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| 1 | AN ACT concerning health. | |||||||||||||||||||
| 2 | Be it enacted by the People of the State of Illinois, | |||||||||||||||||||
| 3 | represented in the General Assembly: | |||||||||||||||||||
| 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 heavy metals. | |||||||||||||||||||
| 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. | |||||||||||||||||||
| 12 | "Baby food" does not include infant formula as defined in | |||||||||||||||||||
| 13 | Section 2.28. | |||||||||||||||||||
| 14 | "Manufacturer" includes a food manufacturer, food | |||||||||||||||||||
| 15 | processor, and food packer. | |||||||||||||||||||
| 16 | "Production aggregate" means a quantity of product that is | |||||||||||||||||||
| 17 | intended to have uniform composition, character, and quality | |||||||||||||||||||
| 18 | and is produced according to a master manufacturing order. | |||||||||||||||||||
| 19 | "Proficient laboratory" means a laboratory that: | |||||||||||||||||||
| 20 | (1) is accredited under the standards of the | |||||||||||||||||||
| 21 | International Organization for | |||||||||||||||||||
| 22 | Standardization/International Electrotechnical Commission | |||||||||||||||||||
| 23 | 17025:2017; | |||||||||||||||||||
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| 1 | (2) uses an analytical method at least as sensitive as | ||||||
| 2 | the analytical method described in Section 4.7 of the U.S. | ||||||
| 3 | Food and Drug Administration Elemental Analysis Manual for | ||||||
| 4 | Food and Related Products; and | ||||||
| 5 | (3) demonstrates proficiency in quantifying each toxic | ||||||
| 6 | heavy metal to at least 6 micrograms of the toxic heavy | ||||||
| 7 | metal to kilogram of food through an independent | ||||||
| 8 | proficiency test by achieving a Z-Score that is less than | ||||||
| 9 | or equal to plus or minus 2. | ||||||
| 10 | "QR code" means a machine-readable code, consisting of an | ||||||
| 11 | array of squares, used for storing data that allows a user to | ||||||
| 12 | access a webpage. | ||||||
| 13 | "Representative sample" means a sample that consists of a | ||||||
| 14 | number of units that are drawn based on rational criteria, | ||||||
| 15 | such as random sampling, and intended to ensure that the | ||||||
| 16 | sample accurately portrays the material being sampled. | ||||||
| 17 | "Toxic heavy metal" means arsenic, cadmium, lead, or | ||||||
| 18 | mercury. | ||||||
| 19 | (b) On and after January 1, 2026, a person may not sell, | ||||||
| 20 | distribute, or offer for sale baby food in the State that | ||||||
| 21 | contains toxic heavy metals that exceed the limits established | ||||||
| 22 | by the U.S. Food and Drug Administration. | ||||||
| 23 | (c) Beginning January 1, 2026, each manufacturer of baby | ||||||
| 24 | food shall test a representative sample of each production | ||||||
| 25 | aggregate of the manufacturer's final baby food product for | ||||||
| 26 | each toxic heavy metal. | ||||||
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| 1 | The testing required under this subsection shall be | ||||||
| 2 | conducted by a proficient laboratory at least once per month. | ||||||
| 3 | A manufacturer may test the final baby food product in | ||||||
| 4 | accordance with this subsection before packaging individual | ||||||
| 5 | units of baby food for sale or distribution. | ||||||
| 6 | (d) On the request of the Department of Public Health, a | ||||||
| 7 | manufacturer of baby food shall provide the results of the | ||||||
| 8 | testing conducted under subsection (c) to an authorized agent | ||||||
| 9 | of the Department of Public Health. | ||||||
| 10 | (e) Beginning January 1, 2027, each manufacturer of baby | ||||||
| 11 | food shall: | ||||||
| 12 | (1) make the following information publicly available | ||||||
| 13 | on the manufacturer's website for each baby food product | ||||||
| 14 | sold, manufactured, delivered, held, or offered for sale | ||||||
| 15 | in the State: | ||||||
| 16 | (A) the name and level of each toxic heavy metal | ||||||
| 17 | present in the final baby food product as determined | ||||||
| 18 | by the testing conducted under subsection (c); | ||||||
| 19 | (B) sufficient information, such as the product | ||||||
| 20 | name, universal product code, or lot or batch number, | ||||||
| 21 | to enable the consumer to identify the final baby food | ||||||
| 22 | products; and | ||||||
| 23 | (C) a link to the U.S. Food and Drug | ||||||
| 24 | Administration's website that includes the most recent | ||||||
| 25 | U.S. Food and Drug Administration guidance and | ||||||
| 26 | information about the health effects of the toxic | ||||||
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| 1 | heavy metals on children; and | ||||||
| 2 | (2) if the baby food is tested for a toxic heavy metal | ||||||
| 3 | subject to an action level, regulatory limit, or tolerance | ||||||
| 4 | established by the U.S. Food and Drug Administration under | ||||||
| 5 | 21 CFR 109, include on the baby food product label: | ||||||
| 6 | (A) the following statement, "For information | ||||||
| 7 | about the toxic heavy metal testing on this product, | ||||||
| 8 | scan the Quick Response (QR) Code"; and | ||||||
| 9 | (B) a QR code or other machine-readable code that | ||||||
| 10 | allows consumers to access the following information | ||||||
| 11 | on the manufacturer's website on the baby food | ||||||
| 12 | product's information page: | ||||||
| 13 | (i) the test results for the toxic heavy | ||||||
| 14 | metals; and | ||||||
| 15 | (ii) a link to the webpage on the U.S. Food and | ||||||
| 16 | Drug Administration website that includes the most | ||||||
| 17 | recent guidance and information about the health | ||||||
| 18 | effects of the toxic heavy metal on children. | ||||||
| 19 | (f) If a consumer believes, based on information gathered | ||||||
| 20 | through the use of the QR code or other machine-readable code | ||||||
| 21 | included on the baby food product label, that baby food is | ||||||
| 22 | being sold in the State with toxic heavy metals that exceed | ||||||
| 23 | limits established by the U.S. Food and Drug Administration, | ||||||
| 24 | the consumer may report that baby food to the Department of | ||||||
| 25 | Public Health. The Department of Public Health shall adopt | ||||||
| 26 | rules to implement a system for consumer reporting of baby | ||||||
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| 1 | foods under this subsection. | ||||||