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Gelest’s Antimicrobial Agent Receives EPA Food Contact Clearance

Published on 2017-05-09. Author : SpecialChem

MORRISVILLE, Pa. -- Gelest has announced that BIOSAFE HM4100 now provides permanent protection of polymers, coatings, thin films, laminates, polymeric beverage tubing, and filter media that come in contact with food and drinking water, an altogether new market for the BIOSAFE product line. BIOSAFE is more cost effective than conventional silver-based antimicrobials, while eliminating leaching concerns even at maximum prescribed levels.

BIOSAFE Antimicrobial Technology


Biosafe-antimicrobial-food

The enduring effectiveness of our BIOSAFE additive, combined with its compelling chemical and safety profile, makes this antimicrobial a powerful new tool for reducing unwanted microbes in food and drinking water applications,” said Donald J. Wagner II, Technical Marketing Manager and inventor on the BIOSAFE patent. BIOSAFE antimicrobial technology protects surfaces from staining, pitting, deterioration and odor caused by bacteria, mold, mildew and fungi. It does not compromise end-product safety by migrating out of the plastic or being rubbed off the surface.

Biosafe® HM 4100

  • Broad spectrum antimicrobial. 
  • Produces a high purity, narrow molecular weight polymer containing reactive silanol groups. 
  • Exhibits low toxicity profile, and binds chemically to a variety of substrates, providing non-leachable antimicrobial protection. 
  • Protects from the degrading and odor causing effects of bacteria, fungi: mold and mildew, algae, and yeast.

Applications include commercial food prep surfaces, coatings, thin films, and laminates. Additionally, the EPA and FDA have reviewed the technology and found that BIOSAFE is compliant for use in polymeric beverage tubing and activated carbon water filter media.

EPA Label for BIOSAFE HM4100


Gelest’s amended EPA label for BIOSAFE HM4100 lists it as an approved-use polymer and coating for food prep surfaces and polymeric beverage tubing at a loading level upto 1% by weight. However, the typical loading level of BIOSAFE additive required to effectively treat a given quantity of plastic or coating is between 0.2 and 0.5%.The keystone of Gelest’s BIOSAFE product line is HM4100 Antimicrobial, which the company supplies as a solid powder. It contains no volatile organic compounds (VOCs), heavy metals, arsenic or polychlorinated phenols. Toxicity tests have shown them to cause no irritation or sensitization in skin contact. BIOSAFE chemistry has been reviewed by the FDA and received a Threshold of Regulation Exemption.

An Alternative Antimicrobial - Safe and Effective


The HM4100 Antimicrobial (EPA Reg. No. 83019-1) label was amended and stamped April 12th, 2017 by the FIFRA office of the EPA to include these new food-contact surface uses. “The global market for food contact materials has been in dire need of an alternative antimicrobial that is safe and effective. For years, customers have had to choose between silver or triclosan, both of which have come under tremendous scrutiny and in some cases have been banned outright for consumer products,” said Joel Zazyczny, Executive Vice President. “BIOSAFEHM4100 Antimicrobial, when used as an additive or surface coating, offers value and differentiation in its longer-lasting ability to stay free and clean of microbial stains and odor, and it gives consumers peace-of-mind that their products are protected.” With proper integration, BIOSAFE products exhibit high antimicrobial performance in ISO and ASTM testing.

BIOSAFE for Food Contact Surface Applications


The active ingredient in the BIOSAFE antimicrobial was developed and registered with the U.S. EPA in the mid-1970s, and has since been widely used in numerous applications. Gelest, Inc. has expanded the breadth of applications and manufacturing processes by removing VOCs and making the antimicrobial available in a new polymeric powder. The BIOSAFE powder can be compounded with polymer resins and used in food contact surface applications.

About Gelest

Gelest, Inc., headquartered in Morrisville, Pennsylvania, is recognized worldwide as an innovator, manufacturer and supplier of commercial and research quantities of organosilicon compounds, metal-organic compounds and silicones. Gelest serves advanced technology markets through a materials science-driven approach. The company provides focused technical development and application support for semiconductors, medical materials, pharmaceutical synthesis, diagnostics and separation science, and specialty polymeric materials.

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Source: Gelest
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