Novel Food Information - Coffeeberry Whole Coffee Fruit Derivatives

Health Canada has notified VDF FutureCeuticals, Inc., that it has no objection to the sale of Coffeeberry^® whole coffee fruit derivatives (hereinafter simply referred to as Coffeeberry^®) as ingredients for use in foods and beverages sold in Canada. The Department conducted a comprehensive assessment of these 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 VDF FutureCeuticals, and the evaluation by Health Canada. It contains no confidential business information.

1. Introduction

Coffeeberry^® is a line of products made from whole coffee fruit (including the seed or "bean") of the coffee plant Coffea arabica L. The products include ground whole dried fruit powders (hereinafter referred to as whole powders) produced in various granule sizes and sold under the names Coffeeberry^® Whole Fruit Granules, Coffeberry^®Whole Fruit Powder, and Coffeeberry^® Whole Organic Fruit Powder. The products also include a dried and powdered aqueous ethanolic extract of the ground whole dried fruit, sold under the brand names Coffeeberry^® ForteWhole Coffee Fruit Soluble Concentrate and Neurofactor^®Whole Coffee Fruit Extract.

Coffeeberry^® is not intended for retail; the products will be sold directly to food manufacturers for them to incorporate as ingredients into their beverages and food products at a maximum level of 300 mg per serving.

Coffeeberry^® products naturally contain caffeine at levels of approximately 1 to 2%. It was estimated that their addition to food as proposed would have a negligible impact on caffeine intakes by Canadians. For example, at the maximum proposed level of use, one serving of food or beverage with Coffeeberry^® would contain approximately the same level of caffeine as a serving of chocolate milk.

The safety assessment performed by the Food Directorate considered the development of the products, their intended use, the estimated level of consumption by consumers, the incidental intake of heavy metals and mycotoxins, the nutritional and anti-nutrient composition, the microbiological and toxicological information, and the presence of potential allergens.

The Food Directorate has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in Division 28 of Part B of the Food and Drug Regulations (Novel Foods). The available information on Coffeeberry^® products' history of safe use as a food was insufficient to demonstrate that the food has been an ongoing part of the diet for a number of generations in a large genetically diverse human population where it has been used in ways that are similar to those expected or intended in Canada. Therefore, Coffeeberry^® products were considered to be a novel food under the following part of the definition of novel foods: "(a) a substance, including a microorganism, that does not have a history of safe use as a food".

2. Development of the product

The whole coffee fruit is harvested by hand at specific growth stages ranging from sub-ripe to maturity and then washed twice, quick-dried in food-grade stainless-steel dryers according to a proprietary protocol, and transferred to sanitary shipping containers. The material is then inspected and put into dry storage in a warehouse. This process yields a dried whole coffee fruit that can be ground for use as a food ingredient or further processed.

For the production of whole powders, the warehoused material is ground to the desired particle size.

For the production of the aqueous ethanolic extract, the warehoused material is ground and extracted with a 70% ethanol : 30% water solution by means of a two-step process. The resulting processed material is freeze-dried and subsequently milled into a fine beige powder.

3. Dietary Exposure

Coffeeberry^® is intended mainly to be used as an ingredient in beverage products such as nonalcoholic beverages and beverage bases, coffee, tea, milk (whole and skim) and milk products, processed fruit and vegetable juices, bottled water (flavored and unflavored), and fermented beverages. Coffeeberry^® may also be added to foods such as soups, snack chips, candies and confections, and pastries.

It was estimated that Coffeeberry^® may be consumed in as many as four servings of beverage per day and also in as many as four servings of other food products per day. Assuming a maximum concentration of 300 mg per serving, the potential daily intake of Coffeeberry^® from the addition to beverage and food products is estimated to be 2,400 mg, equivalent to 34.3 mg/kg bw/day for a 70 kg individual.

Although the serving size of each beverage or food will vary, the maximum intended level of Coffeeberry^® products (whole powders or dried aqueous ethanolic extract) in any beverage or other food product is 300 mg per serving.

4. Chemistry

The petitioner confirmed that the ethanol used in the manufacture of the aqueous ethanolic extract version of Coffeeberry^® meets its Food Chemical Codex (FCC) specifications. No other chemical substances are used in the manufacture of Coffeeberry^®. Health Canada has no objection to the use of ethanol in the manufacture of aqueous ethanolic extract of Coffeeberry^® provided that: (1) it meets specifications for ethyl alcohol set out in the most recent edition of the FCC, as confirmed by the petitioner; (2) it is used in the minimum amount required to achieve the intended purpose; and (3) negligible residues remain in the final product.

Analytical data for lead, arsenic, cadmium, and mercury were provided for 5 different lots of Coffeeberry^® whole powders and 4 different lots of Coffeeberry^® aqueous ethanolic extract. The incorporation of 300 mg of Coffeeberry^® products into the target foods would not result in an increase of lead, arsenic, cadmium, or mercury compared to background levels typically observed in similar foods as reported in Health Canada's Total Diet Study as well as the Canadian Food Inspection Agency's (CFIA) Food Safety Action Plan Survey, which included residue data for trace elements in flavoured water and energy drinks. The only exception to this is flavoured water containing Coffeeberry^® that may contain a slightly higher lead concentration than reported in the CFIA's FSAP survey. However, it should be noted that only limited background data for flavoured water is available in the CFIA's dataset. No comparative data were available specifically for sports drinks. Nonetheless, the estimated concentrations of lead in both flavoured water and sports drinks, in which Coffeeberry^® is used at the specified amounts, are up to two orders of magnitude below lead concentrations observed in other types of ready-to-consume beverages that are sold on the Canadian market, such as fruit juices, bottled water and soft drinks.

For mycotoxin analysis (fumonisin B1, B2, B3; aflatoxin B1, B2, G1, G2; OTA), the petitioner provided the results for 3 different lots of Coffeeberry^® whole powders and 2 different lots of Coffeeberry^® organic whole powders. All results were reported as being less than the analytical method's limit of detection and comparable to or lower than levels reported in coffee beans.

5. Microbiology

The petitioner has provided the product microbiological quality results for 5 lots of Coffeeberry^® whole powders and 4 lots of Coffeeberry^® aqueous ethanolic extract to demonstrate that these specifications can be consistently met in a production run. The methods used to test the microbiological purity of Coffeeberry^® are those specified by the AOAC International Official Methods of Analysis and the U.S. FDA's Bacteriological Analytical Manual (FDA BAM). Based on the information provided, Health Canada has no microbiological concerns regarding the use of Coffeeberry^® products as food ingredients.

6. Nutrition

The petitioner provided nutritional composition data including proximates, amino acids, vitamins, minerals, and complete fatty acid profile for the Coffeeberry^® whole powders and the aqueous ethanolic extract. All products are composed mainly of carbohydrates, with lower levels of protein and fat. The aqueous ethanolic extract contains less carbohydrates, protein, and almost no fat compared to the whole powders.

Although Coffeeberry^® products contain a variety of nutrients, the maximum intended serving of 300 mg of Coffeeberry^® whole powders or aqueous ethanolic extract is not considered a source, for labelling purposes, of any macronutrients or micronutrients that have an established Daily Value (DV).

7. Toxicology

The petitioner provided toxicological studies to support the safety of Coffeeberry^®. These included a sub-chronic (90-day) oral toxicity study in rats, an in vitro bacterial reverse mutation assay, and an in vivo micronucleus assay in mice. These studies were conducted in accordance with international standards. A scientific rationale was provided to support the safe use of the products by pregnant women. Dietary exposure was also calculated for caffeine and chlorogenic acids (CGA), the major active constituents of Coffeeberry^®. The information provided was sufficient to assess the safety of the Coffeeberry^® whole powder and aqueous ethanolic extract in foods.

The sub-chronic oral toxicity study conducted in rats (10 rats/sex/group) used the aqueous ethanolic Coffeeberry^® extract at doses ranging from 0 to 5.0% in the diet. A No Observed Adverse Effect Level (NOAEL) of 5% in the diet was established which is equivalent to 3,446 and 4,087 mg/kg bw/day for males and females, respectively. The petitioner provided a conservative dietary intake assessment where it was estimated that individuals would consume up to 8 servings per day of Coffeeberry^® products; 4 servings from beverages and 4 servings from other foods. This is equivalent to doses of 34.3 mg/kg bw/day in adults weighing 70 kg and 68.6 mg/kg bw/day in a 35 kg child. When compared to the NOAEL established in the 90-day study, a margin of exposure (MOE) was determined to be 100 for adults and 50 for children. The lower MOE in children reflects the assumption that children would consume the same amount of Coffeeberry^® from food and beverages as an adult. This MOE was considered large enough from a safety perspective to protect consumers.

Regarding exposure to caffeine, the Coffeeberry^® whole powders contain about 1% caffeine while the aqueous ethanolic extract contains up to 2%. The maximum dietary intake of caffeine from consuming 8 servings of the most concentrated product would be 48 mg/day. This amount would be below the Health Canada guidelines for caffeine in all populations except for young children in whom it would be marginally above their recommended levels (Recommended Maximum Daily Intake of caffeine for 4 to 6 year olds = 45 mg/day). Considering the conservative exposure scenario and the fact that the daily exposure to caffeine per day would resemble consuming 1 can of cola (typically containing 36-50 mg/355 mL serving), this dietary intake of caffeine would not be expected to pose a safety concern.

Coffeeberry^® is also a source of chlorogenic acids (CGAs), with the whole powders containing < 4.5% and the aqueous ethanolic extract containing < 45.0%. CGAs are common constituents of the diet, with the greatest intake being from the consumption of coffee. Since CGAs are regularly consumed in the diet with no apparent toxicity, exposure to CGAs from the consumption of a few servings of Coffeeberry^® per day would not be expected to result in any adverse health effects.

No reproductive studies on Coffeeberry^® were submitted. However, the petitioner argued that Coffeeberry^® products did not exhibit any genotoxic potential and a 90-day oral toxicity study did not result in any adverse health effects at levels much higher than those expected to be consumed in the diet. Furthermore, exposure to caffeine was within Health Canada's recommended maximum daily intake for pregnant women, and the level of chlorogenic acids in one serving of the most concentrated Coffeeberry^® product was similar to consuming one cup of coffee or less. Compositional analyses also demonstrated that any component identified by the petitioner in the coffee berry that was not present in the coffee bean (all identified as polyphenols) was a normal constituent of other commonly consumed foods at comparable levels. No new compounds not previously known to be a component of food were identified by the petitioner. Based on this information, there is no reason to expect that Coffeeberry^® would pose a risk to pregnant women or the developing fetus.

The petitioner did not submit any allergenicity studies or data but stated that Coffeeberry^® products have been sold in several countries for over 10 years and they are not aware of any reports of allergic reactions. Based on the available information, there is no indication that Coffeeberry^® products would pose a major allergenicity concern for the general public.

Conclusion:

Health Canada's review of the information presented in support of the use of Coffeeberry^® whole coffee fruit derivatives as food ingredients in Canada within the proposed conditions of use concluded that there are no food safety concerns for the general population. It is the continuing responsibility of the manufacturers, sellers and distributors of Coffeeberry^® products to ensure that marketed products are in compliance with all applicable statutory and regulatory requirements, including labelling and advertising.

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, PL2204E
251 Frederick Banting Driveway
Ottawa, Ontario K1A 0K9

Telephone: 613-957-1742
Facsimile: 613-952-6400