Novel Food Information - Avocado Pulp, Tomato-based Salsas, and Guacamole Treated by High Pressure Processing (HPP)
Health Canada has notified Gridpath Solutions Inc. that it has no objection to the food use of avocado pulp, guacamole, and tomato-based salsas treated by high pressure processing (HPP). The Department conducted a comprehensive assessment of these HPP-treated food products according to its Guidelines for the Safety Assessment of Novel Foods. These Guidelines are based upon internationally accepted principles for establishing the safety of foods with novel traits.
The following provides a summary of the notification from Gridpath Solutions Inc. and the evaluation by Heath Canada and contains no confidential business information.
This Novel Food Information document has been prepared to summarize the opinion regarding the subject products 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.
Avocado pulp, guacamole, and tomato-based salsas are separately packaged into packaging materials acceptable for HPP treatment. The packaged products are batch loaded into a pressurization chamber and pressurized to 87,000 psi/600 MPa for a treatment holding cycle time of 3 minutes at ambient temperature. Pressurization is achieved by injecting water into the chamber until a defined pressure is reached. Once the defined pressure is reached, it is maintained for the duration of the cycle. The pressure is then released and the treated products are ready for distribution.
The length of the HPP treatment determines the efficacy of inactivation of background microbial flora. The high hydrostatic pressure does not affect any of the structural components of the food itself (e.g., structural proteins, fibres, fats, etc.), nor does it affect the structural integrity of the packaging materials used, as the pressure is applied uniformly on the food and on the package.
The process is used to reduce the level of the background microbial flora (i.e., spoilage microorganisms) inherently present in the treated food products, resulting in an extended refrigerated shelf life.
The assessment conducted by the Food Directorate considered the physical properties (e.g., pH, water activity, etc.) of the treated food products, and the impact of the HPP treatment on the nutritional composition, microbiological safety, and toxicological safety of the treated products. Gridpath Solutions Inc. has provided data which demonstrates that avocado pulp, guacamole, and tomato-based salsas treated at 87,000 psi/600 MPa for a minimum of 3 minutes up to a maximum of 9 minutes are as safe as the equivalent untreated products.
The Food Directorate has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in the Food and Drug Regulations (Division 28). Avocado pulp, guacamole, and tomato-based salsas treated by high pressure processing (HPP) are considered novel foods under the following part of the definition of novel foods:
"b) a food that has been manufactured, prepared, preserved or packaged by a process that
- has not been previously applied to that food, and
- causes that food to undergo a major change."
2. Development of the novel food
Gridpath Solutions Inc. has provided information describing the methods and parameters used to assess the impact of the HPP treatment on the nutritional composition, microbiological safety, and toxicological safety of the treated products.
Nutritional and toxicological data were provided for avocado pulp, guacamole, and tomato-based salsas treated with HPP at 87,000 psi/600 MPa for 3 minutes, 9 minutes, or untreated (negative control). Microbiological data was provided for the finished products treated at 87,000 psi/600 MPa for 3 minutes only, with the rationale that additional treatment would not decrease the microbiological safety of these products. The evaluators considered this rationale acceptable.
Samples were treated with HPP using a batch method. Prior to pressurization, the package-sealed samples were loaded onto a tray, which itself was loaded into the pressurization chamber. The chamber was then sealed and pressurized by injecting water into the chamber until the defined pressure (i.e., 87,000 psi/600 MPa) was reached. Treatment pressure was maintained for a single 3- or 9-minute cycle. Control samples were not subjected to HPP treatment. All samples were packaged in materials acceptable for the intended HPP treatment. The HPP-treated food products still required refrigeration.
3. Dietary Exposure
It is anticipated that HPP-treated avocado pulp, guacamole, and tomato-based salsas will be consumed at a similar rate compared to their non-treated counterparts. It is expected that these HPP-treated products will partially replace their non-treated counterparts in the Canadian marketplace.
The impact of the HPP treatment on the packaging materials used to package HPP-treated avocado pulp, guacamole, and tomato-based salsas has been performed independently of the novel food submission by the Food Packaging Materials and Incidental Additives Section of the Chemical Health Hazard Assessment Division, as per Division 23, Part B of the Food and Drug Regulations.
It should be noted that the packaging material authorization process is independent from the novel food authorization process. The packaging material companies direct any requests concerning the acceptability of packaging materials for HPP treatment to the Canadian Food Inspection Agency (CFIA) to obtain proper clearance. CFIA will contact the Food Packaging Materials and Incidental Additives Section, as necessary, to obtain an opinion on the safety of the packaging material used with a novel process.
The petitioner provided the following microbiological specifications for their HPP-treated avocado pulp and guacamole: an aerobic plate count of less than 104 colony forming units (CFU)/mL, a coliform count of less than 10 CFU/mL, an Escherichia coli count of less than 10 CFU/mL, a yeast count of less than 10 CFU/mL, and a mold count of less than 10 CFU/mL. The petitioner's microbiological specification for tomato-based salsas is an aerobic plate count of less than 104 CFU/mL. Sample testing was conducted according to the Association of Analytical Communities (AOAC) official methods. The petitioner provided testing results from 4 production lots of each HPP-treated product to demonstrate that the specifications are consistently met and that the end products are microbiologically safe for consumption.
The petitioner submitted nutritional data on avocado pulp, guacamole, and tomato-based salsas (both HPP-treated and untreated) to demonstrate that the HPP treatment had little or no impact on the nutritional composition of the treated products. The data supports that a HPP treatment of 87,000 psi/600 MPa for up to a maximum of 9 minutes would not alter the nutrient content of these products.
The toxicological data submitted were limited to a chemical analysis of peroxide levels in HPP-treated and untreated avocado pulp and guacamole. The petitioner postulated that if higher levels of peroxide were observed in the HPP-treated products, it would suggest that the HPP treatment induced rancidity in the products' fatty acids. Analysis showed that both HPP-treated avocado pulp and guacamole had levels of peroxide that were not significantly different from those in their untreated counterparts. The HPP treatment was therefore considered not to induce rancidity in the treated foods.
The petitioner explained that tomato-based salsas were not assessed because they have a low fat content and would not generate significant amounts of peroxide.
From a toxicological perspective, the HPP treatment of avocado pulp, guacamole, and tomato-based salsas at 87,000 psi/600 MPa for up to a maximum of 9 minutes is unlikely to pose a health concern.
Exposure to the HPP treatment of 87,000 psi/600 MPa for up to a maximum of 9 minutes does not cause a significant compositional change in the treated foods, nor have there been any safety concerns raised regarding the use of this process for avocado pulp, guacamole, and tomato-based salsas. On this basis, mandatory labelling requirements are not necessary in this case.
Health Canada's review of the information presented in support of the food use of avocado pulp, guacamole, and tomato-based salsas which have been treated at 87,000 psi/600 MPa for a minimum of 3 minutes up to a maximum of 9 minutes, concluded that this use does not raise concerns related to food safety. Health Canada is of the opinion that these HPP-treated food products are as safe as their untreated counterparts on the Canadian market.
This opinion is solely with respect to the suitability of sale of these HPP-treated food products. It is the continuing responsibility of the food manufacturer or importer 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.
For further information, please contact:
Novel Foods Section
Health Products and Food Branch
Health Canada, PL2204A1
251 Frederick Banting Driveway
Ottawa, Ontario K1A 0K9
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