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Applesauce and Applesauce/Fruit Blends Treated by High Hydrostatic Pressure
Health Canada notified Leahy Orchard Inc., Franklin Centre, QC, in November of 2004 that it has no objection to the sale of applesauce and applesauce/fruit blends treated by high hydrostatic pressure. The Department has conducted a comprehensive assessment of these applesauce and applesauce/fruit blends according to its Guidelines for the Safety Assessment of Novel Foods. These Guidelines are based upon internationally accepted principles for establishing the safety of novel foods.
The following provides a summary of the notification from Leahy Orchard Inc. and the evaluation by Heath Canada and contains no confidential business information.
Typically, applesauce and other fruit preparations are pasteurized by a heat treatment as a means of inactivating spoilage microbial flora and food-borne pathogens which may be present in the raw material. However, there is rising interest in "cold pasteurization" technologies, which achieve the same result without the use of heat. One such technology is high hydrostatic pressure, or HHP, for which Leahy Orchards as notified Health Canada, as an alternative to heat treatment for applesauce and applesauce/fruit blends.
The mode of action of the high hydrostatic pressure in the treated foods is not fully understood but it is theorized that this treatment inactivates the microbial flora by inactivating overall enzyme activity in the living cells, thus interrupting all cellular functions during the high pressure phase. The length of this phase determines the efficacy of the inactivation. The high hydrostatic pressure does not affect any of the structural components of the food itself (structural proteins, fibers, fats, etc.), nor does it affect the structural integrity of the package used, as the pressure is applied uniformly on the food and the package.
The assessment conducted by Food Directorate evaluators determined the efficacy of the high pressure process in inactivating total microbial flora and key food-borne pathogens usually associated with processed fruit products; how the composition and nutritional quality were affected by the process; and the potential for the presence of any toxicants, anti-nutrients, allergens or chemical contaminants brought about by the process. Based on the information provided by Leahy Orchards, the evaluators have not identified any safety or nutritional concerns regarding the use of this process on applesauce and applesauce/fruit blends.
Under Division 28 of Part B of the Food and Drug Regulations, the Food Program has responsibility for pre-market assessment of novel foods and novel food ingredients. High pressure treated apple sauces and apple/fruits blends are considered novel foods, as per B.28.001, as they have been manufactured by a process that has not been previously applied to those foods, and causes the foods to undergo a major change, the major change being, in respect to this food, with regard to its microbiological safety.
2. Description of the Novel Process
The high hydrostatic pressure unit (the Avure Quintus food press) consists of a pressure chamber, and a tray for the packaged food to be treated. Prior to pressurization, packaged foods are loaded in the tray, which is itself loaded into the chamber. The chamber is sealed and then pressurized by injecting water into the chamber until a defined pressure specific for the food to be treated is reached. The packaged food is thus immersed in the pressurized water and is submitted to high hydrostatic pressure.
For this notification, a batch unit is used. Raw applesauce or applesauce/fruit blends are de aerated, packaged in single serving tube format, and loaded in the pressurization chamber of the Quintus unit. The chamber is pressurized to 80 000 PSI (or approx. 5500 bar), which is maintained for one minute. The pressure is released and the treated containers are packed and ready for shipping. The whole process takes approximately four to five minutes. Treated packages are then stored at room temperature. The process is proposed for use on applesauce, apple/blueberry, apple/cranberry/ raspberry, apple/orange, apple/grape, and apple/cherry blends.
Leahy Orchards provided data demonstrating the efficacy of the process in inactivating the following pathogens:
- Salmonella enterica subsp. I (mix of: two strains of serotype Typhymurium, two strains of serotype Typhi, one strain of serotype Enteritidis)
- Escherichia coli O157:H7 (mix of five strains)
- Listeria monocytogenes (mix of five strains)
- Cryptosporidium parvum (from frozen bovine feces)
Data were provided for applesauce and applesauce/blueberry blend spiked separately with each of the above mix of marker species. Spikes were approximately 7.4 to 8 log colony forming units (CFUs)/g puree, except for Cryptosporidium parvum, where the applesauce and blends were spiked with 4.25 log oocysts/g puree (due to the limited amount of oocysts available). The purees were then packaged in the single serving tubes. For each group of microorganisms, three different pressures were applied: 60 000, 70 000, and 80 000 PSI. These pressures were maintained for one minute. Enumeration for each treatment/species was performed at six hours, one week and two months after HHP treatment. Storage of all the tubes was at room temperature.
The 70 000 and 80 000 PSI treatments were effective in inactivating the above bacterial pathogens. For Salmonella spp., L. monocytogenes , and E. coli O157:H7, a bacterial reduction level of more than 7 log units was attained for both the Apple Puree and Apple/Blueberry Puree. All pressure treatments were efficient against Cryptosporidium parvum resulted in complete inactivation of this organism, corresponding to more than 4 log unit reduction.
Data were also provided on the effect of the HHP process on total background aerobic flora, and yeast and moulds, as indicators of spoilage/alteration flora.70 000 and 80 000 PSI treatments resulted in complete inactivation of this flora in all of the products over the two months period (all counts below detection limits). From this, the shelf life at room temperature of the applesauce/blend treated at 70 000 PSI and 80 000 PSI is expected to be similar to that of thermally processed applesauce/blend, as the same efficacy in microbiological load reduction was achieved.
Based on this data, the Bureau of Microbial Hazards has no objection that the process be used on prepackaged applesauce and applesauce/fruit blends, as proposed by the company, i.e., using a pressure of 80 000 PSI for one minute on single serving flexible tube packages. It is also the opinion of the Bureau that if a company wished to use a similar process on applesauce or applesauce/fruit blends where either the process or the packaging have been modified, they would be required to notify the Food Directorate, as per part B, Division 28, of the Food and Drugs Regulations, to demonstrate, if necessary, that an equivalent outcome has been achieved.
4. Dietary Exposure
It is not expected that dietary exposure to applesauce and applesauce/fruit blends would be any different to that of any other applesauce and applesauce/fruit blends. In the population who will be consuming them, these products will likely fully or partially replace their regular counterparts.
The petitioner provided basic analytical data on the applesauce and applesauce/fruit blends before and after treatment including moisture, fat, proteins, sugars, ash and caloric value. Data was also provided from the scientific literature regarding the impact of HHP on vitamins and primary sugars in orange juices. The HHP process did not decrease the content of Vitamin C, pyridoxin (B6), niacin (B3), riboflavin (B2), thiamin (B1) , beta-carotene (vitamin A) and folic acid present in orange juice. The levels of primary sugars such as sucrose, fructose and glucose remained unchanged compared to fresh untreated juice. HHP showed no effects on citric acid content and pH.
The nutrients typically present in applesauce and applesauce/fruit blends are sugars such as glucose and fructose, fibers and micronutrients. Based on the orange juice findings, it is expected that the HHP process would not cause a significant decrease in the level of these nutrients in the applesauce/fruit blends. The primary intention of the HHP process is to destroy microorganisms without altering the nutritional profile, and this has been demonstrated in orange juices, which have a similar macronutrient and sugar composition and also contain higher levels of vitamins than the applesauce/fruit blends. Therefore, the submission did not raise any nutritional concerns with the application of the process to the applesauce/fruit blends.
Although no data pertaining to the effect of the 80 000 PSI treatment on the chemical composition of applesauce or applesauce/fruits blends were submitted, similar data were provided for orange juices treated at 72 500 PSI. The compounds examined were malic acid, citric and isocitric acid, sucrose, fructose and glucose, delta-limonene and beta-carotene, and total carotenes. The data demonstrate that these compounds are not affected by the process and therefore, it is reasonable to expect that the organic acids including malic acid, citric acid, ascorbic acid and the sugars, sucrose, fructose and glucose, of applesauce or applesauce/fruit blends would be similarly unaffected.
Toxicological assessment would be appropriate in a situation where it was shown that the application of HHP to applesauce resulted in the production of compounds of unknown toxicity from normal constituents of the applesauce. Since the chemical assessment showed that application of high pressure to a product of similar composition had no effect on its constituents, a toxicological assessment was considered to be unnecessary.
7. Labelling and other regulatory considerations
The CFIA's Bureau of Food Safety and Consumer Protection and the Processed Products Program have been consulted in regard to this novel food. Since the applesauce and applesauce/fruit blends have a pH lower than 4.6, they are not considered to meet the definition of a low acid food, as per Division 27 of the Food and Drugs Regulations. Furthermore, the microbiological data provided demonstrates that the HHP treated applesauce and applesauce/fruit blends are shelf-stable. The statement "Keep Refrigerated" / "Garder au froid" are thus not required for the HHP treated applesauce and applesauce/fruit blends (CFIA indicates that it could be recommended to the petitioner that the use the mention "refrigerate after opening" could be appropriate for these products). Furthermore, the HHP process described above does not cause a significant compositional change in the food, nor has there been any safety concerns raised by the use of this process in applesauce and applesauce/fruit blends. Based on this, the evaluation team recommends that mandatory labeling requirements are not necessary in this case.
In regard to the proposed Processed Fruit and Vegetable Regulations, where proposed standards applying to applesauces are set in Schedule I , Part I, Sections 16 to 21, of these Regulations, the authorization of the HHP treated applesauce and applesauce/fruit blends will not cause a contravention of these proposed standards, once they come into force. Note that in the proposed Processed Products Regulations, the definition for "processed" will provide for any future novel processes that may arise:
""processed" includes aseptically packed, canned, cold-packed, concentrated, cooked, frozen, glacéd (candied), pasteurized, pickled, vacuum-packed or otherwise prepared to stabilize or prevent spoilage of a food product during storage, transportation and distribution, or to any other process accepted under the novel foods requirements of division 28 of the Food and Drug Regulations..."1.
Health Canada's review of the information presented in support of applesauce and applesauce/fruit blends treated by the high hydrostatic pressure process proposed by the petitioner, i.e. the use of a 80 000 PSI pressure applied for one minute on single serving flexible tube packages, that are the subject of this notification, concluded that there are no human food safety concerns associated with their sale in Canada.
This opinion is solely with respect to the suitability of applesauce and applesauce/fruit blends processed by high hydrostatic pressure treated as above, for sale as human food. It is the continuing responsibility of Leahy Orchards Inc. to ensure that their products are in compliance with all applicable statutory and regulatory requirements. Any new information obtained in relation to these products which have potential health and safety implications should be forwarded to Health Canada for our consideration in order to ensure the continued safety and integrity of all foods available in the Canadian marketplace. The sale of a food which poses a hazard to the health of consumers would contravene the provisions of the Food and Drugs Act.
This Novel Food Information document has been prepared to summarize the opinion regarding the subject product provided by the Food Directorate, Health Products and Food Branch, Health Canada. This opinion is based upon the comprehensive review of information submitted by the petitioner according to the Guidelines for the Safety Assessment of Novel Foods.
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