ISO 17516, “Cosmetics – Microbiology – Microbiological limits,” has just been released. The new 1st Edition is available now from Document Center Inc. in both paper format and for pdf download. The document has been adopted by the European Union already and is available as EN ISO 17416 as well.
Cosmetic products are interesting in that they are not expected to be sterile and yet they must be microbiologically safe for users. So it is incumbent upon manufacturers to insure that these products have been produced under hygienic conditions. This leaves cosmetic companies with the question: When and how much should our products be microbiologically tested?
ISO 29621 provides guidance for developing a risk assessment plan to determine what products are vulnerable to microbiological contamination. And the various testing that may be required can be found in ISO 21148, ISO 21149, ISO 16212, ISO 18415, ISO 18416, ISO 21150, ISO 22717 and ISO 22718. However, there’s been one element that’s been missing.
Now the new ISO 17516 provides you with acceptable quantitative and qualitative limits for cosmetic finished products. The document has the usual scope and definitions sections. Then Clause 3 moves right in the principles guiding the requirements for these types of products. This includes basic information on limits in general as well as for products intended for use on children, on eye areas and on mucous membranes.
Clause 4 provides you with a table that specifically defines the types of microorganisms that should be tested for and limits based on general use or for the specialized uses noted above. Annex A completes the document with the presentation of a flowchart for the interpretation of your test results. And there’s also a 27 item bibliography that you’ll find to be very useful.
Now you need a copy of the new standard. You’ll choose the ISO or the EN ISO edition based on the jurisdiction of your auditor, if your products or processes are certified. Then you’ll order on the Document Center Inc. website, www.document-center.com. Your order options will be available to you there. Of course, you may prefer to set up multi-user access through our Standards Online subscription service. In that case, just contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).
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