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Nutrition Labelling Compliance Test

Nutrition Labelling, Nutrient Content Claims and Health Claims:
CFIA Compliance Test to Assess the Accuracy of Nutrient Values

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Summary

On January 1, 2003, Health Canada published, in Canada Gazette, Part II, amendments to the Food and Drug Regulations to require most prepackaged foods to bear a Nutrition Facts table, listing 13 nutrients and Calories, as well as new and updated regulations for nutrient content claims and diet-related health claims. These amendments will provide Canadians with information to prevent injury to their health by helping them make appropriate food choices.

The Canadian Food Inspection Agency (CFIA) is responsible for enforcing the food requirements of the Food and Drugs Act and Regulations. While industry is responsible for complying with the new regulations within three years (five years for small business), Health Canada and the CFIA are committed to facilitating their implementation in a manner that will retain the confidence of consumers and health professionals in the reliability of the nutrition information. During the transition phase, the CFIA will be training staff and updating inspection tools, such as the 2003 Guide to Food Labelling and Advertising and the Nutrition Labelling Compliance Test (Compliance Test).

The challenges for industry in generating product-specific nutrient data for nutrition labelling are recognized. Industry is responsible for ensuring the accuracy of label values and may choose the risk management strategy best suited to the food(s) to be labelled.

The purpose of the CFIA Compliance Test is to provide a transparent, science-based system for verifying the accuracy of nutrient values on labels and in advertising via laboratory analysis as part of assessing compliance with the Food and Drug Regulations. A consultation document, Nutrition Labelling, Nutrient Content Claims and Health Claims, a Proposed Compliance Test to Assess the Accuracy of Nutrient Values, was issued November 28, 2002, soliciting comments on proposed changes to section 6.3, the Guide to Food Labelling and Advertising (the Guide), titled: Compliance for Nutrient Content Claims and Declarations. The intent was to revise the system to be simpler yet as effective as possible in promoting accurate nutrition information. The document assessed various sampling plans and tolerances using a statistical framework, while considering criteria of public health, consumer protection, fair treatment of manufacturers and efficiency and effectiveness of the inspection system. The comments of stakeholders on compliance issues during the Health Canada consultations were also considered.

The CFIA received responses to the Consultation Document from sixteen stakeholders, including the Consumers' Association of Canada, eight major national associations representing either producers, manufacturers or retailers, a number of individual manufacturers, a commercial laboratory and a university professor of nutritional sciences. The respondents generally supported the science-based approach to minimizing the consumer's risk and producer's risk considering multiple sources of variation. The sampling plan and the acceptance criteria involving a 20% tolerance for the Nutrition Facts table were supported; however, there was less support for some of the more restrictive criteria, for example, those for nutrient content claims. A number of respondents expressed concern that the approach did not provide for the use or development of nationally representative data base values for raw single ingredient foods, such as fruits, vegetables, meat and fish.

The resultant Compliance Test constitutes the CFIA methodology for assessing the accuracy of nutrition labelling and claims. It is based on the laboratory analysis of the nutrient content of three composite samples of four consumer units each, randomly selected from a lot and the results of analysis subjected to three acceptance criteria. The principal acceptance criterion would require accuracy within 20% of declared value for the average of three composite samples for naturally occurring nutrients in the Nutrition Facts table, i.e., the analyzed nutrient content would have to be at least 80% of declared value for protein, carbohydrate, fibre, vitamins and minerals and not more than 120% of declared value for Calories, fat, saturated fat, trans fat, cholesterol, sugars and sodium. For added vitamins, mineral nutrients and amino acids in claims or in the Nutrition Facts table, the amount found in the sample must be at least equal to the label value. In addition, adjustments are made for rounding in accordance with rounding rules in the Food and Drug Regulations. Acceptance criteria for overall variability of nutrient levels also apply.

This test does not apply to a human milk substitute, a food represented as containing a human milk substitute, a formulated liquid diet, a meal replacement, a nutritional supplement, a food represented for use in a very low energy diet, or minimum or maximum requirement for added nutrients, which are not part of the nutrition labelling and claims amendments but subject to their own regulations. Section 6.3 of the Guide will continue to apply to these foods.