Document ID: chunk:federal_register_of_legislation:F2024L01153:body:0:p22
Version: federal_register_of_legislation:F2024L01153
Segment Type: other
Provision Reference: 
Character Range: 60569–63292

*used as a nutritive substance in that product; and
                   (ii) added to that product to achieve that product's intended medical purpose; and
               (d)  any of the following information if declaration of that information is necessary for use of the special medical purpose product for infants for its intended medical purpose:
                   (i) information on sub-group nutrients of protein, fat and/or carbohydrate;
                   (ii) osmolality and osmolarity;
                   (iii)  acid-base balance.
            (2) A reference in subsection (1) to the intended medical purpose is to the intended medical purpose as described in the statement required by paragraph 2.9.1—50(c).

            (3) The label that is required for a special medical purpose product for infants may state information relating to the source or sources of protein in that product.

           2.9.1—54 Labelling requirements—special medical purpose product for infants in inner package

            (1) The label on an *inner package that contains 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) any declaration that is required by section 1.2.3—4;
               (d) date marking information (see section 2.9.1—52).

            (2) The label must comply with section 1.2.1—24 of Standard 1.2.1.

            (3) To avoid doubt, this section continues to apply to the label on the *inner package if a *responsible institution subsequently supplies the inner package to a patient or resident of the responsible institution.

           2.9.1—55 Labelling requirements—special medical purpose product for infants in transportation outer

            (1) If packages of a special medical purpose product for infants are contained in a transportation outer, the information specified in subsection (2) must, in accordance with the provisions indicated, be:

               (a) contained in a label on the transportation outer; or
               (b) contained in a label on a package of the food for sale, and clearly discernible through the transportation outer.

            (2) For subsection (1), the information is:

               (a) a name or description sufficient to indicate the true nature of the food (see section 1.2.2—2); and
               (b) lot identification (see section 1.2.2—3); and
               (c) unless it is provided in accompanying documentation—the name and address of the *supplier (see section 1.2.2—4).