11/1/2010. Key Points to Remember

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1 A Review of Microbial Limits and Objectionable Organisms Steven Schnittger, The Estee Lauder Companies, Inc. Key Points to Remember Cosmetic products are not required to be sterile It is the aim of all cosmetic manufacturers to ensure that their products are free from the numbers and types of organisms that could affect product quality and consumer health (*) To ensure that microorganisms introduced during normal product use will not adversely affect the quality and safety of a product (*) CTFA Microbiology Guidelines

2 Welcome to Microbiology 101 We live in a world of bacteria, from the airwe breathe, to the waterwe drink, to the foodwe eat, to the cosmeticswe apply Cosmetics are applied to skin surfaces where the resident population of bacteria can range from cm 2. Organisms are identified as either resident, transient, opportunistic and / or primary pathogens. Even those bacteria which are considered opportunistic pathogensmay not cause a health hazard when applied to healthy skin Resident Flora Resident flora have a symbiotic relationship where both the bacteria and the hosts may benefit Dermatococcus Malassezia furfur Propionibacterium Corynebacterium Brevibacteruium Micrococcus Staphyloccocus Acinetobacter 2

3 S. warneri S. albus S. hominis S. capitis Resident flora 1 S. epidermidis (most common) M. luteus (most common) M. varians P. acnes 1 Roth, Microbiology of the Skin, Am. Acd. Derm., Vol 20 (3) pg Resident Flora - Benefits Prevents colonization by other microbes on the skin Strains of M.luteus and S.epidermidis produce bacteriocins against S.aureus * and other harmful bacteria and virus Lipolytic action of the bacteria, release fatty acids which help in the natural defense system These fatty acids have activity against gram + bacteria, yeast, and fungi *Jetten, J. Antibacterial Agents & Chemo. 2,

4 Pathogenic Organism* Defined as microorganisms that are capable of causing disease Primarypathogens regularly cause disease among at least a portion of individuals whose defense systems are uncompromised Opportunisticpathogens cause disease only in individuals who are compromised in their defense systems Depends on the ability of the microbe to replicate and survive in the host Many organisms listed as normal flora only become pathogens when the person is compromised through surgery, injury, immune suppression or antibiotic therapy (S.epidermidis) * Falkow, S., ASM News Vol. 63 number 7 pp Compromised System A patient could be considered compromised through the following actions: Injury Surgery Antibiotic Therapy Immunosupression During these conditions resident flora for that body site could become pathogenic (*) * Cundell, A.M. Pharmocopeial Forum Vol 28(3) pg May June

5 Microbial Pathogen A microbial pathogen must be capable of entering a host, finding a unique niche, avoid the host s defense system and multiply in the new setting Entry is not simply the result of casual contact between the host and the infectious agent A site that is suitable for a pathogen may be devoid of commensal bacteria Colony counts of S. aureusless than 10 6 cfu are considered to represent colonization without infection. 2 2 Leyden J.J, Soc. Inv. Derm. Vol 88, No.3, pg Objectionable Organisms For a bacteria to be defined as objectionable in cosmetics or pharmaceuticals, the following question has to be asked: Will the organism proliferate in the product and thus adversely affect its quality attribute? Will the organism, given the route of administration or application have the ability to cause an adverse reaction in the consumer? 5

6 Objectionable Organisms for Cosmetic Products The bacteria Escherichia coli (E. coli) The bacteria Staphylococcus aureus (S. aureus) The yeast Candida albicans (C. albicans) The bacteria Pseudomonas aeruginosa (Ps. aeruginosa) Other Organisms of Concern Salmonella species Pseudomonas cepacia All Gram negative bacteria In foods the list of organisms is much more extensive and the risk to the consumer is much larger 6

7 Microbial Limits Testing General Eye / Baby CTFA NMT 10 3 NMT 10 2 CTPA <1000 <100 Colipa <1000 <100 In-house specifications may be lower Microbiological Specification Industry spec <1000 c.f.u In house spec <100 c.f.u Product is at < 10 c.f.u Eye area products <1 c.f.u for objectionable organisms 7

8 Cosmetic Microbiological Limit Guidelines No product should have a microbial content that is harmful to the user Products should be free from objectionable organisms In-house Guidelines may be more rigorous These limits have been used successfully by the industry for years Process Controls to Minimize Contamination Routine testing of all raw materials and products Adequately Preserved formulations Cleaning and sanitization of equipment Hot process water Pressurized manufacturing kettles CIP system Packaging which prevents contamination Risk Assessment Review 8

9 Things have recently changed! Welcome to Microbiology 2010 New F.D.A Criteria FDA is attempting to modify its existing policy with regard to which organisms are classified as pathogens Numerous imported products have fallen victim to these new criteria of acceptability. 9

10 New F.D.A Criteria All of the products were well within the acceptable limits as specified by PCPC Guidelines The products do not contain significant levels of microorganisms which could do harm during the normal use and application of the products List of Organisms in question Bacillus cereus B. lichenformis S. epidermidis S. hominis S. warneri M. luteus 10

11 All of these organisms are common either on the skin or in the environment All of these organisms have been previously accepted by the FDA as harmless All of these organisms are non-pathogenic under normal cosmetic use and when applied to healthy skin A majority of these incidents were detected at levels of <10 c.f.u s per gr. So. How did these Organisms now become a Concern? 11

12 Process Controls to minimize contamination Routine testing of all raw materials and products Adequately Preserved formulations Cleaning and sanitization of equipment Hot process water Pressurized manufacturing kettles CIP system Packaging which prevents contamination Microbiological Risk Assessment Microbiological Limits Industry spec - <1000 c.f.u In house spec - <100 c.f.u Product is at < 10 c.f.u Eye area products - <1 c.f.u for objectionable organisms 12

13 Conclusion A Risk Assessment must be performed and based on sound science It must be based on a realistic exposure assessment Will that dose lead to an adverse reaction? Must be based on the probability of occurrence and the potential adverse reaction in a given population. A risk assessment must be performed before an organism can be considered objectionable! Review In review I have discussed the standards, limits and guidelines that the Cosmetic Industry puts in place to ensure product safety. Both the microbial limits and guidelines have been very effective in ensuring product safety. The cosmetic industry has a long history of producing safe products especially as it relates to bacterial contamination. In regards to the FDA, we commend the work that they do to protect the consumer especially as it relates to imported products but: 13

14 Recommendations Based on the most recent change in policy we would encourage the FDA to work with Industry to develop rational and achievable domestic standards as they relate to microbiology We would encourage the FDA to work along with international industry trade groups and regulatory bodies to develop rational and achievable international standards as they relate to microbiology 14