ISO 17516
Home >> ASTME2149
ISO 17516 – Assessment of the Microbiological Quality of Cosmetic Products
ISO 17516, established by the International Organization for Standardization or ISO, describes strict acceptable levels of microorganisms in cosmetic products and the complete absence of specified microorganisms. These limitations proposed by this standard ensure that cosmetic products are free from microbial contamination that could pose a threat to the end-users.
The standard applies to all cosmetics products, ranging from products meant for adult use to those used for children below three years of age. However, it also stipulates that other low-risk cosmetics products need not be regularly tested for microbial contamination. The use of contaminated products can cause severe infections or irritation, especially when these products are applied around sensitive areas. Thus, this standard sets clear guidelines for manufacturers and testing laboratories and ensures that products which reach the market are devoid of microbial contamination.
ISO 17516 test method
The standard requires testing cosmetics for the presence or absence of microbial contaminants. These tests can be performed in accordance with other ISO standards which are designed specifically to assess certain microbial aspects of cosmetics. These standards include:
ISO 21149: This test detects and enumerates the aerobic mesophilic bacteria present in cosmetics and thus evaluates the level of microbial contamination.
ISO 16212: This standard specifies the method for determining the total amount of yeasts and molds in cosmetics.
ISO 18415: Tests for the presence of specified and non-specified microorganisms in cosmetics. This assay is used to evaluate low levels of microbial contamination in cosmetics.
ISO 18416: This test specifically detects the presence of Candida albicans within cosmetic products.
ISO 21150: This method detects Escherichia coli in cosmetic products. The presence of E.coli may indicate unsanitary conditions during production or packaging.
ISO 22717: This method detects Pseudomonas aeruginosa, a bacteria that can cause infections if contaminated cosmetics are applied on damaged or sensitive skin.
ISO 22718: This test identifies Staphylococcus aureus, which is known to cause various types of skin infections.
ISO 11930: Assesses the effectiveness of antimicrobial preservatives in cosmetics when exposed to specific microorganisms. It measures the ability of a product to reduce or inhibit microbial growth with time.
Testing procedure
In general, most of these tests involve plating the sample products on a selective media and incubating it under specified conditions. After incubation, the samples are observed for the presence of characteristic colonies and enumerated. Some detection tests might require identification tests to be performed in order to confirm the microorganism.
Efficacy criteria
The standard provides acceptable limits for total aerobic mesophilic microorganisms and necessitates the absence of specific pathogenic microorganisms such as Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans.
The acceptable microbiological limit for general cosmetic products is less than or equal to 1 × 10³ colony-forming units (CFU) per gram or milliliter of the product. However, for products used on infants, the limitation is stricter and should be less than or equal to 1 × 10² CFU per gram or milliliter. In both cases, the presence of the above-specified harmful microorganisms is not acceptable, and products must be completely free of them.
Since the plate count method might show variability, the microbial limits set by the USP 61 standard can also be considered for the interpretation of results. According to USP 61,
- For products designed for infants (used under the eye area or mucous membranes): <200 CFU/ml
- For other products: <2000 CFU/ml.
These microbial limits help set the benchmark for testing laboratories, thus ensuring accuracy and reliability in results.
Importance of ISO 17516 test
Besides safety and quality, the standard is of great importance to manufacturers as it aids in obtaining regulatory compliance. Most countries require that cosmetics sold in their markets meet these regulatory requirements. Testing the products using ISO standards ensures manufacturers that these products are compliant and prevents legal penalties, including product recalls or bans.
The other remarkable feature of this standard includes the assessment of preservative systems of cosmetic products. The standard indicates that preservatives employed in cosmetics must be tested for their effectiveness in preventing the growth of microorganisms throughout their shelf life. This is essential for products used for long durations or are often exposed to different environmental factors.
Additionally, compliance not only protects consumers but also enhances the reputation of the brand by demonstrating a manufacturer’s commitment to quality and safety.
Conclusion
In conclusion, the ISO 17516 test is one of the integral steps in the development and production processes for cosmetic products. It ensures that products are safe for consumers, comply with regulatory requirements, and maintain their quality throughout their shelf life.
Contact Microbe Investigations Switzerland for all-rounded testing services to ensure that your products are safe according to ISO 17516 standards. Our experience and reliability ensure access to efficient microbiological testing, guaranteeing compliance with international standards while protecting your cosmetic products for use.
FAQs
ISO 17516 is the standard which provides the acceptable limits of total number of aerobic mesophilic microorganisms and also requires that specified pathogenic organisms like Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans are completely absent in cosmetics.
The test applies to all types of cosmetic products such as creams and lotions, shampoos, and makeup applied to high-risk areas, including the eyes or mucous membranes, as well as to infants under three years of age.
The turnaround time is greatly dependent upon the product in question and the testing complexity, typically taking a few days to weeks.
Generally, four specified microorganisms are checked at MIS – Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans. Additional strains can be tested upon the customer’s request.
Contact us for more information
Explore Other Tests
ASTME2149 | AATCC-100 | JISZ2801 | JISL1902 | EN 1276 | ISO 22196 | ISO 20743 | ISO 846 | ASTM E2180 | AATCC 147 | ASTM D7907-14 | ASTM E3031 | ASTM G29 | EN 16615 | EN 13697 | PAS 2424 | EN 1040 | EN 14349 | EN 13727 | EN 14561 | ASTM G22 | ASTM E1153 | ASTM D2574 | AATCC 174 | EN 14563 | EN 13704 | EN 1499 | EN 1500 | EN 14347 | EN 14348 | EN 1656 | EN 16437 | EN 12791 | ASTM E1174 | ASTM E2362
Antifungal Testing
AATCC 30 | ASTM G21 | EN 1650 | EN 1657 | EN 13624 | EN 1275 | ASTM C1338 | ASTM D5590
