your product
whenever a formulation, or manufacturing process has been changed or when product
packaging changes
occur.
For USP 51, the product is first evaluated to make sure that inoculated microorganisms can be
accurately recovered from the product. Then it is inoculated separately with each of the 5
strains and initial microbial concentrations are determined. After that, it is held for 14 days at
room temperature then evaluated again for the presence of contaminant microorganisms.
Finally, it is held for another 14 days (making 28 total) and then evaluated again. Of course,
the desired result is that the microbial population is killed off completely by the formulation
over the study period. In the event that some germs survive, the method provides guidance
with regard to whether or not that is significant.
Preservative challenge studies run for a long period in the laboratory and require a great deal
of scientific expertise and labor. Thus, they are relatively expensive, running about $300$1500 per sample, depending on the laboratory.
Some companies find the USP 51 challenge test method to be a low-level product challenge,
and prefer to further challenge test cosmetics by customizing the method to give them extra
confidence that the products won't support microbial growth on the store shelf or in the hands
of consumers. The stringency or challenge level of a preservative challenge test can be
increased using a number of approaches. The most common approach is to supplement the
inoculum with additional microorganisms isolated from manufacturing environments.
Secondarily, the number of inoculated microorganisms can be increased to greater than 10^6
per milliliter. Thirdly, the product can be diluted prior to testing. Finally, the product can be
repeatedly inoculated.
By challenge testing cosmetics with a qualified laboratory, the makers of a product gain a
critical bit of information about their product: They know whether or not the incorporated
preservative will fight off microorganisms introduced into the product during manufacturing
or introduced during use by consumers.
If a cosmetic product fails preservative challenge testing, a knowledgeable laboratory can
help determine the cause and suggest formulation changes that will result in a more
microbiologically stable product.
PCPC (FORMERLY CTFA)
METHODS FOR COSMETICS
TEST
products
proper
formulation and manufacture to preserve them. Cosmetics and personal care products are
intended for use in direct contact with the body and this makes it imperative for these
products to be free of harmful contamination and prepared with effective preservative
systems. Microbial content tests are designed to determine the contamination levels in the
products and preservative challenge testing is designed to verify the ability of cosmetics to
avoid microbial growth upon contamination that may be introduced during manufacturing or
through normal consumer use.
The Personal Care Products Council (formerly Cosmetics, Toiletries, and Fragrance
Association - CTFA) has set forth guidelines specific testing of cosmetic and personal care
product manufacturers to aid in determining the microbial content and the effectiveness of the
preservative system of many different types of cosmetic products.
Cosmetic Test Labs offers microbial examination and challenge testing following these CTFA
guidelines:
CTFA M-5 - Methods for Preservation Testing of Nonwoven Substrate Personal Care
Products
Many cosmetics and personal care products are now available in the form of presaturated towelettes or wipes. Like the majority of personal care products having an
aqueous base, pre-saturated towelettes are susceptible to microbial contamination and
require a preservation system to protect them from degradation. Cosmetics and
personal care products made in the form of towelettes or wipes can harbor harmful
microorganisms just like any other consumer product that is not properly preserved.
Their preservation system must also be verified as appropriate through empirical
challenge testing. The efficacy of such preservatives could be evaluated on the liquid
formulation, however, this alone cannot be considered as good representation for the
formulation when added to the towelettes or wipes.
Cosmetic Test Labs has modified methods for the USP <51> challenge test method,
and the Preservative Challenge Screen, along with the CTFA M-5 method to include
cosmetics and personal care products in the form of pre-saturated towelettes or wipe
products. These modified methods allow the efficacy of preservatives used in
towelette and wipe products to be evaluated while being kept in their original form.
Often time, products during the manufacturing process become contaminated with
microorganisms that are not included in standard preservative challenge tests for
cosmetics. In this case, it may be beneficial to challenge the products with those
specific microorganisms to ensure the preservative system is able to inhibit the growth
of them as well as those typically used in challenge testing. In addition to the
microorganisms used in the standard preservative test methods, Cosmetic Test Labs
has access to an extensive list of problematic microorganisms, including some that
have previously been isolated from contaminated consumer products.
direct and repeated exposure to the body. If they are irritating to the skin or eyes or cause
unwanted immune reactions, consumers will know right away.
Historically, a great number of cosmetic product safety tests were done on animals. Cosmetic
Test Labs likes to think that fewer animal tests are run now than in the past, but that data is
hard to come by. Nevertheless, non-animal toxicity tests are available for cosmetics that are
reliable and accurate. Cosmetic Test Labs does not endorse animal testing for safety purposes,
so the rest of this section focuses on in vitro (non-animal) methods.
Product safety testing is typically the most expensive phase of cosmetic product
development. Therefore, it may be advisable to conduct it last, just before marketing the
product.
There are three key product safety tests personal care product manufacturers should consider
for every finished product. By running all three, on each formulation class, companies can
rest assured their products are safe for use.
The first component of cosmetic product safety testing is dermal irritancy. It is used to
evaluate the potential of a product to cause skin irritation when used by the consumer. Some
cosmetic products can cause skin irritation by passing through the outer layer of the skin and
entering the underlying layers, harming those cells. This, in turn, causes an immediate
physiological response characterized by redness, and itching or pain in the affected area. It is
done by placing the product to be tested on a laboratory-grown bed of cells, designed to
mimic human skin. After a period of time, the cells are evaluated for negative effects
indicative of dermal irritancy.
The second component of cosmetic product safety testing is ocular irritancy. It uses a 3dimensional model of eye tissue to determine the potential for eye irritation from a consumer
product or cosmetic. This test is fundamentally similar to skin irritancy, but done on a labgrown tissue model that more closely resembles the cornea.
The last part of product safety testing for cosmetics is dermal sensitization testing. Dermal
sensitization is crucial for products intended to go on the skin - especially products that
contain potentially sensitizing agents such as certain essential oils. Dermal sensitization takes
place when the body's immune system identifies a component of a cosmetic product as being
harmful. When that happens, the immune system is recruited to fight the "invader," resulting
in rash and swelling. This phenomenon is also known as allergic contact dermatitis. Nonanimal tests are available to investigate the likelihood that a given product will be a skin
sensitizer.
Traditional (animal) product safety tests are very expensive and are burdened by a number of
serious drawbacks, in addition to the pain and suffering they cause animals. In vitro
(laboratory-based) methods offer an excellent alternative to animal testing and are proving to
be equally useful.
Compatibility with other cosmetic and personal care product ingredients is well
understood.
Generally do not interfere with fragrance, lather, color, or other aspects of a given
formulation.
Often lack broad-spectrum activity. For example, a natural preservative may inhibit
the growth of Staphylococcus aureus or "Staph" in a formulation, but may have no
mold-inhibiting effect.
In summary, synthetic preservatives have been around for decades and have successfully
preserved thousands of cosmetics. Lately, the market has been driven toward natural
preservatives by evidence of toxicity of certain traditional synthetic preservatives.
Unfortunately, selection of natural preservatives is limited, they can vary in terms of potency
from manufacturer to manufacturer and batch to batch, and sometimes affect other aspects of
the formulation in an undesirable way.
Regardless of whether your company chooses to use a natural cosmetic preservative or
synthetic cosmetic preservative, Cosmetic Test Labs can verify preservative effectiveness,
ensuring a given formulation remains safe and stable over the course of normal usage.