Preservative Update

November 9, 2005

Regulatory pressures in Japan may ease in the coming months, but novel formulation create a host of new challenges

Asia may be half a world away for many personal care suppliers but, when the subject is perservatives and cosmetics regulations, Asia is always in their thoughts. In recent years the region has been battered by an economic tsunami that barely left some economies above water. Added to that, is the well-known fact that Japan is probably the toughest market on earth to crack due to overzealous regulatory agencies.

But the region may be turning the corner on regulatory issues and economic matters. According to some preservative suppliers, sales are improving in Asia and the Japanese regulatory system may undergo an overhaul by the end of the year.
“The markets in the Asia-Pacific regions definitely improved last year,
” noted Steve Hinden of ISP. “Korea was very strong, Thailand was strong and even Indonesia is coming back.”

According to Mr. Hinden , demand in the U.S. remained high and growth in Latin America was paced by higher sales in Brazil and Mexico. “It all added up to significant increases in preservatives sales for ISP,” said Mr. Hinden.

Lonza also had a good year last year, according to Carl Cappabianca, Lonza. He noted that demand continues to increase for personal care and household formulations. “New product introductions and reformulations create both challenges and opportunities for preservative suppliers,” said Mr. Cappabianca. “These factors helped lead to continued strong preservative volumes. In addition, Lonza’s new preservatives product launches, Glydant Plus Liquid and Dantoguard Plus Liquid, received excellent response.”

According to Mr. Cappabianca, Japanese authorities are giving strong consideration to adopting the European cosmetic raw material standards which would open the door to additional preservative choices in Japan, including two of Lonza’s core chemistries, DMDM hydantoin (Glydant and Dantogard) and iodo-propynyl butylcarbamate (Glycacil).

“Currently, Japan has the most restrictive personal care regulations for preservatives worldwide, which limits global formulators,” said Mr. Cappabianca. “Our understanding is a decision will be made in late 2000 or early 2001 regarding potential adoption of the European standards.”

In Europe, Lonza was pleased to hear that the Scientific Committee on Cosmetic Products and Nonfood Products moved iodopropynyl butylcarbamate (Glycacil) from the “provisionally allowed” preservative list to the permanent “positive” list.

“Permanent approval now allows this potent fungicide to be more extensively and confidently used in Europe and in most global formulations,” said Mr. Cappabianca.

Of course, some companies have already been selling products in Japan for years. “Kathon CG was the first new preservative to be approved by the Ministry of Health and Welfare (MHW) during the past 15 years. We have a proven track record in Japan,” said Jim Hagan of Rohm and Haas. Mr. Hagan agreed that the Japanese regulatory system is improving and Rohm and Haas is taking advantage of the situation. The company’s new global regulatory and toxicology team is preparing two new personal care submissions for the MHW and company executives are confident they will obtain the necessary global approvals to support the global introduction of Neolone 5000, Neolone 950 and Koralone 500 preservatives. Rohm and Haas has already obtained U.S. EPA registration for Neolone M-50 for use in household and industrial products.

While new markets may be opening, old issues, including price pressures, continue to impact the preservative market, according to some executives. “We have definitely seen some growth in the business and have seen some promising trends,” agreed David Andrew of NIPA-Hardwicke, “but this has been countered by strong price competition particularly in the parabens area.”

Maintaining Product Integrity
With more marketers creating products with higher levels of natural ingredients, extra steps must be taken to ensure product integrity. Mr. Hinden of ISP urged marketers to use the right broad spectrum preservative system—one that is highly compatible and stable with all cosmetic ingredients. “The greater the stability and compatibility of the system, the higher the probability of a good shelf life,” he noted.

Mr. Hinden also suggested that marketers retest preservative systems every time they reformulate a product. In addition, preservative challenge tests must be conducted to optimize the preservative systems and good manufacturing procedures must be practiced in the plant to make sure all the equipment is cleaned and sanitized. Mr. Hinden noted that manufacturers must check piping to make sure there are no dead ends in the production or filling lines where microbes may thrive.

“Formulators must pay more attention to manufacturing conditions and the robustness of their preservative systems,” said Eileen Warwick of Rohm and Haas. She said the best way to ensure that a preservative system remains effective is to take a holistic view of preservation which includes a thorough evaluation of the preservative system’s efficacy and chemical stability prior to commercialization.

“A validated plant hygiene program, which includes monitoring incoming raw materials, is essential,” said Ms. Warwick. “Quality control testing on commercial batches provides the final leg of the holistic approach.”

Mike Levinson of Dow Chemical said his company encourages its customers to test their base formulas by offering the Dow 10-Cycle Challenge Test, a repeated exposure study in which product samples are contaminated with microorganisms again and again, a total of 10 times, to ensure the preservative will hold-up during manufacture, shipping and use. “This 10-cycle testing process, versus the industry standard of 3-4 times, better ensures that products containing natural ingredients are well preserved,” said Mr. Levinson.

More Water, More Problems?
Several new formulating trends can also impact preservative systems. Now that California’s lower VOC regulations are firmly in place and inventories of existing products have dwindled, more products with higher water contents are reaching store shelves. Without the right preservative system, microorganisms can thrive in formulas that contain greater amounts of water, according to Mr. Hinden.

Another formulation trend, lamellar gel technology, requires greater selectivity when choosing a preservative system, said Mr. Hinden. “They are trickier to preserve and are more challenging to preserve because of the way the technology works and the interaction of the ingredients.”

According to Mr. Hinden, lamellar gels can even inactivate preservative systems. To overcome this problem, ISP recommends formulators combine its Germall Plus preservative with LiquaPar Optima and LiquaPar PE.

Walter Guthrie of BASF MicroCheck Limited, agreed that multi-phase formulations can cause preservation headaches. “The increasing complexity and sophistication of formulation systems is posing more challenges for the conventional preservation system,” he noted. “In multi-phase formulations there is always a danger that the preservation system is not accessing all the components where microbial contamination can reside.”

Many skin care products loaded with antioxidant materials promise to reduce the signs of aging caused by smoking, pollution and UV damage. But Keith Brunts of Microbial Systems International noted that antioxidants can deactivate many preservatives and he suggested that formulators should minimize the amount of antioxidants in the formulation before carrying out thorough challenge testing.

Another growing trend that can impact a preservative system is some marketers’ tendency to claim or imply an antimicrobial effect on the skin, noted Mr. Guthrie. “This creates a dilemma for the formulator over his choice of preservative and/or ‘active’ agent and whether the two are compatible or mutually exclusive.”

Safety First
Of course, safety is paramount in the personal care industry. Several suppliers noted that the industry is looking for safe and effective preservatives that can be used in global formulations. “One of the reasons why Kathon CG is so popular is because it is one of the few preservatives that can be used in rinse off formulations everywhere around the world,” noted Mike Robertson of Rohm and Haas. “We’re looking to repeat our past regulatory successes with our new non-formaldehyde releasing products: Neolone 5000, Neolone 950 and Koralone 500 preservatives.”

Mr. Guthrie noted that formulators must be aware that many natural ingredients are prone to microbial contamination in their own right depending on their source and/or means of production. They can also be an additional source of proteinaceous materials, which may present difficulties for some preservation systems.

“Formulators must be aware of these potential difficulties and ensure that due attention is paid to minimize the microbial burden at the point of manufacture before the preservative is added to the formulation,” said Mr. Guthrie. “It is also important to check the compatibility of the preservative system in the presence of several batches of any natural ingredient to ensure that consistent performance is maintained.”

Larry Moroni of Protameen Chemicals cautioned that some cosmeceutical ingredients are sensitive to microbial degradation. “In general, a lot of these materials are prone to lipid peroxidation,” he said. “Lipid structures are sensitive to degradation and if they’re loaded with natural ingredients they become even more sensitive.”

Among other formulation issues, Tim Hamilton, Dow Chemical, told Happi the industry will continue to move away from the use of secondary amines in the U.S. personal care market. He said Europe has almost completely transitioned away from the use of secondary amines and noted that Bronopol is commonly used as a preservative in secondary amine-free products. “For the U.S. market, this trend will allow more customers to use Bronopol in more formulations,” said Mr. Hamilton. “Formulators want to reduce the use levels of isothiazolone preservatives while still maintaining performance. Both goals can be met by using a combination of IT and Bronopol. Bronopol is very effective at controlling IT resistant bacteria, particularly pseudomonas.”

Finally, one supplier noted that the main trend in recent years has been the push to minimize the levels of preservatives in formulations with a view to moving away from preservatives altogether at some point in the future. But another supplier had some strong words for these preservative-free formulations.

“More half-baked cosmetic companies are appearing whose promotional material spouts hogwash about the lack of “chemicals” in their formulations,” observed Mr. Brunt. “The consumers must be even dumber than I thought they were if they swallow this garbage.”
Aside from new formulation trends, novel manufacturing and distribution processes can also have an impact on a formula. Reflect.com, for example, customizes each order for its web customers. “If they’re mass customizing, they have to be careful in how they select their preservative systems to make sure it is compatible with a wide range of ingredients,” noted one industry observer.

Company Expansions
In the past year, Rohm and Haas made two acquisitions, restructured the company and focused its business on consumer products called Consum- er and Industrial Specialties. It introduced a range of new preservatives, strengthened its formulation and manufacturing expertise in formulated biocidal products, saw a resurgence in its popular Kathon CG preservative in Europe and now has a broader portfolio of products to meet customer needs. “Our relationships with our strategic customers are stronger than ever and we’re poised to succeed in a challenging future,” said Joan Hoffmeier of Rohm and Haas.

Last year, NIPA-Hardwicke increased capacity at its South Wales, UK plant and Mr. Andrew said the company has an aggressive new product development program. “We are continually introducing new products and blends to take advantage of the synergies of the actives, where they exist, to enable the formulator to add smaller levels of preservatives to achieve the same levels of product protection as well as providing greater choice of preservative systems,” he said.

New Product Introductions
Protameen Chemicals recently introduced a cost effective triclosan product, noted Larry Moroni, who added that DMDM hydantoin has been another growth area for the company.

Rohm and Haas has introduced a range of new preservatives to deliver on customer needs for safe, effective, globally approved preservatives. Based on its popular isothiazolone technology, Neolone preservatives provide formulators with a formaldehyde-free bactericide option, are effective at very low use levels, are compatible with existing fungicides such as parabens and IPBC and are more stable in difficult-to-preserve high pH formulations. These new products are based on methylisothiazolone and are said to be particularly suitable for skin care and sun care formulations, ZPT-based antidandruff shampoos and high pH systems such as surfactants, detergents and polishes. Two products have been introduced to date and a third is in development. EU regulatory approval is pending and the company expects to file in Japan soon.

Koralone 500, the company’s new fungicide, gives formulators a water soluble, easy to dose, fungicide which is effective at very low use levels. Based on octylisothiazolone, the preservative is particularly suited for fungi-prone skin and sun care formulations and it is compatible with a wide array of bactericides. EU approval is pending and Rohm and Haas will also seek approval in Japan for personal care applications.

In addition to its existing manufacturing capabilities, Rohm and Haas executives said the acquisition of Morton and Acima gives the company greater capability to manufacture a full range of high quality biocidal combination products for a variety of market segments including personal care. Acima has expertise in formulation design, offers manufacturing flexibility and has a reputation for high quality products. Rohm and Haas executives noted that one benefit of adding preservatives individually, as personal care products are manufactured, is flexibility. Different formulations have different preservation needs. Biocidal combination products are sold at fixed ratios. For large companies with broad product lines, the use of biocidal combinations may create the need to inventory more preservative products to accommodate their diverse preservation needs. For smaller customers with narrower product lines and less diverse preservation needs, biocidal combinations are probably preferred, according to Rohm and Haas.

Mr. Cappabianca of Lonza said there is a definite trend toward wider use of stable, safe, broad spectrum and easy-to-use liquid preservative systems for both batch and in-line blending operations. This trend, he said, has led to rapid growth of Lonza’s new liquid products such as Glydant Plus Liquid.

“Additionally, the trend toward increasing the number of raw materials used in formulations increases the number and type of potential contaminants,” said Mr. Cappabianca. “Older, single component preservatives cannot handle the range of organisms. Broad spectrum blends such as Glydant Plus Liquid address this trend.”

With the launch of Glydant Plus Liquid and EPA-registered Dantogard Plus Liquid, Lonza has provided two well-accepted and extremely effective preservative chemistries (DMDM hydantoin and iodopropynyl butylcarbamate) in an easy-to-use liquid form. Throughout the year, Lonza is introducing its “2000 Series” of preservatives. The 2000 series are improved versions of the well-known Glydant, Glycacil and Dantogard chemistries. “They’re the next generation of Lonza’s core chemistries,” noted Mr. Cappabianca. Lonza may add other new products and blends as part of the 2000 series later this year.

Within the next year, regulatory pressure may ease in some parts of the world, but as formulations become more complex, demand for effective preservative systems will continue to surge.

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