Document ID: chunk:federal_register_of_legislation:F2024L01153:body:0:p20
Version: federal_register_of_legislation:F2024L01153
Segment Type: other
Provision Reference: 
Character Range: 54517–57794

an application Act.
2.9.1—47 Permitted lactose free claim
  A claim that a special medical purpose product for infants is lactose free may be made if that special medical purpose product for infants contains no detectable lactose.

           2.9.1—48 Labelling and related requirements

            (1) This section applies to a food for sale that is a special medical purpose product for infants.

            (2) If the food for sale is in a package, it is required to *bear a label that complies with section 2.9.1—49.

            (3) If the food for sale is in an *inner package:

               (a) the inner package is required to *bear a label that complies with section 2.9.1—54; and
               (b) there is no labelling requirement under this Code for any other packaging associated with the food for sale.

            (4) If the food for sale is in a *transportation outer:

               (a) the transportation outer or package containing the food for sale is required to *bear a label that complies with section 2.9.1—55; and
               (b) there is no labelling requirement under this Code for any other packaging associated with the food for sale.

           2.9.1—49 Mandatory labelling information

            (1) The label that is required for a special medical purpose product for infants must state the following information in accordance with the provision indicated:

               (a) a name or description sufficient to indicate the true nature of the food (see section 1.2.2—2);
               (b) lot identification (see section 1.2.2—3);
               (c) if the sale of the product for sale is one to which Division 2 or Division 3 of Standard 1.2.1 applies:
                   (i)  information relating to *foods produced using gene technology (see section 1.5.2—4); and
                   (ii) information relating to irradiated food (see section 1.5.3—9);
               (d) any mandatory statements and declarations (see section 2.9.1—50);
               (e) information relating to ingredients (see section 2.9.1—51);
               (f) date marking information (see section 2.9.1—52);
               (g) directions for the preparation, use or storage of the product, if the product is of such a nature to require such directions for health or safety reasons;
               (h) nutrition information (see section 2.9.1—53).

            (2) The label that is required for a special medical purpose product for infants must comply with section 1.2.1—24 of Standard 1.2.1.

           2.9.1—50 Mandatory statements and declarations— special medical purpose product for infants

             For paragraph 2.9.1—49(1)(d), the following statements are required:

               (a) a statement to the effect that the product must be used under medical supervision;
               (b) a statement indicating, if applicable, any precautions and contraindications associated with consumption of the product;
               (c) a statement indicating the medical purpose of the product, which may include a disease, disorder or medical condition for which the product has been formulated;
               (d) a statement describing the properties or characteristics which make the product appropriate for the medical purpose indicated