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Cleaning up in the wipes market: wipes makers face hurdles in getting to market but partnering with a reliable company can help.

The market for disinfectant and antiseptic wipes is red hot, and with new U.S. Environmental Protection Agency (EPA) regulations coming this fall that are expected to level the playing field against reusable cleaning cloths, it should get even hotter. Here, we examine the regulatory hurdles that wipes makers must vault; the pros and cons of the most common active ingredients and market developments in the major segments and provide insights into how wipe suppliers can navigate all this in the quickest ways possible. This paper will focus primarily on hard surface disinfection and sanitization, those areas regulated by the EPA.

U.S. Requirements & Timelines

The U.S. EPA requires all pesticides/biocides to be registered, which includes antimicrobials. The data requirements include physical/chemical properties, acute toxicity and microbiological efficacy. Data development for antimicrobial efficacy alone can cost up to $250,000 per registration! The development of product chemistry and toxicology data can add significant costs. In addition, the EPA requires a service fee, which for a new product is about $4600. The entire registration process takes a minimum of five months but can extend to two years.

Each state in which the regulated product is sold requires its own registration after the EPA registration is obtained. Approval timelines and fees vary from state to state, but it can take up to six months and cost $12,000 to register a product in all 50 states a year.

EPA Oversight of Label Language

Every product must have a label that is accepted by the EPA before the product can be sold or distributed. The EPA also closely regulates all product-related information such as advertisements, website promotions and brochures. The EPA aggressively momtors all forms of product information and will take action against companies whose labels or ads are considered false or misleading. Such misbranding often includes promotional terms such as "safe" or "natural," "high potency" or "superior strength."

EPA or FDA?

Antiseptics are applied to living skin or tissue to prevent infection and are regulated by the Food and Drug Administration (FDA). Disinfectants kill bacteria, virus and fungi on hard surfaces, equipment or other inanimate objects and are regulated by the EPA. The one exception is that the EPA registers certain pesticides, such as tick and mosquito repellant products that are used on human skin or clothing. The regulatory requirements for disinfectants and antiseptics are very different and these products should never be used interchangeably.

Disinfectant or Sanitizer?

A disinfectant is used on hard, inanimate surfaces and is intended to completely destroy or inactivate harmful microorganisms, such as bacteria, viruses or fungi. Disinfectants are classified into two major types: hospital and general use. In layman's terms, this classification refers to the different spectrums of proven efficacy, with hospital disinfectants being required to demonstrate efficacy against a broader range of pathogens than a general use disinfectant.

A sanitizer is intended to reduce but not necessarily eliminate, the number of organisms to non-pathogenic levels. Indirect food contact surface sanitizers have to be effective in one minute or less and are not allowed to be rinsed after application, whereas. a disinfectant can have varying contact times of 10 minutes or less and must be rinsed from indirect food contact surfaces using potable water.

Supplemental Registrations

The best approach for wipes suppliers to quickly bring products to market at greatly reduced costs, is by working with suppliers, such as Lonza, whose formulations are already registered at the EPA. Such registrations include all required product chemistry, toxicity and efficacy data. For example, a Lonza customer, as a sub-registrant, has the ability to distribute its products in the form of a registered Lonza formulation under the customer's brand name. Supplemental Registrations are considered an arm of Lonza's EPA registration and must comply with all federal and state regulations. The supplemental or sub-registrant's product label must comply with the registered Lonza label as well. The supplemental registrant is responsible for obtaining any state registrations where they intend to sell the product.

International Complexity

Regulations vary from country to country and they are constantly changing. What claims can be made? What testing protocol is used to determine efficacy? Which applications can disinfectant wipes be used for? The answers to questions like these will be different depending on the country of interest. Here too, wipes suppliers can benefit from working with industry-leading formulation providers who have already obtained registrations and/or are familiar with the regulatory requirement in the countries of interest.

Technical Overview

The chart below compares the advantages and disadvantages of the most common active ingredients that are either incorporated into wipes or that serve as disinfectants and sanitizers. As the table below demonstrates, there are many different options and no one active ingredient is the best solution for all applications. Marketers should consider the most important needs of their target customer and select the wipes formulation that best fits those needs.

Market Trends/Developments

Thanks to their effectiveness and versatility, wipes have applications in a variety of end-use markets. Here's a look at several of them.

Healthcare: With hospital-acquired infections killing an estimated 99,000 people in the U.S. every year, hospitals, nursing homes and other healthcare facilities want wipes that can control multiple pathogens. The most in-demand products are wipes with broad claims, including those against Noroyirus, that causes gastro-intestinal illnesses, MRSA, CA-MRSA, VRE and others. C.diff spores, a particularly difficult pathogen to inactivate, are of growing concern in the healthcare environment. Healthcare facilities also want faster contact times, both to reduce cross-contamination and to cut labor time and costs.
 Ousts * Bleach Phenolics lodophors Hydrogen
 Peroxide

Effective pH 1-13 9-13 5-9 3-4.5 1-5
Cleaning good poor Fair/good Fair/ poor
 poor

Staining no no no yes yes

Odor low high high moderate moderate

Skin low high medium low medium
irritation

Storage excellent poor Excellentfair poor
stability /poor

Disinfection >450 >2D0 >500 >50 >500
(ppm)

Sanitation 150-flOO 50-200 - 25-50 50-100

Surface high medium medium tow medium
compatibillty

Cost in use low low moderate high moderate

Consumer x x
antibacterial
/sanitizing/
antiseptic
wipes

Hospital x x
antiseptic
wipte

Consumer x
disinfecting,
wipes

Hospital x x x x
disinfecting
wipes

Ho rinse x
indirect food
contact wipes

 Chlorine Peracetic Ethanol Isopropanol PHMB
 Dioxide Acid

Effective pH M4 1-5 1-13 1-13 1-11

Cleaning poor poor good good poor

Staining yes no no no no

Odor high high moderate high low

Skin high high low low low
irritation

Storage poor poor flammable flammable
stability excellent

Disinfection >S >50 >60% >70% >500
(ppm)

Sanitation 1-5 5-10 20%-30% 30%-40% 50-400

Surface low low high high high
compatibillty

Cost in use moderate high high high moderate

Consumer x x x
antibacterial
/sanitizing/
antiseptic
wipes

Hospital x
antiseptic
wipte

Consumer x
disinfecting,
wipes

Hospital x x x
disinfecting
wipes

Ho rinse x
indirect food
contact wipes

* included with this group is Benzethonium chloride.

Benzethonium Chloride and Benzalkonium chloride are are commonly
used for consumer antibacterial wipes Quats used in other
applications tend to be ADBAC, ADEBAC, DDAC. and DDABC X


Consumer In the consumer segment, disinfectant wipes have soared in popularity. Here, wipes for specific tasks and use sites continue to drive growth. Those wipes that make claims of being greener as well as effective in protecting users have a potent marketing advantage. Furthermore, recent regulatory changes in California are forcing consumer wipes to achieve even lower levels of volatile organic compounds (VOC's) than in the past.

Industrial & Institutional: In the industrial and institutional market segment, green is better as well. Green cleaning programs are required to achieve certain environmental certifications and are being mandated by a growing number of states for schools and other government buildings. In addition, multi-purpose wipes that can be used to clean as mony targeted surfaces as possible are attractive, as they are easier for cleaning staff, inventory management and less costly overall.

Food Safety: In the Food Safety segment, cost and labor savings are the major drivers for the switch to wipes; restaurants are moving away from reusable cloths--which many customers see as simply "smearing" germs across multiple surfac-es--to single-use, disposable wipes. Wipes provide an improved. customer experience by eliminating overspray from bottles and cross-contamination. Currently there are pending regulations under review by the EPA expected to level the playing field between wipes and reusable cloths. This segment is also looking for broader efficacy against pathogens such as influenza viruses and Norovirus, but today's sanitizer products are unable to make such claims.

Globalization

The globalization of sourcing has led to more cross-border activities, whether it's sourcing wipes substrates from China or importing packaged wipes from low-cost countries. In some cases, a portion of the wipe's production is performed in one country and other steps take place elsewhere. All of this is done in search of lower costs. The growth side of the globalization equation cannot be ignored as the opportunities to expand into emerging markets hold great potential..

While 'Nipes are typically more costly on a per-use basis versus traditional concentrated liquid disinfectants, end-users choose them for their performance and convenience. While disinfectant wipes use in emerging markets is currently limited, it is. expected to increase quickly as per capita incomes continue to rise and local regulations adapt to this new product class.

Innovation in Substrate Options

Wipes makers and suppliers seek to differentiate themselves in. part by constant innovation and development in wipes substrates. Lanza, for example, is evaluating dispersible and biodegradable wipes that quickly break down in: water. This can make disposal much easier and less costly, and given that an estimated nine billion wipes a year are disposed of in landfills, these wipes offer a sustainability advantage as well. Manufacturers continue to introduce new nonwovens at lighter and 'lighter basis weights (grams per square meter) while maintaining wet strength and overall, performance. This offers their customers significant cost savings.

Another innovation involves incorporating microfibers into disposable wipes. Microfiber containing mops and rags have long been known to improve both cleaning and removal of pathogens. Lonza's Disinfectant Wipes, Wipes Plus and Wipes Plus 2 formulations can be used with numerous cost-effective substrates that include microfiber, viscose, wood pulp, and various synthetic materials. In conjunction with these substrate advances, the Lonza family of wipes formulas offers quat-based, low VOC wipes with contact times as short as four minutes in the healthcare, I&I and consumer markets.

Given technological advances and strong end-market desire for both antiseptic and disinfectant wipes, this is an exciting time for wipes suppliers. The best and quickest route to market is to collaborate with companies that have registered formulations and wipes technologies and who are committed to continual innovations that improve the effectiveness of wipes in protecting human health. Such a partner can get you into the market much more quickly and at a lower cost than could be achieved acting independently and keep you in a competitive position for years to come, regardless of the direction the industry goes.

More info: L017271 Microbiological-Control, Allendale, WI. Techniad support: 201-316-9200 or 800-365-8324; Email: contact.allendale@lonza.cont; Website: www.lonza.com

By David Koehl, Hans Hummel, Andy Colurciello, Ruth Trager and Patti Golick, Lanza Hygiene & Preservation Business
COPYRIGHT 2013 Rodman Publishing
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Author:Koehl, David; Hummel, Hans; Colurciello, Andy; Trager, Ruth; Golick, Patti; Hygiene, Lonza
Publication:Household & Personal Products Industry
Date:Apr 1, 2013
Words:1859
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