“If you live by the sword, you die by the sword,” warned David Steinberg, president, Steinberg & Associates. He issued those words of warning to cosmetics companies that would promote their products as “preservative-free.”

Steinberg’s ominous warning came aboard the Azure Azul, as the speaker on the New York Chapter of the Society of Cosmetic Chemists dinner cruise around Manhattan.

The long-time preservative expert recalled what he termed, “the good old days,” of preservation; i.e., pre-2004. Years ago, in order to create a global formulation, the cosmetic chemist only had to ask herself, “Is it allowed in Japan?” 

“If Japan allowed it, you could use it everywhere,” Steinberg noted.

Unfortunately, today, countries and regions have their own rules and regulations that make a truly global formula truly impossible to create.
 

A Devil of a Deal


It all began to change in the early 1980s, when a distributor promised a UV filter manufacturer that it could make its UV filter No. 1 in the world in exchange for 10% commission, recalled Steinberg. The deal was done and the distributor began attacking Padimate O (INCI: Ethylhexyl dimethyl PABA), which at the time was the top-selling UV filter. Although Padimate O did not contain PABA and was not made from PABA, the distributor linked Padimate O to PABA and its negative properties; i.e., stains fabric, water solubility, etc.  This “guilt by association” led to a proliferation of PABA-free claims and the birth of the ingredient-free movement.

Today, there is the growing demand for free-from formulations; you know, silicone-free, paraben-free, triclosan-free, preservative-free and, of course, chemical-free.

This “free-from” epidemic has gotten so out of hand that England and France have banned the term from product labels. And, Advertising Standards Canada considers “free” claims to be false and misleading. But in the world’s largest cosmetics market, the US, “anything goes,” Steinberg lamented.

And that’s where his ominous warning comes in. Non-government organizations (NGOs), such as the Environmental Working Group and Women’s Voices for the Earth, are like moths to flame whenever the term “-free” is used by cosmetic marketing departments.

“To NGOs, ‘-free’ means not safe; we are our own worst enemy,” he charged.

The parabens came under fire when Philippa Darby, published a poorly researched paper linking breast cancer to use of antiperspirants containing parabens.

“It was junk science; we never even used parabens in antiperspirants,” noted Steinberg. “Darby ultimately retracted her study, but very few people know that!”

Once parabens were in the crosshairs, other preservatives and other ingredient categories became fair game, recalled Steinberg. Parabens were followed by triclosan, quaternium-15, isothiazolinones, formaldehyde releasers, acids, glycols, phenoxyethanol, benzoic acid, sorbic acid and many preservatives.

“Methylchloroisothiazolinone and methylisothiazolinone have come under fire in recent years, even though Beiersdorf has been using Kathon CG in its Nivea formulas since the 1980s,” explained Steinberg. “It’s not the material, it’s how you formulate with it.”
           
Formulators must fight for their preservatives, because they won’t be getting new ones anytime soon, not when it takes years to research and costs millions of dollars to develop and millions of dollars to test a new preservative.
           
“Nobody will spend that kind of time and money,” he said.

Today, more marketers are seeking “natural” preservation systems; a search that is futile, insisted Steinberg, who pointed out that grapefruit seed extract and Japanese honeysuckle extract, on their own, are not preservation systems. The problem with natural materials is that formulators are never sure of what they are getting, as the efficacy level can fluctuate.

So what is a formulator to do if she uses a preservative that won’t work? Steinberg provided a list of solutions, albeit expensive ones:
• Manufacture under strictly enforced cGMPs;
• Establish and use HACCP to where contamination is taking place and eliminate it;
• Hire a good consultant (“This is a paid political announcement,” he joked.);
• Package products so that consumers cannot contaminate them;
• Insist your company stop using self-destructive “free-from” claims; and
• Do not purchase ingredients from suppliers who use negative sales tactics.
           
“If you are brave enough, tell marketing the cost of not using good, safe preservatives,” urged Steinberg. “And never ship anything with a positive plate count.”
 

An FDA Bombshell


Once marketing and R&D’s objectives align, they can turn their attention to the US Food and Drug Administration (FDA), which in February issued new guidelines for cosmetic site inspection. According to Steinberg, FDA is concerned that cosmetic products with label claims such as: “green,” “natural,” “no parabens” and “no preservatives” may not be safe without appropriate safety testing.

Therefore, companies that make such label statements should be given priority over traditionally manufactured cosmetics during inspection and sampling, according to FDA, which considers non-traditional preservatives to include botanical extracts, organic acids, alcohols and glycerols.

FDA instructs manufacturers to collect samples of recently produced and retained products, especially those that are water-based, when the manufacturer is unable to produce challenge test documentationor the adequacy of preservation is otherwise in doubt or non-traditional preservative systems are used.

“The FDA is not concerned with traditional preservatives such as the parabens, Quaternium-15 and DMDM Hydantoin,” concluded Steinberg.

For more insights on preservatives, be sure to read the July issue of Happi.