Record of Decision - Rinsing of aseptic packages following treatment with Oxonia
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Question or Description of Problem
- Does the Canadian Food Inspection Agency (CFIA) have any guidelines for sterile water used for rinsing aseptic packages?
- What water treatment (s) is/are generally acceptable as effective for rendering potable water sterile for the intended usage? i.e., rinsing of aseptic packages
Oxonia, a chemical composed of Peroxyacetic acid and hydrogen peroxide, has been accepted for use as a sterilant for containers subject to direct contact with food provided that the container is thoroughly rinsed with potable water after treatment with the product (See appendix 1). However, for the purpose of maintaining asepsis and minimizing the risk of contamination of aseptic packages, it is recommended that manufacturers apply additional treatments to render the rinse water sterile or suitable for the intended purpose.
Water is regulated under the following acts and regulations: the Food and Drug Regulations, Division 12 (pre-packaged water and ice), Meat Inspection Act, the Fish Inspection Act, the Canada Agricultural Products Act including the related regulations for dairy products, egg and egg products, fresh and processed fruit and vegetables, maple syrup and honey products. However, these regulations tend to address potable water rather than sterile water.
An opinion provided by Health Canada (dated October 27, 2006) in part stated the following:
"Health Canada does not have guidelines for sterile water as it applies to the food industry, nor is there a definition of sterile water for the food industry. Sterile water is used in the Medical / Drug industry. The food industry is required to use potable water, but has the option to further purify this water, or to use some other sterilizing methods should they so desire, depending on their process and final product. Based on the described use of the peroxyacetic acid/hydrogen peroxide chemical (Oxonia), if there is to be a water rinse by the food industry, then it is generally accepted that the rinse should at least be a potable water rinse. How the microbiological quality of that potable water would affect industry's final food product is for them to determine, and as per this case, they maintain the definition of an aseptically packaged product…"
Dairy Establishment Inspection Manual (DEIM) Requirement
Chapter 10 (1.10.01.09 Water/Steam/Quality and Supply) requires that the establishment's water supply source meet the requirements of Health Canada's Guidelines for Canadian Drinking Water Quality. These requirements include standards for microbiological, chemical, physical and radiological contaminants.
Chapter 14 defines Aseptic Processing and Packaging as the processing and packaging of a commercially sterile product into sterilized containers followed by hermetic sealing with a sterilized closure in a manner which prevents viable microbiological recontamination of the sterile product. This definition does not contain any specific or prescriptive requirements for sterile water or methods of sterilizing potable water for usage in rinsing aseptic packages. Furthermore, certain definitions of sterile water such as those provided by the United States Pharmacopeia (USP) for Purified Water and/or Water for Injection are not intended for this purpose i.e., rinsing aseptic packages after treatment with chemicals. Hence, they may not be viable options for industry.
Although Health Canada's letter of no objection of March 17, 1999 permits the use of Oxonia on equipment, containers or surfaces (including water filters) coming into direct contact with food provided it is followed by a thorough rinse step with potable water, it remains the industry's responsibility to ascertain that the water used for rinsing aseptic packages will not result in loss of asepsis throughout the entire shelf-life of the product. It is the industry's responsibility, including the Process Authority, to ensure that their shelf-stable, aseptically packed product meets applicable regulations.
At present, the CFIA recognizes UHT (Ultra-High Temperature) treatment under controlled conditions as the only method capable of achieving commercially sterile water. The industry may choose to employ other methods or technologies to achieve commercial sterility of their rinse water provided they are demonstrable to regulatory authorities as being fit for purpose and scientifically validated. This is usually done via a submission to the CFIA/HC (Health Canada) to obtain a letter of no objection pertaining to that method.
The CFIA acknowledges that, at present, it will be evaluating water treatment systems for sterile rinse water quality on a case-by-case basis.
Letter of no objection dated March 17, 1999, from Health Canada (HC) on the use of Oxonia Active. HC's reply in part is as follows:
Based on the information presently available, we would have no objection to the composition and use of this product on food contact equipment, containers or surfaces (including water filters) without a potable water rinse provided that:
- The use concentration of the product will be the minimum required amount and will not exceed 0.5% product in water
- The surfaces being hard and non-porous in nature (or which facilitate complete drainage) are thoroughly drained prior to re-use
With the addition of the surfactant in Oxonia Active, we would have no objection to the composition and intended use of the product in food plants provide that:
- There will be no contamination of food as a result of its use
- Equipment, containers or surfaces (including water filters) subject to direct contact with food are thoroughly rinsed with potable water after treatment with the product.
In light of the above, we (CFIA) would have no objection to the use of Oxonia Active for the sanitizing of containers provided that; they are constructed of non-porous materials and the containers are rinsed with potable water before re-use.
Recommended by: Program Chief
Approved by: National Manager
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