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Sen. Laura Fine
Filed: 2/26/2025
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| 1 | | AMENDMENT TO SENATE BILL 73
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| 2 | | AMENDMENT NO. ______. Amend Senate Bill 73 by replacing |
| 3 | | everything after the enacting clause with the following: |
| 4 | | "Section 5. The Illinois Food, Drug and Cosmetic Act is |
| 5 | | amended by adding Section 11.7 as follows: |
| 6 | | (410 ILCS 620/11.7 new) |
| 7 | | Sec. 11.7. Baby foods; toxic elements. |
| 8 | | (a) In this Section: |
| 9 | | "Baby food" means food packaged in a jar, pouch, tub, or |
| 10 | | box sold specifically for babies and children under the age of |
| 11 | | 2 years old. "Baby food" does not include infant formula as |
| 12 | | defined in Section 2.28. |
| 13 | | "Final baby food product" means the finished product of |
| 14 | | baby food with a unique universal product code (UPC). "Final |
| 15 | | baby food product" does not include the individual ingredients |
| 16 | | that are in baby food. |
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| 1 | | "Manufacturer" includes a food manufacturer, food |
| 2 | | processor, and food packer. |
| 3 | | "Product label" means a display of written, printed, or |
| 4 | | graphic material that is affixed to a product or the product's |
| 5 | | immediate container. |
| 6 | | "Product shelf life" means the time, measured in number of |
| 7 | | months, between the date of manufacture and the date of |
| 8 | | expiration for a final baby food product. |
| 9 | | "Production aggregate" means a quantity of product that is |
| 10 | | intended to have uniform composition, character, and quality |
| 11 | | and is produced according to a master manufacturing order. |
| 12 | | "Proficient laboratory" means a laboratory that: |
| 13 | | (1) is accredited under the standards of the |
| 14 | | International Organization for |
| 15 | | Standardization/International Electrotechnical Commission |
| 16 | | 17025:2017 regarding the general requirements for the |
| 17 | | competence of testing and calibration laboratories; |
| 18 | | (2) uses an analytical method at least as sensitive as |
| 19 | | the analytical method described in Section 4.7 of the U.S. |
| 20 | | Food and Drug Administration Elemental Analysis Manual for |
| 21 | | Food and Related Products; and |
| 22 | | (3) demonstrates, when using an independent |
| 23 | | proficiency test, the achievement of a z-score within the |
| 24 | | range of plus or minus 2 in quantifying each toxic element |
| 25 | | to at least 6 micrograms of the toxic element per kilogram |
| 26 | | of food. |
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| 1 | | "QR code" means a machine-readable code, consisting of an |
| 2 | | array of squares, used for storing data that allows a user to |
| 3 | | access a webpage. |
| 4 | | "Representative sample" means a sample that consists of a |
| 5 | | number of units that are drawn based on rational criteria, |
| 6 | | such as random sampling, and intended to ensure that the |
| 7 | | sample accurately portrays the material being sampled. |
| 8 | | "Toxic element" means arsenic, cadmium, lead, or mercury. |
| 9 | | (b) No person or entity shall sell or manufacture, |
| 10 | | deliver, or hold or offer for sale in this State any baby food |
| 11 | | that does not comply with the requirements of this Section. |
| 12 | | (c) Each manufacturer of baby food shall test a |
| 13 | | representative sample of each production aggregate of the |
| 14 | | manufacturer's final baby food product for toxic elements at a |
| 15 | | proficient laboratory. |
| 16 | | The testing required under this subsection shall be |
| 17 | | conducted by a proficient laboratory at least once per month. |
| 18 | | A manufacturer may test the final baby food product in |
| 19 | | accordance with this subsection before packaging individual |
| 20 | | units of baby food for sale or distribution. |
| 21 | | (d) Upon the request of the Department of Public Health, a |
| 22 | | manufacturer of baby food shall provide the results of the |
| 23 | | testing conducted under subsection (c) to an authorized agent |
| 24 | | of the Department of Public Health. |
| 25 | | (e) Beginning January 1, 2027, for final baby food |
| 26 | | products sold, manufactured, delivered, or held or offered for |
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| 1 | | sale in this State, each manufacturer of baby food shall |
| 2 | | disclose product information to consumers consistent with the |
| 3 | | following: |
| 4 | | (1) The manufacturer shall make publicly available on |
| 5 | | the manufacturer's website for each final baby food |
| 6 | | product that it manufactures and for the duration of the |
| 7 | | product shelf life for the final baby food product plus |
| 8 | | one month: |
| 9 | | (A) the name and level of each toxic element |
| 10 | | present in each production aggregate of a final baby |
| 11 | | food product as determined by the testing conducted |
| 12 | | under subsection (c); and |
| 13 | | (B) descriptive information, including, but not |
| 14 | | limited to, the product's name, UPC, size, lot |
| 15 | | numbers, or batch numbers, to enable accurate |
| 16 | | identification of the final baby food product by |
| 17 | | consumers. |
| 18 | | (2) If a product is tested for a certain toxic element |
| 19 | | subject to an action level, regulatory limit, or tolerance |
| 20 | | established by the U.S. Food and Drug Administration under |
| 21 | | 21 CFR 109, the manufacturer shall also include on the |
| 22 | | baby food product label: |
| 23 | | (A) a statement that reads: "For information about |
| 24 | | the toxic element testing on this product, scan the |
| 25 | | Quick Response (QR) Code."; and |
| 26 | | (B) a QR code or other machine-readable code that |
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| 1 | | allows consumers to access the following information |
| 2 | | on the manufacturer's website on the final baby food |
| 3 | | product's information page: |
| 4 | | (i) the test results for the toxic elements; |
| 5 | | and |
| 6 | | (ii) a link to the webpage on the U.S. Food and |
| 7 | | Drug Administration website that includes the most |
| 8 | | recent guidance and information about the health |
| 9 | | effects of the toxic element on children. |
| 10 | | (f) The Department of Public Health shall adopt rules to |
| 11 | | implement a system for consumer reporting of baby foods under |
| 12 | | this subsection.". |