ARCHIVED - Novel Food Information on: Use of High Hydrostatic Pressure for Processing Ready to Eat Meat-containing Entrees, Salads and Products

Health Canada has notified Maple Leaf Consumer Foods that it has no objection to the food use of Ready to Eat (RTE) meat-containing entrees, meat-containing salads and meat products which have been treated by high hydrostatic pressure (HHP). The Department conducted a comprehensive assessment of these RTE meat-containing entrees, meat-containing salads and meat 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 novel foods.

Background:

The following provides a summary of the notification from Maple Leaf Consumer Foods and the evaluation by Health Canada, and contains no confidential business information.

1. Introduction

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.

The high hydrostatic pressure (HHP) process consists of applying a high pressure to a packaged food product via compressed water. Prior to pressurization, Ready to Eat (RTE) meat-containing entrees, meat-containing salads and meat products (RTE meals) are loaded in a 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 RTE meal is thus immersed in the pressurized water and is subjected to high hydrostatic pressure. The proposed process is run in batch mode for prepackaged foods; other units also exist which can be run in continuous mode, for easily pumped liquid foods (juices, purees, sauces, etc.).

The length of this HHP process determines the efficacy of inactivation of background microflora. 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 on the package.

This process is proposed for use as a post-processing, post-packaging step in the production of RTE meat-containing entrees, meat-containing salads and meat products to increase shelf-life.

To clarify, RTE meals means Ready to Eat (RTE) meat-containing entrees, meat-containing salads and meat products which have been subjected to a high hydrostatic pressure (HHP) treatment.

The assessment conducted by the Food Directorate determined the effect of the HHP process on the inactivation of the background microflora in the notified foods, how the composition and nutritional quality were affected by the process; and the potential for the presence of any toxicants, allergens or chemical contaminants due to the use of the process. Based on the information provided by Maple Leaf Consumer Foods, no safety or nutritional concerns regarding the use of this process on RTE meals were identified.

The Food Program has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in the Food and Drug Regulations (Part B, Division 28). HHP-treated RTE meals 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 these foods, a change that places the food outside the accepted limits of natural variations for that food, with regard to microbiological safety.

2. Development of the novel food

Batch high hydrostatic pressure units consist of a pressure chamber and a tray for the treatment of packaged RTE meals. Prior to pressurization, RTE meals 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 RTE meal is thus immersed in the pressurized water and is subjected to high hydrostatic pressure (HHP).

Vacuum-packed RTE meals is loaded in the pressurization chamber and the chamber is pressurized to 87 000 PSI (or 600 MPa), which is maintained for 3 minutes. The pressure is released and the treated RTE meals are packed and ready for shipping. Treated RTE meals still require refrigeration.

The process is proposed for use on all RTE meat-containing entrees, meat-containing salads and meat products packaged in flexible films.

3. Dietary Exposure

It is not expected that dietary exposure to treated RTE meals would be any different to that of their untreated counterpart. In the population who will be consuming them, these treated products will likely fully or partially replace their regular counterparts.

4. Chemistry

The impact of the HHP treatment on the packaging materials used to package the meals has been performed independently of the novel food submission by the Food Packaging Materials & 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 HHP treatment to the Canadian Food Inspection Agency (CFIA) to obtain the proper clearance. CFIA will contact the Food Packaging Materials & Incidental Additives Section, as necessary, to obtain an opinion on the safety of the packaging material used with a novel process.

5. Microbiology

Maple Leaf Consumer Foods provided data pertaining to the impact of the process in inactivating the background microflora in samples of three types of RTE meals: chicken cacciatore (cooked chicken, pasta, vegetables and sauce), chicken Alfredo (cooked chicken, pasta, vegetables and sauce) and beef teriyaki (cooked beef, vegetables, rice and sauce). The Bureau of Microbial Hazards (BMH) has assessed the impact of the HHP treatment of 87 000 PSI for 3 minutes on the microflora of these RTE meals.

Treated and untreated control RTE meals were assessed weekly for Aerobic Plate Count (APC) and Lactic Acid Bacteria (LAB) over a 10 week period. In all meals tested, during the first few weeks of sampling there was no significant difference between the treated and untreated control samples (all counts less than 103 CFUs/g). However, a significant difference was noted starting around weeks 4 and 5, when the APC and LAB populations in the untreated control samples started increasing significantly (sometimes above 1012 colony forming units (CFUs)/g) and varied wildly widely, whereas in the treated samples, the populations remained below 104 CFUs/g. These data demonstrate that the application of 87 000 PSI for 3 minutes reduces the total APC and LAB populations in the treated samples, in comparison to the untreated control samples.

In conclusion, these data demonstrate that the high hydrostatic pressure (HHP) treatment of 87 000 PSI for 3 minutes reduces background microflora for up to 10 weeks. It is unlikely that the use of this treatment on RTE meals would make them any less safe than similar products available on the market with similar shelf life. From a microbiological standpoint, the Bureau of Microbial Hazards has no objection to the use of Ready to Eat (RTE) meat-containing entrees, meat-containing salads and meat products which have been subjected to a HHP treatment of 87 000 PSI for 3 minutes.

6. Nutrition

Maple Leaf Foods provided data pertaining to the impact of the process on nutrients in three types of RTE meals: chicken cacciatore (cooked chicken, pasta, vegetables and sauce), chicken Alfredo (cooked chicken, pasta, vegetables and sauce) and roasted chicken (cooked chicken, vegetables and sauce). The study design for all three product categories consisted of two samples and three batches for each HHP treated and untreated control product. Complete fatty acid profile was provided for each sample, in addition to moisture, protein and vitamin A, C, B1, B2 and niacin content.

HHP treatment had no significant effect on the analytes tested, except for vitamin C in all three product categories. Although these products are not a significant source of vitamin C, it was noted that the HHP process resulted in depletion of vitamin C in all samples. Generally, the published literature states that there is little impact of HHP on vitamin content. The petitioner explained that this observed effect was probably due to the oxidative conditions created by the incorporation of potassium lactate in the meals.

On the basis of the data provided in the submission and probable risks associated with this process, the Bureau of Nutritional Science has no objection to the sale of the specified categories of products for food produced by this process in Canada.

7. Toxicology

The toxicological issue was determined to be the potential for this HHP process to generate substances of unknown toxicity from components or chemicals present in the treated foods. From the literature, high pressure treatment is very mild with respect to energy input to the system compared with conventional heat treatment, having the ability only to disrupt hydrophobic bonds such as those between proteins or those within the tertiary structure of the proteins. The HHP process has less impact on chemical components within the food than a traditional thermal process. Consequently, unintentional generation of substances of unknown toxicity from food components by the application of this process would appear to be unlikely.

On this basis, the Bureau of Chemical Safety has no objection to the use of HHP treatment on RTE meals in the manner proposed by the petitioner.

8. Labelling

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 RTE meals. On this basis, mandatory labelling requirements are not necessary in this case.

9. Conclusion

Health Canada's review of the information presented in support of the food use of Ready to Eat (RTE) meat-containing entrees, meat-containing salads and meat products which have been treated by a high hydrostatic pressure (HHP) treatment of 87 000 PSI for 3 minutes, has resulted in the conclusion that this use does not raise concerns related to food safety. Health Canada is of the opinion that these treated RTE meat-containing entrees, meat-containing salads and meat products are as safe as other RTE counterparts in the market.

This opinion is solely with respect to the suitability for sale of these RTE meat-containing entrees, meat-containing salads and meat products which have been treated by high hydrostatic pressure (HHP) of 87 000 PSI for 3 minutes. It is the continuing responsibility of Maple Leaf Consumer Foods to ensure that their products are in compliance with all applicable statutory and regulatory requirements. Any new information obtained which has potential health and safety implications should be forwarded to Health Canada 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.

(Également disponible en français)

For further information, please contact:

Novel Foods Section
Food Directorate
Health Products and Food Branch
Health Canada
Tunney's Pasture
Ottawa, Ontario K1A 0L2

Telephone: (613) 941-5535
Facsimile: (613) 952-6400

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