Document ID: chunk:federal_register_of_legislation:F2024L01153:body:0:p21
Version: federal_register_of_legislation:F2024L01153
Segment Type: other
Provision Reference: 
Character Range: 57512–60846

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 in paragraph (c);
               (e) if the product has been formulated for a specific age group—a statement to the effect that the product is intended for persons within the specified age group;
               (f) a statement indicating whether or not the product is suitable for use as a sole source of nutrition;
               (g) if the product is represented as being suitable for use as a sole source of nutrition:
                   (i) a statement to the effect that the product is not for parenteral use; and
                   (ii) if the product has been modified to vary from the compositional requirement of this Division such that the content of one or more nutrients falls short of the prescribed minimum, or exceeds the prescribed maximum (if applicable):
                      (A) unless provided in other documentation about the product—a statement indicating the nutrient or nutrients which have been modified; and
                      (B) unless provided in other documentation about the product—a 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