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Food > Labelling > Nutrition Labelling Part 2 - Analysis and FeedbackIntroduction and PurposeOn 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 these food regulations of the Food and Drugs Act and Regulations. Health Canada and the Canadian Food Inspection Agency (CFIA) are committed to facilitating the implementation of these regulations in a manner that will retain the confidence of consumers and health professionals in the reliability of the nutrition information. The CFIA strategy for enforcement and compliance calls for a phased-in approach, permitting industry and government time to adapt to the new regulations. During the transition period, the CFIA is training staff and updating inspection tools, such as the 2003 Guide to Food Labelling and Advertising and the Nutrition labelling Compliance Test. Industry is responsible for complying with the regulations within three years (five years for small business <$1 million/year food sales in Canada) and for ensuring the accuracy of label values. The new regulations require that the nutrient values reflect the specific product being labelled. Given the many factors that affect the variability of nutrients in food and the high cost of laboratory analysis, the challenges for achieving accurate product specific information are recognized. In developing and/or verifying label values, industry may choose the risk management strategy best suited to the food(s) to be labelled, including the choice of sampling plans, methods of analysis, laboratories, whether to use a data base and the choice of data base and software. The purpose of this Compliance Test is to provide a 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. With the introduction of mandatory nutrition labelling, encompassing a wide variety of foods and an expanded list of nutrients, as well as the expansion of nutrient content claims and introduction of health claims, it was apparent that the existing system for testing accuracy of nutrient values needed review to achieve an improved, more effective system. 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 CFIA compliance test standard for assessing the accuracy of nutrient values is the result of this consultation. This test applies to nutrient data in the Nutrition Facts table, nutrient content claims and for diet-related health claims, where they appear on labels and in advertising. Information on procedures for generating label values will be provided in a new Guide for Developing Nurtition Labelling Values prepared by Health Canada. This should assist industry in developing their strategy, including sampling and analysis as well as using data bases/software packages to generate nutrient data for labels that are accurate, reliable and in compliance with the Food and Drug Regulations. BackgroundStatutory Authorities: Food and Drugs Act and Regulations The CFIA is responsible for enforcing the food requirements of the Food and Drugs Act and Regulations. Verification of the accuracy of nutrient data on labels and in advertising is one part of the CFIA compliance strategy. In Canada, there are no specific regulations dealing with tolerances and acceptance sampling to determine accuracy of nutrient amounts. Section 5 is the provision of the Food and Drugs Act relevant to truthful, accurate information. Subsection 5(1) makes it an offence to "label, package . . . sell or advertise any food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety". Subsection 5(2) states that "an article of food that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1)". A food label or advertisement that bears nutrient values that are not truthful or accurate may be in violation of subsection 5(1), since it may be false and/or may create an erroneous impression as to the food's composition, merit or safety. In particular, an erroneous impression of safety may occur if the nutrient is one under strict control for the dietary management of disease. Under subsection 5(2), an inaccurate nutrition label may also be in violation of subsection 5(1) if it is considered to be labelled contrary to the requirements of the Food and Drug Regulations. It is not technologically feasible or practical to determine with absolute accuracy the amount of nutrient in every container of food; a statistically sound sampling plan should, however, allow consumer confidence in the nutrition information and meet reasonable expectations of industry responsibility for accurately representing what is in the food, while respecting the inherent variability of nutrients in food and of manufacturing processes. Compliance testing of declared nutrient values applies equally to imported and domestic product. Mutual recognition agreements and/or equivalence with exporting countries' measures will be pursued as appropriate to ensure that compliance with Canadian requirements does not unnecessarily impede trade. History of Assessing Compliance of Nutrient Values in Canada The procedure for evaluating compliance of nutrient levels in foods was first developed by the former Health and Welfare Canada in the 1980s for fortified foods. The procedure was designed using statistical theory of sampling, to provide reasonable assurance that unsatisfactory lots would not be overlooked ( consumer's risk) and that satisfactory lots would not be falsely condemned (producer's risk). The procedure called for the selection of 5 containers at random from a lot, analysis of the nutrient concentration in each, and calculating the average of the 5 measurements. A 10% tolerance was allowed, for example, where a minimum requirement was stipulated, the lot would have been considered unsatisfactory if the average were less than 0.9 of the regulatory minimum. In addition, excessive variability was evaluated. A lot would have been considered unsatisfactory if any one sample were less than 0.3 of the regulatory minimum. In 1990, following the introduction of voluntary nutrition labelling in Canada, Thompson and Jarvis, Health Canada (1), added a second procedure to be used for the enforcement of nutrition labelling and claims by the former Consumer and Corporate Affairs Canada. The procedure called for 12 containers to be selected at random from a lot, and from these 12 containers a composite is formed and its nutrient composition analyzed. If a minimum were implied and if the resulting measurement were less than 0.8 of label declaration, the lot would be unsatisfactory. If a maximum were implied and if the resulting measurement were greater than 1.2 of the label value, the lot would also be considered unsatisfactory. The rationale for using a single composite sample of 12 units for the naturally occurring nutrients was explained as follows: since the manufacturer does not always have control over the variability of the nutrient content from container to container, the sampling plan does not attempt to monitor variability. A tolerance of 20% was allowed in recognition of the variability inherent in these nutrient concentrations, so that manufacturers would be encouraged to label a product with the true lot average. The analysis of a composite of 12 consumer units is the procedure used in the United States by the Food and Drug Administration (FDA) for verifying compliance of declared values in their nutrition facts table for naturally occurring nutrients. The current section 6.3 in the Guide is a modification of the Health Canada procedure. It was developed and issued as a proposal for comment in 1995 (2) as part of the 1995/1996 review of the Guide by Agriculture and Agri-Food Canada. After minor revisions resulting from comments received, it was published as part of the Guide in 1996. This revised procedure tightened requirements for claims to a 10% tolerance and provided no tolerance where a minimum or a maximum requirement is stipulated. International SituationThe Codex Alimentarius lists analytical methods for nutrients in the Codex Methods of Analysis and Sampling as well as general provisions for sampling plans for commodity standards in the Sampling Plans for Prepackaged Foods (3). In the US, the FDA (4) and the US Department of Agriculture (USDA) have, as part of the nutrition labelling rules, provisions for sampling, laboratory analysis and compliance limits for the analyzed value vs. label value, as well as provision for using nutrient data bases for the purpose of nutrition labelling. The Food Standards Australia New Zealand (FSANZ) provides for the use of nutrient values of national food and nutrient data bases for food labelling. Details of the international situation are given in Appendix 1. Description of Nutrition Labelling Compliance TestThe Nutrition Labelling Compliance Test describes a set of conditions that constitutes the CFIA methodology for verifying nutrient accuracy of the Nutrition Facts table and claims set out in the new regulations. The compliance test is not intended as a sampling plan for use by manufacturers. Manufacturers are responsible for determining the accuracy of nutrient values and may choose the method best suited to the food(s) to be labelled. The Compliance Test comprises the laboratory analysis of the nutrient content of a statistically based sample from a lot and acceptance criteria. A minimum of 12 consumer units are to be randomly selected from a production or inspection lot of a food and arranged in three groups of four consumer units, with each group composited to provide three composite sub-samples for lab analysis. The principal acceptance criterion is a one-sided test for naturally occurring nutrients in nutrition labelling and claims, requiring accuracy within 20% of label values, i.e. the analyzed nutrient content must at least 80% of label value for protein, carbohydrate, fibre, vitamins and minerals and not more than 120% of label value for Calories, fat, saturated fat, trans fat, cholesterol, sugars and sodium for the nutrients in the Nutrition Facts table. These tolerances are adjusted for rounding rules, as applicable. Additional acceptance criteria respecting overall variability of nutrient content also apply. For statements or claims respecting added vitamins, mineral nutrients and amino acids, the amount found in the sample must be at least equal to the label value. Amounts may vary above labelled or required amounts where a minimum is stipulated and may vary below labelled or required amounts where a maximum is stipulated within good manufacturing practices. |
Statistical FrameworkThe Compliance Test is based on a sample of units selected from a lot. Basing a decision concerning a lot on a sample taken from that lot involves risk. The risk to the consumer is that a lot that does not meet the declared nutrient value and will be judged satisfactory (consumer's risk); the risk to the producer is that a lot that does meet the declared nutrient value is judged unsatisfactory (producer's risk). A sampling plan is evaluated by estimating the magnitude of these two competing risks. Assumptions are made concerning the distribution of nutrients within and between lots and major sources of variation are considered. Details of the statistical framework are set out in Appendix 2. Selected examples of the risks to consumers and producers of the compliance test are summarized in the tables below. The consumer's risk data suggest that for Class 1 nutrients (added vitamins and minerals, no tolerance), if the average concentration is only 90% of the declared nutrient value, nutrient variability (%CV) between 10% and 20%, test method variability (%CV) of 7%, there is a 3% to 7% chance that these products would be accepted. Producer's risk data for class I suggest that if the average concentration of added nutrients is 120% of label value, the chance that these products would be found noncompliant is between 0.2% - 1.5%. For class II nutrients where nutrient variability is typically higher, consumer's risk and producer's risk ranges are somewhat wider. Table - Examples of consumer's risk data
Table - Examples of producer's risk data
* all variability is reported as % Coefficient of Variation = %CV (= Relative Standard Deviation = RSDr for laboratory test) Nutrition Labelling Compliance Test and Rounding RulesThe amendments to the Food and Drug Regulations include mandatory rounding rules for declared nutrient values. These regulations provide that an accepted range of values is represented by a single rounded value (see Appendix 3). Where determining the critical point for compliance purposes, both the accepted range of values before rounding and the compliance test tolerances must be factored into the calculation. CriteriaA sound statistical framework forms the underpinning of the compliance test. In addition, the following criteria are consistent with CFIA and Health Canada policies and procedures and take into account stakeholder input; they were used to evaluate the CFIA Compliance Test: 1. Public Health: For consumers, label values that pass the Compliance Test should not increase risk to health. Health risk could occur if the nutrient values on most food labels or on a label of a frequently consumed food differed consistently and by a significant amount from the actual concentration, and, as a result, a consumer mistakenly estimated the amount consumed. This could lead to over-consumption of Calories and nutrients such as saturated and/or trans fat or under-consumption of nutrients, such as calcium over the long term. The main objective for the sampling procedure is to ensure that the sample taken is representative of the lot and measures, as closely as possible, the lot average while providing for some variability within the lot. Based on statistical analysis of all sources of variability involved, it is believed that, for most food products, values in the Nutrition Facts table, that pass the compliance test, would be close to the true mean. In addition, provision is made for using a more stringent tolerance on a case by case basis, if warranted, based on a health risk assessment. 2. Consumer Protection: For consumers, label values that pass the Compliance Test should, within reasonable limits of variability, accurately represent the nutrient content of the product purchased. Taking into consideration the inherent variability of nutrients in food, the risk of erroneously accepting products of unacceptable quality with the proposed sampling plan is very low. Detail is presented in Appendix 2. For example, with an acceptance level of 80% of label value for the Nutrition Facts table, typical relative variability of the analytical method of 7%, and a relative nutrient variability of 10% to 40%, a lot of products with a true average of 70% of label value would have a 3%-17% chance of being erroneously accepted. Where the lot average value falls as low as 60% of label value, there is at most a 1% chance of being accepted. More stringent assessment criteria for comparisons were chosen, since, using a 20% tolerance combined with rounding, a comparison may not be valid if nutrient levels are highly variable. Therefore, the basis for assessment of comparative claims is that they be statistically justifiable. The evaluation of such claims usually involves the analysis of both the food for which the claim is made and the food to which it is compared. 3. Fair Treatment of Manufacturers: For food processors accurately describing foods within reasonable limits of variability and following good manufacturing practices, label values should have a high probability of passing the Compliance Test. The tolerances and sampling plan have taken into consideration nutrient content variability among containers within a lot, variability between different lots, as well as method variability and laboratory bias. Producers that use label values that take into account all of the above sources of variability should have a high probability of meeting the Compliance Test for all lots tested. For example, a 20% tolerance for nutrition labelling values as applied to a lot should allow foods to be labelled with representative values taking into account the natural variability of nutrients within the lot and variability in nutrient laboratory methods. 4. Effectiveness and Efficiency of the Inspection System: The Compliance Test should be effective and efficient for industry to comply with and as a tool for government to use for the enforcement of the Food and Drug Regulations. The Compliance Test should be designed so as to fully achieve the objective without unnecessarily impeding trade. The previous practice of using two different sampling plans (five or twelve units) and tolerances (10% and 20%) for nutrient content claims and nutrition labelling, respectively, has often been found to be inefficient. The analysis of 3 composite sub-samples of 4 consumer units each should be cost effective for the CFIA, since it would seem to be the minimum number of units and analyses needed for most situations in order to have confidence that the CFIA has not missed a noncompliant product and that an enforcement action is justified. Further, the Compliance Test should not unnecessarily impede trade, since, with few exceptions, the tolerances, sample number, rounding rules, definitions and laboratory methods are the same as those of the US, Canada's major trading partner. Alternatives ConsideredIt has been recognized for some time that a single analysis of a single container of food yields unreliable nutrient values. Health Canada, therefore, developed a policy to evaluate compliance based on a production lot and a sampling plan and tolerances that would take into account variations in nutrient composition and analytical measurements and that would minimize consumer's and producer's risk. Consequently, a statistically based system with the foregoing characteristics was the only approach considered; the choice of alternatives was among different sampling plans and acceptance criteria. The three sampling plans considered as alternatives to the chosen sampling plan (a sample of 12 consumer units arranged in three groups of four units, composited) were already in use for evaluating nutrient content of a sample, as follows:
The producer's risk and consumer's risk for these three alternative systems incorporating different levels of variation in composition and analytical reproducibility were assessed. These data show that the producer's risk and consumer's risk are generally lowest with the chosen scheme (scenario A - three composite samples of four consumer units). Although any one of the alternative schemes would have met most of the criteria established, there were specific reasons for rejecting each one, as follows:
The following table provides additional information on the relative strengths and weaknesses of the four scenarios considered:
* all variability is reported as % Coefficient of Variation = % CV (= Relative Standard Deviation = RSDr for laboratory test) A difference between the FDA procedure (Scenario B) and the new CFIA procedure (Scenario A) is that the US procedure makes allowance for the variability of the analytical method if it exceeds the tolerances. The Canadian procedure includes the variability of the analytical method in the tolerances. The government's development of representative label values for single ingredient foods for use directly on labels by producers and retailers was considered. Pre-approval of industry data bases for nutrition labelling was also considered. However, it was decided that, before the end of the transition period, industry would be encouraged to develop nutrient data sources and related software and analytical capacity that are needed to generate the Nutrition Facts table. Health Canada would assist in providing guidance and expertise. FeedbackIn response to Health Canada's policy proposals, published in October, 2000 and later proposed regulations in Canada Gazette, Part I, June 16, 2001, many comments were received on compliance of nutrient values on labels and related enforcement issues. Meetings were held with producer groups and manufacturers on nutrient data needs, use of published data and compliance policy respecting nutrient accuracy. Stakeholders commented as follows: Consumer and Health organizations:
Industry
Feedback to the Consultation Document Interested parties were invited to comment within 45 days to a CFIA Consultation Document on a proposed compliance test, issued November 28, 2002. Responses were received 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 overall approach and the sampling plan. The majority supported 20% tolerance limits for the Nutrition Facts table. The need for nationally representative nutrient data for raw single ingredient foods, whose labelling is voluntary, was reiterated. Responses to specific questions are as follows with the CFIA position in bold:
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