Draft – Information Document (Standardized template)
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Notice to the reader
The Minister of Health is proposing to make a class exemption order for the exceptional importation and sale of certain foods for a special dietary purpose to mitigate a shortage or risk of a shortage.
As a condition under Part 1 of the proposed Order, a document with core labelling information in both English and French must be made available to purchasers or consumers when a product is sold pursuant to the Order. On this page is the proposed standardized template for this document.
It is recommended that you download the alternative format of the template to see it in the format it is intended to be made available to purchasers and consumers.
Information document
Notice to the reader
The product described in this document is being exceptionally sold in Canada pursuant to [Enter title of the ministerial order].
As the label on the product does not comply with the requirements of the Food and Drug Regulations, the following document provides the information needed for the safe use of the product.
In accordance with [Enter section] of the Exemption Order, a physical copy of this document must be made available to the purchaser or consumer of the product when it is sold.
Questions about the use of this product? Ask your health care provider or pharmacist.
Brand name and product name:
Instructions: provide the brand name and product name in bold and in a 12-point font size. You may also include an image of the product.
The special dietary purpose of the product:
Instructions: provide the special dietary purpose of the food in bold and in a 12-point font size. The description of the special dietary purpose must include an indication of the food's class (infant formula, human milk fortifier, or formulated liquid diet) and its indications for use.
Examples:
- "Infant formula with iron (milk-based/ready to serve)"
- "Designed for premature infants as a nutritional supplement (human milk fortifier) to be added to human milk"
- "Nutritionally complete liquid formula (formulated liquid diet) for individuals with renal failure"
For infant formula and human milk fortifiers: guidance on appropriate indications for use is available in section 4.13 of the Guide for the preparation of infant formula and human milk fortifier premarket submissions.
Manufacturer and contact information:
Instructions: include the name and contact information (website, mailing address, telephone number, and/or email address) of the product's manufacturer. You may also include the name and contact information of the Canadian importer.
List of ingredients:
Instructions: precede the list with the title 'Ingredients:' in bold; separate the ingredients with either a comma or a bullet point.
Food allergen sources, gluten sources and added sulphites:
Contains:
Instructions: indicate the presence of all food allergen sources, gluten sources and added sulphites that are intentionally added ingredients/components of the food (Eggs; Milk; Mustard; Peanuts; Crustaceans and molluscs; Fish; Sesame seeds; Soy; Sulphites; Tree Nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios and walnuts); Wheat and triticale; and/or Gluten sources (Barley; Oats; Rye; Triticale and Wheat). Note – allergen sources, gluten sources and added sulphites must be noted in this section even if they are highlighted in the List of ingredients. If none, indicate 'n/a'.
May contain:
Instructions: indicate all food allergen sources, gluten sources and added sulphites that may be present due to unavoidable cross-contamination. If none, indicate 'n/a'.
Phenylalanine statement (if aspartame is present in the food):
Instructions: if applicable, include a statement to the effect that the food contains phenylalanine or that aspartame contains phenylalanine. If not applicable, indicate 'n/a'.
Nutritional information:
Instructions: it is highly recommended that the nutritional information be presented in a table format for better readability. Ensure that the units of measure per stated serving for each nutrient are clear and standardized.
| Nutrients | per 100 Calories | Per 100 mL |
|---|---|---|
| Energy | 100 cal | 68 cal |
| Protein | 2.07 g | 1.4 g |
| Fat | 5.4 g | 3.7 g |
| Carbohydrate | 11 g | 7.4 g |
| Vitamins | ||
| Vitamin A | 300 IU | 203 IU |
| Vitamin D | 60 IU | 41 IU |
| Vitamin E | 1.5 IU | 1.0 IU |
| Vitamin K | 8 µg | 5.4 µg |
| Mineral Nutrient | ||
| Calcium | 78 mg | 53 mg |
| Phosphorus | 42 mg | 28 mg |
| Magnesium | 6 mg | 4.1 mg |
| Iron | 1.8 mg | 1.2 mg |
| Zinc | 0.75 mg | 0.51 mg |
| Amino Acids | ||
| Arachidonic acid (ARA) | 18 mg | 12 mg |
Directions for the preparation, use and storage of the product:
Instructions: ensure that directions are clear and concise. The use of bullet points and numbered steps is recommended for better readability.
For infant formula and human milk fortifiers: recommendations on appropriate directions of use are provided in sections 4.12 and 4.13 of the Guide for the preparation of infant formula and human milk fortifier premarket submissions.
For formulated liquid diets: the directions must include a statement that the food is intended to be consumed orally or by tube feeding.
Expiration date of the product:
Instructions: provide the expiration date or directions on where the expiration date may be found on the product and the format of the date, e.g. "see the bottom of the container (dd-mm-yyyy)".
Lot number:
Instructions: Provide the lot number or directions on where the lot number may be found on the product, e.g., "see bottom of the container".