Canadian Food Inspection Agency
Guide to Food Labelling and Advertising

Section VI: Nutrient Content Claims
Annexes 1 - 3

Annex 1: SCHEDULE K (Reasonable Daily Intake) (Food and Drug Regulations)

Reasonable Daily Intake for Various Foods

Annex 2
Foods to Which Vitamins, Mineral Nutrients and Amino Acids May or Must be Added
(Food and Drug Regulations, Table D.03.002)

Note: In the second column of this table, "mandatory" refers to nutrients that must be present in the food at levels specified in the Food and Drug Regulations (FDR). For some mandatory requirements, nutrients may not have to be added to achieve the levels identified in the regulations. "Voluntary" refers to nutrients that may be added to the products listed, also subject to levels specified in the FDR. The third column, "FDR", refers to the sections of the Regulations where nutrient levels and other specific requirements are found.

In addition, Interim Marketing Authorizations (IMA) have been issued by Health Canada to permit the addition of vitamins and minerals to certain foods, as summarized below. The IMA process (FDR B.01.056) bridges the time between the completion of the scientific evaluation supporting certain amendments (e.g. expansion of the list of foods to which certain vitamins and mineral nutrient may be added) and publication of the approved amendments in the Canada Gazette, Part II. The criteria that must be met in order to request an IMA are detailed FDR B.01.056.

Annex 3: The Measurement of Nutrients in Canadian Foods*

The following guidelines are intended for use in the measurement of nutrient levels in marketed foods for the purposes of extending the Canadian Nutrient File or obtaining data to support nutrition labelling. In most instances, nutrients are distributed unevenly in foods and careful planning is needed to obtain a representative value. In the design of a suitable procedure, each commodity must be considered individually and some flexibility in approach is necessary. In general, however, adoption of the following basic guidelines should yield results that are reliable enough for use in tables of food composition. Use of the guidelines in preparation for nutrition labelling will reduce the risk of later failure to pass tests for compliance.

1) All major sources of variation should be considered in the design of the sampling plan. Some of the many factors that can affect nutrient values are the specificity of the food description, season and geographic location of the collection of raw ingredients, processing methods, composition of mixtures, use of different cultivars and length of storage. Such factors are of varying importance in different foods. Sometimes the design of a proper sampling plan will require preliminary analytical tests.

2) Each sample should be a substantial composite to ensure that measurements will be representative. A composite of 12 containers or units is recommended for most products. Composites should be thoroughly blended before removal of a test portion for analysis. Special precautions and equipment may be necessary to avoid destruction of sensitive nutrients.

3) The number of blended composite samples required to obtain reliable data will depend upon the expected and observed variations in the measurements. At least five composites should be examined before accepting results for any application.

4) The methods of analysis results should be validated for the food. Methods designed for the examination of nutrients in concentrates or drugs are not usually applicable to foods. Sometimes several methods or modifications to published methods may appear suitable but only those that have been or can be demonstrated to be acceptable alternatives to procedures used nationally or internationally are worth consideration. Collaboratively-studied methods for nutrients are described in Official Methods of Analysis of the Association of Official Analytical Chemists, 16th Edition, AOAC, Arlington, Virginia, U.S.A. 22209.

Other suitable procedures, which lack validation by collaborative assays but are generally recognized as acceptable, are described in:

Methods for the Determination of Vitamins in Food. Recommended by COST 91. Edited by G. Brubacher, W. Muller-Mulot and D.A.T. Southgate, Elsevier:London 1985.

Methods of Vitamin Assay, 4th Edition (Association of Vitamin Chemists). Edited by J. Augustin, B.P. Klein, D.A. Becker & P. B. Venugopal. Wiley:New York 1985.

5) The analytical work should be performed by experienced analysts in a laboratory in which there is an established system of quality assurance. If the analytical work is undertaken in the laboratory of the producer, the methods of analysis should be tested before the project is commenced and the performance of the analysts should be verified using check samples that have been examined elsewhere. If analysis is performed in academic or research institutions, equivalent systems of quality assurance should exist, and the work must be uniform; data obtained during training of students or research on methodology may not be acceptable.

6) The final report must include complete information concerning the identity of the food, the reliability of the analysis and the variability encountered in the results. The description of the food should correspond exactly with the design of the sampling plan, indicating, for example, restrictions to seasons or varieties. A full name should be provided, and if canned or packaged goods are involved, more specific information concerning identification including brand names, codes and dates of production. The method of analysis should be unambiguously identified, together with the laboratory and analyst or responsible manager. The report must include individual results for all composites; a single averaged value is not acceptable. In addition, the variation in replicate analyses of individual composites may be reported but this should be clearly distinguished from variation between composites and should always include the number of replicates and either the standard error or the standard deviation. Information concerning quality assurance procedures can greatly increase the likelihood of acceptance of data in cases of dispute.

* From: Thompson, J.W. and G. Jarvis, 1990. Compliance Evaluation in Nutrition Labelling: Information for Producers and Manufacturers, Health Protection Branch, Health Canada (with minor revision, 1995).

Glossary

Sample
Portion selected in some manner from a larger quantity of food with the intention that it should be representative. The term implies the existence of uncertainty, or a "sampling error". The term "sample" should be distinguished from the material actually consumed during analysis, which is better described as a "test portion".

Blended Composite Sample
A collection of one or more increments or units from a lot combined and mixed to homogeneity.

Sampling Plan
Predetermined procedure for the selection, withdrawal, preservation, transportation and preparation of the portions to be removed from a lot as samples. In a statistical context, the sampling plan is characterized by the sample size (number of items taken) and the criteria of acceptance.

Marketed Foods
All forms of processed, packaged and raw foods produced for sale in Canada. Data concerning exotic foods with no or few commercial uses are sometimes accepted for use in food tables when collected by methods not complying with the guidelines.