Imported and Manufactured Food Program Revised Analytical Tolerances for the Assessment of Enriched Flour Samples

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February 2012

Issue Summary:

In response to research findings presented by the Canadian National Millers Association (CNMA) to both the Canadian Food Inspection Agency (CFIA) and Health Canada, the analytical tolerances currently employed by the Agency to assess the nutritional compliance of enriched flour will be increased to reflect current milling fortification practices. The revised assessment tolerances as described below will come into effect April 1, 2012.

Background:

The standard for flour as stated in the Food and Drug Regulations (FDR) [B.13.001] requires the mandatory addition of five nutrients (thiamine, riboflavin, niacin, folic acid and iron) and allows for optional addition of four nutrients (vitamin B6, pantothenic acid, magnesium and calcium) at set levels per 100g of flour.

In early 2010, the CNMA presented research findings to Health Canada’s Food Directorate which demonstrated that the fortification levels for enriched flour as they are currently prescribed in B.13.001 of the FDR, cannot consistently be achieved by Canadian millers through current industry fortification practices. In response to these findings, it was agreed that the tolerance utilized by the Agency to assess the compliance of flour samples should be increased.

Decision:

Health Canada has confirmed that a tolerance of no less than 80% and no more than 175% of all nutrient values currently specified in the flour standard would be acceptable when assessing enriched flour samples. Health Canada has determined that these fortification values will not pose a risk to the Canadian consumer, will meet the policy intent for the fortification of food, will comply with applicable health and safety requirements and will be consistently achievable based on current industry practices. However, it should be noted that this decision is subject to reassessment and adjustment as deemed necessary by Health Canada, or as advances in nutritional food safety and milling practices become available.

Guidance and Application:

When the revised analytical tolerance range of 80%-175% is applied to the nutrient values specified in the standard for flour (B.13.001), the following levels of enrichment per 100 grams of flour will be permitted:
Nutrient Permitted Nutrient Values (mg) Nutrient Values Permitted with Increased Tolerance (mg)
Thiamine 0.64 0.51 - 1.12
Riboflavin 0.40 0.32 - 0.70
Niacin or Niacinamide 5.30 4.24 - 9.28
Folic Acid 0.15 0.12 - 0.26
Iron 4.4 3.52 - 7.70
Vitamin B6 0.31 0.25 - 0.54
D-pantothenic Acid 1.3 1.04 - 2.28
Magnesium 190 152 – 333
Calcium 140 112 - 245

Assessment Considerations:

The CFIA will apply the following assessment criteria to flour samples analysed for nutritional adequacy:

  • Satisfactory: 80%-175% of the regulatory level
  • Unsatisfactory: less than 80% of the regulatory level, or more than 175% of the regulatory level
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