FDA Regulation HOCL

Electrolyzed Water Hypochlorous Acid (HOCL)

Offshore Carpet Cleaning & Janitorial Services uses Electrolyzed water when sanitizing properties and surfaces to ensure optimal cleanliness.

Electrolyzed water (ie. hypochlorous acid) is an all-natural, no-rinse, non-toxic, non-irritant and environmentally safe antimicrobial solution that is the product of the electrochemical reaction of water, salt, and electricity. It serves as a potent antimicrobial agent, approximately 100 times as effective as chlorine bleach.

HOCL is generated by the electrolysis of a dilute NaCl solution interacting with an electrolytic cell. This process creates an anolyte solution predominantly of hypochlorous acid (HOCl). HOCl is a powerful oxidant. Offshore Carpet Cleaning & Janitorial Services systems can generate large volumes of concentrated and stable HOCl in solution which is unobtainable via the preparation of traditional chlorinated chemicals. Electrolyzed water is highly biocidal and can kill common foodborne pathogens such as Salmonella, E. coli, Listeria, and Campylobacter in less than 30 seconds of contact. It has been proven to be effective against bacterial spores and viruses that can be highly resistant to other disinfectants. Electrolyzed water is also capable of dislodging and removing biofilm which can be a major contributor to contamination in pipes and clean-in-place (CIP) systems of beverage and dairy manufacturing.

Unlike other oxidants, such as ozone (O3) and chlorine dioxide (ClO2), which are gases and rapidly leave solution in seconds to minutes, HOCl is stable in solution and maintains biocidal concentrations for up to several months. Stability in solution allows for HOCl to be used in many applications in the food industry from the farmer to the table, not only for direct food contact, but also for the disinfection of food contact surfaces. HOCl has been proven to be stable in solution for several months when stored in closed containers protected from oxygen and light and to be stable for several hours when in buckets or sinks that are exposed to the oxygen in the air.

When HOCl is applied on food or contact surfaces, it behaves as an oxidizing agent. When reduced by organic matter, it leaves no harmful residues and therefore no potable water post-rinse is required. The aforementioned features make electrolyzed water (hypochlorous acid) a superior operational solution for any food-service provider, saving time and resources and enabling frequent, real-time application.

There are a broad range of applications for the use of this technology in industries such as agriculture, food and beverage, hospitality, healthcare, and water treatment. Electrolyzed water can be safely and efficiently utilized through a variety of methods such as direct application, pressure spraying, dosing, and fogging.

https://pubmed.ncbi.nlm.nih.gov/18810883/

https://www.marquettemi.gov/departments/public-works/water-distribution/

FDA Food Contact Notification – FCN 1811
FDA Source: Click Here
FDA FCN 1811: Click Here

 hypochlorous acid is an antimicrobial agent in an aqueous solution in the production and preparation of whole or cut meat and poultry; processed and preformed meat and poultry; fish and seafood; fruits and vegetables; and shell eggs. A potable water rinse is not required after use. For more details, click here to view FCN 1811 from the FDA.

What is a Food Contact Notification (FCN)?

A food contact notification (FCN) is the primary method by which the Food and Drug Administration (FDA) regulates food additives that are food contact substances (FCSs). An FCS is any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food. Notifications for an FCS must contain sufficient scientific information to demonstrate that the substance that is the subject of the notification is safe for the intended use (sec. 409(h) of the Act). Because the safety standard is the same for all food additives, whether subject to the petition process or the FCN process, information in an FCN should be comparable to that recommended for inclusion in a food additive petition or in a “Threshold of Regulation” submission (See 21 CFR 170.39). According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.

FDA Stance on “GRAS” Substances
FDA Source: Click Here
GRAS – Hypochlorous Acid: Click Here

What does “GRAS” mean?
“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use.

What are the criteria for GRAS status?
Under 21 CFR 170.30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information.

Produce

In what way are the criteria for the use of a substance to be GRAS similar to that for the approved use of a food additive?
Regardless of whether the use of a substance is a food additive use or is GRAS, there must be evidence that the substance is safe under the conditions of its intended use. FDA has defined “safe” (21 CFR 170.3(i)) as a reasonable certainty in the minds of competent scientists that the substance is not harmful under its intended conditions of use. The specific data and information that demonstrate safety depend on the characteristics of the substance, the estimated dietary intake, and the population that will consume the substance.

Must FDA approve GRAS substances?
No. If the use of a food substance is GRAS, it is not subject to the premarket review and approval requirement by FDA.

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