Laura M. Szymczak-Frye, Global Marketing Manager, Personal Care Preservation, Lonza

The topic of preservation in personal care is heightening and is on the forefront of the minds of cosmetic companies, formulators, and consumers. There is an interesting divide in the way that certain consumers and companies are approaching preservation. While many understand that preservatives are safe when used at the recommended concentrations supported by Regulatory Authorities, others feel that all preservatives are harmful and they seek alternatives. Consumers generally prefer their personal care products to have the fewest ingredients possible, with those ingredients as natural as possible. However, it is important to note that there are many negative consequences tied to not properly preserving a product.

 

What Is a Preservative?

A preservative is a natural or synthetic ingredient that is added to products such as foods, pharmaceuticals and personal care products to prevent spoilage.1

 

Why Are Preservatives Used in Personal Care Products?

The purpose of a preservative is to prevent product damage caused by microorganisms as well as protect the product from inadvertent contamination by the consumer during use.1 As a consumer uses a product, it is inevitable that the product will be exposed to contamination at some point during use. Take a face cream that is sold in an open faced jar with a twist lid, and consider how the product is applied. Once the cap is opened, the cream is susceptible to contamination from its surroundings. Further, once the user places their hand into the jar to extract the cream, any bacteria on the user’s hands can now contaminate the product. If that formulation is not preserved properly where the antimicrobial could act effectively on those harmful organisms, the product can now become a health hazard. In addition, consider where many personal care products are stored…in the bathroom. A bathroom is a moist and warm environment which is the perfect conditions for bacteria and mold to flourish. Ensuring all products are protected is crucial.

There are more advantages to preservation than protecting a formulation from contamination. Additional benefits can include a preservative being added to help stabilize other ingredients in the finished material. When certain ingredients are exposed to oxygen, they may begin to degrade; preservatives can sometimes help reduce the degradation of these materials, allowing the product to remain in its original state through the duration of use. 

In cases where a product is affected by yeast or mold, the result is obvious where the user would most likely see a discolored product, some mold growth or spottiness within the formula, or possibly a thin furry layer on the top. This type of contamination, although unappealing to the eye, has low potential to cause serious adverse health effects if applied. The real risk comes into play when there are bacteria present. These organisms are much more of a health risk. Coupled with the fact that a user cannot see bacteria the way mold would present, this is a dangerous combination. 

In most jurisdictions around the world, it is a legal requirement to ensure that products placed on the market are safe. The importance of microbiological quality and the role of preservation is therefore captured in legal instruments and recognized by different safety and health organizations globally. For example this requirement is  captured in the EU Cosmetic Regulation EC/1223/2009/ which requires that the Product Information File on a cosmetic product is to contain information on microbiological quality and microbial  challenge testing, to demonstrate safety in use. A further and most often referenced and used as a guide in personal care is the European Scientific Committee on Consumer Safety (SCCS) where they have published “The SCCS’s Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation” This publication is currently on its 7th edition and within it, there is a section titled “Guidelines on Microbial Quality of the Finished Cosmetic Product.” This covers the need for cosmetic preservation and offers guidance on the safety of preservatives for different parties (e.g. children or near eye or nose mucosa). It also provides detailed quantitative and qualitative limits for microorganism counts that can be permitted in various cosmetic types. There is an important statement highlighted which reads “In order to ensure the quality of the product and the safety for the consumer, it is necessary to carry out routine microbiological analysis of each batch of the finished product coming on the market.”2 Statements and guidance of this type and guidance from such a well-known organization Scientific Committee emphasize the importance of ensuring a personal care product is properly preserved.

 

What Preservatives Are Permitted for Personal Care?

A reference guide that is most commonly followed by global Regulatory leaders with regards to preservation is derived from the European regulations. In the EU, there is a featured positive list, the EU Cosmetics Regulation, Annex V to Regulation EC/1223/2009 – formerly Annex VI to Council Directive 76/768/EEC (i.e. the approved preservative section of the law),  which is fairly well accepted around the world, and can serve as an accepted standard for when selecting a preservative for a formulation. There are currently 58 preservatives that are on this list which can be considered acceptable for personal care preservation, but not all are used in practice.  Following this EU Cosmetics Regulation brings a formulator seeking a “universal” preservative system, one step closer to that ultimate goal.* “Natural” preservatives are not compliant as such unless they appear in Annex V.  Any natural preservative can only be used legally if preservation is a secondary function, the primary marketed function may be as part of the perfume, (e.g. honeysuckle), or as an effect (e.g. moisturizing).

The EU Cosmetics Regulation is not the only legislation and industry guidance with which formulators need to be familiar. Depending on where a product is to be sold, other regulatory considerations and industry guidance should be considered. Japan for example follows separate regulatory directives, the Japanese Standards for Cosmetics issued by the Ministry of Health and Welfare and the Comprehensive Licensing Standards of Cosmetics. Industry guidance in the US provided by the Personal Care Products Council via the Cosmetic Ingredients Review relates to this issue, and in China, consideration has to be given to ingredient compliance with the SFDA and IECSC raw ingredient inventories.

 

Is There a Risk By Removing Approved Preservatives from the Market?

As preservation is placed under the microscope now more than ever, there is much discussion from multiple personal care organizations on limiting or banning of many well-known and well-documented ingredients that have been used safely for years. What is happening is that the safety data available is being looked at with an increasingly precautionary approach and the opinions of certain personal care organization boards are changing. A consistent trend can be observed toward the removal of select chemistries from the market. Such restrictions may be based on a legislatively driven review by regulatory bodies or be voluntary on the part of formulators on the basis of a concern for public perception of the safety of individual preservatives.  This is of especial concern in the EU which operates a positive list of allowed preservatives (Annex V of the Cosmetic Regulation). It is increasingly apparent that few new actives are added to this Annex and those present are under increasing pressure. Thus the palette of available preservatives is being severely restricted.

The motive behind any new proposal or recommendation for the changes being requested on certain preservatives is tied directly to safety. The main concern for all who play a role in the personal care field is keeping consumers safe. Staying in line with this focus, how safe is it to remove some of these preservatives, leaving formulators with few choices and perhaps choosing options less effective in controlling microorganisms. In addition to the cosmetic product, many of the raw ingredients used in formulating cosmetics require preservation to limit the number of microbes introduced into the final product. With limited preservation options, it increases the likelihood that the raw materials and finished product could be preserved with the same ingredients.  The issue here is that formulators have an obligation not to exceed the maximum use concentration for any given perspective. Therefore where effective preservation of a formulation may have been achieved in the past by a combination of ingredients now has to be achieved by fewer preservatives used to the maximum level. This may not be sufficient for effective preservation. In addition, if all personal care products are preserved with many of the same chemistries, consumers run the risk of being overexposed to a certain ingredient and can therefore be at risk for sensitization, allergic reactions, etc.

Another aspect of this is the spectrum of microbial efficacy of the dwindling preservative options. Preservatives typically are not effective against all microbial types, it is essential that a range of actives be available to afford full protection against a broad range of microorganisms.

 

Why Do Some Believe it Is Better to Not Use a Preservative?

Most of the world is trending toward a more eco-friendly way of life, whether that is by the food they eat, the amount of exercise they do or to the products that they put on their skin. When considering personal care products, whether they are leave on or rinse off, every product contains a number of ingredients each which has a purpose within the product. Many consumers are starting to feel that having fewer ingredients in a product is a better approach because less is applied to their skin and therefore it must be “healthier” and “safer”. While this is a common point of view, this is not necessarily the case.  

When considering preservatives and why certain consumers prefer to not have them in their products, there is a misconception that preservatives as a family are unsafe and may cause damage to the users’ health. What is unfortunate is that it is not always known these ingredients have had the highest level of safety testing and are frequently reviewed by independent bodies to confirm they remain acceptable at recommended use levels.  A key part of this acceptability is the concept of risk assessment. Unfortunately there is poor public understanding of risk vs. hazard. Hazard is the inherent property of a substance, risk is the chance that in normal use the hazard will affect a consumer.

The normal equation is: Risk = hazard x exposure

The basis of safety for preservatives is the levels of exposure. Very small amounts are used in finished cosmetics and the resultant potential exposures are assessed and considered safe.  It is still a difficult concept to pass on to consumers. Another way to look at it is that there is no one material that in excess would still be safe for a human. Take water, there is nothing more natural than this. Yet, if exposure is high, that is water is ingested in excess, it becomes lethal.3

Consumers are focusing on the extreme scenarios which cannot present themselves in personal care due to use levels being substantially lower than what is tied to any negative effect (hazard). What is not being considered is that the antimicrobials used in products are serving the purpose to remove the harmful organisms that may present themselves in a product, and that they are not causing damage to the user (read below “Where is the Risk”). In addition to this, there are many research papers also supporting the safety of most of these preservatives, many of which have been marketed for years.

 

Why Are Finished Goods Manufacturers Considering Less Preservation?

Although most personal care finished goods manufacturers understand the importance for preservation, many are trying to keep their customers satisfied and maintain their consumer base so they are beginning to move in a direction of less preservation or preservative free. In addition to following consumer perceptions companies are actually accelerating the trend by competing with one another with “active” or “preservative-free” claims. There is a danger that such marketing claims may lose sight of the potential negative impacts should a product not be properly preserved.

 

Where is the Risk?

There are many factors to consider when a decision is being made on what is the best approach to protecting a finished product. There is the risk of losing a loyal customer who has become passionate about using products that are labeled with “No Preservatives”. No company wants to lose customers or the ability to provide them what they desire. The question comes down to where is the risk if a company follows customers’ requests and begins to step back from preservation. Is it riskier to have a consumer know there is a preservative that has well documented safety data in their product? Or, is it riskier to have a product contaminated which may lead to:

  • Hazard to consumers’ health
  • Recalls n  Lawsuits
  • Negative brand perception
  • Costs to recall and dispose product, loss of product and packaging  

 

Hazards to Consumers’ Health

In most healthy adults and children, if there were the unfortunate incident where a product were to be contaminated and that product were not properly preserved, a negative health effect would most likely not be seen.  The issue at hand is that it can never be known as to who the final customer will be of any one given personal care product, nor their current state of health.

There are numerous cases where outbreaks occurred due to inadequate preservation. An example is the case in Arizona where from August 1996 through June 1998, 69 ventilated, intensive care unit patients at two local hospitals had nosocomial respiratory tract cultures positive for Burkholderia cepacia. These outbreaks were a result of intrinsically contaminated alcohol-free mouthwash.4 With a situation such as this, the product being contaminated with B cepacia would most likely not cause a negative effect in a healthy individual but is a serious opportunistic pathogen in immunocompromised patients and patients with cystic fibrosis.5  

There are many other specific examples of where contamination can cause serious health hazards. To add to the complexity, each organism that may be in a contaminated product may affect a person differently dependent on any ailments they may or may not be aware of. In the case of certain molds, if there is a contaminated eye product and the product is used on the eyelids, there is the possibility the user may suffer a reaction such as irritation, inflammation to skin around the eye, a respiratory infection if inhaled or loss of eye sight in a worst case scenario. A bacteria such as Enterobacter gergoviae causes a microbiological risk because it can cause infection. 

In the case of a product that is so heavily infected with the bacteria of Pseudomonas aeruginosa, the possibility of infection caused by contact with previously damaged skin or with the ears or eyes cannot be excluded. This is because it is an "opportunistic" organism, which can cause serious infection when normal defenses are weakened, such as people with weakened immune systems.7

Although some of these examples are the extreme, they are powerful illustrations as to how a product that is not preserved properly that becomes contaminated could be a major health risk to consumers.

 

Recalls

Once it becomes known that there is a potential or confirmed product on the shelves that is contaminated, immediate action should be taken in order to reduce the number of customers exposed. Recalls occur more often than one might assume. In the EU, there is the organization RAPEX, which is the EU rapid alert system that facilitates the rapid exchange of information between Member States and the Commission on measures taken to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers with the exception of food, pharmaceutical and medical devices, which are covered by other mechanisms. Personal care products fall under this organizations’ review where random testing is performed on products in the market. A shocking surprise is that between the years of 2005-2012, there were over 200 recalled personal care products in the EU alone which came from over 16 different countries. Of these recalls, 56 of the products were contaminated, most commonly by the organism Psedumonas aeruginosa.8 In the United States, between 2009 -2012, there were 19 recalls tied to microbiological contamination.9

In the event that a recall needs to take place, there are so many pieces to think through which can affect a business, aside of the health risk covered above. Consideration needs to be given to all the negatives associated to a recall: fees associated such as manpower to manage the recall, loss of product and packaging, shipping, destruction of product, possible lawsuits, etc. as well as the brand equity in the future where consumers’ perception may be altered on the quality of the company and the brand.  

 

Costs to recall and dispose product, loss of product and packaging

When a recall takes place, there are so many costs involved that not all may be accounted for when doing the calculations. There is the loss of sales which is the most obvious. In addition, there is the investment in the raw materials, machinery and manpower to make the product, the packaging as well as the shipment of the product. These are expenses that have been paid and cannot be recovered. Added to this, there are the costs associated with management ensuring procedure is followed for the recall such as marketing in providing communications to the public on the matter, legal involvement, and R&D research to understand what caused the need for a recall.

Separate for the direct cost and loss of sales due to the recall, there is also the future impact that it may have on other products under that brand. Depending on the price point, this number will vary immensely. An interesting point of reference is in the case of the Tylenol recall in 2010. The recall took place in January and there were several follow up recalls that took place through the third quarter. Looking solely at the impact the recall had on their over-the-counter, non-prescription drug business, in those nine months, sales of J&J's OTC brands declined 31.1 percent. 11 A loss of sales to that magnitude could be debilitating to some companies where it is hard to recover. If there is any way to avoid something such as this from happening, action must be taken. In the situation of personal care products, proper preservation is the appropriate preventative action.

 

Lawsuit

Litigation could result from improperly preserved products in many situations.  For example adverse health reactions from improperly preserved products could give rise to a claim. Litigation costs could vary depending on how extreme the case, the number of people that were affected by the spoiled product and the length of the trials.  This is just another important component that is worth drawing attention to.

 

Brand Equity and Negative Brand Perception

It is basic way of life that the bad is remembered much more vividly and longer than the good. In the case of a company that may have been producing quality products for years with satisfied consumers, as soon as it is found out that there is a recall due to a potential health hazard, the positive brand perception can change instantly. Although it may just be one product, or one batch that is being recalled, that notation of the recall will most likely remain in a consumers mind.

A study was conducted on understanding the effect that a recall could have on a brand. In this particular study, it was surrounding the time it took a company to implement the recall. BNet Research showed that, “Even the appearance of a sluggish response can turn consumers against a company.” The study sites the Firestone tire recall as an example. “60 percent of consumers believe that Firestone did not act quickly enough. …55 percent will never or likely never buy the brand again.”10 The figure of 55% is really high and it must be mentioned again that this is a response based on there being a delay in enforcing the recall after it was known there was an issue. That may not be the case in all recalls but even the idea of losing a fraction of customers due to a recall can produce a very negative impact on a company.

 

Where Does This Leave Us?

There are an abundance of reasons as to why proper product protection is required in personal care products. Whether one looks at it from a health or safety perspective or from a business and financial point of view, the impact and negative consequences tied to improper preservation are of magnitude and should be evaded. The focus for all involved in this industry is to manufacture safe and effective cosmetic products, which includes choosing effective preservative ingredients that are broad spectrum, safe and used at the proper recommended use levels. 

*Companies following EU regulations are still also required to follow any other applicable regulations, e.g. in the US or elsewhere.

 

References:
1. Cosmeticsinfo.org
2. The SCCS’s Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation
3. Strange but True: Drinking Too Much Water Can Kill. Scientific American. June 21, 2007. http://www.scientificamerican.com/article.cfm?id=strange-but-true-drinking-too-much-water-can-kill 4. Matrician L, Ange G, Burns S, et. al. Outbreak of Nosocomial Burkholderia cepacia Infection and Colonization Associated With Intrinsically Contaminated Mouthwash. Infection Control and Hospital Epidemiology, Vol. 21, No. 11 (November 2000), pp. 739-741
5. Goldmann DA, Klinger JD. Pseudomonas cepacia: biology, mechanisms of virulence, epidemiology. J Pediatr 1986;108:806-812.
6. Nosocomial outbreak of Enterobacter gergoviae bacteraemia in a neonatal intensive care unit Journal of Hospital Infection, Volume 53, Issue 4, Pages 292-296R. Ganeswire, K.L. Thong, S.D. Puthucheary
7. http://www.bbc.co.uk/news/health-16645957
8. Lundov, MD and Zachariae, C. Recalls of microbiologically contaminated cosmetics in EU from 2005 to may 2008. Internaltional Journal of Cosmetic Science, 2008, 30, 471-474.
9. US Food and Drug Association. http://www.fda.gov/Safety/Recalls/default.htm
10. Widmer, Lori, “When Your Name Is at Risk”, November 2000, BNet Research Center
11.  Magic Number: Tylenol Recall Cost J&J $665M in Lost Sales. Jim Edwards / MoneyWatch (CBS online)/ October 19, 2010. http://www.cbsnews.com/8301-505123_162-42846137/magic-number-tylenol-recall-cost-jj-665m-in-lost-sales/