Document ID: chunk:federal_register_of_legislation:F2024C00897:body:0:p21
Version: federal_register_of_legislation:F2024C00897
Segment Type: other
Provision Reference: 
Character Range: 57702–61171

statement indicating whether each modified nutrient has been increased, decreased, or eliminated from the product, as appropriate; and
               (h) the declarations required by section 1.2.3—4.

           2.9.1—51 Information relating to ingredients—special medical purpose product for infants

             For paragraph 2.9.1—49(1)(e), the information relating to ingredients is:

               (a) a statement of ingredients; or
               (b) information that complies with Articles 18, 19 and 20 of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers; or
               (c) information that complies with 21 CFR § 101.4.

           2.9.1—52 Date marking information—special medical purpose product for infants

            (1) For paragraph 2.9.1—49(1)(f), the required date marking information is date marking information in accordance with Standard 1.2.5.

            (2) Despite subsection (1), for subparagraph 1.2.5—5(2)(a)(ii), the words 'Expiry Date', or similar words, may be used on the label.

           2.9.1—53 Nutrition information—special medical purpose product for infants

            (1) For paragraph 2.9.1—49(1)(h), the nutrition information required for a special medical purpose product for infants is the following, expressed per given amount of the product:

               (a) the minimum or *average energy content; and
               (b) the minimum amount or *average quantity of:
                   (i) protein, fat and carbohydrate; and
                   (ii) any vitamin, mineral or electrolyte that has been *used as a nutritive substance in the product; and
 (c) any other substance:
                   (i) *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