Nutrition Labelling Compliance Test
Part 2 - Analysis and Feedback

Introduction and Purpose

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 updated regulations for nutrient content claims and disease risk reductions claims. These regulations 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.

Industry is responsible for complying with the regulations and for ensuring the accuracy of label values. The 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.

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 disease risk reduction claims, where they appear on labels and in advertising.

Information on procedures for generating label values is provided in the Guide for Developing Nutrition Labelling Values prepared by Health Canada. This will 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.

Background

Statutory 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 CanadaFootnote 4, 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.

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 Situation

The 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 FoodsFootnote 5.

In the US, the FDAFootnote 6 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 Test

The 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 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 Framework

The 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 I 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
Nutrient Class Criteria
acceptance level
True Mean % label Variability of nutrients within lot Table Note 5 Method Variability Table Note 5 Between lab & lot variability Table Note 5 Consumer's
Risk (%)
Class I, added vitamins, minerals ≥ 100%

declared nutrient value

90% 10% - 20% 7% 3% 3% - 7%
Class II, protein, carbohydrate fibre, vitamins, minerals ≥ 80%

declared nutrient value

70 % 10%-40% 7% 3% 1% - 13%

Table Notes

Table note 5

all variability is reported as % Coefficient of Variation = %CV (= Relative Standard Deviation = RSDr for laboratory test)

Return to table note 5 referrer

Table - Examples of producer's risk data
Nutrient Class Criteria
rejection level
True Mean
% label value
Variability of nutrients within lot Table Note 6 Method Variability Table Note 6 Between lab & lot variability Table Note 6 Producer's
Risk (%)
Class I, added vitamins, minerals < 100%

declared nutrient value

120% 10% - 20% 7% 3% 0.2% -1.5%
Class II, protein, carbohydrate, fibre, vitamins, minerals < 80%

declared nutrient value

100% 10% - 40% 7% 3% 0.0% - 6%

Table Notes

Table note 6

all variability is reported as % Coefficient of Variation = %CV (= Relative Standard Deviation = RSDr for laboratory test)

Return to table note 6 referrer

Nutrition Labelling Compliance Test and Rounding Rules

The 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.

Criteria

A 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 Considered

It 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:

  • One composite sample of 12 consumer units, used previously to assess the accuracy of nutrition labelling for naturally occurring nutrients, also used by the FDA;
  • One composite sample of six consumer units, used by the USDA to assess the accuracy of nutrition information for meat and poultry; and
  • Five consumer units, analyzed individually, applied by CFIA to fortified foods (added vitamins, mineral nutrients and amino acids).

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:

  • One composite of 12 consumer units (scenario B) was rejected, since it did not include provision for measuring variability within the lot; however, the selection of 12 consumer units was retained in the proposal to facilitate equivalence with the US.
  • One composite of six consumer units (scenario C) although harmonized with that of the USDA (meat only), was found to result in slightly higher risk profiles. Also, it was preferred to choose a single sampling procedure for all products.
  • Similarly, analysis of five individual samples (scenario D) was rejected, since it did not conform to the 12 unit sample scheme, and the analysis of five individual units was more expensive.

The following table provides additional information on the relative strengths and weaknesses of the four scenarios considered:

Comparison of 4 Scenarios Considered
Scenario A
(Compliance Test)
12 units
3 composites 4
Scenario B
12 units
1 composite
Scenario C
6 units
1 composite
Scenario D
5 units
individual
Consumer's risk
within lot nutrient variability Table Note 7 < 20%, method variability Table Note 7 7%
lowest consumer's risk 3rd lowest risk 4th lowest risk 2nd lowest risk
Producer's risk
within lot nutrient variability Table Note 7 < 20% method variability Table Note 7 7%
lowest producer's risk 3rd lowest risk 4th lowest risk 2nd lowest risk
Measures variability within lot yes no no yes
CFIA cost of sample pickup & analysis 2nd highest 3rd highest 4th highest highest
Compatibility with US system same no. units as US FDA, compatible with USDA same as US FDA same as USDA fewer units than FDA and USDA

Table Notes

Table note 7

all variability is reported as % Coefficient of Variation = % CV (= Relative Standard Deviation = RSDr for laboratory test)

Return to table note 7 referrer

A difference between the FDA procedure (Scenario B) and the 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.

Feedback

In 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:

  • emphasized the importance of ensuring accuracy and reliability of label information
  • supported a clear enforcement policy, a standardized process for verification of data and a strong monitoring effort to ensure compliance and public confidence in the new label
  • recommended that the nutrition label value not vary more than 10% from the nutrient value determined in the sample by analysis
  • supported consistency between companies marketing identical foods to avoid consumer confusion
  • favoured updating and expanding the Canadian Nutrient File with government leadership and food industry involvement

Industry

  • favoured reasonable tolerance limits for accuracy of declared nutrients, such as a 20% limit, except where nutrient values are very small
  • favoured system for assessing accuracy equivalent to that of the United States
  • considered a 10% tolerance difficult to meet due to limitations in analytical accuracy, variability in manufacturing, added nutrients and variations in nutrient content of ingredients depending on the variety and season
  • supported the use of data bases and computer software to generate nutrition data to help reduce the economic burden and improve consistency
  • recommended that Health Canada review nutrient data generated for labelling purposes
  • recommended that government work collaboratively with the industry to develop nutrient data bases and/or Canadian Reference Tables for raw single-ingredient commodities
  • favoured updating the Canadian Nutrient File

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:

General

Q1 Do you have comments on the approach to minimizing the consumer's risk and producer's risk in developing a standardized compliance test for verifying product specific nutrient data on labels?

There was general agreement with the proposed approach for the compliance test, i.e. to seek to minimize the consumer's risk and producer's risk. A few expressed reservations, stating that the approach was not useful for raw and/or wild single ingredient foods, which tend to have large seasonal and lot-to-lot variation. However, CFIA notes that since consumers and further processors need reliable nutrient content information, it may be appropriate for these foods to have two sets of labels to more accurately reflect the nutrient value of the product, or alternatively, one label using conservative nutrient values.

The proposed approach, to seek to minimize the consumer's risk and producer's risk, is maintained.

Definition of a lot

Q1 Do you agree with the definition of a lot? Why or why not?

Concern was expressed that the definition of a "lot" needed to be more concise, also that the definition was not well suited to import and retail situations.

The definition of a lot has therefore been revised to more concisely reflect the underlying principle of uniformity when selecting samples.

Sampling

Q1 Do you agree with taking a sample of 12 consumer units from a lot, as in the US, to verify compliance? Why or Why not?

Q2 Do you agree with grouping consumer units in three sub-samples of four for laboratory analysis? Why or Why not?

There was general agreement with the proposed sampling plan. One respondent suggested that the sample be changed to 2 composites of 6 units, as it would be less costly for processors. While internal analysis has shown that 2 of 6 units is less costly, 3 of 4 results in lower producer's risk and consumer's risk. CFIA notes that processors are not compelled to adopt the sampling plan used by the CFIA, and can develop their own sampling plans as appropriate.

The proposed approach to take 12 consumer units from a lot, then group them into three sub-samples of four for laboratory analysis is therefore adopted.

Tolerances

Q1 Given that the tolerances must be applied to the pre-rounded values, resulting in a larger overall tolerance that is variable, is the 20% tolerance for the Nutrition Facts table appropriate?

There was general agreement with the proposal with a few exceptions. One industry representative suggested a tighter tolerance of 15%. However, a consumer group suggested that a range of values be acceptable for raw single ingredient food, especially fruits and vegetables, where the inherent nutrient variability is wide. However, based on CFIA's statistical analysis and experience, a 20% tolerance is sufficiently generous to allow an average value for a lot to be in compliance most of the time (e.g. a 6% risk of food being found out of compliance, if CV of nutrient distribution is less than 40% and method variability is 7%).

The proposed approach to apply a 20% tolerance to the nutrient values declared in the Nutrient Facts table is therefore adopted.

Q2 Do you agree that there should be a tighter tolerance for nutrient values that are the subject of claims (10%) than those in the Nutrition Facts table? Why or Why not?

While several agreed that companies making claims should be held to a higher level of accuracy, most did not agree fully with the proposal for a tighter (10%) cut-off for claims than for the Nutrition Facts table. Concern was expressed that a tighter tolerance for nutrient values that are the subject of claims, particularly in relation to certain "low" and "free" claims, would be more difficult to achieve. Several believed that tolerances for claims and nutrition labelling should be the same, since both are "commitments" under the law, the integrity of the labelling process was being judged and that consumers value other nutrients as well as those claimed when judging products. One association found dealing with several tolerances cumbersome. Another mentioned the difficulties for small businesses and single ingredient foods. The CFIA found these arguments persuasive. In addition, similar treatment of claims and nutrition labelling is consistent with the US approach and the adoption of the same approach in Canada would facilitate mutual equivalence with the US.

The tolerance for analyzed nutrient values that are the subject of a nutrient content claim is therefore revised from the proposed 10% to 20% (80%/120%), the same as for the Nutrition Facts table, with exceptions for a health risk and a comparative claim.

Q3 Do you agree that there should be no tolerance for minimum or maximum requirement for claims e.g. in the case of a low fat claims, the sample may not exceed 3 g per serving? Why or Why not?

There was some support for the proposal, but also a number of objections, similar to those in response to the 10% tolerance. Concern was expressed that allowing no tolerance for minimum and maximum requirements for nutrient values that are the subject of claims would be difficult to achieve, particularly in relation to certain "low" and "free" claims.

Therefore the proposed approach is revised to apply a 20% tolerance to analyzed nutrient values in relation to a minimum and maximum requirement for a nutrient content claim.

Q4 Do you agree that there should be no tolerances for declaration of added nutrients? Why or why not?

Support for the proposal was mixed. Several respondents agreed, stating that nutrient ingredients could be more readily controlled than indigenous nutrients and that manufacturers are selling a benefit that the consumer expects to get and should be held to the amounts claimed. Those adding nutrients expressed the need for a tolerance, due to the variation in the naturally occurring nutrients whose amount in the food is combined with the amount of added nutrient for the label value and the higher analytical variability for vitamins. However, Health Canada is of the opinion that levels should not fall below the declared amount of a vitamin or mineral nutrient that is added. Further, this position is consistent with that of the United States.

As a result, no tolerance for the declaration of added nutrients will be allowed.

Q5 Should there be an allowance for method variability, only, in the case of (Q3) and (Q4)? Why or why not?

Q6 Do you agree that the tolerances should incorporate the variability of the method, rather than be additional to the method variability allowance?

Industry stakeholders supported an additional allowance for method variability in all cases. However, CFIA notes that estimates for consumer's risk and producer's risk include method variability as part of the total variability. Further tolerance provisions for method variability would increase consumer's risk. The CFIA will analyze 3 sub-samples of 4 units, which will reduce method variability to 1/3 of the method variability for a single analysis. As noted above, tolerances have been increased to 20% for claims (Q3).

Due to the foregoing and since the rounding rules already contribute additional consumer risk, allowance for method variability will only be considered for label values of added nutrients.

Acceptance Criteria relating to Variability

Q1 Do you consider the acceptance criteria relating to variability (criteria 1 and 3) reasonable? Why or why not?

Q2 Do you agree that these criteria should only be applied to added nutrients or in the case of claims? Why or why not?

Not many stakeholders had an opinion on this issue. Of the five commenting, three supported Criteria 1 and 3. However, they would apply variability criteria to nutrition labelling as well as to claims and added nutrients. While the CFIA agrees that variability of nutrient distribution within a lot should not be excessive, the inherent variability of naturally occurring nutrients in foods is recognized. Added vitamins and minerals are more readily controlled and there may be safety issues associated with large variability.

Therefore, the proposed criteria 1 and 3 will be retained. Criterion 3 will be applied to Class 1, added nutrients, only.

Variations "within Good Manufacturing Practices"

Q1 Do you agree that values may vary "within good manufacturing practices" over labelled amounts in the case of a minimum requirement or may vary under labelled amounts "within good manufacturing practices" in the case of a maximum requirement?

Q2 What would be a reasonable excess or deficiency? For example, if the vitamin content of a sample must be at least 80% of declared amount, how much variation above the declared amount is reasonable?

Most agreed with the proposal that nutrient values with a minimum requirement, may exceed labelled amounts "within good manufacturing practices" and that nutrient values with a maximum requirement may be less than labelled amounts "within good manufacturing practices". One-sided tolerances were considered appropriate in circumstances where health concerns are relevant primarily to over-consumption or to under-consumption, because they ensure that the claimed amount of the nutrient is present in the food without unreasonably varying beyond what is declared to ensure the declared level is present. A few did not favour one-sided tolerances. It was suggested that there should be upper limits for carbohydrate values, of concern to consumers with diabetes, as well as upper limits for protein values, of concern to those following a special diet low in protein. Also, there was concern that the one-sided tolerances would lead to misleading labels. An industry representative suggested a range between 80% and 120% of the label amount. The CFIA, acknowledges the merits of a two-sided approach, i.e. an acceptable range of 80%-120% of the label amount ; however, since this range may be difficult to achieve for many manufacturers, a one-sided approach, either minimum or maximum provides the greatest health benefit.

Therefore, the proposed approach to allow nutrient values with a minimum requirement to exceed the label value "within good manufacturing practices" and those with a maximum requirement to be less than labelled amounts "within good manufacturing practices" will be retained with the proviso that there is no risk to health.

Other Comments:

Databases

Similar to responses to previous Health Canada consultations on nutrition labelling, a consumer association, as well as producer and retail associations expressed disappointment that development of nationally representative nutrient data for raw single ingredient foods and their acceptance for the purpose of nutrition labelling to provide consistency of values for consumers, was not pursued. It was noted that consumers want relative information for those foods not covered by mandatory nutrition labelling as they provide significant contributions to nutritional intakes.

Definitive compliance will be based on laboratory analysis. Evaluation of data bases is not part of the compliance test. However, a nutrient data base may be used as a tool in developing nutrition labelling values; consideration of data sources is part of the compliance approach and would be incorporated in the compliance assessment tool for nutrition labelling, being developed for use in establishment inspection. Information on procedures for generating label values are provided in the Guide for Developing Nutrition Labelling Values prepared by Health Canada.

References:

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