Microbial contamination is a concern for cosmetic products. Cosmetics can become contaminated during production through raw materials, equipment, personnel, or the environment. Consumers also introduce contamination through product use. To prevent issues, cosmetic manufacturers must ensure proper preservation through effective preservatives and limiting pathogenic microbes. Regular testing of finished products is needed to confirm microbial limits are met.

1. MICROBIAL
CONTAMINATION IN
COSMETIC PRODUCTS

2. INTRODUCTION
 Cosmetic and beauty products are made up of ingredients that are biodegradable, and this
means that microbes can easily break them down.
 When consumers use cosmetics products and health, beauty or personal care products, they
are repeatedly challenging the cosmetics or toiletry products (for example: mascara, eye
shadows, face powder, foundations, lotions, face creams, shampoos, conditioners, etc.) by
contaminating ("challenging") them with their unclean hands.
 This causes a product to become unpleasant and unsafe for consumers with an added
antimicrobial.
 It is also recognized that cosmetic products may be subjected to consumer abuse, possibly
more so than pharmaceutical products.
Philip A.geis, ph.D “Cosmetic Microbiology”,second edition,taylor and francis publication.Pg.163,181.

3.  Although products cannot be protected against extremes of abuse, such as the use of saliva in
the application of eye makeup, or leaving the cap off a bottle of shampoo during use in the
shower, the manufacturer should anticipate misuse when the product is formulated.
 For the manufacturer of cosmetic and personal care products, it is important to ensure that
their products are free of pathogenic (harmful) microorganisms and are safe for consumer use.
 Microorganisms in cosmetics may cause spoilage or chemical change in the product and can
possibly harm cosmetic, health, beauty and personal care product consumers.
 Cosmetics do not need to be sterile, but their preservative system must be able to take care of
harmful microbial contamination.
Philip A.geis, ph.D “Cosmetic Microbiology”,second edition,taylor and francis publication.Pg.163,181.

4. Microbial contaminants usually come from two different origins:
 During production and filling, and
 During the use of the cosmetic by the consumer.
From the moment the cosmetic unit is opened by the consumer, a permanent microbial contamination
of the cosmetic is introduced caused by contact with the consumers hands and body.
Philip A.geis, ph.D “Cosmetic Microbiology”,second edition,taylor and francis publication.Pg.163,181.

5. IMPORTANCE OF MICROBIAL PRESERVATION OF COSMETIC
PRODUCTS
 To ensure the microbial safety of cosmetics for the consumer,
 To maintain the quality of the product, and
 Confirm hygienic and high-quality handling.
Therefore, it is necessary to carry out routine microbiological analysis of each batch of the finished
product coming on the market.
Philip A.geis, ph.D “Cosmetic Microbiology”,second edition,taylor and francis publication.Pg.163,181.

6. RESTRICTED PATHOGENS
There are three main pathogens which are strictly not allowed in any of the cosmetic products:
 Pseudomonas aeruginosa,
 Staphylococcus Aureus and
 Candida Albicans
They are considered the main potential pathogens in cosmetic products. These specific potential
pathogens must not be detectable in 0.1 g or 0.1 ml of a cosmetic product.
The parameters examined, the criteria and methods used, and the results obtained per batch
should be documented.
It is generally acknowledged that neither the occurrence of E. coli nor other members of
Enterobacteriaceae are acceptable in cosmetic products.

7. SOURCES OF CONTAMINATION
RAW MATERIALS
The raw materials used for production can be a potential source of contamination. Raw materials for
use in cosmetics do not have to be sterile. However, proper handling is important to reduce the
potential for microbial growth in the materials and to prevent introduction of microorganisms.
For eg:
 Fats, waxes, and refined oils do not contain sufficient water to support microbial growth, so they
contain relatively few organisms.Natural materials such as gums and herbs are exposed to
environmental contamination and/or aqueous processing, so they are heavily contaminated by a
variety of yeasts, molds, and bacteria.
 In the cosmetics industry, some of the more common raw materials to be contaminated with
Bacillus spores include Aloe vera and a variety of thixotropic agents such as quaternized clays
 Clostridium is another Gram-positive, spore-forming rod. Classic examples are products
associated with shaving and applied to skin (e.g., shave creams, after-shave products and
colognes, lotions, antiperspirants, and deodorants).
Philip A.geis, ph.D “Cosmetic Microbiology”,second edition,taylor and francis publication.Pg.163,181.

8. EQUIPMENT
 During manufacture, the product can easily become contaminated by organisms that
accumulate in the plant as a result of faulty or inadequate cleansing.
 Pieces of equipment with inaccessible joints, pipes, and pumps are often difficult to clean
properly.
 Equipment should be designed to facilitate easy cleaning and disinfection, and inaccessible
grooves and dead ends in all items that come into contact with the product should be
avoided wherever possible.
PERSONNEL
 Probably the greatest microbial hazard to the product during manufacture or packaging is
from the operators. Operators should be properly instructed to appreciate that they are a
potential source of contamination and they should be trained to maintain high standards of
personal hygiene and cleanliness.
Philip A.geis, ph.D “Cosmetic Microbiology”,second edition,taylor and francis publication.Pg.163,181.

9.  Manufacturer must provide workers with proper training in good personal hygiene habits and
also motivate them to want to practice good personal hygiene.
 Generally, employees should cover their street clothes with lab coats or other clean cover-
ups. They should wear coats, masks, aprons, and jumpsuits while working in the
manufacturing area and during material handling.
ENVIRONMENT
 Another possible source of contamination is the air, which contains mainly mold and bacterial
spores, and skin microflora (primarily micrococci).
 Environmental control is facilitated by covering of containers and reduction of air currents
over open product streams.
 Although there may be some seasonal variation in the types and numbers of microorganisms
recovered from the plant environment, routine monitoring of the air and selected surface
sites within the production area is advised so that deviations from normal standards of
cleanliness may be detected and brought back into control.
Philip A.geis, ph.D “Cosmetic Microbiology”,second edition,taylor and francis publication.Pg.163,181.

10. PACKAGING MATERIALS
 Since most products are exposed to further contamination during the filling of containers,
cleaning and disinfection of filling equipment is also important.
 Containers and closures should be dust-free and microbiologically clean.
Philip A.geis, ph.D “Cosmetic Microbiology”,second edition,taylor and francis publication.Pg.163,181.

11. Preservatives
 Preservatives are antimicrobial ingredients added to product formulations to maintain the
microbiological safety of the products by inhibiting the growth of and reducing the amount of
microbial contaminants.
 Preservatives are added to aqueous products to prevent spoilage, that is, to prolong the shelf life
of the product, and to protect the consumer from the possibility of infection.
 The most common type of preservatives used in cosmetic formulations are:
• Parabens
• Formaldehyde releasers
• Isothiazolinoles
• Phenoxyethanol
• Organic acids eg: Benzoic Acid / Sodium Benzoate Sorbic Acid / Potassium sorbate
Kabara, J.J., (ed). Cosmetic and Drug Preservation. Principles and Practice. Marcel Dekker, Inc., New York, 1984.

12. FACTORS INFLUENCING THE EFFECTIVENESS OF PRESERVATIVES
 Concentration of Preservative :Effective concentrations of preservatives range from as little as
0.001% in the case of organic mercurial compounds to 0.5% or even 1% of such materials as
the weak acids, depending on pH and composition of the product
 Dissociation and ph :Formulations of cosmetics and toiletries encompass a wide pH range
since microorganisms of one sort or another are capable of growing between pH 2 and pH 11.
Ideally, a preservative should be effective over this range.
 Partition coefficient
 Succeptibilty to microbial growth
 Interaction between ingredients and preservative.
Kabara, J.J., (ed). Cosmetic and Drug Preservation. Principles and Practice. Marcel Dekker, Inc., New York, 1984.

13. MICROBIAL LIMITS ON FINISHED PRODUCTS:
Finished products are tested to demonstrate that they meet microbial limit
guidelines—that they are free from unacceptable levels of contamination.
The CTFA microbiological limit guideline for cosmetics recommends the following
specific criteria:
Baby products—not more than 500 microorganisms per g or ml Products.
Eye Care Products—not more than 500 microorganisms per g or ml.
All other -products—not more than 1,000 microorganisms per g or ml.
https://archive.org/details/gov.in.is.14648.2011

14. In 1998, the Scientific Committee for Cosmetic Products and Non-Food
Products Intended for Consumers released new microbiology guidelines.
-Category 1 products are those intended for children under three years, eye
area, and mucous membranes;
-Category 2 products are other cosmetic products.
The new guidelines are:
Category 1—total viable count—not more than 100 cfu/g or ml
Category 2—total viable count—not more than 1,000 cfu/g or ml
https://archive.org/details/gov.in.is.14648.2011

15. Product Microbial Limit (CFU/g or CFU/ml)1)
Shampoos, powders Total Microbial Count: 1 000, Max
Yeast and Mould Count: 100, Max
Skin creams and lotions Total Microbial Count: 1000, Max
Yeast and Mould Count: 100, Max
Absence of Gram negative pathogens:
•E. coli and Pseudomonas aeruginosa/g
•S. aureus: absent/g
•C. albicans: absent/g
Baby products Total Microbial Count: 200,Max
Yeast and Mould Count: 100,Max
Absence of Gram negativepathogens:
•E. coli and Pseudomonas aeruginosa/g
•S. aureus: absent/g
•C. albicans: absent/g
MICROBIAL LIMITS

16. Eye products
(Products to be used in and around eyes)
Total Microbial Count: 100, Max
Yeast and Mould Count: 100, Max
Absence of Gram negative pathogens:
•E. coli and Pseudomonas aeruginosa/g
•S. aureus: absent/g
•C. .albicans: absent/g
Tooth paste and tooth powders Total Microbial Count: 1 000, Max
Yeast and Mould Count: 100,Max
Absence of Gram negative pathogens:
•E. coli and Pseudomonas aeruginosa/g
•S. aureus : absent/g
•C. albicans : absent/g
Lipcare Total Microbial Count: 1 000, Max
Yeast and Mould Count: 100, Max
Absence of Gram negative pathogens:
•E. coli and Pseudomonas aeruginosa/g
•S. aureus: absent/g
•C. albicans: absent/g
All other products requiring micro-biological assessment Total Microbial Count: 1 000, Max
Yeast and Mould Count: 100, Max

17. Reference:
André O. Barel, Marc Paye ,Howard I. Maibach, ”HANDBOOK OF COSMETIC SCIENCE AND
TECHNOLOGY”,third edition.
http://cosmetictestlabs.com/five_most_common_types_of_preservatives_used_in_cosmetics.
html
Kabara, J.J., (ed). Cosmetic and Drug Preservation. Principles and Practice. Marcel Dekker, Inc.,
New York, 1984.
 Philip A.geis, ph.D “Cosmetic Microbiology”,second edition,taylor and francis
publication.Pg.163,181.
https://archive.org/details/gov.in.is.14648.2011

18. THANK YOU