ISO 17516:2014— Microbiology of Cosmetics

Scientist performing microbiological examinations of cosmetic make-up products in a laboratory that adhere to ISO 17516:2014.

With the cosmetics industry growing at a rate of approximately 5.3% every year, it is critical to ensure that cosmetic products are safe for consumers to use. Cosmetic products can become harmful if they are contaminated with harmful microorganisms, such as pathogenic bacteria and fungi. ISO 17516:2014— Cosmetics – Microbiology – Microbiological Limits covers the microbiological quality of cosmetics.

How Do Microorganisms Get into Cosmetic Products?

Cosmetics are synthetic or natural substances used on various regions of the human body skin including lips and eyes. They contain a wide range of chemicals such as fragrances, preservatives, pigments, and other substances known as skin sensitizers that can be potentially harmful to general health. Regardless if cosmetics are safe, they continue to be used. In fact, since many cosmetics are manufactured in a media that is infrequently sanitized against microbial growth, most cosmetic products contain several components that are favorable for microbial growth. Here are some of the ways cosmetic products may become contaminated with harmful bacteria or fungi:

  • Contaminated or polluted raw materials, water, or other ingredients
  • Poor manufacturing, factory, and/or storage conditions
  • Ineffective preservation system particularly for ingredients that encourage growth of microorganisms
  • Packaging that does not adequately protect the product
  • Poor shipping or storage conditions
  • Consumer use, such as dipping fingers into the product

Cosmetics Contaminations from Microorganisms

Microorganisms are frequently the cause of organoleptic changes, such as changes in color and viscosity and disagreeable odors. Cosmetics contamination can cause negative effects on our health and infections ranging from mild to severe. This is why batches of formulated cosmetic products should be tested for microbiological quality before release. Luckily, cosmetic manufacturers can adhere to standards like ISO 17516:2014 to minimize cosmetic contamination from microorganisms.

What Is ISO 17516?

ISO 17516:2014 is applicable for all cosmetics, and it assists interested parties in assessing the microbiological quality of products. The standard details that cosmetic products should not contain excessive amounts of microorganisms nor specified microorganisms that have the potential to adversely affect the product quality or consumer safety. As such, every cosmetic manufacturer should have a responsibility relative to the microbiological safety and quality of its products to ensure that they have been produced under hygienic conditions.

ISO 17516:2014 specifies that some cosmetic products considered to have low microbiological risk (see ISO 29621) may not need to be subjected to routine microbiological testing. Manufacturers can decide not to test if they can ensure products meet this standard.

Protecting Against Microbial Contamination in Cosmetic Products

Here are some ways you can protect against microbial contamination in your cosmetics products:

  • Keep the containers of cosmetics clean.
  • Do not share cosmetic products with anyone, since it may be sharing germs.
  • Do not add water or saliva to cosmetic products because it could add harmful microorganisms as well as water down preservatives that aim to keep microorganisms from growing.
  • Store cosmetic products as instructed by manufacturers. Some microorganisms may grow faster in warm or damp storage conditions, and preservatives in the product may break down.
  • Wash your hands before applying cosmetic products, especially if you need to dip your fingers into the container.
  • Pay attention to recalls and safety alerts. Microbial contamination is a common reason for recalls of cosmetic products, having the potential to be a major cause of both economic and product losses.

Microbiological testing of cosmetic samples in laboratories helps reduce microbiological risks, meet regulatory requirements, and ensure the quality and safety of personal care products.

ISO 17516:2014— Cosmetics – Microbiology – Microbiological Limits is available on the ANSI Webstore.

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