- Swiss testing laboratory
ISO 17516:2014 Assessment of Microbiological Limits for Cosmetic Products
Hassle-free testing experience
Need to get a product tested? No worries! To and fro logistics are on us; we collect your products, test them and, deliver them back to you.
Summary
ISO 17516:2014 is a test standard that provides the acceptable microbiological limits for cosmetic products. It sets the total microbial count thresholds and mandates the absence of critical pathogens which in turn ensures product safety and compliance. The standard is applicable to risk-based safety assessment as well as routine quality check.
Related tests for you
Quick understanding of the test
ISO 17516 - Assessment of the Microbiological Quality of Cosmetic Products
ISO 17516 sets the microbiological limits for cosmetic products. Microbiological testing is not required for products classified as microbiologically low-risk.
Application
Mandatory test strains
- Depends on the ISO standard test methods used to assess product compliance.
Methodology
ISO 17516 establishes microbiological limits for cosmetics to ensure that, while not required to be sterile, the microorganisms present do not compromise consumer safety or product quality during normal use. Several international standards can be used to perform a comprehensive microbiological risk assessment of cosmetic products. Some standard test methods include:
ISO 21149: Detection and enumeration of aerobic mesophilic bacteria.
ISO 16212: Determination of the total amount of yeasts and molds in cosmetics.
USP 61: Microbial Enumeration Test
ISO 11930: Preservative Efficacy Test
Aerobic plate count: Estimation of Mesophilic Aerobic Bacteria
- This test helps ensure cosmetics are free from harmful microorganisms by setting strict microbiological limits, which safeguards consumer health
- It promotes smoother international trade by helping cosmetic manufacturers meet regulatory requirements in various markets.
Passing criteria
- The standard necessitates the absence of Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans.
- For products designed for infants (used under the eye area or mucous membranes): <200 CFU/ml
- For other products: <2000 CFU/ml.
Do you have a product that needs testing?
What is ISO 17516?
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.
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 limits on the acceptable limits of microorganisms that can be present in cosmetic products without endangering consumers’ health.
The microbial limits apply 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.
Scope of ISO 17516:2014
ISO 17516 is applicable to all finished cosmetic products. However, if a product is proven to be microbiologically low risk under ISO 29621, the manufacturer may decide that routine microbial testing is not necessary.
ISO 17516 guidelines
Cosmetics and their ingredients donโt need to be sterile, but any microorganisms in the product must not harm consumer safety or product quality during normal use. To ensure this, specific microbiological limits are set for finished cosmetic products.
Several international standards can be used to perform a comprehensive microbiological risk assessment of cosmetic products. Some standard test methods include:
ISO 21149: Detection and enumeration of aerobic mesophilic bacteria.
ISO 16212: Determination of the total amount of yeasts and molds in cosmetics.
USP 61: Microbial Enumeration Test
ISO 11930: Preservative Efficacy Test
Aerobic plate count: Estimation of Mesophilic Aerobic Bacteria
Microbiological limits defined Under ISO 17516
The standard establishes
- Quantitative limits for total aerobic microorganisms
- Qualitative requirements for absence of specific pathogens
What Are the Acceptable Limits for ISO 17516?
Types of microorganisms | Products specifically intended for children under three years of age, the eye area or the mucous membranes | Other products |
Total Aerobic Mesophilic Micro-organisms (Bacteria plus yeast and mould) | โค 1 ร 10ยฒ CFU per g or mlยน | โค 1 ร 10ยณ CFU per g or mlยฒ |
Escherichia coli | Absence in 1 g or 1 ml | Absence in 1 g or 1 ml |
Pseudomonas aeruginosa | Absence in 1 g or 1 ml | Absence in 1 g or 1 ml |
Staphylococcus aureus | Absence in 1 g or 1 ml | Absence in 1 g or 1 ml |
Candida albicans | Absence in 1 g or 1 ml | Absence in 1 g or 1 ml |
These microbial limits help set the benchmark for testing laboratories, thus ensuring accuracy and reliability in results.
Regulatory relevance of ISO 17516
ISO 17516 helps achieve compliance with EU cosmetics regulation by providing clear microbiological quality criteria. It is often followed in the aspect of product safety assessment and documentation during regulatory submission. ISO 17516 defines microbiological limits for cosmetic products, helping manufacturers ensure product safety and consumer protection. It sets acceptable limits for total aerobic microbial count and absence of specified pathogens in finished products.
ISO 17516 test framework
Total aerobic mesophilic count
Determination of total aerobic mesophilic microorganisms (bacteria, yeast, and mold) is typically performed according to ISO 21149 and ISO 16212. Results are evaluated against the limits defined in ISO 17516:2014.
Yeast and mold enumeration
Yeast and mold counts are performed using standardized ISO methods such as ISO 16212, and results are compared with ISO 17516 acceptance criteria.
Detection of specified pathogens
Testing for absence (in 1 g or 1 ml) is performed using specific ISO detection methods:
- Escherichia coli – ISO 21150
- Staphylococcus aureus– ISO 22718
- Pseudomonas aeruginosa– ISO 22717
- Candida albicans – ISO 18416
Interpretation of CFU limits
Results are interpreted based on product category and compared against the microbiological limits defined in ISO 17516, considering inherent variability of plate count methods.
Understanding ISO 17516 Compliance Criteria
A product is compliant when:
- Total microbial counts remain within defined CFU limits
- Specified pathogens are absent in 1 g or 1 ml
- Risk assessment confirms no microbial proliferation risk
Request Cosmetic product testing as per ISO 17516 criteria
At Microbe Investigations Switzerland (MIS), we offer expert microbiological testing services to assess if your cosmetic products meet the microbiological limits set by ISO 17516:2014. Ensure safety, quality, and compliance with our reliable testing solutions. Contact us today to learn more about our microbiology testing services!
For more details, contact our experts here
Frequently Asked Questions
DR. Martinoz Scholtz
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.
For products intended for:
- Children under the age of 3 years
- Area around the eyes
- Mucous membrane
Total aerobic mesophilic count:
โค 1 ร 10ยฒ CFU/g or ml
For all other cosmetic products:
โค 1 ร 10ยณ CFU/g or ml
The standard requires complete absence in 1 g or 1 ml of:
- Escherichia coli
- Staphylococcus aureus
- Pseudomonas aeruginosa
- Candida albicans
These organisms are considered specified microorganisms due to their potential to cause infection or indicate hygienic failure.
ISO 17516 defines acceptance criteria and limits for cosmetic products. Whereas, USP <61> is a test method used to enumerate the microorganisms in non-sterile products.
ISO 17516 is specifically applicable to finished cosmetic products.
Meet the best of the blend of
R&D, Efficacy Testing,
Innovation and Passionate
Experts at MIS.
Explore More
In the cosmetics industry, safety
Evidently, with the expanding cosmetics
In the competitive world of
