Novel Food Information - High Pressure Processing (HPP)-Treated Fruit and Vegetable-Based Smoothies

Health Canada has notified Sunflower Organics Inc. (operated as Drinkme Beverage Co.), that it has no objection to the food use of High Pressure Processing (HPP)-treated fruit and vegetable-based smoothies (trade name: Green, Green3, and Ruby). 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 Sunflower Organics Inc. (operated as Drinkme Beverage Co.) 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 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.

Green smoothie product consists of orange juice, kale, banana, and water. Green3 smoothie product consists of orange juice and kale. Ruby smoothie product consists of orange juice, kale, beets, raspberries, and water. The pH values of these products are within the range of 3.8 to 4.2.

The original manufacturing process does not have a lethality treatment, thus the safety of the products relies solely on the sanitation of the raw materials and storage conditions. The petitioner wishes to enhance the safety of their products by using an HPP-treatment (i.e., 86,000 psi/593 MPa for 2 minutes). The petitioner states that with the added HPP treatment, their products can be stored under refrigeration conditions for up to 14 weeks without spoilage. Thus, the application of the HPP treatment bestows the benefit of shelf life extension to these products.

The assessment conducted by the Food Directorate considered the intended addition of an HPP treatment to the original manufacturing process, the nutritional composition of both HPP-treated and untreated smoothie products, the potential for the HPP treatment to generate any toxic compounds within each product, and the microbiological safety of the finished HPP-treated 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). Fruit and vegetable-based smoothies 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

Sunflower Organics Inc. (operated as Drinkme Beverages Co.) 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 product.

Nutritional, microbiological, and toxicological data were provided for Green and Ruby smoothie products treated with HPP at 86,000 psi/593 MPa for 2 minutes or untreated (negative control). As Green smoothie product contains all the ingredients present in Green3 smoothie product, data for Green smoothie product was used to demonstrate the safety of booth Green and Green3 smoothies. Evaluators determined this rationale to be acceptable.

Samples were treated with HPP using a batch method. Prior to pressurization, the bottled 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., 86,000 psi/593 MPa) was reached. Treatment pressure was maintained for a single 2-minute cycle. Control samples were not subjected to HPP treatment. All samples were bottled in materials acceptable for the intended HPP treatment. The HPP-treated food products still required refrigeration.

3. Dietary Exposure

It is expected that HPP-treated fruit and vegetable-based smoothies will be consumed at a similar rate compared to their non-treated counterparts.

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.

The HPP-treated smoothies are packaged in high-density polyethylene (HDPE) bottles. The petitioner submitted to the Food Packaging Materials and Incidental Additives Section a migration study for their HDPE bottles. The bottles were subjected to 87,000 psi/600 MPa for a maximum of 5 minutes. As the HDPE resin used to produce their bottles (i.e., Petrothene LM600500 produced by Equistar) was not yet on the Lists of Acceptable Polymers for Use in Food Packaging Applications, the petitioner also provided the material safety data sheet (MSDS) for the resin to the Section to obtain both an opinion regarding the acceptability of the resin for food packaging applications and the above mentioned HPP treatment. Based on the information provided, the Section does not object to the proposed HPP treatment (i.e., 87,000 psi/600 MPa for up to 5 minutes) of these HDPE bottles.

5. Microbiology

The petitioner states that the quality of the finished HPP-treated products is measured against the following microbiological specifications: a total aerobic plate count of less than 105 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 104 CFU/ml, and a mold count of less than 104 CFU/ml. The petitioner provided data from 4 samples of each HPP-treated smoothie product to demonstrate that their specifications are consistently met in a production run.

6. Nutrition

The petitioner submitted compositional and nutritional data on Green and Ruby smoothies (both HPP-treated and untreated) to demonstrate that the HPP treatment had little or no effect on the nutritional composition of the smoothies. A rationale, based on the scientific literature, was also provided to support that an HPP treatment of 86,000 psi/593 MPa for 2 minutes would not alter the nutrient content of the smoothies.

Nutritional analysis was performed on triplicate samples of Green and Ruby smoothies (both HPP-treated and untreated). The nutritional markers selected were: total calories, total fat, saturated fatty acids, trans-fatty acids, cholesterol, total carbohydrates, total dietary fibre, total sugars, fructose, galactose, glucose, sucrose, maltose, lactose, total protein, moisture, ash, sodium, iron, vitamin A, and vitamin C. No changes or differences were observed in all the markers analyzed between the HPP-treated and untreated samples.

7. Toxicology

The toxicological data submitted were limited to a chemical analysis determining the levels of glucosinolates in HPP-treated and untreated smoothies. Glucosinolates are a constituent of kale, one of the ingredients in the smoothies. Glucosinolates are organic compounds that contain sulfur and nitrogen and are derived from a combination of glucose and an amino acid. Glucosinolates can adversely affect thyroid, liver, and kidney function. They are also present in many other common foods including broccoli, Brussels sprouts, and cabbage. However, there is little evidence of adverse effects in healthy individuals consuming modest amounts of these vegetables.

The submitted data demonstrated that the levels of the various glucosinolates were not significantly different in HPP-treated smoothies compared to untreated smoothies. Glucosinolates assessed included glucobrassicin, 1-methoxyglucobrassicin, and 4-methoxyglucobrassicin (although only 1-methoxyglucobrassicin was detectable).

The petitioner provided information from the published scientific literature which indicates that people in Canada consume on average about 12-16 mg of glucosinolates per person per day. One serving of these smoothie products would contain about 10 mg of glucosinolates. Although this would result in about a doubling of the daily glucosinolate intake, the petitioner cited data from the United Kingdom (UK) indicating that the mean daily intake of glucosinolates is about 46 mg. Therefore, greater amounts of glucosinolates are commonly consumed and may be considered safe.

8. Labelling

Exposure to the HPP treatment of 86,000 psi/593 MPa for 2 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 fruit and vegetable-based smoothies. 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 fruit and vegetable-based smoothies that have been treated at 86,000 psi/593 MPa for 2 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 this HPP-treated food product. 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 this product 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.

(Également disponible en français)

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