Establishment of Microbial Limits

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For many years there have been discussions on whether total count would be sufficient to guarantee the microbiological quality of a cosmetic, or if the exclusion of specified microorganisms, pathogens, or potential pathogens would also be required. The current trend is to require quantitative and qualitative microbial limits. Acceptance criteria for cosmetics and control methods will be issued in the Seventh Amendment of the European Cosmetic Directive. Nevertheless, the acceptance criteria will be minimal criteria that fulfill the public health expectations, such as:

1. Microbial limits for finished products. Maximum 1000 organisms/g or mL, and absence of Staphylococcus aureus, Candida albicans, enterobacteria, and Pseudomonas aeruginosa in one gram or milliliter of the product. Exceptions are baby-care products, eye products, and products for intimate hygiene—maximum 100 organisms/g or mL, and absence of Staphylococus aureus, Candida albicans, enterobacteria, and Pseudomonas aeruginosa in one gram or milliliter of the product.

2. Microbial limits for raw materials. Maximum 100 organisms/g or mL, and absence of Staphylococcus aureus, Candida albicans, enterobacteria, and Pseudomonas aer-uginosa in one gram or milliliter. Limits for water as raw material could be fixed at maximum 100 organisms/mL and absence of coliforms and Pseudomonas aeruginosa in 100

However, what must be the attitude of a manufacturer if one of the following germs is identified in a product: Gram-negative bacilli other than enterobacteria and Pseudomonas aeruginosa, staphylococci different from Staphylococcus aureus, or fecal streptococci? What is the significance of this regarding manufacturing hygiene? Are these organisms harmless? Furthermore, in addition to the human safety, it must be emphasized that contamination of products with nonharmful organisms can partially or totally destroy the product aesthetic (e.g., perfume, color) and can alter the product performance. The rise of these questions emphasizes the need of internal quantitative and qualitative microbiological safety margins and of a quality-assurance system.

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