Labelling Requirements for Foods for Special Dietary Use
Nutrition Labelling - Foods for Special Dietary Use

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Formulated liquid diets (definition), meal replacements (definition), nutritional supplements (definition) and foods represented for use in a very low energy diet (definition) have detailed and explicit nutrition and other labelling requirements set out in Division 24 of the Food and Drug Regulations (FDR). Therefore, they are prohibited from using the Nutrition Facts table heading (i.e. "Nutrition Facts", "valeur nutritive" or "valeurs nutritives"). An appropriate heading for nutrition labelling could be anything reasonable, including "Nutrition Information". However, these foods may voluntarily use the Nutrition Facts table format with respect to order of presentation, naming of nutrients, fonts, layout, etc., provided the applicable requirements of Divisions 24 are met. [B.01.401 (4) & (5), FDR].

Compliance of Nutrient Content Declarations

As they are prohibited from using the Nutrition Facts table heading, the Nutrition Labelling Compliance Test is not used to verify the nutrient content declaration on the labels of these products. Instead, the Canadian Food Inspection Agency (CFIA) uses the procedure outlined below.

Methods of Analysis

The nutrient content of products can be measured by using internationally accepted methods of analysis such as the Association of Official Analytical Chemists (AOAC) methodsFootnote 1 or Health Canada acceptable methods. A list of validated laboratory methods and techniques can be found in Appendix 4 – Laboratory Issues of CFIA's Nutritional Labelling Compliance Test.

Tolerances

In order to verify the nutrient content of a product, five sample units are to be drawn at random and analysed as a composite or separately and the results averaged. The size of a sample unit will vary depending upon the nutrient analysed, the methodology used and the food; on average, a 250 g sample is sufficient.

The option of testing a composite sample or testing individual samples is provided to address the cost of analysis. It is the responsibility of industry to determine how best to collect and analyze their products to ensure the accuracy of declared values.

When a claim or Regulation stipulates a minimum value, the lot is deemed to be non-compliant if:

  • the mean or the composite of the five samples is less than the declared value where the declaration is at the minimum; or,
  • the mean or the composite of the five samples is less than 90 percent of the declared value where the declaration is above the minimum; or,
  • any one of the five samples is less than 30 percent of the declared value.

When a claim or Regulation stipulates a maximum value, the lot is deemed to be non-compliant if:

  • the mean or composite of the five samples is greater than the declared value where the declaration is at the maximum; or,
  • the mean or the composite or the five simples is greater than 110 percent of the declared value where the declaration is below the maximum; or,
  • any one of the five samples is greater than 170 percent of the declared value.

However, while sodium is considered an added nutrient in foods for special dietary use, there is no Regulation that stipulates a minimum or maximum value for sodium in these foods. For a lot to be deemed compliant, the reported result must be between 90 to 110 percent of the declared value on the label.

Variance

It is recognized that any declaration of the nutrient content is subject to variance. That is why, when the nutrient content is declared at the stipulated minimum or maximum, that level is established as the tolerance for the product.  If the declaration is below the maximum level or above the minimum level, an additional 10 percent tolerance is applied to the declared value. 

The amount of vitamin, mineral, protein, carbohydrate, starch, dietary fibre, polyunsaturated fatty acids, monounsaturated fatty acids or potassium, may vary over labelled amounts within good manufacturing practices. The amount of energy, sugars, fat, saturated fatty acids, cholesterol or sodium may vary under labelled amounts within good manufacturing practice.

Reasonable overages of the added vitamins and minerals within good manufacturing practice should be present to ensure that the required level of vitamins and minerals are maintained within the expected shelf life of the food.

Foods for Special Dietary Use Rounding Rules

  • Calories are to be rounded to the nearest whole number. Kilojoules (kJ) should be rounded to the nearest 10 kJ for energy values of 10 kJ or more, and to the nearest kJ for energy values below 10 kJ.
  • Protein and amino acids are to be rounded to the nearest whole gram for amounts of 10 g or more and to the nearest tenth of a gram for amounts less than 10 g. If no protein is present, its absence is to be indicated by a zero.
  • Fat and fatty acids are to be rounded to the nearest whole number for quantities of 10 g or more, and to the nearest tenth of a gram for quantities less than 10 g. Cholesterol should be rounded to the nearest milligram (i.e., 0.4 mg cholesterol would be declared as 0 mg, 0.6 mg cholesterol would be declared as 1 mg). If no fat or fat components are present, their absence should be indicated by a zero.
  • Carbohydrates and sweeteners are to be rounded to the nearest whole number for quantities of 10 g or more, and to the nearest tenth of a gram for quantities less than 10 g. If no carbohydrate is present, its absence should be indicated by a zero.
  • Sodium and potassium are to be rounded to the nearest whole number.
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