ARCHIVED - Summary of the Basis of Health Canada's Decision to Allow the Use of Caffeine in Carbonated Soft Drinks - Food Safety - Health Canada

Introduction

Caffeine is a chemical found in the leaves, seeds or fruits of a number of plants and it occurs naturally in foods such as coffee, tea, and chocolate. It is also manufactured synthetically and used as a food additive in some carbonated beverages in Canada.

The Food and Drug Regulations have long permitted the use of pure caffeine (whether synthetic or extracted from natural sources) as a food additive in cola-type beverages up to a maximum level of use of 200 parts per million (ppm). This provision has been interpreted to also include the product known as “Dr. Pepper” and some brands of root beer, based on the traditional use of caffeine-containing components in the manufacture of these products.

In 2009, Health Canada’s Food Directorate completed a detailed safety assessment of possible caffeine use in carbonated soft drinks (CSDs) after receiving a food additive submission requesting that Table V, Division 16 of the Food and Drug Regulations be amended to provide for the use of the food additive caffeine in a selected CSD.

Safety Evaluation

As part of the safety evaluation, consideration of the toxicological aspects of the submission were based on a previous Health Canada review, initiated in 2000, of the toxicological effects of caffeine on human health. The results of this detailed review were published in a journal article entitled “Effects of Caffeine on Human Health”. The conclusions and recommendations of this toxicological review can be summarized as follows:

• There is ample evidence indicating that for the general population of adults, daily caffeine intake at a dose level of 400 mg/day (6.5 mg/kg bw/day or the equivalent of about three 236 ml [8-oz] cups of coffee) is not associated with general toxicity, cardiovascular effects, behaviour effects, cancer incidence and adverse effects on male fertility. Moreover, bone status and calcium balance are not affected by this dose level, provided that there is adequate calcium in the diet (although, it was noted that about 50% of Canadian women are calcium deficient);
• It is recommended that caffeine intake for women who may become pregnant or are pregnant should not exceed 300 mg/day (4.6 mg/kg bw/day); and
• It is recommended that caffeine intake for pre-adolescent children should not exceed 2.5 mg/kg bw/day. Using this recommended maximum intake level and based on average body weights of children, the daily intake by those aged 4-6 years, 7-9 years and 10-12 years should not exceed 45 mg/day, 62.5 mg/day and 85 mg/day, respectively. The data did not allow a recommended maximum intake level for adolescents to be derived.

The safety evaluation also considered potential dietary exposure to caffeine from foods with naturally-containing or added caffeine. Exposure was determined for individuals aged 2-12 years, based on (1) food consumption data from the Canadian Community Health Survey – Cycle 2.2 on Nutrition (CCHS, Statistics Canada, 2004); (2) the level of caffeine typically found in other dietary sources of caffeine; and (3) current market use levels of caffeine in cola-type CSDs in Canada and reported U.S. market use levels of caffeine for all other types of CSDs. The resulting estimated caffeine intakes are considered to accurately reflect caffeine intakes by children in Canada under the scenario where the permitted areas of use of caffeine is extended to all CSDs. Children were previously identified as being of concern for potential over-exposure to caffeine if the food additive caffeine is permitted in all CSDs. For this reason, exposures among adults were not estimated.

Median caffeine intake levels ranged from 0.90 mg/kg bw/day for females aged 9-11 years to 1.25 mg/kg bw/day for children aged 2-3 years. At the 75^th percentile, caffeine intake ranged from 1.42 mg/kg bw/day for females aged 9-11 years, to 2.06 mg/kg bw/day for children aged 4-5 years. These values are within the recommended maximum daily intake value of 2.5 mg/kg bw/day for these age groups. For those children who consume significantly higher amounts of CSDs (i.e., those at the 90^th percentile), the data suggest that there is the potential for children in this sub-group to exceed the recommended maximum intake of 2.5 mg/kg bw/day on days when CSDs are consumed. These data are based on a worst-case-scenario in which all CSDs will be caffeinated. It was also noted that under the scenario where only cola-type beverages are caffeinated, there is still the potential for children to exceed the recommend maximum intake of caffeine.

Decision Summary

As a result of the safety assessment, Health Canada scientists concluded that the use of pure caffeine as a food additive in CSDs would not raise any health or safety concerns provided that Health Canada’s recommendations for maximum caffeine daily intakes are not exceeded. As a result, Health Canada issued an  Interim Marketing Authorization legally permitting the addition of caffeine and caffeine citrate to non-cola type carbonated beverages to a maximum level of use of 150 ppm caffeine. The Regulations continue to permit the use of caffeine and caffeine citrate in cola-type beverages to a maximum level of use of 200 ppm caffeine. Health Canada has also identified the need to continue to support measures (e.g., the preparation of educational material; ensuring the availability of information on caffeine) that will encourage high consumers of such beverages to reduce or moderate their rates of consumption.

It is already a regulatory requirement that food additives such as caffeine be declared on the ingredient list of prepackaged foods (carbonated soft drinks are the only food to which pure caffeine can be directly added). However, to ensure that consumers have the necessary information to determine caffeine intake, Health Canada has asked industry to go beyond these food additive labelling requirements (i.e., the mandatory declaration of caffeine in the list of ingredients) and voluntarily identify on product labels the total amount of caffeine contained in their caffeinated products (amount of caffeine per stated serving size), and to also include in this declaration any caffeine from natural ingredients such as guarana. Health Canada has also asked that the presence of caffeine be identified on the front of package labelling (principal display panel) of newly caffeinated beverage formulations. The front of packaging labelling will help consumers to clearly identify the presence of caffeine in products whose previous formulations did not contain caffeine. In this regard, Health Canada has published a preliminary guidance document for industry on the labelling of caffeine content in prepackaged foods.

Health Canada will monitor the labelling practices of industry to determine whether regulatory action is required to ensure consistency in provision of information to consumers.

Additional information that can allow Canadians to monitor dietary caffeine intake is readily available on Health Canada’s website; for example, the It’s Your Health document on caffeine and a caffeine fact sheet that includes caffeine levels found in various foods.

P. Nawrot, S. Jordan, J. Eastwood, J.Rotstein, A. Hugenholtz, M. Feeley, Effects of Caffeine on Human Health. Food Additives and Contaminants, 2003, Vol. 20, No. 1, pg.1-30