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    Features

    Balancing Wipes Performance with Regulatory Requirements for Disinfectants and Sanitizers

    ...

    Balancing Wipes Performance with Regulatory Requirements for Disinfectants and Sanitizers
    Balancing Wipes Performance with Regulatory Requirements for Disinfectants and Sanitizers
    The hard surface disinfectant wipes market is growing 5-7% globally per year.
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    George Gonzalez, Marketing Manager for Hygiene and Preservation, Lonza Inc.09.18.17
    The hard surface disinfectant (HSD) wipes market continues to grow at a rapid pace of 5-7% per year globally1. Initially the growth was fueled by convenience and time savings, but as the market has begun to mature, innovation is increasingly integral to sustainable growth. While innovation in substrate options and packaging continues to be important, the liquid formulation has become equally as important. Market needs and regulatory trends are the key drivers for innovation in the HSD wipe space.

    Disinfectant wipe marketers seeking to maintain competitive advantage face hurdles going to market, staying on-trend, and meeting regulatory requirements: working with an established industry leader can help address these challenges.

    Market Trends/Developments
    Consumer: The global market for household consumer wipes is projected to reach $1.2 billion by 20232. The increasing availability of wipes and the rising awareness about maintaining a hygienic environment is driving sales in this segment. The emergence of private labeling is leading to numerous retailers introducing their own brands that are usually priced lower than branded wipes. In fact, private labeled products now account for the second largest marketshare in the disinfectant wipes category3. The demand for innovation from large retailers (e.g. Wal-Mart, Target, etc.) is driven by cost cutting, desire to stay competitive with branded marketers (e.g. Clorox and Lysol), and efforts to meet the needs of the end-user. As such, private labelers are looking for unique marketing claims (e.g. made in the USA), surface aesthetics (e.g. streaking), improved cleaning performance and greener chemistries to keep up with consumer preferences and name brand competitors’ product extensions.

    Professional: Growth in the professional segment has been strong over the past five years. The rising awareness about the importance of maintaining a hygienic environment has also affected the professional market. Although cost still remains a factor, awareness about hospital-acquired infections and food-borne pathogen outbreaks on cruise ships and restaurants have galvanized this segment. Hospital-acquired infections kill an estimated 75,000 people in the U.S. every year4. Hospitals and other healthcare facilities require disinfectant wipes that can control multiple pathogens, particularly those that are hard to kill (e.g. TB, C. difficile, Acinetobacter), and they are sensitive to maintaining high hospital bed turnover rates, a measure of efficiency. As a result, there is significant demand for disinfection products to have shorter contact times in order to cut labor and time costs, so that cleaning and disinfection processes do not disrupt the functioning of the facility. Since nurses, rather than environmental health experts, are the primary users of disinfectant wipes in hospitals, products with longer shelf lives, printed expiration dates and simple instructions are quickly becoming constraints from healthcare accreditation bodies. Simplicity reduces risk of improper product usage without diminishing hospital efficiency.

    Norovirus is a common food-borne pathogen that manifests itself in a combination of diarrhea, vomiting, cramps, nausea, chill, and body aches. This organism has gained attention due to large outbreaks on cruise ships and national restaurant chains. The virus informally known as ‘winter vomiting disease’ is responsible for about 20 million cases each year5 and it is typically spread through improperly handled food or from people passing the virus to others. Due to many recent high-profile food safety incidents, products that kill Norovirus, are able to be used on food contact surfaces, and do not require a potable water rinse are gaining traction in the marketplace.

    Regulatory Drivers
    The Federal Fungicide, Insecticide and Rodenticide Act (FIFRA) requires all pesticides, which includes disinfectant wipe formulations, sold or distributed in the U.S. to be registered by the United States Environmental Protection Agency (EPA). Due to strict registration and ongoing stewardship requirements, obtaining and maintaining EPA registrations can be complex, resource intensive, and expensive. Product development and registration timelines typically run to two years and longer with costs exceeding $500,000 per registration.6

    Regulatory trends are often as important to new product development as market trends, with substantial implications for the wipes market. One of the key drivers in the quaternary ammonium compound (Quat) based disinfectant wipes market is the EPA’s Re-registration and Eligibility Decision (RED) and the associated Data Call-In (DCI). The EPA required the re-registration of all quat-based antimicrobial active ingredients and end use products, including disinfectant wipes. This activity has re-defined the portfolio of registered antimicrobial wipe products in the marketplace as companies have been obligated to support their registrations with updated data, remove claims from their labels or eliminate products all together. One of the biggest challenges through this process is that a few years ago EPA changed the performance criteria for disinfectant products; products which were registered under the previous standards are now forced to comply with new standards, making it more difficult to maintain efficacy claims. Due to the interaction between the disinfectant formulations and wipe substrates, generating data to satisfy the DCI for wipes requires substantial resources (i.e. analytical, regulatory, etc.), when compared to liquid registrations. Furthermore, as the data requirements for wipe registrations become stricter, wipe suppliers need to adjust by developing new formulations that will meet stricter data requirements and demonstrate efficacy against hard to kill organisms.

    A successful wipes strategy needs to have its finger on the pulse of both market and regulatory trends, as both greatly influence a product’s development, approvals, and commercial success. Choosing a supply partner whose formulations are already EPA-registered and who understands the changing landscapes in both the market and regulations is an ideal way to bring products to market without incurring the high costs of reinventing the wheel when so many resources have already been deployed by the supplier.  Lonza is a supplier that has demonstrated these traits for customers worldwide and would be pleased to help navigate regulatory chasms and provide continuous innovation to future ones.

    1. http://www.smithersapex.com/news/2015/august/future-of-cleaning-and-disinfecting-wipes
    2. Freedonia World Wipes 2015
    3. IRI/Nielsen
    4. https://www.cdc.gov/hai/surveillance/
    5. https://www.cdc.gov/norovirus/trends-outbreaks.html
    6. Lonza internal estimate
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