SUMMARY OF UNITED STATES REGULATION – HYPOCHLOROUS ACID

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  • Positioning Statement, the Government Gazette No. 40480 of 9th of December 2016
  • Establishment licence issued by SAHPRA on the 5th of July 2019. In this licence application under section 4.3 – List of non-IVD medical devices
  • Section 2.8 of the SAHPRA guideline 8.05 – Classification of Medical Devices and IVDs (Attachment 5)

FDA Food Contact Notification 1811 – Hypochlorous Acid at up to 60 ppm for Produce, Fish & Seafood, Meat and Poultry Sanitation 

Hypochlorous Acid may be used in processing facilities at up to 60 ppm for use in process water or ice which comes into contact with food as a spray, wash, rinse, dip, chiller water, and scalding water for whole or cut meat and poultry, including carcasses, parts, trim, and organs; in process water, ice, or brine used for washing, rinsing, or cooling of processed and pre-formed meat and poultry products as defined in 21 CFR 170.3(n)(29) and 21 CFR 170.3(n)(34), respectively; in process water or ice for washing, rinsing or cooling fruits, vegetables, whole or cut fish and seafood; and in process water for washing or rinsing shell eggs. Visit Source at FDA Website 

FDA Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables 

The antimicrobial activity of a chlorine-based disinfectant depends on the amount of hypochlorous acid (also called “free available chlorine”) present in the water. The amount of hypochlorous acid is largely dependent on the pH of the water.

EPA: Food-Contact Surface Sanitizing Solutions – Allowance of Hypochlorous Acid at up to 200 ppm 

The following chemical substances when used as ingredients in an antimicrobial pesticide formulation may be applied to food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils. When ready for use, the end-use concentration of all hypochlorous acid chemicals in the solution is not to exceed 200 ppm determined as total available chlorine.

FOOD CONTACT NOTIFICATION 1811

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FCN 1811 is a Food Contact Notification (FCN) from the FDA for using electrolytically generated hypochlorous acid as 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.

To read more about food contact notification 1811, visit the FDA website in the link below.

See at FDA Website

SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY

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  1. Bettamed products are based on our Medical Device Licence : 1081MD for Bettamed Oxygen Spray 200ml- intended use is for the treatment of wounds with the primary intended action being achieved by physical means (and not by pharmacological, metabolical or immunological means).
  2. “Antiseptics and anti-bacterial agents used on human skin in hospitals’ operating rooms, intensive care units (ICU), burn units, Cath Labs, etc. will be controlled as medicines under the ambit of the Medicines & Related Substances Act, 1965 (Act 101 of 1965) as amended.” However, this was prior to the MCC/ SAHPRA introducing the regulatory pathway for Medical Devices/ In Vitro Diagnostic Medical Devices (IVDs). A few months after the publication of the Positioning Statement, the Government Gazette No. 40480 of 9thof December 2016 (Attachment 2) published Regulations Relating to Medical Devices and IVDs also governed by the Medicines & Related Substances Act, 1965 (Act 101 of 1965) as amended.
  3. SAHPRA is now aligning with Europe and numerous products in the same category as Bettamed are regulated as medical devices in the EU and these products have CE marking affixed to them.
  4. Given the call-up for applications for licencing as Medical Device Establishments mentioned above, Recreation Health Products Medical Device Establishment licence was issued by SAHPRA on the 5thof July 2019 In this licence application under section 4.3 – List of non-IVD medical devices manufactured in South Africa, the following product details were listed as required by SAHPRA (also see Attachment 4):
    • Product name: Bettamed Oxygen Spray
    • GMDN descriptor: Antimicrobial wound irrigation solution, sterile
    • GMDN code: 57973
    • Risk classification: Class B (Rule 1: Non-invasive devices intended to have contact with injured skin)
  5. Bettamed’s primary mode of action is by physical means i.e. it is a natural oxygen-based solution, which gives the wound much needed oxygen, to heal the wound. Section 2.8 of the SAHPRA guideline 8.05 – Classification of Medical Devices and IVDs (Attachment 5) indicates that the risk classification of Bettamed is Class B, Rule 1.