ISO 17516 Cosmetics - Microbiology - Microbiological Limits

The ISO 17516 standard developed by the International Standards Organization (ISO), It applies to all cosmetic products and the requirements are explained to assist interested parties in the assessment of the microbiological quality of these products. Microbiological testing is not required on products that are considered to be microbiologically low risk. For such products, reference is made to the ISO 29621 standard (ISO 29621 Cosmetics - Microbiology - Guidelines for risk assessment and identification of microbiologically low risk products).

All cosmetics producing companies bear responsibility for their microbiological safety and quality to ensure that products are produced under hygienic conditions. Cosmetic products may not contain excessive amounts of microorganisms or certain microorganisms that have the potential to affect product quality or consumer safety. Also, some cosmetic products considered to have low microbiological risk may not need to undergo routine microbiological testing, and manufacturers are not required to test if they are confident that products meet this standard.

Manufacturers have to follow the good manufacturing practices described in the ISO 22716 standard and take the necessary measures to limit the entry of microorganisms from raw materials, processing and packaging. When necessary, microbiological tests defined in ISO 21148, ISO 21149, ISO 16212, ISO 18415, ISO 18416, ISO 21150, ISO 22717 and ISO 22718 standards can be performed.

The purpose of the ISO 17516 standard is to develop acceptable quantitative and qualitative limits for cosmetic finished products.

For the purposes of the ISO 17516 standard,

• The term product refers to a sample of an identified cosmetic product taken for testing in the laboratory.
• The expression aerobic mesophilic microorganisms refers to mesophilic bacteria, yeast and mold that grow aerobically under the conditions specified in ISO 21149 and ISO 16212 standards.
• Specified microorganismThe expression ism refers to aerobic mesophilic bacteria or yeast that is undesirable in a cosmetic product because it can cause skin or eye infection or is an indication of hygienic failure.

Among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors, our organization also provides testing services for microbiological limits in cosmetic products, within the scope of ISO 17516 standard, with its trained and expert staff and advanced technological equipment.