Tom Branna02.01.21
We are writing to expand and clarify the understanding of preservatives and preservation stated by Tiffany Jones in her article, “Preservation & Cosmetics" (October 2020, p. 62). The author states “Preservatives are any substance that, when added to a product, will help prevent microbial growth, contamination, or spoilage,” We expanded this definition to clarify what preservatives are, specifying the contextual meaning in the overlapping regulatory and practical/applied contexts. We did not include the use of antioxidants, mainly because the countries that have positive lists for preservatives do not include antioxidants.
Many countries have a positive list (pre-approval before it can be used) for allowable preservatives in their markets. If the substance is not on their list, it cannot be used in a cosmetic for the purpose as “preservative.” It must have another demonstrated cosmetic function excluding being a UV filter or color additive.
However, and as approvals in markets such as the European Union, Japan and China for addition to their positive list are very expensive (the major cost is safety testing) and time consuming, some antimicrobial ingredients are used effectively as preservatives but are called or claimed to be ingredients with other functions incidental to preservation.
The FDA has said that the purpose of preservatives is to prevent microbial contamination by consumers. The reality is that we cannot find out how consumers actually contaminate products during usage. All of the recalls and alerts cited in the paper are due to the shipment of contaminated finished goods contaminated in or before ingredients are added to production or during the manufacturing process including final packaging. This is due to cGMP failures. Why were contaminated products released by manufacturers? Some of the “reasons” including poor (especially “natural”) preservation systems and trust that the preservative system will kill off the bugs (so ship it!). However, some manufacturers have an inadvertent idea or trust that the preservative system will kill off the bugs in the contaminated product. Many times, this is because of the use of a Preservative Effectiveness Test (PET) that is not robust enough for their intended purpose. For example, the use of USP <51> PET, is insufficient for cosmetics.
In addition, and critical consideration to this article is prevention of contamination in the first place. A proven way: Hazard Analysis Critical Control Point (HACCP) is a systematic way of identifying where contamination may occur in a manufacturing environment and setting a method to prevent this.
In today’s “natural,” anti-preservative environment (marketing never met a preservative they liked), some companies have abandoned the usage of safe preservatives that, in context of HACCP and cGMPs, effectively handled contamination during manufacturing and highly likely in use. Finished product testing within numerical specifications with no detectable objectionable microorganism (especially Gram-negative bacteria) is needed before release of the finished product to the market. We cannot tell if the release of contaminated product was because of one or all of the following situations had occurred: cGMPs had not been strictly followed, a HACCP program had not been established to identify possible sources of microbial contamination during manufacturing finished product testing failed to detect “injured” microorganisms, or was it assumed that the products preservative system would kill off the presence of minor contamination in the product after completion of the manufacturing process?
In any case, the old statement, “never ship a contaminated batch,” remains the answer.
Don English, Phil Geis, Don Orth, Linda Sedlewicz, David Steinberg, John Yablonski
Note: The signers are either retired, doing some consulting work or remain as presidents of their companies. All are recognized for their many years of experience in microbiology and preservatives, including publications of books on this subject, authors of chapters in books and other scientific publications.
Letters
Letters to the editor are always welcome. Email comments and complaints to Tom Branna, tbranna@rodmanmedia.com.
Many countries have a positive list (pre-approval before it can be used) for allowable preservatives in their markets. If the substance is not on their list, it cannot be used in a cosmetic for the purpose as “preservative.” It must have another demonstrated cosmetic function excluding being a UV filter or color additive.
However, and as approvals in markets such as the European Union, Japan and China for addition to their positive list are very expensive (the major cost is safety testing) and time consuming, some antimicrobial ingredients are used effectively as preservatives but are called or claimed to be ingredients with other functions incidental to preservation.
The FDA has said that the purpose of preservatives is to prevent microbial contamination by consumers. The reality is that we cannot find out how consumers actually contaminate products during usage. All of the recalls and alerts cited in the paper are due to the shipment of contaminated finished goods contaminated in or before ingredients are added to production or during the manufacturing process including final packaging. This is due to cGMP failures. Why were contaminated products released by manufacturers? Some of the “reasons” including poor (especially “natural”) preservation systems and trust that the preservative system will kill off the bugs (so ship it!). However, some manufacturers have an inadvertent idea or trust that the preservative system will kill off the bugs in the contaminated product. Many times, this is because of the use of a Preservative Effectiveness Test (PET) that is not robust enough for their intended purpose. For example, the use of USP <51> PET, is insufficient for cosmetics.
In addition, and critical consideration to this article is prevention of contamination in the first place. A proven way: Hazard Analysis Critical Control Point (HACCP) is a systematic way of identifying where contamination may occur in a manufacturing environment and setting a method to prevent this.
In today’s “natural,” anti-preservative environment (marketing never met a preservative they liked), some companies have abandoned the usage of safe preservatives that, in context of HACCP and cGMPs, effectively handled contamination during manufacturing and highly likely in use. Finished product testing within numerical specifications with no detectable objectionable microorganism (especially Gram-negative bacteria) is needed before release of the finished product to the market. We cannot tell if the release of contaminated product was because of one or all of the following situations had occurred: cGMPs had not been strictly followed, a HACCP program had not been established to identify possible sources of microbial contamination during manufacturing finished product testing failed to detect “injured” microorganisms, or was it assumed that the products preservative system would kill off the presence of minor contamination in the product after completion of the manufacturing process?
In any case, the old statement, “never ship a contaminated batch,” remains the answer.
Don English, Phil Geis, Don Orth, Linda Sedlewicz, David Steinberg, John Yablonski
Note: The signers are either retired, doing some consulting work or remain as presidents of their companies. All are recognized for their many years of experience in microbiology and preservatives, including publications of books on this subject, authors of chapters in books and other scientific publications.
Letters
Letters to the editor are always welcome. Email comments and complaints to Tom Branna, tbranna@rodmanmedia.com.