Nutrition Labelling Compliance Test
Appendix 1 - International Context

1. Codex Alimentarius

Codex Guidelines on Nutrition Labelling

The Codex Guidelines on Nutrition Labelling PDF (117 kb) ( set out the nutrients to be declared where nutrition labelling is applied. Dietary fibre, sugars and polyunsaturated fatty acids are defined and the calculation of energy and protein described. Available carbohydrate is declared as "carbohydrates".

The Codex Guidelines recommend that tolerance limits be set in relation to public health concerns, shelf-life, accuracy of analysis, processing variability and inherent lability and variability of the nutrient in the product, and according to whether the nutrient has been added or is naturally occurring in the product.

The guidelines also recommend weighted average values derived from data specifically obtained from analyses of products which are representative of the product being labelled.

Finally, the Guidelines state that, in those cases where a product is subject to a Codex standard, requirements for tolerances for nutrient declaration established by the standard should take precedence over these guidelines.

The 1989 Codex report on laboratory analysis and sampling of nutrients supported the testing of composite samples using AOAC methods.

Codex Methods of Analysis and Sampling

The FAO/WHO Codex Alimentarius Recommended Methods of Analysis and Sampling, Codex Standard 234, ( includes methods for the determination of carbohydrate, protein, fat, polyunsaturated fat, saturated fat and many other nutrients, listed under the Guidelines on Nutrition Labelling or Foods For Special Dietary Use. The Codex Sampling Plan for Prepackaged Foods, 1969, is intended to cover quality requirements in Codex commodity standards. Sample numbers are based on the size of the lot. An Acceptable Quality Level (AQL) would be used for rejecting an inspected lot. For many codex commodity standards the sampling plan would accept a lot that has 6.5% defective units approximately 95% of the time.

2. Australia and New Zealand:

The Food Standards Code of Food Standards Australia New Zealand (FSANZ) provides for the declaration of an average quantity of a substance that may be determined from one or more of the following:

(a) the manufacturer's analysis of the food;

(b) calculation from the actual or average quantity of nutrients in the ingredients used;

(c) calculation from generally accepted data

In addition ANZFA provides a Nutrition Panel Calculator to allow manufacturers to calculate nutrients using the Australian Food and Nutrient Database. The Australian Food and Nutrient Database is supported by ANZFA and contains nutrient data on 4,500 foods sold in Australia.

3. European Union - European Commission

The Council Directive on nutrition labelling for foodstuffs of the Council of European Communities 90/496/EEC includes the following provisions:

"Average value" means the value which best represents the amount of the nutrient which a given food contains, and reflects allowances for seasonal variability, patterns of consumption and other factors which may cause the actual value to vary.

The declared values shall, according to the individual case, be average values based on:

(a) the manufacturer's analysis of the food;

(b) a calculation from the known or actual average value of the ingredients used;

(c) a calculation from generally established and accepted data.

The rules for implementing paragraph (a) with regard to differences between declared values and those established in the course of official checks are decided upon in accordance with a procedure laid down in the Directive.

4. The United States of America

The United States (US) Food and Drug Administration (FDA) and Department of Agriculture (USDA) published final rules codifying the Nutrition Labelling and Education Act (NLEA) in 1993. These rules include compliance provisions for determining accuracy of declared nutrients and setting out methodology for sampling, analysis and tolerances. They also included provisions for use of databases.

The sample for nutrient analysis must consist of a composite of a minimum of 12 consumer units (FDA) or a composite of a minimum of 6 consumer units or the average of 6 individual units (USDA) taken one from each of 12 different randomly chosen shipping cases, to be representative of a production lot.

Methods of analysis are:

  • FDA - the appropriate method in the official methods of AOAC International;
  • USDA - the appropriate USDA method in the Chemistry Laboratory Guidebook or if no method exists in the Guidebook, the appropriate AOAC method.

For Class I nutrients, i.e. added vitamin, mineral, protein, dietary fibre or potassium in fortified or fabricated foods, the nutrient content of the composite sample must be at least equal to the value declared on the label.

For Class II, i.e., naturally occurring (indigenous) nutrients, Class II vitamin, mineral, protein, total carbohydrate, other carbohydrate, polyunsaturated and mono-unsaturated fat or potassium. The nutrient content of the composite must be least equal to 80% of the value for that nutrient declared on the label. The nutrient content of a food with a label declaration of calories, sugars, total fat, saturated fat, cholesterol, or sodium shall not be greater than 20% in excess of the value for that nutrient declared on the label. In addition, the provisions state that no regulatory action will be based on a determination of a nutrient value that falls beyond these levels by an amount less than the variability generally recognized for the analytical method used in that food at the level involved and in the case of USDA, less than the inherent nutrient variation in the product.

The provisions state that reasonable excesses of a vitamin, mineral, protein, total carbohydrate, dietary fibre, other carbohydrate, polyunsaturated or mono-unsaturated fat or potassium over labelled amounts are acceptable within good manufacturing practice. Reasonable deficiencies of calories, sugars, total fat, saturated fat, cholesterol, or sodium under labelled amounts are acceptable within good manufacturing practices.

Provisions also allow for the use of a nutrient database as follows: in the case of FDA, compliance with the above provisions may be provided by use of an FDA approved database that has been computed following FDA guideline procedures and where food samples have been handled in accordance with current good manufacturing practice to prevent nutrient loss; in the case of USDA, for single ingredient raw meat and poultry (including ground beef) products, nutrition labelling is based on the most current representative database values (average values) contained in USDA's National Nutrient Data Bank.

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