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Food > Labelling > Nutrition Labelling > Toolkit Part 1 - Nutrition Labelling Compliance TestPurpose and ScopeThe purpose of the Nutrition Labelling Compliance Test ( Compliance Test ) is to provide a transparent, science-based system for assessing the accuracy of nutrient information for food in Canada. The Compliance Test outlines the Canadian Food Inspection Agency's (CFIA) procedure for assessing the accuracy of nutrient values on food labels and in advertising via laboratory analysis. The test applies to a nutrient, including an added vitamin or mineral nutrient, that is declared in the Nutrition Facts table or is the subject of a nutrient content claim or a diet-related health claim. The Compliance Test also assesses whether a food bearing a nutrient content claim or health claim meets the nutrient content criteria for the claim set out in the Food and Drug Regulations. The Compliance 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 a minimum or maximum requirement for an added vitamin, mineral nutrient or amino acid, for which section 6.3 of the Guide to Food Labelling and Advertising (the Guide) will continue to apply. Guiding PrinciplesTo achieve label information that is accurate and in compliance with the Food and Drugs Act and Regulations, the following general principles apply:
Statistical BasisThe CFIA considers that the measurement of nutrient content for compliance purposes should be based on a sound statistical framework, such that the food industry would have a high probability of a correct label value passing the Compliance Test, while the consumer would have an equally high probability that the label value accurately reflects the nutrient content of the food . To this end, the Compliance Test is comprised of three acceptance criteria applied to the results of laboratory analysis of samples obtained by using a randomized sampling plan. The statistical analysis takes into account nutrient variability in foods as well as method variability. The producer's risk (the probability that a lot with acceptable label values is erroneously rejected) and the consumer's risk (the probability that a lot with unacceptable label values is erroneously accepted) are calculated using several values for each component of variability (see statistical framework in Appendix 2). DefinitionsLot: a collection of identically labelled1 products produced under conditions as nearly uniform as possible2 and available for inspection at one time. Consumer unit: the individual container (a primary container) or a portion of the contents of the primary container. Sample: a collection of consumer units drawn from a lot that is representative of the lot for inspection purposes. Composite sub-sample: a subset of consumer units from the sample that are combined and mixed to homogeneity. Nutrient DefinitionsCalorie calculations and nutrient definitions are found in the Food and Drug Regulations and in Chapter 6 of the 2003 Guide to Food Labelling and Advertising (see www.inspection.gc.ca) Methods of AnalysisNutrients are analysed by appropriate methods found in the most recent edition of Official Methods of Analysis of AOAC International (see www.aoac.org) or other collaboratively studied methods wherever possible. (Refer to Laboratory Issues in Appendix 4). Application of Rounding RulesUnder the rounding rules for nutrition labelling, as set out in the table to section B.01.401 of the Food and Drug Regulations, and summarized in Chapter 6, the 2003 Guide, the declared label value is a single rounded value that represents an accepted range of values. The tolerances described below are added to the minimum or maximum pre-rounded value, to obtain the compliance limit (see rounding rules and calculation of compliance limit in Appendix 3). Classes of NutrientsClass I: a vitamin or mineral nutrient that is added Class II: a nutrient, other than an added vitamin or mineral nutrient that is in the Nutrition Facts table or that is subject to regulations for nutrient content claims or diet-related health claims. SamplingAt least twelve individual consumer units are taken randomly from a lot and then combined to make three composite sub-samples of a minimum of four consumer units each. The three composite samples are analyzed and the mean value of the three composite sub-samples shall be the estimate of the lot nutrient content. Acceptance Criteria for Lot ComplianceThe lot will be considered compliant if the following criteria are met (see rationale in Appendix 2): Criterion 1: Each of the composite sub-samples of four consumer units is within 50% of the declared value expressed as a minimum or maximum value allowed by the appropriate rounding rules, and within 50% of the regulatory requirement,if any; that is, at least half as large or at most 1.5 times as large as the declared value adjusted for rounding and as the regulatory requirement (when a minimum or maximum content specified respectively). Criterion 2: The mean ( Criterion 3 (Class 1 Nutrients only): Where a vitamin or mineral
nutrient is added to a food, the standard deviation (s) of the distribution of the
nutrient content of the three composites of four consumer units, is compared to the mean
value ( Tolerances3 (Criterion 2)Class I Nutrients (no tolerance): For added vitamins and mineral nutrients, listed in the table to section D.03.002, Food and Drug Regulations, and summarized in annex 7-1, the 2003 Guide, the declared nutrient value has no tolerance, i.e., the mean nutrient content of the three composite sub-samples is not less than the declared value, adjusted for rounding as in acceptance criterion 2. Class II Nutrients: (20% tolerance) For vitamins and mineral nutrients other than Class 1 nutrients, protein, polyunsaturated fatty acids, omega-3 fatty acids, omega-6 fatty acids, mono-unsaturated fatty acids, carbohydrate, fibre, soluble fibre, insoluble fibre and potassium, that are declared in the Nutrition Facts table or that are the subject of a nutrient content claim or of a diet-related health claim,
For Calories, fat, saturated fat, trans fat, cholesterol, sodium, sugars and sugar alcohols, that are declared in the Nutrition Facts table or that are the subject of a nutrient content claim or of a diet-related health claim,
Exceptions to Class II Stricter tolerances may be applied, as assessed on a case by case basis, as follows: 1) Where the difference between the declared nutrient value and the compliance limit for the nutrient content of the sample may result in a label value that would be a potential risk to health, based on a health risk assessment established by Health Canada. 2) Where a comparative claim is found not to be statistically valid, i.e. where providing tolerances allows the food bearing the claim to be indistinguishable from the reference food. Overages and Deficiencies - Class I and II nutrients Where a minimum limit applies, the nutrient content of the sample may exceed the declared value by an amount that is consistent with good manufacturing practices, and provided that such an overage does not present a risk to health and is not misleading. Where a maximum limit applies, the nutrient content of the sample may be below the declared value by an amount that is consistent with good manufacturing practices and provided that such a deficiency does not present a risk to health and is not misleading. Use of Data BasesIndustry is responsible for complying with all the requirements for nutrient composition and for the accuracy of the information provided on labels. Companies may choose the risk management strategy for developing accurate nutrient data best suited to the foods to be labelled. The use of nutrient data bases is one tool within this context. To assist manufacturers of multi-ingredient foods, the Food and Drug Regulations require that food ingredients intended solely for use in the manufacture of other prepackaged foods must provide relevant nutrition information about their product. Verification of label values by the CFIA will focus on industry system controls, including record keeping, raw material control and specifications, company lab analysis, documentation of data sources, audit verification, management of ingredient data (including updates, ingredient changes, substitutions and processing effects). The CFIA will not evaluate nutrition labelling data bases, as such. The definitive determination of compliance of label values by the CFIA will be based on laboratory analysis, as outlined in the Compliance Test. A tolerance of 20% is allowed in recognition of the variability inherent in nutrient concentrations and to encourage manufacturers to label the food with the true lot average. Where variation is very high, a conservative label value would avoid exceeding the compliance limit. If any product is found to be out of compliance, the CFIA intends to work with the manufacturer to understand and correct the problem. ImplementationThe CFIA Compliance Test may be applied to labels bearing the Nutrition Facts table, new nutrient content claims or diet-related health claims, published in Canada Gazette II, January 1, 2003. The approach to assessing compliance of nutrient values for raw single ingredient foods for which nutrition labelling is voluntary will be reviewed when adequate data become available for these products. |
Table - Sampling Plan and TolerancesSample is 3 composite sub-samples of 4 consumer units randomly selected from a lot
ExamplesThe following examples show how the three criteria of the Compliance Test would be used to assess the accuracy of declared nutrient values from laboratory analysis data. For each scenario, the following information is shown: the amount of nutrient declared in the Nutrition Facts table and/or required for the nutrient content claim; the laboratory analysis of three sub-samples, mean value and standard deviation (s); and the assessment based on one or all of the criteria and justification. 1. Vegetable Oil - Fat and Fatty acids
2. Lean Ground Beef - Iron
3. Granola Cereal - Fibre
4. Pasta - Added Iron
5. Wieners - fat-reduced
6. Fruit Drink - Vitamin C added
1 Identically labelled means the label is uniform in every detail, including, but not limited to, brand name, common name, net quantity, lot coding (if present), best before date (if present), legal agent name and address, in addition to nutrition labelling and claims. That the products are identically labelled implies that the products themselves are identical within the terms stated above. 2 As nearly uniform as possible includes, but is not restricted to, a continuous eight-hour production period. Some flexibility is necessary to allow for sampling where no lot codes are present, or where the production period is not clearly defined or is not continuous. 3 These tolerances take into consideration variability among containers within a lot, variability in mean nutrient values between different lots, as well as within laboratory and between laboratory method variability. Therefore, no additional tolerance is allowed for method variability. |