Novel Food Information - High Pressure Processing (HPP)-Treated Raw Fruit Juices

Health Canada has notified A. Lassonde Inc., that it has no objection to the food use of High Pressure Processing (HPP)-treated raw fruit juices. 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.

Background:

The following provides a summary of the notification from A. Lassonde Inc. and the evaluation by Heath Canada and contains no confidential business information.

1. Introduction

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.

The petitioner intends to produce HPP-treated raw fruit juices with one or more of the following ingredients: apple, orange, cranberry, and blueberry. The purpose of the HPP treatment is to extend the refrigerated shelf life of the treated products. The raw fruit juices will be packaged into polyethylene terephthalate (PET) bottles prior to HPP treatment. The juices will then be subjected to HPP treatment at 80,000 psi/550 MPa for a 1-min cycle

In the event of an incomplete treatment cycle, the petitioner would like the ability to treat their product for an accumulated treatment time of up to 9 minutes to accommodate a restart of the HPP treatment process.

The standard process to produce raw fruit juices does not have a lethality (i.e. heat) treatment, thus the safety of these HPP-treated juices products relies entirely on the sanitation of the raw materials, the HPP treatment, and the storage conditions (i.e. refrigeration).

The assessment conducted by the Food Directorate considered the intended addition of an HPP treatment to the current manufacturing process, the nutritional composition of both HPP-treated and untreated products, the potential for the HPP treatment to generate any toxic compounds within the products, and the microbiological safety of the finished HPP-treated products. A. Lassonde Inc. has provided scientific rationales which demonstrate that these raw fruit juices treated at 80,000 psi/550 MPa for a minimum of 1 minute up to a maximum of 9 minutes are as safe as their 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). Raw fruit juices 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

  1. has not been previously applied to that food, and
  2. causes that food to undergo a major change."

2. Development of the novel food

A. Lassonde Inc. has provided information describing the impact of the HPP treatment on the nutritional composition, microbiological safety, and toxicological safety of the treated products.

Scientific rationales were provided to support the nutritional and toxicological safety for raw fruit juices treated with HPP at 80,000 psi/550 MPa for up to 9 minutes. Microbiological data was provided for the finished products treated at 80,000 psi/550 MPa for 1 minute only, with the rationale that additional treatment would not decrease the microbiological safety of these products. The evaluators considered this rationale acceptable.

3. Dietary Exposure

It is expected that the HPP-treated raw fruit juices will be consumed at a similar rate compared to untreated raw fruit juices.

4. Chemistry

The safety of all packaging materials is regulated under Division 23, Part B of the Food and Drug Regulations. It is the ongoing responsibility of the manufacturer to ensure that the packaging materials used for their product are acceptable for their intended use. A list of all packaging materials (including those acceptable for HPP treatment) accepted by the Canadian Food Inspection Agency (CFIA), for use in federally-registered establishments, is  available on the CFIA website.

To demonstrate the acceptability of the packaging materials used for HPP-treated raw fruit juices, the petitioner provided a Letter of No Objection (dated April 15, 2014) from the Bureau of Chemical Safety addressed to the petitioner. The letter states that the Bureau has no objection to the use of Ind Lass PET bottles subjected to pressures up to 87,000 psi/600 MPa for a maximum of 9 minutes.

5. Microbiology

The petitioner provided data to demonstrate the microbiological safety of their HPP-treated raw fruit juices against the following microbiological specifications: an aerobic colony count of less than 106 cfu/g, a coliform count of less than 10 cfu/g, a yeast count of less than 106 CFU/g, and a mold count of less than 106 CFU/g. The petitioner provided data from 3 lots of 3 different HPP-treated juices (i.e., orange juice, blueberry juice, and cranberry juice) to demonstrate that their specifications are consistently met. The microbiological methods used to test the HPP-treated juices are from Health Canada's HPB Methods for the Microbiological Analysis of Foods (MFHPB-18, Determination of the Aerobic Colony Count in Foods; MFHPB-22, Enumeration of Yeasts and Moulds in Foods; MFHPB-34, Enumeration of Escherichia coli and Coliforms in Food Products and Food Ingredients Using 3M™ Petrifilm™ E. coli Count Plates).

Based on the data provided, the petitioner demonstrated that these HPP-treated raw fruit juices are just as microbiologically safe as their untreated counterparts. The Bureau of Microbial Hazards therefore has no objection to the food use of these HPP-treated products.

6. Nutrition

The petitioner provided information from Gebhardt et al., (1982) and Mattick and Moyer (1983), the Canadian Nutrient File (2010), and the USDA Nutrient Database, which compared some of the major and minor constituents of the fruit juices of interest, but not all components of nutritional significance. For example, minerals were listed as minor constituents in the petitioner's comparison of fruits and vegetable products and vitamins were not mentioned.

Based on the supporting information from the scientific literature provided by the petitioner and from a literature search performed by the Bureau of Nutritional Sciences, in general, nutritional evaluators have no nutritional concerns with HPP treatment at 80,000 psi (550 MPa) for up to 9 minutes.

7. Toxicology

Aside from water (80-90% of juice), the primary constituents of juices are carbohydrates, primarily sugars (~11-13%), the most abundant of which (sucrose, fructose, glucose) are not affected by HPP. Other components of juices, such as citric acid and ascorbic acid, are less affected by HPP than by thermal treatment. Information from other sources that the Pre-market Toxicology Assessment Section (PTAS) has reviewed showed that HPP does not oxidize the fat in avocados nor affect the pH in tomato-based salsa. HPP treatment also produces fewer Maillard reaction products, especially furans, than thermal processing. Small molecules in fruits and vegetables, such as organic acids, vitamins, colours, and flavour compounds are covalently bound and generally unaffected by HPP.

For the above reasons, toxicological evaluators do not consider that standard HPP treatment constitutes a toxicological concern and have approved a range of fruit and vegetable products treated at 87,000 psi/600 MPa for a minimum of 2 min up to a maximum of 9 min. The proposed treatment of 80,000 psi/550 MPa for 1 min is milder and thus would constitute even less of a toxicological concern.

8. Labelling

Exposure to the HPP treatment of 80,000 psi/550 MPa for up to a maximum of 9 minutes does not cause a significant compositional change in the treated food, nor have there been any safety concerns raised regarding the use of this process for raw fruit juices. On this basis, mandatory labelling requirements are not necessary in this case.

Conclusion:

Health Canada's review of the information presented in support of the food use of raw fruit juices (consisting of apple, orange, cranberry, blueberry, or any combination of these ingredients), which has been treated at 80,000 psi/550 MPa for a minimum of 1 minute 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 has 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
Food Directorate
Health Products and Food Branch
Health Canada, PL2204A1
251 Frederick Banting Driveway
Ottawa, Ontario K1A 0K9
novelfoods-alimentsnouveaux@hc-sc.gc.ca

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